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Utira Delayed-Release Tablets

30/06/10

Generic Name: Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate (hye-oh-SYE-a-meen/meth-EN-a-meen/METH-i-leen/FEN-ill sa-LI-si-late/SOE-dee-um bye-FOS-fate)
Brand Name: Urimax and Utira

Utira Delayed-Release Tablets are used for:

Treating painful and irritating symptoms of the urinary tract due to urinary tract infections or diagnostic procedures.

Utira Delayed-Release Tablets are a urinary antiseptic, urinary acidifier, analgesic, and anticholinergic combination. It works by helping to kill bacteria in the urine, decreasing pain and inflammation, and reducing muscle spasms in the urinary tract. These actions work together to help relieve discomfort while urinating.

Do NOT use Utira Delayed-Release Tablets if:

you are allergic to any ingredient in Utira Delayed-Release Tablets
you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin, other salicylate medicines, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)
you have angle-closure glaucoma, problems with your esophagus, bowel motility problems, a blockage of your bladder or bowel, severe intestinal problems (eg, ulcerative colitis), severe bleeding, flu or chickenpox, myasthenia gravis, severe kidney problems, or you are severely dehydrated
you are taking a sulfonamide (eg, sulfamethoxazole)

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

Before using Utira Delayed-Release Tablets:

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

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have constipation, diarrhea, an infection of the stomach or bowel, a hiatal hernia, or stomach ulcers
if you have nervous system problems, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, gout, influenza, Kawasaki syndrome, rheumatic disease, open-angle glaucoma, risk factors for angle-closure glaucoma, kidney or liver problems, an enlarged prostate, bladder problems, or you are unable to urinate
if you have a history of stroke or brain blood vessel problems (eg, aneurysm), an irregular heartbeat, heart blood vessel problems, congestive heart failure, heart valve problems, or other heart problems
if you are on a low-salt diet

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

Anticholinergics (eg, benztropine) because they may increase the risk of Utira Delayed-Release Tablets’s side effects.
Ketoconazole because it may decrease Utira Delayed-Release Tablets’s effectiveness.
Monoamine oxidase inhibitors (MAOIs) or narcotic pain medicine (eg, codeine) because the risk of serious side effects may be increased
Medicine for myasthenia gravis (eg, ambenonium), phenothiazines (eg, chlorpromazine), sulfonamides (eg, sulfamethoxazole), thiazide diuretics (eg, hydrochlorothiazide), or urinary alkalinizers (eg, sodium bicarbonate) because their effectiveness may be decreased by Utira Delayed-Release Tablets

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

How to use Utira Delayed-Release Tablets:

Use Utira Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Utira Delayed-Release Tablets by mouth with or without food.
Swallow Utira Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.
Do not take antacids or antidiarrheal medicines that has loperamide within 1 hour before or 2 hours after you take Utira Delayed-Release Tablets.
Drinking extra fluids while you are taking Utira Delayed-Release Tablets are recommended. Check with your doctor for instructions.
If you miss a dose of Utira Delayed-Release Tablets, 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 Utira Delayed-Release Tablets.

Important safety information:

Utira Delayed-Release Tablets may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Utira Delayed-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do NOT take more than the recommended dose or use for more often than prescribed without checking with your doctor.
Utira Delayed-Release Tablets may discolor the urine or stools a blue-green color. This is normal and not a cause for concern.
Utira Delayed-Release Tablets contains salicylate. Salicylates have been linked to a serious illness called Reye syndrome. Do not give Utira Delayed-Release Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
Use Utira Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, drowsiness, and confusion.
Utira Delayed-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Utira Delayed-Release Tablets while you are pregnant. Utira Delayed-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Utira Delayed-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Utira Delayed-Release Tablets:

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

Dry mouth; flushing; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; difficulty urinating; dizziness; fast or irregular heartbeat.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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.

Proper storage of Utira Delayed-Release Tablets:

Store Utira Delayed-Release Tablets 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 Utira Delayed-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Utira Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Utira Delayed-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,U

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Uvadex

30/06/10

Generic Name: methoxsalen (Injection route)

meth-OX-a-len

Oral routeCapsule

Methoxsalen with UV radiation should be used only by physicians who have special competence in diagnosis and treatment of psoriasis and who have special training and experience in photochemotherapy. The use of psoralen and ultraviolet radiation therapy should be under constant supervision of such a physician. For the treatment of patients with psoriasis, photochemotherapy should be restricted to patients with severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been supported by biopsy. Because of the possibilities of ocular damage, aging of the skin, and skin cancer (including melanoma), the patient should be fully informed by the physician of the risks inherent in this therapy.

Methoxsalen soft gelatin capsules should not be used interchangeably with regular Methoxsalen hard gelatin capsules. This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Patients should be treated in accordance with the dosimetry specifically recommended for this product. The minimum phototoxic dose (MPD) and phototoxic peak time after drug administration prior to onset of photochemotherapy with this dosage form should be determined .

Methoxsalen with UV radiation should be used only by physicians who have special competence in diagnosis and treatment of psoriasis and who have special training and experience in photochemotherapy. Photochemotherapy should be restricted to patients with severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy. Risks of therapy include ocular damage, aging of the skin, and skin cancer (including melanoma). The soft gelatin capsules should not be used interchangeably with regular methoxsalen hard gelatin capsules due to greater bioavailability and earlier photosensitization onset time .

Injection routeSolution

Read the UVAR photophoresis system operator’s manual prior to prescribing or dispensing this medication. Methoxsalen sterile solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the UVAR® or UVAR® XTS™ Photopheresis System. Please consult the appropriate Operator’s Manual before using this product .

Methoxsalen sterile solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the UVAR(R) or UVAR(R) XTS(TM) Photopheresis System .

Commonly used brand name(s):

In the U.S.

Uvadex

Available Dosage Forms:

Solution
Injectable

Therapeutic Class: Antipsoriatic

Chemical Class: Psoralen

Uses For Uvadex

Methoxsalenbelongs to the group of medicines called psoralens. It is used along with ultraviolet light (found in sunlight and some special lamps) to treat the white blood cells from your blood in a process called photopheresis. The treated white blood cells are returned to your body to control skin problems associated with cutaneous T-cell lymphoma, a cancer of the lymph system.

Methoxsalen is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using Uvadex

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

Allergies

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

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of methoxsalen in children with use in other age groups.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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

Phenytoin

Interactions with Food/Tobacco/Alcohol

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

Proper Use of Uvadex

Dosing

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

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

Precautions While Using Uvadex

Eating certain foods while you are receiving methoxsalen treatment may increase your skin’s sensitivity to sunlight. To help prevent this, avoid eating limes, figs, parsley, parsnips, mustard, carrots, and celery while you are being treated with this medicine.

