Tenicar 40mg

Tablet
Olmesartan Medoxomil
Unimed Unihealth MFG. Ltd

Other Strength:
- Tenicar 20mg

Alternative:
- Olmesan 40mg
- ORBAS 40mg
- Olmecar 40mg
- Ransys 40mg
- Abetis 40mg
- Rezor 40mg



Tenicar
Presentation
Tenicar 20 tablet: Light blue, diamond shaped, scored on one side, Unlogo on other side, film coated tablet; each tablet contains Olmesartan Medoxomil USP 20mg.
Tenicar 40 tablet: Light blue, barrel shaped, scored on one side, film coated tablet; each tablet contains Olmesartan Medoxomil USP 40mg.

Indications
Treatment of essential hypertension.

Contra-indications, warning, etc.
Contra-indications: Hypersensitivity to the active substances, to any of the excipients. Severe renal impairment (creatinine clearance <20 mL/min). Severe hepatic impairment, 2nd and 3rd trimester of pregnancy and biliary obstructive disorders.

Warnings: Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Olmesartan Medoxomil.

Use in Pregnancy and Lactation: When pregnancy is diagnosed, treatment with angiotensin-II antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started. It is not known whether Olmesartan is excreted in human milk. Because no information is available regarding the use of Olmesartan during breastfeeding, Olmesartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Dosage & administration
Adults: The recommended starting dose of Olmesartan Medoxomil is 10mg once daily. In patients whose blood pressure is not adequately controlled at this dose, the dose of Olmesartan Medoxomil may be increased to 20mg once daily as the optimal dose. If additional blood pressure reduction is required, Olmesartan Medoxomil dose may be increased to a maximum of 40mg daily or hydrochlorothiazide therapy may be added. Tenicar tablets can be taken with or without food. Elderly (age 65 years or older): No adjustment of dosage is generally required in elderly patients (see below for dose recommendations in patients with renal impairment). If uptitration to the maximum dose of 40mg daily is required, blood pressure should be closely monitored. Renal impairment: The maximum dose in patients with mild to moderate renal impairment (creatinine clearance of 20-60 mL/min) is 20mg Olmesartan Medoxomil once daily, owing to limited experience of higher dosages in this patient group. The use of Olmesartan Medoxomil in patients with severe renal impairment (creatinine clearance <20 mL/min) is not recommended, since there is only limited experience in this patient group. Hepatic impairment: No adjustment of dosage recommendations is required for patients with mild hepatic impairment. In patients with moderate hepatic impairment, an initial dose of 10mg Olmesartan Medoxomil once daily is recommended and the maximum dose should not exceed 20mg once daily. Close monitoring of blood pressure and renal function is advised in hepatically-impaired patients who are already receiving diuretics and/or other antihypertensive agents. There is no experience of Olmesartan Medoxomil in patients with severe hepatic impairment, therefore use is not recommended in this patient group. Olmesartan Medoxomil should not be used in patients with biliary obstruction. Paediatric population: Olmesartan is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.

Drug Interactions:
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors and, rarely, with angiotensin-II antagonists. Based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels may lead to increases in serum potassium. Such concomitant use is therefore not recommended. NSAIDs and angiotensin-II receptor antagonists may act synergistically by decreasing glomerular filtration. The risk of the concomitant use of NSAIDs and angiotensin-II antagonists is the occurrence of acute renal failure. Monitoring of renal function at the beginning of treatment should be recommended as well as regular hydration of the patient.

Side-effects:
The most commonly reported adverse reactions during treatment with Olmesartan are headache, influenza-like symptoms and dizziness, hypertriglyceridaemia and raised creatine phosphokinase.

Overdose:
The most likely effect of overdosage is hypotension. In the event of overdosage, the patient should be carefully monitored and treatment should be symptomatic and supportive.

Pharmaceutical precautions
Store in a cool and dry place, protected from light.

Packaging quantities
Tenicar 20 tablet: Carton containing 28 tablets in alu-alu blister.
Tenicar 40 tablet: Carton containing 14 tablets in alu-alu blister.

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