Bislol Max Tablet

Introduction

Bisoprolol Fumarate and Amlodipine Besilate are combined in a single formulation to treat hypertension and certain cardiovascular conditions. Bisoprolol is a selective beta-1 blocker, while Amlodipine is a calcium channel blocker. This combination provides a synergistic effect to manage blood pressure and improve cardiovascular outcomes.

Uses

The combination of Bisoprolol Fumarate and Amlodipine Besilate is used to:

• Manage hypertension (high blood pressure) in patients who may not be adequately controlled with monotherapy.
• Treat angina pectoris (chest pain) by improving coronary blood flow.
• Reduce the risk of cardiovascular events in patients with existing coronary artery disease or heart failure.

Mechanism of Action

Bisoprolol Fumarate works by selectively blocking beta-1 adrenergic receptors, which reduces heart rate, myocardial contractility, and cardiac output, leading to lower blood pressure and reduced cardiac workload. Amlodipine Besilate inhibits calcium influx into vascular smooth muscle and cardiac muscle, leading to vasodilation and decreased blood pressure. The combination results in reduced total peripheral resistance and improved cardiovascular function.

How Long Does It Take to Work?

The onset of action for Bisoprolol Fumarate is typically within 1 to 2 hours, with peak effects occurring within 2 to 4 hours. Amlodipine Besilate starts working within 6 to 12 hours, with maximum effect usually seen within 24 to 48 hours. The combination therapy will show a reduction in blood pressure and symptom relief gradually, with noticeable effects typically within a few days to weeks of consistent use.

Absorption

Both Bisoprolol and Amlodipine are well absorbed after oral administration. Bisoprolol has an oral bioavailability of approximately 90%, while Amlodipine has a bioavailability of about 64-90%. The presence of food does not significantly affect the absorption of either drug.

Route of Elimination

Bisoprolol is primarily eliminated by the kidneys, with approximately 50% of the dose excreted unchanged in the urine. Amlodipine is metabolized in the liver and then excreted in the urine as metabolites. A small amount of Amlodipine is excreted unchanged in the urine.

Dosage

The typical dosage of the combination product is:

• Adults: One tablet of Bisoprolol Fumarate and Amlodipine Besilate combination daily. The exact dosage may vary based on individual patient needs and response. Dosages typically range from 5 mg/5 mg to 10 mg/10 mg of Bisoprolol/Amlodipine daily.

Administration

The combination tablet should be taken orally, preferably at the same time each day. It can be taken with or without food. Swallow the tablet whole with a glass of water. Do not crush or chew the tablet.

Side Effects

Common side effects include:

• Dizziness or lightheadedness
• Fatigue
• Headache
• Swelling of the ankles or legs
• Palpitations

• Severe hypotension
• Bradycardia
• Worsening of heart failure
• Allergic reactions (e.g., rash, itching, swelling)

Toxicity

In cases of overdose, symptoms may include severe hypotension, bradycardia, dizziness, and possible signs of heart failure. Management involves discontinuing the medication, providing supportive care, and symptomatic treatment. In severe cases, hospitalization may be required for monitoring and treatment.

Precautions

Precautions should be taken in patients with:

• Pre-existing heart conditions (e.g., heart failure, bradycardia)
• Severe renal or hepatic impairment
• History of allergic reactions or hypersensitivity to beta-blockers or calcium channel blockers
• Asthma or chronic obstructive pulmonary disease (COPD)

Interaction

The combination therapy may interact with:

• Other antihypertensives: Additive effects may lead to excessive blood pressure reduction.
• Beta-blockers: Concurrent use with other beta-blockers may increase the risk of bradycardia and hypotension.
• CYP3A4 inhibitors: May increase Amlodipine levels, necessitating dose adjustments.

Disease Interaction

Use with caution in patients with:

• Chronic respiratory diseases
• Severe hepatic or renal impairment
• Peripheral vascular disease
• Diabetes mellitus with a risk of hypoglycemia

Drug Interaction

Drug interactions may include:

• Antacids: May affect the absorption of Amlodipine.
• Digoxin: May enhance the effects of Bisoprolol, requiring monitoring of heart rate and blood pressure.
• Other calcium channel blockers: May have additive effects on blood pressure and heart rate.

Food Interactions

There are no significant food interactions with the Bisoprolol and Amlodipine combination. The medication can be taken with or without food. However, avoiding excessive alcohol intake is advisable as it may enhance the hypotensive effects.

Pregnancy Use

The combination of Bisoprolol Fumarate and Amlodipine Besilate is generally not recommended during pregnancy unless clearly needed. Bisoprolol is classified as pregnancy category C, and Amlodipine is also category C. Use during pregnancy should involve careful risk-benefit assessment.

Lactation Use

Both Bisoprolol and Amlodipine are excreted in breast milk. While the combination may be used during lactation, caution is advised. Monitor for any potential adverse effects in the nursing infant, and consult a healthcare provider if concerns arise.

Acute Overdose

Acute overdose symptoms may include severe hypotension, bradycardia, dizziness, and potential worsening of heart failure. Management involves discontinuing the medication and providing symptomatic and supportive care. In severe cases, medical intervention may be required.

Contraindication

The combination of Bisoprolol Fumarate and Amlodipine Besilate is contraindicated in patients with:

• Severe bradycardia
• Severe hypotension
• Heart block greater than first degree (unless a pacemaker is present)
• Severe hepatic impairment
• Known hypersensitivity to either Bisoprolol, Amlodipine, or any component of the formulation

Use Direction

Take the medication as prescribed by a healthcare provider. Adhere to the recommended dosage and administration instructions. Regular follow-up visits may be required to monitor blood pressure, heart rate, and overall response to therapy.

Storage Conditions

Store the combination tablet at room temperature, between 20°C and 25°C (68°F and 77°F). Keep away from light and moisture. Store in the original container and keep out of reach of children.

Volume of Distribution

The volume of distribution for Bisoprolol is approximately 3 to 4 liters/kg, and for Amlodipine, it is around 21 liters. The combination therapy ensures effective systemic and local distribution to manage blood pressure and cardiovascular symptoms.

Half Life

The half-life of Bisoprolol is approximately 10 to 12 hours, while for Amlodipine, it is about 30 to 50 hours. The long half-life of Amlodipine allows for once-daily dosing, providing sustained antihypertensive effects.

Clearance

Bisoprolol is cleared primarily by the kidneys, with an average clearance rate of about 15 to 20 L/h. Amlodipine is metabolized in the liver and has a clearance rate of approximately 1.3 to 1.6 L/h. Clearance may be affected by liver and renal function.

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