Your doctor should check your progress at regular visits to make sure this treatment is working and that it does not cause unwanted effects. You also should have regular eye examinations.

This medicine increases the sensitivity of your skin to sunlight and also may cause premature aging of the skin. Therefore, exposure to the sun, even through window glass or on a cloudy day, could cause a serious burn. If you must go out during the daylight hours:

After each treatment, cover your skin with protective clothing for at least 24 hours. In addition, use a sun block product that has a skin protection factor (SPF) of at least 15 on those areas of your body that cannot be covered. If you have any questions about this, check with your health care professional.

For 24 hours after your methoxsalen treatment, your eyes should be protected during daylight hours with special wraparound sunglasses that totally block or absorb ultraviolet light (ordinary sunglasses are not adequate). This is to prevent cataracts. Your doctor will tell you what kind of sunglasses to use. These glasses should be worn even in indirect light, such as light coming through a window, or on a cloudy day.

Uvadex Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Rare

Fever
irregular heartbeat
redness or pain at catheter site

Symptoms of overdose

Blistering and peeling of skin
reddened, sore skin

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

Reddening of skin, slight

Treatment with this medicine usually causes a slight reddening of your skin 24 to 48 hours after the treatment. This is an expected effect and is no cause for concern. However, check with your doctor right away if your skin becomes sore and red or blistered.

There is an increased risk of developing skin cancer after use of methoxsalen. You should check your body regularly and show your doctor any skin sores that do not heal, new skin growths, or skin growths that have changed in the way they look or feel.

Premature aging of the skin may occur as a result of prolonged methoxsalen therapy. This effect is permanent and is similar to what happens when a person sunbathes for long periods of time.

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

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

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

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Uta

30/06/10

Generic Name: Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate (hye-oh-SYE-a-meen/meth-EN-a-meen/METH-i-leen/FEN-ill sa-LI-si-late/SOE-dee-um FOS-fate)
Brand Name: Examples include Uta and Uretron D/S

Uta is used for:

Treating painful and irritating symptoms of the urinary tract due to urinary tract infections or diagnostic procedures.

Uta is a urinary antiseptic, urinary acidifier, analgesic, and anticholinergic combination. It works by helping to kill bacteria in the urine, decreasing pain and inflammation, and reducing muscle spasms in the urinary tract. These actions work together to help relieve discomfort while urinating.

Do NOT use Uta if:

you are allergic to any ingredient in Uta
you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin, other salicylate medicines, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)
you have angle-closure glaucoma, problems with your esophagus, bowel motility problems, a blockage of your bladder or bowel, severe intestinal problems (eg, ulcerative colitis), severe bleeding, flu or chickenpox, myasthenia gravis, severe kidney problems, or you are severely dehydrated
you are taking a sulfonamide (eg, sulfamethoxazole)

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

Before using Uta:

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

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have constipation, diarrhea, an infection of the stomach or bowel, a hiatal hernia, or stomach ulcers
if you have nervous system problems, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, gout, influenza, Kawasaki syndrome, rheumatic disease, open-angle glaucoma, risk factors for angle-closure glaucoma, kidney or liver problems, an enlarged prostate, bladder problems, or you are unable to urinate
if you have a history of stroke or brain blood vessel problems (eg, aneurysm), an irregular heartbeat, heart blood vessel problems, congestive heart failure, heart valve problems, or other heart problems
if you are on a low-salt diet

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

Anticholinergics (eg, benztropine) because they may increase the risk of Uta’s side effects
Ketoconazole because it may decrease Uta’s effectiveness
Monoamine oxidase inhibitors (MAOIs) or narcotic pain medicine (eg, codeine) because the risk of serious side effects may be increased
Medicine for myasthenia gravis (eg, ambenonium), phenothiazines (eg, chlorpromazine), sulfonamides (eg, sulfamethoxazole), thiazide diuretics (eg, hydrochlorothiazide), or urinary alkalinizers (eg, sodium bicarbonate) because their effectiveness may be decreased by Uta

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

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

Take Uta by mouth with or without food.
Do not take antacids or antidiarrheal medicines that has loperamide) within 1 hour before or 2 hours after you take Uta.
Drinking extra fluids while you are taking Uta is recommended. Check with your doctor for instructions.
If you miss a dose of Uta, 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 Uta.

Important safety information:

Uta may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Uta with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.
Uta may discolor the urine or stool a blue-green color. This is normal and not a cause for concern.
Uta contains salicylate. Salicylates have been linked to a serious illness called Reye syndrome. Do not give Uta to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
Use Uta with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, drowsiness, and confusion.
Uta is not recommended for use in CHILDREN younger than 6 years old; safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Uta while you are pregnant. Uta is found in breast milk. If you are or will be breast-feeding while you use Uta, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Uta:

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:

Dry mouth; flushing; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; difficulty urinating; dizziness; fast or irregular heartbeat.

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.

Proper storage of Uta:

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

General information:

If you have any questions about Uta, please talk with your doctor, pharmacist, or other health care provider.
Uta is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Uta. 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: May 5, 2010

Database Edition 10.2.1.002

Med-facts,U

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UTI Relief

30/06/10

Generic Name: phenazopyridine (Oral route)

fen-ay-zoe-PIR-i-deen

Commonly used brand name(s):

In the U.S.

Azo-Gesic
Azo-Septic
Azo-Standard
Baridium
Phenazo 95
Prodium
Pyridiate
Pyridium
RE-Azo
Urinary Pain Relief
Uristat
UTI Relief

Available Dosage Forms:

Tablet
Kit

Therapeutic Class: Analgesic

Uses For UTI Relief

Phenazopyridine is used to relieve the pain, burning, and discomfort caused by infection or irritation of the urinary tract. It is not an antibiotic and will not cure the infection itself.

In the U.S., phenazopyridine is available only with your doctor’s prescription.

Before Using UTI Relief

Allergies

Pediatric

Although there is no specific information comparing use of phenazopyridine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of phenazopyridine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Proper Use of phenazopyridine

This section provides information on the proper use of a number of products that contain phenazopyridine. It may not be specific to UTI Relief. Please read with care.

This medicine is best taken with food or after eating a meal or a snack to lessen stomach upset.

Do not use any leftover medicine for future urinary tract problems without first checking with your doctor. An infection may require additional medicine.

