Losectil MUPS 20 mg

INDICATIONS

Omeprazole MUPS tablet is indicated 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

PHARMACOLOGY

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.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.

Pharmacodynamic advantage:

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.

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, 20-120 mg daily.

Children over 2 years old:

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.

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.

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.

THERAPEUTIC CLASS

Proton Pump Inhibitor

STORAGE CONDITIONS

Store in a cool (below 25°C) and dry place, protected from light and moisture.