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Cardiovascular Agents

Atenolol STADA® 50 mg

 

Pack size:

Box of 10 blisters x 10 tablets.

 

Composition:

Each tablet contains atenolol 50 mg.

 

Shelf-life:

60 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Atenolol is recommended for the treatment of hypertension, chronic stable angina pectoris, supraventricular tachy-arrhythmia, for early intervention in the acute phase of myocardial infarction and long-term treatment to prevent following acute myocardial infarction.
Atenolol STADA® 50 mg is administered orally before meals.

  • Hypertension:
    The usual initial adult oral dosage of atenolol is 25 - 50 mg once daily. The full hypotensive effect of atenolol may be seen after 1 to 2 weeks. Oral dosage may be increased to 100 mg once daily for optimum response. Increasing oral atenolol dosage beyond 100 mg daily usually does not result in further improvement in blood pressure control.
  • Angina pectoris:
    For the management of chronic stable angina pectoris, the initial adult oral dosage of atenolol is 50 mg once daily. If an optimum response is not achieved within one week, oral dosage should be increased to 100 mg once daily.
  • Cardiac  arrhythmias:
    Following control with intravenous atenolol, a suitable oral maintenance dosage is 50 - 100 mg daily, given as a single dose.
  • Early management of acute myocardial infarction:
    Adult: Patients tolerating the total IV dose of 10 mg can receive 50 mg orally 10 minutes later and then 50 mg orally 12 hours later. Dosing is continued orally for 6 - 9 days at 100 mg daily given as a single daily dose or in 2 equally divided doses.
    If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, atenolol should be discontinued.
  • Patients with renal insufficiency:
    The dose of atenolol should be reduced in patients with renal impairment, depending on the creatinine clearance (CC) as follows:
    CC 15-35 ml/minute per 1.73 m2: A maximum oral atenolol dosage of 50 mg daily is recommended.
    CC less than 15 ml/minute per 1.73 m2: 25 mg daily or 50 mg every other day is recommended.
    Dialysis patients: 25 - 50 mg orally after each dialysis.


Or as prescribed by physicians.

 

  • Metabolic acidosis.
  • Hypotension.
  • Severe peripheral arterial circulatory disturbances.
  • Severe asthma.
  • Severe chronic obstructive pulmonary disorders.
  • Patients with sinus bradycardia (< 50 bpm before treatment initiation), AV block greater than first degree, cardiogenic shock, known hypersensitivity to any component of the drug formulations and overt or decompensated cardiac failure.
  • Concomitant therapy with verapamil.

     

Adverse reactions are related to the pharmacological effect, and dose-dependent.
Most common is fatigue, including muscle weakness, which has been reported among 0.5-5% of all treated patients.

Common

  • Weakness, fatigue, peripheral extremity coolness and freezing.
  • Bradycardia, second or third degree AV blockade and hypotension.
  • Diarrhoea, nausea.

Less common

  • Sleep disturbances, reduced libidos.

Rare

  • Vertigo, headache.
  • Thrombocytopenia and leucopenia.
  • Worsening of cardiac insufficiency, AV blockade, postural hypotension, syncope.
  • Nightmares, hallucinatory, depression, anxiety, and psychoses.
  • Alopecia, skin eruptions, psoriasis-like reaction and exacerbation of psoriasis, purpura.
  • Dry eyes, disturbed vision.

     

  • Beta-receptor blocking drugs should not be withdrawn abruptly.
  • Particularly careful medical monitoring is necessary in:
  • Patients with asthma or a history of obstructive airways disease.
  • Diabetics with highly unstable blood glucose concentrations (because of the risk of severe hypoglycemic episodes).
  • Patients following an absolute diet for prolonged periods of time and those subject to great physical exertion (because of the risk of severe hypoglycemic episodes).
  • Patients with pheochromocytoma (tumour of the adrenal medulla; prior alpha-blocker therapy is indicated).
  • Patients with impaired kidney function.
  • Beta-receptor blocking drugs should be used only after careful benefit/risk assessment in patients with a history or family history of psoriasis.
  • Beta-receptor blocking drugs may increase susceptibility to allergens and the severity of anaphylactic reactions. Beta-receptor blocking drug should therefore be used only if clearly needed in patients with a history of severe hypersensitivity reactions and those receiving specific hyposensitisation therapies (because of the risk of exaggerated anaphylactic reactions).
  • The application of atenolol could cause positive results in doping tests. Consequences in health with the application of atenolol as doping drug cannot be foreseen. Heavy health risks cannot be excluded.
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose - galactose malabsorption should not take atenolol.
  • Pregnancy: Atenolol crosses the placental barrier and appears in the cord blood. No studies have been performed on the use of atenolol in the first trimester and the possibility of foetal injury cannot be excluded. Atenolol has been used under close supervision for the treatment of hypertension in the third trimester. Administration of atenolol to pregnant women in the management of mild to moderate hypertension has been associated with intra-uterine growth retardation.
    The use of atenolol in women who are, or may become, pregnant requires that the anticipated benefit be weighed against the possible risks, particularly in the first and second trimesters, since beta-blockers, in general, have been associated with a decrease in placental perfusion which may result in intra-uterine deaths, immature and premature deliveries.
  • Lactation: Atenolol is excreted in human milk at a ratio of 1.5 to 6.8 of plasma maternal concentration. There have been reports of harm for breast fed infants when their mothers use the drug, such as clinically significant bradycardia. Premature infants, or infants with impaired renal function may be more likely to develop adverse effects. Atenolol is not recommended in nursing mother.
  • Effects on ability to drive or use machines: Patients using this medicine must receive regular medical monitoring. Individually different reactions may alter alertness to such an extent as to impair the ability to actively participate in road traffic, operate machines, or work without a firm support. This applies especially at the start of therapy, when increasing the dose or switching medications, or when using alcohol at the same time.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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