Dosing

For oral dosage form (tablets):
- For relieving pain, burning, and discomfort in the urinary tract:
  - Adults and teenagers—200 milligrams (mg) three times a day.
  - Children—The dose is based on body weight and must be determined by your doctor. The usual dose is 4 mg per kilogram (kg) (about 1.8 mg per pound) of body weight three times a day.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using UTI Relief

Check with your doctor if symptoms such as bloody urine, difficult or painful urination, frequent urge to urinate, or sudden decrease in the amount of urine appear or become worse while you are taking this medicine .

Phenazopyridine causes the urine to turn reddish orange . This is to be expected while you are using it. This effect is harmless and will go away after you stop taking the medicine. Also, the medicine may stain clothing.

For patients who wear soft contact lenses:

It is best not to wear soft contact lenses while being treated with this medicine. Phenazopyridine may cause discoloration or staining of contact lenses. It may not be possible to remove the stain.

For diabetic patients:

This medicine may cause false test results with urine sugar tests and urine ketone tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

Before you have any medical tests, tell the person in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

UTI Relief Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Blue or blue-purple color of skin
fever and confusion
shortness of breath, tightness in chest, wheezing, or troubled breathing
skin rash
sudden decrease in the amount of urine
swelling of face, fingers, feet, and/or lower legs
unusual tiredness or weakness
weight gain
yellow eyes or skin

Less common or rare

Dizziness
headache
indigestion
itching of the skin
stomach cramps or pain

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

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

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Usept

30/06/10

Generic Name: Belladonna Alkaloids/Methenamine/Methylene Blue/Phenyl Salicylate (bell-a-DON-a/meth-EN-a-meen/METH-i-leen/FEN-ill sa-LI-si-late)
Brand Name: Examples include Urised and Usept

Usept is used for:

Treating painful and irritating symptoms of the urinary tract due to urinary tract infections or diagnostic procedures.

Usept is a urinary antiseptic, analgesic, and anticholinergic combination. It works by helping to kill bacteria in the urine, decreasing pain and inflammation, and reducing muscle spasms in the urinary tract. These actions work together to help relieve discomfort while urinating.

Do NOT use Usept if:

you are allergic to any ingredient in Usept
you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin, other salicylate medicines, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)
you have angle-closure glaucoma, problems with your esophagus, bowel motility problems, a blockage of your bladder or bowel, severe intestinal problems (eg, ulcerative colitis), severe bleeding, flu or chickenpox, myasthenia gravis, severe kidney problems, or you are severely dehydrated
you are taking a sulfonamide (eg, sulfamethizole)

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

Before using Usept:

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

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have constipation, diarrhea, an infection of the stomach or bowel, a hiatal hernia, or stomach ulcers
if you have nervous system problems, glucose-6-phosphate-dehydrogenase (G-6-PD) deficiency, gout, influenza, Kawasaki syndrome, rheumatic disease, open-angle glaucoma, risk factors for angle-closure glaucoma, kidney or liver problems, an enlarged prostate, bladder problems, or you are unable to urinate
if you have a history of stroke or brain blood vessel problems (eg, aneurysm), an irregular heartbeat, heart blood vessel problems, congestive heart failure, heart valve problems, or other heart problems
if you are on a low-salt diet

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

Anticholinergics (eg, benztropine) because the side effects of Usept may be increased
Ketoconazole because the effectiveness of Usept may be decreased
Monoamine oxidase (MAO) inhibitors or narcotic pain medicine (eg, codeine) because the risk of serious side effects may be increased
Medicine for myasthenia gravis (eg, ambenonium), phenothiazines (eg, chlorpromazine), sulfonamides (eg, sulfamethizole), thiazide diuretics (eg, hydrochlorothiazide), or urinary alkalinizers (eg, sodium bicarbonate) because effectiveness may be decreased by Usept

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

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

Usept may be taken with or without food.
Do not take antacids or antidiarrheal medicines (eg, loperamide) within 1 hour before or after taking Usept.
Drink plenty of fluids while taking Usept.
If you miss a dose of Usept, 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 Usept.

Important safety information:

Usept may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Usept. Using Usept alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Do not take Usept more often or in larger amounts than prescribed by your health care provider.
Usept may discolor the urine or feces a blue-green color. This is normal and not a cause for concern.
Usept contains an aspirin-like medicine, which has been linked to Reye syndrome. Do not give Usept to children or teenagers during or after chickenpox, flu, or other viral infections without checking with your doctor or pharmacist.
Use Usept with caution in the ELDERLY because they may be more sensitive to its effects, especially excitement, agitation, drowsiness, and confusion.
Usept is not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: It is unknown if Usept can cause harm to the fetus. If you become pregnant while taking Usept, discuss with your doctor the benefits and risks of using Usept during pregnancy. Usept is excreted in breast milk. If you are or will be breast-feeding while you are using Usept, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Usept:

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:

Dry mouth; flushing; nausea; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; difficulty urinating; dizziness; fast or irregular heartbeat.

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.

Proper storage of Usept:

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

General information:

If you have any questions about Usept, please talk with your doctor, pharmacist, or other health care provider.
Usept is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Usept. 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: May 5, 2010

Database Edition 10.2.1.002

Med-facts,U

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ustekinumab (Subcutaneous route)

30/06/10

us-te-KIN-ue-mab

Commonly used brand name(s):

In the U.S.

Stelara

Available Dosage Forms:

Solution

Pharmacologic Class: Monoclonal Antibody

Uses For ustekinumab

Ustekinumab is used to treat moderate-to-severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments.

ustekinumab is available only with your doctor’s prescription.

Before Using ustekinumab

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ustekinumab in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ustekinumab in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of ustekinumab

A nurse or other trained health professional will give you ustekinumab. ustekinumab is given as a shot under your skin, usually on the upper arms, buttocks, abdomen (stomach), or thighs.

ustekinumab comes with a medication guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Precautions While Using ustekinumab

It is very important that your doctor check your progress at regular visits to make sure that ustekinumab is working properly. Blood tests may be needed to check for unwanted effects.

It is important to check with your doctor if you have any symptoms of an infection such as fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination.

You will need to have a skin test for tuberculosis before you start using ustekinumab. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test or been exposed to tuberculosis.

ustekinumab may increase your risk of getting some forms of cancer. Talk to your doctor about this risk if you have concerns.

Stop using ustekinumab and check with your doctor if you have headache, seizures, confusion, blurred vision or other visual problems. These may be symptoms of a rare and serious condition called reversible posterior leukoencephalopathy syndrome (RPLS).

