Pantopra 40mg

Tablet
Pantoprazole
Alco Pharma

Other Strength:
- Pantopra 20mg

Alternative:
- Pantobex 40mg
- PROTOCID 40mg
- Pregel 40mg
- Nixpan 40mg
- Pantogut 40mg
- Pantex 40mg
- Pantodac 40mg
- Prilosec 40mg
- Proton-P 40mg
- Pantotop 40mg
- Trupan 40mg
- Protonil 40mg



Pantopra
Description:
Pantoprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. Pantoprazole inhibits secretion of gastric acid by blocking the hydrogen-potassium-adenosine triphosphatase enzyme system, the so called 'Proton Pump'of the gastric parietal cell. Absorption of Pantoprazole begins only after the tablet leaves the stomach. Peak serum concentration (Cmax) and area under the serum concentration time curve (AUC) increase in a manner proportional to oral dose from 10 mg to 80 mg. Pantoprazole does not accumulate and its pharmacokinetics are unaltered with multiple daily dosing. Following oral administration, the serum concentration of Pantoprazole declines biexponentially with a terminal elimination half-life of approximately one hour. The absorption of Pantoprazole is rapid, with a Cmax of 2.5 mcg/ml, which occurs approximately 2.5 hours after single or multiple oral 40-mg doses. Pantoprazole is well absorbed. It undergoes little first-pass metabolism resulting in an absolute bioavailability of approximately 77%. Administration of Pantoprazole with food may delay its absorption up to 2 hours or longer. However, the Cmax and the extent of Pantoprazole absorption (AUC) are not altered. Thus, Pantoprazole may be taken without regard to timing of meals. The serum protein binding of Pantoprazole is about 98%, primarily to albumin. Pantoprazole is extensively metabolized in

the liver through the cytochrome P450 (CYP) system. After a single oral 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. There was no renal excretion of unchanged Pantoprazole.

Composition:
Pantopra-20: Each tablet contains Pantoprazole Sodium Sesquihydrate BP equivalent to Pantoprazole 20 mg.

Pantopra-40: Each tablet contains Pantoprazole Sodium Sesquihydrate BP equivalent to Pantoprazole 40 mg.

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

Dosage Guideline:
The usual recommended adult oral dose is 40 mg given once daily, before breakfast. The duration of therapy is ranging from 2-8 weeks. Duodenal Ulcers: Pantopra 40 mg tablet, once daily for 2 to 4 weeks. Duodenal ulcer generally heals within 2 weeks. Gastric ulcers: Pantopra 40 mg tablet, once daily for 4 to 8 weeks. Gastric ulcer generally heals within 4 weeks. Reflux esophagitis: Pantopra 40 mg tablet, once daily for 4 to 8 weeks. Reflux esophagitis generally heals within 4 weeks of treatment. In resistant ulcers: Pantopra 40 mg tablet, once daily for 8 weeks. Ulcers induced by NSAIDs: Pantopra 40 mg tablet once daily, in patients receiving continuous treatment with NSAIDs. GI bleeding from stress or acid peptic diseases: Usual adult oral dosage, if required the dosage may be increased. Eradication of Helicobacter pylori: Triple therapy of Pantopra 40 mg twice daily in combination with appropriate antibiotic for one week achieved eradication rates of 90 to100%. Zollinger-Ellison syndrome: 4 Pantopra 40 mg tablets per day. Once control of acid secretion has been achieved, the dose should be gradually reduced to the lowest effective dose that maintains acid control. Prophylaxis for acid aspiration syndrome during induction of anaesthesia: 1 or 2 Pantopra 40 mg tablet should be given the evening before surgery and repeated again the morning of surgery.

Side Effects:
Potentially life-threatening effects: None has been reported with respect to Pantoprazole. Severe or irreversible adverse effects: No serious adverse reactions have been described to date. Symptomatic adverse effects: Headache (1.3%) and diarrhoea (1.5%) are the two commonest reported adverse events. It doesn't influence renal, cardiovascular, respiratory, endocrine, cognitive or motor functions and no consistent change have been found in any biochemical or haematological parameters. Peripheral edema has occasionally been reported in female patients. Other side effects may include abdominal pain, dizziness, nausea, epigastric discomfort, flatulence, skin rash, pruritus etc.

Contraindication:
Pantopra tablets are contraindicated in patients with known hypersensitivity to any of the formulation.

Use in Pregnancy & Lactation:
Pregnant women: USFDA pregnancy category B. Studies using animals have not found any risk to fetus.
Neonates & Children: No data are available on administration of Pantoprazole.

Precaution:
Patients should be cautioned that Pantopra tablets should not be split, chewed or crushed.

Therapeutic Class:
Anti-Ulcerant

Dosage Form:
Tablet

Storage:
Store in a cool (below 25oc) and dry place, protected from light and moisture.

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