PANTOP-S

COMPOSITION:

Pantop-S

Each enteric coated tablet contains:

S (-) Pantoprazole sodium equivalent to

S (-) Pantoprazole        20 mg.

Colour: Yellow Oxide of Iron & Titanium Dioxide IP

CLINICAL PHARMACOLOGY:

Mechanism of Action: S-Pantoprazole is a proton pump inhibitor (PPI) that suppresses 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 for longer than 24 hours.

Pharmacokinetics:

Absorption: Rapid absorption with peak plasma concentration (~2-3 µg/ml) occurring 2.5 hours after a 40 mg oral dose, with a bioavailability of 77%. Food does not affect bioavailability, but it increases variability in lag-time.

Distribution: 98% serum protein binding, with a volume of distribution of 0.15 L/kg.

Metabolism: Primarily metabolized in the liver via CYP2C19 (demethylation) and CYP3A4 (oxidation).

Elimination: Terminal half-life of 1 hour, with 80% of metabolites excreted in urine. The main metabolite is desmethylpantoprazole, with a similar half-life to pantoprazole (1.5 hours).

INDICATION AND USAGE:

S (-) Pantoprazole Tablets is indicated for the treatment of duodenal ulcer and gastric ulcer, gastroesophageal reflux disease (GERD) and pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome). 

DOSAGE AND ADMINISTRATION:

The usual recommended adult oral dose is 20mg given once daily for upto 8 weeks. Higher or lower doses may be used at the discretion of the physician.

WARNING AND PRECAUTIONS:

Warnings:Long-term high-dose use of pantoprazole (>1 year) may increase the risk of hip, wrist, and spine fractures.Symptomatic response does not rule out the presence of gastric malignancy.

Precautions:Monitor liver enzymes regularly in patients with severe liver impairment.Avoid co-administration with HIV protease inhibitors.Note potential vitamin B12 malabsorption and increased risk of gastrointestinal infections with prolonged use.

ADVERSE REACTIONS:

The most common adverse reactions for adults (>2%) include headache, diarrhea, and nausea, while for pediatrics (>4%) they include URI, headache, and fever.

USE IN SPECIAL POPULATION:

Pregnancy: Moderate data show no malformative or fetal toxicity, but animal studies suggest reproductive toxicity; avoid pantoprazole during pregnancy unless clearly necessary.

Nursing Mothers: Pantoprazole is excreted in animal milk, and its excretion in human milk is also reported; a risk to infants cannot be excluded, so use should be carefully considered.

Pediatric Use: Pantoprazole’s pharmacokinetics in children (5-16 years) are similar to adults, with no significant age or weight-related clearance changes observed in children aged 2-16 years.

Geriatric Use: Slight increases in AUC and Cmax in elderly patients are not clinically relevant; safety and efficacy in elderly patients have not been established.

CONTRAINDICATIONS:

Hypersensitivity to the active substance, substituted benzimidazoles 

OVERDOSAGE:

There was no case reports received for overdose with s-pantoprazole. There are no known symptoms of overdose in man for pantoprazole. Systemic exposure with up to 240mg administered intravenously over 2 minutes was well tolerated.

STORAGE: Store protected from light and moisture at a temperature not exceeding 30°C.

PRESENTATION: 

Pantop-S: Carton containing 10 Tablets in cold form blister pack.