While you are being treated with ustekinumab, and after you stop treatment with it, do not have any immunizations (especially live vaccinations) without your doctor’s approval. Ustekinumab may lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, the other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also avoid persons who have recently taken oral polio vaccine. Do not get close to them or stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective mask that covers the nose and mouth.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

ustekinumab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

Cough or hoarseness
fever or chills
lower back or side pain
painful or difficult urination

Rare

Blurred or loss of vision
clear or bloody discharge from the nipple
confusion
difficult or frequent urination
dimpling of the breast skin
disturbed color perception
double vision
halos around lights
headache
inverted nipple
itching, pain, redness, swelling, tenderness, or warmth on the skin
lump in the breast or under the arm
night blindness
overbright appearance of lights
persistent crusting or scaling of the nipple
redness or swelling of the breast
seizures
sore on the skin of the breast that does not heal
tunnel vision

Less common

Back pain
bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
depression
dizziness
sore throat
unusual tiredness or weakness

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

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

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Ustekinumab

30/06/10

Generic Name: Ustekinumab (US-te-KIN-ue-mab)
Brand Name: Stelara

Ustekinumab is used for:

Treating certain patients with moderate to severe plaque psoriasis. It may also be used for other conditions as determined by your doctor.

Ustekinumab is a monoclonal antibody. It works by blocking certain substances in the body that affect inflammation and the body’s immune system.

Do NOT use Ustekinumab if:

you are allergic to any ingredient in Ustekinumab
you will be receiving a live vaccine (eg, measles, mumps)
you have had a Bacillus Calmette-Guerin (BCG) vaccine within the past year
you have a severe infection (eg, sepsis) or any other active infection

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

Before using Ustekinumab:

Some medical conditions may interact with Ustekinumab. 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, including rubber or latex
if you have a history of an infection that keeps coming back, tuberculosis (TB) infection or positive TB skin test, cancer, or a neurological disorder called reversible posterior leukoencephalopathy syndrome (RPLS)
if you have immune system problems, you have or a member of your household has recently received a vaccine, or you are scheduled to receive a vaccine or to have surgery
if you have open cuts or sores on your body, have flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or are using medicine to treat an infection
if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB
if you are having phototherapy or you take medicine that may decrease your immune system (eg, cyclosporine)

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

Cyclosporine or warfarin because the risk of their side effects may be increased

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

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

Ustekinumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ustekinumab refilled.
Ustekinumab is usually given as an injection at your doctor’s office, hospital, or clinic.
Ustekinumab is colorless to light yellow and may contain a few small white particles. Do not use Ustekinumab if it contains other particles, is cloudy or discolored, or if the vial is cracked or damaged.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Ustekinumab, contact your doctor right away.

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

Important safety information:

Patients should receive a TB skin test before using Ustekinumab. Patients who test positive for TB should begin treatment for TB before starting Ustekinumab. All patients should also be monitored for signs of TB while using Ustekinumab even if their TB test is negative.
Serious infections, including tuberculosis, fungal infection, and other types of infections, have occurred in patients using Ustekinumab. Avoid contact with people who have colds or infections. Contact your doctor immediately if you develop signs of TB or any other type of infection (eg, persistent cough; muscle weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin; increased or painful urination; persistent diarrhea or stomach pain).
Ustekinumab may increase the risk of developing certain types of cancer. Discuss any questions or concerns with your doctor.
Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. It is not known if using Ustekinumab for more than 2 years is safe and effective.
Tell your doctor or dentist that you take Ustekinumab before you receive any medical or dental care, emergency care, or surgery.
Do not receive a live vaccine (eg, measles, mumps) while you are taking Ustekinumab. Talk with your doctor before you or a member of your household receives any vaccine.
Do not receive a Bacillus Calmette-Guerin (BCG) vaccine for 1 year before, during, or 1 year after treatment with Ustekinumab.
Lab tests, including TB tests, may be performed while you use Ustekinumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Ustekinumab 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 using Ustekinumab while you are pregnant. Ustekinumab is found in breast milk. If you are or will be breast-feeding while you use Ustekinumab, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ustekinumab:

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:

Headache; mild redness at the injection site; mild sore throat; tiredness; upper respiratory infection.

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); change in a mole; confusion; open sore that does not heal; persistent pain, swelling, or redness at the injection site; seizures; severe or persistent headache; signs of infection (eg, fever, chills, or persistent sore throat; cough; muscle aches; shortness of breath; warm, red, or painful skin; increased or painful urination; stomach pain or diarrhea; blood in phlegm; unexplained weight loss); unusual lump or skin growth; unusual tiredness or weakness; vision changes.

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.

Proper storage of Ustekinumab:

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

General information:

If you have any questions about Ustekinumab, please talk with your doctor, pharmacist, or other health care provider.
Ustekinumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ustekinumab. 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: May 5, 2010

Database Edition 10.2.1.002

Med-facts,U

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Ursodiol Capsules

30/06/10

Dosage Form: capsule

Ursodiol Capsules, USP
9380
Rx only

PRESCRIBING INFORMATION

SPECIAL NOTE

Gallbladder stone dissolution with ursodiol treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who do dissolve their stones on bile acid therapy. Patients should be carefully selected for therapy with ursodiol, and alternative therapies should be considered.

Ursodiol Capsules Description

Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration.

Ursodiol is ursodiol USP (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting, white powder freely soluble in ethanol and glacial acetic acid; slightly soluble in chloroform; sparingly soluble in ether; and practically insoluble in water. The chemical name for ursodiol is 3α, 7β-dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol USP has a molecular weight of 392.58. Its structural formula is shown below:

Inactive Ingredients: colloidal silicon dioxide, corn starch, D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake, FD&C blue No. 2 aluminum lake, FD&C red No. 40, FD&C red No. 40 aluminum lake, gelatin, magnesium stearate, pharmaceutical glaze (modified) in SD-45, propylene glycol, synthetic black iron oxide, and titanium dioxide. The imprinting ink may contain antifoam DC 1510 and soya lecithin.

Ursodiol Capsules – Clinical Pharmacology

About 90% of a therapeutic dose of ursodiol is absorbed in the small bowel after oral administration. After absorption, ursodiol enters the portal vein and undergoes efficient extraction from portal blood by the liver (i.e., there is a large “first-pass” effect) where it is conjugated with either glycine or taurine and is then secreted into the hepatic bile ducts. Ursodiol in bile is concentrated in the gallbladder and expelled into the duodenum in gallbladder bile via the cystic and common ducts by gallbladder contractions provoked by physiologic responses to eating. Only small quantities of ursodiol appear in the systemic circulation and very small amounts are excreted into urine. The sites of the drug’s therapeutic actions are in the liver, bile, and gut lumen.

