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2. Summary
EPIRANT® is a historical brand name for ranitidine hydrochloride, a histamine H₂-receptor antagonist formerly used to suppress gastric acid secretion in acid-related gastrointestinal disorders.
Ranitidine products were globally withdrawn or suspended between 2019 and 2020 after detection of N-nitrosodimethylamine (NDMA), a probable human carcinogen, which may form during storage under certain conditions.
While some secondary sources report that a reformulated ranitidine with enhanced manufacturing and storage controls received FDA approval in late 2025, this information should be considered regulatory-specific and not universally applicable. As of December 2025, there is no confirmed public re-approval or re-registration of ranitidine in Egypt, and EPIRANT® remains discontinued.
3. Brand Name
EPIRANT® (discontinued / historical)
4. Category
- Histamine H₂-receptor antagonist (H₂-blocker)
- Anti-ulcer agent
- Gastrointestinal therapeutic agent
5. Active Ingredient
Ranitidine hydrochloride
6. Pharmaceutical Form & Strength
- Tablets: 150 mg
- Ampoules for injection: 50 mg / 2 mL (25 mg/mL) for IV or IM use
7. Manufacturer & Marketing Authorization Holder
Egyptian International Pharmaceutical Industries Co. (EIPICO) Tenth of Ramadan City, Egypt (Marketing authorization effectively inactive following global withdrawal of ranitidine)
8. Mechanism of Action
Ranitidine is a competitive and reversible antagonist of histamine H₂ receptors on gastric parietal cells. Inhibition of these receptors reduces activation of adenylate cyclase and intracellular cAMP, resulting in:
- Decreased basal and stimulated gastric acid secretion
- Reduced gastric volume and hydrogen ion concentration
- Decreased pepsin secretion
9. Spectrum of Activity
- No antimicrobial or antiviral activity
- Selective suppression of gastric acid secretion
- Minimal effect on cytochrome P450 enzymes compared with cimetidine
10. Pharmacokinetics
Absorption: Oral bioavailability ~50%; peak plasma concentration in 2–3 hours. IM administration peaks within ~15 minutes.
Distribution: Weak plasma protein binding (~15%); volume of distribution ~1.4 L/kg. Crosses placenta and is excreted into breast milk at higher concentrations than plasma.
Metabolism: Hepatic metabolism; N-oxide is the primary metabolite.
Excretion: Primarily renal. ~30% of oral and ~70% of IV doses excreted unchanged in urine within 24 hours.
Half-life: 2–3 hours (prolonged in renal impairment and elderly patients).
CNS penetration: Does not readily cross the blood–brain barrier.
11. Indications
(Historical indications prior to withdrawal)
- Duodenal ulcer
- Gastric ulcer
- Gastroesophageal reflux disease (GERD)
- Erosive esophagitis
- NSAID-associated ulcer prophylaxis
- Stress-related mucosal disease prophylaxis
- Pathological hypersecretory conditions (e.g., Zollinger–Ellison syndrome)
- Prevention of recurrent bleeding in peptic ulcer disease
- Prevention of acid aspiration syndrome during general anesthesia
12. Administration
- Oral
- Intravenous (IV)
- Intramuscular (IM)
13. Method of Preparation
(Historical preparation guidance only)
- IV bolus: Dilute 50 mg in 20 mL of 0.9% sodium chloride; administer slowly over ≥2 minutes
- IV infusion: May be administered intermittently or continuously using compatible IV solutions
- IM injection: Administer undiluted
14. Contraindications
- Hypersensitivity to ranitidine or other H₂-receptor antagonists
- History of acute porphyria (precautionary contraindication)
15. Warnings & Precautions
- Gastric malignancy must be excluded before treatment of gastric ulcers
- Critical safety issue: NDMA formation during storage led to global withdrawal
- Dose reduction required in renal impairment
- Rapid IV administration may cause bradycardia
- Increased risk of infections (e.g., pneumonia, C. difficile-associated diarrhea) with acid suppression
16. Drug Interactions
- Reduced absorption of drugs requiring acidic pH (e.g., ketoconazole, itraconazole, iron salts)
- Minimal interaction with CYP450 enzymes
- Reduced renal clearance of procainamide
- Rare effects on warfarin anticoagulation (monitor INR)
17. Side Effects
Common:
- Headache, dizziness, fatigue
- Diarrhea or constipation
- Rash
Rare:
- Elevated liver enzymes, hepatitis
- Bradycardia, arrhythmias (especially IV)
- Blood dyscrasias (thrombocytopenia, leukopenia)
- Hypersensitivity reactions, including anaphylaxis
18. Use in Special Populations
- Pregnancy: Category B (historical); use only if clearly needed
- Lactation: Excreted in breast milk; monitor infant
- Pediatrics: Safety historically established from 1 month to 16 years
- Elderly: Reduced renal clearance; dose adjustment advised
- Renal impairment: Dose reduction mandatory
19. Storage Conditions
- Historical: Store below 30°C, protected from light and moisture
- Updated safety context: Improper storage accelerates NDMA formation; historical ranitidine products should not be used
20. Additional Sections
Regulatory Status Update
- Global withdrawal requested by FDA and EMA in 2020
- EPIRANT® is discontinued
- Reports of FDA approval of reformulated ranitidine (2025) apply only to specific formulations and jurisdictions and do not imply reinstatement of older products
Therapeutic Alternatives
- Famotidine (preferred H₂-blocker)
- Proton pump inhibitors: Omeprazole, Esomeprazole, Pantoprazole
- Antacids for short-term symptom relief
21. Frequently Asked Questions (FAQ)
Is EPIRANT® currently available? No. EPIRANT® remains discontinued.
Is ranitidine safe now? Only reformulated versions approved by specific regulatory authorities may be considered; older products are unsafe.
Does ranitidine cause cancer? The concern relates to NDMA contamination, not the pharmacological action of ranitidine itself.
What is the safest alternative? Famotidine or proton pump inhibitors, depending on the clinical indication.
22. References
- FDA. Request for Removal of All Ranitidine Products from the Market, 2020.
- EMA. Suspension of Ranitidine Medicines in the EU, 2020.
- EIPICO. EPIRANT® Product Leaflet, May 2008 (historical reference).
- NCBI. Ranitidine and NDMA Formation, updated reviews.
- Drugs.com. Ranitidine Prescribing Information (archived).
- Pharmacy Times & regulatory summaries on post-withdrawal ranitidine developments.