Company: Actavis Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Omeprazole 10mg, 20mg, 40mg.
Description: Gastro-resistant, hard capsules. 10mg, 20mg: Opaque yellow. 40mg: Opaque blue and white.
Presentation: 10mg-28; 20mg-28; 40mg-14. Prices available on request.
Indications: Treatment of duodenal ulcers; benign gastric ulcers; reflux oesophagitis (RO); Zollinger-Ellison syndrome (ZES); NSAID related gastric and duodenal ulcers. Prophylaxis of RO and NSAID related gastric and duodenal ulcers. Symptomatic treatment of gastroesophageal reflux disease (GORD). Eradication of Helicobacter pylori in patients with H. pylori associated peptic ulcers in combination with antibacterial therapy.
Pharmacology: Omeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, omeprazole blocks the final step in acid production, inhibiting both basal and stimulated acid secretion.
Dosage: Swallow whole with fluid. Adult: Duodenal ulcers: 20mg once daily for 2-4 weeks. Benign gastric ulcers: 20mg once daily for 4-(6)–8 weeks. RO: Treatment, 20mg once daily for 4-8 weeks. Prophylaxis, 10-20mg depending on clinical response. All previous 3 indications, may increase to 40mg once daily. Monotherapy in duodenal and benign gastric ulcers only if H. pylori therapy is not indicated or has failed. ZES: Initially, 60mg once daily; adjust individually; doses above 80mg daily, divide and admin. twice daily; no time limit. NSAID related gastric and duodenal ulcers: Treatment, 20mg daily for 4-8 weeks. Prophylaxis, 20mg daily. GORD: 10-20mg daily depending on clinical response for 2-4 weeks. Investigate if no response after 2 weeks. Eradication of H. pylori: 20mg with 1g amoxicillin and 500mg clarithromycin, all twice daily for 1 week, or 20mg with 250mg clarithromycin and 400-500mg metronidazole, all twice daily for 1 week. Limit metronidazole combination treatment periods to < 10 days. Hepatic impairment: Maximum 20mg daily. Elderly: As per adults. Children: Above 2 years and adolescents, severe RO only: 10-20kg, 10mg daily; > 20kg, 20mg daily. Usual duration, 4-8 weeks; maximum 12 weeks. Under 2 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Special precautions: Determine H. pylori status in patients with peptic ulcers; treat if positive. Exclude possibility of malignancy. Confirm RO endoscopically. Slightly increased risk of GI infections (Salmonella, Campylobacter). Renal or hepatic impaired patients during combination therapy. Severe hepatic impairment (monitor hepatic enzymes). Limit prophylactic treatment of NSAID-related peptic ulcers to high-risk patients. Long-term treatment (review periodically). Monitor visual and auditory senses in severely ill patients. Driving/using machines. Pregnancy, lactation (only if benefit outweighs risk). Contains sucrose.
Drug interactions: Contra: Atazanavir, clarithromycin (in hepatic impairment). Avoid: Ketoconazole, itraconazole, St. John’s Wort. Caution: CYP2C19 and CYP2C9 substrates, diazepam, benzodiazepines (triazolam, flurazepam), phenytoin, warfarin or other coumarin derivatives, hexobarbital, citalopram, escitalopram, imipramine, clomipramine, voriconazole, disulfiram, ciclosporin, tacrolimus, clarithromycin, vitamin B12, digoxin.
Adverse drug reactions: Somnolence, sleep disturbances (insomnia), vertigo, headaches, drowsiness, diarrhoea, constipation, flatulence, abdominal pain, nausea, vomiting.
Full prescribing information and references available from Actavis Ireland Ltd. Telephone: 1890 333231. Fax: (021) 4619049. Email: firstname.lastname@example.org