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Pantolok

Pantoprazole BP

NAME STRENGTH PACK SIZE DOSAGE FORM
Pantolok 40 40 mg 5X10 Tablet
Pantolok 40 IV 40 mg/ Vial 1's IV injection
Pantolok 20 20 mg 10X10 Tablet

Description

Pantolok (Pantoprazole) is chemically a novel substituted benzimidazole derivative, which suppresses the final step in gastric acid production by forming a covalent bond to two sites of the H+/K+ - ATPase enzyme system at the secretory surface of the gastric parietal cell. This leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the H+/K+ - ATPase results in duration of antisecretory effect that persists longer than 24 hours. Pantoprazole (Pantolok) is quantitatively absorbed and bioavailability does not change upon multiple dosing. Pantoprazole (Pantolok) is extensively metabolized in the liver. Almost 80% of an oral dose is excreted as metabolites in urine; the remainder is found in feces and originates from biliary secretion.

Pantolok 20 tablet: Each delayed release tablet contains Pantoprazole Sodium Sesquihydrate BP equivalent to Pantoprazole 20 mg. Pantolok 40 tablet: Each delayed release tablet contains Pantoprazole Sodium Sesquihydrate BP equivalent to Pantoprazole 40 mg. Pantolok 40 IV injection: Each vial contains Pantoprazole 40 mg (as lyphollized powder of pantoprazole sodium sesquihydrate BP) and each ampoule contains 10 ml of 0.9% Sodium Chloride Injection BP.

Indication Pantolok is indicated where suppression of acid secretion is of therapeutic benefit. Pantolok is registered for the following indications: - ♦ Peptic ulcer diseases (PUD) ♦ Gastro esophageal reflux diseases (GERD) ♦ Treatment of ulcer resistant to H2 receptor antagonists (H2RAs) ♦ Treatment of ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs) ♦ Gastrointestinal (GI) bleeding from stress or acid peptic diseases ♦ Eradication of Helicobacter pylori (in combination with antibiotics) ♦ Zollinger-Ellison syndrome ♦ Prophylaxis for acid aspiration syndrome during induction of anesthesia

Indiacations Dose Duration Duodenal ulcers 40 mg once daily for 2 to 4 weeks. Gastric ulcers 40 mg once daily for 4 to 8 weeks. Reflux esophagitis 40 mg once daily for 4 to 8 weeks. In resistant ulcers 40 mg once daily for 8 weeks. Ulcers induced by 40 mg once daily, in patients receiving NSAIDs. Continuous treatment with NSAIDs GI bleeding from stress or acid peptic diseases 40 mg once daily, if required the dosage may be increased. Eradication of Helicobacter pylori 40 mg twice daily in combination with appropriate antibiotic. Zollinger-Ellison 40 mg Four times daily. Once control of acid syndrome secretion has been achieved, the dose should be gradually reduced to the lowest effective dose that maintains acid control. Prophylaxis for acid 40 mg 1 or 2 tablet should be given the aspiration syndrome evening before surgery and repeated during induction of again the morning of surgery anesthesia Children: Safety and effectiveness have not been established. Injection: Indications Dosage Duodenal ulcer and gastric ulcer 40 mg IV once daily for 7-10 days Gastroesophageal reflux disease 40 mg IV once daily for 7-10 days associated with a history of erosive esophagitis Prevention of rebleediing of peptic 80 mg IV followed by 8 mg/hour ulcer infusion for 72 hours Prophylaxis of acid aspiration 80 mg IV every 12 h for 24 hours followed by 40 mg every 12 h. Zollinger-Ellision syndrome / 80 mg IV every 12 hours, may pathologic hypersecretion increase to 80 mg every 8 hours if needed; may titrate to higher doses depending on acid output. Direction for use of IV injection Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30°c) for a maximum 4 hours. Direction for use of IV infusion Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30°c) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30°c) and must be used within 24 hours from the time of initial reconstitution. Maintenance therapy Maintenance treatment should involve the lowest dose of the drug. Both 20 and 40 mg doses of Pantolok are safe and effective in maintaining patients with healed reflux esophagitis and PUD in remission.

Pantoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

Proton pump inhibitor should be used with caution in patients with liver diseases, in pregnancy and in breast-feeding. Proton pump inhibitors may mask symptoms of gastric cancer; particular care is required in those whose symptoms change and in those over 45 years of age; the presence of gastric malignancy should be excluded before treatment.

Side effects of the Proton pump inhibitor include gastro-intestinal disturbances including diarrhea, nausea, vomiting, constipation, abdominal pain, blurred vision, depression and dry mouth.

There are no data on the excretion of Pantoprazole into the breast milk and also there are no available data on administration of Pantoprazole to pregnant women. A decision should be made whether to discontinue the drug, taking into account the benefit of the drug to the mother.

Pantoprazole is metabolized through the cytochrome P-450 system, and subsequently undergoes Phase II conjugation. Based on studies evaluating possible interactions of Pantoprazole with other drugs metabolized by the cytochrome P-450 system, no dosage adjustment is needed with concomitant use of the following drugs; theophylline, antipyrine, caffeine, carbamazepine, diazepam, diclofenac, digoxin, ethanol, glyburide, oral contraceptive (Levonorgestrel / ethinyl estradiol), metoprolol, nifedipine, phenytoin, or warfarin. There was also no interaction with concomitantly administered of antacids.

Presentation Pantolok 20 tablet: Each box contains 100 (10x10's) tablets in Alu-Alu blister strips. Pantolok 40 tablet: Each box contains 50 (5x10's) tablets in Alu-Alu blister strips. Pantolok 40 IV injection: Each box contains one vial of 40 mg Pantoprazole, one ampoule of 10 ml of 0.9% Sodium Chloride Injection and one sterile disposable syringe (10 ml)