i took malaria tablets and my breast ar painin what could be da cause?
 

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Antimalarial agents


Antimalarials agents are drugs effective in the treatment of malaria. Malaria is an infectious disease caused by the bite of an anopheles mosquito infected with certain protozoans. The best way to prevent malaria is by taking antimalarial drugs prophylactically prior to entering an endemic area.

Antimalarial agents are classified according to their action against different stages of the life cycle of the parasite. Certain antimalarial agents are more effective in the acute attack of malaria, and generally more that one agent will be used simultaneously to avoid resistance. Some antimalarial agents are used as prophylactic agents; they kill the parasite when it enters the host.

See also antimalarial combinations antimalarial quinolines miscellaneous antimalarials Drug List:
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Malaria Prevention (Malaria Prophylaxis) Medications


Drugs associated with Malaria Prevention

The following drugs and medications are in some way related to, or used in the treatment of Malaria Prevention. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List:/tags/aralen/
/tags/daraprim/
/tags/doxy-100/
/tags/fansidar/
/tags/malarone/
/tags/monodox/
/tags/oraxyl/
/tags/vibra-tabs/

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Antimalarial combinations


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Antimalarial combinations are products that contain more than one antimalarial agent in the one pill or dose. The different agents generally have different modes of action so attack the bacteria in different ways and in different stages of the life-cycle of the bacteria. These products give better antimicrobial action. Having more than one agent in one pill increases compliance and may prevent drug resistant strains of bacteria from emerging.

See also

Medical conditions associated with antimalarial combinations:

Malaria Malaria Prevention Pneumocystis Pneumonia Prophylaxis Drug List: Malarone Coartem Fansidar Malarone-Pediatric
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Miscellaneous antimalarials


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Antimalarials agents are drugs effective in the treatment of malaria. Malaria is an infectious disease caused by the bite of an anopheles mosquito infected with certain protozoans. The best way to prevent malaria is by taking antimalarial drugs prophylactically prior to entering an endemic area.

Antimalarial agents are classified according to their action against different stages of the life cycle of the parasite. Certain antimalarial agents are more effective in the acute attack of malaria, and generally more that one agent will be used simultaneously to avoid resistance. Some antimalarial agents are used as prophylactic agents; they kill the parasite when it enters the host.

See also

Medical conditions associated with miscellaneous antimalarials:

Acne Actinomycosis Amebiasis Anthrax Anthrax Prophylaxis Bacterial Infection Bartonellosis Bronchitis Brucellosis Bullous Pemphigoid Chlamydia Infection Cholera Cutaneous Bacillus anthracis Ehrlichiosis Enterocolitis Epididymitis, Sexually Transmitted Gastroenteritis Granuloma Inguinale Inclusion Conjunctivitis Lyme Disease Lyme Disease, Arthritis Lyme Disease, Carditis Lyme Disease, Erythema Chronicum Migrans Lyme Disease, Neurologic Lymphogranuloma Venereum Malaria Malaria Prevention Melioidosis Mycoplasma Pneumonia Nongonococcal Urethritis Ocular Rosacea Ornithosis Pelvic Inflammatory Disease Pemphigoid Pemphigus Periodontitis Plague Pleural Effusion Pneumocystis Pneumonia Prophylaxis Pneumonia Proctitis Prostatitis Psittacosis Rabbit Fever Rheumatoid Arthritis Rickettsial Infection Rosacea Skin Infection STD Prophylaxis Syphilis, Early Syphilis, Latent Tertiary Syphilis Toxoplasmosis Toxoplasmosis, Prophylaxis Trachoma Upper Respiratory Tract Infection Urinary Tract Infection Drug List: Oraxyl Doxy-100 Adoxa Doxy-200 Oracea Vibramycin Doryx-Delayed-Release-Capsules Monodox Adoxa-Ck-Kit Adoxa-Tt-Kit Alodox Avidoxy Daraprim Halfan Ocudox-Convenience-Kit Periostat Uracil Vibra-Tabs
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primaquine


Generic Name: primaquine (PRIM a kwin)
Brand Names:

What is primaquine?

Primaquine is an antimalarial drug. The exact way that primaquine works is unknown.

Primaquine is used to treat and prevent malaria.

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

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

Notify your doctor if your urine turns dark.

Use caution when driving or performing other hazardous activities until you know how this medication affects you. Primaquine may cause visual disturbances such as blurred vision, misty vision, and difficulty focusing. Report any vision or hearing changes to your doctor. Who should not take primaquine?

Before taking this medication, tell your doctor if you have

a history of an allergic reaction to previous primaquine therapy,

glucose-6-phosphate dehydrogenase (G-6-PD) deficiency,

rheumatoid arthritis,

lupus erythematosus, or

quinacrine (Atabrine) therapy.

You may not be able to take primaquine, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.

It is not known whether primaquine will harm an unborn baby. Do not take primaquine without first talking to your doctor if you are pregnant. It is not known how primaquine will affect a nursing baby. Do not take primaquine without first talking to your doctor if you are breast-feeding a baby. How should I take primaquine?

Take primaquine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take primaquine with food to lessen stomach upset. Store primaquine at room temperature away from moisture and heat.

See also: Primaquine dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose? Seek emergency medical attention.

Symptoms of a primaquine overdose include nausea, vomiting, stomach upset, and stomach cramps.

What should I avoid while taking primaquine? Use caution when driving or performing other hazardous activities until you know how this medication affects you. Primaquine may cause visual disturbances such as blurred vision, misty vision, and difficulty focusing. Report any vision or hearing changes to your doctor. Primaquine side effects Stop taking primaquine and seek emergency medical attention if you experience an allergic reaction (flushing; swelling of your lips, tongue, or face, difficulty breathing; closing of your throat; vision problems; a rash; or itching).

Notify your doctor if you experience darkening of your urine.

Nausea, stomach pain or upset, vomiting, and loss of appetite may also occur during therapy.

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.

Primaquine Dosing Information

Usual Adult Dose for Malaria:

Manufacturer recommendation: 15 mg base (26.3 mg salt) orally once a day for 14 days
Centers for Disease Control and Prevention (CDC) recommendation: 30 mg base (52.6 mg salt) orally once a day for 14 days; for patients with borderline glucose-6-phosphate dehydrogenase (G6PD) deficiency or as an alternative regimen, 45 mg base (78.9 mg salt) orally once a week for 8 weeks has been recommended

Usual Adult Dose for Malaria Prophylaxis:

Primary prophylaxis of malaria (including chloroquine-resistant malaria):
CDC recommendation: 30 mg base (52.6 mg salt) orally once a day
Primaquine should be taken 1 to 2 days before travel to malarious areas, while in such areas, and for 7 days after leaving the areas. It is generally used for short-duration travel to areas with primarily P vivax.
Terminal prophylaxis of P vivax or P ovale malaria:
Manufacturer recommendation: 15 mg base (26.3 mg salt) orally once a day for 14 days
CDC recommendation: 30 mg base (52.6 mg salt) orally once a day for 14 days

Usual Adult Dose for Pneumocystis Pneumonia:

15 to 30 mg base (26.3 to 52.6 mg salt) orally once a day for 21 days; effective in combination with clindamycin
Primaquine plus clindamycin is recommended as an alternative regimen by the CDC, National Institutes of Health (NIH), and Infectious Diseases Society of America (IDSA). Seriously ill patients should receive IV trimethoprim-sulfamethoxazole or pentamidine therapy.

Usual Pediatric Dose for Malaria:

Manufacturer recommendation: 0.3 mg/kg base (0.526 mg/kg salt) orally once a day for 14 days (not to exceed 15 mg base/day)
CDC recommendation: 0.5 mg/kg base (0.88 mg/kg salt) orally once a day for 14 days (not to exceed 30 mg base/day); for patients with borderline G6PD deficiency or as an alternative regimen, 0.75 mg/kg base (1.3 mg/kg salt) orally once a week for 8 weeks (not to exceed 45 mg base/week) has been recommended

Usual Pediatric Dose for Malaria Prophylaxis:

Primary prophylaxis of malaria (including chloroquine-resistant malaria):
CDC recommendation: 0.5 mg/kg base (0.88 mg/kg salt) orally once a day (not to exceed 30 mg base/day)
Primaquine should be taken 1 to 2 days before travel to malarious areas, while in such areas, and for 7 days after leaving the areas. It is generally used for short-duration travel to areas with primarily P vivax.
Terminal prophylaxis of P vivax or P ovale malaria:
Manufacturer recommendation: 0.3 mg/kg base (0.526 mg/kg salt) orally once a day for 14 days (not to exceed 15 mg base/day)
CDC recommendation: 0.5 mg/kg base (0.88 mg/kg salt) orally once a day for 14 days (not to exceed 30 mg base/day)

Usual Pediatric Dose for Pneumocystis Pneumonia:

0.3 mg/kg base (0.526 mg/kg salt) orally once a day for 21 days (not to exceed 30 mg base/day); effective in combination with clindamycin
Primaquine plus clindamycin is recommended as an alternative regimen by the CDC, NIH, IDSA, Pediatric Infectious Diseases Society, and American Academy of Pediatrics. Seriously ill patients should receive IV trimethoprim-sulfamethoxazole or pentamidine therapy.

What other drugs will affect primaquine?

Do not take primaquine if you have recently taken quinacrine (Atabrine). These two drugs are similar and can cause dangerous side effects if they are taken together.

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

More primaquine resources Primaquine Side Effects (in more detail) Primaquine Dosage Primaquine Use in Pregnancy & Breastfeeding Primaquine Drug Interactions Primaquine Support Group 0 Reviews for Primaquine - Add your own review/rating primaquine Advanced Consumer (Micromedex) - Includes Dosage Information Primaquine MedFacts Consumer Leaflet (Wolters Kluwer) Primaquine Prescribing Information (FDA) Primaquine Phosphate Monograph (AHFS DI) Compare primaquine with other medications Malaria Malaria Prevention Pneumocystis Pneumonia Where can I get more information? Your pharmacist can provide more information about primaquine.

See also: primaquine side effects (in more detail)


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halofantrine


Generic Name: halofantrine (hah low FAN treen)
Brand Names: Halfan

What is halofantrine?

Halofantrine is an antimalarial drug. The exact way that halofantrine works is unknown.

Halofantrine is used to treat malaria.

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

What is the most important information I should know about halofantrine? In rare cases, halofantrine may affect the heart, causing irregular heartbeats that could result in death. Do not take halofantrine if you have a heart condition such as an irregular heartbeats or a history of irregular heartbeats; a history of prolonged QT intervals; a family history of congenital long QT syndrome; heart block or other conduction disturbances; or unexplained episodes of fainting. These conditions may increase the risk of irregular heartbeats and death while taking halofantrine. Take halofantrine on an empty stomach, at least one hour before or two hours after food. Taking halofantrine with food may increase the risk of irregular heartbeats. Use caution when driving or performing other hazardous activities. Halofantrine may cause dizziness. If you experience dizziness, avoid these activities. What should I discuss with my healthcare provider before taking halofantrine? In rare cases, halofantrine may affect the heart, causing irregular heartbeats that could result in death. Do not take halofantrine if you have a heart condition such as an irregular heartbeats or a history of irregular heartbeats; a history of prolonged QT intervals; a family history of congenital long QT syndrome; heart block or other conduction disturbances; or unexplained episodes of fainting. These conditions may increase the risk of irregular heartbeats and death while taking halofantrine.

Before taking halofantrine, tell your doctor if you have

liver disease; or kidney disease.

You may not be able to take halofantrine, or you may require a dosage adjustment or special monitoring during treatment if you have either of the conditions listed above.

Halofantrine is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take halofantrine without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether halofantrine passes into breast milk. Do not take halofantrine without first talking to your doctor if you are breast-feeding a baby. How should I take halofantrine?

Take halofantrine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take halofantrine on an empty stomach, at least one hour before or two hours after food. Taking halofantrine with food may increase the risk of irregular heartbeats. Store halofantrine at room temperature away from moisture, heat, and light.

See also: Halofantrine dosage (in more detail)

What happens if I miss a dose?

Contact your doctor if you miss a dose of halofantrine.

What happens if I overdose? Seek emergency medical attention if an overdose of halofantrine is suspected.

Symptoms of a halofantrine overdose may include nausea, vomiting, abdominal pain and cramping, diarrhea, decreased consciousness, seizures, and irregular heartbeats.

What should I avoid while taking halofantrine? Use caution when driving or performing other hazardous activities. Halofantrine may cause dizziness. If you experience dizziness, avoid these activities. Halofantrine side effects Stop taking halofantrine and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

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

fast or irregular heartbeats;

fluttering feeling in the chest;

lightheadedness or fainting;

chest pain;

decreased consciousness; or

seizures.

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

nausea, vomiting, diarrhea, or loss of appetite;

abdominal pain;

dizziness;

headache;

cough;

itching;

shivering or tremors; or

muscle aches.

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.

Halofantrine Dosing Information

Usual Adult Dose for Malaria:

Mild to moderate Plasmodium falciparum and Plasmodium vivax malaria:
Nonimmune patients: 500 mg orally every 6 hours for 3 doses; repeat course in 7 days.
Semi-immune patients: 500 mg orally every 6 hours for 3 doses. Consideration may be given to omitting the second course.

Usual Pediatric Dose for Malaria:

Mild to moderate Plasmodium falciparum and Plasmodium vivax malaria:
=40 kg:
Nonimmune patients: 500 mg orally every 6 hours for 3 doses; repeat course in 7 days.
Semi-immune patients: 500 mg orally every 6 hours for 3 doses. Consideration may be given to omitting the second course.

What other drugs will affect halofantrine? Halofantrine should not be taken during or immediately following treatment with mefloquine (Lariam). Taking these medications together may increase the risk of potentially fatal irregular heartbeats.

Do not take any other prescription or over-the counter medicines, including herbal products during treatment with halofantrine without first talking to your doctor. Many other medications may affect the way the heart beats or increase the effects of halofantrine, possibly resulting in dangerous irregular heartbeats if taken during treatment with halofantrine.

More halofantrine resources Halofantrine Side Effects (in more detail) Halofantrine Dosage Halofantrine Use in Pregnancy & Breastfeeding Halofantrine Drug Interactions Halofantrine Support Group 0 Reviews for Halofantrine - Add your own review/rating halofantrine Advanced Consumer (Micromedex) - Includes Dosage Information Halofantrine MedFacts Consumer Leaflet (Wolters Kluwer) Halfan Prescribing Information (FDA) Compare halofantrine with other medications Malaria Where can I get more information? Your pharmacist has more information about halofantrine written for health professionals that you may read. What does my medication look like?

Halofantrine is available with a prescription under the brand name Halfan in 250 mg white, to off-white, capsule-shaped tablets. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

See also: halofantrine side effects (in more detail)


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Mefloquine


Pronunciation: ME-floe-kwin
Generic Name: Mefloquine
Brand Name: Generic only. No brands available.
Mefloquine is used for:

Treating or preventing malaria.

Mefloquine is an antimalarial agent. Exactly how it works to kill sensitive malaria parasites is not known.

Do NOT use Mefloquine if: you are allergic to any ingredient in Mefloquine or to a similar medicine (eg, quinine, quinidine) you do not already have malaria and you currently have depression, a recent history of mental illness (eg, anxiety disorder, depression, psychosis, schizophrenia) or a history of seizures you are taking chloroquine, halofantrine, ketoconazole, quinidine, or quinine

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

Before using Mefloquine:

Some medical conditions may interact with Mefloquine. 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 a history of seizures, heart problems (eg, irregular heartbeat), blood clotting problems, liver problems, diabetes, mental or mood problems (eg, depression), or suicidal thoughts or actions if you are taking medicine for diabetes (eg, glyburide) or an anticoagulant (eg, warfarin) if you are scheduled to receive a vaccine

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

Antiarrhythmics (eg, amiodarone, propafenone, quinidine), certain antihistamines (eg, astemizole, terfenadine), beta-blockers (eg, propranolol), calcium channel blockers (eg, amlodipine, verapamil), chloroquine, dofetilide, halofantrine, hydroxychloroquine, ketoconazole, paliperidone, phenothiazines (eg, thioridazine), quinine, tricyclic antidepressants (eg, amitriptyline), or ziprasidone because the risk of heart problems (eg, irregular heartbeat) or seizures may be increased Anticoagulants (eg, warfarin) because the risk of bleeding may be increased Rifampin because it may decrease Mefloquine's effectiveness Anticonvulsants (eg, valproic acid, carbamazepine, phenobarbital, phenytoin) because their effectiveness may be decreased by Mefloquine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mefloquine 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 Mefloquine:

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

Mefloquine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Mefloquine refilled. Take Mefloquine by mouth with a full glass of water (8 oz/240 mL) right after you eat your main meal. Do not take it on an empty stomach. If the tablets cannot be swallowed whole, they may be crushed and mixed with a small amount of water, milk, or other beverage. Be sure to drink all the liquid so that you receive the entire dose. Mefloquine may cause vomiting, especially in children. Check with your doctor to see if you should take another dose if you vomit after taking Mefloquine. If you are taking Mefloquine to prevent malaria, begin taking it 1 week before traveling. Continue to take it for 4 weeks after leaving the malaria area. If you cannot complete the treatment, contact your doctor. If you are taking other medicines, ask your doctor if you should start taking Mefloquine 2 to 3 weeks before traveling in order to make sure that the combination of medicines is well tolerated. Weekly doses of Mefloquine should be taken regularly, on the same day of each week, preferably after the main meal of the day. Continue to use Mefloquine for the full course of treatment. Do not miss any doses. Malaria can be life-threatening. If you miss a dose of Mefloquine and you are taking it to prevent infection, 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 Mefloquine.

