Generic

Pantoprazole Sodium Sesquihydrate

Indications

• Pantoprazole is prescribed when acid secretion suppression is beneficial to the patient’s health, such as in the case of peptic ulcer disease.
• Gastroesophageal reflux disease (GERD) is a type of gastroesophageal reflux
• Nonsteroidal anti-inflammatory medications (NSAIDs) cause ulcers (NSAIDs)
• Helicobacter pylori eradication (in combination with antibiotics)
• Syndrome of Zollinger-Ellison

Pharmacology

Pantoprazole is a proton pump inhibitor that covalently binds to the H+/K+ATPase enzyme system at the surface of the gastric parietal cell, suppressing the final step in gastric acid generation. This impact inhibits both basal and induced stomach acid secretion, regardless of whether the stimulus is present for more than 24 hours.

Dosage & Administration

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Interaction

In clinical trials, no significant medication interactions were discovered.

Contraindications

Pantoprazole is not recommended for those who have a known hypersensitivity to any of the formulation’s ingredients.

Side Effects

Pantoprazole is well tolerated for both short and long-term use. The most common side effects are headache and diarrhea, with abdominal pain, flatulence, rash, sleeplessness, and hyperglycemia being unusual.

Pregnancy & Lactation

Pantoprazole is classified as a pregnancy category B by the US Food and Drug Administration. However, no suitable and well-controlled studies in pregnant women have been conducted. Because animal reproduction studies do not always predict human response, this medication should only be used during pregnancy if absolutely necessary. Pantoprazole has been found to pass through human milk. As a result, a decision should be taken on whether to stop nursing or stop taking the drug, taking into account the drug’s benefit to the mother.

Precautions & Warnings

Pantoprazole tablets should not be split, chewed, or crushed, according to the manufacturer. Pantoprazole therapy for a long time may cause cyanocobalamin (Vitamin B12) malabsorption or raise the risk of osteoporosis-related illnesses.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pharmaceutical Name

ACME Laboratories Ltd.