Description and Composition of Bizoran
What is Bizoran and what does it contain?
Bizoran is a combination product containing Amlodipine, a calcium channel blocker and Olmesartan, an angiotensin II receptor blocker. Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle & cardiac muscle.
Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance & a reduction in blood pressure.
Olmesartan is an angiotensin II receptor blocker that acts on AT1 subtype. By blocking the action of angiotensin II. Olmesartan dilates blood vessels and reduces blood pressure without affecting pulse rate.
Indications and Uses of Bizoran
What is Bizoran used for?
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 combination compared to monotherapy.
Individual blood pressure goals may vary based upon the patient’s risk.
Dosage and Administration of Bizoran
What is the dosage of Bizoran?
The usual starting dose of Bizoran” is one tablet (5/20 mg) once daily. The dosage can be increased after 1 to 2 weeks therapy to a maximum dose of 2 tablets of Bizoran (i.e. 10/40 mg) once daily as needed to control blood pressure. Maximum antihypertensive effects are attained within weeks after change in dose.
Bizoran may be taken with or without food.
Bizoran may be administered with other antihypertensive agents.
Initial therapy with Bizoran is not recommended in patients more than 75 years old or with hepatic impairment.
Bizoran may be substituted for its individually titrated components. When substituting individual components, the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.
Bizoran may be used to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with olmesartan medoxomil (or another angiotensin receptor blocker) alone.
Contraindications of Bizoran
Hypersensitivity to Olmesartan medoxomil or Amlodipine.
Adverse Reactions of Bizoran
What are the side effects of Bizoran?
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.
1. Fetal/Neonatal Morbidity and Mortality:
When pregnancy is detected, this combination should be discontinued as soon as possible.
2. Hypotension in Volume or Salt-Depleted Patients
Symptomatic hypotension may occur after initiation of treatment.
Caution should be exercised when administering the drug particularly in patients with severe aortic stenosis.
4. Patients with severe Obstructive Coronary Artery Disease
Patients may develop increased frequency, duration, or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.
5. Patients with Congestive Heart Failure:
Calcium channel blockers should be used with caution in patients with heart failure.
6. Patients with Impaired Renal Function:
Caution should be exercised when administering the drug to patients with renal impairment.
7. Patients with Hepatic Impairment: Caution should be exercised when administering the drug to patients with severe hepatic impairment.
High Risk Group
Pregnant women: 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.
Nursing Mothers. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug.
Pediatric Use: The safety and effectiveness of Amlodipine & Olmesartan-combination in pediatric patients have not been established.
Geriatric Use: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Impaired Renal Function: No initial dosage adjustment is recommended for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min).
Impaired Hepatic Function: Use caution when administering the drug to patients with severe hepatic impairment.
Drug Interactions with Bizoran
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.
Store in cool & dry place. Keep away from children
Bizoran tablet: Box containing 30 tablets, in 3X10’s alu-alu form packs. Each tablet contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Olmesartan Medoxomil BP 20 mg
Bizoran 5/40 tablet: Box containing 30 tablets, in 3X10’s alu-alu form packs. Each tablet contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Olmesartan Medoxomil BP 40 mg.
BEXIMCO PHARMACEUTICALS LTD.
BL 9297 100314
Bizoran is a registered trademark of Beximco Pharmaceuticals Ltd