Important safety information: Mefloquine may cause drowsiness, dizziness, lightheadedness, or a loss of balance. These effects may be worse if you take it with alcohol or certain medicines. Effects of Mefloquine may continue for a period of time (eg, several weeks), even after you stop taking it. Use Mefloquine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Carry an ID card at all times that says you take Mefloquine. Tell your doctor or dentist that you take Mefloquine before you receive any medical or dental care, emergency care, or surgery. Mefloquine may decrease the effectiveness of live vaccines. Check with your doctor before you receive any vaccines while you are using Mefloquine. Women who may become pregnant should use effective birth control while taking Mefloquine and for up to 3 months after stopping treatment. Check with your doctor if you have questions about using birth control. Contact your doctor right away if you experience mental or mood changes (eg, anxiety, depression, restlessness, confusion, hallucinations, paranoia). You may need to stop taking Mefloquine and start a different malaria medicine. If you have to stop taking Mefloquine for any reason and you do not have access to a doctor or to another malaria medicine, leave the malaria area and contact a doctor as soon as possible. Leaving the area may not protect you from contracting malaria. You may still need to take another medicine to prevent the disease. No medicine is completely effective against malaria. While you are in an area where malaria exists, use bed nets and insect repellents and wear protective clothing (long sleeves and long pants) to decrease your risk. In some situations, you may want to pre-wash your clothes with permethrin, a mosquito repellent that may be effective for weeks after use. Ask your doctor for other ways to protect yourself. Contact your health care provider at once if you develop a fever or flu-like symptoms (eg, chills, headache, muscle pains) after returning from an area where malaria exists. If you are using Mefloquine to treat malaria and your symptoms do not improve within 48 to 72 hours, contact your doctor right away. If your doctor tells you to stop taking Mefloquine, you will need to wait for at least 15 weeks before you start to take certain other medicines (eg, halofantrine, ketoconazole). Ask your doctor when you should start to take any new medicines after you stop Mefloquine. Lab tests, including liver function, complete blood cell count, and eye exams, may be performed while you use Mefloquine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Mefloquine with caution in the ELDERLY; they may be more sensitive to its effects, especially heart problems. Mefloquine should not be used in CHILDREN who are younger than 6 months old or who weigh less than 44 lbs (20 kg); safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not become pregnant while you are taking Mefloquine. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mefloquine while you are pregnant. Mefloquine is found in breast milk. Do not breast-feed while taking Mefloquine. Possible side effects of Mefloquine:

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:

Diarrhea; dizziness; drowsiness; headache; lightheadedness; loss of appetite; muscle aches; nausea; stomach pain or upset; strange dreams; tiredness; trouble sleeping; 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); bizarre behavior; chest pain; fainting; fast, slow, or irregular heartbeat; flu-like symptoms (eg, chills, fever, headache, muscle pain); loss of balance or coordination; memory problems; mental or mood changes (eg, anxiety, confusion, depression, hallucinations, mood changes, paranoia, restlessness); numbness or tingling of the hands or feet; red, swollen or blistered skin; ringing in the ears; seizures; severe or persistent cough; shortness of breath; suicidal thoughts or attempts; symptoms of liver problems (eg, dark urine, pale stools, persistent stomach pain or loss of appetite, persistent tiredness, yellowing of the skin or eyes); tremor; 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: Mefloquine 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 diarrhea; fast, slow, or irregular heartbeat; mental or mood changes; vomiting.

Proper storage of Mefloquine:

Store Mefloquine at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep out of the reach of children and away from pets.

General information: If you have any questions about Mefloquine, please talk with your doctor, pharmacist, or other health care provider. Mefloquine 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 Mefloquine. 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 Mefloquine resources Mefloquine Side Effects (in more detail) Mefloquine Use in Pregnancy & Breastfeeding Drug Images Mefloquine Drug Interactions Mefloquine Support Group 0 Reviews for Mefloquine - Add your own review/rating Mefloquine Prescribing Information (FDA) mefloquine Advanced Consumer (Micromedex) - Includes Dosage Information mefloquine Concise Consumer Information (Cerner Multum) Lariam Monograph (AHFS DI) Lariam Prescribing Information (FDA) Compare Mefloquine with other medications Malaria Malaria Prevention
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Lariam


Pronunciation: ME-floe-kwin
Generic Name: Mefloquine
Brand Name: Generic only. No brands available.
Lariam is used for:

Treating or preventing malaria.

Lariam is an antimalarial agent. Exactly how it works to kill sensitive malaria parasites is not known.

Do NOT use Lariam if: you are allergic to any ingredient in Lariam or to a similar medicine (eg, quinine, quinidine) you do not already have malaria and you currently have depression, a recent history of mental illness (eg, anxiety disorder, depression, psychosis, schizophrenia) or a history of seizures you are taking chloroquine, halofantrine, ketoconazole, quinidine, or quinine

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

Before using Lariam:

Some medical conditions may interact with Lariam. 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 a history of seizures, heart problems (eg, irregular heartbeat), blood clotting problems, liver problems, diabetes, mental or mood problems (eg, depression), or suicidal thoughts or actions if you are taking medicine for diabetes (eg, glyburide) or an anticoagulant (eg, warfarin) if you are scheduled to receive a vaccine

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

Antiarrhythmics (eg, amiodarone, propafenone, quinidine), certain antihistamines (eg, astemizole, terfenadine), beta-blockers (eg, propranolol), calcium channel blockers (eg, amlodipine, verapamil), chloroquine, dofetilide, halofantrine, hydroxychloroquine, ketoconazole, paliperidone, phenothiazines (eg, thioridazine), quinine, tricyclic antidepressants (eg, amitriptyline), or ziprasidone because the risk of heart problems (eg, irregular heartbeat) or seizures may be increased Anticoagulants (eg, warfarin) because the risk of bleeding may be increased Rifampin because it may decrease Lariam's effectiveness Anticonvulsants (eg, valproic acid, carbamazepine, phenobarbital, phenytoin) because their effectiveness may be decreased by Lariam

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lariam 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 Lariam:

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

Lariam comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lariam refilled. Take Lariam by mouth with a full glass of water (8 oz/240 mL) right after you eat your main meal. Do not take it on an empty stomach. If the tablets cannot be swallowed whole, they may be crushed and mixed with a small amount of water, milk, or other beverage. Be sure to drink all the liquid so that you receive the entire dose. Lariam may cause vomiting, especially in children. Check with your doctor to see if you should take another dose if you vomit after taking Lariam. If you are taking Lariam to prevent malaria, begin taking it 1 week before traveling. Continue to take it for 4 weeks after leaving the malaria area. If you cannot complete the treatment, contact your doctor. If you are taking other medicines, ask your doctor if you should start taking Lariam 2 to 3 weeks before traveling in order to make sure that the combination of medicines is well tolerated. Weekly doses of Lariam should be taken regularly, on the same day of each week, preferably after the main meal of the day. Continue to use Lariam for the full course of treatment. Do not miss any doses. Malaria can be life-threatening. If you miss a dose of Lariam and you are taking it to prevent infection, 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 Lariam.

Important safety information: Lariam may cause drowsiness, dizziness, lightheadedness, or a loss of balance. These effects may be worse if you take it with alcohol or certain medicines. Effects of Lariam may continue for a period of time (eg, several weeks), even after you stop taking it. Use Lariam with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Carry an ID card at all times that says you take Lariam. Tell your doctor or dentist that you take Lariam before you receive any medical or dental care, emergency care, or surgery. Lariam may decrease the effectiveness of live vaccines. Check with your doctor before you receive any vaccines while you are using Lariam. Women who may become pregnant should use effective birth control while taking Lariam and for up to 3 months after stopping treatment. Check with your doctor if you have questions about using birth control. Contact your doctor right away if you experience mental or mood changes (eg, anxiety, depression, restlessness, confusion, hallucinations, paranoia). You may need to stop taking Lariam and start a different malaria medicine. If you have to stop taking Lariam for any reason and you do not have access to a doctor or to another malaria medicine, leave the malaria area and contact a doctor as soon as possible. Leaving the area may not protect you from contracting malaria. You may still need to take another medicine to prevent the disease. No medicine is completely effective against malaria. While you are in an area where malaria exists, use bed nets and insect repellents and wear protective clothing (long sleeves and long pants) to decrease your risk. In some situations, you may want to pre-wash your clothes with permethrin, a mosquito repellent that may be effective for weeks after use. Ask your doctor for other ways to protect yourself. Contact your health care provider at once if you develop a fever or flu-like symptoms (eg, chills, headache, muscle pains) after returning from an area where malaria exists. If you are using Lariam to treat malaria and your symptoms do not improve within 48 to 72 hours, contact your doctor right away. If your doctor tells you to stop taking Lariam, you will need to wait for at least 15 weeks before you start to take certain other medicines (eg, halofantrine, ketoconazole). Ask your doctor when you should start to take any new medicines after you stop Lariam. Lab tests, including liver function, complete blood cell count, and eye exams, may be performed while you use Lariam. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Lariam with caution in the ELDERLY; they may be more sensitive to its effects, especially heart problems. Lariam should not be used in CHILDREN who are younger than 6 months old or who weigh less than 44 lbs (20 kg); safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not become pregnant while you are taking Lariam. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lariam while you are pregnant. Lariam is found in breast milk. Do not breast-feed while taking Lariam. Possible side effects of Lariam:

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:

Diarrhea; dizziness; drowsiness; headache; lightheadedness; loss of appetite; muscle aches; nausea; stomach pain or upset; strange dreams; tiredness; trouble sleeping; 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); bizarre behavior; chest pain; fainting; fast, slow, or irregular heartbeat; flu-like symptoms (eg, chills, fever, headache, muscle pain); loss of balance or coordination; memory problems; mental or mood changes (eg, anxiety, confusion, depression, hallucinations, mood changes, paranoia, restlessness); numbness or tingling of the hands or feet; red, swollen or blistered skin; ringing in the ears; seizures; severe or persistent cough; shortness of breath; suicidal thoughts or attempts; symptoms of liver problems (eg, dark urine, pale stools, persistent stomach pain or loss of appetite, persistent tiredness, yellowing of the skin or eyes); tremor; 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: Lariam 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 diarrhea; fast, slow, or irregular heartbeat; mental or mood changes; vomiting.

Proper storage of Lariam:

Store Lariam at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep out of the reach of children and away from pets.

General information: If you have any questions about Lariam, please talk with your doctor, pharmacist, or other health care provider. Lariam 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 Lariam. 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 Lariam resources Lariam Side Effects (in more detail) Lariam Use in Pregnancy & Breastfeeding Drug Images Lariam Drug Interactions Lariam Support Group 0 Reviews for Lariam - Add your own review/rating Lariam Prescribing Information (FDA) Lariam Advanced Consumer (Micromedex) - Includes Dosage Information Lariam Concise Consumer Information (Cerner Multum) Lariam Monograph (AHFS DI) Mefloquine Prescribing Information (FDA) Compare Lariam with other medications Malaria Malaria Prevention
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Plaquenil Sulfate


Generic Name: hydroxychloroquine (hye drox ee KLOR oh kwin)
Brand Names: Plaquenil Sulfate

What is Plaquenil Sulfate (hydroxychloroquine)?

Hydroxychloroquine is used to treat or prevent malaria, a disease caused by parasites. Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Hydroxychloroquine is also used to treat symptoms of rheumatoid arthritis and discoid or systemic lupus erythematosus.

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

What is the most important information I should know about Plaquenil Sulfate (hydroxychloroquine)? You should not use this medication if you are allergic to hydroxychloroquine, or if you have a history of vision changes or damage to your retina caused by hydroxychloroquine or similar anti-malaria medications.

Before using hydroxychloroquine, tell your doctor if you are allergic to any drugs, or if you have psoriasis, porphyria, liver disease, alcoholism, or glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

Call a poison control center at once and then seek emergency medical attention if you think you have used too much of this medicine. An overdose of hydroxychloroquine can be fatal, especially in children. Take this medicine for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Contact your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.

When treating lupus or arthritis, tell your doctor if your symptoms do not improve after 6 months of treatment.

If you take hydroxychloroquine long-term, your doctor may need to check your knee and ankle reflexes and also do blood tests on a regular basis to check for harmful side effects. Your vision may also need to be tested every 3 months. Do not miss any scheduled appointments.

Hydroxychloroquine should not be used for long-term treatment in children.

What should I discuss with my health care provider before taking Plaquenil Sulfate (hydroxychloroquine)? You should not use this medication if you are allergic to hydroxychloroquine, or if you have a history of vision changes or damage to your retina caused by hydroxychloroquine or similar anti-malaria medications.

Hydroxychloroquine should not be used for long-term treatment in children.

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

psoriasis;

porphyria;

liver disease;

alcoholism; or

glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

It is not known whether hydroxychloroquine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Malaria is more likely to cause death in a pregnant woman. If you are pregnant, talk with your doctor about the risks of traveling to areas where malaria is common. It is not known whether hydroxychloroquine 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 Plaquenil Sulfate (hydroxychloroquine)?

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

Take hydroxychloroquine with a meal or a glass of milk, unless your doctor tells you otherwise.

Hydroxychloroquine is sometimes given only once per week. Choose the same day each week to take this medication if you are on a weekly dosing schedule.

To prevent malaria: Start taking the medicine 2 weeks before entering an area where malaria is common. Continue taking the medicine regularly during your stay and for at least 8 weeks after you leave the area.

To treat malaria: Your doctor may recommend a single dose, or a high starting dose followed by a smaller dose 6 to 8 hours later for 2 days in a row. Follow your doctor's instructions.

Take this medicine for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

In addition to taking hydroxychloroquine, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

Contact your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.

When treating lupus or arthritis, hydroxychloroquine is usually given daily for several weeks or months. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 months of treatment.

If you take hydroxychloroquine long-term, your doctor may need to check your knee and ankle reflexes and also do blood tests on a regular basis to check for harmful side effects. Your vision may also need to be tested every 3 months. Do not miss any scheduled appointments.

No medication is 100% effective in treating or preventing all types of malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

Store at room temperature away from moisture, heat, and light. What happens if I miss a dose?

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

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydroxychloroquine can be fatal, especially in children.

Treatment of a hydroxychloroquine overdose must be started quickly. You may be told to induce vomiting right away (at home, before transport to an emergency room). Ask the poison control center how to induce vomiting in the case of a hydroxychloroquine overdose.

Overdose symptoms may include headache, drowsiness, vision changes, slow heart rate, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, seizure (convulsions), shallow breathing, or breathing that stops.

What should I avoid while taking Plaquenil Sulfate (hydroxychloroquine)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Plaquenil Sulfate (hydroxychloroquine) side effects Some people taking this medication over long periods of time or at high doses have developed irreversible damage to the retina of the eye. Stop taking hydroxychloroquine and call your doctor at once if you have trouble focusing, if you see light streaks or flashes in your vision, or if you notice any swelling or color changes in your eyes. 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 a serious side effect such as:

muscle weakness, twitching, or uncontrolled movement;

loss of balance or coordination;

blurred vision, light sensitivity, seeing halos around lights;

pale skin, easy bruising or bleeding;

confusion, unusual thoughts or behavior; or

seizure (convulsions).

Less serious side effects may include:

headache, ringing in your ears;

spinning sensation;

nausea, vomiting, stomach pain;

loss of appetite, weight loss;

mood changes, feeling nervous or irritable;

skin rash or itching; or

hair loss.

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.

What other drugs will affect Plaquenil Sulfate (hydroxychloroquine)?

Hydroxychloroquine can harm your liver. This effect is increased when you also use other medicines harmful to the liver. You may need dose adjustments or special tests if you have recently used:

acetaminophen (Tylenol);

cancer medications;

tuberculosis medications;

birth control pills or hormone replacement therapy;

arthritis medications such as auranofin (Ridaura) or methotrexate (Rheumatrex, Trexall);

an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others;

an antibiotic such as dapsone, erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or rifampin (Rifater, Rifadin, Rifamate);

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

cholesterol medications such as niacin (Advicor, Niaspan, Niacor, Simcor, Slo Niacin, and others), atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), simvastatin (Zocor, Simcor, Vytorin), and others;

HIV/AIDS medications such as lamivudine (Combivir, Epivir), abacavir/lamivudine/zidovudine (Trizivir), nevirapine (Viramune), tenofovir (Viread), or zidovudine (Retrovir);

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or

seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), felbamate (Felbatol), valproic acid (Depakene).

This list is not complete and other drugs may interact with hydroxychloroquine. 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 Plaquenil Sulfate resources Plaquenil Sulfate Side Effects (in more detail) Plaquenil Sulfate Use in Pregnancy & Breastfeeding Plaquenil Sulfate Drug Interactions Plaquenil Sulfate Support Group 35 Reviews for Plaquenil Sulfate - Add your own review/rating Hydroxychloroquine MedFacts Consumer Leaflet (Wolters Kluwer) hydroxychloroquine Advanced Consumer (Micromedex) - Includes Dosage Information Hydroxychloroquine Sulfate Monograph (AHFS DI) Compare Plaquenil Sulfate with other medications Dermatomyositis Lyme Disease, Arthritis Malaria Malaria Prevention Rheumatoid Arthritis Sjogren's Syndrome Systemic Lupus Erythematosus Undifferentiated Connective Tissue Disease Where can I get more information? Your pharmacist can provide more information about hydroxychloroquine.

See also: Plaquenil Sulfate side effects (in more detail)


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hydroxychloroquine


hye-drox-ee-KLOR-oh-kwin

Oral route(Tablet)

Physicians should completely familiarize themselves with the contents of the leaflet before prescribing hydroxychloroquine .

Commonly used brand name(s)

In the U.S.

Plaquenil

Available Dosage Forms:

Tablet

Therapeutic Class: Antimalarial

Chemical Class: Aminoquinoline

Uses For hydroxychloroquine

Hydroxychloroquine belongs to the family of medicines called antiprotozoals. Protozoa are tiny, one-celled animals. Some are parasites that can cause many different kinds of infections in the body.

hydroxychloroquine is used to prevent and to treat malaria and to treat some conditions such as liver disease caused by protozoa. It is also used in the treatment of arthritis to help relieve inflammation, swelling, stiffness, and joint pain and to help control the symptoms of lupus erythematosus (lupus; SLE).

hydroxychloroquine may be given alone or with one or more other medicines. It may also be used for other conditions as determined by your doctor.

