vagifem and urinary incontinence
 

Pills
 

ED Pills

ED Drugs
 

Urinary Incontinence Medications


Definition of Urinary Incontinence:

Incontinence is the inability to control the passage of urine. This can range from an occasional leakage of urine, to a complete inability to hold any urine.

The three main types of urinary incontinence are:

Stress incontinence -- occurs during certain activities like coughing, sneezing, laughing, or exercise.

Stress incontinence is a bladder storage problem in which the strength of the muscles (urethral sphincter) that help control urination is reduced. The sphincter is not able to prevent urine flow when there is increased pressure from the abdomen.

Stress incontinence may occur as a result of weakened pelvic muscles that support the bladder and urethra or because of a malfunction of the urethral sphincter.

Treatment for stress incontinence may include behavioral changes, medication, pelvic floor muscle training or surgery.

Urge incontinence -- involves a strong, sudden need to urinate followed by instant bladder contraction and involuntary loss of urine. You don't have enough time between when you recognize the need to urinate and when you actually do urinate.

In most cases of urge incontinence, no specific cause can be identified.Although urge incontinence may occur in anyone at any age, it is more common in women and the elderly.

Treatment for urge incontinence may include medication, retraining, and surgery.

Mixed incontinence -- contains components of both stress and urge incontinence.

Drugs associated with Urinary Incontinence

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

See sub-topics

Topics under Urinary IncontinenceOveractive Bladder (18 drugs) Learn more about Urinary Incontinence

Medical Encyclopedia:

Urinary incontinence

Harvard Health Guide:

Symptoms and treatment for Urinary Incontinence
Drug List:/tags/a-spaz/
/tags/azo-cranberry/
/tags/colidrops-drops/
/tags/cystospaz/
/tags/detrol-la-extended-release-capsules/
/tags/ditropan-xl-extended-release-tablets/
/tags/elavil/
/tags/gelnique/
/tags/hyomax-dt/
/tags/hyomax-sl/
/tags/hyospaz/
/tags/ib-stat-spray/
/tags/levsin/
/tags/levsinex-extended-release-capsules/
/tags/nulev-orally-disintegrating-tablets/
/tags/sanctura/
/tags/spasdel-drops/
/tags/symax-fastabs-orally-disintegrating-tablets/
/tags/symax-sr-extended-release-tablets/
/tags/urispas/
/tags/vanatrip/

read more / Download


Hypoestrogenism Medications


Drugs associated with Hypoestrogenism

The following drugs and medications are in some way related to, or used in the treatment of Hypoestrogenism. 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: Activella Alora Cenestin Climara Clinagen-La-40 Combipatch-Patch-Bi-Weekly Delestrogen Dep-Gynogen Depo-Estradiol Enjuvia Estrace Estrace-Cream Estraderm-Patch Estradiol-Patch Estragyn-La-5 Estratab Estring-Local Gynodiol Gynogen-La-20 Menaval-20 Menest Mimvey Ogen Ogen-0-625 Ogen-1-25 Ogen-2-5 Ortho-Est Premarin Premarin-Injection Vagifem-Local Vivelle-Patch Vivelle-Dot
read more / Download


Vagifem


Pronunciation: ES-tra-DYE-ol
Generic Name: Estradiol
Brand Name: Vagifem

Vagifem should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Vagifem. Talk with your doctor if you have questions about the benefits and risks of using Vagifem.

Vagifem should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Vagifem.


Vagifem is used for:

Treating itching, burning, and dryness in or around the vaginal area in women past menopause.

Vagifem is a vaginal estrogen tablet. It works by increasing the amount of estrogen in the body in certain women who do not produce enough on their own.

Do NOT use Vagifem if: you are allergic to any ingredient in Vagifem you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding you have unexplained, abnormal vaginal bleeding; known or suspected cancer of the breast or uterus; or estrogen-dependent tumors you have a history of breast cancer, blood clots (eg, deep vein thrombosis, pulmonary embolism), or liver problems you have had a heart attack or stroke within the last year

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

Before using Vagifem:

Some medical conditions may interact with Vagifem. 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 or a family member has a history of lumps in the breast, an abnormal mammogram, or breast cancer if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia) if you have uterine problems (eg, uterine fibroids/endometriosis) or vaginal conditions (eg, abnormal vaginal bleeding, recurring vaginal infections, prolapse, stenosis) if you have abnormal calcium levels in the blood, asthma, cancer, a certain blood disorder (porphyria), cholesterol or lipid problems, depression, diabetes, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver problems, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures (eg, epilepsy), vision problems, or yellowing of the skin or eyes if you smoke, will be having surgery, or will be on bed rest

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

Clarithromycin, erythromycin, itraconazole, ketoconazole, or ritonavir because they may increase the risk of Vagifem's side effects Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Vagifem's effectiveness Blood thinners (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because their actions and the risk of their side effects may be increased by Vagifem

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

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

An extra patient leaflet is available with Vagifem. Talk to your pharmacist if you have questions about this information. To use, tear off a single applicator, separate the plastic wrap, and remove the applicator from the plastic wrap. Select the position for vaginal insertion that is most comfortable for you (lying on the bed, squatting, or standing with one leg on a stool). Use the finger of one hand to press the applicator plunger. Use the other hand to gently and comfortably guide the applicator into the vagina. If the tablet falls out of the applicator before inserting the filled applicator, use a new applicator with a fresh tablet. Insert the tablet as far into the vagina as it can comfortably go without force. After inserting the filled applicator, gently press the plunger until you hear a click and the plunger is fully depressed. This will eject the tablet inside your vagina. The tablet will dissolve slowly over several hours. After depressing the plunger, gently remove the applicator and throw it away. Do not reuse the applicator. You may insert the tablet-filled applicator any time of day. You should use the applicator at the same time each day. Grapefruit and grapefruit juice may increase the risk of Vagifem's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Vagifem. If you miss a dose of Vagifem, 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 Vagifem.

Important safety information: Vagifem may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Vagifem with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Limit alcoholic beverages while you are using Vagifem. Vagifem may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing. Vagifem may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age). Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention. Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Vagifem. Follow your doctor's instructions for examining your breasts, and report any lumps immediately. If you wear contact lenses and you develop problems with them, contact your doctor. If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Vagifem. Vagifem may increase the risk of breast and endometrial cancer. Your doctor may prescribe another hormone (progestin) to decrease this risk. Your doctor should reevaluate you every 3 to 6 months to determine whether you need to continue taking Vagifem. Diabetes patients - Vagifem may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Vagifem may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Vagifem. Lab tests, including hormone levels, physical exams, and blood pressure, may be performed while you use Vagifem. These tests may be used to monitor your condition or check for side effects. You should have breast and pelvic exams and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments. Use Vagifem with caution in the ELDERLY; they may be more sensitive to its effects, including an increased risk of heart problems, stroke, breast or uterine cancer, and certain mental problems (eg, dementia). Vagifem should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Vagifem if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Vagifem is found in breast milk. Do not breast-feed while taking Vagifem. Possible side effects of Vagifem:

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:

Breast pain or tenderness; diarrhea; hair loss; headache; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

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); back pain; breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; coughing up blood; dark urine; dizziness; fainting; fever; memory problems; mental or mood changes (eg, depression); muscle pain; one-sided weakness; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe or persistent stomach pain or swelling; slurred speech; sudden shortness of breath; sunburn-like rash; swelling of the hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; unusual weight changes; vision changes; vomiting; weakness or numbness of an arm or leg; 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.

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 excessive vaginal bleeding; severe nausea; vomiting.

Proper storage of Vagifem:

Store Vagifem 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 Vagifem out of the reach of children and away from pets.

General information: If you have any questions about Vagifem, please talk with your doctor, pharmacist, or other health care provider. Vagifem 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 Vagifem. 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.
read more / Download


Vagifem 25 ?g film-coated tablets


Vagifem 25 micrograms film-coated vaginal tablets

Estradiol hemihydrate

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

Vagifem contains estradiol

Estradiol is a female sex hormone It belongs to a group of hormones called oestrogens It is exactly the same as the estradiol produced by the ovaries of women.

Vagifem belongs to a group of medicines called Hormone Replacement Therapy (HRT).

It is intended for post-menopausal women and is used to relieve menopausal symptoms in the vagina such as dryness or irritation. In medical terms this is known as ‘vaginal atrophy’. It is caused by a drop in the levels of oestrogen in your body. This happens naturally around the menopause.

Vagifem works by replacing the oestrogen which is normally produced in the ovaries of women.

It is inserted into your vagina, so the hormone is released where it is needed.

The experience of treating women older than 65 years is limited.

Before You Use Vagifem Medical check-ups

Before you start using Vagifem, your doctor will tell you about the risks and benefits of the treatment (see also Section 4). Before you start using Vagifem and regularly during treatment, your doctor will check whether Vagifem is the right treatment for you. Once you’ve started on HRT, your doctor will tell you how often to go for regular check-ups. At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.

If you have a close relative (e.g. mother, sister, maternal or paternal grandmother), who has suffered from any serious illness such as blood clots or breast cancer, you might be at a higher risk for serious illness. Always tell your doctor about any close relative(s) suffering from serious illness.

