| Composition |
Each F.C Tablet BLANICARD 5 contains 5 mg Olmesartan medoxomil.
Each F.C Tablet BLANICARD 20 contains 20 mg Olmesartan medoxomil.
Each F.C Tablet BLANICARD 40 contains 40 mg Olmesartan medoxomil. |
| Properties |
Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.
Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist in vascular smooth muscle.
It is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan. |
| Pharmacodynamics properties |
Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensinconverting enzyme (ACE, kinase II).
Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation and renal reabsorption of sodium.
Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of
angiotensin II to the AT1 receptor in vascular smooth muscle. |
| Pharmacokinetics |
Olmesartan medoxomil is rapidly activated by ester hydrolysis to olmesartan during absorption from the GIT tract.
After oral administration bioavailability is about 26%.
After oral administration, the peak plasma concentration (Cmax) of olmesartan is reached after 1 to 2 hours.
Food does not affect the bioavailability of olmesartan.
About 35–50% of absorbed dose is recovered in urine, while the remainder is eliminated in feces via bile.
Elimination half life is about 13 hours.
Steady-state levels of drug are achieved within 3–5 days, and no accumulation in plasma occurs with once-daily dosing. |
| Therapeutic indications |
BLANICARD is indicated for the treatment of hypertension.
It may be used alone or in combination with other antihypertensive agents. |
| Side effect |
Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria.
Chest pain, peripheral edema, vertigo, abdominal pain, dyspepsia, nausea, rash, alopecia, pruritus. |
| Warnings and precautions |
– Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women.
– When pregnancy is detected, discontinue it as soon as possible.
– The use of drugs that act directly on the reninangiotensin system during the second and third
trimesters of pregnancy has been associated with fetal and neonatal injury.
– Hypotension in Volume- or Salt-Depleted Patients: A transient hypotensive response is not a
contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
Impaired Renal Function:
In studies of ACE inhibitors in patients with renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported.
There has been no long-term use of olmesartan in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected. |
| Contraindication |
Hypersensitivity to one of the product components. |
| Pregnancy and lactation |
Pregnancy:
Pregnancy Categories C (first trimester) and D (second and third trimesters).
There is no clinical experience with the use of BLANICARD in pregnant women.
Nursing Mothers:
It is not known whether olmesartan 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. |
| Drug interactions |
No significant drug interactions were reported in studies in which Olmesartan was coadministered with digoxin or warfarin in healthy volunteers.
The bioavailability of olmesartan was not significantly altered by the coadministration of antacids. |
| DOSAGE & ADMINISTRATION |
Adult Hypertension:
The usual recommended starting dose of it is 20 mg once daily when used as monotherapy.
For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of it may be increased to 40 mg.
No initial dosage adjustment is recommended for elderly patients, for patients with renal impairment or with moderate to marked hepatic dysfunction.
It may be administered with or without food.
If blood pressure is not controlled by it alone, a diuretic may be added. It may be administered with other antihypertensive agent.
Pediatric Hypertension (6 to 16 years of age):
Dosage must be individualized.
For children who can swallow tablets, 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 of olmesartan 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.
Hepatic Impairment:
No initial dosage adjustment is recommended for patients with moderate to marked hepatic dysfunction.
Renal Impairment:
Patients with renal insufficiency have elevated serum concentrations of olmesartan compared to subjects with normal renal function.
No initial dosage adjustment is recommended for patients with moderate to marked renal impairment. |
| Overdose |
Limited data are available related to overdosage in humans.
The most likely manifistations of overdose would be hypotention and tachycardia, bradycardia.
If symptomatic hypotension occurs, initiate supportive treatment. |
| Package |
| Carton box of 20 F.C Tablets, blister packed, with inserted leaflet. |
| Storage |
– Store at room temperature (15–30)°C.
– Keep away from reach of children. |