Hydroxychloroquine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, hydroxychloroquine is used in certain patients with the following medical conditions:

Arthritis, juvenile Hypercalcemia, sarcoid-associated Polymorphous light eruption Porphyria cutanea tarda Urticaria, solar Vasculitis, chronic cutaneous Before Using hydroxychloroquine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For hydroxychloroquine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hydroxychloroquine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children are especially sensitive to the effects of hydroxychloroquine. This may increase the chance of side effects during treatment. Overdose is especially dangerous in children. Taking as few as 3 or 4 tablets (250-milligrams [mg] strength) of chloroquine has resulted in death in small children. Because hydroxychloroquine is so similar to chloroquine, it is probably just as toxic.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of hydroxychloroquine in the elderly with use in other age groups.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking hydroxychloroquine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using hydroxychloroquine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Aurothioglucose

Using hydroxychloroquine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Digoxin Metoprolol Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of hydroxychloroquine. Make sure you tell your doctor if you have any other medical problems, especially:

Blood disease (severe)—Hydroxychloroquine may cause blood disorders Eye or vision problems—Hydroxychloroquine may cause serious eye side effects, especially in high doses Glucose-6-phosphate dehydrogenase (G6PD) deficiency—Hydroxychloroquine may cause serious blood side effects in patients with this deficiency Kidney disease—There may be an increased chance of side effects in patients with kidney disease Liver disease—May decrease the removal of hydroxychloroquine from the blood, increasing the chance of side effects Nerve or brain disease (severe), including convulsions (seizures)—Hydroxychloroquine may cause muscle weakness and, in high doses, seizures Porphyria—Hydroxychloroquine may worsen the symptoms of porphyria Psoriasis—Hydroxychloroquine may bring on severe attacks of psoriasis Stomach or intestinal disease (severe)—Hydroxychloroquine may cause stomach irritation Proper Use of hydroxychloroquine

Take hydroxychloroquine with meals or milk to lessen possible stomach upset, unless otherwise directed by your doctor.

Keep hydroxychloroquine out of the reach of children. Children are especially sensitive to the effects of hydroxychloroquine and overdose is especially dangerous in children. Taking as few as 3 or 4 tablets (250-mg strength) of chloroquine has resulted in death in small children. Hydroxychloroquine is probably just as dangerous.

It is very important that you take hydroxychloroquine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of serious side effects.

If you are taking hydroxychloroquine to help keep you from getting malaria, keep taking it for the full time of treatment. If you already have malaria, you should still keep taking hydroxychloroquine for the full time of treatment even if you begin to feel better after a few days. This will help to clear up your infection completely. If you stop taking hydroxychloroquine too soon, your symptoms may return.

Hydroxychloroquine works best when you take it on a regular schedule. For example, if you are to take it once a week to prevent malaria, it is best to take it on the same day each week. Or if you are to take 2 doses a day, 1 dose may be taken with breakfast and the other with the evening meal. Make sure that you do not miss any doses. If you have any questions about this, check with your health care professional.

For patients taking hydroxychloroquine to prevent malaria:

Your doctor may want you to start taking hydroxychloroquine 1 to 2 weeks before you travel to an area where there is a chance of getting malaria. This will help you to see how you react to the medicine. Also, it will allow time for your doctor to change to another medicine if you have a reaction to hydroxychloroquine. Also, you should keep taking hydroxychloroquine while you are in the area and for 4 to 6 weeks after you leave the area. No medicine will protect you completely from malaria. However, to protect you as completely as possible, it is important to keep taking hydroxychloroquine for the full time your doctor ordered. Also, if fever develops during your travels or within 2 months after you leave the area, check with your doctor immediately.

For patients taking hydroxychloroquine for arthritis or lupus:

hydroxychloroquine must be taken regularly as ordered by your doctor in order for it to help you. It may take up to several weeks before you begin to feel better. It may take up to 6 months before you feel the full benefit of hydroxychloroquine.

For patients unable to swallow hydroxychloroquine tablets:

Your pharmacist can crush the tablets and put each dose in a capsule. Contents of the capsules may then be mixed with a teaspoonful of jam, jelly, or jello. Be sure you take all the food in order to get the full dose of medicine. Dosing

The dose of hydroxychloroquine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of hydroxychloroquine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For tablets dosage form: For prevention of malaria: Adults—400 milligrams (mg) once every seven days. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.4 mg per kilogram (kg) (2.9 mg per pound) of body weight once every seven days. For treatment of malaria: Adults—800 mg as a single dose. This may sometimes be followed by a dose of 400 mg six to eight hours after the first dose, then 400 mg once a day on the second and third days. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 32 mg per kg (14.5 mg per pound) of body weight taken over a period of three days. For treatment of arthritis: Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.5 mg per kg (2.9 mg per pound) of body weight per day. Missed Dose

If you miss a dose of hydroxychloroquine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using hydroxychloroquine

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after long-term treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

If your symptoms do not improve within a few days (or a few weeks or months for arthritis), or if they become worse, check with your doctor.

Hydroxychloroquine may cause blurred vision, difficulty in reading, or other change in vision. It may also cause some people to become dizzy or lightheaded. Make sure you know how you react to hydroxychloroquine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well. If these reactions are especially bothersome, check with your doctor.

Malaria is spread by mosquitoes. If you are living in, or will be traveling to, an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

If possible, sleep under mosquito netting to avoid being bitten by malaria-carrying mosquitoes. Wear long-sleeved shirts or blouses and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out. Apply mosquito repellent to uncovered areas of the skin from dusk through dawn when mosquitoes are out. hydroxychloroquine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. When hydroxychloroquine is used for short periods of time, side effects usually are rare. However, when it is used for a long time and/or in high doses, side effects are more likely to occur and may be serious.

Check with your doctor immediately if any of the following side effects occur:

Less common Blurred vision or any other change in vision—this side effect may also occur or get worse after you stop taking hydroxychloroquine Rare Convulsions (seizures) increased muscle weakness mood or other mental changes ringing or buzzing in ears or any loss of hearing sore throat and fever unusual bleeding or bruising unusual tiredness weakness Symptoms of overdose Drowsiness headache increased excitability

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Diarrhea difficulty in seeing to read headache itching (more common in black patients) loss of appetite nausea or vomiting stomach cramps or pain Less common Bleaching of hair or increased hair loss blue-black discoloration of skin, fingernails, or inside of mouth dizziness or lightheadedness nervousness or restlessness skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: hydroxychloroquine side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More hydroxychloroquine resources Hydroxychloroquine Side Effects (in more detail) Hydroxychloroquine Dosage Hydroxychloroquine Use in Pregnancy & Breastfeeding Drug Images Hydroxychloroquine Drug Interactions Hydroxychloroquine Support Group 50 Reviews for Hydroxychloroquine - Add your own review/rating hydroxychloroquine Concise Consumer Information (Cerner Multum) Hydroxychloroquine MedFacts Consumer Leaflet (Wolters Kluwer) Hydroxychloroquine Sulfate Monograph (AHFS DI) Compare hydroxychloroquine with other medications Dermatomyositis Lyme Disease, Arthritis Malaria Malaria Prevention Rheumatoid Arthritis Sjogren's Syndrome Systemic Lupus Erythematosus Undifferentiated Connective Tissue Disease
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Coartem


Generic Name: Artemether and Lumefantrine
Class: Antimalarials
VA Class: AP101
Chemical Name: (3R,5aS,6R,8aS,9R,10S,12R,12aR) - decahydro - 10 - methoxy - 3,6,9 - trimethyl - 3,12 - epoxy - 12H - pyrano[4,3 - j] - 1,2 - benzodioxepine
Molecular Formula: C16H26O5C30H32Cl3NO
CAS Number: 71963-77-4

Introduction

Antimalarial; fixed combination containing 2 antimalarials (artemether, lumefantrine).1

Uses for Coartem Malaria

Treatment of acute, uncomplicated malaria caused by Plasmodium falciparum, including malaria acquired in areas where chloroquine resistance has been reported.1 2 3 4 5 6 7 8 Recommended by CDC as a drug of choice for treatment of uncomplicated chloroquine-resistant P. falciparum malaria.2

Not indicated for treatment of severe or complicated malaria infections caused by P. falciparum.1

Not indicated for prevention of malaria.1

Assistance with diagnosis or treatment of malaria available from CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.2

Coartem Dosage and Administration Administration Oral Administration

Administer orally with food.1

Patients who are unable to swallow the tablets: Crush tablets and mix with a small amount of water (5–10 mL) just prior to administration.1 Rinse container with more water; patient should swallow rinse.1

If vomiting occurs within 2 hours of ingestion, repeat dose.1 2 If the repeat dose is vomited, give an alternative antimalarial agent.1

Dosage

Dosage expressed as number of tablets of the fixed combination containing 20 mg of artemether and 120 mg of lumefantrine.1

Treatment regimen is given over 3 days for a total of 6 doses.1 2

Dosage based on weight.1 2

Pediatric Patients Malaria Treatment of Uncomplicated Malaria Oral Recommended Pediatric Dosage for Treatment of Acute, Uncomplicated Malaria caused by P. falciparum12

Weight

Dosage Expressed as Number of Tablets of Artemether and Lumefantrine

5 kg to <15 kg

1 tablet as initial dose, 1 tablet 8 hours after the initial dose, then 1 tablet twice daily (morning and evening) for the next 2 days (total course of 6 tablets)

15 kg to <25 kg

2 tablets as initial dose, 2 tablets 8 hours after the initial dose, then 2 tablets twice daily (morning and evening) for the next 2 days (total course of 12 tablets)

25 kg to <35 kg

3 tablets as initial dose, 3 tablets 8 hours after the initial dose, then 3 tablets twice daily (morning and evening) for the next 2 days (total course of 18 tablets)

? 35 kg

4 tablets as initial dose, 4 tablets 8 hours after the initial dose, then 4 tablets twice daily (morning and evening) for the next 2 days (total course of 24 tablets)

Adults Malaria Treatment of Uncomplicated Malaria Oral

Adults >16 years of age and weighing ?35 kg: 4 tablets as initial dose, 4 tablets 8 hours after the initial dose, and then 4 tablets twice daily (morning and evening) for the next two days (total course of 24 tablets).1 2

Adults >16 years of age and weighing <35 kg: Use pediatric dosage.1

Special Populations

No dosage adjustments needed in those with mild to moderate hepatic impairment.1

No dosage adjustments needed in those with mild to moderate renal impairment.1

Cautions for Coartem Contraindications

Hypersensitivity to artemether, lumefantrine, or any ingredient in the formulation.1

Warnings/Precautions Warnings Prolongation of the QT Interval

QT interval prolongation reported.1

Do not use in patients with congenital long QT syndrome, clinical conditions known to prolong the QTc interval (e.g., symptomatic cardiac arrhythmias, clinically important bradycardia, severe cardiac disease), family history of congenital long QT syndrome or sudden death, or in those with electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia).1

Do not use in those receiving treatment with class IA or III antiarrhythmic agents, antipsychotics (e.g., pimozide, ziprasidone), antidepressants, certain anti-infectives (e.g., macrolides, fluoroquinolones, imidazole- or triazole-derivative antifungal agents), cisapride (available in the US only under a limited-use protocol), or drugs known to be CYP2D6 substrates with cardiac effects.1 (See Drug Interactions: Specific Drugs.)

Interactions

Concomitant use with certain drugs requires particular caution (e.g., other antimalarial drugs, antiretroviral agents).1 (See Drug Interactions: Specific Drugs.)

Malaria Recrudescence

Increased risk of treatment failure in patients who are unable to eat; monitor these individuals closely.1

Repeated use not recommended following failure of the drug for treatment of malaria.1

P. vivax Infection

Has been effective in a limited number of patients in treating the erythrocytic stage of malaria caused by P. vivax†.1 Relapse occurs; additional therapy indicated to achieve a radical cure (eradication of hypnozoites that remain dormant in the liver).1

Specific Populations Pregnancy

Category C.1

Observational data indicate use not associated with adverse pregnancy outcomes or teratogenic effects, including data from women exposed during the first trimester.1

Efficacy for the treatment of acute uncomplicated malaria has not been established in pregnant women.1 CDC states that the drug may be used in pregnant women for treatment of uncomplicated malaria caused by chloroquine-resistant P. falciparum if other treatment options are not available or are not tolerated and if potential benefits outweigh risks.2

Lactation

Not known whether artemether and lumefantrine are distributed into human milk.1 Weigh benefits against potential risks.1

Pediatric Use

Safety and efficacy not established in children weighing <5 kg.1

Evaluated in children ?2 months of age with weight of ?5 kg.1

Not evaluated in nonimmune children (children residing in nonendemic countries) in clinical studies.1

Geriatric Use

Insufficient experience in patients ?65 years of age to determine whether geriatric patients respond differently than younger adults.1

Use with caution and monitor because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1

Hepatic Impairment

Pharmacokinetics not studied in patients with hepatic impairment.1 Not evaluated in patients with severe hepatic impairment.1

Renal Impairment

Pharmacokinetics not studied in patients with renal impairment.1 Not evaluated in patients with severe renal impairment.1

Common Adverse Effects

Adults: Headache, anorexia, dizziness, asthenia, arthralgia, myalgia.1

Children: Pyrexia, cough, vomiting, anorexia, headache.1

Interactions for Coartem Drugs Affecting Hepatic Microsomal Enzymes

Artemether is metabolized predominantly by CYP 3A4/5 isoenzyme; metabolism also catalyzed by CYP2B6, 2C9, and 2C19.1 Artemether induces CYP3A4.1 Artemether does not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4/5, or 4A9/11.1

Lumefantrine is metabolized principally by CYP3A4.1 Lumefantrine inhibits CYP2D6.1

Potential pharmacokinetic interactions with drugs metabolized by CYP3A4 (decreased concentrations of the drug metabolized by CYP3A4).1 Potential pharmacokinetic interactions with drugs that inhibit or induce CYP3A4 (altered metabolism of artemether and/or lumefantrine).1

Potential pharmacokinetic interactions with drugs metabolized by CYP2D6 (increased concentrations of the drug metabolized by CYP2D6).1 Avoid concurrent use of artemether and lumefantrine with drugs that are CYP2D6 substrates and have the potential to cause QT interval prolongation.1

Drugs that Prolong the QT Interval

Additive effect on the QT interval might occur if artemether and lumefantrine is administered with other agents that prolong the QT interval.1 Avoid concomitant use of artemether and lumefantrine with drugs known to prolong QT interval.1

Specific Drugs

Drug

Interaction

Comments

Antiarrhythmics, class IA or III

Possible additive effects on prolongation of QT interval1

Avoid concomitant use with drugs known to prolong QT interval1

Antidepressants known to prolong QT interval

Possible additive effects on prolongation of QT interval1

Avoid concomitant use with drugs known to prolong QT interval1

Anti-infectives known to prolong QT interval (e.g., macrolides, fluoroquinolones, imidazole- or triazole-derivative antifungal agents)

Possible additive effects on prolongation of QT interval1

Ketoconazole: Increased plasma concentrations of artemether, the active metabolite of artemether, and lumefantrine1 12

Avoid concomitant use with drugs known to prolong QT interval1

Ketoconazole: Dosage adjustment for artemether and lumefantrine not needed;1 12 use with caution1

Antimalarial agents

Antimalarial agents: Safety data on concomitant use limited1

Mefloquine: Decreased plasma concentrations of lumefantrine; no change in artemether or mefloquine concentrations when mefloquine is administered immediately before artemether and lumefantrine1 11

Quinidine: Possible additive effects on prolongation of QT interval1

Quinine: Pharmacokinetic interaction unlikely;1 13 possible additive effects on prolongation of QT interval1

Antimalarial agents: Concurrent use not recommended unless there are no other treatment options1

Mefloquine: Monitor for effectiveness of artemether and lumefantrine; encourage food consumption1 11

Quinidine: Caution advised if quinidine administered after artemether and lumefantrine1

Quinine: Caution advised if quinine administered after artemether and lumefantrine1

Antipsychotics known to prolong QT interval (e.g., pimozide, ziprasidone)

Possible additive effects on prolongation of QT interval1

Avoid concomitant use with drugs known to prolong QT interval1

Antiretroviral agents

Antiretroviral agents: Possible pharmacokinetic interaction; altered plasma concentrations of the antiretroviral agent, artemether, or lumefantrine; possible additive effects on prolongation of QT interval1

Lopinavir/ritonavir: Increased plasma concentrations of lumefantrine; slightly decreased concentrations of artemether and the active metabolite of artemether9

Antiretroviral agents: Caution advised1

Lopinavir/ritonavir: Manufacturer of lopinavir/ritonavir recommends that the drug not be used with drugs known to prolong QT interval10

Cisapride

Possible additive effects on prolongation of QT interval1

Avoid concomitant use with drugs known to prolong QT interval1

Hormonal contraceptives

Possible decreased plasma concentrations of the components of the contraceptive1

Use additional nonhormonal methods of contraception1

Coartem Pharmacokinetics Absorption

Following oral administration, artemether is rapidly metabolized to an active metabolite, dihydroartemisinin.1

Bioavailability

Artemether: Peak plasma concentrations attained approximately 2 hours after a dose.1

Dihydroartemisinin: Peak plasma concentrations attained approximately 2 hours after a dose.1

Lumefantrine: Peak plasma concentrations attained approximately 6–8 hours after a dose.1

Food

Food increases bioavailability of artemether and lumefantrine.1

Artemether: Relative bioavailability increased twofold to threefold when administered after a high-fat meal compared with fasting conditions.1

Lumefantrine: Relative bioavailability increased sixteen-fold when administered after a high-fat meal compared with fasting conditions.1

Distribution Plasma Protein Binding

Artemether: 95.4%.1

Dihydroartemisinin: 47–76%.1

Lumefantrine: 99.7%.1

Elimination Metabolism

Artemether: Metabolized predominately by CYP3A4/5; metabolism also catalyzed by CYP2B6, 2C9, and 2C19.1

Lumefantrine: Metabolized mainly by CYP3A4.1

Elimination Route

No data on urinary excretion in humans.1

Half-life

Artemether: Approximately 2 hours.1

Dihydroartemisinin: Approximately 2 hours.1

Lumefantrine: 3–6 days.1

Special Populations

Pharmacokinetics not evaluated in individuals with renal or hepatic impairment.1

Systemic exposure to artemether, dihydroartemisinin, and lumefantrine in pediatric patients similar to that in adults.1

Stability Storage Oral Tablets

25°C (may be exposed to 15–30°C).1

ActionsActions

Artemether and lumefantrine is a fixed combination of 2 antimalarial agents; both components are blood schizonticides.1

Artemether is rapidly metabolized into an active metabolite dihydroartemisinin.1 The antimalarial activity of artemether and dihydroartemisinin has been attributed to the endoperoxide moiety.1

Exact mechanism by which lumefantrine exerts its antimalarial effect is not well defined.1 Available data suggest lumefantrine inhibits the formation of -hematin by forming a complex with hemin.1

Both artemether and lumefantrine inhibit nucleic acid and protein synthesis.1

Artemether has a rapid onset of action and is eliminated rapidly; lumefantrine has a longer elimination half-life (about 4.5 days).3 6 11 The rationale behind the fixed-combination preparation is that artemether provides rapid symptomatic relief by reducing the number of malaria parasites and then lumefantrine clears any residual parasites.3 6 11

Advice to Patients

Importance of taking artemether and lumefantrine with food and to repeat dose if vomiting occurs within 2 hours of ingestion.1 2

Importance of informing clinician if unable to eat or if any doses of artemether and lumefantrine are vomited.1

Importance of informing clinician if malaria does not improve or flu symptoms, heart rhythm changes, or loss of consciousness occurs.1

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

Importance of informing patients of other precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Artemether and Lumefantrine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

20 mg of artemether and 120 mg of lumefantrine

Coartem

Novartis

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Novartis. Coartem (artemether/lumefantrine) tablets prescribing information. East Hanover, NJ; 2009 Apr.