As well as regular check-ups with your doctor, you should:

Regularly examine your breasts for any changes, such as dimpling or sinking of the skin, changes in the nipple, or any lumps you can see or feel. Tell your doctor if you notice any changes. Go for regular breast screening (mammography) and cervical smear tests. Do not use Vagifem if: You are allergic (hypersensitive) to estradiol or any of the other ingredients of Vagifem (listed in Section 6 below) You have or have ever had, or think you might have breast cancer You have or have had a hormone dependent tumour (e.g. cancer of the lining of the womb) You have unusual vaginal bleeding which you have not told your doctor about You have thickening of the lining of the womb (endometrial hyperplasia) and you are not being treated for it You have or previously have had a blood clot inside the blood vessels of the legs or lungs (deep vein thrombosis or pulmonary embolism) You have porphyria. This is a rare disease which affects the production of some of your blood pigments. You have active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) You have acute liver disease or history of liver disease as long as liver function tests have failed to return to normal

Do not use Vagifem if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.

Take special care with Vagifem

Check with your doctor before using Vagifem if you have or have ever had any of the illnesses in the list below. He or she may want to follow you more closely.

Asthma Epilepsy Diabetes Gallstones High blood pressure Migraines or severe headaches Liver problems such as ‘liver adenoma’ (a benign tumour) Endometrial hyperplasia (thickening of the lining of your womb) Otosclerosis. This is when you lose your hearing over a period of time Systemic lupus erythematosus (a disease affecting the skin, joints and kidneys) Blood clots or risk factors for blood clots (see Section 4 ‘Other side effects of systemic HRT’) Leiomyoma (benign tumours of the womb) or endometriosis (growth of the womb lining outside the womb)

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

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding Do not use Vagifem if you think you might be pregnant, or if you are breast-feeding If you get pregnant while you are using Vagifem, stop using it and see a doctor straight away. Driving and using machines

No known effect.

How To Use Vagifem

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

Using this medicine You can start using Vagifem on any day which is best for you Insert the vaginal tablet into your vagina with the applicator.

The ’USER INSTRUCTIONS’ at the end of the leaflet tell you how to do this. Read the instructions carefully before using Vagifem.

How much to use Use one vaginal tablet each day for the first 2 weeks Then use one vaginal tablet twice a week. Leave 3 or 4 days between each dose. If you use more Vagifem than you should If you have used more Vagifem than you should, talk to a doctor or pharmacist. An overdose of oestrogen could make you feel sick or vomit. If you forget to use Vagifem If you forget a dose, use the medicine as soon as you remember. Do not use a double dose to make up for a forgotten dose.

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

General information about treating symptoms of the menopause When using medicines for any menopausal symptoms, use the lowest dose that works. Also, use the medicine for as short a time as you need to.

Only continue treatment if the benefit is more than the risk.

Talk to your doctor about this.

Possible Side Effects

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

Stop using Vagifem and see a doctor straight away if you notice any of the following side effects: A migraine-type headache you have not had before Yellow colouring of your skin or eyes (jaundice) or other liver problems A big increase in blood pressure Blood clots called ‘deep vein thrombosis’ (see also ‘Other side effects of systemic HRT’) If you develop any of the illnesses listed in Section 2, ’Do not use Vagifem You become pregnant Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days:

Common (may affect more than 1 in 100 women)

Headache Passing wind (flatulence) Feeling sick (nausea) or being sick (vomiting) Indigestion Stomach pain, discomfort or distension Swelling of arms or legs (oedema) Vaginal bleeding, discharge or discomfort An infection of the genitals caused by a fungus or inflamed vagina Breast oedema or breast enlargement, breast pain or breast tenderness.

Very rare (may affect less than 1 in 10000 women)

Breast cancer Cancer of the lining of the womb (endometrial cancer) Thickening of the lining of your womb (endometrial hyperplasia) Blood clots called ‘deep vein thrombosis’ Other side effects of systemic HRT are: Allergic reaction (hypersensitivity) Diarrhoea Weight increase Fluid retention Being unable to sleep (insomnia) Feeling depressed Worsening of existing migraine Rash, including itchy, lumpy rash called ‘hives or urticaria’ Itching of the genitals Vaginal pain, irritation of the vagina, painful spasm of the vagina (vaginismus) or vaginal ulcers Increase in blood oestrogen (shown in blood test) Drug ineffective. Important information on the side effects of HRT

Vagifem is used for local treatment in the vagina and contains only a small amount of estradiol. This means that the chances of getting the diseases described below are less likely than with HRT products used for systemic treatment (treatment that affects the body as a whole).

As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.

Effects on your heart or circulation

Heart disease

HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT. HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.

If you get:

a pain in your chest that spreads to your arm or neck See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.

Stroke

Recent research suggests that systemic HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:

getting older high blood pressure smoking drinking too much alcohol an irregular heartbeat

If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.

For women in their 50s who are taking HRT, the figure would be 4 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.

For women in their 60s who are taking HRT, the figure would be 15 in 1000.

If you get:

unexplained migraine-type headaches, with or without disturbed vision See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Blood clots

Systemic HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.

These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE. DVT and PE are examples of a condition called venous thromboembolism, or VTE.

You are more likely to get a blood clot:

if you are seriously overweight if you have had a blood clot before if any of your close family have had blood clots if you have had one or more miscarriages if you have any blood clotting problem that needs treatment with a medicine such as warfarin if you’re off your feet for a long time because of major surgery, injury or illness if you have a rare condition called SLE

If any of these things apply to you, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.

For women in their 50s who are taking HRT, the figure would be 7 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.

For women in their 60s who are taking HRT, the figure would be 17 in 1000.

If you get:

painful swelling in your leg sudden chest pain difficulty breathing See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot.

If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Effects on your risk of developing cancer

Breast cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT

Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not taking HRT.

The extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT.

Your risk of breast cancer is also higher:

if you have a close relative (mother, sister or grandmother) who has had breast cancer if you are seriously overweight

Compare

Looking at women aged 50 who are not taking HRT - on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.

For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).

If they take oestrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).

If you notice

any changes in your breast, such as:

dimpling of the skin changes in the nipple any lumps you can see or feel Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb)

Taking oestrogen-only HRT tablets orally for a long time can increase the risk of developing cancer of the lining of the womb (the endometrium). It is possible there may be a similar risk with oestrogen cream/rings/tablets used directly in the vagina for repeated treatments or over a long time.

If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, but you should

Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.

Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.

HOW TO STORE Vagifem

Keep out of the reach and sight of children.

Do not store above 25°C. Do not refrigerate. Keep the blisters in the outer carton in order to protect from light.

Do not use Vagifem after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Vagifem contains The active substance is estradiol 25 micrograms (as estradiol hemihydrate) Other ingredients are: hypromellose, lactose monohydrate, maize starch and magnesium stearate The film-coating contains: hypromellose and Macrogol 6000. What Vagifem looks like and content of the pack

Each Vagifem comes in an applicator which is used once only.

There are 15 applicators with vaginal tablets in each box.

Vagifem is engraved with NOVO 279.

Marketing Authorisation Holder Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd Denmark The registered office in the UK is: Novo Nordisk Limited Broadfield Park Crawley West Sussex RH11 9RT Tel:(01293) 613555

This leaflet was last approved in: 04/2010

Detailed information on this medicine is available on the web site of www.emc.medicines.org.uk

User Instructions How to use Vagifem 1. Tear off one single blister pack. Open the end as shown in the picture. 2. Insert the applicator carefully into the vagina.

Stop when you can feel some resistance.

3. To release the tablet, gently press the push button until you feel a click.

The tablet will stick to the wall of the vagina straight away.

It will not fall out if you stand up or walk.

4. Take out the applicator and throw it away

Vagifem is a trademark owned by Novo Nordisk Femcare AG, Switzerland.

© 2010

Novo Nordisk A/S

8-2790-01-033-1


read more / Download


flavoxate


Generic Name: flavoxate (flah VOX ate)
Brand Names: Urispas

What is flavoxate?

Flavoxate reduces muscle spasms of the bladder and urinary tract.

Flavoxate is used to treat bladder symptoms such as frequent or urgent urination, increased night-time urination, bladder pain, and incontinence (urine leakage). These bladder symptoms are often caused by overactive bladder, prostate enlargement, bladder infections, or irritation of the urethra.

Flavoxate will not treat a bacterial or fungal bladder infection. Infections must be treated with an antibiotic.

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

What is the most important information I should know about flavoxate? You should not use this medication if you are allergic to flavoxate, or if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive tract (stomach or intestines), or if you are unable to urinate.

Before using flavoxate, tell your doctor if you have glaucoma or urinary problems.

Flavoxate can cause drowsiness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly. There may be other medicines that can interact with flavoxate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Stop using this medication and call your doctor if you have serious side effects such as hot and dry skin, confusion, pounding heartbeats, fluttering in your chest, or if you stop urinating.

What should I discuss with my health care provider before taking flavoxate? You should not use this medication if you are allergic to flavoxate, or have certain conditions. Be sure your doctor knows if you have:

a blockage in your stomach or intestines;

a history of stomach ulcer or bleeding; or

if you are unable to urinate.

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

glaucoma; or

urinary problems.

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

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether flavoxate 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 flavoxate?

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

Take this medicine with water. Store flavoxate at room temperature away from moisture, heat, and light.

See also: Flavoxate dosage (in more detail)

What happens if I miss a dose?

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

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

Symptoms of a flavoxate overdose are not known.

What should I avoid while taking flavoxate? Flavoxate can cause drowsiness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Flavoxate side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using flavoxate and call your doctor at once if you have any of these serious side effects:

hot, dry skin and extreme thirst;

confusion;

pounding heartbeats, fluttering in your chest; or

urinating less than usual or not at all.

Less serious side effects may include:

dry mouth;

blurred vision;

nausea, vomiting;

drowsiness, nervousness;

spinning sensation;

headache; or

fever.

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.

