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Methadone Dispersible Tablets


Pronunciation: METH-uh-dohn
Generic Name: Methadone
Brand Name: Methadose

Fatal overdose of Methadone Dispersible Tablets are possible if you take more than the recommended dose. Overdose is also possible if you also consume alcohol or other medications that affect your mind or behavior. Because of the risks associated with Methadone Dispersible Tablets, you should only receive it from approved treatment programs. Obtaining it any other way is illegal.


Methadone Dispersible Tablets are used for:

Temporarily treating a narcotic addiction as part of a treatment program. It may also be used for other conditions as determined by your doctor.

Methadone Dispersible Tablets are a synthetic narcotic analgesic with multiple actions similar to those of morphine, including pain relief. It also provides sedation and temporary maintenance treatment of narcotic addiction.

Do NOT use Methadone Dispersible Tablets if: you are allergic to any ingredient in Methadone Dispersible Tablets you have diarrhea due to poisoning, pseudomembranous colitis, or hypercapnia (abnormally increased carbon dioxide tension in your arteries), or are taking sodium oxybate (GHB) you drink alcohol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Methadone Dispersible Tablets:

Some medical conditions may interact with Methadone Dispersible Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have asthma, prostate problems, a brain tumor, heart problems, liver disease, breathing problems, seizures, bowel problems, urination problems, a lesion or increased pressure on the brain, low blood levels of potassium or magnesium, underactive thyroid, anxiety, low blood volume, kidney problems, Addison disease, or suicidal thoughts if you have ever abused drugs, have head trauma, or have had GI tract surgery

Some MEDICINES MAY INTERACT with Methadone Dispersible Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following.

Efavirenz, HIV protease inhibitors (eg, ritonavir), naltrexone, narcotic antagonists (eg, naloxone), nevirapine, pentazocine, risperidone, or St. John's wort because they may decrease Methadone Dispersible Tablets's effectiveness Barbiturate anesthetics (eg, thiopental), cimetidine, ethanol, fluconazole, fluvoxamine, ketorolac, quinolones (eg, ciprofloxacin), or sodium oxybate (GHB) because side effects such as sedation, confusion and slowed breathing may occur Barbiturate anesthetics (eg, thiopental), desipramine, sodium oxybate (GHB), or zidovudine because their actions and the risk of their side effects may be increased by Methadone Dispersible Tablets Mexiletine or nucleoside reverse transcriptase inhibitors (eg, lamivudine) because their effectiveness may be decreased by Methadone Dispersible Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Methadone Dispersible Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Methadone Dispersible Tablets:

Use Methadone Dispersible Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Methadone Dispersible Tablets by mouth with or without food. Methadone Dispersible Tablets must be administered under close medical supervision. Take Methadone Dispersible Tablets on a regular schedule to get the most benefit from it. It is more effective in preventing pain than in treating pain after it occurs. Methadone Dispersible Tablets are for oral use only and must not be injected. If you miss a dose of Methadone Dispersible Tablets and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Methadone Dispersible Tablets.

Important safety information: Methadone Dispersible Tablets may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Methadone Dispersible Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Methadone Dispersible Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Methadone Dispersible Tablets may cause constipation. Constipation may be avoided by using a stool softener or fiber laxative. Tell your doctor or dentist that you take Methadone Dispersible Tablets before you receive any medical or dental care, emergency care, or surgery. Lab tests, including liver function, kidney function, and complete blood count, may be performed while you use Methadone Dispersible Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Methadone Dispersible Tablets with caution in the ELDERLY; they may be more sensitive to its effects. Methadone Dispersible Tablets should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Methadone Dispersible Tablets while you are pregnant. Methadone Dispersible Tablets are found in breast milk. If you are or will be breast-feeding while you use Methadone Dispersible Tablets, check with your doctor. Discuss any possible risks to your baby.

Some people who use Methadone Dispersible Tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Methadone Dispersible Tablets suddenly, you may have WITHDRAWAL symptoms. These may include convulsions, tremor, stomach and muscle cramps, vomiting, and sweating. Do not stop therapy suddenly or change the dosage without asking your doctor. Discuss overuse with your doctor or pharmacist.

Possible side effects of Methadone Dispersible Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; lightheadedness; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive drowsiness; fainting; itching; pounding in the chest; seizures; shortness of breath; slow heartbeat; sweating.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Methadone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold and clammy skin; deep sleep; difficult or slow breathing, especially when lying down; dizziness; drowsiness; lightheadedness; loss of consciousness; low body temperature; pinpoint pupils; shock; shortness of breath; slow heartbeat.

Proper storage of Methadone Dispersible Tablets:

Store Methadone Dispersible Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Methadone Dispersible Tablets out of the reach of children and away from pets.

General information: If you have any questions about Methadone Dispersible Tablets, please talk with your doctor, pharmacist, or other health care provider. Methadone Dispersible Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Methadone Dispersible Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Methadone resources Methadone Side Effects (in more detail)Methadone Use in Pregnancy & BreastfeedingDrug ImagesMethadone Drug InteractionsMethadone Support Group217 Reviews for Methadone - Add your own review/rating Compare Methadone with other medications Opiate WithdrawalPain
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Methadone Hydrochloride Sugar Free 1mg / 1ml Oral Solution (Plastic Packs)


Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution is and what it is used for 2. Before you take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution 3. How to take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution 4. Possible side effects 5. How to store Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution 6. Further information What Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution is and what it is used for

The name of your medicine is Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution (referred to as Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of medicines called Narcotic Analgesics.

Methadone is used:

to treat opioid drug addiction to treat moderate to severe pain Before you take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution Do not take Methadone Solution and tell your doctor if: you are allergic (hypersensitive) to methadone or any other ingredients in this liquid (see section 6 below). An allergic reaction can include a rash, itching or shortness of breath you have severe breathing problems or a history of asthma. You must not use this medicine during an asthma attack. If you give this medicine to yourself (self-administration), wait until the asthma attack has passed and you are fully recovered you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have taken a MAOI medicine in the past two weeks (see ‘Taking other medicines’) you are dependent on any other drugs you are in labour children must not be given this medicine.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking methadone.

Take special care with Methadone Solution

Before you take this medicine, tell your doctor if:

you have liver or kidney problems you have epilepsy you are addicted to alcohol you have or have recently had a head injury you have low thyroid function (hypothyroid) you have problems with your adrenal glands. These are linked to your kidneys you have an enlarged prostate gland you have low blood pressure you are in shock you have a muscle weakness disease called myasthenia gravis you have bowel problems you have a history of irregular heart beat you have a history of heart disease you have a family history of people dying suddenly without cause you have low potassium, sodium or magnesium levels you are pregnant or breast-feeding you are extremely ill or an older person. You may be more sensitive to the medicine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking methadone.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because methadone can affect the way some other medicines work. Also some medicines can affect the way methadone works.

You must not take Methadone Solution:

at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).

Some medicines can increase the risk of heart problems when used with methadone. Talk to your doctor before taking methadone if you are taking:

medicines for heart problems such as verapamil and enalapril medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:

medicines that dull your senses such as medicines for depression (for example, fluvoxamine, fluoxetine), medicines to help you sleep (including anaesthetics) and medicines to calm you down called tranquillisers cimetidine, used to treat stomach ulcers rifampicin, used to treat tuberculosis (TB) medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and primidone medicines that make your urine acidic such as ascorbic acid (vitamin C) narcotic painkillers such as codeine and pentazocine naloxone used to reverse the effects of opioid drugs medicines used to stop opioid drugs working such as naltrexone and buprenorphine medicines used to treat HIV such as nevirapine, efavirenz and nelfinavir. The doctor may have to change the amount of methadone you take whilst on these medicines antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin medicines used to treat fungal infections such as ketoconazole or fluconazole St. John’s Wort - a herbal preparation for depression.

If any of the above apply to you, talk to your doctor before taking Methadone Solution.

Taking Methadone Solution with food and drink

Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can make you feel sleepy and drinking alcohol will make you even more sleepy.

Pregnancy and Breast-feeding talk to your doctor before taking Methadone Solution if you are pregnant or likely to become pregnant take care if you are taking a pregnancy test as the methadone may interfere with the results you should not take this medicine whilst you are in labour do not breast-feed if you are taking Methadone Solution. Driving and using machines

Methadone Solution will severely affect your ability to drive or use machines, whilst taking it and afterwards. You should only start doing these activities again with the permission of your doctor.

Important information about what is in Methadone Solution:

This medicine contains:

methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine. How to take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.

Taking this medicine this medicine contains 1mg of methadone in each 1ml take this medicine by mouth. Adults

For addiction

the starting dose is 10mg to 20mg (10ml to 20ml) each day the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.

For pain

the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours the dose may be changed by your doctor. Older people and very ill people if you have to have repeated doses of this medicine, the doctor may want to monitor you more closely. Children

Children must not take this medicine.

If you take more Methadone Solution than you should

If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you.

If you forget to take Methadone Solution if you forget a dose do not take it. Wait until the next dose is due and take only that amount do not take a double dose (two doses at the same time) to make up for a forgotten dose. If you stop taking Methadone Solution do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal effects your doctor will tell you how to lower the dose gradually.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Methadone can cause side effects although not everybody gets them.

Stop taking this medicine and see a doctor straight away if you have an allergic reaction to Methadone Solution.

An allergic reaction may include:

swelling of your face, lips, tongue or throat or difficulty breathing or swallowing severe itching of your skin with raised lumps. Stop taking this medicine and see a doctor straight away if you have any of the following: heart problems. The signs of this may include changes in the way your heart beats, such as it beating faster or missed heart beats, breathing difficulties and dizziness if your breathing becomes slow and shallow. Keep taking the medicine but tell your doctor straight away if you get any of the following side effects: if you have asthma and it gets worse worsening of the pressure inside your head if you already have this condition following an injury to your brain or brain disease. Tell your doctor if you get any of these side effects: feeling sick (nausea) or being sick (vomiting) constipation sweating a lot more than usual feeling dizzy, particularly when standing up. This may be a sign that you have low blood pressure small pupils breast growth and production of breast milk difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle spasms dry mouth, eyes or nose, facial flushing feeling drowsy, confused or restless changes in your mood, feeling “high” or over excited seeing or hearing things that are not there (hallucinations) headache, rashes low body heat (hypothermia) lower sexual urge or desire painful periods or lack of periods.

You may notice that some of the side effects become less severe with time as you get used to the methadone.

When taken for a long period of time, it is possible that you may become dependent on methadone solution.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution Keep out of the reach and sight of children Store below 25°C. Protect from light Do not use after the expiry date (month, year) stated on the label and carton Use within 1 month of opening If it is out of date or you no longer want it, take it back to the pharmacy Do not use Methadone Solution if you notice anything wrong with the medicine. Talk to your pharmacist Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Further information What Methadone Solution contains The active ingredient is methadone hydrochloride The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), caramel (E150), liquid maltitol (E965), patent blue (E131) and purified water. What Methadone Solution looks like and contents of the pack A green solution.

It is available in plastic bottles of 2500ml and 5000ml. Other pack sizes are available.

Marketing Authorisation Holder and Manufacturer Rosemont Pharmaceuticals Ltd. Yorkdale Industrial Park Braithwaite Street Leeds LS11 9XE UK

This leaflet was last approved in December 2009

P00491


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Methadone Hydrochloride Sugar Free 1mg / 1ml Oral Solution (Glass Packs)


Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution is and what it is used for 2. Before you take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution 3. How to take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution 4. Possible side effects 5. How to store Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution 6. Further information What Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution is and what it is used for

The name of your medicine is Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution (referred to as Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of medicines called Narcotic Analgesics.

Methadone is used:

to treat opioid drug addiction to treat moderate to severe pain Before you take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution Do not take Methadone Solution and tell your doctor if: you are allergic (hypersensitive) to methadone or any other ingredients in this liquid (see section 6 below). An allergic reaction can include a rash, itching or shortness of breath you have severe breathing problems or a history of asthma. You must not use this medicine during an asthma attack. If you give this medicine to yourself (self-administration), wait until the asthma attack has passed and you are fully recovered you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have taken a MAOI medicine in the past two weeks (see ‘Taking other medicines’) you are dependent on any other drugs you are in labour children must not be given this medicine.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking methadone.

Take special care with Methadone Solution

Before you take this medicine, tell your doctor if:

you have liver or kidney problems you have epilepsy you are addicted to alcohol you have or have recently had a head injury you have low thyroid function (hypothyroid) you have problems with your adrenal glands. These are linked to your kidneys you have an enlarged prostate gland you have low blood pressure you are in shock you have a muscle weakness disease called myasthenia gravis you have bowel problems you have a history of irregular heart beat you have a history of heart disease you have a family history of people dying suddenly without cause you have low potassium, sodium or magnesium levels you are pregnant or breast-feeding you are extremely ill or an older person. You may be more sensitive to the medicine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking methadone.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because methadone can affect the way some other medicines work. Also some medicines can affect the way methadone works.

You must not take Methadone Solution:

at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).

Some medicines can increase the risk of heart problems when used with methadone. Talk to your doctor before taking methadone if you are taking:

medicines for heart problems such as verapamil and enalapril medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:

medicines that dull your senses such as medicines for depression (for example, fluvoxamine, fluoxetine), medicines to help you sleep (including anaesthetics) and medicines to calm you down called tranquillisers cimetidine, used to treat stomach ulcers rifampicin, used to treat tuberculosis (TB) medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and primidone medicines that make your urine acidic such as ascorbic acid (vitamin C) narcotic painkillers such as codeine and pentazocine naloxone used to reverse the effects of opioid drugs medicines used to stop opioid drugs working such as naltrexone and buprenorphine medicines used to treat HIV such as nevirapine, efavirenz and nelfinavir. The doctor may have to change the amount of methadone you take whilst on these medicines antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin medicines used to treat fungal infections such as ketoconazole or fluconazole St. John’s Wort - a herbal preparation for depression.

If any of the above apply to you, talk to your doctor before taking Methadone Solution.

Taking Methadone Solution with food and drink

Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can make you feel sleepy and drinking alcohol will make you even more sleepy.

Pregnancy and Breast-feeding talk to your doctor before taking Methadone Solution if you are pregnant or likely to become pregnant take care if you are taking a pregnancy test as the methadone may interfere with the results you should not take this medicine whilst you are in labour do not breast-feed if you are taking Methadone Solution. Driving and using machines

Methadone Solution will severely affect your ability to drive or use machines, whilst taking it and afterwards. You should only start doing these activities again with the permission of your doctor.

Important information about what is in Methadone Solution:

This medicine contains:

methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine. How to take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.

Taking this medicine this medicine contains 1mg of methadone in each 1ml take this medicine by mouth. Adults

For addiction

the starting dose is 10mg to 20mg (10ml to 20ml) each day the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.

For pain

the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours the dose may be changed by your doctor. Older people and very ill people if you have to have repeated doses of this medicine, the doctor may want to monitor you more closely. Children

Children must not take this medicine.

If you take more Methadone Solution than you should

If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you.

If you forget to take Methadone Solution if you forget a dose do not take it. Wait until the next dose is due and take only that amount do not take a double dose (two doses at the same time) to make up for a forgotten dose. If you stop taking Methadone Solution do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal effects your doctor will tell you how to lower the dose gradually.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Methadone can cause side effects although not everybody gets them.

Stop taking this medicine and see a doctor straight away if you have an allergic reaction to Methadone Solution.

An allergic reaction may include:

swelling of your face, lips, tongue or throat or difficulty breathing or swallowing severe itching of your skin with raised lumps. Stop taking this medicine and see a doctor straight away if you have any of the following: heart problems. The signs of this may include changes in the way your heart beats, such as it beating faster or missed heart beats, breathing difficulties and dizziness if your breathing becomes slow and shallow. Keep taking the medicine but tell your doctor straight away if you get any of the following side effects: if you have asthma and it gets worse worsening of the pressure inside your head if you already have this condition following an injury to your brain or brain disease. Tell your doctor if you get any of these side effects: feeling sick (nausea) or being sick (vomiting) constipation sweating a lot more than usual feeling dizzy, particularly when standing up. This may be a sign that you have low blood pressure small pupils breast growth and production of breast milk difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle spasms dry mouth, eyes or nose, facial flushing feeling drowsy, confused or restless changes in your mood, feeling "high" or over excited seeing or hearing things that are not there (hallucinations) headache, rashes low body heat (hypothermia) lower sexual urge or desire painful periods or lack of periods.

You may notice that some of the side effects become less severe with time as you get used to the methadone.

When taken for a long period of time, it is possible that you may become dependent on methadone solution.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution Keep out of the reach and sight of children Store below 25°C. Protect from light Do not use after the expiry date (month, year) stated on the label and carton If it is out of date or you no longer want it, take it back to the pharmacy Do not use Methadone Solution if you notice anything wrong with the medicine. Talk to your pharmacist Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Further information What Methadone Solution contains The active ingredient is methadone hydrochloride The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), caramel (E150), liquid maltitol (E965), patent blue (E131) and purified water. What Methadone Solution looks like and contents of the pack A green solution.

