Famotidine drug profile pdf

Synonyms of this drug are famodil, gastridin, pepcid, and others. Famotidine should not be administered to patients with a history of hypersensitivity to other h 2receptor antagonists. Relevant published information was not found as of the revision date. Like ranitidine, famotidine belongs to the group of secondgeneration h 2receptorblocking drugs, and also like two other drugs described above, it is used for treating stomach and duodenum ulcers and other conditions accompanied by elevated acidity of the gastrointestinal tract. Laspartic acid 4 mg, mannitol 20 mg and water for injection q. Drug name active ingredients strength dosage formroute marketing status te code rld rs. However, in elderly patients with decreased renal function, the clearance of the drug may be decreased see precautions, geriatric use. Famotidine can reduce the absorption of other drugs, due to its effect on. After intravenous administration the plasma famotidine concentrationtime profile exhibits a biexponential decay, with a distribution halflife of about 0. Famotidine injection, usp famotidine 20 mg2 ml 10 mgml40. Mylan manufactures famotidine injection, usp famotidine in strengths of 20 mg2 ml 10 mgml40 mg4 ml 10 mgml200 mg20 ml 10 mgml.

Formulation and characterization of effervescent floating. Famotidine is a member of 1,3thiazoles, a sulfonamide and a member of guanidines. It is used to prevent and treat heartburn and other symptoms caused by too. Famotidine helps reduce the risk of ulcers in the stomach or intestines that can be caused by longterm. If your pill doesnt have one, it could be a vitamin, supplement, or foreign drug. If your institution subscribes to this resource, and you dont have a myaccess profile, please contact your librarys reference desk for information on how to gain access to this resource from offcampus. Famotidine tablets fda prescribing information, side. Number of ph measurements by drug groups cimetidine famotidine ranitidine mylanta total ph 4. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Drug profiles table of contents dated 9172015 except.

As a result, famotidine should be used in a lower dosage and at longer dosing intervals when used in patients with sever renal insufficiency. The remaining drug is excreted via metabolic routes 56. It has a role as an antiulcer drug, a h2receptor antagonist and a p450 inhibitor. Famotidine can reduce the absorption of other drugs, due to its effect on reducing intragastric acidity. Following oral or iv administration in rats, famotidine is widely distributed, appearing in highest concentrations in the kidney, liver, pancreas, and submandibular gland. Famotidine inhibits basal and stimulated gastric acid secretion in a dosedependent manner after oral administration of 5 to 40. List of drug master files dmf of famotidine active pharmaceutical ingredient api submitted to the u. Learn about side effects, drug interactions, dosages, warnings, and more. Guidance on famotidine food and drug administration.

Capitals indicate lifethreatening, underlines indicate most frequent. For this medicine, the following should be considered. This promotes local delivery of these drugs to receptors in the parietal cell wall and increases bioavailibility. Drug profiles table of contents dated 9172015 except where noted abciximab oxytocin acetylsalicylic acid, aspirin, asa phenylephrine nasal spray 0. Famotidine c8h15n7o2s3 cid 3325 structure, chemical names, physical. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. Famotidine has poor bioavailibility 50% due to low gastroretention time. Daviss drug guide for rehabilitation professionals ciccone cd.

Comparative efficacy of cimetidine, famotidine, ranitidine. Drugs az pill identifier supplements symptom checker diseases dictionary media. The recommended dose of famotidine is one 40 mg tablet daily taken at night. Hussain3 1division of product quality research, center for drug evaluation and research, food and drug administration, hfd941, white oak, life sciences building 64, 10903 new hampshire avenue. It comes as a generic drug and as the brandname drug pepcid. These medications may interact and cause very harmful effects. It also treats conditions in which the stomach produces too much acid, such as zollingerellison syndrome. Famotidine has been used by veterinarians as a preferred h 2 blocker, but there is a lack of evidence to demonstrate superiority over other drugs in this class. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Clinical studies the majority of clinical study experience involved oral administration of famotidine tablets, and is provided herein for reference. Some studies have demonstrated efficacy at 1 mgkg in dogs, while other studies have not demonstrated differences between famotidine and a placebo in dogs for increasing stomach ph. Famotidine is a histamine2 blocker that works by decreasing the amount of acid the stomach produces. To view the entire topic, please sign in or purchase a subscription. The apparent volume of distribution of the drug is reported to be 1.

