Doctra

Doctra

rabeprazole

Manufacturer:

Stallion Labs

Distributor:

Glorious Dexa Mandaya

Marketer:

Ambica
Full Prescribing Info
Contents
Rabeprazole Na.
Description
Each enteric coated tablet contains: Rabeprazole sodium 20 mg.
Rabeprazole sodium is a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1H benzimidazole sodium salt. It has an empirical formula C18H20N3NaO3S and a molecular weight of 381.43. Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform and ethyl acetate and insoluble in ether and n-hexane. The stability of Rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions.
Rabeprazole tablets are available for oral administration as delayed-release, enteric coated tablets containing 20 mg of Rabeprazole sodium.
Inactive ingredients are carnauba wax, crospovidone, deacetylated monoglyceride, ethyl cellulose, hydroxypropyl cellulose, hypromellose phthalate, magnesium stearate, mannitol, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide, and sunset yellow FCF as a coloring agent.
Action
Pharmacology: Rabeprazole sodium is a proton-pump inhibitor. II is prodrug. After administration it diffuses into the parietal cell of the stomach and accumulates in the secretory canaliculi. In the acidic medium Rabeprazole is converted to sulfonamide. This sulfonamide covalently interacts with sulfhydryl (SH) group in the proton pump (H+ K+ ATPase) and inhibits the exchange of extra cellular K+ for intracellular H+ ion.
Rabeprazole sodium irreversibly inhibits proton pump activity and decreases gastric acid secretion. Rabeprazole produces fastest acid suppression and helps in mucin synthesis.
Pharmacokinetics: Peak plasma-rabeprazole concentrations reach about 3.5 hours after a dose by mouth. The oral bioavailability is about 52% with the enteric-coaled tablet formulation, because of first-pass metabolism, and does not appear lo vary after single or repealed doses. Rabeprazole is 97% bound lo plasma proteins. It is extensively metabolized in the liver by cytochrome P450 isoenzymes CYP2C19 and CYP3A4 lo the thioether, thioether carboxylic acid, sulfone, and desmethyl thioether. Metabolites are excreted principally in the urine about 90% with the remainder in the feces. The plasma half-life is about 1 hour, increased two or threefold in hepatic impairment, 1.6 times in CYP2C19 slow metabolizers and by 30% in the elderly.
Indications/Uses
Short term treatment for gastric and duodenal ulcer; also used in combination with antibacterials for eradication of Helicobacter pylori; treatment for gastro-oesophageal reflux disease and Zollinger-Ellison syndrome.
Dosage/Direction for Use
Benign gastric ulcer: 20 mg daily in the morning for 6 weeks, continued for further 6 weeks if not fully healed.
Duodenal ulcer: 20 mg/day in the morning for 4 weeks, continued for further 4 weeks if not fully healed.
Ulcerative or Erosive Gastroesophageal reflux disease: 20 mg once daily for 4-8 weeks; maintenance 10-20 mg daily; symptomatic treatment in the absence of oesophagitis, 10 mg daily for up to 4 weeks, then 10 mg daily when required.
Duodenal and benign gastric ulcer associated with: 20 mg twice daily + clarithromycin 500 mg twice daily and amoxicillin 1 gram twice daily for 7 days.
Overdosage
Give supportive measures and symptoms treatment.
Contraindications
Rabeprazole is contraindicated in patients with known hypersensitivity to Rabeprazole, substituted benzimidazole or lo any component of the formulation.
Warnings
Contains FD & C yellow No. 5 (Tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible individuals.
Special Precautions
Special precautions are to be exercised specifically in the event of Hepatic impairment.
Monitor gastric malignancy.
Use In Pregnancy & Lactation
Pregnancy: This drug should be used during pregnancy only if clearly needed.
Nursing Mother:
A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
Most common adverse effects observed with Rabeprazole are Diarrhea, Nausea, Headache, Vomiting, Abdominal pain, Dizziness, Flatulence, Constipation, Dyspepsia, Flu like syndrome, Insomnia, Back pain, Cough, Rhinitis, Pharyngitis and Rash.
Drug Interactions
Patients receiving proton-pump inhibitors, including Rabeprazole and warfarin concomitantly may lead to abnormal bleeding and even death because of increased in INR and prothrombin time. Co-administration of Rabeprazole sodium results in a 33% decrease in ketoconazole levels.
Rabeprazole-Digoxin co-administration results in increased through digoxin levels in normal subjects.
Storage
Store at a temperature not exceeding 30°C.
ATC Classification
A02BC04 - rabeprazole ; 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 20 mg x 28's.
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