Capsule Presentation

Each hard gelatin capsule contains:
Aceclofenac IP                   200 mg
(As Sustained Release)
Rabeprazole Sodium IP    10 mg/20 mg
(As Enteric Coated)

This is a combination of two medicines: Aceclofenac and Rabeprazole, which relieves pain. Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) which works by blocking the release of certain chemical messengers that cause pain and inflammation (redness and swelling).

Rabeprazole is a proton pump inhibitor (PPI). It works by reducing the amount of acid in the stomach which helps in the relief of acid-related indigestion and ulcers.

Indications:

• Intestinal ulcers and duodenal ulcers
• Gastroesophageal reflux disease (GERD)
• Maintaining healing and reducing relapse rates of heartburn symptoms
• Treatment of pathological hypersecretory conditions (Zollinger - Ellison syndrome)

Mechanism of Action

Aceclofenac:

Aceclofenac is a NSAID that inhibits both isoforms of COX enzyme, a key enzyme involved in the inflammatory cascade. COX-1 enzyme is a constitutive enzyme involved in prostacyclin production and protective functions of gastric mucosa whereas COX-2 is an inducible enzyme involved in the production of inflammatory mediators in response to inflammatory stimuli. Through COX-2 inhibition, aceclofenac downregulates the production of various inflammatory mediators including prostaglandin E2 (PGE2), IL-1β, and TNF from the arachidonic acid (AA) pathway. It is rapidly and completely absorbed from GIT. Time to reach maximum concentration in plasma is about 1.23-3 hours. It is highly bound protein drug with 99% and the volume of distribution is about 25 L. It is metabolised by CYP enzyme family and 70-80% of the metabolites are excreted in urine with only 20% excreted in feces. The half-life is approximately 4 hours.

Rabeprazole:

Rabeprazole is an antiulcer drug in the class of proton pump inhibitors. It is a prodrug - in the acid environment of the parietal cells it turns into active sulphenamide form. Rabeprazole inhibits the H+, K+ATPase of the coating gastric cells and dose-dependent oppresses basal and stimulated gastric acid secretion. Rabeprazole blocks the final step of gastric acid secretion. In gastric parietal cells, rabeprazole is protonated, accumulates, and is transformed to an active sulfenamide. When administered orally, the bioavailability is only 52% and 96.3% of the drug is bound to plasma protein. It is metabolised in liver and about 90% of the drug is excreted in urine. The half-life of rabeprazole is 1-2 hours.

Side Effects

Generally well tolerated. Most common side effects are Headache, abdominal pain, dry mouth, dizziness, nausea and diarrhea.