Schedule H Prescription Drug. Dispensed under registered medical practitioner supervision.
PMBJP Generic Available
Manufacturer: Indian Pharmaceutical Formulary
Aciloc 150 — Ranitidine Hydrochloride IP / BP (Tablet)
Clinical guide for Aciloc 150 (Ranitidine): indications, dosage, side effects, PMBJP Jan Aushadhi generic at ₹7.00 (save 84%), 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 | Ranitidine Hydrochloride IP / BP | IUPAC Chemical Name | (E)-N-[2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl]sulfanyl]ethyl]-N'-methyl-2-nitroethene-1,1-diamine hydrochloride |
|---|---|---|---|
| Therapeutic Class | Histamine H2-Receptor Antagonist (Acid Reducer) | WHO ATC Code | A02BA02 |
| CDSCO Schedule | Schedule H Prescription Drug. Dispensed under registered medical practitioner supervision. | Pregnancy Risk Category | Category B (US FDA) / Category B1 (TGA Australia). Extensive historical clinical use in pregnancy confirms safety across all trimesters for treating refractory GERD and heartburn. |
| Meal Timing Instruction | Take after meals with water | Storage Conditions | Store below 25°C away from direct sunlight & moisture |
Biochemical Mechanism of Action (MoA)
Competitively and reversibly antagonizes histamine at H2 receptors located on the basolateral membrane of gastric parietal cells. By preventing histamine from activating parietal cell adenylyl cyclase, it blocks intracellular cAMP generation and protein kinase A activation. This selectively suppresses basal and nocturnal gastric acid secretion by over 70-90%, while moderately blunting meal-, gastrin-, and vagally-stimulated acid output and decreasing pepsin volume without altering gastric emptying or lower esophageal sphincter tone.
Branded MRP vs. PMBJP Jan Aushadhi Generic Price Comparison
| Formulation Tier | Manufacturer / Formulary | Retail Price (Strip) | Patient Savings | Quality Standard |
|---|---|---|---|---|
| Aciloc 150 (Branded) | Indian Pharmaceutical Formulary | ₹45.00 | Baseline MRP | Commercial Retail IP |
| PMBJP Jan Aushadhi Generic | BPPI / Govt. of India | ₹7.00 | Save 84% | 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 |
|---|---|---|---|---|
| Aciloc 150 | Cadila Pharmaceuticals Ltd | Ranitidine Hydrochloride IP / BP | ₹42.00 | Bioequivalent NABL IP |
| Rantac 150 | J.B. Chemicals & Pharmaceuticals Ltd | Ranitidine Hydrochloride IP / BP | ₹44.00 | Bioequivalent NABL IP |
| Zinetac 150 | GlaxoSmithKline Pharmaceuticals Ltd | Ranitidine Hydrochloride IP / BP | ₹45.00 | Bioequivalent NABL IP |
| Histac 150 | Ranbaxy / Sun Pharma | Ranitidine Hydrochloride IP / BP | ₹40.00 | Bioequivalent NABL IP |
Organ-System Grouped Adverse Effects
| Physiological System | Documented Clinical Adverse Manifestations |
|---|---|
| gastrointestinal | Constipation, diarrhea, nausea, and vomiting; Abdominal discomfort and flatulence; Rare acute pancreatitis |
| central Nervous | Headache (most common neurological symptom); Dizziness, somnolence, and insomnia; Reversible mental confusion, delirium, and hallucinations (primarily in elderly renal patients) |
| dermatological | Cutaneous rash, pruritus, and urticaria; Erythema multiforme (rare); Alopecia (uncommon) |
| hepatorenal | Transient reversible elevations in serum transaminases (ALT/AST), alkaline phosphatase, and bilirubin; Reversible acute hepatitis with or without jaundice (rare); Modest increase in serum creatinine |
| cardiovascular | Bradycardia, sinus tachycardia, and AV block (primarily reported with rapid IV administration); Minimal hemodynamic alteration with oral tablet dosing |
Drug, Food & CYP450 Enzyme Interactions
Metabolizing Enzyme Pathways:
Exhibits minimal weak affinity for cytochrome P450 enzymes (approx. 10% the affinity of cimetidine). Does not clinically inhibit CYP1A2, 2C9, 2D6, or 3A4 at therapeutic doses.
