Bizoran Tablet 5mg+20mg

Bizoran

Amlodipine and Olmesartan Medoxom

Description

Bizoran" is a combinon product containing Amlodipine, a calcium channel blocker and Olmesartan, an angiotensin receptor blocker Amiodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle & cardiac muscle Amiodipine is a peripheral arterial vasodilator that directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance & a reduction in blood pressure. Olmesartan is an angiotensin receptor blocker that acts on AT subtype. By blocking

the action of angiotensin 1, Olmesartan diates blood vessels and reduces blood pressure without affecting pulse rate. Indications

Bzoran is indicated for the treatment of hypertension alone or with other

anhypertensive agents Boran may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Desage and Administration Intial Therapy:

The usual starting dose of Bizoran" is 5/20 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 10/40 mg tablet once daily to control blood pressure. Inibal therapy with Bizoran" is not recommended in patients ≥ 75 years old or with hepatic impairment. General Considerations

The side effects of olmesartan medoxomil are generally rare and apparently independent of dose. Those of amlodipine are generally

dose-dependent (mostly edema).

Maximum antihypertensive effects are attained within 2 weeks after a change in dose. Bizoran may be taken with or without

food Baoran may be administered with other antihypertensive agents Dosage may be increased after 2 weeks up to the maximum recommended dose of 1040 mg

Replacement Therapy Bizoran

may be substituted for its individually titrated components. When substituting for individual components, the dose of one or both of the components can be increased it blood pressure control has not been

satisfactory Add-on Therapy

Bizoran may be used to provide additional

blood pressure lowering for patients not adequately controlled with amlodipine for another dihydropyridine calum channel blocker) alone or with olmesartan medoxomil (or another angiotensin receptor blocker)

alone

Contraindications

Hypersensitivity to Olmesartan Medoxomil of

Amlodipine

Adverse Reactions The most common side effects include

peripheral edema, fushing, palpitations. dizziness. Other adverse reactions that occurred in placebo-controlled clinical trials are orthostatic hypotension, diarrhea, rash, abdominal pain, fatigue, back pain, pruritus, thabdomyolysis.

Warning & Precautions

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.

3. Vasodilatation: 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 a of dosage increase.

The time 5. Patients with Congestive Heart Falure Calcium channel blockers should be used with

caution in patients with heart failure Patents 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 Barani gered trademans of benca PharmaceVICA LA 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. Drug Interaction

In clinical trials, Amlodipine has been safely

administered

beta-blockers, with enzyme inhibitors tharide diuretics angiotensin-converting sublingual nitroglycern, digoxin warfarin non-steroidal long-acting nitrates. an-infammatory drugs. antibiotics, and oral hypoglycemic drugs. No significant drug interactions were reported in studies in which Olmesartan Modoxomil was co-administered with digoxin or warfarin, antacids Olmesartan Medoxomil is not

metabolized by the cytochrome Paso system and has no effects on Paso enzymes Keep out of the reach of children. Keep in cool

Pharmaceutical Precaution

& dry place. Protect from light.

Commercial Pack Bizoran" Tablet: Box containing 30 tablets, in 2X15's alu-alu form packs. Each tim coated 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 2X15's alu-au form packs. Each film coated tablet contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Olmesartan Medoxomil BP 40 mg.

Manufactured by

BEXIMCO PHARMACEUTICALS LTD.

TONGI, BANBANGLADESH.