Indications

Bislol Max is a combination tablet indicated for the treatment of hypertension. It is used as a substitution therapy for patients whose blood pressure is already well-controlled by separate tablets of Amlodipine and Bisoprolol at the same dose level.

Pharmacology

• Amlodipine: A dihydropyridine calcium antagonist that inhibits the influx of calcium ions into vascular smooth muscle. This causes a direct reduction in peripheral vascular resistance, leading to a decrease in blood pressure. It has a greater effect on blood vessels than on cardiac muscle.
• Bisoprolol Fumarate: A synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. It primarily blocks beta1-receptors in the heart, with low affinity for beta2-receptors in the lungs and blood vessels. This action helps reduce blood pressure without significantly affecting airway resistance.

Dosage & Administration

The recommended dosage is one tablet once daily. This is for patients who are already on stable doses of the individual components (Amlodipine and Bisoprolol) and are being switched to the fixed-dose combination.

Interaction

• Not Recommended: Verapamil or diltiazem type calcium antagonists, and centrally-acting antihypertensive drugs.
• Use with Caution: CYP3A4 inhibitors or inducers, Simvastatin, Tacrolimus, Cyclosporine, antiarrhythmic drugs, topical beta-blockers, insulin and oral antidiabetic drugs, anesthetic agents, Digitalis glycosides, NSAIDs, sympathomimetic agents, and other blood pressure-lowering drugs.

Contraindications

This medication is contraindicated in patients with:

• Acute heart failure or decompensation.
• Cardiogenic shock, second or third-degree AV block, sick sinus syndrome.
• Severe hypotension or bradycardia.
• Severe bronchial asthma.
• Severe peripheral arterial occlusive disease or Raynaud's syndrome.
• Untreated pheochromocytoma, metabolic acidosis.
• Hypersensitivity to bisoprolol, amlodipine, or any of the components.

Side Effects

• Common: Dizziness, headache, fatigue, somnolence, palpitations, flushing, coldness in extremities, and gastrointestinal issues like nausea, vomiting, diarrhea, constipation, and abdominal pain.
• Uncommon: Insomnia, mood changes, depression, visual disturbances, tinnitus, bradycardia, hypotension, shortness of breath, rhinitis, dry mouth, rash, muscle cramps, and sexual dysfunction.
• Rare: Allergic reactions, nightmares, hallucinations, confusion, hepatitis, and increased liver enzymes.

Pregnancy & Lactation

Bislol Max is not recommended for use during pregnancy or lactation.

Precautions & Warnings

• Heart Failure: Use with caution in patients with heart failure due to the risk of worsening ventricular function.
• Withdrawal: Do not stop treatment abruptly, as this can worsen clinical conditions, especially in patients with ischemic heart disease.
• Hepatic/Renal Impairment: Caution is advised in patients with impaired liver or kidney function.
• Asthma: Beta-blockers should be avoided in patients with obstructive airway diseases unless absolutely necessary.
• Diabetes: Symptoms of hypoglycemia may be masked.
• Surgery: Inform the anesthetist of the beta-blockade before general anesthesia.

Use in Special Populations

• Geriatric Use: The usual doses can be given to elderly patients, but caution is advised when increasing the dose.
• Pediatric Use: The safety and efficacy in patients under 18 have not been established.
• Liver Disease: Use with special caution, and the daily bisoprolol dose should not exceed 10 mg in severe cases.
• Kidney Disease: No dose adjustment is needed for mild to moderate impairment. The daily bisoprolol dose should not exceed 10 mg in severe impairment. Amlodipine is not dialyzable.

Overdose Effects

Overdose may cause severe bradycardia, hypotension, bronchospasm, and acute cardiac insufficiency. Amlodipine overdose can lead to excessive vasodilation and shock. In case of overdose, discontinue the drug and provide supportive and symptomatic treatment.

Therapeutic Class

This is an anti-hypertensive medication.

Storage Conditions

Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.