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Bisostad 5
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Bisoprolol is a beta 1-selective adrenergic receptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range.

Pack size Box of 30 tablets, 60 tablets.
Shelf-life 24 months
Composition Bisoprolol Fumarate
Dosage forms and strengths Film coated tablet: 5 mg.
Product code :

PRESCRIBING INFORMATION

Indications:

Treatment for 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 of bisoprolol fumarate is 5 to 10 mg orally as a single daily dose; the maximum recommended dose is 20 mg daily
  • Congestive heart failure: The initial oral dose of bisoprolol fumarate is 1.25 mg once daily.
  • If tolerated, the dose should be doubled after 1 week, and then increased gradually at 1 to 4 week intervals to the maximum dose tolerated; this should not exceed 10 mg once daily.
  • Dosage in renal and hepatic impairment: The initial dose of bisoprolol fumarate 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 (creatinine clearance less than 40 ml/minute). A maximum dose of 10 mg daily for both angina pectoris and hypertension in patients with severe hepatic impairment or with a creatinine clearance of less than 20 ml/minute.

Usage:

Bisostad 5 is orally administered.

Known hypersensitivity to any of the active substance or excipients.

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.

Dizziness, vertigo, headache, paresthesia, hypoaesthesia, somnolence, anxiety, restlessness, decreased concentration/memory. Vivid dreams, insomnia, depression.

Dry mouth. Gout. Purpura.

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.

Muscle/joint pain, back/neck pain, muscle cramps, twitching/tremor.

Rash, eczema, skin irritation, pruritus, flushing, sweating, alopecia, angioedema, exfoliative dermatitis, cutaneous vasculitis.

Visual disturbances, ocular pain/pressure, abnormal lacrimation, tinnitus, earache, taste abnormalities.

Asthma/bronchospasm, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis.

Decreased libido/impotence, cystitis, renal colic.

Fatigue, asthenia, chest pain, malaise, edema, weight gain.

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.

Do not abrupt cessation of therapy with beta – blockers in patients with coronary artery disease and hyperthyroidism.

Beta – blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.

Use 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 in patients subject to spontaneous hypoglycemia or diabetic patients receiving insulin or oral hypoglycemic agents.

Particular care should be taken when anesthetic, agents which depress myocardial function, are used.

Bisoprolol is not recommended for pregnancy and breastfeeding.

Patients should be aware of how they react to drug before driving or operating machinery (especially when starting treatment, dosage adjustment, alcohol drinking).