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Cardiovascular Agents

Bisoprolol STADA® 5 mg

 

Pack size:

Box of 3 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains bisoprolol fumarate 5 mg.

 

Shelf- life:

24 months from the date of manufacturing.

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


 

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

Orally administered in: 

  • Management of hypertension and anginapectoris. It is also used as an adjunct to standard therapy in patients with stable chronic heart failure.
  • Hypertension or angina pectoris:
    Usual dose: 5 - 10 mg orally as a single daily dose.
    Maximum recommended dose: 20 mg daily.
  • Congestive heart failure:
    Initial dose: 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 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.


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 of second or third degree (without a pacemaker).
  • Sick sinus syndrome.
  • Sinoatrial block.
  • Bradycardia with less than 60 beats/min before the start of 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, chesh 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/bronchospam, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis.
  • Decreased libido/impotence, cystitis, renal colic.
  • Purpura.
  • Fatigue, asthenia, chest pain, malaise, edema, weight gain.

     

  • Caution must be used in dosing titrating patients with hepatic impairment or renal dysfunction.

  • 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 of cardiac 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-blockertherapycan be continuedwhile heart failureis treatedwith otherdrug.

  • 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.Abeta 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 insulin-induced 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.

  • Thyrotoxicosis: Beta-blockers may mask clinical signs of hyperthyroidism, such as tachycardia.

  • Pregnancy: There are no adequate and well - controlled studies in pregnant women. Bisoprolol should be used during if the potential benefit justifies the potential risk to the fetus.

  • Lactation: :Small amounts of bisoprolol have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk 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.


     

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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