Beyond conjugation, ursodiol is not altered or catabolized appreciably by the liver or intestinal mucosa. A small proportion of orally administered drug undergoes bacterial degradation with each cycle of enterohepatic circulation. Ursodiol can be both oxidized and reduced at the 7-carbon, yielding either 7-keto-lithocholic acid or lithocholic acid, respectively. Further, there is some bacterially catalyzed deconjugation of glyco- and tauro- ursodeoxycholic acid in the small bowel. Free ursodiol, 7-keto-lithocholic acid, and lithocholic acid are relatively insoluble in aqueous media and larger proportions of these compounds are lost from the distal gut into the feces. Reabsorbed free ursodiol is reconjugated by the liver. Eighty percent of lithocholic acid formed in the small bowel is excreted in the feces, but the 20% that is absorbed is sulfated at the 3-hydroxyl group in the liver to relatively insoluble lithocholyl conjugates which are excreted into bile and lost in feces. Absorbed 7-keto-lithocholic acid is stereospecifically reduced in the liver to chenodiol.

Lithocholic acid causes cholestatic liver injury and can cause death from liver failure in certain species unable to form sulfate conjugates. Lithocholic acid is formed by 7-dehydroxylation of the dihydroxy bile acids (ursodiol and chenodiol) in the gut lumen. The 7-dehydroxylation reaction appears to be alpha-specific, i.e., chenodiol is more efficiently 7-dehydroxylated than ursodiol and, for equimolar doses of ursodiol and chenodiol, levels of lithocholic acid appearing in bile are lower with the former. Man has the capacity to sulfate lithocholic acid. Although liver injury has not been associated with ursodiol therapy, a reduced capacity to sulfate may exist in some individuals, but such a deficiency has not yet been clearly demonstrated.

Pharmacodynamics

Ursodiol suppresses hepatic synthesis and secretion of cholesterol, and also inhibits intestinal absorption of cholesterol. It appears to have little inhibitory effect on synthesis and secretion into bile of endogenous bile acids, and does not appear to affect secretion of phospholipids into bile.

With repeated dosing, bile ursodeoxycholic acid concentrations reach a steady state in about 3 weeks. Although insoluble in aqueous media, cholesterol can be solubilized in at least two different ways in the presence of dihydroxy bile acids. In addition to solubilizing cholesterol in micelles, ursodiol acts by an apparently unique mechanism to cause dispersion of cholesterol as liquid crystals in aqueous media. Thus, even though administration of high doses (e.g., 15 to 18 mg/kg/day) does not result in a concentration of ursodiol higher than 60% of the total bile acid pool, ursodiol-rich bile effectively solubilizes cholesterol. The overall effect of ursodiol is to increase the concentration level at which saturation of cholesterol occurs.

The various actions of ursodiol combine to change the bile of patients with gallstones from cholesterol-precipitating to cholesterol-solubilizing, thus resulting in bile conducive to cholesterol stone dissolution.

After ursodiol dosing is stopped, the concentration of the bile acid in bile falls exponentially, declining to about 5% to 10% of its steady-state level in about 1 week.

Clinical Results

Gallstone Dissolution

On the basis of clinical trial results in a total of 868 patients with radiolucent gallstones treated in 8 studies (three in the U.S. involving 282 patients, one in the U.K. involving 130 patients, and four in Italy involving 456 patients) for periods ranging from 6 to 78 months with ursodiol doses ranging from about 5 to 20 mg/kg/day, an ursodiol dose of about 8 to 10 mg/kg/day appeared to be the best dose. With an ursodiol dose of about 10 mg/kg/day, complete stone dissolution can be anticipated in about 30% of unselected patients with uncalcified gallstones < 20 mm in maximal diameter treated for up to 2 years. Patients with calcified gallstones prior to treatment, or patients who develop stone calcification or gallbladder nonvisualization on treatment, and patients with stones > 20 mm in maximal diameter rarely dissolve their stones. The chance of gallstone dissolution is increased up to 50% in patients with floating or floatable stones (i.e., those with high cholesterol content), and is inversely related to stone size for those < 20 mm in maximal diameter. Complete dissolution was observed in 81% of patients with stones up to 5 mm in diameter. Age, sex, weight, degree of obesity, and serum cholesterol level are not related to the chance of stone dissolution with ursodiol.

A nonvisualizing gallbladder by oral cholecystogram prior to the initiation of therapy is not a contraindication to ursodiol therapy (the group of patients with nonvisualizing gallbladders in the ursodiol studies had complete stone dissolution rates similar to the group of patients with visualizing gallbladders). However, gallbladder nonvisualization developing during ursodiol treatment predicts failure of complete stone dissolution and in such cases therapy should be discontinued.

Partial stone dissolution occurring within 6 months of beginning therapy with ursodiol appears to be associated with a > 70% chance of eventual complete stone dissolution with further treatment; partial dissolution observed within 1 year of starting therapy indicates a 40% probability of complete dissolution.

Stone recurrence after dissolution with ursodiol therapy was seen within 2 years in 8/27 (30%) of patients in the U.K. studies. Of 16 patients in the U.K. study whose stones had previously dissolved on chenodiol but later recurred, 11 had complete dissolution on ursodiol. Stone recurrence has been observed in up to 50% of patients within 5 years of complete stone dissolution on ursodiol therapy. Serial ultrasonographic examinations should be obtained to monitor for recurrence of stones, bearing in mind that radiolucency of the stones should be established before another course of ursodiol is instituted. A prophylactic dose of ursodiol has not been established.

Gallstone Prevention

Two placebo-controlled, multicenter, double-blind, randomized, parallel group trials in a total of 1316 obese patients were undertaken to evaluate ursodiol in the prevention of gallstone formation in obese patients undergoing rapid weight loss. The first trial consisted of 1004 obese patients with a body mass index (BMI) ≥ 38 who underwent weight loss induced by means of a very low calorie diet for a period of 16 weeks. An intent-to-treat analysis of this trial showed that gallstone formation occurred in 23% of the placebo group, while those patients on 300, 600, or 1200 mg/day of ursodiol experienced a 6%, 3%, and 2% incidence of gallstone formation, respectively. The mean weight loss for this 16 week trial was 47 lb for the placebo group, and 47, 48, and 50 lb for the 300, 600, and 1200 mg/day ursodiol groups, respectively.