Flavoxate Dosing Information

Usual Adult Dose for Urinary Incontinence:

100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

Usual Adult Dose for Urinary Frequency:

100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

Usual Adult Dose for Dysuria:

100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

Usual Pediatric Dose for Urinary Incontinence:

Greater than 12 years: 100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

Usual Pediatric Dose for Urinary Frequency:

Greater than 12 years: 100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

Usual Pediatric Dose for Dysuria:

Greater than 12 years: 100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

What other drugs will affect flavoxate?

Tell your doctor if you are using any other bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare).

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

More flavoxate resources Flavoxate Side Effects (in more detail) Flavoxate Dosage Flavoxate Use in Pregnancy & Breastfeeding Drug Images Flavoxate Drug Interactions Flavoxate Support Group 1 Review for Flavoxate - Add your own review/rating flavoxate Advanced Consumer (Micromedex) - Includes Dosage Information Flavoxate Professional Patient Advice (Wolters Kluwer) Flavoxate MedFacts Consumer Leaflet (Wolters Kluwer) Flavoxate Prescribing Information (FDA) Flavoxate Hydrochloride Monograph (AHFS DI) Urispas Prescribing Information (FDA) Compare flavoxate with other medications Dysuria Overactive Bladder Urinary Incontinence Where can I get more information? Your pharmacist can provide more information about flavoxate.

See also: flavoxate side effects (in more detail)


read more / Download


Genitourinary tract agents


Genitourinary tract agents are medicines, which are used to treat conditions of the reproductive organs and excretory system or urinary tract. They include medicines used for bladder spasms, urinary pH modifiers, medicines for erectile dysfunction in men and medicines that suppress uterine contractions to prevent preterm labor.

See also impotence agents miscellaneous genitourinary tract agents tocolytic agents urinary antispasmodics urinary pH modifiers uterotonic agents Drug List:
read more / Download


Vagifem 10 micrograms vaginal tablets


1. Name Of The Medicinal Product

Vagifem 10 micrograms vaginal tablets.

2. Qualitative And Quantitative Composition

Each vaginal tablet contains:

Estradiol hemihydrate equivalent to estradiol 10 micrograms.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Vaginal tablet.

White, film-coated, biconvex tablet, engraved with NOVO 278 on one side. Diameter 6 mm.

4. Clinical Particulars 4.1 Therapeutic Indications

Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1).

The experience treating women older than 65 years is limited.

4.2 Posology And Method Of Administration

Vagifem is administered intravaginally using the applicator.

Initial dose: One vaginal tablet daily for two weeks.

Maintenance dose: One vaginal tablet twice a week.

Treatment may be started on any convenient day.

If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.

A switch to the higher dose product Vagifem 25 micrograms should be considered if the response after three months is insufficient for satisfactory symptom relief.

Vagifem may be used in women with or without an intact uterus.

During treatment, especially during the first two weeks of daily administration, minimal systemic absorption may occur but as plasma estradiol levels usually do not exceed normal postmenopausal levels the addition of a progestagen is not recommended.

Vaginal infections should be treated before start of the Vagifem therapy.

Administration:

1. Open the blister pack at the plunger end.

2. Insert the applicator in the vagina until resistance is met (8-10 cm).

3. Release the tablet by pressing the plunger.

4. Withdraw the applicator and discard.

4.3 Contraindications

• Known, past or suspected breast cancer

• Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)

• Undiagnosed genital bleeding

• Untreated endometrial hyperplasia

• Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)

• Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)

• Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal

• Known hypersensitivity to the active substances or to any of the excipients

• Porphyria.

4.4 Special Warnings And Precautions For Use

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

Medical examination/follow-up

Before initiating or reinstituting hormone therapy, a complete personal and family medical history should be obtained. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse. Investigations including mammography should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.

Conditions which need supervision

If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during systemic oestrogen treatment, in particular:

• Leiomyoma (uterine fibroids) or endometriosis

• A history of, or risk factors for, thromboembolic disorders (see below)

• Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer

• Hypertension

• Liver disorders (e.g. liver adenoma)

• Diabetes mellitus with or without vascular involvement

• Cholelithiasis

• Migraine or (severe) headache

• Systemic lupus erythematosus

• A history of endometrial hyperplasia (see below)

• Epilepsy

• Asthma

• Otosclerosis.

Due to the local administration of low dose estradiol in Vagifem, the recurrence or aggravation of the above mentioned conditions is less likely than with systemic oestrogen treatment.

Reasons for immediate withdrawal of therapy

Therapy should be discontinued in case a contra-indication is discovered and in the following situations:

• Jaundice or deterioration in liver function

• Significant increase in blood pressure

• New onset of migraine-type headache

• Pregnancy

Endometrial hyperplasia

Women with intact uterus with abnormal bleeding of unknown aetiology or women with an intact uterus who have previously been treated with unopposed oestrogens should be examined with special care in order to exclude hyperstimulation/malignancy of the endometrium before initiation of treatment with Vagifem.

The risk of endometrial cancer after treatment with oral unopposed oestrogens is dependent on both duration of treatment and on oestrogen dose. The dose of estradiol in Vagifem is very low and treatment is local. A minor degree of systemic absorption may occur in some patients, especially during the first two weeks of once daily administration (see section 5.2). No systemic effect is expected during the local oestrogen treatment with Vagifem, and the addition of a progestagen is not recommended.

As a general rule, oestrogen replacement therapy should not be prescribed for longer than one year without another physical, including gynaecological examination being performed.

If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.

The woman should be advised to contact her doctor in case bleeding or spotting occurs during treatment with Vagifem.

Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis. Therefore caution is advised when using this product in women who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis.

Vagifem is a locally acting low dose estradiol preparation and therefore the occurrence of the below mentioned conditions is less likely than with systemic oestrogen treatment.

Breast cancer

Systemic oestrogen or oestrogen-progestagen treatment may increase the risk of breast cancer. Relative risk of breast cancer with conjugated equine oestrogens or estradiol was greater when a progestagen was added, either sequentially or continuously, and regardless of type of progestagen. A large randomised clinical trial (WHI trial) showed no increase in breast cancer incidence in hysterectomised postmenopausal women treated with conjugated equine oestrogen alone.

Venous thromboembolism

Systemic HRT is associated with a higher relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.

In the oestrogen alone sub-study of WHI, the risk of VTE (DVT and pulmonary embolism (PE)) was reported to be increased for women receiving daily conjugated equine oestrogens (CEE) compared to placebo (30 versus 22 per 10,000 women-years). The occurrence of such an event is more likely in the first year of treatment than later.

Generally recognised risk factors for VTE include a personal history or family history, severe obesity (BMI>30 kg/m2) and systemic lupus erythematosus (SLE). The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery. Where prolonged immobilisation is liable to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs, consideration should be given to temporarily stopping HRT 4 to 6 weeks prior to surgery, if possible. Treatment should not be restarted until the woman is completely mobilised.

If VTE develops after initiating therapy, the drug should be discontinued. Patients should be told to contact their doctors immediately when they experience a potential thromboembolic symptom (e.g., painful swelling of a leg, sudden pain in the chest, dyspnea). Those women already on anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.

Coronary artery disease (CAD)

There is no evidence from randomised controlled trials that oestrogens or combined oestrogen-progestagen protect against coronary artery disease.

Stroke

In the WHI estrogen alone sub-study, a statistically significant increased risk of stroke was reported in women receiving daily conjugated oestrogens (CE 0.625 mg) compared to placebo (45 versus 33 per 10,000 women-years). The increase in risk was demonstrated after the first year of treatment and persisted.

Ovarian cancer

Use of systemic oestrogen alone and oestrogen plus progestagen therapies for at least 5-10 years has been associated with a slightly increased risk of ovarian cancer in some epidemiological studies.

Other conditions

Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed during the first weeks of treatment.

There is no conclusive evidence for improvement of cognitive function. There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65. It is unknown whether the findings apply to younger post-menopausal women or other HRT products.

Intravaginal applicator may cause minor local trauma, especially in women with serious vaginal atrophy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Due to a local administration of the very low dose of estradiol in Vagifem, systemic interactions of clinical relevance are not expected.

4.6 Pregnancy And Lactation

Vagifem is not indicated during pregnancy. If pregnancy occurs during medication with Vagifem, treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to oestrogens indicate no teratogenic or foetotoxic effect.

Lactation

Vagifem is not indicated during lactation.

4.7 Effects On Ability To Drive And Use Machines

No effects known.

4.8 Undesirable Effects

Adverse events from clinical trials:

More than 673 patients have been treated with Vagifem 10 micrograms in clinical trials, including over 497 patients treated up to 52 weeks.

Oestrogen–related adverse events such as breast pain, peripheral oedema and postmenopausal bleedings have been reported at very low rates, similar to placebo, with Vagifem 10 micrograms, but if they occur, they are most likely present only at the beginning of the treatment. The adverse events observed with a higher frequency in patients treated with Vagifem 10 micrograms as compared to placebo and which are possibly related to treatment are presented below.

System organ class

Common

Uncommon

Rare

Infections and infestations

 

Vulvovaginal mycotic infection

 

Nervous system disorders

Headache

   

Gastrointestinal disorders

Abdominal pain

Nausea

 

Reproductive system and breast disorders

Vaginal haemorrhage, vaginal discharge or vaginal discomfort

   

Skin and subcutaneous tissue disorders

 

Rash

 

Investigations

 

Weight increased

 

Vascular disorders

 

Hot flush

Hypertension

 

Post-marketing experience:

In addition to the above mentioned adverse drug reactions, those presented below have been spontaneously reported for patients being treated with Vagifem 25 micrograms, and are considered possibly related to treatment. The reporting rate of these spontaneous adverse reactions is very rare (<1/10,000 patient years).

