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Cardiovascular Agents

Bisoplus STADA® 5 mg/12,5 mg

 

Pack size:

Box of 3 blisters x 10 film-coated tablets.


Composition:

Each film-coated tablet contains bisoprolol fumarate 5 mg and hydrochlorothiazide 12.5 mg. 


Shelf-life: 
      
36 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

  • Treatment of hypertension is not controlled properly with bisoprolol fumarate and hydrochlorothiazide alone.
  • Administered orally. It can be taken with glass of water in the morning.
  • When combination therapy is required in the management of hypertension, dosage can be first adjusted by administering each drug separately. If it is determined that the optimum maintenance dosage corresponds to the ratio in the commercial combination preparation, the fixed combination may be used.
    Adults:
    The usual initial daily dose is 1 tablet per day. If necessary, the dose can be increased 2 tablets per day.
    Patients with renalorhepatic impairment:
    The dosage should be reduced.
    Children:
    This product has not been studied in children, so its use not recommended in children.


Or as prescribed by physicians.


 

  • Patients with untreated or decompensated cardiac failure, cardiogenic shock, sinoatrial block, second or third degree AV block, marked bradycardia (heart rate less than 60 beats/min), acute myocardial infarction, severe asthma, severe renal or hepatic failure, Addison's disease.
  • Patients with a known hypersensitivity to bisoprolol or thiazides or sulphonamides or to any other ingredient of the drug.

     

Bisoprolol fumarate:

  • 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/bronchospam, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis.
  • Decreased libido/impotence, cystitis, renal colic.
  • Purpura.
  • Fatigue, asthenia, chest pain, malaise, edema, weight gain.

Hydrochlorothiazide:

  • Weakness.
  • Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation.
  • Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.
  • Purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema.
  • Hyperglycemia, glycosuria, hyperuricemia.
  • Muscle spasm.
  • Restlessness.
  • Renal failure, interstitial nephritis.
  • Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis.
  • Transient blurred vision, xanthopsia.

     

Bisoprololfumarate:

  • Although beta blockers are used in the management of heart failure, they should not be given to patients with uncontrolled heart failure and treatment should be begun with great care,starting with a low dose and cautiously titrating upwards.
  • Use with care in patients with a prolonged PR conduction interval, poor cardiac reserve andperipheral circulatory disease such as Raynaud's phenomena.
  • Bisoprolol must be used with caution in bronchospasm (bronchial asthma, obstructive airways diseases). In some asthmatic patients, some increase in airway resistance may occur, and this may be regarded as a signal to discontinue therapy. Bronchospasm canusually be reversed by commonly used bronchodilators such as salbutamol.
  • Bisoprolol does not impair carbohydrate metabolism but in diabetic patients, the symptoms of hypoglycaemia may be masked.
  • Beta blockers may mask the symptoms ofhyperthyroidism in patients with thyrotoxicosis.
  • Abrupt withdrawal of bisoprolol may exacerbate angina symptoms and/or precipitate myocardial infarction and ventricular arrhythmias in patients with coronary artery disease, or may precipitate thyroid storm in patients with thyrotoxicosis. Therefore, patients receiving bisoprolol (especially those with ischemic heart disease) should be warned not to interrupt or discontinue therapy without consulting their physician. Because coronary artery disease is common and may be undiagnosed, abrupt withdrawal also should be avoided in patientsreceiving bisoprolol for other conditions (e.g., Hypertension). When bisoprolol is discontinued in patients with coronary artery disease or suspected thyrotoxicosis, the patient should beobserved carefully; patients with coronary artery disease should be advised to temporarily limit their physical activity. If exacerbation of angina occurs or acute coronary insufficiency develops after bisoprolol therapy is interrupted or discontinued, treatment with the drug should be reinstituted, at least temporarily.

Hydrochlorothiazide:

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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