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OMEPRADEX 20mg

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OMEPRADEX

Alimentary System-Antacids and Defrothicants

Alimentary System-Gastro-intestinal sedatives

ACTIVE INGREDIENTS

= Additional active ingredients

Each caplet contains Omeprazole 10 mg, 20 mg or 40 mg.

OMEPRAZOLE

PRESENTATION AND DOSSAGE

CAPLETS: 30 x 10 mg.

CAPLETS: 14 x 20 mg.

CAPLETS: 30 x 20 mg.

CAPLETS: 30 x 40 mg.

RELATED INFORMATION


INDICATIONS

Acute Duodenal Ulcer.  Acute Gastric Ulcer. Helicobacter Pylori-Associated Peptic Ulcer Disease in combination with antibiotics.

Reflux Esophagitis.: Treatment, Long-Term Management, Maintenance Treatment for the Prevention of Relapse in Patients with Severe Reflux Esophagitis, Severe Reflux Esophagitis in Children from 6 Years of Age and Older, Maintenance Treatment for the Prevention of Relapse in Patients with Poorly Responsive Peptic Ulcer. Zollinger-Ellison Syndrome.

Treatment and prevention of NSAID-associated duodenal and gastric ulcers or erosions in high risk  patients.


CONTRAINDICATIONS

Known hypersensitivity to omeprazole, substituted benzimidazoles, or to any of the other constituents of the formulation. Omeprazole, like other proton pump inhibitors (PPIs), should not be administered with nelfinavir.


SPECIAL PRECAUTIONS

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

Co-administration of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g virus load) 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 metabolised 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 proton pump inhibitors (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 medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals should consider monitoring magnesium levels prior to initiation of PPI treatment and periodically during treatment. Proton pump inhibitors, 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 recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%. Some of this increase may be due to other 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. Interference with laboratory tests Increased chromogranin A (CgA ) level may interfere with investigations for neuroendocrine tumours. To avoid this interference the omeprazole treatment should be stopped for at least 14 days before CgA measurements. Some children with chronic illnesses may require long-term treatment although it is not recommended. Omepradex contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter. As in all long-term treatments, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

For full details see prescribing information.


SIDE EFFECTS

The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.

Paediatric Population: The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years with acid-related disease. There are limited long term safety data from 46 children who received maintenance therapy of omeprazole during a clinical study for severe erosive esophagitis for up to 749 days. The adverse event profile was generally the same as for adults in short- as well as in long-term treatment. There are no long term data regarding the effects of omeprazole treatment on puberty and growth.


DRUG INTERACTIONS

Effects of omeprazole on the pharmacokinetics of other active substances: Active substances with pH dependent absorption: The decreased intragastric acidity during treatment with omeprazole might increase or decrease  the absorption of active substances with a gastric pH dependent absorption.

Nelfinavir, atazanavir: The plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with omeprazole. Concomitant administration of omeprazole with nelfinavir is contraindicated.

Co-administration of omeprazole (40 mg once daily) reduced mean nelfinavir exposure by ca. 40% and the mean exposure of the pharmacologically active metabolite M8 was reduced by ca. 75-90%. The interaction may also involve CYP2C19 inhibition. Concomitant administration of omeprazole with atazanavir is not recommended. Concomitant administration of omeprazole (40 mg once daily) and atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a 75% decrease of the atazanavir exposure. Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. The co-administration of omeprazole (20 mg once daily) with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted in a decrease of approximately 30% in the atazanavir exposure as compared to atazanavir 300 mg/ritonavir 100 mg once daily.

Digoxin: Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10%. Digoxin toxicity has been rarely reported. However caution should be exercised when omeprazole is given at high doses in elderly patients. Therapeutic drug monitoring of digoxin should be then be reinforced.

Mycophenolate mofetil (MMF):  Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycofenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving omeprazole and MMF. Use omeprazole with caution in transplant patients receiving MMF.

Clopidogrel: Results from studies in healthy subjects have shown a pharmacokinetic (PK)/pharmacodynamic (PD) interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and omeprazole (80 mg p.o. daily) resulting in a decreased exposure to the active metabolite of clopidogrel by an average of 46% and a decreased maximum inhibition of (ADP induced) platelet aggregation by an average of 16%. Inconsistent data on the clinical implications of this PK/PD interaction in terms of major cardiovascular events have been reported from both observational and clinical studies. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged.

