Composition

Each film coated MUPS tablet contains 20 mg Omeprazole enteric coated micro pellets

Indications

Omeprazole (Multiple-Unit Pellet System) is indixated in-

Duodenal and Gastric ulcers

NSAID-induced gastric and duodenal ulcers

Reflux Oesophagitis

GERD (Gastroesophageal Reflux Disease)

Eradication of H. pylori with appropriate antibiotics

Zollinger-Ellison Syndrome

Therapeutic Class

Proton Pump Inhibitor

Description

MUPS is abbreviation for Multiple-Unit Pellet System. However, from pharmaceutical industry and research perspective, the term in general refers to MUPS compacted into tablets. Thus, the resulting tablets prepared by compaction of modified release coated multiparticulates or pellets are called as MUPS. It is the more recent and challenging technology that combines the advantages of both tablets and pellet filled capsules in one dosage form.

MUPS ensure rapid and uniform gastric emptying and subsequently uniform drug dissolution of pellets in the gastrointestinal tract due to their small size and larger surface, uniform drug absorption is facilitated which results in consistent and controlled pharmacological action.

A further reduction in inter- and intra-subject variability in drug absorption and clinical response is facilitated since the number of pellets per MUPS dosage form is much more than a conventional pellet-filled capsule and possibility of dose dumping(in stomach) and incomplete drug release is further minimized.

Pharmacology

Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole 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 acid secretion irrespective of the stimulus.

Clinical advantage of omeprazole mups tablet compared to conventional modified-release omeprazole tablets and pellet-filled omeprazole capsules:

Ensures greater bioavailability

Ensures uniform emptying of micro pellets from stomach into small intestine facilitates rapid dissolution of enteric coating and drug release resulting in early Tmax and Cmax (peak time and peak plasma concentration)

Ensures lesser possibility of dose dumping

Is a combination of fast acting and sustained action

Ensures uniform drug release

Once daily dosing

Ensures lesser chance of localized irritation

Ensures better and more uniform drug absorption

Better than capsules in reducing the esophageal residence time

Minimizes fluctuation in plasma concentration of drug

Dosage

Adult:

GERD (Gastroesophageal Reflux Disease): 20 mg Once daily for 4 weeks

Gastric ulcer: 20 mg Once daily for 4-8 weeks; in severe cases Twice daily

Duodenal ulcer: 20 mg Once daily for 2-4 weeks; in severe cases Twice daily

NSAID-induced ulceration: 20 mg Once daily for 4-8 weeks

Reflux esophagitis: 20 mg Once daily for 4-8 weeks; in severe cases Twice daily

H. pylori eradication (Omeprazole MUPS tablet with Amoxicillin and Clarithromycin or Metronidazole): 20 mg Twice daily for 1 week

Zollinger-Ellison Syndrome: 60 mg Once daily; Usual maintenance, 20-120mg daily

Children:

Acid regurgitation in GERD (Gastroesophageal Reflux Disease): 20 mg Once daily for 2-4 week

Reflux esophagitis: 20 mg Once daily for 4-8 weeks

Administration

Swallow the tablet whole with a glass of water. The tablet must not be chewed or crushed. OR

If the patients have trouble swallowing the tablets, put the tablet into a glass of water (Do not use other liquids). Stir the preparation until the tablets disintegrate. Then drink the liquid within 30 minutes. Stir the mixture just always before drinking.

Interaction

Omeprazole is metabolized through CYP2C19 . When starting or stopping treatment with Omeprazole should be taken into account potential interactions with medicines which are CYP2C19 metabolized.

Contraindications

Omeprazole is contraindicated in those patients who have known hypersensitivity to any other components of the formulation.

Pregnancy & Lactation

Not known to be harmful. Omeprazole can be used during pregnancy. Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

Precautions & Warnings

Omeprazole tablet should be used carefully if the patient has severe liver dysfunction and severe renal impairment.

Storage Conditions

Store in a cool (below 30° C) and dry place, protected from light and moisture.