• Neoplasms benign and malignant (incl. cysts and polyps): breast cancer, endometrial cancer

• Immune system disorders: generalized hypersensitivity reactions (e.g. anaphylactic reaction/shock)

• Metabolism and nutrition disorders: fluid retention

• Psychiatric disorders: insomnia

• Nervous system disorders: migraine aggravated

• Vascular disorders: deep venous thrombosis

• Gastrointestinal disorders: diarrhoea

• Skin and subcutaneous tissue disorders: urticaria, rash erythematous, rash pruritic, genital pruritus

• Reproductive system and breast disorders: endometrial hyperplasia, vaginal irritation, vaginal pain, vaginismus, vaginal ulceration

• General disorders and administration site conditions: drug ineffective

• Investigations: weight increased, blood oestrogen increased.

Other adverse reactions have been reported in association with systemic oestrogen treatment:

• Myocardial infarction, congestive heart disease

• Stroke

• Gall bladder disease

• Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura

• Increase in size of fibroids

• Epilepsy

• Libido disorder

• Deterioration of asthma

• Probable dementia (see section 4.4).

4.9 Overdose

Vagifem is intended for intravaginal use and the dose of estradiol is very low. Overdose is therefore unlikely, but if it occurs, treatment is symptomatic.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Natural and semisynthetic oestrogens, plain

ATC code: G03CA03

The active ingredient, synthetic 17?-estradiol, is chemically and biologically identical to endogenous human estradiol.

Endogenous 17?-estradiol induces and maintains the primary and secondary female sexual characteristics. The biological effect of 17?-estradiol is carried out through a number of specific oestrogen receptors. The steroid receptor complex is bound to the cells DNA and induces synthesis of specific proteins.

Maturation of the vaginal epithelium is dependant upon oestrogens. Oestrogens increase the number of superficial and intermediate cells and decrease the number of basal cells in vaginal smear.

Oestrogens maintain vaginal pH around normal range (4.5) which enhances normal bacterial flora.

A 12-month double-blind, randomized, parallel group, placebo-controlled multicenter study was conducted to evaluate the efficacy and safety of Vagifem 10 micrograms in the treatment of postmenopausal vaginal atrophy symptoms.

After 12 weeks of treatment with Vagifem 10 micrograms the change from baseline, in comparison with placebo treatment, demonstrated significant improvements in the three primary endpoints: Vaginal Maturation Index and Value, normalization of Vaginal pH and relief of the moderate/severe urogenital symptoms considered most bothersome by the subjects.

Endometrial safety of Vagifem 10 micrograms was evaluated in the above mentioned trial and a second, open-label, multicenter trial. In total, 386 women underwent endometrial biopsy at the beginning and at the end of 52 weeks treatment. Incidence rate of hyperplasia and/or carcinoma was 0.52% (95% CI 0.06%, 1.86%), indicating no increased risk.

5.2 Pharmacokinetic Properties

Absorption

Oestrogens are well absorbed through the skin, mucous membranes, and the gastrointestinal tract. After vaginal administration, estradiol is absorbed circumventing first-pass metabolism.

A 12 weeks single-centre randomised, open label, multiple dose, parallel-group trial was conducted to evaluate the extent of systemic absorption of estradiol from the Vagifem 10 micrograms tablet. Subjects were randomized 1:1 to receive either 10 micrograms or 25 micrograms Vagifem. Plasma levels of estradiol (E2), oestrone (E1) and oestrone sulphate (E1S) were determined. AUC(0-24) for plasma E2 levels increased almost proportionally after the administration of 10 micrograms and 25 micrograms Vagifem. The AUC(0-24) indicated higher systemic estradiol levels for the 10 micrograms E2 tablet as compared to baseline on treatment days 1, 14 and 83, being statistically significant at days 1 and 14 (Table 1). However, average plasma E2 concentrations (Cave (0-24)) at all evaluated days remained within the normal postmenopausal range in all subjects. The data from days 82 and 83 as compared to baseline indicate that there is no cumulative effect during twice weekly maintenance therapy.

Table 1 Values of PK parameters from plasma Estradiol (E2) concentrations:

 

Vagifem 10 micrograms

   

AUC(0-24)

pg.h/mL

(geom. mean)

Cave(0-24)

pg/mL

(geom. mean)

Day -1

75.65

3.15

Day 1

225.35

9.39

Day 14

157.47

6.56

Day 82

44.95

1.87

Day 83

111.41

4.64

The levels of oestrone and oestrone sulphate after 12 weeks of Vagifem 10 micrograms administration did not exceed baseline levels, i.e., no accumulation of oestrone or oestrone sulphate was observed.

Distribution

The distribution of exogenous oestrogens is similar to that of endogenous oestrogens. Oestrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Oestrogens circulate in the blood largely bound to sex hormone binding globulin (SHBG) and albumin.

Biotransformation

Exogenous oestrogens are metabolized in the same manner as endogenous oestrogens. The metabolic transformations take place mainly in the liver. Estradiol is converted reversibly to oestrone, and both can be converted to oestriol, which is the major urinary metabolite. In postmenopausal women, a significant portion of the circulating oestrogens exist as sulphate conjugates, especially oestrone sulphate, which serves as a circulating reservoir for the formation of more active oestrogens.

Elimination

Estradiol, oestrone and oestriol are excreted in the urine along with glucuronide and sulfate conjugates.

Special patient groups

The extent of systemic absorption of estradiol during treatment with Vagifem 10 micrograms has been evaluated in postmenopausal women, aged 60-70 (mean age 65.4) only.

5.3 Preclinical Safety Data

17?-Estradiol is a well-known substance. Nonclinical studies provided no additional data of relevance to clinical safety beyond those already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Tablet core:

Hypromellose

Lactose monohydrate

Maize starch

Magnesium stearate

Film-coating:

Hypromellose

Macrogol 6000

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not refrigerate.

6.5 Nature And Contents Of Container

Each tablet is contained in a disposable single-use polyethylene/polypropylene applicator. The applicators are packed separately in PVC/aluminium foil blisters.

18 packs contain 3 blister cards of 6 applicators with inset tablets

24 packs contain 4 blister cards of 6 applicators with inset tablets

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Novo Nordisk A/S

Novo All?

DK-2880 Bagsv?rd

Denmark

The registered office in the UK is:-

Novo Nordisk Ltd

Broadfield Park

Brighton Road

Crawley

West Sussex

RH11 9AT

Tel: 01293 613555

8. Marketing Authorisation Number(S)

PL 04668/0237

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 17th February 2010

10. Date Of Revision Of The Text
read more / Download


Urinary pH modifiers


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.

Urinary pH modifiers are agents that increase the pH of urine. They make the urine more alkaline and prevent the formation of kidney stones. Making the urine more alkaline also helps the kidneys to remove toxic substances.

See also

Medical conditions associated with urinary pH modifiers:

Alkalosis Asystole Diabetic Ketoacidosis GERD Hyperkalemia Hyperuricemia Secondary to Chemotherapy Hyponatremia Indigestion Metabolic Acidosis Nephrolithiasis Renal Tubular Acidosis Urinary Alkalinization Drug List: Urocit-K Neut
read more / Download


Urispas


flavoxate hydrochloride
Dosage Form: Tablets
Urispas Description

Urispas® (flavoxate HCl) tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.

Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C24H25NO4• HCl. The molecular weight is 427.94. The structural formula appears below.

Urispas® is supplied in tablets for oral administration. Each round, white, film-coated Urispas® tablet is debossed with the product name Urispas® and contains flavoxate hydrochloride, 100 mg. Inactive ingredients consist of calcium phosphate, hypromellose, magnesium stearate, polyethylene glycol, starch and talc.

Urispas - Clinical Pharmacology

Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle.

In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the flavoxate HCl was excreted in the urine within 24 hours.

Indications and Usage for Urispas

Urispas® (flavoxate HCl) is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Urispas® is not indicated for definitive treatment, but is compatible with drugs used for the treatment of urinary tract infections.

Contraindications

Urispas® (flavoxate HCl) is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

Warnings

Urispas® (flavoxate HCl) should be given cautiously in patients with suspected glaucoma.

Precautions Information for Patients:

Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Urispas® (flavoxate HCl) have not been performed.

Pregnancy:

Teratogenic Effects-Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate HCl. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urispas® is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children below the age of 12 years have not been established.

Adverse Reactions

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Renal: Dysuria.

Overdosage

The oral LD50 for flavoxate HCl in rats is 4273 mg/kg. The oral LD50 for flavoxate HCl in mice is 1837 mg/kg.

It is not known whether flavoxate HCl is dialyzable.

Urispas Dosage and Administration Adults and children over 12 years of age:

One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.

How is Urispas Supplied

Urispas® (flavoxate HCl), 100 mg, is supplied as round, white, film-coated tablets, debossed with the product name Urispas® in bottles of 100.

100 mg 100's: NDC 17314-9220-1

Store between 15° and 30°C (59° and 86°F).

Rx only

Revision Date: AUGUST 2004

Manufactured by

Cardinal Health

Winchester, Kentucky 40391

Distributed by
ORTHO-McNEIL PHARMACEUTICAL, INC.
Raritan, New Jersey 08869

Printed in U.S.A.

