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Cardiovascular Agents

Bisostad 2,5


Pack size:

Box of 3 blisters x 10 film-coated tablets.


Composition:

Each film-coated tablet contains bisoprolol fumarate 2.5 mg.


Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place.

Protect from light and moisture. Do not store above 30oC.

 

 

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

  • Hypertension
    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.
  • Angina
    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.
  • Stable chrome heart failure with reduced systolic left ventricular function in addition to ACE inhibitor, and diuretics, and optionally cardiac glycosides.
    Standard treatment of CHF consists of anACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors) a beta-blocking agent, diuretics, and when appropriate cardiac glycosides. Patients should be stable (without acute failure) when bisoprolol treatment is initiated.
    Adults:
    The treatment of stable chronic heart failure with bisoprolol requires a titration phase.
    Bisostad 2,5 is used once daily on the second week. The treatment with bisoprolol is to be started with a gradual up titration according to the following steps:
    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
    There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with impaired hepatic or renal function.
    Uptitration of the dose in these populations should therefore be made with additional caution.
    Elderly: No dosage adjustment is required.
    Paediatric population: There is no paediatric experience with bisoprolol, therefore its use cannot be recommended in paediatric patients.
    Use of suitable dosage forms is recommended when using bisoprolol with doses of 1.25 mg.
     
  • Administered orally, should be taken in the morning and can be taken with food.


Or as prescribed by physicians.

.

  • Hypersensitivity to bisoprolol or to any ingredient of the drug.
  • Acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy.
  • Cardiogenic shock.
  • AV block ofsecond or third degree (without a pacemaker).
  • Sick sinus syndrome.
  • Sinoatrial block.
  • Bradycardia with less than 60 beats/min before the start oftherapy.
  • Hypotension (systolic blood pressure less than 100 mm/Hg).
  • Severe bronchial asthma or severe chronic obstructive pulmonary disease.
  • Late stages ofperipheral 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.


     

  • Cardiac failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure and beta - blockade may result in further depression of myocardial contractility and precipitate more severe failure.
  • In patients without a history ofcardiac failure: Continued depression of the myocardium with beta - blockers can, in some patients, precipitate cardiac failure.At the first signs or symptoms of heart failure, discontinuation of bisoprolol should be considered. In some cases, beta blocker therapy can be continued while heart failure is treated with other drug.
  • Abrupt cessation of therapy: 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 oftherapy with beta - blockers.
  • Peripheral vascular disease: Beta - blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
  • Bronchospastic disease: In general, patients with bronchospastic disease should not receive beta - blockers. Because of its relative beta 1 – selectivity, however, bisoprolol may be used with caution in patients with bronchospastic disease who do not respond to, or who cannot tolerate other antihypertensive treatment. Since beta 1 – selectivity is not absolute, the lowest possible dose of bisoprolol should be used, with therapy starting at 2.5 mg. A beta 2 agonist (bronchodilator) should be made available.
  • Diabetes and hypoglycemia: Beta - blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective beta-blockers may potentiate insulininduced hypoglycemia and delay recovery of serum glucose levels. Because of its beta 1 -selectivity, this is less likely with bisoprolol. However, patients subject to spontaneous hypoglycemia or diabetic patients receiving insulin or oral hypoglycemic agents, should be cautioned about these possibilities and bisoprolol fumarate should be used with caution.
  • Pregnancy: Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the foetus/newborn. In general, beta-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labor.
    The newborn infant must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days.
  • Lactation: There is no data on the excretion of bisoprolol in human breast milk or the safety of bisoprolol exposure in infants. Therefore, breastfeeding is not recommended during administration of bisoprolol.
  • In a study with coronary heart disease patients bisoprolol did not impair driving performance. However, due to individual variations in reactions to the drug, the ability to drive a vehicle or to operate machinery may be impaired. This should be considered particularly at start of treatment and upon change ofmedication as well as in conjunction with alcohol.



 

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