The second trial consisted of 312 obese patients (BMI ≥ 40) who underwent rapid weight loss through gastric bypass surgery. The trial drug treatment period was for 6 months following this surgery. Results of this trial showed that gallstone formation occurred in 23% of the placebo group, while those patients on 300, 600, or 1200 mg/day of ursodiol experienced a 9%, 1%, and 5% incidence of gallstone formation, respectively. The mean weight loss for this 6 month trial was 64 lb for the placebo group, and 67, 74, and 72 lb for the 300, 600, and 1200 mg/day ursodiol groups, respectively.

ALTERNATIVE THERAPIES

Watchful Waiting

Watchful waiting has the advantage that no therapy may ever be required. For patients with silent or minimally symptomatic stones, the rate of development of moderate-to-severe symptoms or gallstone complications is estimated to be between 2% and 6% per year, leading to a cumulative rate of 7% to 27% in 5 years. Presumably the rate is higher for patients already having symptoms.

Cholecystectomy

For patients with symptomatic gallstones, surgery offers the advantage of immediate and permanent stone removal, but carries a high risk in some patients. About 5% of cholecystectomized patients have residual symptoms or retained common duct stones. The spectrum of surgical risk varies as a function of age and the presence of disease other than cholelithiasis.

Mortality Rates for Cholecystectomy in the U.S. (National Halothane Study, JAMA 1966; 197:775-8) 27,600 Cholecystectomies (Smoothed Rates) Deaths/1000 Operations*
			Cholecystectomy
Low Risk Patients†			+Common Duct
	Age (Yrs)	Cholecystectomy	Exploration

* Includes both elective and emergency surgery. † In good health or with moderate systemic disease. ‡ With severe or extreme systemic disease.
Women	0 to 49	.54	2.13
	50 to 69	2.80	10.10
Men	0 to 49	1.04	4.12
	50 to 69	5.41	19.23
High Risk Patients‡
Women	0 to 49	12.66	47.62
	50 to 69	17.24	58.82
Men	0 to 49	24.39	90.91
	50 to 69	33.33	111.11

Women in good health or who have only moderate systemic disease and are under 49 years of age have the lowest surgical mortality rate (0.054); men in all categories have a surgical mortality rate twice that of women. Common duct exploration quadruples the rates in all categories. The rates rise with each decade of life and increase tenfold or more in all categories with severe or extreme systemic disease.

Indications and Usage for Ursodiol Capsules

Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established.
Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

Contraindications

Ursodiol will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for ursodiol therapy.
Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for ursodiol therapy.
Allergy to bile acids.

Precautions

Liver Tests

Ursodiol therapy has not been associated with liver damage. Lithocholic acid, a naturally occurring bile acid, is known to be a liver-toxic metabolite. This bile acid is formed in the gut from ursodiol less efficiently and in smaller amounts than that seen from chenodiol. Lithocholic acid is detoxified in the liver by sulfation and, although man appears to be an efficient sulfater, it is possible that some patients may have a congenital or acquired deficiency in sulfation, thereby predisposing them to lithocholate-induced liver damage.

Abnormalities in liver enzymes have not been associated with ursodiol therapy and, in fact, ursodiol has been shown to decrease liver enzyme levels in liver disease. However, patients given ursodiol should have SGOT (AST) and SGPT (ALT) measured at the initiation of therapy and thereafter as indicated by the particular clinical circumstances.

Drug Interactions

Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of ursodiol by reducing its absorption. Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with ursodiol in the same manner as the bile acid sequestering agents. Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion, and encourage cholesterol gallstone formation and hence may counteract the effectiveness of ursodiol.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Ursodeoxycholic acid was tested in 2 year oral carcinogenicity studies in CD-1 mice and Sprague-Dawley rats at daily doses of 50, 250, and 1000 mg/kg/day. It was not tumorigenic in mice. In the rat study, it produced statistically significant dose-related increased incidences of pheochromocytomas of adrenal medulla in males (p = 0.014, Peto trend test) and females (p = 0.004, Peto trend test.) A 78 week rat study employing intrarectal instillation of lithocholic acid and tauro-deoxycholic acid, metabolites of ursodiol and chenodiol, has been conducted. These bile acids alone did not produce any tumors. A tumor-promoting effect of both metabolites was observed when they were coadministered with a carcinogenic agent. Results of epidemiologic studies suggest that bile acids might be involved in the pathogenesis of human colon cancer in patients who had undergone a cholecystectomy, but direct evidence is lacking. Ursodiol is not mutagenic in the Ames test. Dietary administration of lithocholic acid to chickens is reported to cause hepatic adenomatous hyperplasia.

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits with ursodiol doses up to 200 fold the therapeutic dose and have revealed no evidence of impaired fertility or harm to the fetus at doses of 20 to 100 fold the human dose in rats and at 5 fold the human dose (highest dose tested) in rabbits. Studies employing 100 to 200 fold the human dose in rats have shown some reduction in fertility rate and litter size. There have been no adequate and well-controlled studies of the use of ursodiol in pregnant women, but inadvertent exposure of 4 women to therapeutic doses of the drug in the first trimester of pregnancy during the ursodiol trials led to no evidence of effects on the fetus or newborn baby. Although it seems unlikely, the possibility that ursodiol can cause fetal harm cannot be ruled out; hence, the drug is not recommended for use during pregnancy.

Nursing Mothers

It is not known whether ursodiol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ursodiol is administered to a nursing mother.

Pediatric Use

The safety and effectiveness of ursodiol in pediatric patients have not been established.

Geriatric Use

In worldwide clinical studies of ursodiol, approximately 14% of subjects were over 65 years of age (approximately 3% were over 75 years old). In a subgroup analysis of existing clinical trials, patients greater than 56 years of age did not exhibit statistically significantly different complete dissolution rates from the younger population. No age related differences in safety and effectiveness were found. Other reported clinical experience has not identified differences in response in elderly and younger patients. However, small differences in efficacy and greater sensitivity of some elderly individuals taking ursodiol cannot be ruled out. Therefore, it is recommended that dosing proceed with caution in this population.

Adverse Reactions

The nature and frequency of adverse experiences were similar across all groups.

