Epiphen may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Phenobarbital is reported as an ingredient of Epiphen in the following countries:
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Generic Name: yellow fever vaccine (Subcutaneous route)
YEL-oh FEE-ver VAX-een
In the U.S.
Available Dosage Forms:
Therapeutic Class: Vaccine
Yellow fever vaccine is used to prevent infection by the yellow fever virus. This vaccine works by causing your body to produce its own protection (antibodies) against the virus.
Vaccination against yellow fever is recommended for all persons 9 months of age and older who are traveling to or living in areas of Africa, South America, or other countries where there is yellow fever infection and for people who are traveling to countries that require yellow fever immunization (certificate of vaccination). It is also needed by other people who might come into contact with the yellow fever virus.
Pregnant women should be vaccinated only if they must travel to areas where there is an epidemic of yellow fever and they cannot be protected from mosquito bites.
The certificate of vaccination for yellow fever is valid for 10 years beginning 10 days after the first vaccination, or on the date of the second vaccination if within 10 years of the first injection.
Yellow fever vaccine may not protect all persons given the vaccine.
This vaccine is given only at authorized Yellow Fever Vaccination Centers. The location of these centers can be obtained from your state, province, and local health departments.
In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:
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.
Yellow fever vaccine is recommended for children 9 months of age or older if they are traveling to, or living in, areas where there is yellow fever infection, or if they are traveling to areas that require yellow fever immunization (certificate of vaccination). However, the vaccine is not recommended for infants younger than 9 months of age, because of an increased risk of encephalitis.
Use of this vaccine should be limited to elderly patients older than 65 years of age who are traveling to, or living in, areas where there is yellow fever infection.
| 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. |
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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Receiving this vaccine 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.
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.
The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you this vaccine. This vaccine is given as a shot under your skin.
A booster dose of the vaccine is recommended every 10 years for patients who are at continuous risk of exposure to the yellow fever virus, and is required by his or her doctor.
It is very important that you or your child return to your doctor at the right time for the second dose (as directed by your doctor). Be sure to tell your doctor about any side effects that occur after you receive this vaccine.
This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble breathing after you receive the vaccine.
Side effects from this vaccine could occur up to 30 days after you receive the shot. Be sure to tell your doctor about any serious side effects that occur during that time.
Yellow fever vaccine may cause a serious side effect called neurotropic disease or post-vaccinal encephalitis. Check with your doctor right away if you or your child have confusion, irritability, headache, seizures, stiff neck, or vomiting.
This vaccine may cause serious allergic reactions affecting multiple body organs (e.g., liver or kidney). Check with your doctor right away if you have the following symptoms: fever, dark urine, headache, rash, stomach pain, unusual tiredness, or yellow eyes or skin.
Since the vaccine may not protect everyone completely, it is very important that you use precautions to reduce your chance of mosquito bites. These include using insect repellents and mosquito nets, wearing protective clothing, and staying indoors during twilight and after dark.
The stopper of the vial contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start receiving this vaccine.
Tell your doctor if you are receiving a treatment or using a medicine that causes a weak immune system. This may include radiation therapy, steroid medicines, or cancer medicines.
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:
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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Yf-Vax side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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.
Liotondol may be available in the countries listed below.
Ketoprofen is reported as an ingredient of Liotondol in the following countries:
International Drug Name Search
Evaluating how well the hypothalamus and pituitary glands are working. It may also be used for other conditions as determined by your doctor.
Gonadorelin is a gonadotropin-releasing hormone. It works by causing the pituitary gland to release other hormones (luteinizing hormone and follicle-stimulating hormone) that control development in children and fertility in adults.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Gonadorelin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Gonadorelin. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Gonadorelin 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.
Use Gonadorelin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Gonadorelin.
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; lightheadedness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast pulse; flushing; hoarseness; shortness of breath; swelling, pain, and redness at the injection site.
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: Gonadorelin side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Gonadorelin is usually handled and stored by a health care provider. If you are using Gonadorelin at home, store Gonadorelin as directed by your pharmacist or health care provider. Keep Gonadorelin out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Gonadorelin. 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.
Vasranta may be available in the countries listed below.
Trimetazidine dihydrochloride (a derivative of Trimetazidine) is reported as an ingredient of Vasranta in the following countries:
International Drug Name Search
Ursodiol Tablets USP, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cirrhosis (PBC).
The recommended adult dosage for Ursodiol Tablets USP, 250 mg and 500 mg in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.
The Ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage.
To break the Ursodiol 500 mg scored 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 scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets.[see How Supplied/Storage and Handling (16.2)].
Known hypersensitivity or intolerance to Ursodiol or any of the components of the formulation.
Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The following table summarizes the adverse reactions observed in two placebo-controlled clinical trials.
| Note: Those adverse reactions occurring at the same or higher incidence in the placebo as in the UDCA group have been deleted from this table (this includes diarrhea and thrombocytopenia at 12 months, nausea/vomiting, fever and other toxicity). | ||||
| ADVERSE REACTIONS | VISIT AT 12 MONTHS | VISIT AT 24 MONTHS | ||
UDCA n (%) | Placebo n (%) | UDCA n (%) | Placebo n (%) | |
| Diarrhea | --- | --- | 1 (1.32) | --- |
| Elevated creatinine | --- | --- | 1 (1.32) | --- |
| Elevated blood glucose | 1 (1.18) | --- | 1 (1.32) | --- |
| Leukopenia | --- | --- | 2 (2.63) | --- |
| Peptic ulcer | --- | --- | 1 (1.32) | --- |
| Skin rash | --- | --- | 2 (2.63) | -- |
| Thrombocytopenia | --- | --- | 1 (1.32) | --- |
| UDCA = Ursodeoxycholic acid = Ursodiol | ||||
In a randomized, cross-over study in sixty PBC patients, seven patients (11.6%) reported nine adverse reactions: abdominal pain and asthenia (1 patient), nausea (3 patients), dyspepsia (2 patients) and anorexia and esophagitis (1 patient each). One patient on the twice a day regimen (total dose 1000 mg) withdrew due to nausea. All of these nine adverse reactions except esophagitis were observed with the twice a day regimen at a total daily dose of 1000 mg or greater. However, an adverse reaction may occur at any dose.
The following adverse reactions, presented by system organ class in alphabetical order, have been identified during postapproval use of Ursodiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorder: alopecia, pruritus, rash
Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of Ursodiol Tablets, 250 mg and 500 mg by reducing its absorption.
Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with Ursodiol Tablets, 250 mg and 500 mg 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 Tablets, 250 mg and 500 mg.
Pregnancy Category B. Reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to Ursodiol. There are no adequate or 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.
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 Tablets, 250 mg and 500 mg are administered to a nursing mother.
The safety and effectiveness of Ursodiol Tablets, 250 mg and 500 mg in pediatric patients have not been established.
There have been no reports of accidental or intentional overdosage with Ursodiol. Single oral doses of Ursodiol at 10 g/kg in mice and dogs, and 5 g/kg in rats were not lethal. A single oral dose of Ursodiol at 1.5 g/kg was lethal in hamsters. Symptoms of acute toxicity were salivation and vomiting in dogs, and ataxia, dyspnea, ptosis, agonal convulsions and coma in hamsters.
Ursodiol Tablets USP, 250 mg are available as film-coated tablets for oral administration. Ursodiol Tablet USP, 500 mg are available as scored film-coated tablets for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is 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 consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water. The chemical name of Ursodiol is 3α,7ß-dihydroxy-5ß-cholan-24-oic acid (C24H40O4). Ursodiol has a molecular weight of 392.56. Its structure is shown below :
Inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, ethylcellulose, dibutyl sebacate, carnauba wax, hydroxypropyl methylcellulose, PEG 3350, PEG 8000, cetyl alcohol and sodium lauryl sulfate.
Ursodiol, a naturally occurring hydrophilic bile acid, derived from cholesterol, is present as a minor fraction of the total human bile acid pool. Oral administration of Ursodiol increases this fraction in a dose related manner, to become the major biliary acid, replacing/displacing toxic concentrations of endogenous hydrophobic bile acids that tend to accumulate in cholestatic liver disease. In addition to the replacement and displacement of toxic bile acids, other mechanisms of action include cytoprotection of the injured bile duct epithelial cells (cholangiocytes) against toxic effects of bile acids, inhibition of apotosis of hepatocytes, immunomodulatory effects, and stimulation of bile secretion by hepatocytes and cholangiocytes.
Lithocholic acid, when administered chronically to animals, causes cholestatic liver injury that may lead to death from liver failure in certain species unable to form sulfate conjugates.Ursodiol is 7-dehydroxylated more slowly than chenodiol. For equimolar doses of Ursodiol and chenodiol, steady state levels of lithocholic acid in biliary bile acids are lower during Ursodiol administration than with chenodiol administration. Humans and chimpanzees can sulfate lithocholic acid. Although liver injury has not been associated with Ursodiol therapy, a reduced capacity to sulfate may exist in some individuals.
