Othera 20mg Tablet

20 mg tablet: It contains Esomeprazole Magnesium Trihydrate USP enteric coated micro pellets equivalent to Esomeprazole 20 mg.
40 mg tablet: It contains Esomeprazole Magnesium Trihydrate USP enteric coated micro pellets equivalent to Esomeprazole 40 mg.
20 mg capsule: It contains Esomeprazole Magnesium Trihydrate USP enteric coated micro pellets equivalent to Esomeprazole 20 mg.
40 mg capsule: It contains Esomeprazole Magnesium Trihydrate USP enteric coated micro pellets equivalent to Esomeprazole 40 mg.

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 technologies that combine the advantages of both tablets and pellet-filled capsules in one dosage form.

• 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
• 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.
• Is better than capsules in reducing the esophageal residence time.
• Minimizes fluctuation in plasma concentration of drug.

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.

The proton pump inhibitor Esomeprazole inhibits gastric acid by blocking the hydrogen-potassium adenosine triphosphatase enzyme system (the proton pump) of the gastric parietal cell. Proton pump inhibitors are effective for short-term treatment of gastric and duodenal ulcers. Esomeprazole is also used in the prevention and treatment of NSAID associated gastric ulcers.

Adults (from the age of 18 years)–
Gastroesophageal reflux disease (GERD):

• Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation): 20 mg Once daily for 24 weeks
• Maintenance treatment of NERD (i.e. heartburn and regurgitation): 20 mg Once daily
• Reflux esophagitis or erosive esophagitis: 20 mg or 40 mg Once daily for 4-8 weeks
• Maintenance therapy of healing of reflux esophagitis: 20 mg Once daily

Healing of NSAID associated gastric ulcers: 20 mg Once daily for 4-8 weeks

Risk reduction of NSAID associated gastric ulcers: 20 mg Once daily

Zollinger-Ellison Syndrome: 40 mg Twice daily

H. pylori eradication (Esomeprazole with amoxicillin 1000 mg and clarithromycin 500 mg): 20 mg tab. twice daily for 7 days or 40 mg cap. once daily for 10 days

Pediatrics (12 to 17 years)–
Gastroesophageal reflux disease (GERD):

• Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation): 20 mg Once daily for 2-4 weeks
• Reflux esophagitis or erosive esophagitis: 20 mg or 40 mg Once daily for 4-8 weeks.

Esomeprazole MUPS tablet is taken orally with or without food. This should be swallowed whole with liquid. The tablets should not be chewed or crushed. If required, the tablets can also be dispersed in half a glass of non-carbonated water (mineral water is not suitable). No other liquids should be used. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed.

Othera is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Othera is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Othera does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Othera may potentially interfere with CYP2C19, the major Othera metabolizing enzyme. Co-administration of Othera 30 mg anddiazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Othera inhibits gastric acid secretion. Therefore, Othera may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).

Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Othera.

Combination Therapy with Clarithromycin: Co-administration of Othera, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of Othera and 14-hydroxyclarithromycin.

Esomeprazole is contraindicated in patient with known hypersensitivity to any of the formulation.

The most common side effects of Othera are nausea, vomiting, abdominal pain, flatulence, diarrhea, constipation and headache. Less frequent side effects include dry mouth, peripheral edema, dizziness, sleep disturbances, fatigue, paraesthesia, arthralgia, myalgia, rash and pruritus. Other side effects reported rarely or very rarely include taste disturbance, stomatitis, hepatitis, jaundice, hypersensitivity reactions (including anaphylaxis, bronchospasm), fever, depression, hallucinations, confusion, gynaecomastia, interstitial nephritis, hyponatraemia, blood disorders (including leucopenia, leukocytosis, pancytopenia, thrombocytopenia), visual disturbances, sweating, photosensitivity, alopecia, Stevens-Johnson Syndrome and toxic epidermal necrolysis.

Pregnancy: For esomeprazole, limited clinical data on exposed pregnancies are available. Esomeprazole should only be given to pregnant women if its use is considered essential.

Lactation: It is not known whether esomeprazole is excreted in breast milk. Therefore esomeprazole should not be used during breast-feeding.

Othera should be used carefully if the patient has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like Othera may slightly increase the risk of hip, wrist and spine fracture, particularly when it is taken over a period of more than one year.

There is very limited experience to date with deliberate overdose. The symptoms described in connection with 280 mg were gastrointestinal symptoms and weakness. Single doses of 80 mg Othera were uneventful. No specific antidote is known. Othera is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilized.

Proton Pump Inhibitor

Store in a cool & dry place below 25ºC, protect from light. Keep out of reach of children.