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,
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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.

Dosage & Administration

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.

Interaction

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.

Contraindications

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

Side Effects

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.

Precautions & Warnings

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.

Overdose Effects

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.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

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