It comes in a brown glass bottle holding 30ml, 40ml, 50ml, 100ml or 500ml of solution.

Marketing Authorisation Holder and Manufacturer Rosemont Pharmaceuticals Ltd. Yorkdale Industrial Park Braithwaite Street Leeds LS11 9XE UK

This leaflet was last approved in December 2009

P0492


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Methadone Hydrochloride DTF 1mg / 1ml Oral Solution (Plastic Packs)


Methadone Hydrochloride DTF 1mg/1ml Oral Solution

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for 2. Before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution 3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution 4. Possible side effects 5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution 6. Further information What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for

The name of your medicine is Methadone Hydrochloride DTF 1mg/1ml Oral Solution (referred to as Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of medicines called Narcotic Analgesics.

Methadone is used:

to treat opioid drug addiction to treat moderate to severe pain Before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution Do not take Methadone Solution and tell your doctor if: you are allergic (hypersensitive) to methadone or any other ingredients in this liquid (see section 6 below). An allergic reaction can include a rash, itching or shortness of breath you have severe breathing problems or a history of asthma. You must not use this medicine during an asthma attack. If you give this medicine to yourself (self-administration), wait until the asthma attack has passed and you are fully recovered you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have taken a MAOI medicine in the past two weeks (see ‘Taking other medicines’) you are dependent on any other drugs you are in labour children must not be given this medicine.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking methadone.

Take special care with Methadone Solution

Before you take this medicine, tell your doctor if:

you have liver or kidney problems you have epilepsy you are addicted to alcohol you have or have recently had a head injury you have low thyroid function (hypothyroid) you have problems with your adrenal glands. These are linked to your kidneys you have an enlarged prostate gland you have low blood pressure you are in shock you have a muscle weakness disease called myasthenia gravis you have bowel problems you have a history of irregular heart beat you have a history of heart disease you have a family history of people dying suddenly without cause you have low potassium, sodium or magnesium levels you are pregnant or breast-feeding you are extremely ill or an older person. You may be more sensitive to the medicine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking methadone.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because methadone can affect the way some other medicines work. Also some medicines can affect the way methadone works.

You must not take Methadone Solution:

at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).

Some medicines can increase the risk of heart problems when used with methadone. Talk to your doctor before taking methadone if you are taking:

medicines for heart problems such as verapamil and enalapril medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:

medicines that dull your senses such as medicines for depression (for example, fluvoxamine, fluoxetine), medicines to help you sleep (including anaesthetics) and medicines to calm you down called tranquillisers cimetidine, used to treat stomach ulcers rifampicin, used to treat tuberculosis (TB) medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and primidone medicines that make your urine acidic such as ascorbic acid (vitamin C) narcotic painkillers such as codeine and pentazocine naloxone used to reverse the effects of opioid drugs medicines used to stop opioid drugs working such as naltrexone and buprenorphine medicines used to treat HIV such as nevirapine, efavirenz and nelfinavir. The doctor may have to change the amount of methadone you take whilst on these medicines antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin medicines used to treat fungal infections such as ketoconazole or fluconazole St. John’s Wort - a herbal preparation for depression.

If any of the above apply to you, talk to your doctor before taking Methadone Solution.

Taking Methadone Solution with food and drink

Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can make you feel sleepy and drinking alcohol will make you even more sleepy.

Pregnancy and Breast-feeding talk to your doctor before taking Methadone Solution if you are pregnant or likely to become pregnant take care if you are taking a pregnancy test as the methadone may interfere with the results you should not take this medicine whilst you are in labour do not breast-feed if you are taking Methadone Solution. Driving and using machines

Methadone Solution will severely affect your ability to drive or use machines, whilst taking it and afterwards.

You should only start doing these activities again with the permission of your doctor.

Important information about what is in Methadone Solution:

This medicine contains:

methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine sucrose (0.9g per 5ml) and liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine. The amount of sucrose should be taken into account if you have diabetes. Sucrose may be harmful to your teeth colours - tartrazine (E102) and sunset yellow (E110). These may cause allergic reactions. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.

Taking this medicine this medicine contains 1mg of methadone in each 1ml take this medicine by mouth. Adults

For addiction

the starting dose is 10mg to 20mg (10ml to 20ml) each day the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.

For pain

the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours the dose may be changed by your doctor.

Older people and very ill people

if you have to have repeated doses of this medicine, the doctor may want to monitor you more closely. Children

Children must not take this medicine.

If you take more Methadone Solution than you should if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you the signs you may notice are difficulty in breathing; feeling very drowsy which may lead to a stupor or coma; very small pupils; cold and clammy skin; a very slow pulse rate and muscle weakness. In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart attack which could lead to death. If you forget to take Methadone Solution if you forget a dose do not take it. Wait until the next dose is due and take only that amount do not take a double dose (two doses at the same time) to make up for a forgotten dose. If you stop taking Methadone Solution do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal effects your doctor will tell you how to lower the dose gradually.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Methadone can cause side effects although not everybody gets them.

Stop taking this medicine and see a doctor straight away if you have an allergic reaction to Methadone Solution.

An allergic reaction may include:

swelling of your face, lips, tongue or throat or difficulty breathing or swallowing severe itching of your skin with raised lumps. Stop taking this medicine and see a doctor straight away if you have any of the following: heart problems. The signs of this may include changes in the way your heart beats, such as it beating faster or missed heart beats, breathing difficulties and dizziness if your breathing becomes slow and shallow. Keep taking the medicine but tell your doctor straight away if you get any of the following side effects: if you have asthma and it gets worse worsening of the pressure inside your head if you already have this condition following an injury to your brain or brain disease. Tell your doctor if you get any of these side effects: feeling sick (nausea) or being sick (vomiting) constipation sweating a lot more than usual feeling dizzy, particularly when standing up. This may be a sign that you have low blood pressure small pupils breast growth and production of breast milk difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle spasms dry mouth, eyes or nose, facial flushing feeling drowsy, confused or restless changes in your mood, feeling "high" or over excited seeing or hearing things that are not there (hallucinations) headache, rashes low body heat (hypothermia) lower sexual urge or desire painful periods or lack of periods.

You may notice that some of the side effects become less severe with time as you get used to the methadone.

When taken for a long period of time, it is possible that you may become dependent on methadone solution.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution Keep out of the reach and sight of children Store below 25°C but not in a refrigerator. Protect from light Do not use after the expiry date (month, year) stated on the label and carton Use within 1 month of opening If it is out of date or you no longer want it, take it back to the pharmacy Do not use Methadone Solution if you notice anything wrong with the medicine. Talk to your pharmacist Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Further information What Methadone Solution contains The active ingredient is methadone hydrochloride The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), liquid maltitol (E965), sucrose, tartrazine (E102), sunset yellow (E110), green s (E142), poloxamer 188, simethicone emulsion 30% and purified water. What Methadone Solution looks like and contents of the pack A green solution.

It is available in plastic bottles of 2500ml and 5000ml. Other pack sizes are available.

Marketing Authorisation Holder and Manufacturer Rosemont Pharmaceuticals Ltd. Yorkdale Industrial Park Braithwaite Street Leeds LS11 9XE UK

This leaflet was last approved in December 2009

P0494


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Methadone Linctus BP


1. Name Of The Medicinal Product

Methadone Linctus BP

2. Qualitative And Quantitative Composition

Methadone Hydrochloride BP 0.04% w/v

3. Pharmaceutical Form

Oral Solution

4. Clinical Particulars 4.1 Therapeutic Indications

For the suppression of cough in terminal disease.

4.2 Posology And Method Of Administration

Oral

Recommended dose:

Adults and children over 12 years:

 

2.5ml-5ml every 4-6 hours, reduced to

 

twice daily on prolonged use.

 

Use with caution in the elderly.

Not recommended for use in children under 12 years.

4.3 Contraindications

• Hypersensitivity to methadone or to any of the excipients.

• Respiratory depression, obstructive airways disease, and during an asthma attack.

• Risk of paralytic ileus.

• Acute alcoholism.

• Avoid in raised intracranial pressure or head injury (in addition to interfering with respiration, affects pupillary responses vital for neurological assessment).

• Use during labour (prolonged duration of action increases the risk of neonatal depression).

• Contra-indicated in patients taking monoamine oxidase inhibitors (including moclobemide) or within 14 days of stopping such treatment.

4.4 Special Warnings And Precautions For Use

Tolerance and dependence of the morphine type may occur. Methadone should be given with caution to patients with asthma (see Section 4.3), convulsive disorders, depressed respiratory reserve, hypotension, shock, prostatic hyperplasia, adrenocortical insufficiency, inflammatory or obstructive bowel disorders, myasthenia gravis or hypothyroidism. In cases of hepatic or renal impairment the use of methadone should be avoided or given in reduced doses.

Dosage should be reduced in elderly and debilitated patients and those with a history of drug abuse.

Children are very sensitive to the depressant effects.

Cases of QT interval prolongation and torsade de pointes have been reported during treatment with methadone, particularly at high doses (>100mg/d). Methadone should be administered with caution to patients at risk of development of prolonged QT interval, e.g. in case of:

-history of cardiac conduction abnormalities,

-advanced heart disease or ischaemic heart disease,

-Liver disease,

-family history of sudden death,

-Electrolyte abnormalities, i.e. hypokalaemia, hypomagnesaemia

-concomitant treatments with drugs that have a potential for QT-prolongation,

-concomitant treatment with drugs which may cause electrolyte abnormalities,

-concominant treatment with cytochrome P450 CYP 3A4 inhibitors (see section 4.5).

In patients with recognised risk factors of QT prolongation, or in case of concomitant treatment with drugs that have a potential for QT prolongation, ECG monitoring is recommended prior to methadone treatment, with a further ECG test at dose stabilisation. ECG monitoring is recommended, in patients without recognised risk factors for QT prolongation, before dose titration above 100mg/d, and at seven days after titration.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Interactions potentiating the effects of methadone;

Cytochrome P450 3A4 inhibitors: methadone clearance is decreased when co-administered with drugs which inhibit CYP3A4 activity, such as some anti-HIV agents, macrolide antibiotics, cimetidine, ciprofloxacin and azole antifungal agents (since the metabolism of methadone is mediated by the CYP3A4 isoenzyme).

Cimetidine and phenytoin – may lead to potentiation of opioid activity due to displacement of methadone from protein binding sites. However, as phenytoin is also a hepatic enzyme inducer, it may lower plasma methadone levels (see below).

Fluvoxamine may increase plasma concentrations of methadone.

The depressant effects of methadone are likely to be enhanced by depressants of the CNS, such as other opioid analgesics, alcohol (see section 4.3), anaesthetics, antipsychotics, anxiolytics, hypnotics and sedatives, major and minor tranquilisers and phenothiazines. As well as CNS depression, there may be respiratory depression and/or hypotension. Tricyclic antidepressants may exert a similar effect.

Interactions reducing the effects of methadone;

The opioids antagonists, naloxone and naltrexone, will precipitate an acute withdrawal syndrome in methadone-dependent individuals. Naloxone will also antagonise the analgesic, CNS and respiratory depressant effects of methadone.

Buprenorphine and pentazocine may also rapidly precipitate withdrawal symptoms in patients addicted to methadone.

The hepatic enzyme-inducing drugs, nevirapine, rifampicin (and other rifamycins), phenytoin, phenobarbital and carbamazepine may lower plasma methadone levels and produce symptoms of withdrawal in methadone dependent patients. Similar effects have been reported with efavirenz nelfinavir, ritonavir and possibly abacavir.

Urinary acidifiers: Acidification of the urine will increase the rate of elimination of methadone by the kidney thereby reducing plasma concentrations.

Effects of methadone on other drugs;

Methadone may increase plasma desipramine levels and increase desipramine side-effects when given concurrently.

Zidovudine – methadone may increase the plasma concentrations of zidovudine.

Mexiletine – methadone may delay mexiletine absorption.

Metoclopramide and domperidone – the gastrointestinal effects may be antagonised by methadone.

Methadone treatment has been found to decrease the rate of absorption and decrease the bioavailability of the nucleoside reverse transcriptase inhibitors didanosine and to a lesser extent stavudine.

Other important interactions;

In patients taking drugs affecting cardiac conduction or drugs which may affect electrolyte balance, there is a risk of cardiac events when methadone is taken concurrently.

As serious and sometimes fatal reactions have occurred following administration of pethidine to patients receiving MAOIs, other drugs related to pethidine are contraindicated in patients taking MAOI's (including moclobemide) or within 14 days of stopping such treatment, (see section 4.3) as there is a risk of CNS excitation or depression.

Cross tolerance and cross dependence can be expected between other opioids acting at the same receptors.

4.6 Pregnancy And Lactation

Pregnancy;

There is no or inadequate evidence of safety in human pregnancy, but the drug has been widely used for many years without apparent ill consequence and animal studies have not shown any hazard.

Opioid analgesics taken in pregnancy may depress neonatal respiration and cause withdrawal effects in neonates of dependent mothers. May cause gastric stasis and risk of inhalation pneumonia in mothers during labour.

Lactation;

Methadone is excreted in breast milk. A decision must be made whether to discontinue breastfeeding or discontinue the methadone therapy.

Taken during breastfeeding may cause withdrawal symptoms in the infant.

A maintenance dose may be acceptable during breastfeeding, but the dose should be kept to a minimum and the baby should be monitored to avoid sedation.

4.7 Effects On Ability To Drive And Use Machines

May cause drowsiness and or dizziness. If affected do not drive or operate machinery.

4.8 Undesirable Effects

Blood and lymphatic system disorders

Lymphocytosis

Endocrine disorders

Increased prolactin concentrations

Psychiatric disorders

Dependence, hallucinations, confusion, mood changes including dysphoria, decreased libido, restlessness

Nervous system disorders

Raised intracranial pressure occurs in some patients. Dizziness, headache, drowsiness

Eye disorders

Miosis

Ear and labyrinth disorders

Vertigo

Cardiac disorders

Cases of QT prolongation and torsade de pointes have been rarely reported. Bradycardia, palpitations, tachycardia

Vascular disorders

Hypotension, facial flushing

Respiratory, thoracic and mediastinal disorders

Respiratory depression, Exacerbation of existing asthma

Gastrointestinal disorders

Nausea, vomiting, constipation, dry mouth

Hepatobiliary disorders

Biliary spasm

Skin and subcutaneous tissue disorders

Rashes, pruritus, urticaria, sweating

Renal and urinary disorders

Difficulty in micturation, ureteric spasm, antidiuretic effect

Reproductive system and breast disorders

Erectile dysfunction

General disorders and administration site conditions

Hypothermia.

Investigations

Globulins increased, blood albumin increased

4.9 Overdose

Symptoms of overdosage with opiods include respiratory depression, pinpoint pupils, pulmonary odema and coma. Hypotension may occur and rhabdomyolysis progressing to renal failure has been reported. The presence of signs of drug abuse supports the diagnosis. In children methadone overdose produces drowsiness, floppiness, pinpoint pupils and apnoea.

Treatment consists of the establishment of a patent airway together with supportive measures, and the administration of a specific opioid antagonist, preferably naloxone given as per local guidance. Reversal of coma and respiratory depression is seen within 2 minutes of naloxone administration. Repeated treatment with naloxone may be required to prevent recurrence of coma because the duration of action of naloxone is shorter than that of methadone. Patients should be monitored for signs of relapse for at least 48 hours.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Methadone hydrochloride is a potent analgesic with action similar to that of morphine, but having a less marked sedative effect. It has a depressant action on the cough centre and is given to control non-productive coughing of intractable disorders, such as lung cancer. It is also used as part of the treatment of dependence on opioid drugs. It is readily absorbed from the gastro-intestinal tract. It is widely distributed in the tissues and diffuses across the placenta. It is extensively protein bound. It is metabolised in the liver, mainly by n-demethylation and cyclisation and the metabolites are excreted in the bile and urine.

5.2 Pharmacokinetic Properties

The analgesic effect begins about 45 minutes after administration by mouth (about 15 minutes after subcutaneous injection) and the effect lasts about 4 hours. It has a prolonged half life. As accumulation occurs following repeated doses the effects become more prolonged.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerol, tolu flavour solution, purified water, tartrazine compound solution, syrup.

6.2 Incompatibilities

None known.

6.3 Shelf Life

500ml : 24 months unopened.

6.4 Special Precautions For Storage

This product is subject to the Controlled Drugs Regulations. Store in an authorised location.

6.5 Nature And Contents Of Container

500ml: Plain amber glass bottle with plastic cap and viskring.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

00240/6420R

9. Date Of First Authorisation/Renewal Of The Authorisation

15.01.81 /16.07.98

10. Date Of Revision Of The Text

16.04.2010


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Metharose Sugar Free 1mg / 1ml Oral Solution


Metharose Sugar Free 1mg/1ml Oral Solution

Methadone hydrochloride

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What is Metharose and what is it used for? 2. Before you take Metharose 3. How to take Metharose 4. Possible side effects 5. How to store Metharose 6. Further information What is Metharose and what is it used for?

The name of your medicine is Metharose. It contains methadone hydrochloride. This belongs to a group of medicines called Narcotic Analgesics.

