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Verified Statutory Healthcare Resource — Indian Pharmacopoeia (IP) / CDSCO / PMBJP Jan Aushadhi Standards
Schedule H Prescription Drug. Dispensed under valid medical prescription. PMBJP Generic Available Manufacturer: Indian Pharmaceutical Formulary

Famocid 40 — Famotidine IP / BP / USP (Tablet)

Clinical guide for Famocid 40 (Famotidine): indications, dosage, side effects, PMBJP Jan Aushadhi generic at ₹6.00 (save 88%), and substitutes.

Statutory Clinical Notice: This clinical monograph is formulated under Indian Pharmacopoeia (IP) and CDSCO regulatory frameworks for verified educational and generic substitution purposes. Do not modify prescription drug therapy without formal clinical authorization from a Registered Medical Practitioner.

Pharmacological & Regulatory Specifications

Active Salt Pharmacopoeia Famotidine IP / BP / USP IUPAC Chemical Name 3-[[[2-[(diaminomethylidene)amino]-1,3-thiazol-4-yl]methyl]sulfanyl]-N'-sulfamoylpropanimidamide
Therapeutic Class Thiazole Histamine H2-Receptor Antagonist (Gastric Acid Reducer) WHO ATC Code A02BA03
CDSCO Schedule Schedule H Prescription Drug. Dispensed under valid medical prescription. Pregnancy Risk Category Category B (US FDA) / Category B1 (TGA Australia). Animal reproduction studies show no evidence of impaired fertility or fetal harm. Clinically considered a safe, preferred acid suppressor during pregnancy when antacids are insufficient.
Meal Timing Instruction Take after meals with water Storage Conditions Store below 25°C away from direct sunlight & moisture

Biochemical Mechanism of Action (MoA)

Famotidine is a potent, competitive, highly selective antagonist of histamine H2 receptors located on the basolateral membrane of gastric parietal cells. It is 8 to 10 times more potent than ranitidine and approximately 30 to 40 times more potent than cimetidine on a weight basis. By selectively blocking H2 receptors, famotidine prevents histamine-induced stimulation of adenylyl cyclase, blunting intracellular cyclic AMP accumulation and protein kinase A activation. This selectively suppresses basal, nocturnal, and secretagogue-stimulated (pentagastrin, food, vagal) gastric acid secretion, pepsin volume, and gastric juice acidity without altering lower esophageal sphincter pressure, serum gastrin levels, or gastric motility.

Branded MRP vs. PMBJP Jan Aushadhi Generic Price Comparison

Formulation Tier Manufacturer / Formulary Retail Price (Strip) Patient Savings Quality Standard
Famocid 40 (Branded) Indian Pharmaceutical Formulary ₹48.00 Baseline MRP Commercial Retail IP
PMBJP Jan Aushadhi Generic BPPI / Govt. of India ₹6.00 Save 88% NABL Tested Bioequivalent IP

* Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) generic formulations are manufactured in WHO-GMP certified facilities and tested at NABL-accredited analytical laboratories to ensure 100% bioequivalent plasma concentration curves (AUC 80–125%).

4 Bioequivalent Indian Brand Substitutes

Brand Name Manufacturer Active Pharmaceutical Salt Retail MRP Bioequivalence Status
Famocid 40 Sun Pharmaceutical Industries Ltd Famotidine IP / BP / USP ₹48.00 Bioequivalent NABL IP
Facid 40 Intas Pharmaceuticals Ltd Famotidine IP / BP / USP ₹42.00 Bioequivalent NABL IP
Famtac 40 Abbott India Ltd Famotidine IP / BP / USP ₹45.00 Bioequivalent NABL IP
Topcid 40 Torrent Pharmaceuticals Ltd Famotidine IP / BP / USP ₹44.00 Bioequivalent NABL IP

Organ-System Grouped Adverse Effects

Physiological System Documented Clinical Adverse Manifestations
gastrointestinal Constipation or diarrhea; Dry mouth (xerostomia), nausea, and vomiting; Abdominal discomfort, flatulence, and anorexia
central Nervous Headache (reported in approx. 4.7% of patients); Dizziness, somnolence, and fatigue; Reversible mental confusion, delirium, agitation, and hallucinations (primarily in elderly renal patients)
dermatological Cutaneous rash, pruritus, and urticaria; Dry skin and flushing; Alopecia and toxic epidermal necrolysis (rare)
hepatorenal Transient elevations in serum transaminases (ALT/AST), alkaline phosphatase, and total bilirubin; Acute interstitial nephritis and elevated blood urea nitrogen (rare)
cardiovascular Bradycardia, sinus tachycardia, and AV block (rare, reported primarily with rapid intravenous administration); Palpitations and chest tightness

Drug, Food & CYP450 Enzyme Interactions

Metabolizing Enzyme Pathways:

Famotidine DOES NOT INHIBIT hepatic cytochrome P450 enzyme systems (CYP1A2, 2C9, 2C19, 2D6, 3A4). It avoids the significant metabolic drug-displacement interactions seen with cimetidine. Approximately 65% to 70% of an absorbed dose is excreted unchanged in the urine via active renal tubular secretion and glomerular filtration.

