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.
A step-wise titration of the dosage of the individual components is recommended before changing to the fixed combination.
When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. Maximum
antihypertensive effects are attained within 2 weeks after a change in dose.
For convenience, patients receiving olmesartan medoxomil and amlodipine from separate tablets may be switched to
Bizoran® tablets containing the same component doses.
Initial therapy with Bizoran®
is not recommended in patients ≥ 75 years old or with hepatic impairment.
Contraindications
Hypersensitivity to the active substances, to dihydropyridine derivatives or to any of the excipients.
Second and third trimesters of pregnancy.
Severe hepatic insufficiency and biliary obstruction.
The concomitant use of Bizoran® with aliskiren-containing products is contraindicated in patients with diabetes mellitus or
renal impairment (GFR < 60 mL/min/1.73 m2)
Due to the component amlodipine, Bizoran® is also contraindicated in patients with:
– severe hypotension.
– shock (including cardiogenic shock).
– obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis).
– haemodynamically unstable heart failure after acute myocardial infarction
Drug Interaction
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
Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium
channel blockers. Clinical data are insufficient regarding the potential effect of amlodipine on fertility. In one rat study,
adverse effects were found on male 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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