Metharose is used:

to treat opioid drug addiction to treat moderate to severe pain Before you take Metharose Do not take Metharose and tell your doctor if: you are allergic (hypersensitive) to methadone or any other ingredients in this liquid (see section 6 below). An allergic reaction can include a rash, itching or shortness of breath you have severe breathing problems or a history of asthma. You must not use this medicine during an asthma attack. If you give this medicine to yourself (self-administration), wait until the asthma attack has passed and you are fully recovered you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have taken a MAOI medicine in the past two weeks (see ‘Taking other medicines’) you are dependent on any other drugs you are in labour children must not be given this medicine.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Metharose.

Take special care with Metharose

Before you take this medicine, tell your doctor if:

you have liver or kidney problems you have epilepsy you are addicted to alcohol you have or have recently had a head injury you have low thyroid function (hypothyroid) you have problems with your adrenal glands. These are linked to your kidneys you have an enlarged prostate gland you have low blood pressure you are in shock you have a muscle weakness disease called myasthenia gravis you have bowel problems you have a history of irregular heart beat you have a history of heart disease you have a family history of people dying suddenly without cause you have low potassium, sodium or magnesium levels you are pregnant or breast feeding you are extremely ill or an older person. You may be more sensitive to the medicine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Metharose.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because Metharose can affect the way some other medicines work. Also some medicines can affect the way Metharose works.

You must not take Metharose

at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).

Some medicines can increase the risk of heart problems when used with Metharose. Talk to your doctor before taking Metharose if you are taking:

medicines for heart problems such as verapamil and enalapril medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:

medicines that dull your senses such as medicine for depression (for example, fluvoxamine, fluoxetine), medicines to help you sleep (including anaesthetics) and medicines to calm you down called tranquillisers cimetidine, used to treat stomach ulcers rifampicin, used to treat tuberculosis (TB) medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and primidone medicines that make your urine acidic such as ascorbic acid (vitamin C) narcotic painkillers such as codeine and pentazocine naloxone used to reverse the effects of opioid drugs medicines used to stop opioid drugs working such as naltrexone and buprenorphine medicines used to treat HIV such as nevirapine, efavirenz and nelfinavir. The doctor may have to change the amount of methadone you take whilst on these medicines antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin medicines used to treat fungal infections such as ketoconazole or fluconazole St. John’s Wort - a herbal preparation for depression.

If any of the above apply to you, talk to your doctor before taking Metharose.

Taking Metharose with food and drink

Do not drink alcohol whilst taking Metharose. This is because Metharose can make you feel sleepy and drinking alcohol will make you even more sleepy.

Pregnancy and breast-feeding talk to your doctor before taking Metharose if you are pregnant or likely to become pregnant take care if you are taking a pregnancy test as the methadone may interfere with the results you should not take this medicine whilst you are in labour do not breast-feed if you are taking Metharose Driving and using machines

Metharose will severely affect your ability to drive or use machines, whilst taking it and afterwards.

You should only start doing these activities again with the permission of your doctor.

Important information about what is in Metharose:

This medicine contains:

methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine. How to take Metharose

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.

Taking this medicine this medicine contains 1mg of methadone in each 1ml take this medicine by mouth Adults

For addiction

the starting dose is 10mg to 20mg (10ml to 20ml) each day the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.

For pain

the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours the dose may be changed by your doctor Older people and very ill people if you have to have repeated doses of this medicine, the doctor may want to monitor you more closely. Children

Children must not take this medicine.

If you take more Metharose than you should

If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you.

If you forget to take Metharose if you forget a dose do not take it. Wait until the next dose is due and take only that amount do not take a double dose (two doses at the same time) to make up for a forgotten dose. If you stop taking Metharose do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal effects your doctor will tell you how to lower the dose gradually.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Metharose can cause side effects although not everybody gets them.

Stop taking this medicine and see a doctor straight away if you have an allergic reaction to Metharose.

An allergic reaction may include:

swelling of your face, lips, tongue or throat or difficulty breathing or swallowing severe itching of your skin with raised lumps. Stop taking this medicine and see a doctor straight away if you have any of the following: heart problems. The signs of this may include changes in the way your heart beats, such as it beating faster or missed heart beats, breathing difficulties and dizziness if your breathing becomes slow and shallow. Keep taking the medicine but tell your doctor straight away if you get any of the following side effects: if you have asthma and it gets worse worsening of the pressure inside your head if you already have this condition following an injury to your brain or brain disease. Tell your doctor if you get any of these side effects: feeling sick (nausea) or being sick (vomiting) constipation sweating a lot more than usual feeling dizzy, particularly when standing up. This may be a sign that you have low blood pressure small pupils breast growth and production of breast milk difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle spasms dry mouth, eyes or nose, facial flushing feeling drowsy, confused or restless changes in your mood, feeling ”high” or over excited seeing or hearing things that are not there (hallucinations) headache, rashes low body heat (hypothermia) lower sexual urge or desire painful periods or lack of periods.

You may notice that some of the side effects become less severe with time as you get used to the methadone

When taken for a long period of time, it is possible that you may become dependent on Metharose.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Metharose keep out of the reach and sight of children store below 25°C. Protect from light do not use after the expiry date (month, year) stated on the label and carton if it is out of date or you no longer want it, take it back to the pharmacy do not use Metharose if you notice anything wrong with the medicine. Talk to your pharmacist medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment. Further information What Metharose contains The active ingredient is methadone hydrochloride The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), caramel (E150), liquid maltitol (E965) and purified water. What Metharose looks like and contents of the pack

A brown solution

It comes in a brown glass bottle holding 500ml of solution.

Marketing Authorisation Holder and Manufacturer Rosemont Pharmaceuticals Ltd Yorkdale Industrial Park Braithwaite Street Leeds LS11 9XE UK

This leaflet was last approved in May 2009.

P0459


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naloxone and pentazocine


Generic Name: naloxone and pentazocine (oral) (nal OX one and pen TAZ oh seen)
Brand Names: Talwin NX

What is naloxone and pentazocine?

Pentazocine is in a group of drugs called narcotic pain relievers.

Naloxone is an special narcotic drug that reverses the effects of other narcotic medicines.

The combination of naloxone and pentazocine is used to treat moderate-to-severe pain. Naloxone is included in this combination to prevent the misuse of the narcotic ingredient.

Naloxone and pentazocine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about naloxone and pentazocine?

Never crush a naloxone and pentazocine tablet to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of pentazocine and similar prescription drugs.

Pentazocine may be habit-forming and should be used only by the person it was prescribed for. Naloxone and pentazocine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are taking naloxone and pentazocine. Alcohol can increase some of the side effects of narcotic pain medicine. Never take more than your prescribed dose of naloxone and pentazocine. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Naloxone and pentazocine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not stop using naloxone and pentazocine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. What should I discuss with my health care provider before taking naloxone and pentazocine?

Before using naloxone, tell your doctor if you are using any other narcotic pain medicines. The pain-relieving effects of any narcotic medications you use will be reversed if you use them while you are taking naloxone and pentazocine.

Do not use this medication if you have ever had an allergic reaction to naloxone (Narcan) or pentazocine. Pentazocine may be habit-forming and should be used only by the person it was prescribed for. Naloxone and pentazocine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using naloxone and pentazocine, tell your doctor if you are allergic to any drugs, or if you have:

asthma, COPD, sleep apnea, or other breathing disorders;

liver or kidney disease;

heart disease or history of heart attack;

brain tumor or head injury;

epilepsy or other seizure disorder;

low blood pressure;

gallbladder disease;

mental illness;

a history of drug or alcohol addiction; or

if you have recently received other narcotic pain medicine or methadone.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take naloxone and pentazocine.

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether naloxone and pentazocine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take naloxone and pentazocine?

Never crush a naloxone and pentazocine tablet to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of pentazocine and similar prescription drugs.

Take this medication exactly as it was prescribed for you. Never take naloxone and pentazocine in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not stop using naloxone and pentazocine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Store naloxone and pentazocine at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Pentazocine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

See also: Naloxone and pentazocine dosage (in more detail)

What happens if I miss a dose?

Since this medication is sometimes used as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include extreme drowsiness, weak pulse, shallow breathing, or fainting.

What should I avoid while taking naloxone and pentazocine? Do not take naloxone and pentazocine with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Do not drink alcohol while you are taking naloxone and pentazocine. Alcohol can increase some of the side effects of narcotic pain medicine. Naloxone and pentazocine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Naloxone and pentazocine side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using naloxone and pentazocine and call your doctor at once if you have any of these serious side effects:

confusion, hallucinations;

fast heart rate;

weak or shallow breathing;

chest pain;

seizure (convulsions);

cold, clammy skin;

tremors;

confusion, unusual thoughts or behavior;

severe anxiety or restlessness; or

feeling like you might pass out.

Less serious side effects may include:

dizziness, drowsiness;

headache, weakness;

sleep problems (insomnia), strange dreams;

diarrhea, constipation;

nausea, vomiting, loss of appetite;

warmth, redness, or tingly feeling under your skin;

sweating;

blurred vision; or

ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Naloxone and pentazocine Dosing Information

Usual Adult Dose for Pain:

Initial: 50 mg orally every 3 to 4 hours. May increase dose to 100 mg if needed.
Maximum dose: 600 mg/day.

Usual Geriatric Dose for Pain:

Initial: 50 mg orally every 3 to 4 hours. Cautious use and the lower end of the dosing range is recommended in elderly patients.

Usual Pediatric Dose for Pain:

>12 years:
Initial: 50 mg orally every 3 to 4 hours. May increase dose to 100 mg if needed.
Maximum dose: 600 mg/day.

What other drugs will affect naloxone and pentazocine?

Before you take naloxone and pentazocine, tell your doctor if you are now using or have recently used other narcotic medications such as:

fentanyl (Actiq, Duragesic);

hydrocodone (Lortab, Vicodin);

hydromorphone (Dilaudid, Palladone);

levorphanol (Levo-Droman);

meperidine (Demerol);

methadone (Diskets, Methadose, Dolophine);

morphine (Duramorph, Kadian, MS Contin, Oramorph, and others);

nalbuphine (Nubain);

oxycodone (Oxycontin);

oxymorphone (Numorphan, Opana); or

pentazocine (Talwin Lactate).

This list is not complete and there may be other drugs that can interact with naloxone and pentazocine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More naloxone and pentazocine resources Naloxone and pentazocine Side Effects (in more detail) Naloxone and pentazocine Dosage Naloxone and pentazocine Use in Pregnancy & Breastfeeding Drug Images Naloxone and pentazocine Drug Interactions Naloxone and pentazocine Support Group 12 Reviews for Naloxone and pentazocine - Add your own review/rating Compare naloxone and pentazocine with other medications Pain Where can I get more information? Your pharmacist can provide more information about naloxone and pentazocine.

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Mycobutin


1. Name Of The Medicinal Product

Mycobutin.

2. Qualitative And Quantitative Composition

Rifabutin INN

150.0 mg 3. Pharmaceutical Form

Opaque, red-brown, hard gelatin capsules Size N°. 0 containing 150 mg rifabutin in transparent PVC/Al blisters or in amber glass bottles.

The capsules are for oral administration.

4. Clinical Particulars 4.1 Therapeutic Indications

Mycobutin is indicated for:

- the prophylaxis of M. avium intracellulare complex (MAC) infections in patients with HIV disease with CD4 counts lower than 75 cells/mcl.

- the treatment of non-tuberculous mycobacterial disease (such as that caused by MAC and M. xenopi).

- pulmonary tuberculosis.

4.2 Posology And Method Of Administration

Mycobutin can be administered as a single, daily, oral dose at any time independently of meals.

Adults

- prophylaxis of M. avium intracellulare complex (MAC) infections in patients with HIV disease with CD4 counts lower than 75 cells/mcl.:

300 mg (2 capsules) as a single agent.

- treatment of non-tuberculous mycobaterial disease:

450 - 600 mg (3 - 4 capsules) in combination regimens for up to 6 months after negative cultures are obtained.

When Mycobutin is given in association with clarithromycin (or other macrolides) and/or fluconazole (or related compounds) the Mycobutin dosage may need to be reduced to 300 mg (see Section 4.5).

- treatment of pulmonary tuberculosis:

150 - 450 mg (1 - 3 capsules) in combination regimens for at least 6 months.

In accordance with the commonly accepted criteria for the treatment of mycobacterial infections, Mycobutin should always be given in combination with other anti-mycobacterial drugs not belonging to the family of rifamycins.

Children

There are inadequate data to support the use of Mycobutin in children at the present time.

Elderly

No specific recommendations for dosage alterations in the elderly are suggested.

4.3 Contraindications

Mycobutin is contra-indicated in patients with a history of hypersensitivity to rifabutin or other rifamycins (eg rifampicin).

Due to insufficient clinical experience in pregnant and breast-feeding women and in children, Mycobutin should not be used in these patients.

4.4 Special Warnings And Precautions For Use

Before starting Mycobutin prophylaxis, patients should be assessed to ensure that they do not have active disease caused by pulmonary tuberculosis or other mycobacteria.

Prophylaxis against MAC infection may need to be continued throughout the patient's lifetime.

Mycobutin may impart a red-orange colour to the urine and possibly to skin and body secretions. Contact lenses, especially soft, may be permanently stained.

Mild hepatic impairment does not require a dose modification. Mycobutin should be used with caution in cases of severe liver insufficiency. Mild to moderate renal impairment does not require any dosage adjustment.

Severe renal impairment (creatinine clearance below 30 ml/min) requires a dosage reduction of 50%.

It is recommended that white blood cell and platelet counts and liver enzymes be monitored periodically during treatment.

Because of the possibility of occurrence of uveitis, patients should be carefully monitored when rifabutin is given in combination with clarithromycin (or other macrolides) and/or fluconazole (and related compounds). If such an event occurs, the patient should be referred to an ophthalmologist and, if considered necessary, Mycobutin treatment should be suspended.

Uveitis associated with Mycobutin must be distinguished from other ocular complications of HIV.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including rifabutin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Rifabutin has been shown to induce the enzymes of the cytochrome P450 3A subfamily and therefore may affect the pharmacokinetic behaviour of drugs metabolised by the enzymes belonging to this subfamily. Upward adjustment of the dosage of such drugs may be required when administered with Mycobutin.

Similarly, Mycobutin might reduce the activity of analgesics, anticoagulants, corticosteroids, cyclosporin, digitalis (although not digoxin), oral hypoglycaemics, narcotics, phenytoin and quinidine.

Clinical studies have shown that Mycobutin does not affect the pharmacokinetics of didanosine (DDI), and isoniazid (however, for the latter refer also to undesirable effects). On the basis of the above metabolic considerations no significant interaction may be expected with ethambutol, theophylline, sulphonamides, pyrazinamide and zalcitabine (DDC).

As p-aminosalicylic acid has been shown to impede GI absorption of rifamycins it is recommended that when it and Mycobutin are both to be administered they be given with an interval of 8 - 12 hours.

The following table provides details of the possible effects of co-administration, on rifabutin and the co-administered drug, and risk-benefit statement.

Coadministered drugs

Effect on rifabutin

Effect on co-administered drug

Comments

ANTIVIRALS

     

Indinavir

20% increase in AUC.

32% decrease in AUC.

 

 

Saquinavir

No data.

40% decrease in AUC.

 

 

Ritonavir

4-fold increase in AUC, 2.5-fold increase in Cmax

No data

Due to this multifold increase in rifabutin concentrations and the subsequent risk of side effects, patients requiring both rifabutin and a protease inhibitor, other protease inhibitors should be considered.

Zidovudine

No significant change in kinetics

Approx. 32% decrease in Cmax and AUC.

A large clinical study has shown that these changes are of no clinical relevance.

ANTIFUNGALS

     

Fluconazole

82% increase in AUC.

No significant change in steady-state plasma concentrations

 

 

Itraconazole

No data.

70-75% decrease in Cmax and AUC.

A case report indicates an increase in rifabutin serum levels in the presence of itraconazole.

Ketoconazole/ miconazole

No data.

No data.

Co-administered medications, sucha s ketoconazole, that competitively inhibit the Cyt P450IIIA activity may increase circulating drug levels of rifabutin.

ANTI-PCP (Pneumocystis carinii pneumonia)

     

Dapsone

No data.

Approximately 27%-40% decrease in AUC.

Study conducted in HIV infected patients (rapid and slow acetylators)

Sulfamethoxazole-Trimethoprim

No significant change in Cmax and AUC.

Approx. 15-20% decrease in AUC.

In another study, only trimethoprim (not sulfamethoxazole had 14% decrease in AUC and 6% in Cmax but were not considered clinically significant.

ANTI-MAC (Mycobacterium avium intracellulare complex)

     

Clarithromycin

Approx. 77% increase in AUC.

Approx. 50% decrease in AUC.

Study conducted in HIV infected patients

OTHER

     

Methadone

No data.

No significant effect.

No apparent effect of rifabutin on either peak levels of methadone or systemic exposure based upon AUC. Rifabutin kinetics not evaluated.

