Each enteric film-coated tablet contains Pantoprazole sodium sesquihydrate 45.1 mg (eq. to pantoprazole 40 mg).
Pharmacology: Pharmacodynamics: Pantoprazole is a proton pump inhibitor (PPI) that 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 effect is dose-related and leads to inhibition of both basal and simulated 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. Within 2.5 hours of administration of a 40 mg dose to healthy individuals, gastric acid secretion was inhibited by a mean of 51% which is increased to a mean of 85% following administration of 40 mg once daily for 7 days. Gastric acid secretion returned to normal within a week after pantoprazole discontinuance, and there was no evidence of rebound hypersecretion. Because the pantoprazole molecule is acid labile, the drug is administered as a delayed-release, enteric-coated tablet formulation that increases oral bioavailability by delaying absorption until after the tablets leaves the stomach. Pantoprazole can suppress gastric Helicobacter Pylori in patients with duodenal ulcer/or reflux esophagitis infected with the organism. Combined therapy with pantoprazole and one or more anti-infectives (e.g. amoxicillin, clarithromycin) can effectively eradicate Helicobacter Pylori gastric infection.
Pharmacokinetics: Pantoprazole is rapidly absorbed, but to a variable extent, following oral administration. Absorption of pantoprazole is affected by food. Pantoprazole acid-labile and various formulations have been developed in attempt to improve bioavailability from the gastro intestinal tract. Consequently, its pharmacokinetics may vary with different formulations of the drug. The absorption of pantoprazole, as well as being formulation-dependent, also appears to be dose-dependent, as increasing the dosage has been reported disproportionately to increase the plasma concentrations.
Bioavailability of pantoprazole may be increased in elderly patients, and in patients with impaired hepatic function, but is not markedly affected in patients with renal impairment.
Following absorption, pantoprazole is almost completely metabolized in the liver and rapidly eliminated mostly in the urine. Although the elimination half-life from plasma is short, being reported to be about 0.5 to 3 hours, its duration of action with regard to inhibition of acid secretion is much longer allowing it to be used in single daily dose and it is suggested that its distribution to the tissues, and particularly to the gastric parietal cells, accounts for this action. Pantoprazole is highly bound (about 95%) to plasma proteins.
For the treatment of gastro-oesophageal reflux disease, peptic ulcer disease, patients who require prophylaxis for NSAID-associated ulceration, and pathological hypersecretory states such as the Zollinger-Ellison syndrome.
Pantoprazole is administered orally once daily. Tablets should be swallowed intact and not split, crushed or chewed. Food may delay the rate but does not affect the extent of GI absorption of the drug; therefore, pantoprazole may be administered without regard to meals. Antacids do not affect the absorption of pantoprazole and may be administered concomitantly with drug.
Duodenal Ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
Benign Gastric Ulcer and Gastro-oesophageal Reflux Disease: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks if not fully healed.
Elderly & Renally Impaired Patients: 40 mg daily should not be exceeded in the elderly or those with renal impairment.
Hepatic Impairment due to Cirrhosis: 40 mg every other day is recommended in patients with hepatic impairment due to cirrhosis.
Helicobacter pylori Eradication: 7 days course, continued for further 7 days if not fully healed: Pantoprazole 40 mg twice daily + clarithromycin 500 mg twice daily + Amoxicillin 1000 mg twice daily.
Pantoprazole 40 mg twice daily + Metronidazole 400 mg twice daily + clarithromycin 500 mg twice daily.
Pantoprazole 40 mg twice daily + Amoxicillin 1000 mg twice daily + metronidazole 500 mg twice daily.
Missed Dose: 1 a dose is missed, take it as soon as remembered. If it is almost time for the next dose, take only that dose. Do not take double or extra dose.
Pantoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
This product may contain FD & C Yellow # 5 (Tartrazine) which may cause allergic reactions including bronchial asthma in certain susceptible person.
Do not stop taking pantoprazole without speaking to the doctor first.
Do not take indigestion remedies at the same time of day as this medicine. Take them at least two hours before or two hours after a dose of pantoprazole.
Pantoprazole can cause dizziness and blurred vision. Make sure reactions are normal before driving, operating machinery or doing any other jobs which could be dangerous if the patient was to become dizzy or was unable to see properly.
Do not smoke. Smoking increases the amount of acid produced by the stomach and will aggravate the patient's condition.
Try to avoid foods that may upset the stomach such as alcohol, citrus fruits/juices, drinks containing caffeine, tomatoes or spicy food.
Safety and effectiveness in pediatric patients have not yet been established.
Safety and effectiveness for long term treatment (greater than 16 weeks) has not yet been determined.
Before taking pantoprazole make the doctor or pharmacist knows: If the patient is pregnant, trying for a baby or breast- feeding. If the patient suffers from liver or kidney problems.
If the patient ever had an allergic reaction to this or any other medicine. Dosage may need to be reduced in renal hepatic impairment; liver function should be monitored regularly.
The adverse effects reported most frequently with pantoprazole have diarrhea, skin rashes and headache; they have sometimes been severe enough to require discontinuation of treatment. Effects on the central nervous system, including reversible confusional state in severely ill patients, have occurred. Other adverse effects reported rarely include arthralgia and myalgia, blood disorders including leucopenia and thrombocytopenia, interstitial nephritis and hepatotoxicity.
Pantoprazole is metabolized through the cytochrome P450 system, primarily the CYP2C19 and CYP3A4 isoenzymes, and subsequently undergoes phase II conjugation. Based on studies evaluating possible interactions of pantoprazole with other drugs metabolized by the cytochrome P450 system, no dosage adjustment is needed with the concomitant use of the following drugs: theophylline, cisapride, antipyridine, carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glyburide, and oral contraceptive (levonorgestrel/ethinyl estradiol) metoprolol, nifedipine, phenytoin or warfarin. Clinically relevant interactions of pantoprazole with other drugs with the same metabolic pathways are not expected. Therefore, when co-administered with pantoprazole, adjustment of the dosage of pantoprazole or such of drugs may not necessary. There was also no interaction with concomitantly administered antacids. Because of profound and long lasting inhibition of gastric secretion, it is theoretically possible that pantoprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (e.g. ketoconazole, ampicillin, esters and iron salts).
Store at temperatures not exceeding 30°C.
A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Enteric-film coated tab 40 mg x 7's.