2. Centers for Disease Control and Prevention. Guidelines for treatment of malaria in the United States (based on drugs currently available for use in the United States). From the CDC website. Accessed 2009 Jul 1.

3. Omari AA, Gamble C, Garner P. Artemether-lumefantrine (six-dose regimen) for treating uncomplicated falciparum malaria. Cochrane Database Syst Rev. 2005; :CD005564.

4. Vugt MV, Wilairatana P, Gemperli B et al. Efficacy of six doses of artemether-lumefantrine (benflumetol) in multidrug-resistant Plasmodium falciparum malaria. Am J Trop Med Hyg. 1999; 60:936-42. [PubMed 10403324]

5. van Vugt M, Looareesuwan S, Wilairatana P et al. Artemether-lumefantrine for the treatment of multidrug-resistant falciparum malaria. Trans R Soc Trop Med Hyg. 2000 Sep-Oct; 94:545-8.

6. Lef?vre G, Looareesuwan S, Treeprasertsuk S et al. A clinical and pharmacokinetic trial of six doses of artemether-lumefantrine for multidrug-resistant Plasmodium falciparum malaria in Thailand. Am J Trop Med Hyg. 2001 May-Jun; 64:247-56.

7. Hatz C, Soto J, Nothdurft HD et al. Treatment of acute uncomplicated falciparum malaria with artemether-lumefantrine in nonimmune populations: a safety, efficacy, and pharmacokinetic study. Am J Trop Med Hyg. 2008; 78:241-7. [PubMed 18256423]

8. Falade C, Makanga M, Premji Z et al. Efficacy and safety of artemether-lumefantrine (Coartem) tablets (six-dose regimen) in African infants and children with acute, uncomplicated falciparum malaria. Trans R Soc Trop Med Hyg. 2005; 99:459-67. [PubMed 15837358]

9. German P, Parikh S, Lawrence J et al. Lopinavir/Ritonavir Affects Pharmacokinetic Exposure of Artemether/Lumefantrine in HIV-Uninfected Healthy Volunteers. J Acquir Immune Defic Syndr. 2009; 51:424-429. [PubMed 19506482]

10. Abbott Laboratories. Kaletra (lopinavir/ritonavir) oral tablets and solution prescribing information. North Chicago, IL; 2009 Apr.

11. Lef?vre G, Bindschedler M, Ezzert F et al. Pharmacokinetic interaction trial between co-artemether and mefloquine. Eur J Pharm Sci. 2000; 10:141-51.

12. Lef?vre G, Carpenter P. Souppart C et al. Pharmacokinetics and electrocardiographic pharmacodynamics of artemether-lumefantrine (Riamet) with concomitant administration of ketoconazole in healthy subjects. Br J Clin Pharmacol. 2002; 54:485-92.

13. Lef?vre G, Carpenter P. Souppart C et al. Interaction trial between artemether-lumefantrine (Riamet) and quinine in healthy subjects. J Clin Pharmacol. 2002: 42:1147-58.

More Coartem resources Coartem Side Effects (in more detail)Coartem DosageCoartem Use in Pregnancy & BreastfeedingCoartem Drug InteractionsCoartem Support Group0 Reviews for Coartem - Add your own review/rating Coartem Prescribing Information (FDA) Coartem Advanced Consumer (Micromedex) - Includes Dosage Information Coartem MedFacts Consumer Leaflet (Wolters Kluwer) Coartem Consumer Overview Compare Coartem with other medications Malaria
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pyrimethamine


Generic Name: pyrimethamine (PIR i METH a meen)
Brand Names: Daraprim

What is pyrimethamine?

Pyrimethamine is an antiparasitic drug. It prevents the growth and reproduction of parasites.

Pyrimethamine is used to treat and prevent malaria. Pyrimethamine is also used in the treatment of toxoplasmosis.

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

What is the most important information I should know about pyrimethamine? Stop taking pyrimethamine and seek medical attention at the first sign of a skin rash, sore throat, paleness of the skin, unusual bruising under the skin, or swelling of the tongue. These may be early symptoms of serious side effects of pyrimethamine. Pyrimethamine may cause stomach upset or vomiting. Take each dose with food to lessen this side effect. What should I discuss with my healthcare provider before taking pyrimethamine?

Before taking pyrimethamine, tell your doctor if you have

had an allergic reaction to previous treatment with pyrimethamine,

megaloblastic anemia due to folate deficiency,

seizures or epilepsy,

kidney disease, or liver disease.

You may not be able to take pyrimethamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Pyrimethamine is in the FDA pregnancy category C. This means that it is not known whether pyrimethamine will be harmful to an unborn baby. Do not take pyrimethamine without first talking to your doctor if you are pregnant or could become pregnant during treatment. Pyrimethamine passes into breast milk and may be harmful to a nursing infant. Do not take pyrimethamine without first talking to your doctor if you are breast-feeding a baby. How should I take pyrimethamine?

Take pyrimethamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take pyrimethamine with food to lessen stomach upset. Store pyrimethamine at room temperature away from moisture and heat.

See also: Pyrimethamine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of the medication.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a pyrimethamine overdose may include abdominal pain, nausea, severe vomiting (possibly with blood in the vomit), anxiety or excitability, and seizures.

What should I avoid while taking pyrimethamine?

There are no restrictions on foods, beverages, or activities during treatment with pyrimethamine unless otherwise directed by your doctor.

Pyrimethamine side effects Stop taking pyrimethamine and seek emergency medical attention if you experience an allergic reaction (swelling of the lips, tongue, or face; difficulty breathing; closing of the throat; or hives) during treatment with pyrimethamine. Stop taking pyrimethamine and seek medical attention at the first sign of a skin rash, sore throat, paleness of the skin, unusual bruising under the skin, or swelling of the tongue. These may be early symptoms of serious side effects of pyrimethamine.

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

nausea, vomiting, or loss of appetite;

insomnia;

headache;

lightheadedness; or

dryness of the mouth.

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.

Pyrimethamine Dosing Information

Usual Adult Dose for Malaria Prophylaxis:

25 mg orally once a week. Prophylaxis should begin one week prior to departure and continue for at least 6 to 10 weeks following exposure.

Usual Adult Dose for Toxoplasmosis:

Initially: 50 to 75 mg orally once a day with 1 to 4 g of a sulfonamide (e.g., sulfadoxine, sulfadiazine). Continue for 1 to 3 weeks, depending on response and tolerance. Dosage for each drug may then be reduced by one-half and continued for an additional 4 or 5 weeks. Patients receiving pyrimethamine should also receive folinic acid.

Usual Adult Dose for Toxoplasmosis -- Prophylaxis:

1 mg/kg or 15 mg/m2 (max 25 mg) orally every day plus folinic acid (leucovorin) 5 mg orally every 3 days plus sulfadiazine 85 to 120 mg/kg/day divided into 2 to 4 oral doses. Clindamycin 20 to 30 mg/kg/day may be used in place of sulfadiazine as an alternative regimen.

Usual Adult Dose for Pneumocystis Pneumonia Prophylaxis:

50 to 75 mg orally once a week. Pyrimethamine is used in combination with dapsone and leucovorin. This is considered an alternative regimen for patients who do not tolerate trimethoprim-sulfamethoxazole.

Usual Pediatric Dose for Malaria Prophylaxis:

Less than 4 years: 6.25 mg orally once a week.
4 to 10 years: 12.5 mg orally once a week.

Usual Pediatric Dose for Toxoplasmosis:

Newborns and infants:
Initial: 2 mg/kg/day orally divided every 12 hours for 2 days, then 1 mg/kg/day once daily given with sulfadiazine for the first 6 months; next 6 months: 1 mg/kg/day 3 times per week with sulfadiazine; oral folinic acid 5 to 10 mg 3 times per week should be administered to prevent hematological toxicity.
1 to 12 years: 2 mg/kg/day divided every 12 hours for 3 days followed by 1 mg/kg/day (maximum 25 mg/day) once daily or divided twice daily for 4 weeks given with sulfadiazine; oral folinic acid 5 to 10 mg 3 times per week should be administered to prevent hematological toxicity.

What other drugs will affect pyrimethamine?

Before taking pyrimethamine, tell your doctor if you are taking any of the following medicines:

auranofin (Ridaura);

aurothioglucose (Solganal); or

or gold sodium thiomalate (Aurolate, Myochrysine).

You may not be able to take pyrimethamine, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with pyrimethamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More pyrimethamine resources Pyrimethamine Side Effects (in more detail) Pyrimethamine Dosage Pyrimethamine Use in Pregnancy & Breastfeeding Pyrimethamine Drug Interactions Pyrimethamine Support Group 0 Reviews for Pyrimethamine - Add your own review/rating pyrimethamine Advanced Consumer (Micromedex) - Includes Dosage Information Pyrimethamine Professional Patient Advice (Wolters Kluwer) Pyrimethamine MedFacts Consumer Leaflet (Wolters Kluwer) Daraprim Prescribing Information (FDA) Daraprim Monograph (AHFS DI) Compare pyrimethamine with other medications Malaria Prevention Pneumocystis Pneumonia Prophylaxis Toxoplasmosis Toxoplasmosis, Prophylaxis Where can I get more information? Your pharmacist can provide more information about pyrimethamine.

See also: pyrimethamine side effects (in more detail)


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Quinidine Gluconate


Class: Class Ia Antiarrhythmics
Note: This monograph also contains information on Quinidine Sulfate
VA Class: CV300
CAS Number: 7054-25-3

Mortality

In many antiarrhythmic drug trials for non-life-threatening arrhythmias, active antiarrhythmic drug therapy was associated with increased mortality.163 167 168 169 170

Risk associated with antiarrhythmic drug therapy probably is greatest in patients with structural heart disease.163 167 168 169 170

A meta-analysis of data from several randomized, controlled studies in patients with atrial flutter and fibrillation indicates that quinidine therapy may be associated with a mortality rate >3 times higher than that associated with placebo.163 167 168 169 170

A meta-analysis in patients with various non-life-threatening ventricular arrhythmias showed mortality associated with quinidine was consistently greater than that associated with various other antiarrhythmic agents (i.e., flecainide, mexiletine, propafenone, tocainide).163 167 168 169 170

Introduction

Antiarrhythmic agent (class IA); antimalarial.119 161 163 167 168 169 170

Uses for Quinidine Gluconate

Comparably effective to procainamide for atrial or ventricular arrhythmias; choice based on pharmacokinetics and adverse effect profile.b

Supraventricular Tachyarrhythmias

Used principally for prophylactic therapy to maintain normal sinus rhythm after conversion of atrial fibrillation and/or flutter by other means.b

Abnormal ventricular rate and CHF should first be controlled by administration of digoxin.b Electrical cardioversion usually is considered the treatment of choice for conversion of atrial fibrillation or flutter.b

Prevention of recurrence of atrial fibrillation or flutter is controversial because mortality may increase despite recurrence suppression.b

May maintain normal sinus rhythm for long periods in recent onset of atrial fibrillation or flutter without CHF, atrial enlargement, or left ventricular hypertrophy, but long-standing atrial fibrillation is likely to recur even with quinidine maintenance therapy.b

Generally, quinidine should not be used prophylactically for atrial fibrillation if the ventricular rate is adequately controlled by digoxin and the patient is asymptomatic.b

Treatment of paroxysmal atrial tachycardia or paroxysmal AV junctional rhythm.b

Atrial Premature Complexes

Treatment of atrial premature complexes; however, these arrhythmias usually are treated with digoxin.b

Ventricular Premature Complexes (VPCs)

Treatment of VPCs; however, parenteral lidocaine is considered the drug of choice because quinidine can decrease myocardial contractility.b

Like other antiarrhythmic drugs, not shown to decrease mortality rate in VPCs associated with AMI.b

Avoid in treatment of asymptomatic VPCs.b

Not for treatment of cardiac glycoside-induced ventricular arrhythmias.b

VT

Treatment of paroxysmal VT that is not associated with complete heart block; however, treatment with cardioversion or lidocaine usually is preferred.b

Suppression and prevention of recurrent ventricular arrhythmias (e.g., sustained VT) that in the judgment of the clinician are life-threatening.b

Because of arrhythmogenic potential and the lack of evidence for improved survival for class I antiarrhythmic agents,146 147 not recommended for less severe VTs; avoid treatment in asymptomatic VPCs.b

Malaria

Treatment of severe, life-threatening malaria caused by Plasmodium falciparum.101 102 104 105 119 122 124 126 142 153 158 162 Drug of choice for initial treatment of severe malaria.101 126 142 153 154 158 162

Severe malaria usually is caused by P. falciparum and requires initial aggressive treatment with a parenteral antimalarial regimen initiated as soon as possible after diagnosis.158 162 Exchange transfusions can be considered if parasitemia is >10% or patient has cerebral malaria, altered mental status, non-volume-overload pulmonary edema, or renal complications.158 162

For initial treatment of severe malaria in adults or children, CDC recommends a regimen of IV quinidine gluconate in conjunction with doxycycline, tetracycline, or clindamycin (oral or IV as tolerated).158 162 After at least 24 hours and when parasitemia is reduced to <1% and an oral regimen can be tolerated, IV quinidine gluconate can be discontinued and oral quinine sulfate initiated to complete 3 or 7 days of total quinidine and quinine therapy as determined by the geographic origin of the infecting parasite (3 days if malaria acquired in Africa or South America or 7 days if acquired in Southeast Asia).158 162

Because of potentially fatal consequences of delays in initiating treatment of severe malaria, institutional pharmacy services should be aware of the essential role of ready availability of IV quinidine gluconate.142 143 153 158 (See Availability for Use in Treatment of Severe Malaria under Cautions.)

When IV quinidine gluconate is unavailable or cannot be used because of intolerance or contraindications, parasitemia is high or has not responded to quinidine gluconate therapy, and a parenteral regimen is indicated, IV artesunate is available from CDC under an investigational new drug (IND) protocol for the treatment of severe malaria.158 162 171 172 WHO and other clinicians recommend artesunate as a drug of choice for the treatment of severe malaria.101 173

Although oral quinidine sulfate has been used for the treatment of malaria,167 170 including uncomplicated malaria† caused by multidrug-resistant P. falciparum,102 104 108 109 110 112 oral quinine sulfate is not included in CDC recommendations for treatment of uncomplicated or severe P. falciparum malaria.158 162

Assistance with diagnosis or treatment of malaria and assistance obtaining IV quinidine gluconate or IV artesunate for treatment of severe malaria is available by contacting the CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.158 162 171 172

Quinidine Gluconate Dosage and Administration General Arrhythmias

Initiate quinidine or adjust quinidine dosage in a setting where facilities and personnel for patient monitoring and resuscitation are continuously available, especially if used in patients with known structural heart disease or other risk factors for toxicity.163 167 168 169 170

ECG monitoring of cardiac function and determination of plasma concentrations are recommended, especially when given IV or when >2 g is administered orally daily, and in patients with an increased risk of adverse reactions to quinidine (e.g., severe heart disease, hypotension, hepatic or renal disease).b

Use for conversion of atrial fibrillation/flutter only after alternative measures (e.g., use of other drugs to control ventricular rate) have been inadequate.163 167 168 169 170 Discontinue quinidine if sinus rhythm is not restored within a reasonable amount of time.119 163 167 168 169 170

Discontinue quinidine and consider other means of conversion if QRS complex widens to 130% of its pretreatment duration, QTc interval widens to 130% of its pretreatment duration and is >500 milliseconds, P waves disappear, or patient develops clinically important tachycardia, symptomatic bradycardia, or hypotension.119 163 167 168 169 170

Malaria

Initiate IV quinidine gluconate regimen as soon as possible after severe P. falciparum malaria is diagnosed.158 162 CDC recommends the regimen be initiated in patients with strong clinical evidence of severe malaria, even if initial blood smears do not demonstrate parasitemia or indicate P. vivax, P. ovale, or P. malariae infection.158

CDC and others recommend the IV quinidine gluconate regimen be administered in an intensive care facility with close monitoring.101 111 122 123 124 125 126 141 153 158

Monitor BP, plasma quinidine concentrations, and ECG closely and monitor blood glucose periodically in patients receiving quinidine for treatment of malaria; adjust dosage accordingly.101 102 104 111 141 158 162

Because most deaths from severe malaria occur within the first 24–48 hours of illness, an initial loading dose is used to attain therapeutic plasma concentrations rapidly during this critical period of elevated parasitemia.158 A loading dose should not be used if patient received >40 mg/kg of quinine in the previous 48 hours or received mefloquine in the previous 12 hours.158

Calculate loading dose and infusion rate carefully to prevent acute cardiac events.153 Consider that the risk of serious ventricular arrhythmias associated with quinidine is increased by bradycardia, hypokalemia, hypomagnesemia, and concomitant use of drugs that can prolong QT interval (e.g., halofantrine [an antimalarial drug not commercially available in the US], mefloquine, quinine).101 153 158

CDC recommends consultation with a cardiologist and a clinician with experience in treating malaria.153 158 162 A cardiologist may be helpful if attempting to resume IV infusion of quinidine gluconate in patients who develop prolongation of QT interval or hypotension during treatment.153

Administration

Administer quinidine sulfate orally.163 167 Administer quinidine gluconate orally168 169 or by IV infusion.119

IM administration of quinidine gluconate is not recommended because absorption may vary depending on the patient’s peripheral perfusion.119

Oral Administration

Administer quinidine sulfate orally as conventional167 170 or extended-release tablets.163

Administer quinidine gluconate orally as extended-release tablets.168 169

May be administered with food or antacids to decrease adverse GI effects.b Avoid grapefruit juice.156 163 168 169 (See Specific Drugs and Foods under Interactions.)

