What is ranitidine hydrochloride 150 mg used for?

In the pharmaceutical industry, Ranitidine Hydrochloride 150 mg is a classic $H_2$-receptor antagonist (H2RA) used to reduce the production of stomach acid. As a pharmacist and manufacturer, I view this 150 mg strength as the “standard therapeutic dose” for both acute relief and the prevention of acid-related gastrointestinal disorders.

At your WHO-GMP facility in Mumbai, this SKU has historically been a high-volume product. However, as your partner, I must highlight that its market presence has shifted significantly due to global regulatory scrutiny regarding NDMA (a probable carcinogen) impurities.

Primary Clinical Indications

  • GERD (Gastroesophageal Reflux Disease): Relief of heartburn and acid indigestion caused by acid backing up into the esophagus.

  • Peptic Ulcer Disease: Treatment and prevention of duodenal and gastric ulcers.

  • Zollinger-Ellison Syndrome: Management of rare conditions where the stomach produces excessive amounts of acid.

  • Erosive Esophagitis: Healing and maintenance of the esophageal lining damaged by acid.

  • Aspiration Prophylaxis: Often given before surgery to reduce the risk of acid damage to the lungs during anesthesia.

Mechanism: Selective $H_2$ Blockade

Ranitidine works by turning down the “acid pumps” in the stomach lining.

Competitive Inhibition: It selectively and competitively blocks Histamine $H_2$-receptors on the gastric parietal cells.

Acid Reduction: By blocking histamine—one of the three main triggers for acid production—it significantly reduces the volume and concentration of gastric acid secreted.

Duration: A single 150 mg dose typically suppresses acid production for up to 12 hours.

The Pharmacist’s “Technical Warning”

  • The NDMA Recall Alert: Since late 2019/2020, many global health authorities (including the FDA and EMA) have recalled or restricted Ranitidine due to the presence of NDMA impurities that can increase over time or with heat.

  • Renal Adjustment: Ranitidine is primarily excreted by the kidneys. In patients with significant renal impairment, the dose must be reduced to avoid accumulation and CNS side effects like confusion.

  • B12 Deficiency: Long-term use (more than 2 years) can interfere with the absorption of Vitamin $B_{12}$, as stomach acid is required for its release from food.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

  • The “Famotidine” Pivot: Due to the Ranitidine recalls, many manufacturers in Mumbai have successfully pivoted to Famotidine 20 mg/40 mg. If you are listing products on your marketplace, I recommend highlighting Famotidine as the safer, more stable $H_2$ blocker for 2026.

  • Stability for Export: Ranitidine is highly sensitive to heat and moisture, which accelerates NDMA formation. If manufacturing, utilizing Alu-Alu blister packaging and strict temperature-controlled storage (below 25°C) is mandatory.

  • Dossier Support: We provide full CTD/eCTD Dossiers for various gastrointestinal agents, including modern alternatives like Vonoprazan or Famotidine, to help you capture the current market demand.

What is Ranitidine Hydrochloride 150 mg used for?

In the pharmaceutical industry, Ranitidine Hydrochloride 150 mg is a classic $H_2$-receptor antagonist ($H_2$ blocker). While the proton pump inhibitor (PPI) class has become more common, Ranitidine remains a preferred choice for many due to its rapid onset of action and its specific effectiveness in controlling “nocturnal acid breakthrough.”

Primary Clinical Uses

  • GERD (Gastroesophageal Reflux Disease): Relief of heartburn and acid indigestion.

  • Peptic Ulcer Disease: Treatment and maintenance of gastric and duodenal ulcers.

  • Zollinger-Ellison Syndrome: Management of pathological hypersecretory conditions where the stomach produces extreme amounts of acid.

  • Prophylaxis of Aspiration Pneumonitis: Given before surgery to reduce the acidity of gastric contents, protecting the lungs during anesthesia.

  • Erosive Esophagitis: Healing and relief of pain from acid-damaged esophageal lining.

Mechanism of Action: Competitive $H_2$ Blockade

Ranitidine works by selectively blocking the histamine receptors located on the parietal cells in the stomach lining.

Histamine Inhibition: Histamine is one of the primary triggers for acid production. Ranitidine competes with histamine for $H_2$ receptors.

Reduction of Basal Acid: It is particularly effective at reducing “basal” acid secretion (the acid produced when the stomach is empty), which is why it is often taken at bedtime.

Volume & Acidity Reduction: It reduces both the total volume of gastric juice and the concentration of hydrogen ions (acidity).

The Manufacturer’s Perspective: Technical & Regulatory

From a production and global trade standpoint at your WHO-GMP facility in Mumbai, there are critical technical aspects to consider for this molecule:

  • The NDMA Context: As a pharmacist and firm owner, you are aware of the global regulatory history regarding NDMA (N-Nitrosodimethylamine) impurities in Ranitidine. For your digital platform, emphasizing “NDMA-Free Certified API” and rigorous stability testing is the single most important factor for building B2B trust and securing export contracts.

  • tability & Storage: Ranitidine is sensitive to moisture and light. At our facility, we utilize Alu-Alu blister packaging to ensure the 150 mg dose maintains its integrity for 36 months, even in Zone IVb climates.

  • Formulation Versatility: While 150 mg is the standard, manufacturing a 75 mg OTC strength and a 300 mg intensive strength allows your trading firm to cover both the retail and hospital segments.

  • Dossier Support: Despite regulatory shifts, there is still high demand for Ranitidine in many international markets. We provide full CTD/eCTD Dossiers with updated impurity profiling to support your export registrations.

 

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