Olmetab 20 Tablet

Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.

No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min), or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision, and consideration should be given to the use of a lower starting dose. Olmesartan may be administered with or without food.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.

No significant drug interactions were reported in studies in which Olmetab was co-administered with digoxin or warfarin in healthy volunteers. The bioavailability of olmesartan was not significantly altered by the co-administration of antacids. Olmetab is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce, or are metabolized by those enzymes are not expected. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) in patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including Olmetab, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Olmetab and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including Olmetab, may be attenuated by NSAIDs, including selective COX-2 inhibitors.

Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.

Olmetab has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. Treatment with Olmetab was well tolerated, with an incidence of adverse reactions similar to placebo. The overall frequency of adverse reactions was not dose-related. Analysis of gender, age, and race groups demonstrated no differences between Olmetab and placebo-treated patients. The rate of withdrawals due to adverse reactions in all trials of hypertensive patients was 2.4% of patients treated with Olmetab and 2.7% of control patients. In placebo-controlled trials, the only adverse reaction that occurred in more than 1% of patients treated with Olmetab and at a higher incidence versus placebo was dizziness (3% vs. 1%)

The following adverse reactions occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with Olmetab, but also occurred at about the same or greater incidence in patients receiving placebo: back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis and sinusitis. The incidence of cough was similar in placebo (0.7%) and Olmetab (0.9%) patients.

When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with Olmetab. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with Olmetab.

There is no experience of overdose with Olmetab. The most likely effects of Olmetab overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred. If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmetab requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.

Store in a cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.