Omeraz 20 (bottle)

ADMINISTRATION 

- It is recommended to take OMERAZ 20 in the morning, swallowed whole with half a glass of water. The capsules must not be chewed or crushed. 

For patients with swallowing difficulties and for children who can drink or swallow semi-solid food: Patients can open the capsule and swallow the contents with half a glass of water or mix the contents in a slightly acidic fluid e.g.  orange juice, apple juice and  swallowed immediately.

DOSAGE 

Adults

 Treatment of gastric ulcers, duodenal ulcers

-The recommended dose is 20 mg once daily. If needed, the dose can be increased 40 mg once daily.  Ulcer healing time is usually 2-4 weeks for duodenal ulcers and 4-8 weeks for gastric ulcers . 

Prevention of relapse of gastric ulcers, duodenal ulcers 

-The recommended dose is 20 mg once daily. In patients with poorly responsive, the dose can be increased 40 mg once daily. 

In combination with antibiotics in treatment of duodenal ulcer caused by H.pylori

- Omeprazole 20 mg twice daily, can be combined with antibiotics for the eradication of H. pylori. The selection of antibiotics should consider the individual patient's drug tolerance and should be undertaken in accordance with national, regional and local resistance patterns and treatment guidelines. 

Treatment of NSAID-associated gastric and duodenal ulcers 

-The recommended dose is 20 mg once daily. In most patients healing occurs within four weeks.   In patients with poorly responsive, healing is usually achieved within eight weeks . 

Prevention of NSAID-associated gastric and duodenal ulcers 

- The recommended dose is omeprazole 20 mg once daily. 

Treatment of reflux oesophagitis 

-The recommended dose is omeprazole 20 mg once daily.  In patients with severe oesophagitis omeprazole 40 mg once daily is recommended and healing occurs within four weeks and may last 8 weeks for patients with severe inflammation or poor response

Treatment of symptomatic gastro-oesophageal reflux 

-The recommended dose is 20 mg daily. Patients may respond adequately to 10 mg daily. If symptom control has not been achieved after four weeks treatment with 20 mg daily, further investigation is recommended. 

Treatment of Zollinger-Ellison syndrome 

- The recommended initial dose is 60 mg daily.  The dose should be individually adjusted and treatment continued as long as clinically indicated.  All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of omeprazole 20-120 mg daily. When dose exceed omeprazole 80 mg daily, the dose should be divided and given twice daily. Children 

Children > 2 vear of age and > 20kg

- Posology: 20mg once daily. If needed, the dose can be increased 40 mg once daily. 

-The treatment time: 

+ Reflux oesophagitis: 4-8 weeks. 

+ Symptomatic treatment of heartburn and acid regurgitation in gastro - oesophageal reflux disease: 2 - 4 weeks. If symptom control has not been achieved after 2-4 weeks, further investigation is recommended. 

Children and adolescents over 4 years of age: 

- In combination with antibiotics in treatment of duodenal ulcer caused by H.pylori: Omeprazole 20 mg/day, dosage of antibiotics should consider the individual patient's weight. 

-The treatment time: 1-2 weeks. 

Renal impairment: Dose adjustment is not needed in patients with impaired renal function. 

Hepatic impairment: In patients with impaired hepatic function a daily dose of 20 mg may be sufficient. 

Elderly: Dose adjustment is not needed in the elderly, if liver function is normal.

CONTRAINDICATIONS 

- Hypersensitivity to any the ingredients.

- Omeprazole must not be used concomitantly with nelfinavir. 

WARNINGS AND PRECAUTIONS 

Conditions of caution when using the drug

- In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.

- Co-administration omeprazole with atazanavir  is not recommended. If the combination  omeprazole with atazanavir is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; omeprazole 20 mg should not be exceeded.

- Omeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy.

- Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with omeprazole, the potential for interactions with drugs metabolized through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged. 

-Severe hypomagnesaemia has been reported in patients treated with PPIs like omeprazole for at least three months and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.

- For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

- PPIs, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognized risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.

- PPIs are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE). If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping this medicine. SCLE after previous treatment with PPI may increase the risk of SCLE with other PPIs.

- Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, omeprazole treatment should be stopped for at least 5 days before CgA measurements. 

- Some children with chronic illnesses may require long-term treatment although it is not 

recommended.

- Treatment with PPIs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

Pregnancy and lactation 

- Pregnancy: Epidemiological studies indicate no adverse effects of omeprazole on pregnancy or on the health of the foetus/newbom. Omeprazole can be used during pregnancy.

-  Breast-feeding : Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. 

Effects on ability to drive and use machines 

-  Omeprazol is not likely to affect the ability to drive or use machines. Adverse drug reactions such as dizziness and visual disturbances may occur. If affected, patients should not drive or operate machinery.

SHELF-LIFE 

36 months from the manufacturing date. Do not use after the expiry date.

- Aluminium/Aluminium blisters: 

Box of 10 blisters x 07 capsules containing enteric coated pellets .

Box of 04 blisters x 07 capsules containing enteric coated pellets .

- Aluminium/Aluminium strips:

Box of 02 strips x 10 capsules containing enteric coated pellets .

Box of 03 strips x 10 capsules containing enteric coated pellets . 

Box of 05 strips x 10 capsules containing enteric coated pellets . 

Box of 05 strips x 04 capsules containing enteric coated pellets . 

Box of 07 strips x 04 capsules containing enteric coated pellets . 

Box of 10 strips x 04 capsules containing enteric coated pellets . 

Box of 10 strips x 10 capsules containing enteric coated pellets .

- PET bottle:

Box of 01 bottle x 28 capsules containing enteric coated pellets .