631-10-843-2


Urispas 
flavoxate hydrochloride  tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17314-9220 Route of Administration ORAL DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength flavoxate hydrochloride (flavoxate) Active 100 MILLIGRAM  In 1 TABLET calcium phosphate Inactive   hypromellose Inactive   magnesium stearate Inactive   polyethylene glycol Inactive   starch Inactive   talc Inactive   Product Characteristics Color WHITE (white ) Score no score Shape ROUND (round) Size 10mm Flavor Imprint Code Urispas Contains          Coating true Symbol false Packaging # NDC Package Description Multilevel Packaging 1 17314-9220-1 100 TABLET In 1 BOTTLE None
Revised: 02/2006ORTHO-McNEIL PHARMACEUTICAL, INC. More Urispas resources Urispas Side Effects (in more detail) Urispas Dosage Urispas Use in Pregnancy & Breastfeeding Drug Images Urispas Drug Interactions Urispas Support Group 0 Reviews for Urispas - Add your own review/rating Urispas Concise Consumer Information (Cerner Multum) Urispas MedFacts Consumer Leaflet (Wolters Kluwer) Urispas Monograph (AHFS DI) Urispas Advanced Consumer (Micromedex) - Includes Dosage Information Flavoxate Professional Patient Advice (Wolters Kluwer) Compare Urispas with other medications Dysuria Overactive Bladder Urinary Incontinence
read more / Download


Urinary Tract Tumors Medications


Drugs associated with Urinary Tract Tumors

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

Learn more about Urinary Tract Tumors

Micromedex Care Notes:

Bladder Cancer

Medical Encyclopedia:

Bladder cancer Cancer Cancer - renal pelvis or ureter Tumor
Drug List: Theracys Tice-Bcg Tice-Bcg-Vaccine Valstar
read more / Download


Urinary anti-infectives


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.

Urinary anti-infectives are drugs that are used to prevent or treat urinary tract infections. There are several classes of antibacterial agents in this category and they have different mechanisms of action. However, majority of these drugs tend to have high concentration in the urine and therefore are ideal to treat urinary tract infections, or used as prophylaxis for urinary tract infections.

See also

Medical conditions associated with urinary anti-infectives:

Bladder Infection Methemoglobinemia Otitis Media Pneumocystis Pneumonia Prevention of Bladder infection Transurethral Prostatectomy Urinary Tract Infection Drug List: Monurol Hiprex Mandelamine Macrodantin Macrobid Cinobac Furadantin-Suspension Neggram Primsol-Solution Proloprim Trimpex Urex Urolene-Blue-Oral-And-Injection
read more / Download


Flavoxate Hydrochloride


Class: Genitourinary Smooth Muscle Relaxants
ATC Class: G04BD02
VA Class: GU201
Chemical Name: 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride
CAS Number: 3717-88-2
Brands: Urispas

Introduction

Genitourinary antispasmodic.a b

Uses for Flavoxate Hydrochloride Overactive Bladder

Symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence associated with cystitis, prostatitis, urethritis, urethrocystitis, or urethrotrigonitis. b Not indicated as definitive treatment, but is compatible with drugs used for treatment of urinary tract infections.a

Has not been shown to be more effective in the treatment of these conditions than antimuscarinic agents.a

Flavoxate Hydrochloride Dosage and Administration Administration Oral Administration

Administer orally 3 or 4 times daily.a b

Dosage

Available as flavoxate hydrochloride; dosage expressed in terms of the salt.b

Pediatric Patients Oral

Children ?12 years of age: 100 or 200 mg 3 or 4 times daily. a b May reduce dosage as symptoms improve.a b

Adults Oral

100 or 200 mg 3 or 4 times daily. a b May reduce dosage as symptoms improve.a b

Special Populations

No special population dosage recommendations at this time.b

Cautions for Flavoxate Hydrochloride Contraindications

Pyloric or duodenal obstruction. a b

Obstructive intestinal lesions or ileus.a b

Achalasia.a b

GI hemorrhage.a b

Obstructive uropathies of the lower urinary tract.a b

Warnings/Precautions Warnings Glaucoma

Use with caution in patients with suspected glaucoma. a b

Specific Populations Pregnancy

Category B.b

Lactation

Not known whether flavoxate is distributed into milk.a b Caution if used in nursing women.b

Pediatric Use

Safety and efficacy not established in children <12 years of age. a b

Geriatric Use

Possible increased incidence of mental confusion compared with younger adults.b

Common Adverse Effects

Nausea, vomiting, dry mouth, vertigo, headache, mental confusion, drowsiness, nervousness, blurred vision.b

Interactions for Flavoxate Hydrochloride

No formal drug interaction studies to date.a b

Flavoxate Hydrochloride Pharmacokinetics Absorption Bioavailability

Appears to be well absorbed from the GI tract. a

Onset

Following oral administration in healthy males, onset of action was 55 minutes.a

Duration

Following oral administration in healthy males, peak effect occurred at 112 minutes.a

Distribution Extent

Not known whether flavoxate is distributed into milk.a

Elimination Elimination Route

57% of an oral dose of flavoxate is excreted in urine within 24 hours.a b

Special Populations

Not known whether flavoxate is dialyzable.a

Stability Storage Oral Tablets

15–30°C.a b

ActionsActions

Exerts a direct spasmolytic (papaverine-like) action on smooth muscle of the urinary tract.a b

Increases urinary bladder capacity in patients with evidence of bladder spasticity, possibly as a result of action on the detrusor muscle.a

Advice to Patients

Risk of drowsiness or blurred vision; use caution when driving, operating machinery, or participating in activities where alertness is required.b

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.b

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

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

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Flavoxate Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

100 mg*

Urispas

Ortho-McNeil

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Flavoxate HCl 100MG Tablets (GLOBAL PHARMACEUTICAL CORP): 100/$99.99 or 300/$279.96

Urispas 100MG Tablets (MCNEIL): 28/$51.99 or 84/$145.97

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 September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2004. McEvoy GK, ed. Flavoxate. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3600-1.

b. Ortho-McNeil Pharmaceutical, Inc. Urispas (flavoxate hydrochloride) prescribing and patient information. Raritan, NJ; 2004 Aug.

More Flavoxate Hydrochloride resources Flavoxate Hydrochloride Side Effects (in more detail) Flavoxate Hydrochloride Dosage Flavoxate Hydrochloride Use in Pregnancy & Breastfeeding Drug Images Flavoxate Hydrochloride Drug Interactions Flavoxate Hydrochloride Support Group 1 Review for Flavoxate Hydrochloride - Add your own review/rating Flavoxate MedFacts Consumer Leaflet (Wolters Kluwer) Flavoxate Prescribing Information (FDA) Flavoxate Professional Patient Advice (Wolters Kluwer) Urispas Prescribing Information (FDA) flavoxate Concise Consumer Information (Cerner Multum) flavoxate Advanced Consumer (Micromedex) - Includes Dosage Information Compare Flavoxate Hydrochloride with other medications Dysuria Overactive Bladder Urinary Incontinence
read more / Download


Sanctura XR


Generic Name: trospium (tros PEE um)
Brand Names: Sanctura, Sanctura XR

What is Sanctura XR (trospium)?

Trospium relieves spasms of the bladder.

Trospium is used to treat overactive bladder and symptoms of urinary incontinence, frequency, and urgency.

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

What is the most important information I should know about Sanctura XR (trospium)? You should not take this medicine if you are allergic to trospium, or if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive system, or if you are unable to urinate. Take trospium on an empty stomach, at least 1 hour before a meal. Avoid drinking alcohol within 2 hours before or after you take trospium. Drinking alcohol can increase certain side effects of trospium.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Trospium can decrease sweating, which makes it easier for you to have heat stroke. Drink plenty of fluids while you are taking this medication.

Before using trospium, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by trospium. What should I discuss with my healthcare provider before taking Sanctura XR (trospium)? You should not use trospium if you are allergic to it, or if you have:

untreated or uncontrolled narrow-angle glaucoma;

a blockage in your digestive system; or

if you are unable to urinate.

FDA pregnancy category C. It is not known whether trospium will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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

glaucoma;

liver disease;

kidney disease;

a stomach or intestinal disorder such as ulcerative colitis;

a muscle disorder such as myasthenia gravis; or

an enlarged prostate.

It is not known whether trospium 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.

Older adults may be more likely to have side effects from this medicine.

How should I take Sanctura XR (trospium)?

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 trospium on an empty stomach, at least 1 hour before a meal. Extended-release trospium (Sanctura XR) should be taken once each morning, at least 1 hour before a meal. Do not crush, chew, break, or open an extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Store at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose 1 hour before your next meal. 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.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Sanctura XR (trospium)? This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Avoid drinking alcohol within 2 hours before or after you take trospium. Drinking alcohol can increase certain side effects of trospium.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Trospium can decrease sweating, which makes it easier for you to have heat stroke. Drink plenty of fluids while you are taking this medication.

Sanctura XR (trospium) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using trospium and call your doctor at once if you have a serious side effect such as:

severe stomach pain or bloating;

severe constipation; or

urinating less than usual or not at all.

Less serious side effects may include:

dry mouth or throat;

headache;

mild constipation;

upset stomach, gas;

drowsiness, or

dry eyes.

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 Sanctura XR (trospium)? Before using trospium, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by trospium.

