Esoprol MUPS

Adults (from the age of 18 years)-

Gastroesophageal reflux disease (GERD)

Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation),

• Maintenance treatment of NERD (i.e. heartburn and regurgitation),
• Reflux esophagitis or erosive esophagitis,
• ... Read more
• Adults (from the age of 18 years)-

Gastroesophageal reflux disease (GERD)

Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation),

• Maintenance treatment of NERD (i.e. heartburn and regurgitation),
• Reflux esophagitis or erosive esophagitis,
• Maintenance treatment of patients with reflux esophagitis
• Healing of NSAID associated gastric ulcers
• Reduction of risk of NSAID associated gastric ulcers
• Zollinger-Ellison Syndrome
• H. pylori eradication
• Pediatrics (12-17 years of age)-
• Gastroesophageal reflux disease (GERD)

Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation)

Reflux esophagitis or erosive esophagitis.

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.

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.

The most common side effects of Esoprol MUPS 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.

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

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

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.

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 Esoprol MUPS were uneventful. No specific antidote is known. Esoprol MUPS 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.

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

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

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

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

What is Esoprol MUPS 20 mg MUPS Table?

Esoprol MUPS 20 mg MUPS Table is a proton pump inhibitor (PPI). PPIs work by reducing the amount of acid produced in the stomach. Esoprol MUPS 20 mg MUPS Table is used to treat gastroesophageal reflux disease (GERD), ulcers, and other conditions that involve too much stomach acid.

What is MUPS Tablet?

MUPS is abbreviation for Multiple-Unit Pellet System. This tablets prepared by compaction of modified release coated multiparticulates or pellets are called as MUPS.

What is Esoprol MUPS 20 mg MUPS Table used for?

Esoprol MUPS 20 mg MUPS Table has multiple uses. It relieves heartburn and GERD symptoms. It also aids in healing erosive esophagitis, a condition caused by stomach acid damaging the esophagus lining. Additionally, Esoprol MUPS 20 mg MUPS Table effectively prevents erosive esophagitis recurrence.

What are the side effects of Esoprol MUPS 20 mg MUPS Table?

Esoprol MUPS 20 mg MUPS Table may cause common side effects like headaches, diarrhea, nausea, gas, stomach pain, constipation, and dry mouth. There aren't any differences in the types of side effects between long-term (up to 12 months) and short-term use.

Can I take Esoprol MUPS 20 mg MUPS Table if I am pregnant or breastfeeding?

Esoprol MUPS 20 mg MUPS Table doesn't have any side-effects if you are pregnant or breastfeeding. You still should talk to your doctor about the risks and benefits of taking Esoprol MUPS 20 mg MUPS Table.

How long does it take for Esoprol MUPS 20 mg MUPS Table to work?

Esoprol MUPS 20 mg MUPS Table usually starts to work within a few hours of taking it.

• Esoprol MUPS 20 mg MUPS Table is a well-tolerated medicine and provides relief for a long time.
• Avoid eating late at night or before bedtime.
• Inform your doctor if you get watery diarrhea, fever or stomach pain that does not go away.
• Long-term use of Esoprol MUPS 20 mg MUPS Table can cause weak bones and a deficiency of minerals such as magnesium. Take adequate dietary intake of calcium and magnesium or their supplements as prescribed by your doctor.
• Consult your doctor right away if you develop decreased urination, edema (swelling due to fluid retention), lower back pain, nausea, fatigue, and rash or fever. These could be signs of a kidney problem.