PANTOPRAZOLE –Najo 20 & 40 MG TAB
Category: Proton pump inhibitor.
INDICATIONS:
Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Maintenance of Healing of Erosive Esophagitis
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
DOSAGE AND ADMINISTRATION:
Treatment of Erosive Esophagitis: The recommended adult oral dose is 40 mg given once daily for up to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole may be considered.
Maintenance of Healing of Erosive Esophagitis: The recommended adult oral dose is Pantoprazole 40 mg, taken daily.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome: The dosage of Pantoprazole in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult starting dose is 40 mg twice daily. Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered. Some patients have been treated continuously with Pantoprazole for more than 2 years.
Pantoprazole-Najo Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole.
CLINICAL PHARMACOLOGY:
Mechanism of Action: Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H+,K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the (H+,K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested.
Metabolism: Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system. There is no evidence that any of the pantoprazole metabolites have significant pharmacologic activity.
Elimination: After a single oral or intravenous dose of 14C-labeled pantoprazole to healthy, normal metabolizer volunteers, approximately 71% of the dose was excreted in the urine with 18% excreted in the feces through biliary excretion.
CONTRAINDICATIONS:
PANTOPRAZOLE is contraindicated in patients with known hypersensitivity to any component of the formulation.
PRECAUTIONS:
Pregnancy: Pregnancy Category B
Nursing Mothers: a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Renal Impairment: No dosage adjustment is necessary in patients with renal impairment or in patients undergoing hemodialysis.
Hepatic Impairment: No dosage adjustment is needed in patients with mild to severe hepatic impairment. Doses higher than 40 mg/day have not been studied in hepatically-impaired patients.
OVERDOSAGE:
There have also been spontaneous reports of patients taking similar amounts of pantoprazole (400 mg and 600 mg) with no adverse effects. Pantoprazole is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive.
SIDE EFFECTS: Headache 6, Diarrhea 4, Flatulence 2, Abdominal pain 1, Rash < 1, Eructation 1, Hyperglycemia 1.
DRUG INTERACTION: Theophylline, cisapride, antipyrine, caffeine, carbamazepine, diazepam, diclofenac, naproxen, piroxicam, digoxin, ethanol, glyburide, levonorgestrel/ethinyl estradiol, metoprolol, nifedipine, phenytoin, warfarin , midazolam, clarithromycin, metronidazole, or amoxicillin, ketoconazole, ampicillin esters, and iron salts.
How Supplied: Each Package of Pantoprazole-Najo contains 1 Blister and 14 Tablets.
storage: Store at controlled room temperature to 30°C. Protect from light and moisture.
For more information please refer to:
USPDI for Professional Health Care, 2007,
IRAN NAJO PHARMACEUTICAL COMPANY
www.irannajo.com
Address: No. 9, West Hoveiseh,
Sabounchi St., Sohrevardi Ave., Tehran 1533693317, Iran
Tel: +9821-88747363 Fax: +9821-88740644 info@irannajo.com