Ranitidine (Zydus) Tablet – Uses, Side Effects, Dosage, Precautions, and More

Ranitidine is a medication that belongs to a class of drugs known as H2 (histamine-2) blockers. It is used to reduce the amount of acid produced in the stomach. The 300 mg dosage form of Ranitidine by Zydus is specifically designed to provide a higher dose for the treatment of more severe conditions. This medication was widely used for various gastrointestinal conditions, but its usage has seen significant changes due to safety concerns.

Uses

Ranitidine 300 mg is prescribed for:

1. Gastroesophageal Reflux Disease (GERD): GERD is a chronic condition where stomach acid flows back into the esophagus, causing heartburn and irritation. Ranitidine helps to reduce acid production, alleviating these symptoms.
2. Peptic Ulcer Disease: This includes both gastric and duodenal ulcers. Ranitidine aids in healing these ulcers by lowering stomach acid levels, which prevents further damage to the ulcer site and promotes healing.
3. Zollinger-Ellison Syndrome: This is a rare condition characterized by tumors in the pancreas or duodenum that cause excessive stomach acid production. Ranitidine helps manage this excessive acid production.
4. Erosive Esophagitis: This condition involves inflammation and damage to the esophagus due to acid reflux. Ranitidine can help reduce acid and promote healing of the esophageal lining.
5. Prevention of Stress Ulcers: In hospitalized patients, particularly those in intensive care units, stress ulcers can develop due to severe illness. Ranitidine is used prophylactically to prevent these ulcers.
6. Treatment of Heartburn and Acid Indigestion: Ranitidine is often used for the short-term relief of heartburn, acid indigestion, and sour stomach caused by excess acid.

Dosage

The typical dosage for Ranitidine 300 mg varies based on the condition being treated:

• GERD: 300 mg once daily at bedtime or 150 mg twice daily.
• Peptic Ulcer Disease: 150 mg twice daily or 300 mg once daily at bedtime.
• Zollinger-Ellison Syndrome: The initial dose may be 150 mg twice daily, but it can be adjusted based on patient response, sometimes requiring up to 600 mg per day.
• Erosive Esophagitis: 150 mg four times daily.
• Prevention of Stress Ulcers: Dosing varies based on the clinical scenario but typically involves 150 mg twice daily.
• Heartburn and Acid Indigestion: 75 mg to 150 mg as needed.

Patients should follow their healthcare provider’s instructions closely and not adjust the dosage without consultation.

Side Effects

Ranitidine is generally well-tolerated, but it can cause side effects. Common side effects include:

• Headache: A common, mild side effect that usually resolves on its own.
• Dizziness: Some patients may experience dizziness, especially when standing up quickly.
• Constipation or Diarrhea: Gastrointestinal side effects can vary, with some patients experiencing either constipation or diarrhea.
• Nausea and Vomiting: Mild nausea and occasional vomiting may occur.

Less common but more serious side effects include:

• Allergic Reactions: Symptoms such as rash, itching, swelling, severe dizziness, or trouble breathing require immediate medical attention.
• Liver Function Changes: Elevated liver enzymes can occur, indicating liver stress or damage.
• Cardiac Issues: Rarely, Ranitidine can cause heart rhythm problems.
• Blood Disorders: Rare cases of blood count abnormalities, such as thrombocytopenia (low platelet count), have been reported.

Safety Concerns and Recall

In 2019, concerns emerged about the presence of N-nitrosodimethylamine (NDMA), a probable human carcinogen, in some Ranitidine products. This led to widespread recalls and increased scrutiny of Ranitidine’s safety profile.

In April 2020, the U.S. Food and Drug Administration (FDA) requested the removal of all Ranitidine products from the market due to the potential risk of NDMA contamination. This decision was based on findings that NDMA levels in some Ranitidine products could increase over time and when stored at higher temperatures, posing a risk to patients.

Alternatives

Due to the recall, many healthcare providers have switched patients to alternative medications, such as:

• Proton Pump Inhibitors (PPIs): Drugs like omeprazole, lansoprazole, and esomeprazole are commonly used to reduce stomach acid production.
• Other H2 Blockers: Alternatives such as famotidine and cimetidine are available and have not been implicated in the NDMA contamination issue.

Usage and Storage

Patients who still have Ranitidine should discontinue use and consult their healthcare provider for alternatives. Proper disposal methods should be followed to ensure environmental safety.

Ranitidine should be stored at room temperature away from light and moisture. Due to the recall, pharmacies no longer dispense Ranitidine, and patients are advised to seek alternative medications.

Conclusion

Ranitidine 300 mg tablets were once a mainstay treatment for various acid-related gastrointestinal conditions. However, safety concerns, particularly regarding NDMA contamination, have led to significant changes in its usage and availability. Patients previously using Ranitidine should consult their healthcare providers for appropriate alternatives and ensure they follow safe disposal practices for any remaining medication.

Also read: Fexofenadine Tablet: Uses, Side Effects, Dosage, Precautions and More