Page 5 - D'Conner PRODUCT catalogue

FORMULATION:
Each Delayed-Release capsule contains:
Lansoprazole (as enteric-coated pellets) …... 30 mg
DESCRIPTION:
It is a substituted benzimidazole. 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl]
succinyl] benzimidazole, a compound that inhibits gastric acid secretion. This is a white to
brownish- white powder which melts with decomposition at approximately 166⁰C. Lansoprazole
is freely soluble in dimethylformamide and practically insoluble in water.
Clinical Pharmacology:
PHARMACODYNAMICS: It has been characterized as a gastric acid-pump inhibitor; in that it
blocks the final step of acid production. This effect is dose related and leads to inhibition of both
basal and stimulated gastric acid secretion irrespective of the stimulus. It does not exhibit
anticholinergic or histamine type-2 antagonistic activity.
PHARMACOKINETICS: This contains enteric coated pellets formulation of lansoprazole.
Absorption begins only after the pellets leave the stomach. It is absorbed rapidly with an 80%
bioavailability and its half-life is at 1.5 hours.97% is plasma protein bound and it is extremely
metabolized in the liver.
INDICATION:
It is used to treat peptic ulcer disease and in other conditions where inhibition of gastric acid
secretion may be beneficial.
DOSAGE AND ADMINISTRATION:
 Relief of Acid-related dyspepsia: 15 or 30 mg daily for 2-4 weeks.
 Gastroesophageal reflux disease: 30 mg daily for 4-8 weeks. Maintenance: 15 or 30 mg
daily
 Peptic Ulcer Disease: 30 mg once daily for 4 weeks (duodenal ulcer) or 8 weeks (gastric
ulcer)
 Prevention of duodenal ulcer relapse: 15 mg Daily. Eradication of H. Pylori: Lansoprazole
30 mg twice a day w/ clarithromycin 500 mg twice a day and either amoxicillin 1 g twice
a day or metronidazole 400 mg twice a day.
 NSAID-associated ulcers: 15 or 30 mg daily for 4-8 weeks.
Zollinger-Ellison syndrome: Initially 60 mg daily up to 90 mg twice a day
Contraindication:
 Contraindicated in patients with known hypersensitivity to any component of the
formulation
 Do not take with: Warfarin, Tacrolimus, Theophylline, Clopidogrel, Methotrexate
 Not recommended for lactation
WARNINGS AND PRECAUTIONS:
 Gastric malignancy, Clostridium difficile-associated diarrhea,
 It may cause Bone Fracture
PREGNANCY CATEGORY B (AFTER THE FIRST TRIMESTER)
AVAILABILITY: Box of 30’s
SHELF-LIFE: 36 mos.
MANUFACTURER: Scott-Edil Pharmacia Limited, India
IMPORTER: Pharmakon Biotech Inc.
DISTRIBUTOR: D’Conner Pharma