Betabis 5 mg

Description

Indications:
Betabis Tablet is used for the treatment of:

• Hypertension (High Blood Pressure)
• Angina (Chest Pain)
• Moderate to Severe Heart Failure

Please note, Betabis is not suitable for the emergency treatment of hypertensive crises.

Use as directed by a registered healthcare provider.

Pharmacology:
Betabis contains Bisoprolol Fumarate, which is a highly selective beta-1 blocker. It has the highest affinity for the ß1 receptor compared to other beta-blockers available. Bisoprolol works by selectively blocking ß1 adrenergic receptors in the heart and smooth muscle of the blood vessels, which leads to a reduction in heart rate and cardiac output, thereby lowering arterial blood pressure.

Unlike non-selective ß-blockers, Bisoprolol does not negatively affect lipid metabolism or alter cholesterol fractions, including the beneficial HDL-cholesterol, when used for long-term therapy.

Pharmacokinetics:

• Absorption: Bisoprolol is absorbed almost completely (>90%) from the gastrointestinal tract. The high absorption rate and minimal first-pass effect (<10%) result in an absolute bioavailability of 88%.
• Distribution: The drug is widely distributed, with a medium distribution volume of 3.51 L/kg.
• Metabolism: Bisoprolol undergoes oxidative metabolism without subsequent conjugation. Its metabolites are very polar and are eliminated via the kidneys. It is primarily metabolized by the CYP3A4 enzyme (95%) with a minor contribution from CYP2D6.
• Elimination: Bisoprolol is cleared through both renal elimination (50%) and hepatic metabolism (50%). The total clearance rate is approximately 15 L/h, and its elimination half-life is between 10-12 hours.

Dosage & Administration:

• Adults: For the treatment of mild to moderate hypertension, Bisoprolol should be tailored to the patient’s needs. The usual starting dose is 5 mg once daily, either alone or with a diuretic. If the response to 5 mg is insufficient, the dose can be increased to 10 mg, and if needed, to 20 mg once daily. An appropriate interval for dose adjustment is 2 weeks. Increasing the dose beyond 20 mg offers only a minor additional benefit.

• Children: The safety and effectiveness of Betabis in children have not been established.

• Renal or Hepatic Impairment: In patients with liver conditions (such as hepatitis or cirrhosis) or kidney dysfunction (creatinine clearance less than 40 mL/min), the initial dose should be 5 mg daily. Caution is advised in dose titration, and since Bisoprolol is not dialyzable, no dose adjustments are necessary for dialysis patients.

• Elderly: Typically, no dose adjustment is required in elderly patients unless there is significant renal or hepatic dysfunction.

Always use as prescribed by a registered healthcare provider.

Drug Interactions:

• Other Beta-Blockers: Betabis should not be combined with other beta-blocking agents.
• Catecholamine-Depleting Drugs: Monitor closely when used with drugs like reserpine or guanethidine, as Betabis may cause an excessive reduction in sympathetic activity.
• Centrally Acting Antihypertensives: Concurrent use of Betabis with clonidine may exacerbate rebound hypertension when clonidine is withdrawn. If coadministered, stop Betabis several days before discontinuing clonidine.
• Antiarrhythmic Agents: Use with caution if combined with myocardial depressants or drugs that inhibit A-V conduction, such as certain calcium antagonists or antiarrhythmic drugs like disopyramide.
• Calcium Channel Blockers: Combining Betabis with calcium channel blockers that have negative inotropic effects can result in slowed conduction and potentially severe hypotension, bradycardia, or heart failure.

Contraindications:
Betabis is contraindicated in patients with:

• Cardiogenic shock
• Overt heart failure
• Second or third-degree A-V block
• Right ventricular failure secondary to pulmonary hypertension
• Sinus bradycardia

Side Effects:
Like all medications, Betabis may cause side effects, but they are not guaranteed to occur. Known side effects include:

• Fatigue, dizziness, headache
• Gastrointestinal disturbances such as nausea, vomiting, diarrhea, constipation, or abdominal pain
• Cold or numb extremities (e.g., hands and feet)
• Muscle weakness or cramps
• Slower than normal heart rate
• Breathing difficulties, particularly in individuals with asthma or COPD due to bronchospasm

Pregnancy & Lactation:

• Pregnancy: Animal studies have shown that Bisoprolol fumarate does not cause birth defects, but it was fetotoxic at higher doses. There are no adequate studies in pregnant women. Betabis should only be used during pregnancy if the potential benefits outweigh the risks to the fetus.

• Lactation: Bisoprolol fumarate is detected in the milk of lactating rats, but it is unknown if it is excreted in human milk. If necessary, mothers should discontinue breastfeeding when taking this medication.

Precautions & Warnings:

• Renal and Hepatic Impairment: Use caution when adjusting the dose in patients with impaired kidney or liver function.
• Anaphylaxis: Beta-blockers may increase sensitivity to allergens and make it harder to treat allergic reactions with epinephrine.

Storage Conditions:
Store Betabis in a dry place, away from light and heat. Keep out of the reach of children.

Chemical Information:

• Molecular Formula: C18H31NO4
• Chemical Structure: Bisoprolol Fumarate Structure

Common Questions About Betabis 5 mg Tablet:

1. What is Betabis 5 mg Tablet?
   Betabis 5 mg Tablet is a beta-blocker that helps lower blood pressure, reduce the heart’s workload, and prevent chest pain by blocking the effects of adrenaline.

2. What is Betabis used for?
   It is used to treat high blood pressure (hypertension), chest pain (angina), and heart failure by slowing the heart rate and widening the blood vessels.

3. How should I take Betabis 5 mg Tablet?
   Take one tablet daily, with or without food. It is recommended to take it at the same time each day for consistency.

4. What are the side effects of Betabis 5 mg Tablet?
   Side effects may include dizziness, fatigue, headache, slow heart rate, difficulty breathing, and cold hands/feet.

5. Is Betabis 5 mg Tablet safe?
   Betabis is generally safe, but consult your doctor before use if you have asthma, diabetes, heart issues, liver/kidney problems, or low blood pressure.

6. Should I take Betabis before or after food?
   Betabis should be taken after food as prescribed by your doctor.

7. Storage & Disposal:
   Store Betabis in a cool, dry place in its original packaging, away from children and pets.

Quick Tips:

• Betabis may cause dizziness. If so, stand up slowly from a sitting or lying position.
• If diabetic, monitor blood sugar levels regularly, as Betabis may mask symptoms of low blood sugar.
• Do not suddenly stop taking Betabis, as this can cause a sudden rise in blood pressure and increase the risk of a heart attack or stroke.