Adults (18 years and above)

Gastroesophageal reflux disease (GERD)

• Non-erosive reflux disease (NERD), such as heartburn and regurgitation
• Maintenance therapy for NERD (heartburn and regurgitation)
• Reflux esophagitis or erosive esophagitis
• Maintenance treatment in patients with reflux esophagitis

Healing of gastric ulcers associated with NSAID use

Prevention of NSAID-related gastric ulcers

Zollinger–Ellison syndrome

Eradication of H. pylori infection

Pediatrics (12–17 years of age)

• Gastroesophageal reflux disease (GERD)
• Non-erosive reflux disease (NERD), including heartburn and regurgitation
• Reflux esophagitis or erosive esophagitis

MUPS stands for Multiple-Unit Pellet System. In pharmaceutical practice, it generally refers to tablets formed by compressing modified-release coated pellets. This advanced technology combines the benefits of both conventional tablets and pellet-filled capsules in a single dosage form.

• Ensures improved bioavailability.
• Promotes uniform emptying of micro-pellets from the stomach to the small intestine, allowing rapid dissolution of enteric coating and early drug release (earlier Tmax and Cmax).
• Reduces the risk of dose dumping.
• Provides both rapid onset and sustained therapeutic effect.
• Ensures consistent and uniform drug release.
• Allows once-daily dosing.
• Minimizes the risk of localized irritation.
• Enhances overall drug absorption.
• Reduces esophageal residence time compared to capsules.
• Minimizes fluctuations in plasma drug concentration.

MUPS enables rapid and uniform gastric emptying, followed by consistent dissolution of pellets throughout the gastrointestinal tract. Due to their small size and larger surface area, uniform drug absorption is achieved, resulting in controlled and predictable pharmacological action.

Additionally, variability in drug absorption and clinical response (both between and within patients) is reduced. Since MUPS contains a greater number of pellets compared to conventional capsule systems, the risks of dose dumping and incomplete drug release are further minimized.

20 mg tablet: Contains Esomeprazole Magnesium Trihydrate USP in enteric-coated micro-pellet form equivalent to 20 mg Esomeprazole

40 mg tablet: Contains Esomeprazole Magnesium Trihydrate USP in enteric-coated micro-pellet form equivalent to 40 mg Esomeprazole

20 mg capsule: Contains Esomeprazole Magnesium Trihydrate USP enteric-coated micro pellets equivalent to 20 mg Esomeprazole

40 mg capsule: Contains Esomeprazole Magnesium Trihydrate USP enteric-coated micro pellets equivalent to 40 mg Esomeprazole

Esomeprazole, a proton pump inhibitor, reduces gastric acid secretion by blocking the hydrogen-potassium ATPase enzyme system (proton pump) in the gastric parietal cells. It is effective in the short-term management of gastric and duodenal ulcers. Additionally, it is used for both prevention and treatment of gastric ulcers associated with NSAID use.

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.

Administration

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.

 Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole 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 Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 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. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole 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 Esomeprazole.

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

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

The most common side effects of esomeprazole 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.

Esomeprazole should be used carefully if the patient has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like Esomeprazole 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 esomeprazole were uneventful. No specific antidote is known. Esomeprazole 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.