Oral contraceptives

No data.

No data.

Contraceptive cover may not be adequate during concomitant therapy with rifabutin, therefore, patients should be advised to use other methods of contraception.

Tacrolimus

No data.

No data.

Rifabutin decreases tacrolimus trough blood levels.

4.6 Pregnancy And Lactation

Due to lack of data in pregnant women, as a precautionary measure, Mycobutin should not be administered to pregnant women or those breast-feeding children even though in experimental animal studies the drug was not teratogenic.

Mycobutin may interact with oral contraceptives (see Section 4.5).

4.7 Effects On Ability To Drive And Use Machines

There have been no reports of adverse effects on ability to drive and use machines.

4.8 Undesirable Effects

The tolerability of Mycobutin in multiple drug regimens, was assessed in both immunocompetent and immunocompromised patients, suffering from tuberculosis and non-tuberculous mycobacteriosis in long term studies with daily dosages up to 600 mg.

Bearing in mind that Mycobutin was often given in these studies as part of a multidrug regimen it is not possible to define with certainty a drug-event relationship. Treatment discontinuation was necessary only in a very few cases. The most commonly reported adverse events, were primarily related to:

- the gastro-intestinal system, such as nausea, vomiting, increase of liver enzymes, jaundice;

- the blood and lymphatic system, such as leucopenia, neutropenia, thrombocytopenia and anemia, where the frequency and severity of haematologic reactions could be increased by combined administration of isoniazid;

- the musculo-skeletal system: arthralgia and myalgia.

Also, fever, rash and rarely other hypersensitivity reactions such as eosinophilia, bronchospasm and shock might occur as has been seen with other antibiotics.

In addition, mild to severe, reversible uveitis has been reported. The risk appears to be low, when Mycobutin is used at 300 mg as monotherapy in MAC prophylaxis, but increases when Mycobutin is administered at higher doses in combination with clarithromycin (or other macrolides) for MAC treatment (see Section 4.4). The possible role of fluconazole (and related compounds) has not been established yet.

Asymptomatic corneal opacities have been reported after long term therapy.

Pseudojaundice (yellow skin discolouration with normal plasma bilirubin) has been reported with high doses of rifabutin. Flu-like syndrome, chest pressure or pain with dyspnoea and rarely hepatitis and haemolysis. Clostridium difficile diarrhoea has been reported rarely.

4.9 Overdose

Gastric lavage and diuretic treatment should be carried out. Supportive care and symptomatic treatment should be administered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

In vitro activity of rifabutin against laboratory strains and clinical isolates of M. tuberculosis has been shown to be very high. In vitro studies carried out so far have shown that from one-third to half of M.tuberculosis strains resistant to rifampicin are susceptible to rifabutin, indicating that cross-resistance between the two antibiotics is incomplete.

The in vivo activity of rifabutin on experimental infections caused by M. tuberculosis was about 10 times greater than that of rifampicin in agreement with the in vitro findings.

Rifabutin was seen to be active against non-tuberculous (atypical) mycobacteria including M. avium-intracellulare (MAC), in vitro as well as in experimental infections caused by these pathogens in mice with induced immuno-deficiency.

5.2 Pharmacokinetic Properties

In man, rifabutin is rapidly absorbed and maximum plasma concentrations are reached around 2-4 hours after oral administration. The pharmacokinetics of rifabutin is linear after single administration of 300, 450, and 600 mg to healthy volunteers. With these doses, C max is in the range of 0.4-0.7 µg/ml. Plasma concentrations are maintained above the MIC values for M. tuberculosis up to about 30 hours from administration.

Rifabutin is widely distributed in various animal organs with the exception of the brain. In particular, in human lung tissue the concentrations measured up to 24 hours after dosing were about 5-10 times higher than the plasma levels.

The intracellular penetration of rifabutin is very high as demonstrated by intracellular/extracellular concentration ratios which ranged from 9 in neutrophils to 15 in monocytes, both obtained from human sources.

The high intracellular concentration is likely to play a crucial role in sustaining the efficacy of rifabutin against intracellular pathogens such as mycobacteria.

Rifabutin and its metabolites are eliminated mainly by the urinary route. The t? of rifabutin in man is approximately 35-40 hours.

5.3 Preclinical Safety Data

Preclinical safety studies of rifabutin indicate a good safety margin in rodents and in monkeys.

In repeated dose studies, target organs were identified at doses producing blood levels higher than those achieved with recommended doses for human therapy. The main target organs are liver and, to a lesser degree, erythrocytes.

Rifabutin did not show any teratogenic, mutagenic or carcinogenic potential.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Microcrystalline cellulose

Sodium lauryl sulphate

Magnesium stearate

Silica gel

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months at room temperature.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Transparent PVC/Al blisters in cardboard cartons containing 30 capsules or amber glass bottles containing 30 or 100 capsules.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for handling.

Administrative Data 7. Marketing Authorisation Holder

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00057/1017

9. Date Of First Authorisation/Renewal Of The Authorisation

15th January 2003.

10. Date Of Revision Of The Text

February 2010

Ref: MY_4_0


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alvimopan


Generic Name: alvimopan (AL vi MOE pan)
Brand Names: Entereg

What is alvimopan?

Alvimopan reduces certain side effects of narcotic medications that are often used to prevent pain caused by surgery.

Narcotic medications can cause stomach pain, bloating, nausea, vomiting, and constipation. These side effects can delay recovery in patients undergoing gastrointestinal surgery.

Alvimopan works by preventing these side effects without reducing the pain-relieving effects of the narcotic.

Alvimopan is used to speed recovery of stomach and intestinal functions after a gastrointestinal surgery and to prevent side effects caused by narcotic medications.

Alvimopan may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about alvimopan? You should not use this medication if you are allergic to alvimopan, or if you have used a narcotic medication within the past 7 days. You may be more likely to have unpleasant effects on your stomach if you have recently taken a narcotic medication.

Before you receive alvimopan, tell your doctor if you have liver or kidney disease.

Alvimopan is given only in a hospital for a short period of time.

Tell your caregivers right away if you have pale skin, easy bruising or bleeding, painful or difficult urination, or confusion with uneven heart rate, leg discomfort, muscle weakness or limp feeling, and increased urination.

What should I discuss with my health care provider before I receive alvimopan? You should not use this medication if you are allergic to alvimopan, or if you have used a narcotic medication within the past 7 days, such as:

fentanyl (Actiq, Duragesic);

hydrocodone (Lortab, Vicodin);

hydromorphone (Dilaudid, Palladone);

levorphanol (Levo-Dromoran);

meperidine (Demerol);

methadone (Methadose, Diskets, Dolophine);

morphine (Kadian, MS Contin, Oramorph, and others);

nalbuphine (Nubain);

oxycodone (OxyContin);

oxymorphone (Numorphan, Opana); or

pentazocine (Talwin).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using alvimopan, tell your doctor if you have:

liver disease; or

kidney disease.

FDA pregnancy category B. Alvimopan is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alvimopan passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How is alvimopan given?

Alvimopan is given only in a hospital for a short period of time.

You will receive your first dose of alvimopan up to 5 hours before your surgery. You will then be given additional doses two times per day for up to 7 days.

What happens if I miss a dose?

Since alvimopan is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Since alvimopan is given by a healthcare professional, an overdose of this medication is not likely to occur.

What should I avoid while receiving alvimopan?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving alvimopan.

Alvimopan side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

pale skin, easy bruising or bleeding, weakness;

painful or difficult urination;

urinating less than usual or not at all; or

confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include:

stomach pain or upset;

nausea, vomiting; diarrhea;

constipation, gas; or

back pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Alvimopan Dosing Information

Usual Adult Dose for Gastrointestinal Surgery:

Accelerate the time to upper and lower gastrointestinal recovery following partial large or small resection surgery with primary anastomosis:
Initial dose: 12 mg orally once, administered 30 minutes to 5 hours prior to surgery
Maintenance dose: 12 mg orally twice daily beginning the day after surgery for a maximum of 7 days or until discharge
Maximum dose: Not to exceed 15 doses

What other drugs will affect alvimopan?

Tell your doctor about all other medications you are using. It is especially important to tell your doctor if you have taken a narcotic medication within the past 7 days. You may be more likely to have unpleasant effects on your stomach if you have recently taken a narcotic medication.

There may be other drugs that can interact with alvimopan. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More alvimopan resources Alvimopan Side Effects (in more detail)Alvimopan DosageAlvimopan Use in Pregnancy & BreastfeedingAlvimopan Drug InteractionsAlvimopan Support Group0 Reviews for Alvimopan - Add your own review/rating alvimopan Advanced Consumer (Micromedex) - Includes Dosage Information Alvimopan Professional Patient Advice (Wolters Kluwer) Alvimopan MedFacts Consumer Leaflet (Wolters Kluwer) Alvimopan Monograph (AHFS DI) Entereg Prescribing Information (FDA) Entereg Consumer Overview Compare alvimopan with other medications Gastrointestinal SurgeryPostoperative Ileus Where can I get more information? Your doctor or pharmacist can provide more information about alvimopan

See also: alvimopan side effects (in more detail)


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ketamine


Generic Name: ketamine (KET a meen)
Brand Names: Ketalar

What is ketamine?

Ketamine is an anesthetic medication.

Ketamine is used as a general anesthetic to prevent pain and discomfort during certain medical tests or procedures, or minor surgery.

Ketamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about ketamine?

Before you receive ketamine, tell your doctor if you are allergic to any drugs, or if you have a history of alcoholism.

It may take you longer to recover from anesthesia with ketamine if you have recently used a barbiturate such as phenobarbital (Luminal) or secobarbital (Seconal), or a narcotic medication such as fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), oxycodone (OxyContin), propoxyphene (Darvocet, Darvon), and others.

Ketamine may be harmful to an unborn baby. Before you receive ketamine, tell your doctor if you are pregnant.

You may feel strange or slightly confused when you first come out of anesthesia. Tell your caregivers if these feelings are severe or unpleasant.

Ketamine can cause side effects that may impair your thinking or reactions for 24 hours or longer. Be careful if you drive or do anything that requires you to be awake and alert. You will probably not be allowed to drive yourself home after your surgery or medical procedure.

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you recover from anesthesia.

What should I discuss with my health care provider before receiving ketamine?

Before you receive ketamine, tell your doctor if you are allergic to any drugs, or if you have a history of alcoholism.

Ketamine may be harmful to an unborn baby. Before you receive ketamine, tell your doctor if you are pregnant. How is ketamine given?

Ketamine is given as an injection through a needle placed into a vein or muscle. You will receive this injection in a clinic or hospital setting.

Your caregivers will monitor your heart function, blood pressure, and breathing while you are under the effects of ketamine.

You may feel strange or slightly confused when you first come out of anesthesia. Tell your caregivers if these feelings are severe or unpleasant.

What happens if I miss a dose?

Since ketamine is usually given for anesthesia, you are not likely to be on a dosing schedule.

What happens if I overdose?

An overdose of ketamine is unlikely to occur since the medication is given by a doctor. Your vital signs will be closely watched while you are under anesthesia to make sure the medication is not causing any harmful effects.

What should I avoid after receiving ketamine? Ketamine can cause side effects that may impair your thinking or reactions for 24 hours or longer. Be careful if you drive or do anything that requires you to be awake and alert. You will probably not be allowed to drive yourself home after your surgery or medical procedure.

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you recover from anesthesia.

Ketamine side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have any of these serious side effects within 24 hours after you receive ketamine:

severe confusion;

hallucinations;

unusual thoughts; or

extreme fear.

Less serious side effects may include:

dream-like feeling;

double vision;

jerky muscle movements;

dizziness, drowsiness;

nausea, vomiting, loss of appetite; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Ketamine Dosing Information

Usual Adult Dose for Anesthesia:

Parenteral:
Intravenous:
Induction: 1 to 4.5 mg/kg; alternatively, 1 to 2 mg/kg at a rate of 0.5 mg/kg/min may be used. (2 mg/kg dose provides 5 to 10 minutes of surgical anesthesia within 30 seconds following injection).
Maintenance: The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.
Intramuscular:
Induction: 6.5 to 13 mg/kg; (9 to 13 mg/kg dose provides 12 to 25 minutes of surgical anesthesia within 3 to 4 minutes following injection).
Maintenance: The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.

What other drugs will affect ketamine?

Before you receive ketamine, tell your doctor if you have recently used any of the following:

a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

narcotic medication such as fentanyl (Actiq, Duragesic, Ionsys), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid, Palladone), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin, Oramorph), oxycodone (OxyContin, Percocet, Roxicodone), propoxyphene (Darvocet, Darvon), and others.

If you are using any of these drugs, it may take you longer to recover from anesthesia with ketamine.

There may be other drugs that can affect ketamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More ketamine resources Ketamine Side Effects (in more detail) Ketamine Dosage Ketamine Use in Pregnancy & Breastfeeding Ketamine Drug Interactions Ketamine Support Group 5 Reviews for Ketamine - Add your own review/rating Ketamine MedFacts Consumer Leaflet (Wolters Kluwer) Ketalar Prescribing Information (FDA) Compare ketamine with other medications Anesthesia Pain Where can I get more information? Your doctor or pharmacist can provide more information about ketamine.

See also: ketamine side effects (in more detail)


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Ziprasidone


Pronunciation: zi-PRAS-i-done
Generic Name: Ziprasidone
Brand Name: Geodon

Ziprasidone is an atypical antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Ziprasidone is not approved to treat mental problems caused by dementia. Discuss any questions or concerns with your doctor.


Ziprasidone is used for:

Treating acute agitation in patients with schizophrenia who require an injectable medicine. It may also be used for other conditions as determined by your doctor.

Ziprasidone is an antipsychotic. It may work by altering the balance of certain chemicals that occur naturally in the brain, which are responsible for thinking and behavior.

Do NOT use Ziprasidone if: you are allergic to any ingredient in Ziprasidone you have recently had a heart attack, have severe heart failure, or have a history of certain types of irregular heartbeat (eg, long QT syndrome) you are taking astemizole, cisapride, dofetilide, droperidol, halofantrine, levomethadyl, a macrolide immunosuppressive (eg, tacrolimus), mefloquine, methadone, nilotinib, pentamidine, certain phenothiazines (eg, thioridazine), pimozide, probucol, procainamide, quinidine, certain quinolone antibiotics (eg, moxifloxacin), a serotonin receptor antagonist antiemetic (eg, dolasetron), sotalol, sparfloxacin, terfenadine, or tetrabenazine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ziprasidone:

Some medical conditions may interact with Ziprasidone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have considered or attempted suicide if you have had any problems with fainting or dizziness if you have a history of heart problems (eg, heart failure, slow or irregular heartbeat), low blood potassium or magnesium levels, low blood volume, low white blood cell counts, a drug-induced movement disorder, diabetes, kidney or liver problems, stroke, heart attack, low blood pressure, seizures, difficulty swallowing, neuroleptic malignant syndrome (NMS), Alzheimer disease, or dementia if you have diabetes or a family history of diabetes or if you are very overweight if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk for breast cancer if you are dehydrated, drink alcohol, or will be exposed to high temperatures

Some MEDICINES MAY INTERACT with Ziprasidone. Tell your health care provider if you are taking any other medicines, especially any of the following:

Arsenic, astemizole, bepridil, chloroquine, cisapride, class III antiarrhythmics (eg, amiodarone, sotalol), dofetilide, domperidone, droperidol, halofantrine, haloperidol, IA and IC antiarrhythmics (eg, flecainide, procainamide, propafenone, quinidine), kinase inhibitors (eg, lapatinib, nilotinib), levomethadyl , macrolide immunosuppressives (eg, tacrolimus), macrolides and ketolides (eg, azithromycin, erythromycin), maprotiline, mefloquine, methadone, pentamidine, phenothiazines (eg, thioridazine), pimozide, probucol, quinolones (eg, ciprofloxacin, moxifloxacin), serotonin receptor antagonist antiemetics (eg, dolasetron), sparfloxacin, streptogramins (eg, mitomycin, pristinamycin), terfenadine, or tetrabenazine because the risk of side effects such as abnormal heart rhythms may be increased Tramadol because the risk of seizures may be increased Ketoconazole because it may increase the risk of Ziprasidone's side effects Carbamazepine because it may decrease Ziprasidone's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ziprasidone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ziprasidone:

Use Ziprasidone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ziprasidone is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Ziprasidone at home, a health care provider will teach you how to use it. Be sure you understand how to use Ziprasidone. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Ziprasidone if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Ziprasidone, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Ziprasidone.