To determine possible idiosyncrasy to quinidine, administer a test dose of 200 mg of quinidine sulfate orally several hours before initiating full dosage.b For children, the test dose for idiosyncrasy is 2 mg/kg (up to 200 mg) of quinidine sulfate orally.164 b

Extended-release Tablets

Used principally for maintenance therapy in the management of arrhythmias.b

Quinidine gluconate extended-release tablets may be broken in half in order to titrate dosage; however, do not chew or crush.168 169

IV Administration

Arrhythmias: Administer by IV infusion.119

Malaria: Administer by continuous or intermittent IV infusion.101 102 104 111 119 122 123 124 125 158 162

Dilution

Arrhythmias: Dilute contents of multiple-dose vial containing 800 mg of quinidine gluconate (10 mL of 80-mg/mL injection) in 40 mL of 5% dextrose injection to provide solution containing 16 mg/mL.119

Malaria (continuous IV infusion regimen): Dilute loading dose of 6.25 mg/kg of quinidine (10 mg/kg of quinidine gluconate)101 119 141 153 158 in approximately 5 mL/kg of 0.9% sodium chloride injection.119

Malaria (intermittent IV infusion regimen): Dilute loading dose of 15 mg/kg of quinidine (24 mg/kg of quinidine gluconate)119 153 158 in 250 mL of 0.9% sodium chloride injection.119

Rate of Administration

Minimize length of IV tubing because of quinidine adsorption to PVC tubing.119 (See Compatibility under Stability.)

Overly rapid IV administration can cause potentially severe cardiovascular effects.119 (See IV Administration under Cautions.)

Arrhythmias: Up to 0.25 mg/kg per minute (i.e., about 1 mL/kg per hour of 16-mg/mL dilution).119

Malaria (continuous IV infusion regimen): Give loading dose of 6.25 mg/kg of quinidine (10 mg/kg of quinidine gluconate) by IV infusion over 1–2 hours, followed by continuous IV infusions given at a rate of 12.5 mcg/kg of quinidine per minute (20 mcg/kg of quinidine gluconate per minute) for at least 24 hours.101 119 153 158 Administer infusion at a rate that maintains a plasma quinidine concentration of 3–8 mcg/mL.158 Decrease infusion rate or interrupt flow if corrected QT interval is >0.6 seconds, corrected QT interval exceeds baseline by >25%, QRS widening is >50% of baseline, or clinically important hypotension unresponsive to fluid expansion develops.111 124 128 158

Malaria (intermittent IV infusion regimen): Give loading dose of 15 mg/kg of quinidine (24 mg/kg of quinidine gluconate) by IV infusion over 4 hours, followed 4 hours later (i.e., 8 hours after the beginning of the loading-dose infusion) by maintenance doses of 7.5 mg/kg of quinidine (12 mg/kg of quinidine gluconate) given by IV infusion over 4 hours at 8-hour intervals.119 153 158 Administer infusion at a rate that maintains a plasma quinidine concentration of 3–8 mcg/mL.158 Decrease infusion rate or interrupt flow if corrected QT interval is >0.6 seconds, corrected QT interval exceeds baseline by >25%, QRS widening exceeds baseline by >50%, or clinically important hypotension unresponsive to fluid expansion develops.158

Dosage

Available as quinidine sulfate163 167 170 and quinidine gluconate.119 168 169 Dosage for treatment of arrhythmias usually expressed in terms of the salt;119 163 167 168 169 170 dosage for treatment of malaria expressed in terms of the base or salt.119 158 162

On a molar basis, approximately 267 mg of quinidine gluconate is equivalent to 200 mg of quinidine sulfate.b

Each 100 mg of quinidine gluconate contains 62.5 mg of quinidine.119

Pediatric Patients Quinidine Sulfate Arrhythmias† Oral

15–60 mg/kg of quinidine sulfate daily given in divided doses every 6 hours has been recommended by some clinicians.164 165 Others recommend 30 mg/kg daily or 900 mg/m2 daily, given in 5 divided doses.b

Quinidine Gluconate Arrhythmias† Oral

20–60 mg/kg of quinidine gluconate daily given in divided doses every 8 hours has been recommended by some clinicians.165

IV

30 mg/kg daily or 900 mg/m2 daily of quinidine gluconate, given in 5 divided doses, is recommended by some clinicians.b

Severe Malaria IV

Continuous IV infusion regimen: Initial loading dose of 6.25 mg/kg of quinidine (10 mg/kg of quinidine gluconate) given by IV infusion over 1–2 hours,101 119 158 162 followed by a maintenance infusion of 12.5 mcg/kg of quinidine per minute (20 mcg/kg of quinidine gluconate per minute) continued for ?24 hours and until parasitemia is reduced to <1% and oral quinine sulfate can be substituted.101 111 119 122 123 124 125 141 158 162 Some clinicians state initial loading dose should not exceed 375 mg of quinidine (600 mg of quinidine gluconate).101

Intermittent IV infusion regimen: Initial loading dose of 15 mg/kg of quinidine (24 mg/kg of quinidine gluconate) given by IV infusion over 4 hours, followed 4 hours later (i.e., 8 hours after the beginning of the loading-dose infusion) by maintenance doses of 7.5 mg/kg of quinidine (12 mg/kg of quinidine gluconate) given by IV infusion over 4 hours at 8-hour intervals until 3 maintenance doses have been administered and parasitemia is reduced to <1% and oral quinine sulfate can be substituted.119 153 158 162

After ?24 hours of quinidine gluconate and when clinically indicated, switch to oral quinine sulfate therapy to complete a total of 3 or 7 days of total quinidine and quinine therapy as determined by the geographic origin of the infecting parasite (3 days if malaria was acquired in Africa or South America or 7 days if acquired in Southeast Asia).122 123 141 158 162

The IV quinidine gluconate regimen followed by oral quinine sulfate is used in conjunction with a 7-day regimen of doxycycline, tetracycline, or clindamycin (given IV or orally as tolerated).158

Adults Quinidine Sulfate Arrhythmias Oral

Conversion of atrial fibrillation/flutter (conventional tablets): Manufacturers recommend 400 mg of quinidine sulfate (332 mg of quinidine) every 6 hours initially; dose may be cautiously increased if conversion is not attained after 4 or 5 doses.167 170

Conversion of atrial fibrillation/flutter (extended-release tablets): Manufacturer recommends 300 mg of quinidine sulfate (249 mg of quinidine) every 8–12 hours initially; dose may be cautiously increased if conversion not attained, quinidine serum concentrations are within the therapeutic range, and the drug is well tolerated.163

If successful conversion of atrial fibrillation does not occur when quinidine serum concentrations are in the therapeutic range, further dosage increases generally are unsuccessful and increase the possibility of toxicity.b

Reduction in frequency of relapse into atrial fibrillation/flutter (conventional tablets): Manufacturers recommend 200 mg of quinidine sulfate (166 mg of quinidine) every 6 hours initially.167 170 Dose may be cautiously increased if well tolerated, serum quinidine concentrations are within therapeutic range, and average time between arrhythmic episodes has not been satisfactorily increased.167 170 Use such prophylaxis only if alternative measures have been inadequate and if potential benefits outweigh risks;167 170 consider mortality risk.167 170

Reduction in frequency of relapse into atrial fibrillation/flutter (extended-release tablets): Manufacturer recommends 300 mg of quinidine sulfate (249 mg of quinidine) every 8–12 hours initially.163 Dose may be cautiously increased if well tolerated, serum quinidine concentrations are within therapeutic range, and average time between arrhythmic episodes has not been satisfactorily increased.163 Use such prophylaxis only if alternative measures have been inadequate and if potential benefits outweigh risks;163 consider mortality risk.163

Manufacturers state that dosage regimens for suppression of life-threatening ventricular arrhythmias have not been adequately studied, but regimens similar to those used in the management of atrial fibrillation/flutter have been described.163 167 170 Whenever possible, such therapy should be guided by results of programmed electrical stimulation and/or Holter monitoring with exercise.163 167 170

Malaria Oral

300–600 mg or 10 mg/kg of quinidine sulfate every 8 hours for 5–7 days has been used for the treatment of uncomplicated P. falciparum malaria.102 103 108 109 110

Not included in CDC recommendations for treatment of uncomplicated or severe malaria.158 162 (See Malaria under Uses.)

Quinidine Gluconate Arrhythmias Oral

Conversion of atrial fibrillation/flutter (extended-release tablets): Manufacturers recommend 648 mg of quinidine gluconate (403 mg of quinidine) every 8 hours initially; dose may be cautiously increased if conversion is not attained after 3 or 4 doses.168 169 Alternatively, manufacturers state that a regimen of 324 mg of quinidine gluconate (202 mg of quinidine) may be given every 8 hours for 2 days, then 648 mg of quinidine gluconate (403 mg of quinidine) every 12 hours for 2 days, and then 648 mg of quinidine gluconate (403 mg of quinidine) every 8 hours for up to 4 days.168 169 If the 648-mg dose is not tolerated, the lower dosage can be continued for the last 4 days.168 169

Reduction in frequency of relapse into atrial fibrillation/flutter (extended-release tablets): Manufacturers recommend 324 mg of quinidine gluconate (202 mg of quinidine) every 8 or 12 hours initially.168 169 Dose may be cautiously increased if well tolerated, serum quinidine concentrations are within therapeutic range, and average time between arrhythmic episodes has not been satisfactorily increased.168 169 Use such prophylaxis only if alternative measures have been inadequate and if potential benefits outweigh risks;168 169 consider mortality risk.168 169

Manufacturers state that dosage regimens for suppression of life-threatening ventricular arrhythmias have not been adequately studied, but regimens similar to those used in the management of atrial fibrillation/flutter have been described.168 169 Whenever possible, such therapy should be guided by results of programmed electrical stimulation and/or Holter monitoring with exercise.168 169

IV

Treatment of symptomatic atrial fibrillation/flutter: Initially, up to 0.25 mg/kg of quinidine gluconate per minute (i.e., up to 1 mL/kg per hour) of 16-mg/mL dilution.119 Discontinue IV infusion as soon as sinus rhythm is restored.119

Most arrhythmias responsive to IV quinidine respond to a total IV dosage <5 mg/kg, although 10 mg/kg may be required in some patients.119 If conversion to sinus rhythm has not occurred after infusion of quinidine gluconate 10 mg/kg, discontinue the infusion and consider other means of cardioversion.119

Although dosing regimens for the management of life-threatening ventricular arrhythmias have not been systematically evaluated, regimens similar to that used in the management of atrial fibrillation/flutter have been described.119

Severe Malaria IV

Continuous IV infusion regimen: Initial loading dose of 6.25 mg/kg of quinidine (10 mg/kg of quinidine gluconate) given by IV infusion over 1–2 hours,101 119 141 158 162 followed by a maintenance infusion of 12.5 mcg/kg of quinidine per minute (20 mcg/kg of quinidine gluconate per minute) continued for ?24 hours and until parasitemia is reduced to <1% and oral quinine sulfate can be substituted.101 111 119 122 123 124 125 141 158 162 Some clinicians state initial loading dose should not exceed 375 mg of quinidine (600 mg of quinidine gluconate).101

Intermittent IV infusion regimen: Initial loading dose of 15 mg/kg of quinidine (24 mg/kg of quinidine gluconate) given by IV infusion over 4 hours, followed 4 hours later (i.e., 8 hours after the beginning of the loading-dose infusion) by maintenance doses of 7.5 mg/kg of quinidine (12 mg/kg of quinidine gluconate) given by IV infusion over 4 hours at 8-hour intervals until 3 maintenance doses have been administered and parasitemia is reduced to <1% and oral quinine sulfate can be substituted.119 153 158 162

After ?24 hours of quinidine gluconate and when clinically indicated, switch to oral quinine sulfate therapy to complete a total of 3 or 7 days of total quinidine and quinine therapy as determined by the geographic origin of the infecting parasite (3 days if malaria was acquired in Africa or South America or 7 days if acquired in Southeast Asia).122 123 141 158

The IV quinidine gluconate regimen followed by oral quinine sulfate is used in conjunction with a 7-day regimen of doxycycline, tetracycline, or clindamycin (given IV or orally as tolerated).158 162

Prescribing Limits Pediatric Patients Arrhythmias† Quinidine Gluconate or Quinidine Sulfate Oral

2.4 g of quinidine sulfate or quinidine gluconate daily.165

Severe Malaria Quinidine Gluconate IV

Continuous IV infusion regimen: Maximum initial loading dose of 375 mg of quinidine (600 mg of quinidine gluconate).101

Adults Severe Malaria Quinidine Gluconate IV

Continuous IV infusion regimen: Maximum initial loading dose of 375 mg of quinidine (600 mg of quinidine gluconate).101

Special Populations Hepatic Impairment

Dosage reduction may be necessary to avoid toxicity.119 163 167 168 169 170

Renal Impairment

Dosage reduction may be necessary to avoid toxicity.119 163 167 168 169 170

In patients with severe malaria receiving IV quinidine gluconate, CDC states that initial (including loading) doses do not need to be reduced in those with renal failure.158 If renal failure persists or clinical improvement does not occur in such patients, CDC recommends reducing maintenance IV infusion rate by one-third to one-half on the third day of treatment.158

CHF

Dosage reduction may be necessary to avoid toxicity.119 163 167 168 169 170

Geriatric Patients

Select dosage with caution, usually starting at the low end of the dosage range, and consider age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.119

Cautions for Quinidine Gluconate Contraindications

Patients with AV junctional or idioventricular pacemaker, including those in complete AV block.119 163 167 168 169 170

History of quinidine- or quinine-associated thrombocytopenic purpura.119 163 167 168 169 170

Myasthenia gravis or other conditions that might be adversely affected by anticholinergic effects.119 163 167 168 169 170

Known hypersensitivity to quinidine.119 163 167 168 169 170

Warnings/Precautions Warnings Mortality

Pooled analysis of data from several randomized, controlled studies in patients with ventricular arrhythmias indicates that mortality rate associated with quinidine therapy is at least as high as that associated with other antiarrhythmic agents (e.g., flecainide, mexiletine, propafenone, tocainide).b

Use quinidine only for life-threatening arrhythmias.145 Avoid use for less severe ventricular arrhythmias and treatment of asymptomatic VPCs.145

Additionally, pooled analysis of data from several randomized, controlled studies in patients with atrial flutter and fibrillation indicates that quinidine therapy may be associated with a mortality rate more than 3 times higher than that associated with placebo;163 167 168 169 170 consider the increased risk of death when initiating quinidine therapy.144

Use with extreme caution, if at all, in patients with incomplete AV nodal block, since complete heart block and asystole may result.b Parenteral administration is especially hazardous in the presence of AV block, in the absence of atrial activity, and in patients with extensive myocardial injury.b

Proarrhythmic Effects

The possibility that potentially serious cardiac arrhythmias, including torsades de pointes, could occur if used concomitantly with other drugs that prolong the QTc interval should be considered and such combined use should be avoided.151

Hypokalemia, hypoxia, and disorders of acid-base balance must be eliminated as potentiating factors in patients who require large doses of antiarrhythmic agents to control ventricular arrhythmias.b

Paradoxical Increase in Ventricular Rate in Atrial Flutter/Fibrillation

Paradoxically, an extremely rapid ventricular rate may occur when used in the treatment of atrial flutter or fibrillation, due to a reduction in the degree of AV nodal block to a 1:1 ratio.b The anticholinergic action on the AV node also may increase the heart rate.b

This tachycardia may be prevented by prior digitalization.b

If cessation of atrial fibrillation or flutter is accompanied by depression of the normal pacemaker, an idioventricular rhythm (including ventricular tachycardia and fibrillation) may result.b

Exacerbated Bradycardia in Sick Sinus Syndrome

Possible marked sinus node depression and bradycardia.b

IV Administration

Overly rapid IV administration may cause peripheral vascular collapse and hypotension.119

Sensitivity Reactions Hypersensitivity Reactions

Idiosyncratic and hypersensitivity reactions to quinidine may occur, and the reaction to a test dose or the first dose of the drug should be observed carefully.b (See Oral Administration under Dosage and Administration.)

Observe for hypersensitivity for the first weeks of therapy.b

Symptoms of cinchonism such as tinnitus, headache, vertigo, fever, dizziness, lightheadedness, tremor, nausea, and disturbed vision may occur in sensitive patients after a single dose.b

Decrease dosage if signs of cinchonism appear.b

General Precautions Cardiovascular Effects

Possible syncope, probably due to ventricular tachycardia or fibrillation in usual doses.b May subside spontaneously, but occasionally are fatal.b If quinidine-induced syncope occurs, discontinue the drug.b Also may cause bradycardia.b

Severe hypotension may occur following IV administration or oral overdosage.b Vascular collapse, respiratory distress, and respiratory arrest may occur.b Reportedly related to the dose and rate of administration of the drug.102 107 119 Rapid IV injection of as little as 200 mg reportedly may cause a decrease in blood pressure of 40–50 mm Hg.119 Norepinephrine or metaraminol may be used if necessary to treat vascular collapse; artificial respiration and other supportive measures may be required.b

While substantial cardiovascular toxicity generally has not occurred, ECG changes, including prolonged QT interval, widened QRS complex, and flattened T waves (without dysrhythmia), have occurred frequently and hypotension and ventricular tachycardia have occurred occasionally in patients receiving IV quinidine gluconate for the treatment of Plasmodium falciparum malaria.102 104 108 124

Use with caution in patients without implanted pacemakers at high risk of complete atrioventricular block (e.g., digitalis intoxication, second-degree atrioventricular block, severe intraventricular conduction defects).163 167 168 169 170

Availability for Use in Treatment of Severe Malaria

Because of potentially fatal consequences of delays in initiating treatment of severe malaria, institutional pharmacy services should be aware of the essential role of ready availability of IV quinidine gluconate.b 142 143 153 158

If IV quinidine gluconate is not readily available for a patient with severe P. falciparum malaria (e.g., in hospitals where the drug is not maintained on formulary or otherwise available), health-care professionals should contact a nearby healthcare facility that stocks the drug.158 If a local source cannot be found, contact the local or regional distributor of the drug.158

If IV quinidine gluconate is unavailable, cannot be used because of intolerance or contraindications, or parasitemia is high or has not responded to quinidine gluconate therapy, IV artesunate is available from the CDC under an IND protocol for treatment of severe malaria.158 162 171 (See Malaria under Uses.)

