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Panzo 40(oral,inj)

Pantoprazole Tablets 40mg

 

COMPOSITION

Each enteric coated tablet contains:

Pantoprazole Sodium Sesquihydrate

Equivalent to Pantoprazole 40mg

Excipients: q.s

Colour: Iron oxide yellow

 

Description

Pantoprazole is proton pump Inhibitor ,i.e, it inhibits specifically and dose proportionally H+,K+-ATPase the enzyme which is responsible for gastric acid secretion in the parietal cells of the stomach.

 

Interactions

Concomitant intake of food has no influence on the bioavailability

Pantoprazole may reduce or increase the absorption of drugs whose bioavailability is Ph-dependent e.g.ketoconazole.

Studies in humans reveal no interaction with the cytochrome P450-system of the liver. There was no induction of the cytochrome P450-system after chronic administration as shown with marker antipyrine and no interactions were observed after concomitant administration of Pantoprazole with either antiphyrine, diazepam, theophylline, digoxin, oralconraceptiveshenytoin, nifedipine, carbamazepine, diclofenac, metoprolol, glibenclamide, ethanol and caffeine. Concomitant administration of warfarin or phenprocoumon has no influence on its effect on coagulation factors.

 

Antacid do not interact with Pantoprazole.

 

INDICATIONS

Pantoprazole 40 is indicated for the short-term treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis. If the duodenal ulcer has been demonstrated to be associated with Helicobacter pylori infection.

Pantoprazole 40used in combination with appropriate antibiotic may be useful.

 

CONTRAINDICATIONS

Hypersensitivity to Pantoprazole.

 

Safety in pregnancy and during lactation has not been established. Safety and efficacy in children have not been established. Safety and efficacy in children have not been established. Severely impaired liver function.

 

DOSAGE AND DIRECTIONS FOR USE

The recommended once daily dosage of Pantoprazole should be taken in the morning. Panzo40 should be swallowed whole with a little water either before or during breakfast.

Duodenal ulcer: The recommended oral dosage is 40mg Pantoprazole once daily in the morning for 2 to 4 weeks. If the duodenal ulcer has been demonstrated to be associated with Helicobacter pylori infection, Panzo 40 used in combination with appropriate antibiotics may be useful.

 

Gastric ulcer: The recommended oral dosage is 40mg Pantoprazole once daily in the morning for 4 to 8 weeks. In case of a suspected gastric ulcer, malignancy of the ulcer should be excluded, as treatment could conceal the symptoms and may delay diagnosis.

 

Reflux oesophagitis: The recommended oral dosage is 40mg Pantoprazole once daily in the morning for 4 to 8 weeks.

 

Elderly patients

No dosage adjustment is necessary in the elderly.

 

Impaired renal and liver function

No dosage adjustment is required in the presence of impaired renal and liver function.

 

ADVERSE EFFECTS AND SPECIAL PRECAUTIONS

Side-effects

Headache and gastro-intestinal complaints such as upper abdominal pain, diarrhea, constipation or flatulence have been reported. With contained treatment complaints usually diminish.

There have been reports of allergic reactions such as skin rash, pruritus and in isolated cases also urticaria, angioedema or anaphylactic shock.

There have been less frequent reports of nausea, dizziness or disturbances in vision (blurred-vision). Peripheral edema, depression, fever or myalgia has been reported in individual cases.

 

Special precautions

Pantoprazole is not indicated for mild gastro-intestinal complaints such as­­­ nervous dyspepsia.

Prior to treatment, the possibility of malignant gastric ulcer or a malignant disease of the oesophagus should be excluded, as the treatment with Pantoprazole may alleviate the symptoms of malignant ulcers and can thus delay diagnosis.

Diagnosis of reflux oesophagitis should be confirmed by endoscopy.

 

PRESENTATION:

Blister pack of 10 tablets.

 

 

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