(fa moe' ti deen)
P : Caution when used during pregnancy
L : Contraindicated in lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
|Indication(s) & Dosage||
Famotidine is indicated in:
Short-term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use Famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year.
Short-term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
Short-term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short-term treatment of patients with symptoms of GERD .
Famotidine is also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy .
Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas).
Benign gastric and duodenal ulceration
Gastro-oesophageal reflux disease
|Administration||May be taken with or without food.
|Special Precautions||Impaired renal function, liver cirrhosis; pregnancy. Possibility of malignancy should be considered prior to initiating treatment as drug may mask symptoms and delay diagnosis. No safety and efficacy data is available for children <1 yr.|
|Adverse Drug Reaction(s)||Headache, dizziness, constipation, diarrhoea, nausea, rash, GI discomfort, fatigue, gynaecomastia, impotence.|
|Drug Interactions||Reduced absorption of famotidine with antacids hence admin should be separated by 2 hr. Reduced absorption of ketoconazole and itraconazole. Avoid ethanol (may cause gastric mucosal irritation).|
|Pregnancy Category (FDA) and use in Specific Population||
Pregnancy Category B
Reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively, and in both species at I.V. doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to Famotidine. While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (250 times the usual human dose) or higher. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Studies performed in lactating rats have shown that famotidine is secreted into breast milk. Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of at least 600 times the usual human dose. Famotidine is detectable in human milk. Because of the potential for serious adverse reactions in nursing infants from Famotidine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Patients <1 year of age
Use of Famotidine in pediatric patients <1 year of age is supported by evidence from adequate and well-controlled studies of Famotidine in adults, and by the following studies in pediatric patients <1 year of age.
Two pharmacokinetic studies in pediatric patients <1 year of age (N=48) demonstrated that clearance of famotidine in patients >3 months to 1 year of age is similar to that seen in older pediatric patients (1-15 years of age) and adults. In contrast, pediatric patients 0-3 months of age had famotidine clearance values that were 2- to 4-fold less than those in older pediatric patients and adults. These studies also show that the mean bioavailability in pediatric patients <1 year of age after oral dosing is similar to older pediatric patients and adults. Pharmacodynamic data in pediatric patients 0-3 months of age suggest that the duration of acid suppression is longer compared with older pediatric patients, consistent with the longer famotidine half-life in pediatric patients 0-3 months of age.
In a double-blind, randomized, treatment-withdrawal study, 35 pediatric patients <1 year of age who were diagnosed as having gastroesophageal reflux disease were treated for up to 4 weeks with famotidine oral suspension (0.5 mg/kg/dose or 1 mg/kg/dose). Although an intravenous famotidine formulation was available, no patients were treated with intravenous famotidine in this study. Also, caregivers were instructed to provide conservative treatment including thickened feedings. Enrolled patients were diagnosed primarily by history of vomiting (spitting up) and irritability (fussiness). The famotidine dosing regimen was once daily for patients <3 months of age and twice daily for patients â‰¥3 months of age. After 4 weeks of treatment, patients were randomly withdrawn from the treatment and followed an additional 4 weeks for adverse events and symptomatology. Patients were evaluated for vomiting (spitting up), irritability (fussiness) and global assessments of improvement. The study patients ranged in age at entry from 1.3 to 10.5 months (mean 5.6 Â± 2.9 months), 57% were female, 91% were white and 6% were black. Most patients (27/35) continued into the treatment-withdrawal phase of the study. Two patients discontinued famotidine due to adverse events. Most patients improved during the initial treatment phase of the study. Results of the treatment-withdrawal phase were difficult to interpret because of small numbers of patients. Of the 35 patients enrolled in the study, agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued; agitation was not observed in patients on placebo.
These studies suggest that a starting dose of 0.5 mg/kg/dose of famotidine oral suspension may be of benefit for the treatment of GERD for up to 4 weeks once daily in patients <3 months of age and twice daily in patients 3 months to <1 year of age; the safety and benefit of famotidine treatment beyond 4 weeks have not been established. Famotidine should be considered for the treatment of GERD only if conservative measures (e.g., thickened feedings) are used concurrently and if the potential benefit outweighs the risk.
Pediatric Patients 1-16 years of age
Use of Famotidine in pediatric patients 1-16 years of age is supported by evidence from adequate and well-controlled studies of Famotidine in adults, and by the following studies in pediatric patients: In published studies in small numbers of pediatric patients 1-15 years of age, clearance of famotidine was similar to that seen in adults. In pediatric patients 11-15 years of age, oral doses of 0.5 mg/kg were associated with a mean area under the curve (AUC) similar to that seen in adults treated orally with 40 mg. Similarly, in pediatric patients 1-15 years of age, intravenous doses of 0.5 mg/kg were associated with a mean AUC similar to that seen in adults treated intravenously with 40 mg. Limited published studies also suggest that the relationship between serum concentration and acid suppression is similar in pediatric patients 1-15 years of age as compared with adults. These studies suggest a starting dose for pediatric patients 1-16 years of age as follows:
Peptic ulcer - 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations - 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.
