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 multiple dose vials of 4 ml and 20 ml also contain benzyl alcohol 0. The recommended dose of famotidine is one 40 mg tablet daily taken at night. It has a role as an antiulcer drug, a h2receptor antagonist and a p450 inhibitor. Each ml of the single dose solution contains 10 mg of famotidine and the following inactive ingredients.
Capitals indicate lifethreatening, underlines indicate most frequent. Famotidine injection is supplied as a sterile concentrated solution for intravenous injection. This draft guidance, once finalized, will represent the food and drug administration s fdas current thinking on this topic. 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. Phase solubility profile indicated that the solubility of famotidine was significantly. Famotidine is a prescription drug and over the counter drug used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers. Check with your doctor immediately if any of the following side effects occur while taking famotidine. The apparent volume of distribution of the drug is reported to be 1. It also treats conditions in which the stomach produces too much acid, such as. Famotidine is a member of 1,3thiazoles, a sulfonamide and a member of guanidines. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Guidance on famotidine s this guidance represent the food and drug administration s fdas current thinking on this topic.
Comparative efficacy of cimetidine, famotidine, ranitidine. While oral formulations of famotidine are more commonly used, the intravenous solution of. Drug name active ingredients strength dosage formroute marketing status te code rld rs. Famotidine drugs and lactation database lactmed ncbi. These medications may interact and cause very harmful effects. Famotidine injection, usp famotidine 20 mg2 ml 10 mgml40. Studies with famotidine in man, in animal models and in vitro have shown no significant interference with the disposition of drug. Number of ph measurements by drug groups cimetidine famotidine ranitidine mylanta total ph 4. Famotidine inhibits basal and stimulated gastric acid secretion in a dosedependent manner after oral administration of 5 to 40.
Famotidine is a potent histamine h2receptor antagonist widely used in the treatment and prevention of peptic ulcer disease. 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. Along with its needed effects, famotidine may cause some unwanted effects. Famotidine is a histamine2 blocker that works by decreasing the amount of acid the stomach produces. Drug profiles table of contents dated 9172015 except. Famotidine is used to treat and prevent ulcers in the stomach and intestines. Laspartic acid 4 mg, mannitol 20 mg and water for injection q. 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. To retrieve all information, including data published postapproval, use the all studies containing famotidine query. Guidance on famotidine food and drug administration. For more interactions complete data for famotidine 10 total, please visit. It is gener ally well tolerated in patients with cardio vascular, renal, or hepatic dysfunction or with zollingerellison syndrome who. Formulation and characterization of effervescent floating.
Gerd is a condition where the acid in the stomach washes back up into the esophagus. Each tablet for oral administration contains either 20 mg or 40 mg of famotidine. Although not all of these side effects may occur, if they do occur they may need medical attention. Synonyms of this drug are famodil, gastridin, pepcid, and others. Famotidine api dmfs us drug master file dmf details. The tolerability and safety profile of famotidine sciencedirect. 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. Includes dosages for gastroesophageal reflux disease, dyspepsia, gastric ulcer and more. After intravenous administration the plasma famotidine concentrationtime profile exhibits a biexponential decay, with a distribution halflife of about 0. Famotidine should not be administered to patients with a history of hypersensitivity to other h 2receptor antagonists.
Detailed famotidine dosage information for adults and children. Clinical studies the majority of clinical study experience involved oral administration of famotidine tablets, and is provided herein for reference. 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 helps reduce the risk of ulcers in the stomach or intestines that can be caused by longterm. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. June 1991 efficacy of h, blockers in preventing stress ulcers 15 17 table i. Famotidine can reduce the absorption of other drugs, due to its effect on.
Fixed combination of famotidine, calcium carbonate, and magnesium hydroxide pepcid complete. Famotidine belongs to a class of drugs known as h2 blockers. 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. Daviss drug guide for rehabilitation professionals ciccone cd. This promotes local delivery of these drugs to receptors in the parietal cell wall and increases bioavailibility.
Following oral or iv administration in rats, famotidine is widely distributed, appearing in highest concentrations in the kidney, liver, pancreas, and submandibular gland. Famotidine is a histamine type 2 receptor antagonist h2 blocker which is commonly used for treatment of acidpeptic disease and heartburn. 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. Famotidine tablets fda prescribing information, side. It is also used to treat certain conditions where there is too much acid in the stomach eg. Unused constituted oral suspension should be discarded after 30 days. If your pill doesnt have one, it could be a vitamin, supplement, or foreign drug. 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. No drug interactions of clinical importance have been identified. Total body clearance of the drug averages 381483 mlmin, and renal clearance of the drug averages 250450 mlmin 56. Pdf on aug 30, 2016, raphael sunday onuku and others published drug profile of famotidine find, read and cite all the research. This medication is also available without a prescription. Famotidine is used to treat stomach ulcers gastric and duodenal, erosive esophagitis heartburn or acid indigestion, and gastroesophageal reflux disease gerd.
Pepcid famotidine side effects, dosage, interactions. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Learn about side effects, drug interactions, dosages, warnings, and more. Mylan manufactures famotidine injection, usp famotidine in strengths of 20 mg2 ml 10 mgml40 mg4 ml 10 mgml200 mg20 ml 10 mgml. Stability profiles of drug products extended beyond. Pepcid, act famotidine dosing, indications, interactions.
Famotidine c8h15n7o2s3 cid 3325 structure, chemical names, physical. 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. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated. Clinical pharmacokinetics of famotidine springerlink. However, in elderly patients with decreased renal function, the clearance of the drug may be decreased see precautions, geriatric use. To view the entire topic, please sign in or purchase a subscription. It also treats conditions in which the stomach produces too much acid, such as zollingerellison syndrome. Famotidine has poor bioavailibility 50% due to low gastroretention time. Famotidine has been linked to rare instances of clinically apparent acute liver injury. It does not create or confer any rights for or on any person and does. Learn about side effects, warnings, dosage, and more. Relevant published information was not found as of the revision date. Famotidine reference guide for safe and effective use from the american society of. Famotidineibuprofen side effects, dosage, interactions.
Each tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following. Drug profiles table of contents dated 9172015 except where noted abciximab oxytocin acetylsalicylic acid, aspirin, asa phenylephrine nasal spray 0. Drugs az pill identifier supplements symptom checker diseases dictionary media. For this medicine, the following should be considered. Pepcid is the brand name for famotidine, a drug that works to reduce the amount of acid your stomach produces. It is used to prevent and treat heartburn and other symptoms caused by too. The remaining drug is excreted via metabolic routes 56. Use the scriptsave wellrx pill identifier to quickly and easily identify unknown medicines by imprint, shape, number, and color.
It comes as a generic drug and as the brandname drug pepcid. Famotidine can reduce the absorption of other drugs, due to its effect on reducing intragastric acidity. List of drug master files dmf of famotidine active pharmaceutical ingredient api submitted to the u. Average concentrations of famotidine in breastmilk were 53 and 55 mcgl at 3 and 6 hours after a dose, respectively. This information should not be interpreted without the help of a healthcare provider. 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 less soluble at higher ph, and when used in combination with antacids gastroretention time is increased. Famotidine oral route description and brand names mayo.
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