The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level:

Gallstone Dissolution
	Ursodiol		Placebo
	8 to 10 mg/kg/day
	(N = 155)		(N = 159)
	N	(%)	N	(%)
Body as a Whole
Allergy	8	(5.2)	7	(4.4)
Chest Pain	5	(3.2)	10	(6.3)
Fatigue	7	(4.5)	8	(5.0)
Infection Viral	30	(19.4)	41	(25.8)
Digestive System
Abdominal Pain	67	(43.2)	70	(44.0)
Cholecystitis	8	(5.2)	7	(4.4)
Constipation	15	(9.7)	14	(8.8)
Diarrhea	42	(27.1)	34	(21.4)
Dyspepsia	26	(16.8)	18	(11.3)
Flatulence	12	(7.7)	12	(7.5)
Gastrointestinal Disorder	6	(3.9)	8	(5.0)
Nausea	22	(14.2)	27	(17.0)
Vomiting	15	(9.7)	11	(6.9)
Musculoskeletal System
Arthralgia	12	(7.7)	24	(15.1)
Arthritis	9	(5.8)	4	(2.5)
Back Pain	11	(7.1)	18	(11.3)
Myalgia	9	(5.8)	9	(5.7)
Nervous System
Headache	28	(18.1)	34	(21.4)
Insomnia	3	(1.9)	8	(5.0)
Respiratory System
Bronchitis	10	(6.5)	6	(3.8)
Coughing	11	(7.1)	7	(4.4)
Pharyngitis	13	(8.4)	5	(3.1)
Rhinitis	8	(5.2)	11	(6.9)
Sinusitis	17	(11.0)	18	(11.3)
Upper Respiratory Tract Infection	24	(15.5)	21	(13.2)
Urogenital System
Urinary Tract Infection	10	(6.5)	7	(4.4)

Gallstone Prevention
	Ursodiol		Placebo
	600 mg
	(N = 322)		(N = 325)
	N	(%)	N	(%)
Body as a Whole
Fatigue	25	(7.8)	33	(10.2)
Infection Viral	29	(9.0)	29	(8.9)
Influenza-like Symptoms	21	(6.5)	19	(5.8)
Digestive System
Abdominal Pain	20	(6.2)	39	(12.0)
Constipation	85	(26.4)	72	(22.2)
Diarrhea	81	(25.2)	68	(20.9)
Flatulence	15	(4.7)	24	(7.4)
Nausea	56	(17.4)	43	(13.2)
Vomiting	44	(13.7)	44	(13.5)
Musculoskeletal System
Back Pain	38	(11.8)	21	(6.5)
Musculoskeletal Pain	19	(5.9)	15	(4.6)
Nervous System
Dizziness	53	(16.5)	42	(12.9)
Headache	80	(24.8)	78	(24.0)
Respiratory System
Pharyngitis	10	(3.1)	19	(5.8)
Sinusitis	17	(5.3)	18	(5.5)
Upper Respiratory Tract Infection	40	(12.4)	35	(10.8)
Skin and Appendages
Alopecia	17	(5.3)	8	(2.5)
Urogenital System
Dysmenorrhea	18	(5.6)	19	(5.8)

Overdosage

Neither accidental nor intentional overdosing with ursodiol has been reported. Doses of ursodiol in the range of 16 to 20 mg/kg/day have been tolerated for 6 to 37 months without symptoms by 7 patients. The LD50 for ursodiol in rats is over 5000 mg/kg given over 7 to 10 days and over 7500 mg/kg for mice. The most likely manifestation of severe overdose with ursodiol would probably be diarrhea, which should be treated symptomatically.

Ursodiol Capsules Dosage and Administration

Gallstone Dissolution

The recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8 to 10 mg/kg/day given in 2 or 3 divided doses.

Ultrasound images of the gallbladder should be obtained at 6 month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.

Gallstone Prevention

The recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).

How is Ursodiol Capsules Supplied

Ursodiol Capsules USP, 300 mg are supplied as hard gelatin capsule with white opaque body and red opaque cap, either imprinted “93” over “9380” on the body and cap or imprinted “9380” on the body and “TEVA” on the cap in bottles of 100.

Do not store above 86°F (30°C).

Dispense in tight container (USP).

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. D 1/2010

PRINCIPAL DISPLAY PANEL

300 mg – 100 Capsules Label Text

NDC 0093-9380-01

URSODIOL

Capsules USP

300 mg

Each capsule contains:

ursodiol, USP 300 mg

Dispense in a tight container (USP).

Rx only

100 CAPSULES

TEVA

URSODIOL
ursodiol capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0093-9380
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
URSODIOL (URSODIOL)	URSODIOL	300 mg

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
LECITHIN, SOYBEAN

Product Characteristics
Color	RED, WHITE	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	93;9380;or;9380;TEVA
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0093-9380-01	100 CAPSULE In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075592	04/26/2010

Labeler - TEVA Pharmaceuticals USA Inc (118234421)

Revised: 04/2010TEVA Pharmaceuticals USA Inc

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ursodiol (Oral route)

30/06/10

ur-soe-DYE-ol

Commonly used brand name(s):

In the U.S.

Actigall
Urso
Urso 250
Urso Forte

Available Dosage Forms:

Tablet
Capsule

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Bile Acid

Uses For ursodiol

Ursodiol is used in the treatment of gallstone disease. It is taken by mouth to dissolve the gallstones.

Ursodiol is used in patients with gallstones who do not need to have their gallbladders removed or in those in whom surgery should be avoided because of other medical problems. However, ursodiol works only in those patients whose gallstones are made of cholesterol and works best when these stones are small and of the “floating” type.

Ursodiol is also used to help prevent gallstones in patients who are on rapid weight-loss programs.

Ursodiol is also used in patients with cirrhosis of the liver. Cirrhosis causes a patient’s liver to have problems and not work properly.

Ursodiol is available only with your doctor’s prescription.

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

Chronic liver disease
Liver transplant (to help reduce the risk of rejection)

Before Using ursodiol

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ursodiol in the pediatric population. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of ursodiol in geriatric patients .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of ursodiol

Take ursodiol with meals for best results, unless otherwise directed by your doctor.

Take ursodiol for the full time of treatment, even if you begin to feel better. If you stop taking ursodiol too soon, the gallstones may not dissolve as fast or may not dissolve at all.

It is thought that body weight and the kind of diet the patient follows may affect how fast the stones dissolve and whether new stones will form. However, check with your doctor before going on any diet.

Ursodiol forte tablet can be broken in halves to provide recommended dosage. To break the tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the groove then apply gentle pressure until it breaks apart. Swallow each segment with water. Do not chew .

Half-tablets can be used for up to 28 days when kept in the medicine bottle. Due to the bitter taste, segments should be stored separately .

