Abetis^®

Abetis is the preparation of Olmesartan Medoxomil which is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan Medoxomil blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in vascular smooth muscle. Its action is, therefore, independent of the pathways for angiotensin II synthesis.

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Abetis is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood
pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Route of administration: Abetis  should be taken in oral route

Abetis may be administered with or without food. If blood pressure is not controlled by Abetis alone, a diuretic may be added. Abetis may be administered with other antihypertensive agents.

Hepatic impairment
The maximum dose in patients with moderate hepatic impairment is 20 mg daily. Abetis is not recommended in patients with severe hepatic impairment.

Renal impairment
The maximum dose in patients with renal impairment is 20 mg daily if eGFR 20–60 ml/minute/1.73 m 2 . Abetis is not recommended in patients with severe renal impairment

Use in pregnancy and lactation

Pregnancy: Use of drugs that act on the renin angiotensin system during the second and third trimesters of pregnancy reduces fetal renal
function and increases fetal and neonatal morbidity and death. When pregnancy is detected, discontinue olmesartan medoxomil as soon as
possible.

Lactation: It is not known whether olmesartan medoxomil is excreted in human milk. 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.

Use in children and adolescents
Olmesartan medoxomil has not been shown to be effective for hypertension in children < 6 years of age. Children < 1 year of age must not
receive olmesartan medoxomil for hypertension.

Angiotensin II receptor antagonist should be used with caution in patients with severe congestive heart failure. Caution should be taken with an activated renin-angiotensin-aldosterone system, such as volume and/or salt-depleted patients. Serum potassium should be monitored during treatment.

The most common side effects are headache, influenza- like symptoms and dizziness.

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Drug interaction with medication: The blood pressure lowering effect of olmesartan can be increased by concomitant use of other antihypertensive medications. Use of potassium sparing diuretics, potassium supplements and salt substitutes containing potassium or other drugs that may increase serum potassium levels (e.g., heparin) may lead to increases in serum potassium, such concomitant use is therefore not recommended. Concomitant use with aliskiren-containing products is contraindicated in patients with diabetes mellitus or
renal impairment (GFR < 60 ml/min/1.73 m 2 ).

Drug interaction with food and others: Not applicable.

In case of overdose, hypotension and tachycardia; bradycardia could be encountered if parasympathetic stimulation occurs. If symptomatic hypotension occurs, initiate supportive treatment. The dialyzability of olmesartan medoxomil is unknown.

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Storage
Store below 30º C in a dry place, protected from light. Keep away from the reach of children.

Packing
Abetis® 10 tablet: Carton of 70 tablets in blister pack.
Abetis ® 20 tablet: Carton of 70 tablets in blister pack.
Abetis ® 40 tablet: Carton of 70 tablets in blister pack