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Bisoprolol STELLA 10 mg
Rx

Bisoprolol STELLA 10 mg contains bisoprolol fumarate which is a beta 1-selective adrenergic receptor blocking agent. Bisoprolol is given as the fumarate in the management of hypertension and angina pectoris.

Pack size Box of 30 tablets, 60 tablets
Shelf-life 24 months
Composition Bisoprolol fumarate
Dosage forms and strengths Film-coated tablet: 10 mg
Product code :

PRESCRIBING INFORMATION

Indications:

Management of hypertension and angina pectoris.

It is also used as an adjunct to standard therapy in patients with stable chronic heart failure.

Dosage:

  • Hypertension or angina pectoris: The usual dose is 5 to 10 mg orally as a single daily dose, the maximum recommended dose is 20 mg daily.
  • Congestive heart failure: The initial dose of is 1.25 mg once daily, the dose should be doubled after 1 week, and then increased gradually at 1 to 4 week intervals to the maximum dose; this should not exceed 10 mg once daily.
  • Renal and hepatic impairment: The initial dose for hypertension should be 2.5 mg daily and that the dose should be increased cautiously in patients with severe hepatic impairment or renal impairment (ClCr < 40 ml/minute). A maximum dose of 10 mg daily for both angina pectoris and hypertension in patients with severe hepatic impairment or with ClCr < 20 ml/minute.

Usage:

Bisoprolol STELLA 10 mg is only administered orally.

  • Acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy.
  • Cardiogenic shock.
  • AV block of second or third degree (without a pacemaker).
  • Sick sinus syndrome.
  • Sinoatrial block.
  • Bradycardia with less than 60 beats/minute before the start of therapy.
  • Hypotension (systolic blood pressure less than 100 mmHg).
  • Severe bronchial asthma or severe chronic obstructive pulmonary disease.
  • Late stages of peripheral arterial occlusive disease and Raynaud’s syndrome.
  • Untreated phaeochromocytoma.
  • Metabolic acidosis.
  • Hypersensitivity to bisoprolol or to any of the excipients.

Dizziness, vertigo, headache, paresthesia, hypoaesthesia, somnolence, anxiety, restlessness, decreased concentration/ memory; Bradycardia, palpitations and other rhythm disturbances, cold extremities, claudication, hypotension, chest pain, congestive heart failure, dyspnea on exertion; Gastric/epigastric/abdominal pain, gastritis, dyspepsia, nausea, vomiting, diarrhea, constipation; Rash, eczema, skin irritation, pruritus, flushing, sweating, alopecia, angioedema, exfoliative dermatitis, cutaneous vasculitis; Visual disturbances, ocular pain/pressure, abnormal lacrimation, tinnitus, earache, taste abnormalities.

  • Caution must be used in dosing titrating patients with hepatic impairment or renal dysfunction.
  • Beta-blockade may result in further depression of myocardial contractility and precipitate more severe failure.
  • At the first signs or symptoms of heart failure, discontinuation of bisoprolol should be considered.
  • Exacerbation of angina pectoris and in some instances, myocardial infarction or ventricular arrhythmia, have been observed in patients with coronary artery disease following abrupt cessation of therapy with beta-blockers.
  • Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
  • In general, patients with bronchospastic disease should not receive beta-blockers. However, bisoprolol may be used with caution in patients with bronchospastic disease who do not respond to, or who cannot tolerate other antihypertensive treatment.
  • Beta-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia; clinical signs of hyperthyroidism, such as tachycardia.
  • Bisoprolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when bisoprolol is administered to nursing women.
  • As bisoprolol can cause drowsiness, dizziness and fatigue as side effects, these may affect the patient’s ability to drive or operate machinery.