Of the 4,966 subjects in clinical studies who were treated with famotidine, 488 subjects (9.8%) were 65 and older, and 88 subjects (1.7%) were greater than 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, greater sensitivity of some older individuals cannot be ruled out.
No dosage adjustment is required based on age. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Dosage adjustment in the case of moderate or severe renal impairment is necessary.
|Storage||Intravenous: Refrigerate at 2-8Â°C. Do not freeze. Oral: Store below 25Â°C.|
|Pharmacology||Famotidine competitively blocks histamine H2-receptors thus reducing basal, nocturnal and stimulated gastric acid secretion. Pepsin secretion is reduced resulting in decreased peptic activity. It effectively heals duodenal and gastric ulcers and prevents recurrence.
Absorption: Readily but incompletely absorbed from the GI tract; peak plasma concentrations after 1-3 hr (oral).
Distribution: Enters the breast milk. Protein-binding: 15-20%.
Metabolism: Hepatic (small proportion); converted to famotidine S-oxide.
Excretion: Urine (as unchanged) within 24 hr; 2.5-3.5 hr (elimination half-life).
|ATC Classification||A02BA03 - famotidine; Belongs to the class of H2-receptor antagonists. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|FAMODIN||The Acme Laboratories Ltd.||Famotidine USP 20mg & 40mg||Tablet||100's each: 150.00 & 300.00 MRP|
|FAMOTACK 20||Square Pharmaceuticals Ltd.||Famotidine 20mg||Tablet||10x10's: 200.00 MRP|
|FAMOTACK 40||Square Pharmaceuticals Ltd.||Famotidine 40mg||Tablet||5x10's: 201.00 MRP|
|NACID||Sonear Laboratories Ltd.||Famotidine USP 20mg||Tablet||100's: 205.00 MRP|
|NOVATAC||ACI Ltd.||Famotidine USP 40mg||Tablet||100's: 412.00 MRP|
|PEPTID||Opsonin Pharma Limited||Famotidine USP 20mg||Tablet||100's: 190.00 MRP|
|SERVIPEP||Sandoz/Novartis||Famotidine USP 20mg & 40mg||Tablet||20mgx 50's: MRP 200.00; 40mg x 50's: MRP 300.00|
|YAMADIN 20||Beximco Pharmaceuticals Ltd||Famotidine USP 20mg||Film Coated Tablet||200's: 380.00 MRP|
|YAMADIN 40||Beximco Pharmaceuticals Ltd||Famotidine USP 40mg||Film Coated Tablet||100's: 382.00 MRP|
|ZACTROL||Peoples Pharma Ltd.||Famotidine USP 20mg & 40mg||Tablet||100's each: 115.00 & 230.00 MRP|
Why is Famotidine prescribed?
Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.
How should Famotidine be used?
Prescription famotidine may come as a tablet and a suspension (liquid) to take by mouth. It is usually taken once daily at bedtime or two to four times a day. Over-the-counter famotidine comes as a tablet, a chewable tablet, and a capsule to take by mouth. It is usually taken once or twice a day. To prevent symptoms, it is taken 15 to 60 minutes before eating foods or drinking drinks that may cause heartburn. Follow the directions on your prescription or the package label carefully, and ask your doctor to explain any part you do not understand. Take famotidine exactly as directed. Do not take more or less of it or take it more often or for a longer time than prescribed by your doctor.
Shake the liquid well for 5 to 10 seconds before each use to mix the medicine evenly.
Swallow the tablets/capsules with a full glass of water.
Thoroughly chew the chewable tablets before swallowing them. Swallow the chewed tablet with a full glass of water.
Do not take more than two tablets, capsules, or chewable tablets of over-the-counter famotidine in 24 hours and do not take over-the-counter famotidine for longer than 2 weeks unless your doctor tells you that you should. If symptoms of heartburn, acid indigestion, or sour stomach last longer than 2 weeks, stop taking over-the-counter famotidine and call your doctor.
Other uses for FamotidineFamotidine may be prescribed for other uses; ask your doctor for more information.
What special precautions should I follow?Before taking famotidine,
- tell your doctor if you are allergic to famotidine, cimetidine, nizatidine, ranitidine, or any other medications.
- tell your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any other medications for heartburn. Do not take over-the-counter famotidine with any other prescription or nonprescription medications for heartburn unless a doctor tells you that you should.
- tell your doctor if you have phenylketonuria (PKU, an inborn disease in which mental retardation develops if a specific diet is not followed), and if you have or have ever had trouble swallowing or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking famotidine, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?If you forget a dose of prescription famotidine, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Over-the-counter famotidine is usually taken as needed. If your doctor has told you to take over-the-counter famotidine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can Famotidine cause?
Famotidine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
fussiness (in babies who take famotidine)
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them call your doctor immediately:
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
Famotidine may cause other side effects. Call your doctor if you have any unusual problems while taking Famotidine.
What storage conditions are needed for Famotidine?
Ref: MedlinePlus, U.S. Natl. Library of Medicine
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