Company: Clonmel Healthcare.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Esomeprazole (as magnesium dihydrate) 20mg, 40mg.
Description: 20mg: Opaque yellow and white gastro-resistant hard capsule marked 20mg, containing off-white to greyish spherical microgranules. 40mg: Opaque yellow gastro-resistant hard capsule marked 40mg, containing off-white to greyish spherical microgranules.
Presentation: 20mg-28, €20.09; 40mg-28, €30.92.
Indications: Treatment of erosive reflux oesophagitis (RO); long-term management of healed oesophagitis to prevent relapse; symptomatic treatment of gastroesophageal reflux disease (GORD). In combination with appropriate antibacterial therapy: Healing of Helicobacter pylori associated duodenal ulcers; prevention of H. pylori associated peptic ulcers. Healing of gastric ulcers associated with NSAID therapy; prevention of NSAID associated gastric and duodenal ulcers in at risk patients. Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers. Treatment of Zollinger Ellison syndrome (ZES).
Pharmacology: Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. Both the R- and S-isomer of omeprazole have similar pharmacodynamic activity. Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+K+-ATPase and inhibits both basal and stimulated acid secretion.
Dosage: Adult: Swallow whole with liquid. Erosive RO: Treatment, 40mg once daily for 4 weeks, double duration if not fully healed or symptoms persist. Prevention of relapse, 20mg once daily. GORD without oesophagitis: 20mg once daily until resolved. Maintenance, 20mg when required. H. pylori associated ulcers: Healing/prevention, 20mg with 1g amoxicillin and 500mg clarithromycin, all twice daily for 7 days. NSAID associated ulcers: Healing, 20mg once daily, duration 4-8 weeks. Prevention, 20mg once daily. Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers: 40mg once daily for 4 weeks. ZES: Initially, 40mg twice daily. Usual range, 80-160mg daily. Doses above 80mg daily, divide and administer twice daily. Severe hepatic impairment: Maximum 20mg daily. Elderly: As per adults. Children: Above 12 years, RO and GORD only, as per adults. Under 12 years, not recommended.
Contraindications: Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the formulation. Lactation.
Special precautions: In gastric ulcer, exclude malignancy before treatment. Long-term treatment (monitor). Advise patients on on-demand treatment to report changes in their symptoms. Slightly increased risk of GI infections (Salmonella, Campylobacter). Renal insufficiency. Pregnancy. Contains sucrose and parahydroxybenzoates.
Drug interactions: Contraindicated: Nelfinavir. Not recommended: Atazanavir. Caution: Ketoconazole, itraconazole, CYP2C19 substrates (e.g. diazepam, citalopram, imipramine, clomipramine, phenytoin, voriconazole) and inhibitors, warfarin or other coumarin derivatives, cisapride, CYP3A4 inhibitors (clarithromycin).
Adverse drug reactions: Headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting.
Full prescribing information and references available from Clonmel Healthcare. Telephone: (052) 6177777. Fax: (052) 6177791. E-mail: email@example.com
Company: Clonmel Healthcare.