Approved colours used in empty capsule.
Each capsule contains: Omeprazole BP 20 mg (enteric-coated granules).
Lomac (Omeprazole) is a substituted benzimidazole with potent inhibitory action on gastric acid secretion. Chemically it is 5-methoxy-2-(4-methoxy-3, 5-dimethyl 2-pyridyl methylsulphinyl) benzimidazole.
Pharmacology: Omeprazole belongs to a new class of antisecretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or H2-histamine antagonistic properties but that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid pump inhibitor in that it blocks the final step of acid production.
This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion, irrespective of the stimulus.
Animal studies indicate that after rapid disappearance from plasma, omeprazole can be found within the gastric mucosa for a day or more.
Lomac-20 is indicated for maintenance therapy of duodenal ulcer, gastric ulcer, gastroesophageal reflux disease.
Lomac-20 is indicated for short term treatment of duodenal ulcer, gastric ulcer, gastroesophageal reflux disease and management of Zollinger-Ellison syndrome.
Lomac-20 is indicated to combine with antibacterial for the eradication of Helicobacter pylori in peptic ulceration.
Lomac-20 is indicated for the treatment and prevention of NSAID-associated ulceration.
Lomac should be taken before meals.
Patients should be cautioned that the Lomac capsules should not be opened, chewed or crushed and should be swallowed whole.
Duodenal ulcers, gastric ulcers and reflux oesophagitis. The recommended dosage is one capsule of Lomac (20 mg) once daily.
In patients with duodenal ulcers symptom relief is rapid and healing occurs within 2 weeks in most cases. For those patients who may not have fully healed after the initial course, healing usually occurs during a further 2 weeks treatment period.
In patients with gastric ulcers and reflux oesophagitis symptom relief is rapid and healing occurs within 4 weeks in most cases.
For those patients who may not have fully healed after the initial course healing usually occurs during a further 4 weeks treatment period.
In patients refractory to other treatment regiments, 2 capsules of Lomac (40 mg) once daily has been used and healing achieved usually within 4 weeks in patients with duodenal ulcer and within 8weeks in patients with gastric ulcers or reflux oesophagitis.
Zollinger-Ellison syndrome: The recommended initial dosage is 3 capsules of Lomac (60 mg) once daily. The dosage should be adjusted individually and treatment continued as long as is clinically indicated. All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of patients maintained on the doses of 20-120 mg daily. With doses above 80 mg daily, the dose should be divided and given twice daily.
Impaired renal and liver function: No dosage adjustments is required in patients with impaired renal or liver function and in the elderly.
Eradication of Helicobacter pylori: Lomac may be combined with antibacterials in dual or triple therapy. Effective triple therapy regimens include Lomac 20 mg twice daily combined with: Amoxicillin 500 mg and metronidazole 400 mg, both three times daily: clarithromycin 500 mg and metronidazole 400 mg (or tinidazole 500 mg) both twice daily; or with Amoxicillin 1 g and clarithromycin 500 mg both twice daily. These regimens are given for 1 week.
Dual therapy regimens such as Lomac 40 mg daily with either amoxicillin 750 mg to 1 g twice daily or clarithromycin 500 mg three times daily, are less effective and must be given for 2 weeks. Omeprazole alone may be continued for a further 2 to 8 weeks.
Treatment and Prevention of NSAID-associated Ulceration: Doses of 20 mg daily are used in the treatment of NSAID-associated ulceration: a dose of 20 mg daily may also be used for prophylaxis in patients with a previous history of gastroduodenal lesions who require continued NSAID treatment.
There is no information available on the effects of overdosage in man and specific recommendations for treatment cannot be given. Single oral doses of up to 160 mg have been well tolerated.
There are no known contraindications to the use of omeprazole.
Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors (PPIs) for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Long-term (a year or longer) and multiple daily dose PPI therapy maybe associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile. Proton pump inhibitors 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 LOMAC-20. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Use in Children: There is no experience with omeprazole in children.
Use in the Elderly: No dose adjustment is necessary in the elderly.
As with all drugs, Lomac should not be given during pregnancy and lactation, unless its use is considered essential. Animal studies have not shown evidence of any hazard from the administration of omeprazole during pregnancy and lactation and there is no evidence of foetal toxicity or teratogenic effect.
Lomac is well tolerated. Nausea, headache, diarrhoea, constipation and flatulence are reported but occur rarely. There events are mild and transient and there has been no consistent relationship with treatment.
Omeprazole can prolong the eliminations of diazepam, warfarin and phenytoin, drugs that are metabolized by oxidation in the liver. Monitoring of patients also receiving warfarin or phenytoin is recommended and reduction of dose of phenytoin with propranolol or theophylline has been found, but interactions with other drugs also metabolised via the cytochrome P450 enzyme system cannot be excluded. No interaction with concomitantly administered antacids has been found.
Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart.
Literature suggests that concomitant use of Proton Pump Inhibitors (PPIs) with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. A temporary withdrawal of the PPI may be considered in some patients receiving treatments with high dose methotrexate.
Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.
Store in a cool dry place below 25°C.
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Lomac-20 gastro-resistant cap 20 mg
60's
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