Indications
Bizoran® is indicated for the treatment of hypertension, alone or with other antihypertensive agents.
Bizoran®
may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve
their blood pressure goals.
Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart
attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use
a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood
pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy.
Individual blood pressure goals may vary based upon the patient’s risk.
Dosage and Administration
The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet should not be chewed
and should be taken at the same time each day. Bizoran®
may be taken with or without food.
Initial Therapy:
The usual recommended dosage of Bizoran®
is one tablet once daily.
Bizoran®
(5 mg/20 mg) Tablet may be administered in patients whose blood pressure is not adequately controlled by 20 mg
olmesartan medoxomil or 5 mg amlodipine alone.
Bizoran®
5/40 may be administered in patients whose blood pressure is not adequately controlled by Bizoran®
(5 mg/20 mg)
Tablet.
In clinical trials, Amlodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin-converting
enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs,
antibiotics, and oral hypoglycemic drugs. No significant drug interactions were reported in studies in which Olmesartan
medoxomil was co-administered with digoxin or warfarin, antacids. Olmesartan medoxomil is not metabolized by the
cytochrome P450 system and has no effects on P450 enzymes.
Fertility, Pregnancy and Lactation
Pregnancy
US FDA pregnancy category D.
When pregnancy is detected, discontinue Bizoran® 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.
Lactation
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. Excreted into human milk: Yes
(amlodipine); Unknown (olmesartan). Excreted into animal milk: Yes (olmesartan).
Fertility
Side Effects
The most common side effects include peripheral edema, flushing, palpitations, dizziness. Other adverse reactions that
occurred in placebo-controlled clinical trials are orthostatic hypotension, diarrhea, rash, abdominal pain, fatigue, back pain,
pruritus, rhabdomyolysis.
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