Generic Name: Pantoprazole Sodium Sesquihydrate 20mg
Company Name: Delta Pharma Limited
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Indications
Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e
Peptic ulcer diseases
Gastroesophageal reflux diseases
Ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs)
Eradication of Helicobacter pylori (in combination with antibiotics)
Zollinger-Ellison Syndrome
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 last step in a gastric acid generation. This action inhibits both basal and induced stomach acid production, 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 the 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 adverse effects are headache and diarrhea, with stomach discomfort, 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 appropriate and well-controlled trials in pregnant women have been conducted. Because animal reproduction studies do not always anticipate a human response, this medication should only be taken during pregnancy if absolutely necessary. Pantoprazole has been found to pass through human milk. As a result, a choice should be taken on whether to stop breastfeeding or stop taking the medicine, taking into account the drug's value to the mother.
Precautions & Warnings
Pantoprazole tablets should not be split, chewed, or crushed, according to the manufacturer. Pantoprazole treatment for a long time may cause cyanocobalamin (Vitamin B12) malabsorption or raise the risk of osteoporosis-related diseases.
Storage Conditions
Keep in a dry place, away from light and heat. Keep out of the reach of children.
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