Important safety information: Ziprasidone may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Ziprasidone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ziprasidone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Ziprasidone may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Do not become overheated in hot weather or while you are being active; heatstroke may occur. Ziprasidone may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens. Ziprasidone is intended for short-term control of acute agitation symptoms. If you require continuous treatment for your condition, your doctor may switch you to an oral medicine. Ziprasidone may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. Ziprasidone may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. Diabetes patients - Ziprasidone may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Serotonin syndrome is a possibly fatal syndrome that can be caused by Ziprasidone. Your risk may be greater if you take Ziprasidone with certain other medicines (eg, "triptans," monoamine oxidase inhibitors [MAOIs]). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms. NMS is a possibly fatal syndrome that can be caused by Ziprasidone. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms. Ziprasidone may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breast, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms. Some patients who take Ziprasidone may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Ziprasidone in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Ziprasidone. Lab tests, including electrolyte levels, complete blood cell counts (CBC), or fasting blood sugar levels, may be performed while you use Ziprasidone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Ziprasidone with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness and lightheadedness upon sitting or standing up and uncontrolled muscle movements. Ziprasidone should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Ziprasidone while you are pregnant. Using Ziprasidone during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if Ziprasidone is found in breast milk. Do not breast-feed while taking Ziprasidone. Possible side effects of Ziprasidone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth; feeling unusually tired or sleepy; headache; increased cough or runny nose; loss of appetite; nausea; pain at the injection site; restlessness; upset stomach; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; change in amount of urine produced; confusion; decreased sexual ability; difficulty speaking or swallowing; enlarged breasts; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; inability to move; missed menstrual period; muscle rigidity; muscle spasms or twitching; nipple discharge; pounding in the chest; prolonged or painful erection; seizures; shortness of breath; suicidal thoughts or attempts; sweating; symptoms of high blood sugar (increased thirst, increased urination, confusion, flushing, rapid breathing, or fruity breath odor); tremor; uncontrolled movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual mood or mental changes; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ziprasidone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; irregular heartbeat; seizure; slurring of speech; uncontrolled movement of the head and neck.

Proper storage of Ziprasidone:

Ziprasidone is usually handled and stored by a health care provider. If you are using Ziprasidone at home, store Ziprasidone as directed by your pharmacist or health care provider. Keep Ziprasidone, as well as needles and syringes, out of the reach of children and away from pets.

General information: If you have any questions about Ziprasidone, please talk with your doctor, pharmacist, or other health care provider. Ziprasidone is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ziprasidone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Ziprasidone resources Ziprasidone Side Effects (in more detail) Ziprasidone Use in Pregnancy & Breastfeeding Ziprasidone Drug Interactions Ziprasidone Support Group 86 Reviews for Ziprasidone - Add your own review/rating Ziprasidone Professional Patient Advice (Wolters Kluwer) Ziprasidone Monograph (AHFS DI) ziprasidone Advanced Consumer (Micromedex) - Includes Dosage Information Geodon Prescribing Information (FDA) Geodon Consumer Overview Compare Ziprasidone with other medications Autism Bipolar Disorder Body Dysmorphic Disorder Paranoid Disorder Schizoaffective Disorder Schizophrenia Tourette's Syndrome
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Videx


didanosine
Dosage Form: powder for oral solution
FULL PRESCRIBING INFORMATION WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS

Fatal and nonfatal pancreatitis has occurred during therapy with Videx used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Videx should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis [see Warnings and Precautions (5.1)].

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk [see Warnings and Precautions (5.2)].

Indications and Usage for Videx

Videx® (didanosine, USP), also known as ddI, in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14)].

Videx Dosage and Administration

Videx should be administered on an empty stomach, at least 30 minutes before or 2 hours after eating.

Recommended Dosage (Adult and Pediatric Patients)

The preferred dosing frequency of Videx is twice daily because there is more evidence to support the effectiveness of this dosing regimen. Once-daily dosing should be considered only for patients whose management requires once-daily dosing of Videx [see Clinical Studies (14)]. The recommended adult total daily dose is based on body weight (kg) (see Table 1).

Table 1: Recommended Dosage (Adult) at least 60 kg less than 60 kg Preferred dosing 200 mg twice daily 125 mg twice daily Dosing for patients whose management requires once-daily frequency 400 mg once daily 250 mg once daily

Pediatric Patients (2 weeks old to 18 years old): The recommended dose of Videx (didanosine) in pediatric patients between 2 weeks old and 8 months old is 100 mg/m2 twice daily, and the recommended Videx dose for pediatric patients greater than 8 months old is 120 mg/m2 twice daily but not to exceed the adult dosing recommendation.

Dosing recommendations in patients less than 2 weeks of age cannot be made because the pharmacokinetics of didanosine in these children are too variable to determine an appropriate dose. There are no data on once-daily dosing of Videx in pediatric patients.

Renal Impairment Adult Patients

In adult patients with impaired renal function, the dose of Videx should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of Videx in adult patients with renal insufficiency are presented in Table 2.

Table 2: Recommended Dosage in Patients with Renal Impairment Creatinine Clearance
(mL/min) Recommended Videx Dose by Patient Weight at least 60 kg less than 60 kg a 400 mg once daily (at least 60 kg) or 250 mg once daily (less than 60 kg) for patients whose management requires once-daily frequency of administration. at least 60 200 mg twice dailya 125 mg twice dailya 30-59 200 mg once daily
or 100 mg twice daily 150 mg once daily
or 75 mg twice daily 10-29 150 mg once daily 100 mg once daily less than 10 100 mg once daily 75 mg once daily Pediatric Patients

Urinary excretion is also a major route of elimination of didanosine in pediatric patients, therefore the clearance of didanosine may be altered in pediatric patients with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of Videx in this patient population, a reduction in the dose should be considered (see Table 2).

Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis

For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance of less than 10 mL/min, shown in Table 2. It is not necessary to administer a supplemental dose of Videx following hemodialysis.

Dosage Adjustment Concomitant Therapy with Tenofovir Disoproxil Fumarate

In patients who are also taking tenofovir disoproxil fumarate, a dose reduction of Videx to 250 mg (adults weighing at least 60 kg with creatinine clearance of at least 60 mL/min) or 200 mg (adults weighing less than 60 kg with creatinine clearance of at least 60 mL/min) once daily is recommended. Videx and tenofovir disoproxil fumarate may be taken together in the fasted state. Alternatively, if tenofovir disoproxil fumarate is taken with food, Videx should be taken on an empty stomach (at least 30 minutes before food or 2 hours after food). The appropriate dose of Videx coadministered with tenofovir disoproxil fumarate in patients with creatinine clearance of less than 60 mL/min has not been established. ([See Drug Interactions (7) and Clinical Pharmacology (12.3)]; see the complete prescribing information for Videx EC (enteric-coated formulation of didanosine) for results of drug interaction studies of tenofovir disoproxil fumarate with reduced doses of the enteric-coated formulation of didanosine.)

Hepatic Impairment

No dose adjustment is required in patients with hepatic impairment [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

Dosage Forms and Strengths

Videx (didanosine, USP) Pediatric Powder for Oral Solution is supplied in 4- and 8-ounce glass bottles containing 2 g or 4 g of Videx, respectively.

Contraindications

These recommendations are based on either drug interaction studies or observed clinical toxicities.

Allopurinol

Coadministration of didanosine and allopurinol is contraindicated because systemic exposures of didanosine are increased, which may increase didanosine-associated toxicity [see Clinical Pharmacology (12.3)].

Ribavirin

Coadministration of didanosine and ribavirin is contraindicated because exposures of the active metabolite of didanosine (dideoxyadenosine 5?-triphosphate) are increased. Fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving both didanosine and ribavirin.

Warnings and Precautions Pancreatitis

Fatal and nonfatal pancreatitis has occurred during therapy with Videx used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Videx should be suspended in patients with signs or symptoms of pancreatitis and discontinued in patients with confirmed pancreatitis. Patients treated with Videx in combination with stavudine may be at increased risk for pancreatitis.

When treatment with life-sustaining drugs known to cause pancreatic toxicity is required, suspension of Videx (didanosine) therapy is recommended. In patients with risk factors for pancreatitis, Videx should be used with extreme caution and only if clearly indicated. Patients with advanced HIV-1 infection, especially the elderly, are at increased risk of pancreatitis and should be followed closely. Patients with renal impairment may be at greater risk for pancreatitis if treated without dose adjustment. The frequency of pancreatitis is dose related. [See Adverse Reactions (6).]

Lactic Acidosis/Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk [see Use in Specific Populations (8.1)]. Particular caution should be exercised when administering Videx to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with Videx should be suspended in any patient who develops clinical signs or symptoms with or without laboratory findings consistent with symptomatic hyperlactatemia, lactic acidosis, or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

Hepatic Toxicity

The safety and efficacy of Videx have not been established in HIV-infected patients with significant underlying liver disease. During combination antiretroviral therapy, patients with preexisting liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities, including severe and potentially fatal hepatic adverse events, and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.

Hepatotoxicity and hepatic failure resulting in death were reported during postmarketing surveillance in HIV-infected patients treated with hydroxyurea and other antiretroviral agents. Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine, and stavudine. This combination should be avoided. [See Adverse Reactions (6).]

Non-cirrhotic Portal Hypertension

Postmarketing cases of non-cirrhotic portal hypertension have been reported, including cases leading to liver transplantation or death. Cases of didanosine-associated non-cirrhotic portal hypertension were confirmed by liver biopsy in patients with no evidence of viral hepatitis. Onset of signs and symptoms ranged from months to years after start of didanosine therapy. Common presenting features included elevated liver enzymes, esophageal varices, hematemesis, ascites, and splenomegaly.

Patients receiving Videx should be monitored for early signs of portal hypertension (eg, thrombocytopenia and splenomegaly) during routine medical visits. Appropriate laboratory testing including liver enzymes, serum bilirubin, albumin, complete blood count, and international normalized ratio (INR) and ultrasonography should be considered. Videx should be discontinued in patients with evidence of non-cirrhotic portal hypertension.

Peripheral Neuropathy

Peripheral neuropathy, manifested by numbness, tingling, or pain in the hands or feet, has been reported in patients receiving Videx therapy. Peripheral neuropathy has occurred more frequently in patients with advanced HIV disease, in patients with a history of neuropathy, or in patients being treated with neurotoxic drug therapy, including stavudine. Discontinuation of Videx should be considered in patients who develop peripheral neuropathy. [See Adverse Reactions (6).]

Retinal Changes and Optic Neuritis

Retinal changes and optic neuritis have been reported in adult and pediatric patients. Periodic retinal examinations should be considered for patients receiving Videx [see Adverse Reactions (6)].

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Videx. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.

 Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barr? syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

Fat Redistribution

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections:

Pancreatitis [see Boxed Warning, Warnings and Precautions (5.1)] Lactic acidosis/severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions (5.2)] Hepatic toxicity [see Warnings and Precautions (5.3)] Non-cirrhotic portal hypertension [see Warnings and Precautions (5.4)] Peripheral neuropathy [see Warnings and Precautions (5.5)] Retinal changes and optic neuritis [see Warnings and Precautions (5.6)] Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

Selected clinical adverse reactions that occurred in adult patients in clinical studies with Videx are provided in Tables 3 and 4.

Table 3: Selected Clinical Adverse Reactions from Monotherapy Studies   Percent of Patients*   ACTG 116A ACTG 116B/117 Adverse Reactions Videx
n=197 zidovudine
n=212 Videx
n=298 zidovudine
n=304 *  The incidences reported included all severity grades and all reactions regardless of causality. Diarrhea 19 15 28 21 Peripheral Neurologic
  Symptoms/Neuropathy 17 14 20 12 Abdominal Pain 13 8 7 8 Rash/Pruritus 7 8 9 5 Pancreatitis 7 3 6 2 Table 4: Selected Clinical Adverse Reactions from Combination Studies   Percent of Patientsa,c   AI454-148b START 2b
Adverse Reactions Videx +
stavudine +
nelfinavir
n=482 zidovudine +
lamivudine +
nelfinavir
n=248 Videx +
stavudine +
indinavir
n=102 zidovudine +
lamivudine +
indinavir
n=103 a  Percentages based on treated subjects. b  Median duration of treatment 48 weeks. c  The incidences reported included all severity grades and all reactions regardless of causality. *  This event was not observed in this study arm. Diarrhea 70 60 45 39 Nausea 28 40 53 67 Peripheral Neurologic
  Symptoms/Neuropathy 26 6 21 10 Headache 21 30 46 37 Rash 13 16 30 18 Vomiting 12 14 30 35 Pancreatitis (see below) 1 * less than 1 *

Pancreatitis resulting in death was observed in one patient who received Videx (didanosine) plus stavudine plus nelfinavir in Study Al454-148 and in one patient who received Videx plus stavudine plus indinavir in the START 2 study. In addition, pancreatitis resulting in death was observed in 2 of 68 patients who received Videx plus stavudine plus indinavir plus hydroxyurea in an ACTG clinical trial [see Warnings and Precautions (5)].

The frequency of pancreatitis is dose related. In phase 3 studies, incidence ranged from 1% to 10% with doses higher than are currently recommended and from 1% to 7% with recommended dose.

Selected laboratory abnormalities in clinical studies with Videx are shown in Tables 5-7.

Table 5: Selected Laboratory Abnormalities from Monotherapy Studies   Percent of Patients   ACTG 116A ACTG 116B/117 Parameter Videx
n=197 zidovudine
n=212 Videx
n=298 zidovudine
n=304 ULN = upper limit of normal. SGOT (AST) (greater than 5 x ULN) 9 4 7 6 SGPT (ALT) (greater than 5 x ULN) 9 6 6 6 Alkaline phosphatase (greater than 5 x ULN) 4 1 1 1 Amylase (at least 1.4 x ULN) 17 12 15 5 Uric acid (greater than 12 mg/dL) 3 1 2 1 Table 6: Selected Laboratory Abnormalities from Combination Studies (Grades 3-4)   Percent of Patientsa   AI454-148b START 2b Parameter Videx +
stavudine +
nelfinavir
n=482 zidovudine +
lamivudine +
nelfinavir
n=248 Videx +
stavudine +
indinavir
n=102 zidovudine +
lamivudine +
indinavir
n=103 ULN = upper limit of normal. NC = Not Collected. a  Percentages based on treated subjects. b  Median duration of treatment 48 weeks. Bilirubin (greater than 2.6 x ULN) less than 1 less than 1 16 8 SGOT (AST) (greater than 5 x ULN) 3 2 7 7 SGPT (ALT) (greater than 5 x ULN) 3 3 8 5 GGT (greater than 5 x ULN) NC NC 5 2 Lipase (greater than 2 x ULN) 7 2 5 5 Amylase (greater than 2 x ULN) NC NC 8 2 Table 7: Selected Laboratory Abnormalities from Combination Studies (All Grades)   Percent of Patientsa   AI454-148b START 2b Parameter Videx +
stavudine +
nelfinavir
n=482 zidovudine +
lamivudine +
nelfinavir
n=248 Videx +
stavudine +
indinavir
n=102 zidovudine +
lamivudine +
indinavir
n=103 NC = Not Collected. a  Percentages based on treated subjects. b  Median duration of treatment 48 weeks. Bilirubin 7 3 68 55 SGOT (AST) 42 23 53 20 SGPT (ALT) 37 24 50 18 GGT NC NC 28 12 Lipase 17 11 26 19 Amylase NC NC 31 17 Pediatric Patients

In clinical trials, 743 pediatric patients between 2 weeks and 18 years of age have been treated with didanosine. Adverse reactions and laboratory abnormalities reported to occur in these patients were generally consistent with the safety profile of didanosine in adults.

In pediatric phase 1 studies, pancreatitis occurred in 2 of 60 (3%) patients treated at entry doses below 300 mg/m2/day and in 5 of 38 (13%) patients treated at higher doses. In study ACTG 152, pancreatitis occurred in none of the 281 pediatric patients who received didanosine 120 mg/m2 every 12 hours and in less than 1% of the 274 pediatric patients who received didanosine 90 mg/m2 every 12 hours in combination with zidovudine [see Clinical Studies (14)].

Retinal changes and optic neuritis have been reported in pediatric patients.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of didanosine. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to Videx, or a combination of these factors.

  Blood and Lymphatic System Disorders – anemia, leukopenia, and thrombocytopenia.      Body as a Whole – alopecia, anaphylactoid reaction, asthenia, chills/fever, pain, and redistribution/accumulation of body fat [see Warnings and Precautions (5.8)].      Digestive Disorders – anorexia, dyspepsia, and flatulence.      Exocrine Gland Disorders – pancreatitis (including fatal cases) [see Boxed Warning, Warnings and Precautions (5.1)], sialoadenitis, parotid gland enlargement, dry mouth, and dry eyes.      Hepatobiliary Disorders – symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis [see Boxed Warning, Warnings and Precautions (5.2)]; non-cirrhotic portal hypertension [see Warnings and Precautions (5.4)]; hepatitis and liver failure.      Metabolic Disorders – diabetes mellitus, hypoglycemia, and hyperglycemia.      Musculoskeletal Disorders – myalgia (with or without increases in creatine kinase), rhabdomyolysis including acute renal failure and hemodialysis, arthralgia, and myopathy.      Ophthalmologic Disorders – retinal depigmentation and optic neuritis [see Warnings and Precautions (5.6)]. Use with Stavudine- and Hydroxyurea-Based Regimens

When didanosine is used in combination with other agents with similar toxicities, the incidence of these toxicities may be higher than when didanosine is used alone. Thus, patients treated with Videx in combination with stavudine, with or without hydroxyurea, may be at increased risk for pancreatitis and hepatotoxicity, which may be fatal, and severe peripheral neuropathy [see Warnings and Precautions (5)]. The combination of Videx and hydroxyurea, with or without stavudine, should be avoided.

