Famotidine


Generic Medicine Info
Indications and Dosage
Intravenous
Benign gastric ulcer, Duodenal ulcer
Adult: In hospitalised patients with intractable ulcers or when oral therapy is not feasible: Recommended dose: 20 mg 12 hourly via inj over at least 2 minutes or via infusion over 15-30 minutes.

Intravenous
Hypersecretory conditions
Adult: For cases such as Zollinger-Ellison syndrome and multiple endocrine adenomas in hospitalised patients or when oral therapy is not feasible: Recommended dose: 20 mg 12 hourly via inj over at least 2 minutes or via infusion over 15-30 minutes.

Intravenous
Gastro-oesophageal reflux disease
Child: 1-16 years Recommended dose: Initially, 0.25 mg/kg 12 hourly via inj over at least 2 minutes or via infusion over 15 minutes, may increase up to 40 mg daily.

Oral
Duodenal ulcer
Adult: Recommended dose: 40 mg once daily at bedtime for 4-8 weeks. Alternatively, 20 mg bid. Therapy duration may be shortened if the ulcer has healed based on endoscopy. Maintenance (prevention of ulcer recurrence): 20 mg once daily at bedtime.
Child: As oral susp: 1-16 years Recommended dose: Initially, 0.5 mg/kg daily as a single dose at bedtime or in 2 divided doses, may increase up to 40 mg daily.

Oral
Gastro-oesophageal reflux disease
Adult: For the short-term symptomatic relief of GERD: Recommended dose: 20 mg bid for 6 weeks. For patients with oesophageal erosion or ulceration associated with GERD: 20 mg or 40 mg bid for 6-12 weeks. Maintenance (prevention of recurrence of oesophageal erosion or ulceration): 20 mg bid.
Child: As oral susp: Recommended dose: <3 months 0.5 mg/kg once daily; 3 months-<1 year 0.5 mg/kg bid; 1-16 years 0.5 mg/kg bid up to Max of 40 mg bid.

Oral
Hypersecretory conditions
Adult: For the treatment of pathological cases such as Zollinger-Ellison syndrome and multiple endocrine adenomas: Recommended dose: Initially, 20 mg 6 hourly, may be adjusted up to 800 mg daily according to patient's response and needs. Continue therapy for as long as clinically indicated.