Specific Populations Pregnancy

Category C.119 163 166 167 168 169 170

Generally considered relatively safe at usual dosages, but may exhibit oxytocic effect (possible abortion) at high dosages.166

Lactation

Distributed into milk.119 163 166 167 168 169 170 Avoid, if possible, in nursing women.119 163 167 168 169 170

Pediatric Use

Safety and efficacy as an antiarrhythmic agent in children not established.119 163 167 168 169 170 Has been used in children with arrhythmias†.165 b

Study and experience in children with malaria suggest that safety and efficacy of IV quinidine gluconate are similar to those in adults.119

Geriatric Use

Safety and efficacy not systematically studied in geriatric patients.119 167 168 169 170 Clinical studies did not include sufficient numbers of patients ?65 years of age to determine whether they respond differently than younger adults;119 other reported clinical experience has not identified differences in responses between geriatric adults and younger patients.119

When used in geriatric patients, select dosage with caution, usually initiating therapy at the low end of dosage range, and consider the greater frequency of decreased hepatic, renal, and/or cardiac function and concomitant disease and drug therapy in this age group.119

Hepatic Impairment

Decreased clearance;119 163 167 168


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Pyrimethamine/Sulfadoxine


Generic Name: Pyrimethamine/Sulfadoxine (peer-i-METH-a-meen/sul-fa-DOX-een)
Brand Name: Fansidar

Severe and sometimes fatal reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been associated with the use of Pyrimethamine/Sulfadoxine. Contact your doctor immediately if you develop signs of infection (eg, fever, chills, sore throat), unusual tiredness or weakness, unusual bruising or bleeding, a skin rash, or if you develop red, swollen, or blistered skin.


Pyrimethamine/Sulfadoxine is used for:

Treating and preventing malaria when other medicines (eg, chloroquine) are not effective or appropriate.

Pyrimethamine/Sulfadoxine is an antimalarial agent. It works by blocking the formation of folinic acid within the malaria organism, which kills the parasite.

Do NOT use Pyrimethamine/Sulfadoxine if: you are allergic to pyrimethamine or any other ingredient in Pyrimethamine/Sulfadoxine you are pregnant and at term or you are breast-feeding you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide you have severe kidney or liver problems or certain blood problems (eg, anemia due to folate deficiency) the patient being treated is younger than 2 months of age

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

Before using Pyrimethamine/Sulfadoxine:

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

if you are planning to become pregnant 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 a history of asthma, severe allergies, kidney or liver problems, the blood disease porphyria or other blood problems, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, seizures, alcohol abuse, or depression if you have diarrhea, a stomach or intestinal infection, or a sore throat

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

Methotrexate because side effects may be increased by Pyrimethamine/Sulfadoxine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pyrimethamine/Sulfadoxine 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 Pyrimethamine/Sulfadoxine:

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

Take Pyrimethamine/Sulfadoxine after a meal. Swallow Pyrimethamine/Sulfadoxine whole. Do not break, crush, or chew before swallowing. Drinking extra fluids while you are taking Pyrimethamine/Sulfadoxine is recommended. Check with your doctor for instructions. If you miss a dose of Pyrimethamine/Sulfadoxine, 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 Pyrimethamine/Sulfadoxine.

Important safety information: Pyrimethamine/Sulfadoxine may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pyrimethamine/Sulfadoxine. Using Pyrimethamine/Sulfadoxine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. If you have had a severe allergic reaction to Pyrimethamine/Sulfadoxine or any other sulfonamide medicine (eg, sulfisoxazole, sulfamethoxazole, glyburide, probenecid), contact your doctor or pharmacist before taking Pyrimethamine/Sulfadoxine. A severe reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to Pyrimethamine/Sulfadoxine or if a certain medicine is a sulfonamide, contact your doctor or pharmacist. It is important to use Pyrimethamine/Sulfadoxine for the full course of treatment. Failure to do so may decrease the effectiveness of Pyrimethamine/Sulfadoxine and increase the risk that the bacteria will no longer be sensitive to Pyrimethamine/Sulfadoxine and will not be able to be treated by this or certain other antibiotics in the future. Pyrimethamine/Sulfadoxine may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor. Pyrimethamine/Sulfadoxine may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Pyrimethamine/Sulfadoxine. Use a sunscreen or wear protective clothing if you must be outside for a prolonged period. Diabetes patients - Pyrimethamine/Sulfadoxine may cause low blood sugar (eg, increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting). It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you do not have a reliable source of glucose available, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or nondiet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To prevent hypoglycemia, eat meals on a regular schedule and do not skip meals. LAB TESTS, including complete blood cell counts and liver and kidney function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments. Use Pyrimethamine/Sulfadoxine with caution in the ELDERLY because they may be more sensitive to its effects. Pyrimethamine/Sulfadoxine is not recommended for use in CHILDREN younger than 2 months of age. Safety and effectiveness in this age group have not been confirmed. If you are traveling to an area where malaria is common, avoid becoming pregnant while using Pyrimethamine/Sulfadoxine and for 3 months after the last dose. Talk with your doctor about using effective contraception. PREGNANCY and BREAST-FEEDING: Pyrimethamine/Sulfadoxine may cause harm to the fetus. Avoid becoming pregnant while taking Pyrimethamine/Sulfadoxine. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Pyrimethamine/Sulfadoxine during pregnancy. Pyrimethamine/Sulfadoxine is excreted in breast milk. Do not breast-feed while taking Pyrimethamine/Sulfadoxine. Possible side effects of Pyrimethamine/Sulfadoxine:

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:

Diarrhea; dizziness; headache; 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); cough; dark urine; decreased urination; depression; hallucinations; joint pain; lack of coordination; persistent sore throat, fever, or chills; red, swollen, or blistered skin; ringing in the ears; seizures; shortness of breath; sores on the mouth or lips; stomach pain; swelling or stinging of the tongue; tingling or numbness of the skin; unusual bruising or bleeding; unusual tiredness or weakness; 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: Pyrimethamine/Sulfadoxine 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 chills; crystals in the urine; loss of appetite; seizures; shaking; swelling of the tongue; vomiting.

Proper storage of Pyrimethamine/Sulfadoxine:

Store Pyrimethamine/Sulfadoxine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pyrimethamine/Sulfadoxine out of the reach of children and away from pets.

General information: If you have any questions about Pyrimethamine/Sulfadoxine, please talk with your doctor, pharmacist, or other health care provider. Pyrimethamine/Sulfadoxine 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.

This information is a summary only. It does not contain all information about Pyrimethamine/Sulfadoxine. 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 Pyrimethamine/Sulfadoxine resources Pyrimethamine/Sulfadoxine Side Effects (in more detail) Pyrimethamine/Sulfadoxine Use in Pregnancy & Breastfeeding Pyrimethamine/Sulfadoxine Drug Interactions Pyrimethamine/Sulfadoxine Support Group 0 Reviews for Pyrimethamine/Sulfadoxine - Add your own review/rating Compare Pyrimethamine/Sulfadoxine with other medications Malaria Malaria Prevention Pneumocystis Pneumonia Prophylaxis
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Aralen


Generic Name: Chloroquine (KLOR-oh-kwin)
Brand Name: Aralen
Aralen is used for:

Treating and suppressing acute attacks of certain strains of malaria and a certain type of parasitic infection (extraintestinal amebiasis). It may also be used for other conditions as determined by your doctor.

Aralen is an aminoquinoline. It is thought to kill sensitive malaria parasites by stopping normal metabolism inside the parasite.

Do NOT use Aralen if: you are allergic to any ingredient in Aralen you have vision problems or retinal changes you are taking arsenic, astemizole, terfenadine, cimetidine, cisapride, quinacrine, or dofetilide

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

Before using Aralen:

Some medical conditions may interact with Aralen. 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 or other substances if you have porphyria or any other blood disease, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, or a history of seizures if you have psoriasis, stomach or intestinal problems, liver disease, or central nervous system problems

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

Cimetidine or quinacrine because the side effects of Aralen may be increased Ampicillin, rabies vaccine, or thyroid hormones (eg, levothyroxine) because the effectiveness of these medicines may be decreased Arsenic, astemizole, cisapride, dofetilide, or terfenadine because the risk of severe side effects, including irregular heartbeat, may be increased Cyclosporine because its side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aralen 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 Aralen:

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

Aralen is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Aralen at home, carefully follow the injection procedures taught to you by your health care provider. If Aralen contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it. Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal. If you miss a dose of Aralen, 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 Aralen.

Important safety information: Aralen may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Aralen. Using Aralen alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. If your symptoms do not improve or if they become worse, check with your doctor. Aralen may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Aralen. Use a sunscreen or protective clothing if you must be outside for a prolonged period. Contact your health care provider if you notice any muscle weakness or problems with vision or hearing. Your knee and ankle reflexes will be tested periodically. LAB TESTS, such as complete blood cell counts and eye tests, may be needed to monitor your progress. Be sure to keep appointments. Use Aralen with caution in the ELDERLY because they may be more sensitive to its effects. Caution is advised when using Aralen in CHILDREN because they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Aralen, discuss with your doctor the benefits and risks of using Aralen during pregnancy. Aralen is excreted in breast milk. Do not breast-feed while taking Aralen. Possible side effects of Aralen:

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; clumsiness; diarrhea; dizziness; feeling of whirling motion; mild headache; nausea; stomach cramps; 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); bizarre behavior; change in color or skin or inside of mouth; diarrhea; difficulty seeing and reading (words, letters, or parts of objects missing when reading); fever or sore throat; hair loss; hearing loss; mood changes; ringing in the ears; seizures; sensitivity to sunlight; unusual bleeding or bruising; unusual weakness; vision problems; weight loss.

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: Aralen 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 blurred vision; drowsiness; excessive excitability; fainting; headache; irregular heartbeat; loss of consciousness; mood changes; seizures; severe drowsiness or dizziness; slow, shallow breathing.

Proper storage of Aralen:

Store Aralen in a tightly closed container at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aralen out of the reach of children and away from pets.

General information: If you have any questions about Aralen, please talk with your doctor, pharmacist, or other health care provider. Aralen 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.

This information is a summary only. It does not contain all information about Aralen. 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 Aralen resources Aralen Side Effects (in more detail) Aralen Use in Pregnancy & Breastfeeding Aralen Drug Interactions Aralen Support Group 0 Reviews for Aralen - Add your own review/rating Compare Aralen with other medications Amebiasis Malaria Malaria Prevention Sarcoidosis
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Vibramycin


Pronunciation: DOX-i-SYE-kleen HYE-klate
Generic Name: Doxycycline Hyclate
Brand Name: Examples include Vibra-Tabs and Vibramycin
Vibramycin is used for:

Treating certain bacterial infections. It may be used in combination with other medicines to treat acne or certain amoeba infections. It may be used to prevent certain types of malaria in travelers who will be visiting malaria-infected areas for less than 4 months. It may also be used to prevent or slow the progression of anthrax after exposure.

Vibramycin is a tetracycline antibiotic. It works by slowing the growth of bacteria. Slowing the bacteria's growth allows the body's immune system to destroy the bacteria.

Do NOT use Vibramycin if: you are allergic to any ingredient in Vibramycin or to another tetracycline (eg, minocycline) you are taking acitretin, isotretinoin, or a penicillin (eg, amoxicillin) you have recently received or will be receiving a live oral typhoid vaccine

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

Before using Vibramycin:

Some medical conditions may interact with Vibramycin. 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 diarrhea, a history of lupus, or the blood disease porphyria

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

Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), iron, or urinary alkalinizers (eg, sodium bicarbonate) because they may decrease Vibramycin's effectiveness Acitretin, anticoagulants (eg, warfarin), digoxin, isotretinoin, methotrexate, or methoxyflurane because the side effects and toxic effects may be increased by Vibramycin Live oral typhoid vaccine, hormonal birth control (eg, birth control pills), or penicillins (eg, amoxicillin) because their effectiveness may be decreased by Vibramycin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vibramycin 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 Vibramycin:

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

Take Vibramycin by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Do not take an antacid that has aluminum, calcium, or magnesium in it; bismuth-containing products; iron; urinary alkalinizers (eg, sodium bicarbonate); or multivitamins with minerals within 2 hours before or 2 hours after you take Vibramycin. To clear up your infection completely, take Vibramycin for the full course of treatment. Keep taking it even if you feel better in a few days. Drink plenty of fluids with Vibramycin to wash it down and avoid the risk of throat irritation. Do not use Vibramycin if it is outdated or has been stored incorrectly. If you are taking Vibramycin to prevent malaria, you should begin to take it 1 to 2 days before you travel to the malaria-infected area. You will need to keep taking it for 4 weeks after you leave the area. Discuss any questions with your doctor. If you miss a dose of Vibramycin, 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 Vibramycin.

Important safety information: Be sure to use Vibramycin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Vibramycin only works against bacteria; it does not treat viral infections (eg, the common cold). Long-term or repeated use of Vibramycin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. If you are taking Vibramycin to prevent malaria, please note that no malaria medicine, including Vibramycin, guarantees protection against malaria. Stay in well-screened areas, use mosquito nets, cover the body with clothing, and use insect repellent to avoid being bitten by mosquitoes. Hormonal birth control (eg, birth control pills) may not work as well while you are using Vibramycin. To prevent pregnancy, use an extra form of birth control (eg, condoms). Vibramycin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Vibramycin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or blood stools occur. Do not treat diarrhea without first checking with your doctor. Do not take more than the recommended dose or take Vibramycin for longer than prescribed without checking with your doctor. Tell your doctor or dentist that you take Vibramycin before you receive any medical or dental care, emergency care, or surgery. Vibramycin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Vibramycin. Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Vibramycin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Vibramycin with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel. Vibramycin should not be used in CHILDREN younger than 8 years old; permanent yellow-gray-brown tooth discoloration may occur. PREGNANCY and BREAST-FEEDING: Vibramycin has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vibramycin while you are pregnant. Vibramycin is found in breast milk. Do not breast-feed while taking Vibramycin. Possible side effects of Vibramycin:

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:

Loss of appetite; nausea; sensitivity to sunlight; 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; unusual hoarseness); bloody stools; chest pain; dark urine; decreased urination; fever, chills, or sore throat; moderate to severe sunburn; red, swollen, blistered, or peeling skin; severe diarrhea; severe or persistent headache; stomach pain or cramps; throat irritation; trouble swallowing; unusual bruising or bleeding; unusual joint pain; unusual tiredness; vaginal irritation or discharge; vision changes; 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: Vibramycin 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.

Proper storage of Vibramycin:

Store Vibramycin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vibramycin out of the reach of children and away from pets.

General information: If you have any questions about Vibramycin, please talk with your doctor, pharmacist, or other health care provider. Vibramycin 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 Vibramycin. 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 Vibramycin resources Vibramycin Side Effects (in more detail) Vibramycin Dosage Vibramycin Use in Pregnancy & Breastfeeding Drug Images Vibramycin Drug Interactions Vibramycin Support Group 3 Reviews for Vibramycin - Add your own review/rating Vibramycin Prescribing Information (FDA) Doxycycline Professional Patient Advice (Wolters Kluwer) Doxycycline Monograph (AHFS DI) Doxycycline Prescribing Information (FDA) Adoxa Advanced Consumer (Micromedex) - Includes Dosage Information Alodox Prescribing Information (FDA) Doryx Prescribing Information (FDA) Doxycycline Calcium Monograph (AHFS DI) Monodox Prescribing Information (FDA) Oracea Prescribing Information (FDA) Oracea Consumer Overview Periostat Prescribing Information (FDA) Compare Vibramycin with other medications Acne Actinomycosis Amebiasis Anthrax Anthrax Prophylaxis Bacterial Infection Bartonellosis Bronchitis Brucellosis Bullous Pemphigoid Chlamydia Infection Cholera Cutaneous Bacillus anthracis Ehrlichiosis Enterocolitis Epididymitis, Sexually Transmitted Gastroenteritis Granuloma Inguinale Inclusion Conjunctivitis Lyme Disease Lyme Disease, Arthritis Lyme Disease, Carditis Lyme Disease, Erythema Chronicum Migrans Lyme Disease, Neurologic Lymphogranuloma Venereum Malaria Malaria Prevention Melioidosis Mycoplasma Pneumonia Nongonococcal Urethritis Ocular Rosacea Ornithosis Pelvic Inflammatory Disease Pemphigoid Pemphigus Periodontitis Plague Pleural Effusion Pneumonia Proctitis Prostatitis Psittacosis Rabbit Fever Rickettsial Infection Rosacea Skin Infection STD Prophylaxis Syphilis, Early Syphilis, Latent Tertiary Syphilis Trachoma Upper Respiratory Tract Infection Urinary Tract Infection
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Fansidar


sulfadoxine and pyrimethamine
Dosage Form: Tablets

WARNING: FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF Fansidar HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME AND TOXIC EPIDERMAL NECROLYSIS. Fansidar PROPHYLAXIS MUST BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH, IF A SIGNIFICANT REDUCTION IN THE COUNT OF ANY FORMED BLOOD ELEMENTS IS NOTED, OR UPON THE OCCURRENCE OF ACTIVE BACTERIAL OR FUNGAL INFECTIONS.

Fansidar Description

Fansidar is an antimalarial agent, each tablet containing 500 mg N1-(5,6-dimethoxy-4-pyrimidinyl) sulfanilamide (sulfadoxine) and 25 mg 2,4-diamino-5-(p-chlorophenyl)-6-ethylpyrimidine (pyrimethamine). Each tablet also contains cornstarch, gelatin, lactose, magnesium stearate and talc.

Fansidar - Clinical Pharmacology Microbiology Mechanism of Action

Sulfadoxine and pyrimethamine, the constituents of Fansidar, are folic acid antagonists. Sulfadoxine inhibits the activity of dihydropteroate synthase whereas pyrimethamine inhibits dihydrofolate reductase.

Activity in vitro

Sulfadoxine and pyrimethamine are active against the asexual erythrocytic stages of Plasmodium falciparum. Fansidar may also be effective against strains of P. falciparum resistant to chloroquine.