Famotidine is a potent histamine h2receptor antagonist widely used in the treatment and prevention of peptic ulcer disease. Famotidineibuprofen side effects, dosage, interactions. It also treats conditions in which the stomach produces too much acid, such as. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Famotidine oral route description and brand names mayo. Each ml of the single dose solution contains 10 mg of famotidine and the following inactive ingredients. Search results for famotidine pepcid ulcers and gastroesophageal reflux disease gerd hide all summaries there are nondrug treatments, with no safety concerns, and less expensive drugs that may be effective for gerd. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext.

Detailed famotidine dosage information for adults and children. Learn about side effects, warnings, dosage, and more. Famotidine api dmfs us drug master file dmf details. Famotidine is a histamine type 2 receptor antagonist h2 blocker which is commonly used for treatment of acidpeptic disease and heartburn. Famotidine is less soluble at higher ph, and when used in combination with antacids gastroretention time is increased. This medication is also available without a prescription. Clinical pharmacokinetics of famotidine springerlink. Studies with famotidine in man, in animal models and in vitro have shown no significant interference with the disposition of drug. It is also used to treat certain conditions where there is too much acid in the stomach eg. Pharmacodynamics of famotidine in humans the american journal. Formulation and characterization of effervescent floating matrix tablets of famotidine hydrochloride ajay kumar 1, ashni verma1,geetika sharma, rupinder saini, shivani sharma1, sukhdev singh1, upendra k jain1, mandeep sharma pharmaceutics division, chandigarh college of pharmacy, landran, mohali 140307. For more interactions complete data for famotidine 10 total, please visit.

Gerd is a condition where the acid in the stomach washes back up into the esophagus. Pepcid is the brand name for famotidine, a drug that works to reduce the amount of acid your stomach produces. Phase solubility profile indicated that the solubility of famotidine was significantly. Famotidine belongs to a class of drugs known as h2 blockers. Use the scriptsave wellrx pill identifier to quickly and easily identify unknown medicines by imprint, shape, number, and color. Guidance on famotidine s this guidance represent the food and drug administration s fdas current thinking on this topic. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated. Seven women were given oral famotidine 40 mg daily in 2 or 4 divided doses for 3 days at 12 to 16 weeks postpartum. Famotidine reference guide for safe and effective use from the american society of. While oral formulations of famotidine are more commonly used, the intravenous solution of.

Pepcid famotidine side effects, dosage, interactions. Includes dosages for gastroesophageal reflux disease, dyspepsia, gastric ulcer and more. Pepcid, act famotidine dosing, indications, interactions. Each tablet for oral administration contains either 20 mg or 40 mg of famotidine. Average concentrations of famotidine in breastmilk were 53 and 55 mcgl at 3 and 6 hours after a dose, respectively. It does not create or confer any rights for or on any person and does. Famotidine has been linked to rare instances of clinically apparent acute liver injury. No drug interactions of clinical importance have been identified. Famotidine is used to treat stomach ulcers gastric and duodenal, erosive esophagitis heartburn or acid indigestion, and gastroesophageal reflux disease gerd. The multiple dose vials of 4 ml and 20 ml also contain benzyl alcohol 0. Although not all of these side effects may occur, if they do occur they may need medical attention. Unused constituted oral suspension should be discarded after 30 days. It is gener ally well tolerated in patients with cardio vascular, renal, or hepatic dysfunction or with zollingerellison syndrome who.

Each tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following. Stability profiles of drug products extended beyond. This draft guidance, once finalized, will represent the food and drug administration s fdas current thinking on this topic. Famotidine injection is supplied as a sterile concentrated solution for intravenous injection. This information should not be interpreted without the help of a healthcare provider. June 1991 efficacy of h, blockers in preventing stress ulcers 15 17 table i. Famotidine is used to treat and prevent ulcers in the stomach and intestines. Along with its needed effects, famotidine may cause some unwanted effects. Total body clearance of the drug averages 381483 mlmin, and renal clearance of the drug averages 250450 mlmin 56. To retrieve all information, including data published postapproval, use the all studies containing famotidine query.

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