Tell your doctor about all other medicines you use, especially:

atropine (Atreza, Sal-Tropine, and others);

belladonna (Donnatal, and others);

benztropine (Cogentin);

dicyclomine (Bentyl);

dimenhydrinate (Dramamine);

metformin (Actoplus Met, Avandamet, Glucophage, Glucovance, Janumet, Kombiglyze, Metaglip, PrandiMet);

morphine (Kadian, MS Contin, Oramorph);

procainamide (Procanbid, Pronestyl);

tenofovir (Viread);

vancomycin (Vancocin);

bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

ulcer medications such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with trospium. 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 Sanctura XR resources Sanctura XR Side Effects (in more detail) Sanctura XR Use in Pregnancy & Breastfeeding Sanctura XR Drug Interactions Sanctura XR Support Group 5 Reviews for Sanctura XR - Add your own review/rating Sanctura XR Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Sanctura XR Prescribing Information (FDA) Sanctura Prescribing Information (FDA) Sanctura Monograph (AHFS DI) Sanctura Advanced Consumer (Micromedex) - Includes Dosage Information Sanctura MedFacts Consumer Leaflet (Wolters Kluwer) Sanctura Consumer Overview Compare Sanctura XR with other medications Interstitial Cystitis Overactive Bladder Urinary Incontinence Where can I get more information? Your pharmacist can provide more information about trospium.

See also: Sanctura XR side effects (in more detail)


read more / Download


Herbal products


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.

Herbal products are medicines derived from plants. They are used as supplements to improve health and well being, and may be used for other therapeutic purposes. Herbal products are available as tablets, capsules, powders, extracts, teas and so on.

Herbal medicines are thought to be safe as it is natural, but in fact it can cause serious adverse effects and interaction with other drugs and supplements.

See also

Medical conditions associated with herbal products:

Acne ADHD Allergies Anemia Anorexia Anxiety Anxiety and Stress Aphthous Ulcer Asthma Atopic Dermatitis Bacterial Infection Bacterial Skin Infection Benign Prostatic Hyperplasia Bronchitis Burns, External Cancer Chronic Fatigue Syndrome Cold Sores Cold Symptoms Condylomata Acuminata Constipation Constipation, Chronic Coronary Artery Disease Cough Depression Dermatitis Diabetes, Type 1 Diabetes, Type 2 Diabetic Nerve Damage Diarrhea Diarrhea, Acute Diarrhea, Chronic Dry Skin Eczema Enuresis Epicondylitis, Tennis Elbow Epilepsy Erectile Dysfunction Eye Dryness/Redness Eye Redness/Itching Fever Fibromyalgia Gallbladder Disease Gas GERD Gingivitis Gout Headache Heart Disease Hemorrhoids Herbal Supplementation High Blood Pressure High Cholesterol Hot Flashes Human Papilloma Virus Indigestion Infectious Gastroenteritis Inflammatory Conditions Influenza Insomnia Labor Induction Labor Pain Liver Cirrhosis Menopausal Disorders Menstrual Disorders Migraine Migraine Prevention Mild Cognitive Impairment Motion Sickness Muscle Pain Muscle Spasm Nasal Congestion Nausea/Vomiting Neuralgia Night Terrors Nocturnal Leg Cramps Nonalcoholic Fatty Liver Disease Obesity Oral and Dental Conditions Osteoarthritis Otitis Externa Overactive Bladder Peripheral Neuropathy Photoaging of the Skin Postmenopausal Symptoms Premenstrual Dysphoric Disorder Prostate Cancer Psoriasis Rheumatoid Arthritis Rhinorrhea Sciatica Sedation Sinus Symptoms Sinusitis Sjogren's Syndrome Skin and Structure Infection Skin Infection Skin Rash Smallpox Prophylaxis Stomach Ulcer Strep Throat Sunburn Systemic Lupus Erythematosus Tonsillitis/Pharyngitis Upper Respiratory Tract Infection Urinary Incontinence Urinary Tract Infection Urticaria Varicose Veins Vomiting Weight Loss Drug List: Azo-Cranberry Evening-Primrose-Oil 5-Htp Carrington-Oral-Wound-Rinse Ginkgo-Biloba Menopause-Support Oramagic-Rx Primrose-Oil Venastat
read more / Download


Trospium Extended-Release Capsules


Pronunciation: TROSE-pee-um
Generic Name: Trospium
Brand Name: Sanctura XR
Trospium Extended-Release Capsules are used for:

Treating overactive bladder with symptoms such as urinary incontinence, urgency, and frequency.

Trospium Extended-Release Capsules are an antispasmodic and antimuscarinic agent. It works by reducing muscle tone of the bladder, which decreases urinary spasm and frequency.

Do NOT use Trospium Extended-Release Capsules if: you are allergic to any ingredient in Trospium Extended-Release Capsules you have delayed or slow emptying of the stomach or uncontrolled narrow-angle glaucoma, you are unable to urinate, or you are at risk of developing these conditions you have severe kidney problems you are taking a solid oral potassium product (eg, tablet)

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

Before using Trospium Extended-Release Capsules:

Some medical conditions may interact with Trospium Extended-Release Capsules. 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 use alcohol or have a history of alcohol abuse if you have liver or kidney problems, or glaucoma or increased pressure in the eye if you have stomach or bowel problems (eg, inflammation, constipation, blockage, problems with the muscles in your intestines), myasthenia gravis, bladder blockage, or trouble urinating

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

Solid oral potassium products (eg, tablets) because the risk of stomach or bowel irritation may be increased by Trospium Extended-Release Capsules Anticholinergic medicines (eg, scopolamine), metformin, morphine, procainamide, tenofovir, or vancomycin because they may increase the risk of Trospium Extended-Release Capsules's side effects Phenothiazines (eg, thioridazine) because their effectiveness may be decreased by Trospium Extended-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trospium Extended-Release Capsules 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 Trospium Extended-Release Capsules:

Use Trospium Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Trospium Extended-Release Capsules. Talk to your pharmacist if you have questions about this information. Take Trospium Extended-Release Capsules by mouth with water on an empty stomach at least 1 hour before eating, preferably in the morning or as directed by your doctor. If you miss a dose of Trospium Extended-Release Capsules, 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 Trospium Extended-Release Capsules.

Important safety information: Trospium Extended-Release Capsules may cause drowsiness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Trospium Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol within 2 hours before or after you take Trospium Extended-Release Capsules. Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Trospium Extended-Release Capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Trospium Extended-Release Capsules may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute. Do not become overheated in hot weather or while you are being active; heatstroke may occur. Tell your doctor or dentist that you take Trospium Extended-Release Capsules before you receive any medical or dental care, emergency care, or surgery. A severe and sometimes life-threatening side effect called angioedema has been reported with Trospium Extended-Release Capsules. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness. Use Trospium Extended-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially dry mouth, constipation, stomach pain or upset, and trouble urinating. Trospium Extended-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Trospium Extended-Release Capsules while you are pregnant. It is not known if Trospium Extended-Release Capsules are found in breast milk. If you are or will be breast-feeding while you take Trospium Extended-Release Capsules, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Trospium Extended-Release Capsules:

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

Constipation; dry mouth or eyes; gas; nasal dryness; nausea; upset stomach.

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

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; dark urine; difficulty urinating; fainting; fast or irregular heartbeat; hallucinations; mental or mood changes; muscle pain or weakness; red, swollen, peeling, or blistered skin; 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: Trospium 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 ( http://www.aapcc.org), or emergency room immediately. Symptoms may include fast or irregular heartbeat.

Proper storage of Trospium Extended-Release Capsules:

Store Trospium Extended-Release Capsules 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 Trospium Extended-Release Capsules out of the reach of children and away from pets.

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

This information is a summary only. It does not contain all information about Trospium Extended-Release Capsules. 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 Trospium resources Trospium Side Effects (in more detail) Trospium Dosage Trospium Use in Pregnancy & Breastfeeding Drug Images Trospium Drug Interactions Trospium Support Group 17 Reviews for Trospium - Add your own review/rating Compare Trospium with other medications Interstitial Cystitis Overactive Bladder Urinary Incontinence
read more / Download


Valstar


Generic Name: valrubicin (val ROO bi sin)
Brand Names: Valstar

What is Valstar (valrubicin)?

Valrubicin is a cancer (antineoplastic) medication. Valrubicin interferes with the growth of cancer cells and slows their growth and spread in the body.

Valrubicin is used to treat bladder cancer.

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

What is the most important information I should know about Valstar (valrubicin)?

Valrubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of valrubicin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with valrubicin.

Who should not use Valstar (valrubicin)? Do not use valrubicin without first talking to your doctor if you have

a urinary tract infection;

a perforated or otherwise damaged bladder;

kidney disease; or

irritable bladder disorder.

The use of valrubicin may be dangerous if you have any of the conditions listed above.

Valrubicin is in the FDA pregnancy category C. Systemic exposure to valrubicin may result in harm to an unborn baby. Do not use valrubicin without first talking to your doctor if you are pregnant. Men and women being treated with valrubicin should discuss with their doctor the appropriate use of birth control during treatment with valrubicin if necessary. Because of the potential for serious side effects in a nursing infant, breast-feeding should be avoided during treatment with valrubicin. The safety and effectiveness of valrubicin in children has not been established. How should I use Valstar (valrubicin)?

Valrubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with valrubicin depending upon the type of cancer being treated and other factors. Valrubicin has caused a complete response in only about 1 in 5 patients and delaying surgery could lead to wide-spread bladder cancer, which is lethal. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with valrubicin to monitor progress and side effects.

Skin accidentally exposed to valrubicin should be rinsed thoroughly with soap and warm water.

Your healthcare provider will store valrubicin as directed by the manufacturer. If you are storing valrubicin at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of valrubicin.

What happens if I overdose? If for any reason an overdose of valrubicin is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a valrubicin overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using Valstar (valrubicin)?

Valrubicin can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with valrubicin. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Skin accidentally exposed to valrubicin should be rinsed thoroughly with soap and warm water.