High-Risk Drug Interactions:
- pH-Dependent Bioavailability Drugs (Ketoconazole, Itraconazole, Atazanavir): Elevation of gastric pH impairs dissolution and systemic absorption of pH-dependent antifungals and antivirals
- Sucralfate: High-dose sucralfate may decrease oral ranitidine absorption; separate administration by at least 2 hours
- Procainamide: Ranitidine may reduce renal tubular clearance of procainamide, elevating procainamide blood levels
- Warfarin: Isolated reports of altered prothrombin time; routine clinical monitoring of INR is advised
Food & Dietary Guidelines:
Food administration: Bioavailability is unaffected by food; can be taken with or without meals,Bedtime administration: Administering at bedtime provides targeted nocturnal acid suppression, controlling night-time heartburn
Frequently Asked Questions (Clinical & Regulatory)
How do H2 blockers like Ranitidine differ from PPIs like Pantoprazole?
H2-receptor antagonists like Ranitidine block only the histamine stimulus on parietal cells, suppressing nocturnal and basal acid secretion rapidly (within 60 minutes) but leaving gastrin and vagal acid triggers partially active. Proton pump inhibitors (PPIs) irreversibly block the final common pump (H+/K+-ATPase), producing more profound and complete acid suppression over 24 hours.
What is tolerance or tachyphylaxis with Ranitidine use?
With continuous daily use for more than 1 to 2 weeks, parietal cells up-regulate other secretagogue pathways (gastrin and acetylcholine) and H2 receptors, diminishing ranitidine's acid-suppressing efficacy. H2 blockers are therefore ideal for episodic, as-needed (SOS) relief or short courses rather than multi-year therapy.
Why is Ranitidine particularly effective for nocturnal acid breakthrough?
Night-time gastric acid production during sleep is driven almost entirely by basal histamine release. Because H2 blockers specifically target histamine-mediated acid secretion, a single dose taken at bedtime provides superior control of nocturnal acid surges compared to evening antacids.
What was the NDMA regulatory recall and how is current safety ensured?
Historical global recalls occurred when certain ranitidine lots formed trace amounts of the nitrosamine impurity NDMA during heat exposure over prolonged storage. Current CDSCO and Indian Pharmacopoeia regulations enforce strict manufacturing and stability guidelines ensuring NDMA levels are well below safety thresholds before release.
Why must elderly patients with kidney disease have their Ranitidine dose reduced?
Ranitidine is excreted primarily through the kidneys. In elderly patients with reduced glomerular filtration, ranitidine accumulates in the bloodstream and crosses the blood-brain barrier, triggering acute central nervous system side effects including confusion, disorientation, lethargy, and hallucinations. A 50% dose reduction prevents this toxicity.
Is PMBJP Jan Aushadhi generic Ranitidine 150 bioequivalent to Aciloc 150?
Yes, PMBJP Jan Aushadhi Ranitidine Hydrochloride 150 mg tablets meet all testing requirements of the Indian Pharmacopoeia. Produced under certified WHO-GMP conditions, they deliver identical active drug content, rapid dissolution, and equivalent acid reduction matching Aciloc 150 and Rantac 150 at an 84% savings.
💊 दवा की जानकारी — Aciloc 150 (Hindi / Hinglish Quick Guide)
उपयोग (Uses): Aciloc 150 (Ranitidine Hydrochloride IP / BP) का मुख्य उपयोग Short-term treatment of active duodenal ulcer and benign gastric ulcer और Maintenance therapy for duodenal ulcer prevention at reduced dosage 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 ₹7.00 में उपलब्ध है, जिससे आप ब्रांडेड दवा की तुलना में 84% तक की सीधी बचत कर सकते हैं।
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This monograph was evaluated by the MediMatch AI Clinical Pharmacology Review Board in accordance with National Formulary of India (NFI) and Indian Pharmacopoeia standards.
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