Rabesta 20

Rabesta 20

rabeprazole

Manufacturer:

Stallion Labs

Distributor:

Ambica

Marketer:

Macropharma Corp
Full Prescribing Info
Contents
Rabeprazole sodium.
Description
Each enteric-coated tablet contains rabeprazole sodium 20 mg.
Rabeprazole sodium is a substituted benzimidazole that inhibits gastric acid secretion. It is chemically known as 2-[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl] sulfinyl]-1H-benzimidazole sodium salt. It has an empirical formula of 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 rabeprazole sodium 20 mg. Inactive ingredients are carnauba wax, crospovidone, deacetylated monoglyceride, ethylcellulose, 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 (PPI). It is a prodrug. After administration, it diffuses in the parietal cell of the stomach and accumulated 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 extracellular K+ for intracellular H+ ion.
Rabeprazole sodium irreversibly inhibits proton-pumps activity and decreases gastric acid secretion.
Rabeprazole produces fastest acid suppression and helps in mucin synthesis.
Pharmacokinetics: Peak plasma-rabeprazole concentrations (Cmax) are about 3.5 hrs after a dose by mouth. The oral bioavailability is about 52% with the enteric-coated tablet formulation, because of first-pass metabolism and does not appear to vary after single or repeated doses. Rabeprazole is 97% bound to plasma proteins. It is extensively metabolized in the liver by cytochrome P450 isoenzymes CYP2C19 and CYP3A4 to the thioether, thioether carboxylic acid, sulfone and desmethylthioether. Metabolites are excreted principally in the urine about 90% with the remainder in the feces. The plasma half-life (t½) is about 1 hr, increased 2- or 3-fold in hepatic impairment, 1.6 times in CYP2C19 slow metabolizers and by 30% in the elderly.
Indications/Uses
Active duodenal ulcer, benign gastric ulcer, Zollinger-Ellison syndrome and ulcerative or erosive gastroesophageal reflux disease (GERD).
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 GERD: 20 mg once daily for 4-8 weeks; maintenance 10-20 mg daily; symptomatic treatment in the absence of esophagitis, 10 mg daily for up to 4 weeks, then 10 mg daily when required.
Duodenal and Benign Gastric Ulcer Associated with Helicobacter pylori: 20 mg twice daily plus clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily for 7 days.
Overdosage
Give supportive measures and symptoms treatment.
Contraindications
Hypersensitivity to rabeprazole, substituted benzimidazole or to any of the component of Rabesta.
Warnings
Contains FD and 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: Rabeprazole sodium should be used during pregnancy only if clearly needed.
A decision should be made to discontinue nursing or discontinue rabeprazole sodium, taking into account the importance of rabeprazole sodium to the mother.
Use In Pregnancy & Lactation
Use in pregnancy: Rabeprazole sodium should be used during pregnancy only if clearly needed.
Use in lactation: A decision should be made to discontinue nursing or discontinue rabeprazole sodium, taking into account the importance of rabeprazole sodium 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 PPIs, including rabeprazole, and warfarin concomitantly may lead to abnormal bleeding and even death because of increase in international normalized ratio (INR) and prothrombin time. Co-administration of rabeprazole sodium results in a 33% decrease in ketoconazole levels. Rabeprazole-digoxin co-administration results in increased trough digoxin levels in normal subjects.
Storage
Store at temperature not exceeding 30°C in a tightly closed container. Protect from light.
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 30's.
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