Combicard
Generic Name
Bisoprolol Fumarate + Amlodipine Besylate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| combicard 5 mg tablet | ৳ 7.00 | ৳ 70.00 |
Description
Overview of the medicine
Combicard 2.5/5 mg Tablet is a combination medicine containing Bisoprolol (a beta-blocker) and Amlodipine (a calcium channel blocker). It is primarily used to treat essential hypertension (high blood pressure) and may also be used in stable angina.
Uses & Indications
Dosage
Adults
Usually one Combicard 2.5/5 mg tablet once daily. Dosage may be adjusted based on clinical response and tolerability, up to a maximum of 10/10 mg daily.
Elderly
No special dosage adjustment is generally required, but caution is advised due to potential for decreased renal/hepatic function and increased sensitivity.
Renal_impairment
No dosage adjustment needed for mild to moderate renal impairment. For severe renal impairment, lower initial dose and careful monitoring are advised.
How to Take
Take the tablet orally, once daily, preferably in the morning, with or without food. Swallow the tablet whole with water; do not crush, chew, or break it.
Mechanism of Action
Bisoprolol selectively blocks beta-1 adrenergic receptors, reducing heart rate and myocardial contractility, thereby lowering blood pressure. Amlodipine inhibits calcium ion influx across vascular smooth muscle and cardiac muscle, causing peripheral arterial vasodilation and reducing afterload, which also lowers blood pressure and improves blood flow to the heart.
Pharmacokinetics
Onset
Antihypertensive effect begins within 2 hours for Bisoprolol; for Amlodipine, it is gradual over several hours.
Excretion
Bisoprolol is excreted renally (50% unchanged, 50% as metabolites). Amlodipine metabolites are primarily excreted via urine, with a small portion via feces.
Half life
Bisoprolol: 10-12 hours. Amlodipine: 30-50 hours.
Absorption
Both Bisoprolol and Amlodipine are well absorbed orally. Bisoprolol has ~90% bioavailability, Amlodipine has ~60-64% bioavailability. Peak plasma concentrations are reached within 2-4 hours for Bisoprolol and 6-12 hours for Amlodipine.
Metabolism
Bisoprolol is metabolized in the liver (approx. 50%). Amlodipine is extensively metabolized in the liver to inactive metabolites (approx. 90%).
Side Effects
Contraindications
- Acute heart failure or decompensated heart failure requiring intravenous inotropes
- Cardiogenic shock
- Sick sinus syndrome (unless a pacemaker is in place)
- Second or third-degree AV block (unless a pacemaker is in place)
- Severe bradycardia (<50 beats/min)
- Severe hypotension
- Severe bronchial asthma or severe chronic obstructive pulmonary disease
- Severe peripheral arterial occlusive disease or Raynaud's syndrome
- Metabolic acidosis
- Untreated pheochromocytoma
- Hypersensitivity to Bisoprolol, Amlodipine, or any component of the formulation
Drug Interactions
Insulin and Oral Antidiabetics
Beta-blockers may mask symptoms of hypoglycemia and prolong hypoglycemic episodes.
Digitalis Glycosides (e.g., Digoxin)
Bisoprolol may prolong AV conduction time.
NSAIDs (Non-steroidal Anti-inflammatory Drugs)
May attenuate the antihypertensive effect of both components.
Class I Antiarrhythmics (e.g., Disopyramide, Quinidine)
May potentiate the negative inotropic effect of Bisoprolol.
Other Antihypertensives (e.g., ACE inhibitors, ARBs, diuretics)
May enhance the hypotensive effect.
Calcium Channel Blockers (non-dihydropyridine, e.g., Verapamil, Diltiazem)
Increased risk of bradycardia, AV block, and heart failure with Bisoprolol.
CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin)
May increase Amlodipine plasma concentrations, leading to increased risk of hypotension and edema.
