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ESOLOK MUPS

ESOMEPRAZOLE


NAME STRENGTH PACK SIZE DOSAGE FORM
ESOLOK MUPS 20 MG 20 MG 50 S MUPS TABLET
ESOLOK MUPS 40 MG 40 MG 30 S MUPS TABLET

Esolok MUPS 20 Tablet: Each MUPS (Multiple Unit Pellet System) tablet contains Esomeprazole Magnesium Trihydrate USP as enteric coated pellets equivalent to Esomeprazole 20 mg.

Esolok MUPS 40 Tablet: Each MUPS (Multiple Unit Pellet System) tablet contains esomeprazole Magnesium Trihydrate USP as enteric coated pellets equivalent to esomeprazole 40 mg.

MUPS: Multiple Unit Pellet System is known as MUPS. The tablets are prepared by compaction of modified release coated pellets along with cushioning granules. MUPS is the latest technology which combines both tablets and pellets – filled capsule in one single dosage form.

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ -ATPase in the gastric parietal cell. It blocks the final step in acid production thus reducing gastric acidity.

Clinical Advantage of Esolok MUPS Tablet:

  1. Ensures greater bioavailability 2. Ensures Tmax & Cmax very fast 3.Once daily dose 4. No fluctuation in plasma concentration of drug 5. Ensures reduction of esophageal residence time 6. Ensure less possibility of dose dumping 7. Ensures less chance of localized irritation 8. Gives efficacy very fast & effective for long time.

Pharmacodynamic Advantage:

Pellets of MUPS tablet quickly transfer from stomach to intestine as a result absorption occur very fast. Due to small size pellets it covers largest area and maximum absorption occurs in intestine

  • For the healing of erosive esophagitis
  • For the maintenance of healing of erosive esophagitis
  • For symptomatic gastroesophageal reflux disease
  • For the risk reduction of NSAID induced gastric ulcers
  • For the eradication of Helicobacter pylori in combination with Amoxicillin and Clarithromycin

For Adults from age 18 years-

Indication

Dosage

Frequency

Gastro Esophageal Reflux Disease (GERD)

Erosive Esophagitis

40 mg

Once daily for 4 to 8 weeks

Maintenance of healing of Erosive Esophagitis

20 mg

Once daily

Symptomatic Gastroesophageal Reflux Disease

20 mg

Once daily for 4 weeks

Risk reduction of NSAID induced Gastric Ulcer

20 mg/40 mg

Once daily for up to 6 months

Helicobacter pylori Eradication (Esomeprazole MUPS tablet with Amoxicillin & Clarithromycin)

40 mg

Twice daily for 7 days

 

Adolescents aged 12 – 17 years-

Indication

Dosage

Frequency

Gastro Esophageal Reflux Disease (GERD)

Erosive Esophagitis

40 mg

Once daily for 4 weeks

Maintenance of healing of Erosive Esophagitis

20 mg

Once daily

Helicobacter pylori Eradication (Esomeprazole MUPS tablet with Amoxicillin & Clarithromycin)

20 mg

Twice daily for 7 days

*Esomeprazole MUPS Tablet is not recommended for children under 12 years of age

Method of Taking Tablet:

Shallow the whole tablet with a glass of water. The tablet should not be chewed or crushed.

             

If patients have complications to swallow the tablet, put the tablet into a glass of water then stir the preparation until the tablet disintegrate and drink liquid within 30 minutes. Stir the mixture just always before drinking.

                  

This tablet can shallow before or after meal.

Esomeprazole MUPS is contraindicated in those patients who have known hypersensitivity to any component of the formulation of Esomeprazole. When used for H. Pylori eradication the contraindication of Amoxicillin and Clarithromycin should be followed.

Exclude the possibility of malignancy when gastric ulcer is suspected and before treatment for dyspepsia. When using in combination with antibiotic refer to the prescribing information of the respective antibiotics. For patient with severe liver impairment, a dose of 20 mg of esomeprazole should not be exceeded.

Headache, abdominal pain, diarrhea, flatulence, nausea or vomiting etc.

Manufacturer advices caution and there is no information available. It is not known whether Esomeprazole is excreted in breast milk or not.

Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability such as Ketoconazole, Iron Salts and Digoxin.

A single oral dose of Esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), has been lethal to rats. The major signs of acute toxicity are reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. There have been no reports of overdose with Esomeprazole. No specific antidote for Esomeprazole is known. Since Esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.

Store in a cool (below 30° C) and dry place, protect from light. Keep out of reach of children.

Esolok MUPS 20 Tablet: Each box contains 5x10 MUPS tablets in Alu-Alu blister pack.

Esolok MUPS 40 Tablet: Each box contains 3x10 MUPS tablets in Alu-Alu blister pack.