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Bisostad 2.5
Rx

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: 2.5 mg.
Product code :

PRESCRIBING INFORMATION

Indications:

  • Hypertension
  • Angina
  • Treatment of stable chrome heart failure with reduced systolic left ventricular function in addition to ACE inhibitor, and diuretics, and optionally cardiac glycosides.

Dosage:

Hypertension and angina for adults:

The usual starting dose is 2.5 – 5 mg once daily. If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily.

Chrome heart failure (CHF) for adults:

Standard treatment of CHF: Patients should be stable (without acute failure) when bisoprolol treatment is initiated. The treatment with bisoprolol is to be started with a gradual up titration according to the following steps:

  • 1.25 mg (Use of suitable dosage forms when using doses of 1.25 mg) once daily for 1 week, if well tolerated increase to.
  • 2.5 mg once daily for a further week, if well tolerated increase to.
  • 3.75 mg once daily for a further week, if well tolerated increase to.
  • 5 mg once daily for the 4 following weeks, if well tolerated increase to
  • 7.5 mg once daily for the 4 following weeks, if well tolerated increase to
  • 10 mg once daily for the maintenance therapy
  • The maximum recommended dose is 10 mg once daily.

Renal or hepatic impairment: Titration of the dose in these populations should therefore be made with additional caution.

Usage:

Bisostad 2.5 is administered orally, should be taken in the morning and can be taken with food.

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 bloc.

Bradycardia with less than 60 beats/min before starting therapy.

Hypotension (systolic blood pressure less than 100 mm/Hg).

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.
  • Dry mouth.
  • Bradycardia, palpitations and other rhythm disturbances, cold extremities, claudication, hypotension, chest pain, congestive heart failure, dyspnea on exertion.
  • Vivid dreams, insomnia, depression.
  • 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.
  • Gout.
  • Asthma/bronchospasm, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis.
  • Decreased libido/impotence, cystitis, renal colic.
  • Purpura.
  • 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).