Pantoprazole Sodium IP eq. to Pantoprazole 40 mg Tablet

Before taking pantoprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as lansoprazole, omeprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Symptomatic response does not preclude presence of gastric malignancy

Atrophic gastritis has been noted with long-term therapy

Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.

Hypomagnesemia has been reported rarely with prolonged treatment with PPIs

Patients with a history of hypersensitivity to pantoprazole or to any constituents of the medication. It is also contraindicated in patients with cirrhosis of the liver and in cases of severe liver disease

Gastrointestinal: abdominal pain (3%), diarrhea (4%), flatulence (4%)

Neurologic: headache (5%)

Chest pain, headache, nausea, pain, anxiety

Gastroesophageal reflux disease (treatment) Oral, 40 mg per day for up to eight weeks. An additional eight-week course may be considered in patients who have not healed after four to eight weeks of treatment.
Disclaimer:To be taken only after consulting with the doctor.

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 (20 mg to 120 mg).

Pharmacokinetics

Absorption: Rapidly absorbed. However, absorption may be delayed up to 2 hours or more if pantoprazole is taken with food.
Bioavailability (oral)- 77%.
Distribution: VolD - Following intravenous administration to extensive metabolizers: 0.17 L per kg (11 to 23.6 L).
Protein Binding: Very high (98%); primarily to albumin.
Half-Life: Elimination - Following oral or intravenous administration: 1 hour.
The half-life of pantoprazole is prolonged (7 to 9 hours) in patients with cirrhosis of the liver and in genetically determined slow metabolizers (3.5 to 10 hours).

Interactions

Pantoprazole tablets may influence the effectiveness of other medicines, so tell your doctor if you are taking
• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazole tablets may stop these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks.
• Atazanavir (used to treat HIV-infection).

Pregnancy and Breast-feeding:
There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported. If you are pregnant, or think you may be pregnant, or if you are breast-feeding, you should use this medicine only if your doctor considers the benefit for you greater than the potential risk for your unborn child or baby.

Take pantoprazole exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Pantoprazole tablets can be taken with or without food. Pantoprazole oral granules should be taken 30 minutes before a meal.

Do not crush, chew, or break the tablet. Swallow it whole.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the condition is fully treated. If you use pantoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it. Call your doctor if your symptoms do not improve or if they get worse while you are taking this medicine. If you use pantoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it. This medicine can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking pantoprazole.

Pantoprazole sodium) Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4.
Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.