CYP3A4 Inducers (e.g., Rifampicin, Carbamazepine, Phenytoin, Phenobarbital, St. John's Wort)
May decrease Amlodipine plasma concentrations, reducing efficacy.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include excessive hypotension, bradycardia, dizziness, drowsiness, nausea, vomiting, and shock. Management involves symptomatic and supportive measures. Gastric lavage, activated charcoal, and IV fluids may be administered. For severe bradycardia, atropine or isoproterenol may be used; for hypotension, vasopressors. Hemodialysis is unlikely to be beneficial.
Pregnancy & Lactation
Not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus (Category C). Amlodipine is excreted in breast milk, and it is unknown if Bisoprolol is. It is generally advisable to avoid use during lactation.
Side Effects
Contraindications
- Acute heart failure or decompensated heart failure requiring intravenous inotropes
- Cardiogenic shock
- Sick sinus syndrome (unless a pacemaker is in place)
- Second or third-degree AV block (unless a pacemaker is in place)
- Severe bradycardia (<50 beats/min)
- Severe hypotension
- Severe bronchial asthma or severe chronic obstructive pulmonary disease
- Severe peripheral arterial occlusive disease or Raynaud's syndrome
- Metabolic acidosis
- Untreated pheochromocytoma
- Hypersensitivity to Bisoprolol, Amlodipine, or any component of the formulation
Drug Interactions
Insulin and Oral Antidiabetics
Beta-blockers may mask symptoms of hypoglycemia and prolong hypoglycemic episodes.
Digitalis Glycosides (e.g., Digoxin)
Bisoprolol may prolong AV conduction time.
NSAIDs (Non-steroidal Anti-inflammatory Drugs)
May attenuate the antihypertensive effect of both components.
Class I Antiarrhythmics (e.g., Disopyramide, Quinidine)
May potentiate the negative inotropic effect of Bisoprolol.
Other Antihypertensives (e.g., ACE inhibitors, ARBs, diuretics)
May enhance the hypotensive effect.
Calcium Channel Blockers (non-dihydropyridine, e.g., Verapamil, Diltiazem)
Increased risk of bradycardia, AV block, and heart failure with Bisoprolol.
CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin)
May increase Amlodipine plasma concentrations, leading to increased risk of hypotension and edema.
CYP3A4 Inducers (e.g., Rifampicin, Carbamazepine, Phenytoin, Phenobarbital, St. John's Wort)
May decrease Amlodipine plasma concentrations, reducing efficacy.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include excessive hypotension, bradycardia, dizziness, drowsiness, nausea, vomiting, and shock. Management involves symptomatic and supportive measures. Gastric lavage, activated charcoal, and IV fluids may be administered. For severe bradycardia, atropine or isoproterenol may be used; for hypotension, vasopressors. Hemodialysis is unlikely to be beneficial.
Pregnancy & Lactation
Not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus (Category C). Amlodipine is excreted in breast milk, and it is unknown if Bisoprolol is. It is generally advisable to avoid use during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities (e.g., DGDA)
Patent Status
Generic available (Off-patent for active ingredients)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Bisoprolol and Amlodipine combination in managing hypertension and angina, showing superior blood pressure control and tolerability compared to monotherapy.
Lab Monitoring
- Blood pressure monitoring
- Heart rate monitoring
- Renal function (BUN, creatinine)
- Liver function tests (ALT, AST)
- Electrolyte levels (potassium)
Doctor Notes
- Emphasize the importance of patient adherence due to the potential for rebound hypertension with abrupt beta-blocker withdrawal.
- Consider starting with a lower dose in elderly patients or those with impaired renal/hepatic function.
- Advise patients on lifestyle modifications as an integral part of hypertension management.
Patient Guidelines
- Take this medicine regularly as prescribed, even if you feel well.
- Do not stop taking this medicine abruptly without consulting your doctor.
- Inform your doctor about all other medicines you are taking, including over-the-counter drugs and herbal supplements.
- Monitor your blood pressure regularly as advised by your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, fatigue, or somnolence, especially at the beginning of treatment or when the dose is changed. If affected, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet low in sodium and saturated fats.
- Engage in regular physical activity as approved by your doctor.
- Avoid smoking and limit alcohol consumption.
- Manage stress through relaxation techniques or other methods.
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