Drug Resistance

Strains of P. falciparum with decreased susceptibility to sulfadoxine and/or pyrimethamine can be selected in vitro or in vivo. P. falciparum malaria that is clinically resistant to Fansidar occurs frequently in parts of Southeast Asia and South America, and is also prevalent in East and Central Africa. Therefore, Fansidar should be used with caution in these areas. Likewise, Fansidar may not be effective for treatment of recrudescent malaria that develops after prior therapy (or prophylaxis) with Fansidar.

Pharmacokinetics Absorption

After administration of 1 tablet, peak plasma levels for pyrimethamine (approximately 0.2 mg/L) and for sulfadoxine (approximately 60 mg/L) are reached after about 4 hours.

Distribution

The volume of distribution for sulfadoxine and pyrimethamine is 0.14 L/kg and 2.3 L/kg, respectively.

Patients taking 1 tablet a week (recommended adult dose for malaria prophylaxis) can be expected to have mean steady state plasma concentrations of about 0.15 mg/L for pyrimethamine after about four weeks and about 98 mg/L for sulfadoxine after about seven weeks. Plasma protein binding is about 90% for both pyrimethamine and sulfadoxine. Both pyrimethamine and sulfadoxine cross the placental barrier and pass into breast milk.

Metabolism

About 5% of sulfadoxine appears in the plasma as acetylated metabolite, about 2 to 3% as the glucuronide. Pyrimethamine is transformed to several unidentified metabolites.

Elimination

A relatively long elimination half-life is characteristic of both components. The mean values are about 100 hours for pyrimethamine and about 200 hours for sulfadoxine. Both pyrimethamine and sulfadoxine are eliminated mainly via the kidneys.

Characteristics in Patients

In malaria patients, single pharmacokinetic parameters may differ from those in healthy subjects, depending on the population concerned. In patients with renal insufficiency, delayed elimination of the components of Fansidar must be anticipated.

Indications and Usage for Fansidar Treatment of Acute Malaria

Fansidar is indicated for the treatment of acute, uncomplicated P. falciparum malaria for those patients in whom chloroquine resistance is suspected. However, strains of P. falciparum (see CLINICAL PHARMACOLOGY: Microbiology) may be encountered which have developed resistance to Fansidar, in which case alternative treatment should be administered.

Prevention of Malaria

Malaria prophylaxis with Fansidar is not routinely recommended and should only be considered for travelers to areas where chloroquine-resistant P. falciparum malaria is endemic and sensitive to Fansidar, and when alternative drugs are not available or are contraindicated (see CONTRAINDICATIONS). However, strains of P. falciparum may be encountered which have developed resistance to Fansidar.

Contraindications Repeated prophylactic (prolonged) use of Fansidar is contraindicated in patients with renal or hepatic failure or with blood dyscrasias; Hypersensitivity to pyrimethamine, sulfonamides, or any other ingredient of Fansidar; Patients with documented megaloblastic anemia due to folate deficiency; Infants less than 2 months of age; Prophylactic use of Fansidar in pregnancy at term and during the nursing period. WARNINGS

FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF Fansidar HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME AND TOXIC EPIDERMAL NECROLYSIS. Fansidar PROPHYLAXIS MUST BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH, IF A SIGNIFICANT REDUCTION IN THE COUNT OF ANY FORMED BLOOD ELEMENTS IS NOTED, OR UPON THE OCCURRENCE OF ACTIVE BACTERIAL OR FUNGAL INFECTIONS.

Fatalities associated with the administration of sulfonamides, although rare, have occurred due to severe reactions, including fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Fansidar prophylactic regimen has been reported to cause leukopenia during a treatment of 2 months or longer. This leukopenia is generally mild and reversible.

Precautions General

Oral Fansidar has not been evaluated for the treatment of cerebral malaria or other severe manifestations of complicated malaria, including hyperparasitemia, pulmonary edema or renal failure. Patients with severe malaria are not candidates for oral therapy. In the event of recrudescent P. falciparum infections after treatment with Fansidar or failure of chemoprophylaxis with Fansidar, patients should be treated with a different blood schizonticide.

Fansidar should be given with caution to patients with impaired renal or hepatic function, to those with possible folate deficiency and to those with severe allergy or bronchial asthma. As with some sulfonamide drugs, in glucose-6-phosphate dehydrogenase-deficient individuals, hemolysis may occur. Urinalysis with microscopic examination and renal function tests should be performed during therapy of those patients who have impaired renal function. Excessive sun exposure should be avoided.

Information for the Patient

Patients should be warned that at the first appearance of a skin rash, they should stop use of Fansidar and seek medical attention immediately. Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation.

Patients should also be warned that the appearance of sore throat, fever, arthralgia, cough, shortness of breath, pallor, purpura, jaundice or glossitis may be early indications of serious disorders which require prophylactic treatment to be stopped and medical treatment to be sought.

Females should be cautioned against becoming pregnant and should not breastfeed their infants during Fansidar therapy or prophylactic treatment.

Patients should be warned to keep Fansidar out of reach of children.

Patients also should be advised:

that malaria can be a life-threatening infection; that Fansidar is being prescribed to help prevent or treat this serious infection; that no chemoprophylactic regimen is 100% effective, and protective clothing, insect repellents, and bednets are important components of malaria prophylaxis; to seek medical attention for any febrile illness that occurs after return from a malarious area and inform their physician that they may have been exposed to malaria; that in a small percentage of cases, patients are unable to take this medication because of side effects, and it may be necessary to change medications; that when used as prophylaxis, the first dose of Fansidar should be taken 1 or 2 days prior to arrival in an endemic area; that if the patient experiences any symptom that may affect the patient's ability to take this drug as prescribed, the physician should be contacted and alternative antimalarial medication should be considered. Laboratory Tests

Regularly scheduled complete blood counts, liver enzyme tests and analysis of urine for crystalluria should be performed whenever Fansidar is administered for more than three months.

Drug Interactions

There have been reports which may indicate an increase in incidence and severity of adverse reactions when chloroquine is used with Fansidar as compared to the use of Fansidar alone. Fansidar is compatible with quinine and with antibiotics. However, antifolic drugs such as sulfonamides, trimethoprim, or trimethoprim-sulfamethoxazole combinations should not be used while the patient is receiving Fansidar for antimalarial prophylaxis. Fansidar has not been reported to interfere with antidiabetic agents.

If signs of folic acid deficiency develop, Fansidar should be discontinued. When recovery of depressed platelets or white blood cell counts in patients with drug-induced folic acid deficiency is too slow, folinic acid (leucovorin) may be administered in doses of 5 to 15 mg intramuscularly daily for 3 days or longer.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Pyrimethamine was not found carcinogenic in female mice or in male and female rats. The carcinogenic potential of pyrimethamine in male mice could not be assessed from the study because of markedly reduced life-span. Pyrimethamine was found to be mutagenic in laboratory animals and also in human bone marrow following 3 or 4 consecutive daily doses totaling 200 mg to 300 mg. Pyrimethamine was not found mutagenic in the Ames test. Testicular changes have been observed in rats treated with 105 mg/kg/day of Fansidar and with 15 mg/kg/day of pyrimethamine alone. Fertility of male rats and the ability of male or female rats to mate were not adversely affected at dosages of up to 210 mg/kg/day of Fansidar. The pregnancy rate of female rats was not affected following their treatment with 10.5 mg/kg/day, but was significantly reduced at dosages of 31.5 mg/kg/day or higher, a dosage approximately 30 times the weekly human prophylactic dose or higher.

Pregnancy Teratogenic Effects: Pregnancy Category C

Fansidar has been shown to be teratogenic in rats when given in weekly doses approximately 12 times the weekly human prophylactic dose. Teratology studies with pyrimethamine plus sulfadoxine (1:20) in rats showed the minimum oral teratogenic dose to be approximately 0.9 mg/kg pyrimethamine plus 18 mg/kg sulfadoxine. In rabbits, no teratogenic effects were noted at oral doses as high as 20 mg/kg pyrimethamine plus 400 mg/kg sulfadoxine.

There are no adequate and well-controlled studies in pregnant women. However, due to the teratogenic effect shown in animals and because pyrimethamine plus sulfadoxine may interfere with folic acid metabolism, Fansidar therapy should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women of childbearing potential who are traveling to areas where malaria is endemic should be warned against becoming pregnant, and should be advised to practice contraception during prophylaxis with Fansidar and for three months after the last dose.

Nonteratogenic Effects

See CONTRAINDICATIONS

Nursing Mothers

See CONTRAINDICATIONS

Pediatric Use

Fansidar should not be given to infants less than 2 months of age because of inadequate development of the glucuronide-forming enzyme system.

Geriatric Use

Clinical studies of Fansidar did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. This drug 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, and it may be useful to monitor renal function.

Adverse Reactions

For completeness, all major reactions to sulfonamides and to pyrimethamine are included below, even though they may not have been reported with Fansidar (see WARNINGS and PRECAUTIONS: Information for the Patient).

Hematological Changes

Agranulocytosis, aplastic anemia, megaloblastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia, methemoglobinemia, and eosinophilia.

Skin and Miscellaneous Sites Allergic Reactions

Erythema multiforme, Stevens-Johnson syndrome, generalized skin eruptions, toxic epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital edema, conjunctival and scleral injection, photosensitization, arthralgia, allergic myocarditis, slight hair loss, Lyell's syndrome, and allergic pericarditis.

Gastrointestinal Reactions

Glossitis, stomatitis, nausea, emesis, abdominal pains, hepatitis, hepatocellular necrosis, diarrhea, pancreatitis, feeling of fullness, and transient rise of liver enzymes.

Central Nervous System Reactions

Headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo, insomnia, apathy, fatigue, muscle weakness, nervousness, and polyneuritis.

Respiratory Reactions

Pulmonary infiltrates resembling eosinophilic or allergic alveolitis.

Genitourinary

Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, and crystalluria.

Miscellaneous Reactions

Drug fever, chills, periarteritis nodosa and LE phenomenon have occurred.

The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration has produced thyroid malignancies in the species.

Overdosage

Acute intoxication may be manifested by headache, nausea, anorexia, vomiting and central nervous system stimulation (including convulsions), followed by megaloblastic anemia, leukopenia, thrombocytopenia, glossitis and crystalluria. In acute intoxication, emesis and gastric lavage followed by purges may be of benefit. The patient should be adequately hydrated to prevent renal damage. The renal, hepatic, and hematopoietic systems should be monitored for at least 1 month after an overdosage. If the patient is having convulsions, the use of parenteral diazepam or a barbiturate is indicated. For depressed platelet or white blood cell counts, folinic acid (leucovorin) should be administered in a dosage of 5 mg to 15 mg intramuscularly daily for 3 days or longer.

Fansidar Dosage and Administration

(See INDICATIONS AND USAGE)

The dosage should be swallowed whole, and not chewed, with plenty of fluids after a meal.

Treatment of Acute Malaria Adults 2 to 3 tablets taken as a single dose.       Pediatric patients
(>2 months to 18 years) The dosage for treatment of malaria in children is based upon body weight: Weight (kg) Number of Tablets Taken
as a Single Dose >45 3 31 to 45 2 21 to 30 1 ? 11 to 20 1 5 to 10 ? Prevention of Malaria

The malaria risk must be carefully weighed against the risk of serious adverse drug reactions (see INDICATIONS AND USAGE). If Fansidar is prescribed for prophylaxis, it is important that the physician inquires about sulfonamide intolerance and points out the risk and the need for immediate drug withdrawal if skin reactions do occur.

The first dose of Fansidar should be taken 1 or 2 days before arrival in an endemic area; administration should be continued during the stay and for 4 to 6 weeks after return.

Once Weekly Once Every
2 Weeks Adults 1 tablet 2 tablets Pediatric patients
(>2 months to 18 years) The dosage for prevention of malaria in children is based upon body weight: Weight (kg) Number of Tablets Taken
Once Weekly >45 1 ? 31 to 45 1 21 to 30 ? 11 to 20 ? 5 to 10 ?

Prophylaxis with Fansidar should not be continued for more than two years, since no experience of more prolonged administration is available to date.

How is Fansidar Supplied

Scored tablets, containing 500 mg sulfadoxine and 25 mg pyrimethamine — unit dose packages of 25 (NDC-0004-0161-03). Imprint on tablets: Fansidar ((ROCHE LOGO)) ROCHE.

Manufactured by:
F. Hoffmann-La Roche Ltd.
Basel, Switzerland

Distributed by:

27898797

Copyright © 1996-2004 by Roche Laboratories Inc. All rights reserved.


Fansidar 
sulfadoxine and pyrimethamine  tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0004-0161 Route of Administration ORAL DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength Sulfadoxine (Sulfadoxine) Active 500 MILLIGRAM  In 1 TABLET Pyrimethamine (Pyrimethamine) Active 25 MILLIGRAM  In 1 TABLET cornstarch Inactive   gelatin Inactive   lactose Inactive   magnesium stearate Inactive   talc Inactive   Product Characteristics Color WHITE (white) Score 2 pieces Shape ROUND (ROUND) Size 13mm Flavor Imprint Code Fansidar;ROCHE Contains          Coating false Symbol true Packaging # NDC Package Description Multilevel Packaging 1 0004-0161-03 25 TABLET In 1 BOX, UNIT-DOSE None
Revised: 12/2005Roche Pharmaceuticals More Fansidar resources Fansidar Side Effects (in more detail) Fansidar Dosage Fansidar Use in Pregnancy & Breastfeeding Drug Images Fansidar Drug Interactions Fansidar Support Group 0 Reviews for Fansidar - Add your own review/rating Fansidar Concise Consumer Information (Cerner Multum) Fansidar Advanced Consumer (Micromedex) - Includes Dosage Information Fansidar MedFacts Consumer Leaflet (Wolters Kluwer) Compare Fansidar with other medications Malaria Malaria Prevention Pneumocystis Pneumonia Prophylaxis
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Miscellaneous antibiotics


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Antibiotics are drugs that can either kill an infectious bacteria or inhibit its growth. Different antibiotics work by different mechanisms and are used to treat infections caused by bacteria that are sensitive to that particular antibiotic.

See also

Medical conditions associated with miscellaneous antibiotics:

Acne Amebiasis Anthrax Aspiration Pneumonia Babesiosis Bacteremia Bacterial Infection Bacterial Skin Infection Bacterial Vaginitis Bone infection Bronchitis Brucellosis Cholera Clostridial Infection Crohn's Disease Crohn's Disease, Acute Crohn's Disease, Maintenance Cystic Fibrosis Deep Neck Infection Dental Abscess Diarrhea Diverticulitis Dracunculiasis Endocarditis Epiglottitis Febrile Neutropenia Giardiasis Glanders Gonococcal Infection Gonococcal Infection, Disseminated Gonococcal Infection, Uncomplicated Gram Negative Infection Granuloma Inguinale Helicobacter Pylori Infection Hepatic Encephalopathy Infection Prophylaxis Intraabdominal Infection Irritable Bowel Syndrome Joint Infection Kidney Infections Leishmaniasis Malaria Melioidosis Meningitis Methicillin-Resistant Staphylococcus Aureus Infection Nocardiosis Nosocomial Pneumonia Ornithosis Otitis Media Pelvic Inflammatory Disease Peritonitis Plague Pneumocystis Pneumonia Pneumocystis Pneumonia Prophylaxis Pneumonia Pneumonia with Cystic Fibrosis Prevention of Bladder infection Prostatitis Pseudomembranous Colitis Psittacosis Rabbit Fever Rickettsial Infection Shigellosis Sinusitis Skin and Structure Infection Skin Infection Surgical Prophylaxis Toxoplasmosis Toxoplasmosis, Prophylaxis Traveler's Diarrhea Trichomoniasis Trypanosomiasis Upper Respiratory Tract Infection Urinary Tract Infection Drug List: Sulfatrim-Suspension Zyvox Xifaxan Septra Chloromycetin-Oral-Intravenous-Injection Smz-Tmp-Ds Septra-Ds Flagyl Bactrim-Ds Flagyl-Er-Extended-Release-Tablets Bactrim Metro Azactam Baci-Im-Injection Cayston Chloromycetin-Sodium-Succinate Co-Trimoxazole Coly-Mycin-M Cotrim Cubicin Eryzole Flagyl-375 Flagyl-I-V Mepron Nebupent-Solution Neutrexin Pediazole Pentam Pentam-300 Sulfatrim-Pediatric Sulfimycin Synercid Trobicin
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Halfan


halofantrine hydrochloride
Dosage Form: tablets
Warning

Halfan HAS BEEN SHOWN TO PROLONG QTc INTERVAL AT THE RECOMMENDED THERAPEUTIC DOSE. THERE HAVE BEEN RARE REPORTS OF SERIOUS VENTRICULAR DYSRHYTHMIAS SOMETIMES ASSOCIATED WITH DEATH, WHICH MAY BE SUDDEN. Halfan IS THEREFORE NOT RECOMMENDED FOR USE IN COMBINATION WITH DRUGS OR CLINICAL CONDITIONS KNOWN TO PROLONG QTc INTERVAL, OR IN PATIENTS WHO HAVE PREVIOUSLY RECEIVED MEFLOQUINE, OR IN PATIENTS WITH KNOWN OR SUSPECTED VENTRICULAR DYSRHYTHMIAS, A-V CONDUCTION DISORDERS OR UNEXPLAINED SYNCOPAL ATTACKS. Halfan SHOULD BE PRESCRIBED ONLY BY PHYSICIANS WHO HAVE SPECIAL COMPETENCE IN THE DIAGNOSIS AND TREATMENT OF MALARIA, AND WHO ARE EXPERIENCED IN THE USE OF ANTIMALARIAL DRUGS. PHYSICIANS SHOULD THOROUGHLY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING Halfan.

Halfan Description

Halfan (halofantrine hydrochloride) is an antimalarial drug available as tablets containing 250 mg of halofantrine hydrochloride (equivalent to 233 mg of the free base) for oral administration.

The chemical name of halofantrine hydrochloride is 1,3-dichloro-?-[2-(dibutylamino) ethyl]-6-(trifluoromethyl)-9-phenanthrene-methanol hydrochloride.

The drug, a white to off-white crystalline compound, is practically insoluble in water. Halofantrine hydrochloride has a calculated molecular weight of 536.89. The empirical formula is C26H30Cl2F3NO•HCl and the structural formula is

Inactive Ingredients

Inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, and talc.