Valstar (valrubicin) side effects

If you experience an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to valrubicin, seek emergency medical attention.

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

bladder irritation (increased frequency of urination, painful urination, a very strong feeling of needing to urinate, blood in the urine);

urinary incontinence;

urinary tract infection;

red colored urine for 24 hours following a dose; or

nausea.

Talk to your doctor immediately if you have prolonged (longer than 24 hours after a dose) red-colored urine or prolonged bladder irritation.

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 Valstar (valrubicin)? Do not receive "live" vaccines during treatment with valrubicin. Administration of a live vaccine may be dangerous during treatment with valrubicin.

Other drugs may interact with valrubicin. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with valrubicin.

More Valstar resources Valstar Side Effects (in more detail) Valstar Use in Pregnancy & Breastfeeding Valstar Drug Interactions Valstar Support Group 0 Reviews for Valstar - Add your own review/rating Valstar Prescribing Information (FDA) Valstar Advanced Consumer (Micromedex) - Includes Dosage Information Valstar MedFacts Consumer Leaflet (Wolters Kluwer) Valrubicin Professional Patient Advice (Wolters Kluwer) Compare Valstar with other medications Urinary Tract Tumors Where can I get more information? Your healthcare provider may have additional information about valrubicin that you may read.

See also: Valstar side effects (in more detail)


read more / Download


valrubicin


Generic Name: valrubicin (val ROO bi sin)
Brand Names: Valstar

What is valrubicin?

Valrubicin is a cancer (antineoplastic) medication. Valrubicin interferes with the growth of cancer cells and slows their growth and spread in the body.

Valrubicin is used to treat bladder cancer.

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

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

Valrubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of valrubicin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with valrubicin.

Who should not use valrubicin? Do not use valrubicin without first talking to your doctor if you have

a urinary tract infection;

a perforated or otherwise damaged bladder;

kidney disease; or

irritable bladder disorder.

The use of valrubicin may be dangerous if you have any of the conditions listed above.

Valrubicin is in the FDA pregnancy category C. Systemic exposure to valrubicin may result in harm to an unborn baby. Do not use valrubicin without first talking to your doctor if you are pregnant. Men and women being treated with valrubicin should discuss with their doctor the appropriate use of birth control during treatment with valrubicin if necessary. Because of the potential for serious side effects in a nursing infant, breast-feeding should be avoided during treatment with valrubicin. The safety and effectiveness of valrubicin in children has not been established. How should I use valrubicin?

Valrubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with valrubicin depending upon the type of cancer being treated and other factors. Valrubicin has caused a complete response in only about 1 in 5 patients and delaying surgery could lead to wide-spread bladder cancer, which is lethal. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with valrubicin to monitor progress and side effects.

Skin accidentally exposed to valrubicin should be rinsed thoroughly with soap and warm water.

Your healthcare provider will store valrubicin as directed by the manufacturer. If you are storing valrubicin at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of valrubicin.

What happens if I overdose? If for any reason an overdose of valrubicin is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a valrubicin overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using valrubicin?

Valrubicin can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with valrubicin. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Skin accidentally exposed to valrubicin should be rinsed thoroughly with soap and warm water.

Valrubicin side effects

If you experience an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to valrubicin, seek emergency medical attention.

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

bladder irritation (increased frequency of urination, painful urination, a very strong feeling of needing to urinate, blood in the urine);

urinary incontinence;

urinary tract infection;

red colored urine for 24 hours following a dose; or

nausea.

Talk to your doctor immediately if you have prolonged (longer than 24 hours after a dose) red-colored urine or prolonged bladder irritation.

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.

Valrubicin Dosing Information

Usual Adult Dose for Urinary Tumor:

For intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality:
Valrubicin is recommended at a dose of 800 mg administered intravesically once a week for six weeks. Administration should be delayed at least two weeks after transurethral resection and/or fulguration. For each instillation, four 5 mL vials (200 mg valrubicin/5 mL vial) should be allowed to warm slowly to room temperature, but should not be heated. Twenty milliliters of valrubicin should then be withdrawn from the four vials and diluted with 55 mL 0.9% Sodium Chloride Injection, USP providing 75 mL of a diluted valrubicin solution. A urethral catheter should then be inserted into the patient's bladder under aseptic conditions, the bladder drained, and the diluted 75 mL valrubicin solution instilled slowly via gravity flow over a period of several minutes. The catheter should then be withdrawn. The patient should retain the drug for two hours before voiding. At the end of two hours, all patients should void. (Some patients will be unable to retain the drug for the full two hours.) Patients should be instructed to maintain adequate hydration following treatment.

What other drugs will affect valrubicin? Do not receive "live" vaccines during treatment with valrubicin. Administration of a live vaccine may be dangerous during treatment with valrubicin.

Other drugs may interact with valrubicin. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with valrubicin.

More valrubicin resources Valrubicin Side Effects (in more detail) Valrubicin Dosage Valrubicin Use in Pregnancy & Breastfeeding Valrubicin Drug Interactions Valrubicin Support Group 0 Reviews for Valrubicin - Add your own review/rating valrubicin Intravesical Advanced Consumer (Micromedex) - Includes Dosage Information Valrubicin MedFacts Consumer Leaflet (Wolters Kluwer) Valrubicin Professional Patient Advice (Wolters Kluwer) Valstar Prescribing Information (FDA) Compare valrubicin with other medications Urinary Tract Tumors Where can I get more information? Your healthcare provider may have additional information about valrubicin that you may read.

See also: valrubicin side effects (in more detail)


read more / Download


Sanctura


Generic Name: Trospium Chloride
Class: Genitourinary Smooth Muscle Relaxants
VA Class: GU201
Chemical Name: spiro[8-azoniabicyclo[3,2,1]octane-8,1’-pyrrolidinium]-3-[(hydroxydiphenyl-acetyl)- oxy]chloride,(1?, 3?, 5?)
Molecular Formula: C25H30ClNO3
CAS Number: 10405-02-4

Introduction

Genitourinary antispasmodic; quaternary ammonium antimuscarinic.1 3

Uses for Sanctura Overactive Bladder

Management of overactive bladder for the relief of symptoms associated with voiding (e.g., urge urinary incontinence, urgency, frequency).1 3 5

Appears to be as effective as immediate-release preparations of oxybutynin or tolterodine in decreasing urinary frequency;2 4 5 6 may be more effective than immediate-release preparations of tolterodine in decreasing urgency incontinence.5 6

May offer no advantage over extended-release anticholinergic preparations for the treatment of overactive bladder.3

Sanctura Dosage and Administration Administration Oral Administration

Administer orally twice daily, at least 1 hour before meals or on an empty stomach.1

Dosage

Available as trospium chloride; dosage expressed in terms of the salt.1

Adults Overactive Bladder Oral

20 mg twice daily.1

Special Populations Hepatic Impairment

Use caution in patients with moderate or severe hepatic impairment.1 (See Special Populations under Pharmacokinetics.)

Renal Impairment

In patients with severe renal impairment (Clcr <30 mL/minute), decrease dosage to 20 mg once daily at bedtime.1

Geriatric Patients

In geriatric patients ?75 years of age, may decrease dosage to 20 mg once daily based on patient tolerance.1 (See Geriatric Use under Cautions.)

Cautions for Sanctura Contraindications

Presence or risk of urinary retention.1

Presence or risk of gastric retention.1

Presence or risk of risk of uncontrolled angle-closure glaucoma.1

Known hypersensitivity to trospium or any ingredient in the formulation.1

Warnings/Precautions General Precautions Urinary Retention

Risk of urinary retention; use with caution in patients with clinically important bladder outflow obstruction.1

Decreased GI Motility

Risk of gastric retention; use caution with obstructive GI disorders.1

May decrease GI motility; use with caution in patents with ulcerative colitis, intestinal atony, or myasthenia gravis.1

Controlled Angle-closure Glaucoma

Use only if potential benefits outweigh the risks; use with caution and monitor carefully.1

Specific Populations Pregnancy

Category C.1

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 Use with caution and only if potential benefit justifies the risk to the infant.1

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

In patients ?75 years of age, possible increased incidence of adverse anticholinergic effects compared with younger adults.1 (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution in patients with moderate or severe hepatic impairment.1 (See Special Populations under Pharmacokinetics.)

