Topix Rabepratop 20 Rabeprazole Sodium Tablet

RABEPRATOP-2O

Rabeprazole Sodium Tablet 20mg

 

Each Enteric coated Tablet contains:

Rabeprazole Sodium 20mg.

Excipients Q.S.

 

Description

Rabeprazole sodium is a substituted benzimidazoIe that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy) -3-methyl-2-pyridinyl]-methyl]sulfinyl] -1Hbenzimidazole sodium salt. It has an emperical formula of C18H23N3Na3S 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 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 10/20 mg of rabeprazole sodium. Inactive ingredients are carnauba wax, crospovidone, diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose phthalate, magnesium stearate, mannitol, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide and Sunset Yellow FCF as a colouring agent.

 

Pharmacological Action

Rabeprazole sodium is a proton pump inhibitor. It is a prodrug. After administration it diffuses in to the parietal cell of the stomach and accumulates in the secretory canaliculi. In the acidic medium rabeprazole is converted to sulfenamide. This sulfenamide 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 add secretion. Rabeprazole produces fast acid suppression and helps in mucin synthesis.

 

Indications

Rabeprazole is indicated in active duodenal ulcers, benign gastric ulcers, Zodinger-Ellison syndrome and erosive gastroesophageal reflux disease (GERD).

 

Contraindications

Rabeprazole is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles or to any component of the formulation.

 

Drug Interaction

Patients receiving proton pump inhibitors, including rabeprazole, and warfarin concomitantly may lead to abnormal bleeding and even death because of increases 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 trough digoxin levels in normal subjects.

 

Warning

PREGNANCY: This drug should be used during pregnancy only if clearly needed.

NURSING MOTHERS: A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

 

Precautions

Special precautions are to be exercised specifically in the event of Hepatic impairment. Symptomatic response to therapy with rabeprazole does not preclude the possible presence of gastric malignancy. Tablets should be swallowed whole and not chewed or crushed.

 

Adverse Effects

Most common adverse effects observed with rabeprazole are diarrhoea, nausea headache, vomiting, abdominal pain, dizziness, flatulence, constipation, dyspepsia, flu like syndrome, insomnia, back pain, cough, rhinitis, pharyngitis and rash.

 

Overdose

Give supportive measures and symptomatic treatment.

 

Dosage

Oral Adult: 10-20 mg/day to be taken whole usually in the morning with or without food.

Children: not recommended

Duodenal Ulcer: 20mg/day in the morning for a period up to 4 weeks. If needed, dose can be continued for 4 more weeks.

Benign Gastric Ulcer: 20mg/day in the morning for 6 weeks. If needed, dose can be continued for 6 more weeks.

Zollinger-Ellison Syndrome: Initial dose: 60mg /day if needed increase the dose up to 120mg/day in 2 divided doses.

Erosive Gastroesophageal Reflux Disease (GERD): 20mg / day for 4 to 8 weeks. Long term management 10-20mg once daily before breakfast for 1 year.

 

Storage

Store in a cool, dry place. Protect from light.

Keep medicines out of reach of children.

 

Presentation

Alu-Alu Blister packing of 3 x 10 Tablets.

 

Manufactured by

Stallion Laboratories Pvt. Ltd.

C-1B, 305/2 & 3, GIDC Kerala (Bavia)

Dist.: Ahmedabad, Gujarat, India.

 

Marketed by

Topix Pharmaceuticals (Nig) Ltd.

Adj. Umoro, Shehu Hospital Maiduguri,

Bornu State, Nigeria.

Advertisements

Leave a Reply