Bisoren M 2.5/5 Tablet 1 Strip

✔️ Dosage & Administration

One tablet once daily is recommended for patients previously maintained on the same doses of bisoprolol and amlodipine as separate agents.

• Elderly: Dose adjustment generally not needed, but monitor response.
• Pediatric: Not established; safety and efficacy data lacking.
• Liver Dysfunction: Amlodipine clearance may be reduced. Use with caution.
• Kidney Dysfunction: Generally, no dose adjustment required in mild-to-moderate impairment. Amlodipine is not dialyzable. In severe renal impairment (CrCl <20 ml/min), the bisoprolol dose should not exceed 10 mg daily.

✔️ Side Effects

Common: Headache, dizziness, drowsiness, flushing, GI upset (nausea, diarrhea), peripheral edema (e.g., ankle swelling), fatigue.

Uncommon: Mood disorders, sleep disturbances, visual issues, tinnitus, AV block, worsening heart failure, bronchospasm, skin rashes, muscle pain or cramps, urinary symptoms, erectile dysfunction, weight changes.

Rare: Allergic skin reactions, hallucinations, hepatitis, elevated liver enzymes or triglycerides, hearing disturbances.

✔️ Drug Interactions

• Avoid Combining With: Verapamil, diltiazem, centrally-acting antihypertensives (e.g., clonidine).
• Use With Caution: CYP3A4 inhibitors/inducers, simvastatin, tacrolimus, cyclosporine, antiarrhythmics (Class I/III), insulin, oral antidiabetics, anesthetics, NSAIDs, digitalis, sympathomimetics, other antihypertensives.
• Consider Potential Interactions With: Rifampicin, mefloquine, ergotamine derivatives, MAO inhibitors (excluding MAO-B inhibitors).

✔️ Not to be used in patients with:

• Acute or decompensated heart failure
• Severe aortic stenosis or cardiogenic shock
• Advanced AV block or sick sinus syndrome
• Symptomatic bradycardia or hypotension
• Severe bronchial asthma or Raynaud’s syndrome
• Untreated phaeochromocytoma
• Metabolic acidosis
• Hypersensitivity to bisoprolol, amlodipine, or similar agents

✔️ Use in Pregnancy & Lactation

Not recommended during pregnancy or breastfeeding due to potential fetal and neonatal risks.

✔️ Overdose Management

Overdose symptoms may include:

• From Bisoprolol: Bradycardia, hypotension, bronchospasm, hypoglycemia, and acute heart failure.
• From Amlodipine: Severe hypotension, reflex tachycardia, potential shock.
  Treatment: Discontinue the drug, initiate supportive measures, including cardiovascular support and symptomatic care.

✔️ Precautions & Warnings

• Use cautiously in heart failure, hepatic impairment, and elderly patients.
• Avoid abrupt discontinuation of bisoprolol—taper gradually.
• Monitor patients with respiratory disorders (e.g., asthma, COPD), diabetes (may mask hypoglycemia), or peripheral vascular disease.
• Caution in psoriasis, thyrotoxicosis, or during desensitization therapy.
• Inform the anesthesiologist if undergoing surgery, as beta-blockers may interfere with anesthetic response.

✔️ Storage Conditions

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