Esomeprazole (MUPS preparation)

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.

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.

Somazole MUPS is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Somazole 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 Somazole MUPS does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin. Somazole MUPS may potentially interfere with CYP2C19, the major Somazole MUPS metabolizing enzyme. Co-administration of Somazole 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. Somazole MUPS inhibits gastric acid secretion. Therefore, Somazole 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 Somazole MUPS. Combination Therapy with Clarithromycin: Co-administration of Somazole MUPS, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of Somazole MUPS and 14-hydroxyclarithromycin.

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

The most common side effects of Somazole 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.

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.

Somazole MUPS should be used carefully if the patient has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like Somazole 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.

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

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