Dosing

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

For oral dosage form (capsules or tablets):
- For gallstone disease:
  - Adults and children 12 years of age and older—The dose is based on body weight and must be determined by your doctor. The usual dose is 8 to 10 milligrams (mg) per kilogram (kg) (3.6 to 4.5 mg per pound) of body weight a day, divided into two or three doses. Each dose is usually taken with a meal.
  - Children up to 12 years of age—Use and dose must be determined by your doctor.
- For prevention of gallstones during rapid weight loss:
  - Adults—Oral, 300 mg two times a day.
  - Children up to 12 years of age—Use and dose must be determined by your doctor.
- For cirrhosis of the liver:
  - Adults—The dose is based on body weight and must be determined by your doctor. The usual dose is 13 to 15 milligrams (mg) per kilogram (kg) (5.85 to 6.75 mg per pound) of body weight a day, divided into two to four doses. Each dose should be taken with a meal.
  - Children up to 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

If you miss a dose of ursodiol, take it as soon as possible or double your next dose.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using ursodiol

It is important that your doctor check your progress at regular visits. Laboratory tests will have to be done every few months while you are taking ursodiol to make sure that the gallstones are dissolving and your liver is working properly.

Do not take aluminum-containing antacids (e.g., ALternaGEL®, Maalox®), cholestyramine (Questran®), colestipol (Colestid®), clofibrate (Atromid-S®), or estrogen or birth control pills while taking ursodiol. To do so may keep ursodiol from working properly. Before using these medicines, check with your doctor first .

Check with your doctor immediately if severe abdominal or stomach pain, especially toward the upper right side, or severe nausea and vomiting occur. These symptoms may mean that you have other medical problems or that your gallstone condition needs your doctor’s attention.

ursodiol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Bladder pain
bloody or cloudy urine
difficult, burning, or painful urination
dizziness
fast heartbeat
frequent urge to urinate
indigestion
lower back or side pain
severe nausea
shortness of breath
skin rash or itching over the entire body
stomach pain
vomiting
weakness
wheezing

Less common

Black, tarry stools
blood in vomit
chest pain
chills
cough
fever
painful or difficult urination
severe or continuing stomach pain
sore throat
sores, ulcers, or white spots on lips or in mouth
swollen glands
unusual bleeding or bruising
unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Diarrhea

More common

Back pain
body aches or pain
congestion
constipation
cough producing mucus
difficulty in breathing
dryness or soreness of throat
ear congestion
general feeling of discomfort or illness
hair loss
headache
heartburn
loss of appetite
loss of voice
muscle aches and pains
muscle or bone pain
muscle stiffness
nasal congestion
nausea
pain, swelling, or redness in joints
runny nose
shivering
sneezing
sweating
tightness in chest
trouble in swallowing
trouble sleeping
voice changes

Less common or rare

Worsening psoriasis

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

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

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ursodiol

30/06/10

Generic Name: ursodiol ( ur so DY all)
Brand names: Actigall, Urso, Urso Forte, Urso DS

What is ursodiol?

Ursodiol is a bile acid that decreases the amount of cholesterol produced by the liver and absorbed by the intestines. Ursodiol helps break down cholesterol that has formed into stones in the gallbladder. Ursodiol also increases bile flow in patients with primary biliary cirrhosis.

Ursodiol is used to treat small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. Ursodiol is also used to treat primary biliary cirrhosis.

Ursodiol is not for treating gallstones that are calcified.

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

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

Before taking ursodiol, tell your doctor if you are also taking cholestyramine (Questran), colestipol (Colestid), or estrogens (birth control pills or hormone replacement).

Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb ursodiol.

To treat gallstones, you may have to take ursodiol for several months, and not all gallstones may completely dissolve. Many people who use this medicine will develop gallstones again within 5 years after treatment with ursodiol. Talk to your doctor about your specific risks for repeated gallstones.

To be sure this medication is helping your condition, your doctor may perform ultrasound examinations of your gallbladder on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

What should I discuss with my healthcare provider before taking ursodiol?

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have liver disease.

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 ursodiol 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 ursodiol?

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

Take each dose with a full glass of water. The medication can be taken with meals unless your doctor tells you otherwise.

It may take several months of taking ursodiol before your gallstones dissolve. Take this medication for the entire length of time prescribed by your doctor.

It is important to take ursodiol regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store ursodiol at room temperature away from heat, moisture, and light.

See also: Ursodiol 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, skip the missed dose and take the medicine at the next regularly scheduled time. 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.

An overdose of ursodiol is likely to cause diarrhea.

What should I avoid while taking ursodiol?

Ursodiol 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.

Other less serious side effects are more likely to occur, such as:

fever, chills, body aches, flu symptoms;
stomach pain, nausea, diarrhea, constipation;
dizziness, tired feeling;
back pain;
runny or stuffy nose, cold symptoms; or
headache.

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

Ursodiol Dosing Information

Usual Adult Dose for Biliary Cirrhosis:

Primary biliary cirrhosis:
13 to 15 mg/kg/day in 3 to 4 divided doses.

Usual Adult Dose for Gallbladder Disease:

Gallstone prevention: 300 mg orally twice a day.

Cholestasis of Pregnancy, Study (n=20): 1.5-2 g/day (20-25 mg/kg/day), given in 3 divided doses.

Gallbladder stone-dissolution:
8 to 10 mg/kg/day orally in 2 or 3 divided doses; maintenance therapy: 250 mg daily at bedtime for 6 months to 1 year; use beyond 24 months is not established.

Usual Pediatric Dose for Gallbladder Disease:

Biliary atresia:
10 to 15 mg/kg orally once a day.

Study (n=5): <1 month
TPN-induced cholestasis: 20 to 30 mg/kg/day orally in 3 divided doses.

>=1 years:
Cholestatic liver disease in cystic fibrosis, Study (n=30): 20 to 30 mg/kg/day orally in 3 divided doses.
Primary Sclerosing cholangitis, Study (n=10): range 9 to 37 mg/ kg (mean: 17 mg/kg) orally in 3 divided doses.

What other drugs will affect ursodiol?

Before taking ursodiol, tell your doctor if you are using any of the following drugs:

cholestyramine (Questran);
colestipol (Colestid);
estrogens (birth control pills or hormone replacement); or
antacids that contain aluminum, such as Rolaids, Mylanta, or Maalox).

If you are using any of these drugs, you may not be able to use ursodiol or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect ursodiol. 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.

Where can I get more information?

Your pharmacist has more information about ursodiol written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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ustekinumab Side Effects

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