Oral
Benign gastric ulcer
Adult: Recommended dose: 40 mg once daily at bedtime for 4-8 weeks. Therapy duration may be shortened if the ulcer has healed based on endoscopy.
Child: As oral susp: 1-16 years Recommended dose: Initially, 0.5 mg/kg daily as a single dose at bedtime or in 2 divided doses, may increase up to 40 mg daily.
Renal Impairment
CrCl (mL/min) Dosage
<10 to <50 Reduce dose to half of the recommended dose or prolong the dosing interval to 36-48 hours based on clinical response.
Administration
May be taken with or without food.
Reconstitution
Powder for oral susp: Reconstitute bottle containing 400 mg famotidine with 46 mL water to provide a suspension containing 40 mg/5 mL. Shake vigorously (for 5-10 seconds) until suspended. IV inj: Dilute 2 mL (20 mg) with 0.9% NaCl inj or other compatible IV solution to a total volume of either 5 mL or 10 mL. IV infusion: Dilute 2 mL (20 mg) with 100 mL of 5% dextrose in water or other compatible solution.
Contraindications
Hypersensitivity to famotidine or other H2-receptor antagonists.
Special Precautions
Patient with chronic lung disease and diabetes. Immunocompromised or intubated (in ICU setting) patient. May mask symptoms of gastric malignancy. Renal impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: CNS effects including confusion, disorientation, hallucinations, delirium, agitation, lethargy and seizure (particularly in elderly and patients with renal impairment); may increase the risk of developing community-acquired pneumonia; may decrease the absorption of vitamin B12.
Blood and lymphatic system disorders: Rarely, thrombocytopenia, pancytopenia, leucopenia.
Cardiac disorders: Arrhythmia, atrioventricular block, palpitations.
Gastrointestinal disorders: Constipation, diarrhoea, dry mouth, nausea, vomiting, dysgeusia, flatulence, abdominal discomfort or distension.
General disorders and administration site conditions: Fever, fatigue, asthenia; transient irritation at inj site (IV).
Hepatobiliary disorders: Rarely, cholestatic jaundice, hepatitis.
Immune system disorders: Rarely, hypersensitivity reaction (e.g. anaphylaxis, angioedema).
Investigations: Rarely, increased liver enzymes.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Rarely, musculoskeletal pain, arthralgia, muscle cramps.
Nervous system disorders: Headache, dizziness. Rarely, somnolence.
Psychiatric disorders: Rarely, insomnia.
Skin and subcutaneous tissue disorders: Rash, pruritus, dry skin, urticaria. Very rarely, alopecia, Stevens-Johnson syndrome, toxic epidermal necrolysis.
IV/Parenteral/PO: B
Monitoring Parameters
Rule out the presence of gastric malignancy before initiating therapy. Monitor gastric pH and occult blood with gastrointestinal bleeding; CBC and liver function (prolonged use with high doses).
Drug Interactions
May decrease the serum concentrations of atazanavir, delavirdine, rilpivirine, ketoconazole, itraconazole, cefditoren, nilotinib, erlotinib, ledipasvir, and fosamprenavir. May reduce the absorption of dasatinib. Probenecid may delay the excretion of famotidine. Antacids may reduce the absorption of famotidine.
Action
Description: Famotidine competitively blocks histamine at H2-receptors of the gastric parietal cells, resulting in the inhibition of gastric acid secretion and reduction of gastric volume.
Onset: Antisecretory effect: Within 1 hour (oral).
Duration: Antisecretory effect: 10-12 hours (oral, IV).
Pharmacokinetics:
Absorption: Incompletely absorbed from the gastrointestinal tract. Bioavailability: Approx 40-45% (oral). Time to peak plasma concentration: Approx 1-3 hours (oral).
Distribution: Crosses the placenta and enters breast milk. Volume of distribution: 1.3 ± 0.2 L/kg (IV). Plasma protein binding: Approx 15-20%.
Metabolism: Metabolised in the liver (up to 30-35%) to form famotidine S-oxide. Undergoes minimal first-pass metabolism.
Excretion: Via urine (approx 25-30% [oral], 65-70% [IV]) as unchanged drug. Elimination half-life: 2.5-3.5 hours.
Chemical Structure

Chemical Structure Image
Famotidine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5702160. https://pubchem.ncbi.nlm.nih.gov/compound/5702160. Accessed June 28, 2022.

Storage
Tab: Store between 15-30°C. Protect from light. Oral susp: Store at 25°C. Do not freeze. Solution for inj: Store between 2-8°C.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
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).
References
Anon. Famotidine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 05/04/2022.

Anon. Famotidine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/04/2022.

Buckingham R (ed). Famotidine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/04/2022.

Douglas Pharmaceuticals Ltd. Pepzan 20 mg and 40 mg Tablet data sheet 11 February 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 15/06/2022.

Famotidine 40 mg Film-coated Tablets (Teva UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/04/2022.

Famotidine Injection, Solution (Fresenius Kabi USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/04/2022.

Famotidine Powder for Suspension (Zydus Pharmaceuticals USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/04/2022.

Famotidine Tablet (Alembic Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/04/2022.

Famotin Tablets (Teva Pharmaceutical Investments Singapore Pte. Ltd.). MIMS Singapore. http://www.mims.com/singapore. Accessed 05/04/2022.

Joint Formulary Committee. Famotidine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/04/2022.

Sunpepcin Tablet (Sunward Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/04/2022.

Disclaimer: This information is independently developed by MIMS based on Famotidine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2023 MIMS. All rights reserved. Powered by MIMS.com
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