Ursodiol (UDCA) is normally present as a minor fraction of the total bile acids in humans (about 5%). Following oral administration, the majority of Ursodiol is absorbed by passive diffusion and its absorption is incomplete. Once absorbed, Ursodiol undergoes hepatic extraction to the extent of about 50% in the absence of liver disease. As the severity of liver disease increases, the extent of extraction decreases. In the liver, Ursodiol is conjugated with glycine or taurine, then secreted into bile. These conjugates of Ursodiol are absorbed in the small intestine by passive and active mechanisms. The conjugates can also be deconjugated in the ileum by intestinal enzymes, leading to the formation of free Ursodiol that can be reabsorbed and reconjugated in the liver. Nonabsorbed Ursodiol passes into the colon where it is mostly 7-dehydroxylated to lithocholic acid. Some Ursodiol is epimerized to chenodiol (CDCA) via a 7-oxo intermediate. Chenodiol also undergoes 7-dehydroxylation to form lithocholic acid. These metabolites are poorly soluble and excreted in the feces. A small portion of lithocholic acid is reabsorbed, conjugated in the liver with glycine, or taurine and sulfated at the 3 position. The resulting sulfated lithocholic acid conjugates are excreted in bile and then lost in feces. In healthy subjects, at least 70% of Ursodiol (unconjugated) is bound to plasma protein. No information is available on the binding of conjugated Ursodiol to plasma protein in healthy subjects or PBC patients. Its volume of distribution has not been determined, but is expected to be small since the drug is mostly distributed in the bile and small intestine. Ursodiol is excreted primarily in the feces. With treatment, urinary excretion increases, but remains less than 1% except in severe cholestatic liver disease. During chronic administration of Ursodiol, it becomes a major biliary and plasma bile acid. At a chronic dose of 13 to 15 mg/kg/day, Ursodiol constitutes 30-50% of biliary and plasma bile acids.
In two 24-month oral carcinogenicity studies in mice, Ursodiol at doses up to 1,000 mg/kg/day (3,000 mg/m2/day) was not tumorigenic. Based on body surface area, for a 50 kg person of average height (1.46 m2 body surface area), this dose represents 5.4 times the recommended maximum clinical dose of 15 mg/kg/day (555 mg/m2/day).
In a two-year oral carcinogenicity study in Fischer 344 rats, Ursodiol at doses up to 300 mg/kg/day (1,800 mg/m2/day, 3.2 times the recommended maximum human dose based on body surface area) was not tumorigenic.
In a life-span (126-138 weeks) oral carcinogenicity study, Sprague-Dawley rats were treated with doses of 33 to 300 mg/kg/day, 0.4 to 3.2 times the recommended maximum human dose based on body surface area. Ursodiol produced a significantly (p<0.5, Fisher's exact test) increased incidence of pheochromocytomas of the adrenal medulla in females of the highest dose group.
In 103-week oral carcinogenicity studies of lithocholic acid, a metabolite of Ursodiol, doses up to 250 mg/kg/day in mice and 500 mg/kg/day in rats did not produce any tumors. In a 78-week rat study, intrarectal instillation of lithocholic acid (1 mg/kg/day) for 13 months did not produce colorectal tumors. A tumor-promoting effect was observed when it was administered after a single intrarectal dose of a known carcinogen N-methyl-N'-nitro-N-nitrosoguanidine. On the other hand, in a 32-week rat study, Ursodiol at a daily dose of 240 mg/kg (1,440 mg/m2, 2.6 times the maximum recommended human dose based on body surface area) suppressed the colonic carcinogenic effect of another known carcinogen azoxymethane.
Ursodiol was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y, TK+/-) forward mutation test, the human lymphocyte sister chromatid exchange test, the mouse spermatogonia chromosome aberration test, the Chinese hamster micronucleus test and the Chinese hamster bone marrow cell chromosome aberration test.
Ursodiol at oral doses of up to 2,700 mg/kg/day (16,200 mg/m2/day, 29 times the recommended maximum human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.
A U.S., multicenter, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of ursodeoxycholic acid at a dose of 13 to 15 mg/kg/day, administered in 3 or 4 divided doses in 180 patients with PBC (78% received four times a day dosage).
Upon completion of the double-blind portion, all patients entered an open-label active treatment extension phase. Treatment failure, the main efficacy end point measured during this study, was defined as death, need for liver transplantation, histologic progression by two stages or to cirrhosis, development of varices, ascites or encephalopathy, marked worsening of fatigue or pruritus, inability to tolerate the drug, doubling of serum bilirubin and voluntary withdrawal.
After two years of double-blind treatment, the incidence of treatment failure was significantly (p<0.01) reduced in the Ursodiol tablets 250 mg group (20 of 86 (23%)) as compared to the placebo group (40 of 86 (47%)). Time to treatment failure, which excluded doubling of serum bilirubin and voluntary withdrawal, was also significantly (p<0.001) delayed in the Ursodiol tablets 250 mg treated group (n=86, 803.8±24.9 d vs. 641.1±24.4 d for the placebo group (n=86) on average) regardless of either histologic stage or baseline bilirubin levels (>1.8 or <1.8 mg/dl).
