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Losec

Reals Pharmaceuticals Limited
Plot 1 Junaid Dosunmu Street,Central Business District, Alausa, P.0. Box 3560 Ikeja, Lagos, Nigeria.
Email: reals@realsgroup.com
Tel: + 234-1-774-1205
Fax: +234-1-263-0919
Website: http://realsgroup.com

Brand Name

Losec

Manufacturer

AstraZeneca, Silk Court, Silk Road Business Park, Macclesfield, Cheshire SK10 2NA, England.

Therapeutic Class

Antiulcerants, Proton pump inhibitors (PPI)

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Capsules (NRN: 04-0001): Omeprazole 10 mg, 20 mg or 40 mg

Pack Size

Pharmacology

Losec reduces gastric acid secretion through a highly targeted mechanism of action by being a specific inhibitor of the acid pump in the parietal cell. It is rapidly acting and provides control through reversible inhibition of gastric acid secretion with once daily dosing.

Indications

See “Dosage and Administration” below

Contra-indications

Known hypersensitivity to omeprazole.

Precautions/Warnings

In the presence of any alarm symptoms (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, the possibility of gastric malignancy should excluded before treatment is initiated.

Use in pregnancy and lactation: Avoid unless Losec is considered essential.

Interactions

Due to the decreased intragastric acidity, the absorption of ketoconazole can decrease during omeprazole treatment. Losec can delay the elimination of warfarin and phenytoin. Monitoring of patients receiving warfarin or phenytoin is recommended and a reduction of the dose of these drugs may be necessary when Losec is given concomitantly.

However, concomitant treatment with Losec 20 mg once daily did not change blood concentration of phenytoin in patients on continuous treatment with this drug or coagulation time in patients on continuous treatment with warfarin.

Adverse Effects

In clinical trials with Losec, the following adverse events were reported to occur in 1% or more of patients: nausea/vomiting, diarrhoea, constipation, abominal pain, flatulence and headache. Skin rashes and other hypersensitivity reactions have been seen rarely.

Dosage & Administration

Duodenal Ulcer: Losec 20 mg once daily for 2-4 weeks. In patients with poorly responsive duodenal ulcer, Losec 40 mg once daily is recommended and healing is usually achieved within 4 weeks.

Gastric Ulcer: Losec 20 mg once daily for 4-8 weeks. In patients with poorly responsive gastric ulcer, Losec 40 mg once daily is recommended and healing is usually achieved within 8 weeks.

Reflux Oesophagitis: Losec 20 mg once daily for 4-8 weeks. In patients with severe reflux oesophagitis, Losec 40 mg once daily is recommended and healing is usually achieved within 8 weeks.

NSAID associated gastric and duodenal ulcers or erosions: Losec 20 mg once daily for 4-8 weeks.

Symptomatic gastro-oesophageal reflux disease: Losec 20 mg once daily for 4 weeks. Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered.

Acid related dyspepsia: Losec 20 mg once daily for 4 weeks. Patients may respond adequately to 10 mg and therefore this dose could be considered as starting dose.

Helicobacter pylori-associated peptic ulcer disease: Triple therapy regimens:- Losec 20 mg, amoxycillin 1 g and clarithromycin 500 mg, all b.i.d. for one week OR Losec 20 mg, metronidazole 400 mg (or tinidazole 500 mg) and clarithromycin 250 mg, all b.i.d. for one week OR Losec 40 mg once daily with amoxycillin 500 mg and metronidazole 400 mg, both t.i.d. for one week.

Dual therapy regimens: Losec 40-80 mg daily with amoxycillin 1.5 g daily in divided doses for two weeks (in clinical studies, daily doses of 1.5-3 g of amoxycillin have been used) OR Losec 40 mg once daily with clarithromycin 500 mg t.i.d. for two weeks. To ensure healing in patients with active peptic ulcer disease, follow dosage recommendations of duodenal and gastric ulcer.

For the long term management of patients with healed reflux oesophagitis and the prevention of relapse in patients with duodenal ulcer disease: Losec 10 mg once daily is recommended. If needed the dose can be increased to 20-40 mg once daily.

For the prevention of relapse in patients with poorly responsive gastric ulcer: the recommended dose is Losec 20 mg once daily. If needed the dose can be increased to Losec 40 mg once daily.

For the prevention of NSAID associated gastric ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic symptoms: the recommended dosage of Losec is 20 mg once daily.

Zollinger-Ellison Syndrome: The recommended initial dose is Losec 60 mg once daily. The dose should be individually adjusted and treatment continued as long as clinically indicated.

Severe reflux oesophagitis in children from one year and older: For children weighing 10 - 20 kg, Losec 10 mg once daily. For children weighing more than 20 kg, Losec 20 mg once daily. If needed dosage may be increased to 20 mg and 40 mg respectively.

Storage/Handling Recommendations

Review Date

2016-07-14 11:07:26