Halfan - Clinical Pharmacology

The interindividual variability in the pharmacokinetic parameters of halofantrine is very wide and has led to great difficulty in precisely determining the pharmacokinetic characteristics of this product.

Following administration of halofantrine hydrochloride tablets in single oral doses of 250 mg to 1,000 mg to healthy volunteers, peak plasma levels were reached in 5 to 7 hours. High variability in the peak plasma levels was observed in all studies, suggesting erratic absorption from the gastrointestinal tract. An approximately 7-fold increase in peak plasma concentration and a 3-fold increase in area under the curve (AUC) of halofantrine were obtained when a single 250-mg tablet was administered with high-fat food to healthy subjects.

Healthy volunteers who were given 3 oral doses of 500 mg of halofantrine hydrochloride (500 mg every 6 hours), when fed 2 hours before the second and third doses, had similar 3- to 5-fold increases in absorption. A mean Cmax of 3,200 ng/mL (range 1,555 to 4,920 ng/mL) with a corresponding Tmax of 9 to 17 hours was attained following this multiple-dose regimen.

Halofantrine has a relatively long distribution phase with a half-life of 16 hours and a variable terminal elimination half-life of 6 to 10 days. The half-life of halofantrine varies considerably among individuals.

The primary metabolite of halofantrine is n-desbutyl halofantrine. Cmax valuesranging from 310 to 410 ng/mL were observed to occur between 32 and 56 hours following oral administration of multiple doses of 500 mg halofantrine q6h for 3 doses. The apparent terminal elimination half-life of the metabolite is 3 to 4 days.

Based on animal studies, hepatobiliary clearance with fecal elimination of halofantrine parent compound and metabolite predominates. The extent to which halofantrine is bound to plasma proteins and the extent to which halofantrine is taken up into red blood cells are unknown.

The pharmacokinetics of halofantrine in patients with compromised renal or hepatic function has not been investigated.

The course of the anemia developed by a few malaria patients treated with halofantrine whose red blood cells were deficient in glucose-6-phosphate dehydrogenase (G6PD) was not different from that in malaria patients with normal G6PD values.

Microbiology

Halofantrine is a blood schizonticidal antimalarial agent with no apparent action on the sporozoite, gametocyte, or hepatic stages of the infection. The exact mechanism of its action is unknown. The primary metabolite, n-desbutyl halofantrine, and the parent compound are equally active in vitro.

While in vitro studies indicate that there may be cross-resistance between halofantrine and mefloquine, the clinical data do not support this view. No significant correlation between halofantrine and mefloquine resistance was observed in clinical trials.

Clinical Trials

In controlled clinical trials involving 90 non-immune patients with malaria due to Plasmodium falciparum, treatment with Halfan (500 mg every 6 hours for 3 doses on days 0 and 7) had a cure rate of 99%. Patients were followed for 28 days or more after initiation of treatment.

In trials involving 583 acute malaria patients, the majority of whom were semi-immune, treatment with Halfan (500 mg every 6 hours for 3 doses) produced a cure rate of 90% against Plasmodium falciparum infection (n=512), and a cure rate of 99% against Plasmodium vivax (n=71).

Indications and Usage for Halfan

Halfan tablets are indicated for the treatment of adults who can tolerate oral medication and who have mild to moderate malaria (equal to or less than 100,000 parasites/mm3) caused by Plasmodium falciparum or Plasmodium vivax.

NOTE: Patients with acute P. vivax malaria treated with Halfan are at risk of relapse because halofantrine does not eliminate the exoerythrocytic (hepatic phase) parasites. To avoid relapse after initial treatment of the acute P. vivax infection with Halfan, patients should subsequently be treated with an 8-aminoquinoline to eradicate the exoerythrocytic parasites.

NOTE: THE EFFICACY OF Halfan IN THE PROPHYLAXIS OF MALARIA HAS NOT BEEN ESTABLISHED.

Contraindications

Halfanis contraindicated in patients with a known family history of congenital QTc prolongation. (See BOXED WARNING.) Use of this drug is contraindicated in patients with a known hypersensitivity to halofantrine.

Warnings

In life-threatening, severe, or overwhelming malarial infections, patients should be treated immediately with an appropriate parenteral antimalarial drug. The safety and efficacy of Halfan in the treatment of patients with cerebral malaria or other forms of complicated malaria have not been established.

Halfan has been shown to prolong QTc interval at the recommended therapeutic dose. There have been rare reports of serious ventricular dysrhythmias sometimes associated with death, which may be sudden. Halfan is therefore not recommended in combination with drugs, or clinical conditions, known to prolong QTc interval, or in patients with known or suspected ventricular dysrhythmias, A-V conduction disorders, or unexplained syncopal attacks. Physicians should perform an ECG prior to dosing to ensure that the patient’s baseline QTc interval is within normal limits. Cardiac rhythm should be monitored during and for 8 to 12 hours following completion of therapy.

Caution should be used with concomitant intake of drugs which are known to significantly inhibit the hepatic cytochrome P450 enzyme, CYP3A4.

Halfan should be taken on an empty stomach as increased absorption and, thus, increased toxicity may result from dosing in association with food. Do not exceed recommended doses, as higher than recommended doses of Halfan have been shown to further prolong QTc interval.

Data on the use of Halfan subsequent to administration of mefloquine suggest a significant, potentially fatal, prolongation of the QTc interval.1 Therefore, Halfan should not be given simultaneously with, or subsequent to, mefloquine. (See PRECAUTIONS—Drug Interactions.)

Halofantrine has been shown to be embryotoxic in animal tests. Use in women of childbearing potential only with due caution regarding the potential effect on the fetus if the patient is pregnant. (See PRECAUTIONS—Pregnancy subsection.)

Precautions General

A phototoxic potential cannot be ruled out on the basis of the chemical moiety of halofantrine and the results of animal tests. (See ANIMAL TOXICOLOGY.) However, there is no evidence for this effect in humans.

Drug Interactions

Although no drug interaction studies have been conducted, Halfan should not be administered with drugs known to prolong the QTc interval. In clinical use, an interaction with mefloquine has been reported to lead to further prolongation of the QTc interval.1 The prolongation may be significant and potentially fatal; therefore, Halfan should not be given simultaneously with or subsequent to mefloquine. There have been no drug interactions reported when halofantrine is coadministered with chloroquine.

In vitro studies have shown that drugs which inhibit hepatic CYP3A4, e.g., ketoconazole, lead to an inhibition of halofantrine metabolism. Further, in dogs orally administered ketoconazole, the metabolism of halofantrine was decreased (SEE WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies of halofantrine hydrochloride in animals have not been performed to evaluate carcinogenic potential.

Genotoxicity of halofantrine hydrochloride was evaluated in 5 assay test systems including an Ames test, a gene mutation test in Chinese hamster ovary cells, a chromosomal aberration analysis in Chinese hamster ovary cells, a micronucleus test in mice, and a dominant lethal assay. No mutagenic potential was demonstrated in any of these test systems.

Halofantrine hydrochloride did not adversely affect male or female fertility in the rat at an oral dose of 30 mg/kg (1/6 of the maximum recommended human dose based on mg/m2).

Pregnancy Teratogenic Effects

Pregnancy Category C: In pregnant rabbits, maternal-lethal doses (decremental dose schedule of 360 to 120 mg/kg, equivalent to 3.6 times to 1.2 times the maximum recommended human dose, respectively, based on mg/m2) were associated with abortion and an increased incidence of skeletal malformations, but oral doses up to 60 mg/kg (6/10 of the maximum recommended human dose based on mg/m2) did not produce maternal or fetal developmental toxicity.

Non-teratogenic Effects

In reproduction teratology studies in the rat, oral doses ?30 g/kg (1/6 of the maximum recommended human dose based on mg/m2) produced postimplantation embryonic death and reduced fetal weight and viability. Halofantrine hydrochloride at doses of 15 mg/kg/day (1/10 of the maximum recommended human dose based on mg/m2) had no embryotoxicity or teratogenicity. These effects occurred at and below doses that produced overt maternal toxicity in the rats.

Halofantrine has been shown to be embryocidal in rats. There are no adequate and well-controlled studies in pregnant women. Halfan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

In lactation studies performed in rats, dose-related decreases in offspring body weight were observed at a dose of 25 mg/kg/day and above (1/8 of the maximum recommended human dose based on mg/m2). Control pups breast-fed by high-dosed mothers had significant decreases in body weight and survival at doses of 50 and 100 mg/kg/day (1/4 to 1/2 of the maximum recommended human dose based on mg/m2).

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from halofantrine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of halofantrine hydrochloride tablets in the pediatric population have not been established.

Geriatric Use

There are no studies on the use of halofantrine hydrochloride in elderly individuals.

Adverse Reactions Normal Subjects

The following adverse events were reported in normal subjects given Halfan 1,000 mg to 1,500 mg in a single dosing course.

Gastrointestinal

Abdominal pain (10%), anorexia (5%), diarrhea (5%), nausea (10%), vomiting (10%).

Central Nervous System

Dizziness (5%), headache (5%).

Clinical Trials

In clinical trials involving 933 patients treated with three 500 mg doses (500 mg every 6 hours), the following clinical adverse events were reported.

There were no deaths or permanent disabilities thought related to drug toxicity. Five patients discontinued medication due to adverse events. Three patients vomited medicine repeatedly.

Though temporally related to drug administration, the relationship of the following serious adverse events to malaria or underlying illness as opposed to drug toxicity could not be established. Two patients had decreased consciousness; other serious adverse events reported during clinical trials included convulsions (3 cases), stomatitis (3 cases), moderately severe diarrhea (2 cases), pulmonary edema (1 case), tetany (1 case), hypertensive crisis (1 case), cerebrovascular accident (1 case).

The most frequently reported adverse events thought possibly— or probably—related to halofantrine were: Abdominal pain (8.5%), diarrhea (6.0%), dizziness (4.5%), vomiting (4.3%), nausea (3.4%), cough (3.0%), headache (3.0%), pruritus (2.6%), rigors (1.7%), and myalgias (1.3%). These events are also characteristic of malaria.

Pruritus was reported in a higher proportion of highly pigmented patients than in other patients.

Adverse events thought possibly—or probably—related to halofantrine affecting <1% of patients studied in the clinical trials included:

Body as a Whole

Fatigue, malaise.

Cardiovascular

Chest pain, palpitations, postural hypotension.

Dermatologic

Rash.

Gastrointestinal

Abdominal distention, anorexia, constipation, dyspepsia.

Mucous Membrane

Stomatitis.

Musculoskeletal

Arthralgia, back pain.

Central Nervous System

Asthenia, confusion, convulsions, depression, paresthesia, sleep disorder.

Renal

Urinary frequency.

Special Senses

Abnormal vision, tinnitus.

Laboratory

The most frequently noted laboratory abnormalities that occurred following drug administration in the clinical trials were decreased hematocrit, elevated hepatic transaminases, decreased and increased white blood cell counts, and decreased platelet counts. These alterations returned to normal limits within 2 to 3 weeks post-infection. The causal relationship of these changes to Halfan is unclear, as these laboratory abnormalities can also occur with acute malaria.

Postmarketing Experience

Halofantrine was marketed in Europe starting in 1988. The following additional adverse experiences have been reported in postmarketing surveillance outside the United States: Facial edema and urticaria (allergic/anaphylactic reactions) in rare cases.

Hemolysis/hemolytic anemia (including immune hemolytic anemia) which may compromise renal function have been reported in patients with malaria who have been treated with halofantrine. Hemolytic reactions may also be observed in patients with malaria in the absence of halofantrine.

Prolongation of QT interval has been reported. There have been rare reports of serious ventricular dysrhythmias sometimes associated with death. These cases have occurred particularly under certain conditions which include uses of doses higher than recommended, recent or concomitant treatment with mefloquine, or presence of pre-existing prolongation of QT interval.1

Overdosage

In case of overdosage, vomiting should be induced, in conjunction with appropriate supportive measures, which should include ECG monitoring. The possibility of neurologic toxicity, especially decreased consciousness and seizures, should be evaluated. Dehydration secondary to gastrointestinal toxicity with diarrhea and vomiting may require treatment with intravenous fluid therapy.

Gastrointestinal distress with abdominal pain, vomiting, cramping, and diarrhea occurs at doses higher than the recommended therapeutic regimen. Palpitations have also been reported at these higher doses.

Halfan Dosage and Administration

(See INDICATIONS AND USAGE.)

Halfan should be given on an empty stomach at least 1 hour before or 2 hours after food. (See WARNINGS.) The recommended dosage regimen to treat adults able to tolerate oral medications, who have mild to moderate malaria caused by P. falciparum or P. vivax is:

Non-immune Patients

Patients with no previous exposure or minimal exposure to malaria should be considered “non-immune.” These patients should receive 500 mg (2 x 250 mg tablets) of halofantrine hydrochloride every 6 hours for 3 doses (total first course dosage 1,500 mg). This course of therapy should be repeated 7 days after the first course.

Semi-immune Patients

Patients with a history of life-long residence in endemic areas and a clear history of recent previous malaria caused by the same Plasmodium species may be considered semi-immune. In these patients, omitting the second course of therapy may be considered. Clinical trials in semi-immune patients have utilized this one-course regimen with satisfactory efficacy and safety.

Hepatic or Renally Impaired Patients

There is no information on dosing alterations needed because of hepatic or renal impairment.

How is Halfan Supplied

Halfan is available as a white to off-white, capsule-shaped tablet containing 250 mg of halofantrine hydrochloride in bottles of 60 tablets. The tablets are imprinted Halfan on 1 side.

Store at controlled room temperature between 20° to 25°C (68° to 77°F) and protect from light.

250 mg 60’s: NDC 0007-4195-18

Animal Toxicology

In a phototoxicity study, halofantrine hydrochloride was phototoxic to mice at 80 mg/kg (6/10 of the maximum recommended human dose based on mg/m2). At 40 mg/kg, the lowest dose tested, there was a slight erythematous response.

In a whole-body radioautographic study in the rat, it was demonstrated that high drug levels of halofantrine are retained in the retina and in the Harderian gland for an entire 4-week observation period. Moreover, the estimated half-lives for the radiolabeled equivalents in the retina and Harderian gland were from 91 to 778 hours for the 4-week observation period. The drug passes the blood-brain barrier and is retained for an undetermined time in the central nervous system.

Elevated cholesterol values have been reported in the rat when halofantrine hydrochloride is administered for 4 weeks at oral doses of 30 mg/kg (2/10 of the maximum recommended human dose based on mg/m2) and higher.

Increases in serum cholesterol have also been reported in dogs administered halofantrine hydrochloride for 28 days at oral doses of 25 mg/kg (1/2 of the recommended human dose based on mg/m2) and higher.

REFERENCES Nosten F, ter Kuile FO, Luxemburger C, et al. Cardiac effects of antimalarial treatment with halofantrine. Lancet. 1993;341:1054-56.

DATE OF ISSUANCE JUNE 2003

©2003, GlaxoSmithKline

Manufactured by King Pharmaceuticals, Inc.

Bristol, TN 37620

for

GlaxoSmithKline

Research Triangle Park NC 27709

HL:L5


Halfan 
halofantrine hydrochloride  tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0007-4195 Route of Administration ORAL DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength halofantrine hydrochloride (halofantrine) Active 250 MILLIGRAM  In 1 TABLET magnesium stearate Inactive   microcrystalline cellulose Inactive   povidone Inactive   pregelatinized starch Inactive   sodium starch glycolate Inactive   talc Inactive   Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL (capsule-shaped) Size 15mm Flavor Imprint Code Halfan Contains          Coating false Symbol false Packaging # NDC Package Description Multilevel Packaging 1 0007-4195-18 60 TABLET In 1 BOTTLE None
Revised: 09/2006GlaxoSmithKline More Halfan resources Halfan Side Effects (in more detail) Halfan Dosage Halfan Use in Pregnancy & Breastfeeding Halfan Drug Interactions Halfan Support Group 0 Reviews for Halfan - Add your own review/rating Halfan MedFacts Consumer Leaflet (Wolters Kluwer) Halfan Concise Consumer Information (Cerner Multum) halofantrine Advanced Consumer (Micromedex) - Includes Dosage Information Compare Halfan with other medications Malaria
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Boots Heartburn Relief Aniseed Flavour (150ml)


Boots Heartburn Relief Aniseed Flavour

(Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate)

For fast, effective relief of Heartburn and Acid Indigestion Sugar Free

e 150 ml

Read all of this label for full instructions.

Uses: This medicine contains an antacid to relieve the symptoms of indigestion and heartburn in pregnancy and other conditions which cause acid reflux.

Before you take this medicine Do not take: If you are allergic to any of the ingredients Talk to your pharmacist or doctor: If you are on a low salt (sodium) diet (each 5 ml spoonful contains 71 mg of sodium) If you take other medicines ACE inhibitors (for high blood pressure) Quinidine (for heart problems) Medicines to treat infections or malaria Lithium (for mood disorders) Antipsychotics (for mental health conditions) Medicines for epilepsy Medicines for osteoporosis, pain or rheumatoid arthritis

Do not take this medicine within 1 to 2 hours of taking any other medicine.

E214 and E216 may cause allergic reactions such as skin rash (possibly delayed).

How to take this medicine

Shake the bottle well before use.

Adults and children of 12 years and over: Two to four 5 ml spoonfuls.

Children of 6 to 11 years: One to two 5 ml spoonfuls. Swallow this medicine after meals and at bedtime.

Do not give to children under 6 years.

Do not take more than the amount recommended.

If symptoms do not go away within 2 weeks talk to your doctor.

If you take too much: You may get a bloated stomach. If this happens talk to your pharmacist or doctor.

Possible side effects

Most people will not have problems, but some may get some of these:

Constipation, wind, stomach cramps, burping

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Do not store above 25°C. Do not refrigerate.

Keep all medicines out of the sight and reach of children.

Active ingredients: Each 5 ml of oral suspension contains Calcium Carbonate 80 mg, Sodium Alginate 250 mg, Sodium Bicarbonate 133.5 mg. Also contains: carbomer, sodium hydroxide, saccharin sodium, ethyl hydroxybenzoate (E214), propyl hydroxybenzoate (E216), butyl hydroxybenzoate, isopropyl alcohol, erythrosine (E127), aniseed oil, purified water.

PL04917/0021

Text prepared 11/08

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Pinewood Laboratories Limited Ballymacarbry Clonmel Co. Tipperary Ireland

3581aeMC


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