Renal Impairment

Dosage reduction necessary in patients with severe renal impairment (Clcr<30 mL/per minute); not studied in patients with mild or moderate renal impairment1 (See Renal Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.) 1

Common Adverse Effects

Dry mouth,1 2 3 constipation.1 2

Interactions for Sanctura

Minimally metabolized by CYP isoenzymes; does not inhibit CYP1A2, 3A4, 2A6, 2C9, 2C19, 2D6, or 2E1 in vitro.1 2 7 Pharmacokinetic interactions unlikely with drugs metabolized by CYP isoenzymes or with CYP enzyme inducers or inhibitors.1 2 7

Drugs Eliminated by Active Tubular Secretion

Possible competition for renal secretion, decreased renal elimination, and increased serum concentrations of trospium and/or other drug.1 Use concomitantly with caution; monitor carefully.1

Drugs Affected by GI Motility

Potential for altered absorption because of decreased GI motility.1

Specific Drugs

Drug

Interaction

Comment

Alcohol

Potential for additive sedative effects1

Anticholinergic agents

Potential for additive anticholinergic effects1

Digoxin

Potential for decreased renal elimination and increased serum concentrations of trospium and/or digoxin1 3

Use concomitantly with caution; monitor carefully1

Metformin

Potential decreased renal elimination and increased serum concentrations of trospium and/or metformin1 3

Use concomitantly with caution; monitor carefully1

Morphine

Potential for decreased renal elimination and increased serum concentrations of trospium and/or morphine 1 3

Use concomitantly with caution; monitor carefully1

Pancuronium

Potential for decreased renal elimination and increased serum concentrations of trospium and/or pancuronium1

Use concomitantly with caution; monitor carefully1

Procainamide

Potential for decreased renal elimination and increased serum concentrations of trospium and/or procainamide1 3

Use concomitantly with caution; monitor carefully1

Tenofovir

Potential for decreased renal elimination and increased serum concentrations of trospium and/or tenofovir1

Use concomitantly with caution; monitor carefully1

Vancomycin

Potential for decreased renal elimination and increased serum concentrations of trospium and/or vancomycin1

Use concomitantly with caution; monitor carefully1

Sanctura Pharmacokinetics Absorption Bioavailability

Absorption from GI tract is incomplete.1 3 5 7

Mean absolute oral bioavailability is about 9.6%.1

Food

High-fat meal reduces AUC and peak plasma concentrations by about 70–80%.1 3

Distribution Extent

In blood, plasma to whole blood ratio is 1.6 to 1.1

Hydrophilic; theoretically should not cross the blood-brain barrier.5 7

Distributed into milk in rats; not known whether distributed into human milk.1

Plasma Protein Binding

50–85%.1

Elimination Metabolism

Metabolism not fully elucidated;1 2 7 major pathway may be ester hydrolysis and subsequent glucuronidation to form inactive metabolites.1 7 Minimally metabolized by CYP isoenzymes.1 2 7

Elimination Route

Excreted principally in feces (about 85%) and in urine (5.8%), mainly as unchanged drug.1 2 3 5 7

Active tubular secretion is a major elimination route.1

Half-life

About 20 hours.1 7

Special Populations

In patients with severe renal impairment (Clcr<30 mL/per minute), peak plasma concentrations and AUC increased 2-fold and 4.5-fold, respectively, and an additional elimination phase (half-life of about 33 hours) occurred.1 7

In patients with mild or moderate hepatic impairment, peak plasma concentrations increased (12 or 63%, respectively); AUC was similarly increased.1

Stability Storage Oral Tablets

20–25°C.1

ActionsActions

Antagonizes acetylcholine at muscarinic receptors in cholinergically innervated organs.1 3 5

Parasympatholytic action reduces the tonus of smooth muscle in the urinary bladder.1 3

Increases maximum cystometric capacity and volume at first detrusor contraction in patients with involuntary detrusor contractions.1 5

Little or no affinity for nicotinic receptors compared with muscarinic receptors at concentrations achieved following usual therapeutic doses.1 7

Advice to Patients

Importance of informing patients of potential adverse anticholinergic effects (e.g., dizziness, blurred vision, heat prostration when used in a hot environment).1

Importance of taking trospium chloride on an empty stomach or at least 1 hour before meals, and if a dose is skipped, taking the next scheduled dose at least 1 hour before the next meal.1

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

Importance of using alcohol with caution, since it may enhance drowsiness caused by trospium.1

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

Importance of advising patients of other important 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.

Trospium Chloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

20 mg

Sanctura

Odyssey

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Sanctura 20MG Tablets (ALLERGAN DERMATOLOGICS): 30/$85.94 or 90/$242.47

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 October 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Odyssey Pharmaceuticals. Sanctura™ (trospium chloride) tablets prescribing information. East Hanover, NJ; 2004. From Sanctura website (http://www.sanctura.com/Sanctura_Prescribing_Information.pdf).

2. Zinner N, Gittelman M, Harris R et al. Trospium chloride improves overactive bladder symptoms: a multicenter phase II trial. J Urol. 2004; 171:2311-5. [IDIS 519949] [PubMed 15126811]

3. Anon. Trospium Chloride (Sanctura): Another anticholinergic for overactive bladder. Med Lett Drugs Ther. 2004; 46:63-4. [PubMed 15289745]

4. Halaska M, Ralph G, Wiedemann A et al. Controlled, double-blind, multicentre clinical trial to investigate long-term tolerability and efficacy of trospium chloride in patients with detrusor instability. World J Urol. 2003; 20:392-9. [IDIS 519866] [PubMed 12811500]

5. Hashim H, Abrams P. Drug treatment of overactive bladder. Efficacy, cost and quality-of-life considerations. Drugs. 2004; 64:1643-56. [PubMed 15257626]

6. UK Medicines Information Pharmacists Group. Trospium. New Medicines on the market. Evaluated Information for the NHS. 2002 Feb. From UKMi website (http://www.ukmi.nhs.uk/NewMaterial/html/docs/trospium.pdf)

7. Rovner ES. Trospium chloride in the management of overactive bladder. Drugs. 2004; 64:2433-2446. [PubMed 15482001]

More Sanctura resources Sanctura Side Effects (in more detail)Sanctura DosageSanctura Use in Pregnancy & BreastfeedingDrug ImagesSanctura Drug InteractionsSanctura Support Group11 Reviews for Sanctura - Add your own review/rating Sanctura Prescribing Information (FDA) Sanctura Advanced Consumer (Micromedex) - Includes Dosage Information Sanctura Consumer Overview Sanctura MedFacts Consumer Leaflet (Wolters Kluwer) Sanctura XR Prescribing Information (FDA) Sanctura XR Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Compare Sanctura with other medications Interstitial CystitisOveractive BladderUrinary Incontinence
read more / Download


Anticholinergics/antispasmodics


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.

Anticholinergic/antispasmodic agents inhibit the action of acetylcholine. They stop the transmission of parasympathetic nerve impulses therefore lessen the spasms of smooth muscle, such as in the gastrointestinal tract and in the bladder. They are used to treat spasms or conditions with disturbances in the bladder or gastrointestinal motility.

See also

Medical conditions associated with anticholinergics/antispasmodics:

Anesthesia Anticholinesterase Poisoning AV Heart Block Bradyarrhythmia Colitis Crohn's Disease Duodenal Ulcer Endoscopy or Radiology Premedication Enterocolitis Enuresis Excessive Salivation Gas GERD Hot Flashes Irritable Bowel Syndrome Menopausal Disorders Motion Sickness Nausea/Vomiting Organophosphate Poisoning Overactive Bladder Parkinson's Disease Parkinsonian Tremor Peptic Ulcer Perimenopausal Symptoms Postmenopausal Symptoms Urinary Incontinence Drug List: Levsin-Sl Pamine Donnatal Belladonna-Tincture Donnatal-Extentabs-Controlled-Release-Tablets Hyomax-Sl Levbid-Extended-Release-Tablets Levsin Scopace Bentyl Librax Symax-Duotab-Controlled-Release-Tablets Hyomax Hyomax-Sr Robinul Transderm-Scop-Patch Hyosyne-Drops Pamine-Forte A-Spaz Alkabel-Sr-Controlled-Release-Tablets Anaspaz Antispasmodic Atreza Atropen Bel-Phen-Ergot Bellamine Bellamine-S Bellamor Bellaphen-S Bellaspas Bellatal Bellergal-S Cantil Colidrops-Drops Cuvposa Cystospaz D-Tal Digex-Nf Duragal-S Ed-Spaz Eperbel-S Hyomax-Dt Hyomax-Ft Hyosophen Hyospaz Ib-Stat-Spray Levsinex-Extended-Release-Capsules Levsinex-Sr Maldemar Nulev-Orally-Disintegrating-Tablets Pb-Hyos-Elixir Pro-Banthine Quadrapax-Elixir Quarzan Re-Pb-Hyos-Elixir Robinul-Forte Sal-Tropine Servira Spasdel-Drops Spasmolin Spastrin Symax-Fastabs-Orally-Disintegrating-Tablets Symax-Sl Symax-Sr-Extended-Release-Tablets
read more / Download


Skeletal muscle relaxants


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.

Skeletal muscle relaxants are centrally acting agents that work by reducing the tone of skeletal muscle causing muscle to relax. There are many classes of drugs that are classed as skeletal muscle relaxants and how they work may differ. These drugs are used to relieve skeletal muscle spasms due to spastic conditions and can be used to relieve musculoskeletal pain and spasms.

See also

Medical conditions associated with skeletal muscle relaxants:

Alcohol WithdrawalBlepharospasmCerebral SpasticityCervical DystoniaCluster HeadachesDystoniaFacial WrinklesFibromyalgiaHiccupsHuntington's DiseaseHyperhidrosisMalignant HyperthermiaMigraineMigraine PreventionMuscle PainMuscle SpasmMuscle TwitchingNeuralgiaNocturnal Leg CrampsOpiate WithdrawalOveractive BladderPeriodic Limb Movement DisorderSciaticaSpasticityStrabismusTemporomandibular Joint DisorderTetanusTrigeminal NeuralgiaUpper Limb SpasticityUrinary Incontinence Drug List:/tags/dantrium/
/tags/botox-cosmetic/
/tags/botox/
/tags/zanaflex/
/tags/amrix-extended-release-capsules/
/tags/flexeril/
/tags/fexmid/
/tags/parafon-forte-dsc/
/tags/lioresal-intrathecal/
/tags/gablofen/
/tags/comfort-pac-with-cyclobenzaprine/
/tags/dysport/
/tags/mio-rel/
/tags/orphenate/
/tags/vanadom/

read more / Download


Related Search:

Search


 

Best ED Pills

 

Erectile Dysfunction

 

RX Pharmacy Drugs List - Buy Pills Online

RSS | Site Map | Map | PageMap

Copyright © Online Pharmacy Drug Store. All rights reserved.