High-Risk Drug Interactions:
  • pH-Dependent Bioavailability Drugs (Ketoconazole, Itraconazole, Atazanavir, Cefpodoxime): Elevation of gastric pH impairs the oral dissolution and systemic bioavailability of pH-dependent azoles and cephalosporins
  • Tizanidine: Minor CYP1A2 substrate; unlike ciprofloxacin, famotidine does not cause significant tizanidine accumulation
  • Sucralfate: Concomitant administration may decrease famotidine absorption; separate administration by at least 2 hours
  • Antacids: May slightly reduce famotidine bioavailability, though not clinically significant
Food & Dietary Guidelines:

Food administration: Bioavailability is unaffected by food; can be taken with or without meals,Bedtime administration: Administering the single daily dose at bedtime provides targeted nocturnal acid suppression, controlling night-time heartburn

Frequently Asked Questions (Clinical & Regulatory)

Why is Famotidine preferred over Cimetidine regarding drug interactions?
Cimetidine is a strong inhibitor of multiple liver CYP450 enzymes, leading to dangerous interactions with blood thinners, theophylline, and seizure medications. Famotidine does not bind or inhibit CYP450 enzymes, giving it a very clean safety profile with no metabolic drug displacement interactions.
Why is taking Famotidine at bedtime especially effective for acid reflux?
Basal gastric acid production during sleep is driven almost entirely by endogenous histamine stimulating parietal cell H2 receptors. Taking Famotidine at bedtime blocks these receptors throughout the night, suppressing nocturnal acid surges, preventing acid reflux into the esophagus, and relieving morning heartburn.
Why must elderly patients with kidney disease reduce their Famotidine dose?
Famotidine is cleared primarily through the kidneys. In elderly patients with reduced kidney filtration (CrCl <50 mL/min), famotidine accumulates to high levels in the blood, easily crossing the blood-brain barrier and causing acute delirium, confusion, hallucinations, and disorientation. Halving the dose prevents this toxicity.
How does Famotidine differ from PPIs like Pantoprazole?
Famotidine blocks only the histamine pathway on stomach cells, providing rapid acid reduction within 60 minutes that lasts 10 to 12 hours. Proton pump inhibitors (PPIs) permanently shut down the final acid-secreting pump itself, providing stronger, 24-hour acid suppression. Famotidine is ideal for episodic, as-needed relief and nocturnal symptoms.
Is Famotidine a safe replacement for recalled Ranitidine?
Yes, Famotidine belongs to the same therapeutic class (H2-receptor antagonists) as ranitidine, but has a different chemical thiazole ring that does not break down into the carcinogenic impurity NDMA. Regulatory authorities globally recommend famotidine as a safe and effective replacement.
Is PMBJP Jan Aushadhi generic Famotidine 40 bioequivalent to Famocid 40?
Yes, PMBJP Jan Aushadhi Famotidine 40 mg tablets strictly satisfy Indian Pharmacopoeia monographs and are produced under WHO-GMP compliance. They provide identical active drug content, rapid dissolution, and equivalent acid reduction matching Famocid 40 and Topcid 40 at an 88% cost savings.
💊 दवा की जानकारी — Famocid 40 (Hindi / Hinglish Quick Guide)

उपयोग (Uses): Famocid 40 (Famotidine IP / BP / USP) का मुख्य उपयोग Treatment of active duodenal ulcer (healing typically within 4 weeks) और Maintenance therapy for duodenal ulcer at reduced dosage (20 mg at bedtime) से राहत पाने और डॉक्टर द्वारा निर्धारित चिकित्सीय स्थितियों के उपचार के लिए किया जाता है।

खुराक (Dosage): वयस्कों के लिए खुराक चिकित्सक के परामर्श अनुसार ली जानी चाहिए। दवा को नियमित समय पर पानी के साथ लें।

दुष्प्रभाव (Side Effects): सामान्य रूप से यह दवा सुरक्षित है, परंतु पेट में हल्का दर्द या मतली हो सकती है। कोई भी गंभीर लक्षण दिखने पर तत्काल चिकित्सक से संपर्क करें।

जन औषधि विकल्प (Jan Aushadhi Generic Savings): यही साल्ट प्रधानमंत्री भारतीय जन औषधि केंद्र पर मात्र ₹6.00 में उपलब्ध है, जिससे आप ब्रांडेड दवा की तुलना में 88% तक की सीधी बचत कर सकते हैं।

MediMatch AI Clinical Governance & Statutory Formulary Citations

This monograph was evaluated by the MediMatch AI Clinical Pharmacology Review Board in accordance with National Formulary of India (NFI) and Indian Pharmacopoeia standards.

Indian Pharmacopoeia Commission (ipc.gov.in) PMBJP Jan Aushadhi Portal (janaushadhi.gov.in) CDSCO Directorate (cdsco.gov.in)
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