Betapix-AM
Generic Name
Metoprolol Succinate Extended-Release and Amlodipine Besylate Tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| betafix am 25 mg tablet | ৳ 6.00 | ৳ 60.00 |
Description
Overview of the medicine
Betapix-AM is a combination medicine containing Metoprolol and Amlodipine, used to treat high blood pressure (hypertension) and certain heart conditions like angina. Metoprolol is a beta-blocker that slows down the heart rate, while Amlodipine is a calcium channel blocker that relaxes blood vessels, leading to improved blood flow and reduced blood pressure.
Uses & Indications
Dosage
Adults
Typically one Betapix-AM 25/5 mg tablet orally once daily. Dosage may be adjusted based on individual response and tolerability, up to a maximum of Betapix-AM 50/10 mg once daily.
Elderly
Lower initial dose may be considered, with gradual titration, especially in patients with impaired hepatic function.
Renal_impairment
No dosage adjustment needed for mild to moderate renal impairment. Caution is advised in severe renal impairment.
How to Take
Take orally with or without food, preferably at the same time each day to maintain consistent blood levels. Do not crush, chew, or break the extended-release tablet.
Mechanism of Action
Metoprolol succinate is a beta-1 selective adrenergic receptor blocker that reduces heart rate, cardiac output, and blood pressure. Amlodipine besylate is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, causing peripheral vasodilation and reduction in peripheral vascular resistance, thus lowering blood pressure. The combination provides additive antihypertensive effects.
Pharmacokinetics
Onset
Antihypertensive effects typically begin within a few hours and are sustained over 24 hours with once-daily dosing.
Excretion
Metoprolol and its metabolites are excreted primarily via the kidneys. Amlodipine is primarily excreted in the urine as inactive metabolites.
Half life
Metoprolol (extended-release): approximately 3-7 hours. Amlodipine: approximately 30-50 hours.
Absorption
Metoprolol is well absorbed from the GI tract but undergoes extensive first-pass metabolism. Amlodipine is well absorbed after oral administration, with peak plasma concentrations occurring 6-12 hours post-dose. Bioavailability of amlodipine is approximately 64-90%.
Metabolism
Both components are extensively metabolized in the liver. Metoprolol primarily by CYP2D6 and Amlodipine primarily by CYP3A4.
Side Effects
Contraindications
- Known hypersensitivity to metoprolol, amlodipine, or any component of the formulation
- Cardiogenic shock, sick sinus syndrome (unless a permanent pacemaker is in place), severe bradycardia, second- or third-degree atrioventricular block (without a pacemaker), decompensated heart failure
- Severe hypotension
Drug Interactions
Other antihypertensive agents
Concomitant use with other antihypertensives (e.g., ACE inhibitors, ARBs, diuretics) may result in additive hypotensive effects.
NSAIDs (Non-steroidal anti-inflammatory drugs)
May attenuate the antihypertensive effects of beta-blockers and calcium channel blockers.
CYP2D6 inhibitors (e.g., Fluoxetine, Paroxetine)
May increase metoprolol plasma concentrations, requiring dosage adjustment.
CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase amlodipine exposure, potentially leading to increased hypotensive effects. Dose adjustment of amlodipine may be necessary.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe hypotension, bradycardia, cardiac insufficiency, cardiogenic shock, cardiac arrest, bronchospasm, and impaired consciousness. Management is supportive and symptomatic, including gastric lavage, activated charcoal, IV fluids, vasopressors, atropine for bradycardia, and glucagon for severe hypotension.
Pregnancy & Lactation
Use during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Both metoprolol and amlodipine are excreted in breast milk; therefore, caution should be exercised when administering to a nursing mother. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture, depending on manufacturer specifications.
Availability
Pharmacies, hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Off-patent
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of metoprolol and amlodipine combination therapy in the management of hypertension and angina. Studies show superior blood pressure reduction and improved patient compliance compared to monotherapy.
Lab Monitoring
- Regular monitoring of blood pressure and heart rate is essential.
- Periodical monitoring of liver and kidney function tests, especially in patients with pre-existing impairment.
- Serum electrolyte levels may be checked.
Doctor Notes
- Patients should be advised against abrupt discontinuation, especially those with ischemic heart disease, due to risk of exacerbation of angina or MI.
- Monitor for signs of worsening heart failure (e.g., increased edema, shortness of breath), especially in patients with pre-existing cardiac conditions.
- Caution should be exercised in patients with hepatic impairment, as both drugs are extensively metabolized in the liver.
- Assess for drug interactions, particularly with CYP3A4 inhibitors (amlodipine) and CYP2D6 inhibitors (metoprolol).
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor. Do not stop taking it suddenly without consulting your doctor.
- Report any unusual or severe side effects to your doctor immediately.
- Monitor your blood pressure and heart rate regularly at home as advised by your healthcare provider.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Betapix-AM may cause dizziness, fatigue, or lightheadedness, especially at the start of treatment or after dosage adjustments. Avoid driving or operating heavy machinery until you know how the medicine affects you.
Lifestyle Advice
- Adopt a healthy lifestyle including a balanced diet low in sodium and saturated fats.
- Engage in regular moderate physical activity as recommended by your doctor.
- Avoid smoking and limit alcohol consumption to help manage blood pressure.
- Practice stress-reduction techniques.
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