Other active substances: The absorption of posaconazole, erlotinib, ketoconazol and itraconazol is significantly reduced and thus clinical efficacy may be impaired. For posaconazol and erlotinib concomitant use should be avoided.

Active substances metabolised by CYP2C19: Omeprazole is a moderate inhibitor of CYP2C19, the major omeprazole metabolising enzyme. Thus, the metabolism of concomitant active substances also metabolised by CYP2C19, may be decreased and the systemic exposure to these substances increased. Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.

Cilostazol: Omeprazole, given in doses of 40 mg to healthy subjects in a cross-over study, increased Cmax and AUC for cilostazol by 18% and 26% respectively, and one of its active metabolites by 29% and 69% respectively.

Phenytoin: Monitoring phenytoin plasma concentration is recommended during the first two weeks after initiating omeprazole treatment and, if a phenytoin dose adjustment is made, monitoring and a further dose adjustment should occur upon ending omeprazole treatment.

Unknown mechanism:  Saquinavir, Concomitant administration of omeprazole with saquinavir/ritonavir resulted in increased plasma levels up to approximately 70% for saquinavir associated with good tolerability in HIV-infected patients.

Tacrolimus: Concomitant administration of omeprazole has been reported to increase the serum levels of tacrolimus. A reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be performed, and dosage of tacrolimus adjusted if needed.

Methotrexate: When given together with proton-pump inhibitors, methotrexate levels have been reported to increase in some patients. In high-dose methotrexate administration a temporary withdrawal of omeprazole may need to be considered.

Effects of other active substances on the pharmacokinetics of omeprazole : Inhibitors of CYP2C19 and/or CYP3A4: Since omeprazole is metabolised by CYP2C19 and CYP3A4, active substances known to inhibit CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may lead to increased omeprazole serum levels by decreasing omeprazole’s rate of metabolism. Concomitant voriconazole treatment resulted in more than doubling of the omeprazole exposure. As high doses of omeprazole have been well-tolerated adjustment of the omeprazole dose is not generally required. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.

Inducers of CYP2C19 and/or CYP3A4: Active substances known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St John’s wort) may lead to decreased omeprazole serum levels by increasing omeprazole’s rate of metabolism.

For full details see prescribing information.


DOSAGE

Adults: Treatment of Duodenal Ulcer: The recommended dose is Omepradex 20 mg once daily.

Prevention of relapse of duodenal ulcer: The recommended dose is Omepradex 20 mg once daily.

Treatment of Gastric Ulcer: The recommended dose is Omepradex 20 mg once daily.

Treatment of Reflux Esophagitis:The recommended dose is Omepradex 20 mg once daily.

Treatment  or prevention of NSAID – Associated Gastric and Duodenal Ulcers: The recommended dose is Omepradex 20 mg once daily.

Children: Severe Reflux Esophagitis in Children from 6 Years of Age and Older: The recommended dosage regimen for healing is as follows:

10-20 kg body weight –  10 mg once daily, the dose can be increased to 20 mg once daily if needed.

>20 kg body weight –  20 mg once daily, the dose can be increased to 40 mg once daily if needed.

For full details see prescribing information.


 OVERDOSE

There is limited information available on the effects of overdoses of omeprazole in humans. In the literature, doses of up to 560 mg have been described, and occasional reports have been received when single oral doses have reached up to 2400 mg omeprazole (120 times the usual recommended clinical dose). Nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache have been reported. Also apathy, depression and confusion have been described in single cases.

The symptoms described in connection to omeprazole overdosage have been transient, and no serious outcome has been reported. The rate of elimination was unchanged (first order kinetics) with increased doses. Treatment, if needed, is symptomatic.


PREGNANCY & LACTATION

Results from three prospective epidemiological studies (more than 1000 exposed outcomes) indicated no evidence of adverse events of omeprazole on pregnancy or on the health of the foetus/newborn child. This drug  can be used during pregnancy. Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.


MANUFACTURER & DISTRIBUTER:

Manufacturer: Dexcel Ltd.


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