Betafix-Plus
Generic Name
Bisoprolol Fumarate + Hydrochlorothiazide
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| betafix plus 5 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Betafix-Plus 5 mg Tablet is a combination medicine used to treat high blood pressure (hypertension). It contains Bisoprolol, a beta-blocker, and Hydrochlorothiazide, a thiazide diuretic. This combination helps to lower blood pressure by reducing heart rate, relaxing blood vessels, and increasing the excretion of salt and water from the body.
Uses & Indications
Dosage
Adults
Typically one Betafix-Plus 5 mg tablet orally once daily, in the morning. Dosage may be adjusted based on individual response and tolerability, up to a maximum of Bisoprolol 10 mg/Hydrochlorothiazide 25 mg daily.
Elderly
No specific dosage adjustment is typically required, but caution is advised. Start with the lowest effective dose and monitor renal function.
Renal_impairment
Not recommended for patients with severe renal impairment (creatinine clearance < 30 mL/min). For moderate impairment, dose adjustment or alternative therapies should be considered.
How to Take
Take the tablet orally, once daily in the morning, with or without food. Swallow whole with water, do not chew or crush.
Mechanism of Action
Bisoprolol is a selective beta-1 adrenergic receptor blocker that reduces heart rate and cardiac output, thereby lowering blood pressure. Hydrochlorothiazide is a thiazide diuretic that acts on the distal convoluted tubules of the kidneys to inhibit sodium and chloride reabsorption, leading to increased excretion of water, sodium, potassium, and chloride.
Pharmacokinetics
Onset
Onset of action for both components is typically within 2 hours.
Excretion
Bisoprolol is excreted by both renal (unchanged) and hepatic (metabolites) routes. Hydrochlorothiazide is primarily excreted unchanged by the kidneys.
Half life
Bisoprolol: 9-12 hours; Hydrochlorothiazide: 5.6-14.8 hours.
Absorption
Bisoprolol is well absorbed (80-90%), with peak plasma levels in 2-4 hours. Hydrochlorothiazide is moderately well absorbed (50-80%), reaching peak plasma levels in 1-2.5 hours.
Metabolism
Bisoprolol undergoes ~50% hepatic metabolism (via CYP2D6). Hydrochlorothiazide is not significantly metabolized.
Side Effects
Contraindications
- •Acute heart failure or decompensated heart failure
- •Cardiogenic shock
- •Second or third-degree AV block without a pacemaker
- •Sick sinus syndrome without a pacemaker
- •Severe bradycardia (<50 bpm)
- •Severe asthma or severe chronic obstructive pulmonary disease (COPD)
- •Severe peripheral arterial occlusive disease
- •Untreated pheochromocytoma
- •Metabolic acidosis
- •Anuria
- •Hypersensitivity to bisoprolol, hydrochlorothiazide, or other sulfonamide-derived drugs.
Drug Interactions
NSAIDs
May reduce the antihypertensive effect of Bisoprolol and Hydrochlorothiazide.
Lithium
Increased serum lithium concentrations and toxicity due to reduced renal clearance by hydrochlorothiazide.
Corticosteroids
Enhanced potassium loss due to hydrochlorothiazide.
ACE Inhibitors / ARBs
Increased risk of severe hypotension and renal impairment.
Antiarrhythmics (Class I)
Potentiation of cardiodepressant effects.
Calcium Channel Blockers (Verapamil, Diltiazem)
Increased risk of bradycardia and hypotension.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe bradycardia, hypotension, acute cardiac insufficiency, bronchospasm, acute renal failure, and electrolyte disturbances. Treatment is supportive and symptomatic, involving gastric lavage, activated charcoal, IV fluids, vasopressors, atropine, glucagon, and in some cases, hemodialysis.
Pregnancy & Lactation
Pregnancy Category C/D (depending on trimester for HCTZ). Not recommended during pregnancy, especially in the second and third trimesters, due to potential fetal harm (e.g., fetal growth retardation, neonatal jaundice, thrombocytopenia). Not recommended during lactation as both components are excreted in breast milk.
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, hospitals, and clinics
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Off-patent (for generic components)
WHO Essential Medicine
YesAlternative Medicines in Bangladesh
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Global Brand Names
International brand names for this medicine
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