Famotidine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Benign gastric and duodenal ulceration 40 mg at night for 4-8 weeks. Maintenance: 20 mg at night. Hypersecretory conditions Initially, 20 mg 6 hourly, may increase doses up to 800 mg daily, as necessary. GERD 20 mg bid for 6-12 weeks or up to 40 mg bid if there is oesophageal erosion. Maintenance: 20 mg bid. Non-ulcer dyspepsia 10 or 20 mg bid. IV Benign gastric and duodenal ulceration; Hypersecretory conditions 20 mg 12 hourly.
Dosage Details
Intravenous
Benign gastric and duodenal ulceration, Hypersecretory conditions
Adult: 20 mg 12 hourly via inj over 2 minutes or via infusion over 15-30 minutes.

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

Oral
Hypersecretory conditions
Adult: Initially, 20 mg 6 hourly, may increase doses up to 800 mg daily, as necessary.

Oral
Gastro-oesophageal reflux disease
Adult: 20 mg bid for 6-12 weeks or up to 40 mg bid if there is oesophageal erosion. Maintenance: 20 mg bid.
Child: Recommended dose: As oral solution: <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 40 mg bid.

Oral
Non-ulcer dyspepsia
Adult: 10 or 20 mg bid.

Oral
Benign gastric and duodenal ulceration
Adult: 40 mg daily at night for 4-8 weeks. Maintenance: 20 mg daily at night.
Child: As oral solution: 1-16 years Initially, 0.5 mg/kg at bedtime or in 2 divided doses, may increase dose up to 40 mg daily.
Renal Impairment
CrCl (mL/min) Dosage
<50 to <10 Reduce dose to half or prolong dosing interval to 36-48 hours based on clinical response.
Administration
May be taken with or without food.
Reconstitution
IV inj: Dilute 2 mL 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 with 100 mL of 5% dextrose or other compatible solution.
Special Precautions
Patient with chronic lung disease and diabetes. Immunocompromised or intubated (in ICU setting) patient. Rule out gastric malignancy or possibility of malignancy prior to therapy. Renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Blood and lymphatic system disorders: Rarely, Thrombocytopenia, agranulocytosis, pancytopenia, leucopenia.
Cardiac disorders: Arrhythmia, atrioventricular block, palpitations.
Ear and labyrinth disorders: Tinnitus.
Eye disorders: Orbital oedema, conjunctival injection.
Gastrointestinal disorders: Constipation, diarrhoea, taste disorder, rarely, dry mouth, nausea, vomiting, abdominal discomfort or distension.
General disorders and admin site conditions: Fever, fatigue, asthenia.
Hepatobiliary disorders: Cholestatic jaundice, hepatitis.
Immune system disorders: Angioedema.
Injury, poisoning and procedural complications: Irritation at injection site (IV).
Investigations: Increased liver enzymes.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Musculoskeletal pain including muscle cramps, arthralgia, rhabdomyolysis.
Nervous system disorders: Headache, dizziness, paraesthesia.
Psychiatric disorders: Insomnia, somnolence, agitation, seizure, psychic disturbances including hallucinations, confusion, agitation, depression, anxiety.
Reproductive system and breast disorders: Decreased libido.
Respiratory, thoracic and mediastinal disorders: Bronchospasm, rarely, interstitial pneumonia.
Skin and subcutaneous tissue disorders: Acne, dry skin, rash, pruritus, urticaria. Rarely, toxic epidermal necrolysis, Stevens-Johnson syndrome.
Vascular disorders: Anaphylaxis, flushing.
IV/Parenteral/PO: B
Patient Counseling Information
This drug may cause dizziness, headache or confusion, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor CBC, gastric pH, liver function (prolonged use), and occult blood with gastrointestinal bleeding.
Drug Interactions
May decrease serum concentrations of atazanavir, cefditoren, delavirdine, ketoconazole, and fosamprenavir. May decrease the absorption of dasatinib. Probenecid inhibits the renal tubular secretion of famotidine. Antacids may reduce the absorption of famotidine.
Action
Description: Famotidine competitively inhibits histamine at H2-receptors of the gastric parietal cells thereby inhibiting gastric acid secretion and 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: 40-45% (oral). Time to peak serum concentration: Approx 1-3 hours (oral).
Distribution: Crosses placenta and present in breastmilk. Volume of distribution: 1.3±0.2 L/kg. Plasma protein binding: 15-20%.
Metabolism: Undergoes minimal first-pass metabolism to form S-oxide.
Excretion: Via urine (oral: 25-30%, IV: 65-70% as unchanged drug). Elimination half-life: 2.5-3.5 hours.
Chemical Structure

Chemical Structure Image
Famotidine

Source: National Center for Biotechnology Information. PubChem Database. Pepcid, CID=5702160, https://pubchem.ncbi.nlm.nih.gov/compound/Pepcid (accessed on Jan. 20, 2020)

Storage
Tab/oral solution: Store below 30°C. Protect from light and moisture. Solution for inj: Store between 2-8°C. Do not freeze. Protect from light.
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. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 18/06/2019.

Buckingham R (ed). Famotidine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/06/2019.

Famotidine Injection (Mylan Institutional LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 18/06/2019.

Famotidine Powder for Suspension (Lupin Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 18/06/2019.

Famotidine Tablet (Aurobindo Pharma Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 18/06/2019.

Famotidine Tablet (Mylan Generics UK Limited). MHRA. https://products.mhra.gov.uk/. Accessed 18/06/2019.

Famotin Tablet (Prime Pharmaceutical Sdn. Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 26/06/2019 .

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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