Drug Interactions Established Drug Interactions

Clinical recommendations based on the results of drug interaction studies are listed in Table 8. Pharmacokinetic results of drug interaction studies are shown in Tables 12 and 13 [see Contraindications (4.1 and 4.2), Clinical Pharmacology (12.3)]. 

Table 8: Established Drug Interactions with Videx Drug Effect Clinical Comment ?  Indicates increase. ?  Indicates decrease. a  The dosing recommendation for coadministration of Videx EC and tenofovir disoproxil fumarate with respect to meal consumption differs from that of Videx. See the complete prescribing information for Videx EC. ciprofloxacin ? ciprofloxacin concentration Administer Videx at least 2 hours after or 6 hours before ciprofloxacin. delavirdine ? delavirdine concentration Administer Videx 1 hour after delavirdine. ganciclovir ? didanosine concentration If there is no suitable alternative to ganciclovir, then use in combination with Videx with caution. Monitor for didanosine-associated toxicity. indinavir ? indinavir concentration Administer Videx 1 hour after indinavir. methadone ? didanosine concentration Do not coadminister methadone with Videx pediatric powder due to significant decreases in didanosine concentrations. If coadministration of methadone and didanosine is necessary, the recommended formulation of didanosine is Videx EC. Patients should be closely monitored for adequate clinical response when Videx EC is coadministered with methadone, including monitoring for changes in HIV RNA viral load. nelfinavir No interaction 1 hour after didanosine Administer nelfinavir 1 hour after Videx. tenofovir disoproxil fumarate ? didanosine concentration A dose reduction of Videx to the following dosage once daily is recommended.a
250 mg (adults weighing at least 60 kg with creatinine clearance of at least 60 mL/min) 200 mg (adults weighing less than 60 kg with creatinine clearance of at least 60 mL/min) Videx and tenofovir disoproxil fumarate may be taken together in the fasted state. If tenofovir disoproxil fumarate is taken with food, Videx should be taken on an empty stomach (at least 30 minutes before food or 2 hours after food). Patients should be monitored for didanosine-associated toxicities and clinical response.

Exposure to didanosine is increased when coadministered with tenofovir disoproxil fumarate [Table 8 and see Clinical Pharmacokinetics (12.3, Table 12)]. Increased exposure may cause or worsen didanosine-related clinical toxicities, including pancreatitis, symptomatic hyperlactatemia/lactic acidosis, and peripheral neuropathy. Coadministration of tenofovir disoproxil fumarate with Videx should be undertaken with caution, and patients should be monitored closely for didanosine-related toxicities and clinical response. Videx should be suspended if signs or symptoms of pancreatitis, symptomatic hyperlactatemia, or lactic acidosis develop [see Dosage and Administration (2.3), Warnings and Precautions (5)]. Suppression of CD4 cell counts has been observed in patients receiving tenofovir disoproxil fumarate with didanosine at a dose of 400 mg daily.

Predicted Drug Interactions

Predicted drug interactions with Videx are listed in Table 9.

Table 9: Predicted Drug Interactions with Videx Drug or Drug Class Effect Clinical Comment ?  Indicates increase. ?  Indicates decrease. a  Only if other drugs are not available and if clearly indicated. If treatment with life-sustaining drugs that cause pancreatic toxicity is required, suspension of Videx is recommended [see Warnings and Precautions (5.1)]. b  [See Warnings and Precautions (5.6).] Drugs that may cause pancreatic toxicity ? risk of pancreatitis Use only with extreme cautiona Neurotoxic drugs ? risk of neuropathy Use with cautionb Antacids containing magnesium or aluminum ? side effects associated with antacid components Use caution with Videx Pediatric Powder for Oral Solution Azole antifungals ? ketoconazole or itraconazole concentration Administer drugs such as ketoconazole or itraconazole at least 2 hours before Videx. Quinolone antibiotics (see also ciprofloxacin in Table 8) ? quinolone concentration Consult package insert of the quinolone. Tetracycline antibiotics ? antibiotic concentration Consult package insert of the tetracycline. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at doses up to 12 and 14.2 times the estimated human exposure (based upon plasma levels), respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to didanosine. At approximately 12 times the estimated human exposure, didanosine was slightly toxic to female rats and their pups during mid and late lactation. These rats showed reduced food intake and body weight gains but the physical and functional development of the offspring was not impaired and there were no major changes in the F2 generation. A study in rats showed that didanosine and/or its metabolites are transferred to the fetus through the placenta. Animal reproduction studies are not always predictive of human response.

There are no adequate and well-controlled studies of didanosine in pregnant women. Didanosine should be used during pregnancy only if the potential benefit justifies the potential risk.

Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. It is unclear if pregnancy augments the risk of lactic acidosis/hepatic steatosis syndrome reported in nonpregnant individuals receiving nucleoside analogues [see Warnings and Precautions (5.2)]. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk. Healthcare providers caring for HIV-infected pregnant women receiving didanosine should be alert for early diagnosis of lactic acidosis/hepatic steatosis syndrome.

Antiretroviral Pregnancy Registry

To monitor maternal-fetal outcomes of pregnant women exposed to didanosine and other antiretroviral agents, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.

Nursing Mothers

The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV. A study in rats showed that following oral administration, didanosine and/or its metabolites were excreted into the milk of lactating rats. It is not known if didanosine is excreted in human milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving didanosine.

Pediatric Use

Use of didanosine in pediatric patients from 2 weeks of age through adolescence is supported by evidence from adequate and well-controlled studies of Videx in adult and pediatric patients [see Dosage and Administration (2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

Geriatric Use

In an Expanded Access Program for patients with advanced HIV infection, patients aged 65 years and older had a higher frequency of pancreatitis (10%) than younger patients (5%) [see Warnings and Precautions (5.1)]. Clinical studies of didanosine did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger subjects. Didanosine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. In addition, renal function should be monitored and dosage adjustments should be made accordingly [see Dosage and Administration (2.2)].

Renal Impairment

Patients with renal impairment (creatinine clearance of less than 60 mL/min) may be at greater risk of toxicity from didanosine due to decreased drug clearance [see Clinical Pharmacology (12.3)]. A dose reduction is recommended for these patients [see Dosage and Administration (2)].

Overdosage

There is no known antidote for Videx (didanosine) overdosage. In phase 1 studies, in which Videx was initially administered at doses ten times the currently recommended dose, toxicities included: pancreatitis, peripheral neuropathy, diarrhea, hyperuricemia, and hepatic dysfunction. Didanosine is not dialyzable by peritoneal dialysis, although there is some clearance by hemodialysis [see Clinical Pharmacology (12.3)].

Videx Description

Videx® is a brand name for didanosine, USP, a synthetic purine nucleoside analogue active against HIV-1.

Didanosine is available as Videx, a Pediatric Powder for Oral Solution [see How Supplied/Storage and Handling (16)] and as Videx® EC Delayed-Release Capsules, containing enteric-coated beadlets [consult prescribing information for Videx EC (didanosine)].

The chemical name for didanosine is 2?,3?-dideoxyinosine. The structural formula is:

Didanosine is a white crystalline powder with the molecular formula C10H12N4O3 and a molecular weight of 236.2. The aqueous solubility of didanosine at 25° C and pH of approximately 6 is 27.3 mg/mL. Didanosine is unstable in acidic solutions. For example, at pH less than 3 and 37° C, 10% of didanosine decomposes to hypoxanthine in less than 2 minutes.

Videx - Clinical Pharmacology Mechanism of Action

Didanosine is an antiviral agent [see Clinical Pharmacology (12.4)].

Pharmacokinetics

The pharmacokinetic parameters of didanosine are summarized in Table 10. Didanosine is rapidly absorbed, with peak plasma concentrations generally observed from 0.25 to 1.50 hours following oral dosing. Increases in plasma didanosine concentrations were dos


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methylnaltrexone


Generic Name: methylnaltrexone (METh IL nal TREX own)
Brand Names: Relistor

What is methylnaltrexone?

Methylnaltrexone is a special narcotic drug that blocks certain effects of other narcotic medicines.

Methylnaltrexone reduces constipation caused by narcotic medications that are often used to treat pain in people with terminal illness.

Methylnaltrexone works by preventing this side effect without reducing the pain-relieving effects of the narcotic.

Methylnaltrexone is usually given after laxatives have been tried without successful treatment of constipation.

Methylnaltrexone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about methylnaltrexone? You should not use this medication if you are allergic to methylnaltrexone, or if you have a blockage in your stomach or intestines.

Before you use methylnaltrexone, tell your doctor if you have severe or ongoing diarrhea.

Prepare your dose in a syringe only when you are ready to give yourself an injection. After loading a syringe, if you cannot give the injection right away keep it at room temperature and use it within 24 hours. Methylnaltrexone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. What should I discuss with my health care provider before receiving methylnaltrexone? You should not use this medication if you are allergic to methylnaltrexone, or if you have a blockage in your stomach or intestines.

To make sure you can safely use methylnaltrexone, tell your doctor if you have any of these other conditions:

cancer;

a stomach ulcer; or

colitis or other intestinal disorder.

FDA pregnancy category B. Methylnaltrexone is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether methylnaltrexone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How is methylnaltrexone used?

Methylnaltrexone is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication is usually given once every other day, but not more often than once every 24 hours.

Methylnaltrexone can produce a bowel movement within 30 minutes after injection.

Prepare your dose in a syringe only when you are ready to give yourself an injection. After loading a syringe, if you cannot give the injection right away keep it at room temperature and use it within 24 hours.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Methylnaltrexone should look clear or slightly yellow in color. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Store at room temperature away from moisture, heat, and light. Do not freeze. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use this medication more than once in a 24-hour period.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness, or feeling like you might pass out.

What should I avoid while using methylnaltrexone? Methylnaltrexone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not use any other laxatives that your doctor has not prescribed. Methylnaltrexone side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or ongoing diarrhea, stomach pain that will not go away, black or bloody stools, coughing up blood, or nausea or vomiting that are new or worsening symptoms.

Less serious side effects may include:

stomach pain, gas;

mild nausea or diarrhea;

dizziness; or

increased sweating.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Methylnaltrexone Dosing Information

Usual Adult Dose for Constipation -- Chronic:

Less than 38 kg: 0.15 mg/kg subcutaneously every other day as needed
38 to less than 62 kg: 8 mg subcutaneously every other day as needed
62 to 114 kg: 12 mg subcutaneously every other day as needed
More than 114 kg: 0.15 mg/kg subcutaneously every other day as needed
The usual schedule is one dose every other day, as needed, but no more frequently than one dose in a 24-hour period.

What other drugs will affect methylnaltrexone?

Before receiving methylnaltrexone, tell your doctor if you use any narcotic medication, such as:

buprenorphine (Buprenex, Subutex);

butorphanol (Stadol);

codeine (Tylenol with codeine);

hydrocodone (Lortab, Vicodin);

hydromorphone (Dilaudid);

levorphanol (Levo-Dromoran);

meperidine (Demerol);

methadone (Dolophine, Methadose);

morphine (Kadian, MS Contin, Roxanol);

nalbuphine (Nubain);

naloxone (Narcan);

oxycodone (OxyContin, Roxicodone, Percocet);

oxymorphone (Numorphan); or

propoxyphene (Darvon, Darvocet).

This list is not complete and other drugs may interact with methylnaltrexone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More methylnaltrexone resources Methylnaltrexone Side Effects (in more detail) Methylnaltrexone Use in Pregnancy & Breastfeeding Methylnaltrexone Support Group 7 Reviews for Methylnaltrexone - Add your own review/rating methylnaltrexone Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information Methylnaltrexone MedFacts Consumer Leaflet (Wolters Kluwer) Methylnaltrexone Bromide Monograph (AHFS DI) Relistor Prescribing Information (FDA) Relistor Consumer Overview Compare methylnaltrexone with other medications Constipation, Chronic Constipation, Drug Induced Where can I get more information? Your doctor or pharmacist can provide more information about methylnaltrexone.

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isoniazid, pyrazinamide, and rifampin


Generic Name: isoniazid, pyrazinamide, and rifampin (EYE soe NYE a zid, PIR a ZIN a mide, and rif AM pin)
Brand Names: Rifater

What is isoniazid, pyrazinamide, and rifampin?

Isoniazid, pyrazinamide, and rifampin are antibiotics. They prevent tuberculous bacteria from multiplying in your body.

The combination of isoniazid, pyrazinamide, and rifampin is used to treat tuberculosis (TB).

Isoniazid, pyrazinamide, and rifampin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about isoniazid, pyrazinamide, and rifampin? Take this medication for the full prescribed length of time. Your symptoms may get better before your infection is completely cleared. Isoniazid, pyrazinamide, and rifampin will not treat a viral infection such as the common cold or flu. Avoid drinking alcohol while taking isoniazid, pyrazinamide, and rifampin. Alcohol may increase your risk of liver damage. Isoniazid, pyrazinamide, and rifampin can make birth control pills less effective. Ask your doctor about using a different method of birth control while taking isoniazid, pyrazinamide, and rifampin. Avoid foods that are high in tyramine, listed in the "What should I avoid while taking isoniazid, pyrazinamide, and rifampin?" section of this leaflet. Tyramine can interact with this medication and cause unpleasant side effects. What should I discuss with my healthcare provider before taking isoniazid, pyrazinamide, and rifampin? You should not use this medication if you are allergic to isoniazid, pyrazinamide, or rifampin (Rifamate, Rifadin, Rimactane), or if you have:

severe liver disease;

active gout; or

if you have ever had drug fever, chills, and arthritis caused by taking this medication.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use isoniazid, pyrazinamide, and rifampin:

kidney disease; liver disease;

HIV;

porphyria;

gout;

diabetes; or

if you drink alcohol daily.

FDA pregnancy category C. It is not known whether isoniazid, pyrazinamide, and rifampin is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Isoniazid, pyrazinamide, and rifampin can make birth control pills less effective. Ask your doctor about using a different method of birth control to prevent pregnancy while taking isoniazid, pyrazinamide, and rifampin. Isoniazid, pyrazinamide, and rifampin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take isoniazid, pyrazinamide, and rifampin?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass (8 ounces) of water. Take isoniazid, pyrazinamide, and rifampin on an empty stomach, at least 1 hour before or 2 hours after a meal. Take this medication for the full prescribed length of time. Your symptoms may get better before your infection is completely cleared. Isoniazid, pyrazinamide, and rifampin will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your liver function will need to be checked with blood tests on a regular basis. You may also need routine eye exams during treatment. Do not miss any follow-up visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are taking isoniazid, pyrazinamide, and rifampin.

Store this medication at room temperature away from moisture and heat.

See also: Isoniazid, pyrazinamide, and rifampin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, slurred speech, hallucinations, and seizure.

What should I avoid while taking isoniazid, pyrazinamide, and rifampin? Avoid drinking alcohol while taking isoniazid, pyrazinamide, and rifampin. Alcohol may increase your risk of liver damage.

If you take an antacid, avoid taking it within 1 hour after you have taken isoniazid, pyrazinamide, and rifampin. Antacids can make it harder for your body to absorb rifampin.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, stop taking this medication and call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Certain foods can interact with isoniazid, pyrazinamide, and rifampin, causing unpleasant side effects. Avoid foods that are high in tyramine, including:

avocados, bananas, figs, raisins, and sauerkraut;

beef or chicken liver, fish, meats prepared with tenderizer, bologna, pepperoni, salami, summer sausage, game meat, meat extracts, caviar, dried fish, herring, and shrimp paste;

beer (alcoholic and nonalcoholic), red wine (especially Chianti), sherry, vermouth, and other distilled spirits;

caffeine (including coffee, tea, cola); and

cheeses, including American, blue, boursault, brick, brie, camembert, cheddar, emmenthaler, gruyere, mozzarella, parmesan, romano, roquefort, stilton, and Swiss;

chocolate;

ginseng;

sour cream and yogurt;

soy sauce, miso soup, bean curd, fava beans; or

yeast extracts.

Do not wear soft contact lenses while taking isoniazid, pyrazinamide, and rifampin. This medicine may turn certain body fluids a red color (including tears, saliva, urine, and sweat). While this is a harmless side effect, it may permanently stain contact lenses.

Isoniazid, pyrazinamide, and rifampin side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Isoniazid, pyrazinamide, and rifampin can cause severe liver symptoms. Stop taking this medication and call your doctor at once if you have any of these liver symptoms:

low fever;

nausea, stomach pain, loss of appetite;

dark urine, clay-colored stools; or

jaundice (yellowing of the skin or eyes).

Call your doctor at once if you have any other serious side effects such as:

fever, chills, body aches, flu symptoms, weakness, sores in your mouth and throat;

pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

feeling short of breath, feeling like you might pass out;

cough, chest pain or tightness;

diarrhea that is watery or bloody;

vision problems;

urinating less than usual or not at all; or

drowsiness, mood changes, increased thirst, swelling, weight gain.