Using a definition of treatment failure, which excluded doubling of serum bilirubin and voluntary withdrawal, time to treatment failure was significantly delayed in the Ursodiol tablets 250 mg group. In comparison with placebo, treatment with Ursodiol tablets 250 mg resulted in a significant improvement in the following serum hepatic biochemistries when compared to baseline: total bilirubin, SGOT, alkaline phosphatase and IgM.
A second study conducted in Canada randomized 222 PBC patients to Ursodiol, 14 mg/kg/day or placebo, administered as a once daily dose in a double-blind manner during a two-year period. At two years, a statistically significant (p<0.001) difference between the two treatments (n=106 for the Ursodiol tablets 250 mg group and n=106 for the placebo group), in favor of Ursodiol, was demonstrated in the following: reduction in the proportion of patients exhibiting a more than 50% increase in serum bilirubin; median percent decrease in bilirubin (-17.12% for the Ursodiol tablets 250 mg group vs. +20.00% for the placebo group), transaminases (-40.54% for the Ursodiol tablets 250 mg group vs. +5.71% for the placebo group) and alkaline phosphatase (-47.61% for the Ursodiol tablets 250 mg group vs. -5.69% for the placebo group); incidence of treatment failure; and time to treatment failure. The definition of total serum bilirubin level greater than or equal to 1.5 mg/dl or increasing to a level equal to or greater than two times the baseline level; and the development of ascites or encephalopathy. Evaluation of patients at 4 years or longer was inadequate due to the high drop out rate (n=10 withdrew from the Ursodiol tablets 250 mg group vs. n=15 from the placebo group) and small number of patients. Therefore, death, need for liver transplantation, histological progression by two stages or to cirrhosis, development of varices, ascites or encephalopathy, marked worsening of fatigue or pruritus, inability to tolerate the drug, doubling of serum bilirubin and voluntary withdrawal were not assessed.
A randomized, two-period crossover study in fifty PBC patients compared efficacy of Ursodiol tablets 250 mg in twice a day versus four times a day divided dosing schedules in 50 patients for 6 months in each crossover period. Mean percent changes from baseline in liver test results and Mayo risk score (n=46) and serum enrichment with UDCA (n=34) were not statistically significant with any dosage at any time interval. This study demonstrated that UDCA (13 to 15 mg/kg/day) given twice a day is equally effective to UDCA given four times a day. In addition, Ursodiol tablets 250 mg was given as a single versus three times a day dosing schedules in 10 patients. Due to the small number of patients in this arm of the study, it was not possible to conduct statistical comparisons between these regimens.
Each Ursodiol Tablet USP, 250 mg is white to off-white, oval film-coated tablet debossed with “G72” on one side and “250” on the other side and contains 250 mg Ursodiol USP.
Ursodiol Tablets USP, 250 mg are available in bottles of 30 tablets (NDC 68462-473-30), 100 tablets (NDC 68462-473-01) and 500 tablets (NDC 68462-473-05).
Each Ursodiol Tablet USP, 500 mg is white to off-white, oval shaped, film-coated tablet debossed with “U 11” on one side and break line on the other side and contains 500 mg Ursodiol USP.
Ursodiol Tablets USP, 500 mg are available in bottles of 30 tablets (NDC 68462-474-30), 100 tablets (NDC 68462-474-01) and 500 tablets (NDC 68462-474-05).
Store at 20oC to 25oC (68oF to 77oF) [see USP Controlled Room Temperature]. Dispense in a tight container
Half-tablets (scored 500 mg tablets broken in half) maintain acceptable quality for up to 28 days when stored in the current packaging (bottles) at 20ºC to 25ºC (68ºF to 77ºF). Due to the bitter taste, the halved segments should be stored separately from the whole tablets [see Dosage and Administration (2.2)]
Patients with the following conditions should be instructed to receive appropriate management measures: variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant [see Warnings and Precautions (5)].
Patients should be informed that adsorption of Ursodiol Tablets USP, 250 mg and 500 mg may be reduced if they are taking bile acid sequestering agents, such as cholestyramine and colestipol, aluminum-based antacids, or drugs known to alter the metabolism of cholesterol. [see Drug Interactions (7)].
Manufactured by:
Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India
Manufactured for:
Glenmark Generics Inc., USA
Mahwah, NJ 07430
Questions? 1 (888)721-7115
www.glenmarkgenerics.com
June 2011
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| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA090801 | 07/12/2011 | |
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| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA090801 | 07/12/2011 | |
| Labeler - Glenmark Generics Inc.,USA (835917282) |
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| Name | Address | ID/FEI | Operations |
| Glenmark Generics Ltd | 677318665 | ANALYSIS, ANALYSIS, MANUFACTURE, MANUFACTURE | |
Amoxicilline Ratio may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilline Ratio in the following countries:
International Drug Name Search
