Atenolol
Visa No.: VD-23232-15
Product: Atenolol STADA 50 mg
API: Atenolol
Product Category: Cardiovascular & Metabolism
Version approved leaflet: 201/QĐ-QLD_20/04/2022_174.1
INDICATIONS
Atenolol is indicated for the treatment of:
- Hypertension
- Angina pectoris
- Cardiac arrhythmias
- Myocardial infarction, including early intervention in the acute phase
DOSAGE AND ADMINISTRATION
Dosage
The dose should be inpidualized for each patient, starting with the lowest possible dose.
Adult
Hypertension: One tablet daily. Most patients respond to 100 mg once daily; some respond to 50 mg once daily.
Maximum effect is usually achieved after 1–2 weeks. Additional blood pressure reduction may be achieved by combining atenolol with other antihypertensive agents, e.g., a diuretic.
Angina pectoris:
Most patients with angina respond to 100 mg orally once daily or 50 mg twice daily. Increasing the dose is unlikely to provide additional benefit.
Cardiac arrhythmias:
An appropriate initial dose of atenolol is 2.5 mg (5 mL) by intravenous injection over 2.5 minutes (i.e., 1 mg/min). This may be repeated every 5 minutes until a response is achieved, up to a maximum dose of 10 mg. If atenolol is administered by intravenous infusion, a dose of 0.15 mg/kg body weight may be infused over 20 minutes. If necessary, the injection or infusion may be repeated every 12 hours. After arrhythmia control with intravenous atenolol, the appropriate oral maintenance dose is 50–100 mg once daily.
Myocardial infarction:
In patients suitable for intravenous beta-blocker treatment and presenting within 12 hours of chest pain onset, 5–10 mg atenolol should be given by slow intravenous injection (1 mg/min). Approximately 15 minutes later, 50 mg orally should be given if no adverse effects have occurred. This is followed by 50 mg orally 12 hours later, and then 100 mg once daily thereafter.
Elderly
Dose reduction may be required, particularly in patients with impaired renal function.
Children
There is no experience with atenolol in children; therefore, it is not recommended for use in children.
Patients with renal impairment
As atenolol is excreted via the kidneys, the dose should be reduced in patients with severe renal impairment. No significant accumulation occurs in patients with creatinine clearance greater than 35 mL/min/1.73 m² (normal range: 100–150 mL/min/1.73 m²).
In patients with creatinine clearance between 15 and 35 mL/min/1.73 m² (corresponding to serum creatinine 300–600 micromol/L), the recommended oral dose is 50 mg once daily, and the intravenous dose is 10 mg once every 2 days.
In patients with creatinine clearance below 15 mL/min/1.73 m² (corresponding to serum creatinine greater than 600 micromol/L), the recommended oral dose is 25 mg once daily or 50 mg on alternate days, and the intravenous dose is 10 mg once every 4 days.
Hemodialysis patients: 50 mg orally after each dialysis session under hospital supervision, as marked hypotension may occur.
Method of administration: For oral use.
CONTRAINDICATIONS
As with other beta-blockers, atenolol should not be used in patients with any of the following conditions:
- History of hypersensitivity to atenolol or any component of the product
- Cardiogenic shock
- Uncontrolled heart failure
- Sick sinus syndrome
- Second- or third-degree heart block
- Untreated pheochromocytoma
- Metabolic acidosis
- Bradycardia (<45 beats per minute)
Hypotension
- Severe peripheral arterial circulatory disorders
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.