Less serious side effects may include:

mild stomach pain, heartburn, diarrhea;

mild rash or itching;

muscle or joint pain;

drowsiness, dizziness, spinning sensation;

ringing in your ears; or

numbness or tingling in your legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Isoniazid, pyrazinamide, and rifampin Dosing Information

Usual Adult Dose for Tuberculosis -- Active:

44 kg or less: 4 tablets (200 mg isoniazid, 1200 mg pyrazinamide, and 480 mg rifampin total dose) orally once a day
45 to 54 kg: 5 tablets (250 mg isoniazid, 1500 mg pyrazinamide, and 600 mg rifampin total dose) orally once a day
55 kg or more: 6 tablets (300 mg isoniazid, 1800 mg pyrazinamide, and 720 mg rifampin total dose) orally once a day

Usual Pediatric Dose for Tuberculosis -- Active:

14 years or younger: The ratio of isoniazid, pyrazinamide, and rifampin in the combination tablet may not be appropriate; for example, isoniazid mg/kg doses are typically higher in pediatric patients than adults.
15 years or older:
44 kg or less: 4 tablets (200 mg isoniazid, 1200 mg pyrazinamide, and 480 mg rifampin total dose) orally once a day
45 to 54 kg: 5 tablets (250 mg isoniazid, 1500 mg pyrazinamide, and 600 mg rifampin total dose) orally once a day
55 kg or more: 6 tablets (300 mg isoniazid, 1800 mg pyrazinamide, and 720 mg rifampin total dose) orally once a day

What other drugs will affect isoniazid, pyrazinamide, and rifampin?

Many drugs can interact with isoniazid, pyrazinamide, and rifampin. Below is just a partial list. Tell your doctor if you are using:

cyclosporine (Gengraf, Neoral, Sandimmune);

haloperidol (Haldol);

nortriptyline (Pamelor),

probenecid (Benemid);

theophylline (Elixophyllin, Theo-24, Uniphyl);

an antibiotic such as ciprofloxacin (Cipro), clarithromycin (Biaxin), dapsone, erythromycin (E.E.S., Erythrocin, Ery-Tab), and others;

antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral);

a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

birth control pills or hormone replacement therapy;

a blood thinner such as warfarin (Coumadin);

diabetes medications you take by mouth;

heart or blood pressure medication such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), digoxin (Lanoxin), diltiazem (Cartia, Cardizem), metoprolol (Toprol), propranolol (Inderal), nifedipine (Procardia), verapamil (Covera, Isoptin, Verelan), and others;

heart rhythm medication such as disopyramide (Norpace), mexiletine (Mexitil), quinidine (Quinaglute, Quinidex, Quin-Release);

narcotic medications such as buprenorphine (Buprenex, Subutex), fentanyl (Actiq, Duragesic, Fentora), methadone (Dolophine, Methadose);

a sedative such as diazepam (Valium);

seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), primidone (Mysoline), valproic acid (Depakene);

a steroid such as prednisolone; or

a sulfa drug (Cotrim, Bactrim, Septra, SMX-TMP, and others).

There are many other medicines that can interact with isoniazid, pyrazinamide, and rifampin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you. More isoniazid, pyrazinamide, and rifampin resources Isoniazid, pyrazinamide, and rifampin Side Effects (in more detail) Isoniazid, pyrazinamide, and rifampin Dosage Isoniazid, pyrazinamide, and rifampin Use in Pregnancy & Breastfeeding Isoniazid, pyrazinamide, and rifampin Drug Interactions Isoniazid, pyrazinamide, and rifampin Support Group 0 Reviews for Isoniazid, pyrazinamide, and rifampin - Add your own review/rating Compare isoniazid, pyrazinamide, and rifampin with other medications Tuberculosis, Active Where can I get more information? Your pharmacist can provide more information about isoniazid, pyrazinamide, and rifampin.

See also: isoniazid, pyrazinamide, and rifampin side effects (in more detail)


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Phenytoin 250mg / 5ml Solution for Injection (Beacon Pharmaceuticals)


Phenytoin 250mg/5ml Solution For Injection

(Referred to in this leaflet as Phenytoin Injection)

Please read this leaflet carefully before receiving Phenytoin Injection. If you have already received Phenytoin Injection because of the urgency of your condition, you should still read this leaflet. This is particularly important if you are to continue to be given phenytoin Keep the leaflet in case you want to refer to it again If you want to know more about Phenytoin Injection or have any questions, you should ask your doctor. In this leaflet: 1. What Phenytoin Injection is used for 2. Before you are given Phenytoin Injection 3. How Phenytoin Injection should be given 4. Possible side effects 5. Storing Phenytoin Injection 6. Further information What Phenytoin Injection Is Used For

Phenytoin belongs to a group of medicines called anti-epileptic drugs.

Phenytoin injection is used to treat: severe epileptic seizures or fits (status epilepticus) and prevent seizures for short periods of time when anti-epileptics drugs cannot be taken by mouth or prevent seizures during or after brain surgery and/or severe head injury specific changes in the rhythm of the heart (cardiac arrhythmias), particularly when these are caused by the drug digoxin. Before You Are Given Phenytoin Injection You must NOT be given Phenytoin Injection and you should talk to your doctor immediately if you have: shown signs of hypersensitivity (severe allergy) to phenytoin, phenytoin sodium, other similar drugs (hydantoins) or any of the other ingredients in this medicine a heart condition called heart block Before you are given Phenytoin Injection, tell your doctor if you: have low blood pressure or heart failure have liver disease have diabetes have porphyria (an inherited blood disease) are due to have a surgical procedure, or if you are to be given the anaesthetic agent halothane as this may increase phenytoin levels are (or think you might be) pregnant or are breast-feeding drink large amounts of alcohol. You should limit the amount of alcohol you drink whilst being treated with phenytoin as the concentration in your blood can be altered with excess alcohol.

A small number of people being treated with anti-epileptics such as phenytoin have had thoughts of harming themselves. If at any time you have these thoughts, immediately contact your doctor. Taking/using other medicines

Before you are given Phenytoin Injection, tell your doctor if you taking medicines used to treat: epilepsy (carbamazepine, lamotrigine, phenobarbital, sodium valproate, succinimides e.g. ethosuximide, and vigabatrin) fungal infections (amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole) tuberculosis or other infections (chloramphenicol, isoniazid, rifampicin, sulphonamides, doxycycline and ciprofloxacin) pain and inflammation (phenylbutazone, steroids and salicylates e.g.aspirin) stomach ulcers (omeprazole, sucralfate, medicines known as H2 antagonists e.g. cimetidine, and some antacids) sleeplessness, depression or psychiatric disorders (chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine, methylphenidate, paroxetine, phenothiazines, trazodone, tricyclic antidepressants and viloxazine) heart and circulatory problems (dicoumarol, amiodarone, reserpine, digitoxin, furosemide, quinidine, warfarin and calcium channel blockers e.g. diltiazem, nifedipine) diabetes (tolbutamide), cancer, asthma or bronchitis (theophylline) Phenytoin may also interact with: hormone replacement therapy (oestrogens) the pill (oral contraceptive) methadone halothane (anaesthetic) muscle relaxants used in surgery ciclosporin (to prevent rejection of organ transplants) vitamin supplements such as Vitamin D and folic acid the herbal preparation St John’s wort.

Tell your doctor if you are taking, or have recently taken, any other medicines, including ones you have bought yourself.

Phenytoin may also interfere with certain laboratory tests that you may be given.

How Phenytoin Injection Should Be Given

You will be in hospital when you are given this medicine. Your doctor will decide on the dose and how it will be given to you.

A diluted solution will be either injected into one of your veins or, more rarely, into your muscle. The medicine is injected slowly into your vein or given as an infusion (drip) over a period of time.

Your heart rhythm, blood pressure and breathing will be monitored.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or nurse if you have any concerns.

Possible Side Effects

As with all medicines, phenytoin may cause some side effects in some patients.

Serious side effects

If any of the following happen, tell a doctor or nurse IMMEDIATELY as you may need urgent medical attention:

symptoms of a severe hypersensitivity syndrome which may include: itchy rash, swelling of the face, lips, tongue or throat (which may cause difficulty in swallowing or breathing), raised red patches on the skin, joint pain or fever irritation or burning sensation at the site of the injection rashes, which may be severe, resulting in painful reddening and blistering of the skin, eyes, mouth, anus or genital region and may lead to skin shedding. chest pains, palpitations or feeling faint joint pains If you experience any of the following side effects tell your doctor or nurse as soon as possible:

Effects on the nervous system including:

difficulty in controlling movements unsteadiness, shaking, nervousness uncoordinated movements unusual eye movements confusion, dizziness, slurred speech pins and needles, twitching muscles drowsiness, headaches sleeplessness loss of feeling in the hands and feet.

These effects may occur when the amount of phenytoin in your blood is too high. If you suffer with kidney or liver disease or are elderly you may experience these side effects at lower doses of phenytoin.

Very high amounts can cause extreme confusion, psychosis or encephalopathy (a brain disease), which may lead to irreversible brain injury. Your doctor should measure the amount of phenytoin in your blood and adjust your dose if necessary.

Effects on the skin:

minor skin rashes such as measles-like rash or dermatitis.

Tell your doctor if a rash does not clear up, recurs or you show signs of a serious reaction.

Other side effects: disorders or swelling of the lymph glands (part of your body’s defence system) blood disorders, which may be noticed as bruising, paleness, fever or sore throat liver damage or inflammation which may be recognised by yellowing of the eyes and skin inflammation of the kidneys breathing problems feeling sick, vomiting or constipation increased levels of blood sugar, decreased levels of folic acid and calcium the amount of vitamin D in your body may be altered. Other rare side effects: changes in the hand with difficulty straightening the fingers changes to facial features, enlarged gums or lips abnormal facial or body hair changes to the shape of the penis and painful erection.

Tell your doctor or nurse as soon as possible if you notice these or any side effect not mentioned in this leaflet.

Storing Phenytoin Injection

Keep out of the sight and reach of children.

Keep in the original packaging.

Do not use after the expiry date printed on the carton.

Further Information What is in this medicine:

Each 5 ml ampoule contains 250mg of the active ingredient phenytoin sodium.

The ampoules also contain propylene glycol, ethanol, sodium hydroxide and water.

What this medicine looks like and contents of the pack:

Phenytoin Injection is a clear liquid. Each pack contains 1 or 50 ampoules.

Marketing authorisation holder: Beacon Pharmaceuticals Ltd. Tunbridge Wells Kent TN1 1YG Manufacturer: Laboratorio Reig Jofr?, S.A Spain

Date of approval: 09/09/2008


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Loprazolam 1mg Tablets


LOPRAZOLAM 1MG TABLETS

Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect. In this leaflet: 1. What loprazolam is and what it is used for 2. Before you take loprazolam 3. How to take loprazolam 4. Possible side effects 5. How to store loprazolam 6. Further information What Loprazolam Is And What It Is Used For

The name of your medicine is Loprazolam 1mg Tablets (called loprazolam throughout this leaflet). Loprazolam contains a medicine called loprazolam mesylate.

This belongs to a group of medicines called hypnotics.

It works by acting on your brain to help you sleep.

Loprazolam is used to treat sleep problems such as:

Difficulty falling asleep Waking often during the night

Loprazolam is used for short term sleep problems.

Loprazolam is not meant to be used every day for long periods of time. Ask your doctor for advice if you are unsure.

Before You Take Loprazolam Do not take this medicine and tell your doctor if: You are allergic (hypersensitive) to loprazolam mesylate or any of the other ingredients of this medicine (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You are allergic (hypersensitive) to other benzodiazepines such as nitrazepam or temazepam You have a problem that causes severe muscle weakness (myasthenia gravis) Your lungs do not work properly You have heart problems You suffer from depression, anxiety or mental problems including phobias and obsessive disorders You have ever been addicted to alcohol You have a problem where you stop breathing for short periods at night (sleep apnoea)

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking loprazolam.

Take special care and check with your doctor or pharmacist before taking loprazolam if: You have any liver problems You have any kidney problems You have a history of drug abuse You have been told by your doctor that you have had or are likely to have a stroke You have been told by a doctor that you have a personality disorder You have recently taken loprazolam or other similar medicines for more than four weeks You do not feel you will ever be able to stop taking loprazolam or other medicines used to treat sleep problems

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking loprazolam.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because loprazolam can affect the way some other medicines work. Also some medicines can affect the way loprazolam works.

Tell your doctor if you are taking any of the following:

Medicines to treat stomach problems such as cisapride Medicines which relax muscles (neuromuscular depressants). These are often used during operations or in Intensive Care Units. Medicines for mental problems (antipsychotics) Medicines for depression Medicines for epilepsy (anticonvulsants) Medicines used in surgery (anaesthetics) Medicines to calm or reduce anxiety or for sleep problems (hypnotics) Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine Some medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol Taking loprazolam with food and drink Do not drink alcohol while you are taking loprazolam. Alcohol can increase the effects of loprazolam and make you sleep very deeply so that you do not breathe properly or have difficulty waking. Pregnancy and breast-feeding Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Do not take loprazolam if you are in the last 3 months of pregnancy or during labour because it may be harmful to your baby. However, in some cases your doctor may feel it is absolutely necessary for you to take this medicine during this time. Taking it during this time means your baby may be born with breathing difficulties, limp or weak muscles, a low body temperature (hypothermia) and may have withdrawal symptoms. Do not take loprazolam if you are breast-feeding or planning to breast-feed. This is because small amounts may pass into mother’s milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine may cause drowsiness, lack of concentration, muscle weakness and memory loss. If this happens do not drive or use any tools or machines.

Important information about some of the ingredients of loprazolam

Lactose: This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before having this medicine.

How To Take Loprazolam

Always take loprazolam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine Swallow the tablet whole with a drink of water Take just before bedtime You should not normally take loprazolam for more than 4 weeks. Adults

The usual dose is one tablet (1mg) just before bedtime. This dose may be increased by your doctor to one and a half tablets or 2 tablets (2mg).

Elderly or frail people

The starting dose is half a 1mg tablet just before bedtime. This dose may be increased by your doctor to one whole tablet.

Children

Do not give this medicine to children.

If you take more loprazolam than you should

If you take more loprazolam than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

If you forget to take loprazolam

Loprazolam must only be taken at bedtime. If you forget to take your tablet at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking loprazolam

Keep taking loprazolam until your doctor tells you to stop. Do not stop taking loprazolam suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time.

If you stop taking loprazolam suddenly, your sleep problems may come back and you may get a ‘withdrawal effect’. If this happens you may get some of the effects listed below.

See a doctor straight away if you get any of the following effects:

Feeling anxious, irritable, confused or restless Changes in your behaviour Depression (low mood) Sleep problems Headaches Possible Side Effects

Like all medicines, loprazolam can cause side effects, although not everybody gets them.

Stop taking loprazolam and see a doctor or go to a hospital straight away if: You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).
This may mean you are having an allergic reaction to loprazolam tablets Tell your doctor straightaway if you have any of the following side effects: Poor memory since taking loprazolam (amnesia) Thoughts of harming or killing yourself, depression (low mood) Limp or weak muscles Behavioural changes. This might include angry outbursts or feeling very excited Liver problems that may cause the eyes or skin to go yellow (jaundice) Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days: Skin rash Difficulty passing water (urine) Feeling unsteady or clumsy Feeling sick (nausea), stomach problems If you have recently suffered a bereavement you may find it more difficult to cope Feeling dizzy, sleepy or confused Headache Problems with your eyesight such as blurred vision Changes in your sex drive Feeling dizzy, light headed or faint. These effects are due to low blood pressure You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia)

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

How To Store Loprazolam Keep out of the reach and sight of children Do not store above 25°C Do not use loprazolam after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Store in the original package and protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Further Information What loprazolam 1mg Tablets contain

Each tablet contains 1mg of loprazolam mesylate as the active substance.

The other ingredients are lactose, povidone, colloidal silicon dioxide, maize starch, microcrystalline cellulose and magnesium stearate.

What loprazolam looks like and contents of the pack

Loprazolam tablets are pale yellow, biconvex tablets, with a score line on one side and either Dormonoct 1 or L1 on the other. They are supplied in cartons of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Winthrop Pharmaceuticals PO Box 611 GU1 4YS UK

Manufacturer

Patheon UK Limited Swindon Wiltshire SN3 5BZ

This leaflet was last revised in: January 2009

‘Winthrop’ is a registered trademark © 2009 Winthrop Pharmaceuticals.


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Lipobase


1. Name Of The Medicinal Product

Lipobase.

2. Qualitative And Quantitative Composition

Lipobase contains no active ingredient.

3. Pharmaceutical Form

Cream.

4. Clinical Particulars 4.1 Therapeutic Indications

For use where it is desired by the physician to reduce gradually the topical dosage of Locoid Lipocream. It may also be used where a continuously alternating application of the active product and the base is required e.g. in prophylactic therapy. Application of the Lipobase is also recommended where it is felt by the physician that the use of a bland emollient base is preferable to the cessation of therapy with the active product. Lipobase may also be used as a diluent for the active product in those cases where dilution is regarded as necessary by the prescriber. Lipobase may also be used other than in conjunction with a topical corticosteroid for its emollient action, and for the treatment of mild skin lesions such as pruritus or dry, scaly skin, where topical corticosteroid is not warranted.

