Panwin ECT

Panwin ECT

pantoprazole

Manufacturer:

Brawn Labs

Distributor:

GXI

Marketer:

Ambica
Full Prescribing Info
Contents
Pantoprazole sodium.
Description
Each enteric-coated tablet contains: Pantoprazole Sodium equivalent to Pantoprazole 40 mg.
Action
Pharmacology: Pharmacokinetics: Peak plasma of Pantoprazole concentrations are achieved about 2 to 2.5 hours after a dose by mouth. The oral bioavailability is about 77% with the enteric-coated tablet formulation, and does not vary after single or multiple doses. Pantoprazole is 98% bound to plasma proteins. It is extensively metabolized in the liver, primarily by cytochrome P450 isoenzyme CYP2C19, to desmethylpantoprazole; small amounts are also metabolized by CYP3A4, CYP2D6, and CYP2C9. Metabolites are excreted principally about 80% in the urine, with the remainder being excreted in bile. The terminal elimination half-life is about 1 hour, and is prolonged in hepatic impairment; the half-life in patients with cirrhosis was 3 to 6 hours.
Indications/Uses
It is used in gastroesophageal reflux disease, peptic ulcer disease, duodenal ulceration, benign gastric ulceration, eradication of Helicobacter pylori. Prophylaxis for NSAID-associated ulceration and Zollinger-Ellison syndrome.
Dosage/Direction for Use
Gastroesophageal reflux disease: 20 to 40 mg once daily for 4-8 weeks.
For maintenance therapy: 20-40 mg daily.
Peptic ulcer disease: 40 mg once daily.
Duodenal ulceration: 40 mg once daily for 2 to 4 weeks.
Benign gastric ulceration: 40 mg once daily for 4 to 8 weeks.
For the eradication of Helicobacter pylori: Pantoprazole may be combined with two antibacterials in a 1-week triple therapy regimen.
Effective regimens include Pantoprazole 40 mg twice daily combined with Clarithromycin 500 mg twice daily and either Amoxicillin 1 g twice daily or Metronidazole 400 mg twice daily.
Prophylaxis for NSAID-associated ulceration: 20 mg daily.
Zollinger-Ellison syndrome: 80 mg daily, given in 2 divided doses.
Or as directed by the physician.
Contraindications
Pantoprazole should generally not be used in cases of known hypersensitivity to pantoprazole.
Special Precautions
Before giving Pantoprazole or other proton pump inhibitors to patients with gastric ulcers the possibility of malignancy should be considered since these drugs may mask symptoms and delay diagnosis.
Pantoprazole and other proton pump inhibitors should be used with caution in hepatic impairment.
Adverse Reactions
Headache, diarrhea, and skin rashes. Other adverse or undesirable effects include pruritus, dizziness, fatigue, constipation, nausea and vomiting, flatulence, abdominal pain, arthralgia and myalgia, urticaria, and dry mouth. Isolated cases of photosensitivity, bullous eruption, erythema multiforme, angioedema, and anaphylaxis have been reported.
Effects on the CNS include occasional insomnia, somnolence, and vertigo; reversible confusional states, agitation, depression, and hallucination have occurred in severely ill patients raised liver enzymes, and isolated cases of hepatitis, jaundice, and hepatic encephalopathy, have been reported.
Other adverse effects reported rarely or in isolated cases include paraesthesia, blurred vision, alopecia, stomatitis, sweating, taste disturbances, peripheral oedema, malaise, hyponatraemia, blood disorder (including agranulocytosis, leucopenia, and thrombocytopenia), and interstitial nephritis.
Proton pump inhibitors may increase the risk of gastrointestinal infections because of their acid suppressive effects.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
EC tab 40 mg x 30's, 100's.
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