Generic Name
Olmesartan MedoxomilTherapeutic Class: Cardiovascular (Angiotensin-ll receptor blocker)
Indications:
Olmesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Presentation:
Olmesartan Medoxomil 20: Each tablet contains Olmesartan Medoxomil INN 20 mg.
Description:
Angiotensin II (formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme-ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of the AT1 receptor. Olmesartan does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Dosage & Administration:
Adult Hypertension:
The usual starting dose of Olmesartan is 20 mg once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be increased after 2 weeks to 40 mg. Olmesartan may be administered with or without food.
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.
If blood pressure is not controlled by Olmesartan alone, a diuretic may be added. Olmesartan may be administered with other antihypertensive agents.
Pediatric Hypertension (6 to 16 years of age):
The usual recommended starting dose of Olmesartan is 10 mg once daily for patients who weigh 20 to <35 kg, or 20 mg once daily for patients who weigh > 35 kg. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to a maximum of 20 mg once daily for patients who weigh <35 kg or 40 mg once daily for patients who weigh > 35 kg.
Side Effects:
Treatment with Olmesartan is well tolerated. The common side effects are dizziness, diarrhea, headache, back pain, etc. Other adverse effects are chest pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, vertigo, etc.
Precautions:
Pregnancy: 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.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at a 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.
Interaction:
No significant drug interactions were reported in studies in which olmesartan medoxomil was coadministered with digoxin or warfarin in healthy volunteers. Olmesartan medoxomil 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. The bioavailability of olmesartan is not significantly altered by the co-administration of antacids.
Overdose:
Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension occurs, supportive treatment should be initiated.
Storage:
Store in a cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
Olmesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Presentation:
Olmesartan Medoxomil 20: Each tablet contains Olmesartan Medoxomil INN 20 mg.
Description:
Angiotensin II (formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme-ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of the AT1 receptor. Olmesartan does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Dosage & Administration:
Adult Hypertension:
The usual starting dose of Olmesartan is 20 mg once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be increased after 2 weeks to 40 mg. Olmesartan may be administered with or without food.
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.
If blood pressure is not controlled by Olmesartan alone, a diuretic may be added. Olmesartan may be administered with other antihypertensive agents.
Pediatric Hypertension (6 to 16 years of age):
The usual recommended starting dose of Olmesartan is 10 mg once daily for patients who weigh 20 to <35 kg, or 20 mg once daily for patients who weigh > 35 kg. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to a maximum of 20 mg once daily for patients who weigh <35 kg or 40 mg once daily for patients who weigh > 35 kg.
Side Effects:
Treatment with Olmesartan is well tolerated. The common side effects are dizziness, diarrhea, headache, back pain, etc. Other adverse effects are chest pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, vertigo, etc.
Precautions:
- Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance.
- When pregnancy is detected, Olmesartan must be discontinued as soon as possible.
- Hypotension in volume or salt-depleted patients may occur.
- Impaired renal function
Pregnancy: 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.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at a 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.
Interaction:
No significant drug interactions were reported in studies in which olmesartan medoxomil was coadministered with digoxin or warfarin in healthy volunteers. Olmesartan medoxomil 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. The bioavailability of olmesartan is not significantly altered by the co-administration of antacids.
Overdose:
Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension occurs, supportive treatment should be initiated.
Store in a cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
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