4.2 Posology And Method Of Administration

For adults, children and the elderly: Lipobase may be used either by replacing an application of the active product or alternating the application of the active product and the base, gradually diminishing the application of the active product until therapy ceases, or by the application of the product for its emollient action.

4.3 Contraindications

None stated.

4.4 Special Warnings And Precautions For Use

A small number of people may be hypersensitive (allergic) to the constituents of Lipobase.

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Methyl parahydroxybenzoate may cause allergic skin reactions (possibly delayed).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

None stated.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

None stated.

4.9 Overdose

None stated.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The product acts topically as an emollient cream.

5.2 Pharmacokinetic Properties

Topical administration with no pharmacologically active constituents.

5.3 Preclinical Safety Data

No relevant preclinical safety data has been generated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Cetostearyl alcohol

Macrogol cetostearyl ether

Light liquid paraffin

White soft paraffin

Methyl parahydroxybenzoate

Sodium citrate, anhydrous

Citric acid, anhydrous

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

30g, 50g, 100g and 200g packs, 3 years.

200g and 500g packs, 2 years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Collapsible aluminium tube with plastic screw cap containing 30 g, 50 g, 100 g or 200 g; and pump dispenser containing 200 g or 500 g.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Astellas Pharma Ltd

Lovett House

Lovett Road

Staines

TW18 3AZ

United Kingdom

8. Marketing Authorisation Number(S)

PL0166/0125

9. Date Of First Authorisation/Renewal Of The Authorisation

First authorisation granted 19 February 1985

Renewal granted 23 January 2001.

10. Date Of Revision Of The Text

7th February 2007

11. Legal category

P


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Lamivudine/Zidovudine


Pronunciation: la-MIV-ue-deen/zye-DOE-vue-deen
Generic Name: Lamivudine/Zidovudine
Brand Name: Combivir

One of the 2 active ingredients in Lamivudine/Zidovudine, zidovudine, has been associated with certain blood disorders (eg, low white blood cell levels, severe anemia), especially in patients with advanced HIV disease, and muscle pain and inflammation, when it is used for long periods of time. High levels of lactic acid in the blood and severe liver problems, which may be life-threatening, have been reported with the use of Lamivudine/Zidovudine.

Some patients with both HIV and hepatitis B infection who were taking lamivudine have developed severe worsening of their hepatitis B after they stopped taking lamivudine. Patients who have both HIV and hepatitis B infection and who stop using Lamivudine/Zidovudine should have their liver function closely checked for at least several months after their last dose.


Lamivudine/Zidovudine is used for:

Treating HIV infection in combination with other medicines.

Lamivudine/Zidovudine is an antiviral combination. Lamivudine and zidovudine are both nucleoside analogues that work together to slow the growth of HIV by blocking an enzyme needed by the virus to reproduce.

Do NOT use Lamivudine/Zidovudine if: you are allergic to any ingredient in Lamivudine/Zidovudine you are also taking stavudine, zalcitabine, or other medicines containing lamivudine or zidovudine you have severe kidney problems, decreased liver function, abnormal liver function tests, or high levels of lactic acid in the blood (lactic acidosis)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lamivudine/Zidovudine:

Some medical conditions may interact with Lamivudine/Zidovudine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you weigh less than 66 lbs (30 kg) if you have a history of liver problems (eg, abnormal liver function tests, hepatitis B infection) or lactic acidosis if you have a history of kidney problems, a bone marrow disorder, pancreas problems, abnormal blood cell counts, or nerve or muscle problems if you are significantly overweight

Some MEDICINES MAY INTERACT with Lamivudine/Zidovudine. Tell your health care provider if you are taking any other medicines, especially any of the following:

Interferon alfa or ribavirin because serious liver problems may occur Stavudine because its effectiveness may be decreased by Lamivudine/Zidovudine Clarithromycin, doxorubicin, rifampin, or zalcitabine because they may decrease Lamivudine/Zidovudine's effectiveness Acetaminophen, ganciclovir, ibuprofen, methadone, probenecid, trimethoprim/sulfamethoxazole, valproic acid, vancomycin, or zalcitabine because they may increase the risk of Lamivudine/Zidovudine's side effects or toxic effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lamivudine/Zidovudine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lamivudine/Zidovudine:

Use Lamivudine/Zidovudine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Lamivudine/Zidovudine by mouth with or without food. Continue to use Lamivudine/Zidovudine even if you feel well. Do not miss any doses. Taking Lamivudine/Zidovudine at the same time each day will help you remember to take it. If you miss a dose of Lamivudine/Zidovudine, take it as soon as possible. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lamivudine/Zidovudine.

Important safety information: Lamivudine/Zidovudine may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Lamivudine/Zidovudine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. The risk of side effects may be greater and additional benefits may not be obtained if you take Lamivudine/Zidovudine in high doses. Do NOT take more than the recommended dose without checking with your doctor. Lamivudine/Zidovudine is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. Lamivudine/Zidovudine does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Lamivudine/Zidovudine, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat. Do not stop taking Lamivudine/Zidovudine without first checking with your doctor. Some conditions, including hepatitis B, may become worse if Lamivudine/Zidovudine is suddenly stopped. Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Lamivudine/Zidovudine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. Lab tests, including blood cell counts and liver and kidney function tests, may be performed while you use Lamivudine/Zidovudine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Lamivudine/Zidovudine should not be used in CHILDREN weighing less than 66 lbs (30 kg); safety and effectiveness in these children have not been confirmed. Caution is advised when using Lamivudine/Zidovudine in CHILDREN with a history of pancreatitis, or children who have taken other medicines for HIV infection. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lamivudine/Zidovudine while you are pregnant. Lamivudine/Zidovudine is found in breast milk. Do not breast-feed while taking Lamivudine/Zidovudine. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Lamivudine/Zidovudine to the baby. Possible side effects of Lamivudine/Zidovudine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; changes in body fat; cough; diarrhea; dizziness; fatigue; headache; indigestion; nasal problems; sleeplessness or other sleep problems; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; depression; fast or irregular heartbeat; infection (fever, chills, sore throat); inflammation of the pancreas (severe stomach pain, nausea, vomiting); joint pain; mental or mood changes; muscle pain; nausea; numbness, tingling, or weakness in arms or legs; seizures; shortness of breath; stomach tenderness or pain; swelling or soreness of the mouth or tongue; unusual bleeding or bruising; unusual tiredness; unusual weakness or exhaustion; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lamivudine/Zidovudine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; dizziness; drowsiness; headache; nausea; seizures; tiredness; vomiting.

Proper storage of Lamivudine/Zidovudine:

Store Lamivudine/Zidovudine at room temperature or in the refrigerator, between 36 and 86 degrees F (2 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lamivudine/Zidovudine out of the reach of children and away from pets.

General information: If you have any questions about Lamivudine/Zidovudine, please talk with your doctor, pharmacist, or other health care provider. Lamivudine/Zidovudine is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lamivudine/Zidovudine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Lamivudine/Zidovudine resources Lamivudine/Zidovudine Side Effects (in more detail) Lamivudine/Zidovudine Use in Pregnancy & Breastfeeding Drug Images Lamivudine/Zidovudine Drug Interactions Lamivudine/Zidovudine Support Group 1 Review for Lamivudine/Zidovudine - Add your own review/rating Compare Lamivudine/Zidovudine with other medications HIV Infection Nonoccupational Exposure Occupational Exposure
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isoniazid and rifampin


Generic Name: isoniazid and rifampin (eye so NYE a zid and RIF am pin)
Brand names: Rifamate, IsonaRif

What is isoniazid and rifampin?

Isoniazid and rifampin are antibiotics. They prevent tuberculous bacteria from multiplying in your body.

Isoniazid and rifampin are used together to treat tuberculosis (TB).

Isoniazid and rifampin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about isoniazid and rifampin? Take all of the isoniazid and rifampin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated. Avoid alcohol while taking isoniazid and rifampin. Alcohol will increase the risk of damage to your liver during treatment with this medication.

Call your doctor immediately if you experience a fever, chills, a sore throat, muscle and bone pain, a headache, excessive tiredness or weakness, numbness or tingling in your hands or feet, loss of appetite, nausea and vomiting, yellowing of your skin or eyes, darkening of your urine, unusual bleeding or bruising, a rash, or itching.

Take isoniazid and rifampin on an empty stomach 1 hour before or 2 hours after a meal. This medication may decrease the effectiveness of birth control pills. Talk to your doctor about using another form of birth control during treatment. Who should not take isoniazid and rifampin?

Before taking this medication, tell your doctor if you have

ever had an allergic reaction to isoniazid or rifampin;

disease;

liver disease; or

porphyria.

You may not be able to take isoniazid and rifampin, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether isoniazid and rifampin will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is also not known whether isoniazid and rifampin will harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. How should I take isoniazid and rifampin?

Take isoniazid and rifampin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass (8 ounces) of water. Take isoniazid and rifampin on an empty stomach one hour before or two hours after meals.

If nausea occurs, ask your doctor if you can take isoniazid and rifampin with food.

Take all of the isoniazid and rifampin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Your doctor may also want you to take a supplemental vitamin B6 (pyridoxine) tablet daily during treatment to prevent numbness and tingling caused by low levels of this vitamin.

Store this medication at room temperature away from moisture and heat.

See also: Isoniazid and rifampin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.

What happens if I overdose? Seek emergency medical attention.

Symptoms of an isoniazid and rifampin overdose include nausea, vomiting, abdominal pain, tiredness, dizziness, slurring of speech, yellow skin or eyes, blurred vision, visual hallucinations, seizures, coma, and death.

What should I avoid while taking isoniazid and rifampin?

Do not wear contact lenses while taking isoniazid and rifampin. Rifampin may turn your tears, sweat, saliva, urine, feces, and contact lenses a red-orange color. This effect may be permanent on contact lenses.

This medication may decrease the effectiveness of birth control pills. Talk to your doctor about using another form of birth control during treatment. Avoid alcohol while taking isoniazid and rifampin. Alcohol will increase the risk of damage to your liver during treatment with this medication.

Use caution with the foods listed below. They can interact with isoniazid and rifampin and cause a reaction that includes a severe headache, large pupils, neck stiffness, nausea, vomiting, diarrhea, flushing, sweating, itching, irregular heartbeats, and chest. A reaction will not necessarily occur, but eat these foods with caution until you know if you will react to them. Call your doctor immediately if you experience any of these symptoms.

Eat the following foods with caution:

cheeses, including american, blue, boursault, brick, brie, camembert, cheddar, emmenthaler, gruyere, mozzarella, parmesan, romano, roquefort, stilton, and swiss;

sour cream and yogurt;

beef or chicken liver, fish, meats prepared with tenderizer, bologna, pepperoni, salami, summer sausage, game meat, meat extracts, caviar, dried fish, herring, shrimp paste, and tuna;

avocados, bananas, figs, raisins, and sauerkraut;

soy sauce, miso soup, bean curd, and fava beans;

yeast extracts;

ginseng;

chocolate;

caffeine (coffee, tea, cola, etc.); and

beer (alcoholic and nonalcoholic), red wine (especially Chianti), sherry, vermouth, and other distilled spirits.

Isoniazid and rifampin side effects If you experience any of the following serious side effects, stop taking isoniazid and rifampin and seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

excessive tiredness or weakness;

nausea, vomiting, diarrhea, or loss of appetite;

yellow skin or eyes;

unusual bruising or bleeding;

dark urine;

little or no urine;

numbness or tingling in your hands or feet;

muscle or bone pain;

seizures;

blurred vision;

fever, chills, or a sore throat;

a headache;

a rash or itching; or

confusion or abnormal behavior.

Other, less serious side effects may be more likely to occur. Continue to take isoniazid and rifampin and talk to your doctor if you experience

red-orange coloration of tears, sweat, saliva, urine, or feces; or

mild tiredness or weakness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Isoniazid and rifampin Dosing Information

Usual Adult Dose for Tuberculosis -- Active:

2 capsules (300 mg isoniazid and 600 mg rifampin total dose) orally once a day administered 1 hour before or 2 hours after a meal
Duration: In general, treatment should continue until bacterial conversion and maximal improvement occur.

What other drugs will affect isoniazid and rifampin?

Before taking isoniazid and rifampin, tell your doctor if you are taking any of the following drugs:

antacids;

ketoconazole (Nizoral), fluconazole (Diflucan), or itraconazole (Sporanox);

disulfiram (Antabuse);

warfarin (Coumadin);

carbamazepine (Tegretol);

cycloserine (Seromycin);

phenytoin (Dilantin), ethotoin (Peganone), and mephenytoin (Mesantoin);

meperidine (Demerol);

benzodiazepines such as alprazolam (Xanax), diazepam (Valium), lorazepam (Ativan), and temazepam (Restoril).

acetaminophen (Tylenol, others);

blood thinners such as warfarin (Coumadin);

barbiturates such as phenobarbital (Luminal, Solfoton), amobarbital (Amytal), secobarbital (Seconal), and butabarbital (Butisol);

beta-blockers such as atenolol (Tenormin), propranolol (Inderal), and metoprolol (Lopressor);

heart medicines such as digoxin (Lanoxin), disopyramide (Norpace), quinidine (Quinora, Quinidex, Cardioquin, others), mexiletine (Mexitil), tocainide (Tonocard), verapamil (Calan, Verelan, Isoptin), and enalapril (Vasotec);

corticosteroids such as prednisone (Deltasone, Orasone, Meticorten), prednisolone (Delta Cortef, Prelone, others), methylprednisolone (Medrol), and betamethasone (Celestone);

sulfonylureas such as glipizide (Glucotrol), glyburide (Micronase, Diabeta, Glynase), chlorpropamide (Diabinese), tolbutamide (Orinase), and tolazamide (Tolinase);

sulfa medicines such as sulfamethoxazole (Bactrim, Septra, Gantanol, Azo-Gantanol), and sulfisoxazole (Gantrisin, Azo-Gantrisin);

the HIV and AIDS medicines delavirdine (Rescriptor), saquinavir (Invirase), ritonavir (Norvir), indinavir (Crixivan), nelfinavir (Viracept), and zidovudine (Retrovir);

estrogens such as Premarin, Ogen, Estrace, Menest, Estratab, Ortho-Est, and others;

oral birth control pills such as Triphasil, Ortho-Novum, Ortho-Cyclen, Ortho-Tri-Cyclen, Ovral, Lo/Ovral, Desogen, Nordette, Levora, Levlen, Tri-Levlen, Nelova, Norinyl, Brevicon, Ovcon, Loestrin, Demulen, and others;

phenytoin (Dilantin), ethotoin (Peganone), and mephenytoin (Mesantoin);

theophylline (Theolair, Theo-Dur, Theochron, Theo-Bid, others);

methadone (Dolophine);

clofibrate (Atromid-S); or

cyclosporine (Sandimmune, Neoral).

You may not be able to take isoniazid and rifampin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with isoniazid and rifampin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More isoniazid and rifampin resources Isoniazid and rifampin Side Effects (in more detail) Isoniazid and rifampin Dosage Isoniazid and rifampin Use in Pregnancy & Breastfeeding Isoniazid and rifampin Drug Interactions Isoniazid and rifampin Support Group 0 Reviews for Isoniazid and rifampin - Add your own review/rating Compare isoniazid and rifampin with other medications Tuberculosis, Active Where can I get more information? Your pharmacist has additional information about isoniazid and rifampin written for health professionals that you may read.

See also: isoniazid and rifampin side effects (in more detail)


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Sodium Fluoride Chewable Tablets



Fluoride Chewable Tablets 1 mg

Active Ingredient: 1 mg of fluoride ion from 2.2 mg of sodium fluoride (NaF).

Inactive Ingredients: Lactose, Saccharine, Cherry Flavor, D&C Red #7 Calcium Lake, Magnesium Stearate.

DOSAGE AND ADMINISTRATION:

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

STORAGE:

Store at a Controlled Room Temperature 20?-25?C (68?-77?F)

743634

Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043
Iss. 03/11   172-12

Container Label

NDC 51862-172-12

Fluoride Chewable Tablets

1 mg

(From 2.2 mg of Sodium Fluoride)

Cherry Flavor       120 Tablets       Rx Only

Libertas
Pharma Inc.


FLUORIDE 
fluoride  tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51862-172 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1 mg Inactive Ingredients Ingredient Name Strength CHERRY   LACTOSE   SACCHARIN   D&C RED NO. 7   MAGNESIUM STEARATE   Product Characteristics Color RED Score no score Shape ROUND Size 6mm Flavor CHERRY Imprint Code 172 Contains          Packaging # NDC Package Description Multilevel Packaging 1 51862-172-12 120 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/21/2011
Labeler - Libertas Pharma, Inc. (962128943) Revised: 05/2011Libertas Pharma, Inc.

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