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Cardiovascular Agents

Carvestad 6.25


Pack size:

Box of 3 blisters x 10 tablets.

 

Composition: 

Each tablet contains carvedilol 6.25 mg.

 

Shelf-life:

24 months from the date of manufacturing.

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

 

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

For the treatment of:

  • Hypertension. 
  • Chronic stable angina pectoris.
  • Congestive heart failure.
  • Left ventricular dysfunction following myocardial infarction.

Carvestad 6.25 is administered orally. Dosage of carvedilol must be individualized and adjusted according to the patient's blood pressure response and tolerance.

  • Hypertension:
    Initial dose of 12.5 mg once daily, increased after two days to 25 mg once daily.
    Alternatively, an initial dose of 6.25 mg is given twice daily, increased after one to two weeks to 12.5 mg twice daily. The dose may be increased further, if necessary, at intervals of at least two weeks, to 50 mg once daily or in divided doses. A dose of 12.5 mg once daily may be adequate for elderly patients.
  • Chronic stable angina pectoris:
    Adults:
    The recommended initial dose is 12.5 mg twice daily for two days. Thereafter, the treatment is continued at the dose 25 mg twice daily. If necessary, the dose may be further increased gradually at intervals of at least two weeks. The  recommended maximum daily dose is 100 mg in two doses (50 mg twice daily).
    Elderly:
    The recommended initial dose is 12.5 mg twice daily for two days. Thereafter, the treatment is continued at the dose 25 mg twice daily, which is the recommended maximum daily dose.
  • Congestive heart failure:
    Initial dose is 3.125 mg twice daily, taken with food to reduce the risk of hypotension.
    If tolerated, the dose should be doubled after two weeks to 6.25 mg twice daily and then increased gradually, at intervals of not less than two weeks, to the maximum dose tolerated; this should not exceed 25 mg twice daily in patients with severe heart failure or in those weighing less than 85 kg, or 50 mg twice daily in patients with mild to moderate heart failure weighing more than 85 kg.
  • Left ventricular dysfunction following myocardial infarction:
    Initial dose is 6.25 mg twice daily, increased after 3 to 10 days, if tolerated, to 12.5 mg twice daily and then to a target dose of 25 mg twice daily. A lower initial dose may be used in symptomatic patients.


Or as prescribed by physicians.

  • Bronchial asthma or related bronchospastic conditions.
  • Second or third degree AV block.
  • Sick sinus syndrome or severe bradycardia (unless a permanent pacemaker is in place).
  • Cardiogenic shock.
  • Decompensated heart failure requiring the use of intravenous inotropic therapy.
  • Hepatic impairment.
  • Hypersensitivity to carvedilol or to any ingredient of the drug.

     

Most adverse reactions are transient and disappear with time. The majority of the adverse reactions are seen early when treatment is started. The adverse effects are mainly related to the pharmacological mechanism of action and dose-related. Most common are vertigo and headache.

Common

  • Headache, muscle pain, fatigue, dyspnea.
  • Vertigo, postural hypotension.
  • Nausea.

Less common

  • Bradycardia.
  • Diarrhoea, abdominal pain.

Rare

  • Thrombocythaemia, leukopenia.
  • Malregulation of peripheral circulation, syncope.
  • Depression, sleep disturbances, paresthesia.
  • Vomiting, constipation.
  • Urticaria, itch, psoriasis. 
  • Elevated liver transaminases.
  • Decreased tear production, irritation.
  • Blocked nose.

     

  • Carvestad 6.25 contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
  • Carvedilol should be used with caution in patients with congestive heart failure treated with digitalis, diuretics, or ACE-inhibitors since atrioventricular conduction may be slowed.
  • It should be used cautiously in uncontrolled or difficult to control diabetes, when beta-receptor blockers may disguise hypoglycaemic symptoms.
  • The therapy should be discontinued if any evidence of liver injury occurs.
  • The use should be cautious in patients with peripheral vascular disease,  those undergoing anesthesia, and in hyperthyroidism.
  • If no other antihypertensive is tolerated, very small doses may be cautiously used in patients with bronchospastic disease.
  • Abrupt withdrawal of the drug should be avoided; the drug should be discontinued over 1 - 2 weeks.
  • Consider risk for arrhythmia if carvedilol is concurrently used with inhalation anaesthetics. Consider risk if carvedilol is combined with class-I-antiarrhythmic drugs.
  • The safety and efficacy of carvedilol in children have not been established.
  • Pregnancy: Carvedilol has produced clinical effects on the fetus. It should only be used during pregnancy if the potential benefit justifies the risk, and as a rule not during the third trimester or in connection with partus. 
    Foetal adverse effects such as bradycardia, hypotension, respiratory depression, hypoglycaemia and hypothermia in the newborn may result from treating pregnant women.
  • Lactation: There is possible excretion in breast milk. There is no risk for adverse effect in child.
  • Effects on ability to drive and use machines: As for other drugs which produce changes in blood pressure, patients taking carvedilol should be warned not to drive or operate machinery if they experience dizziness or related symptoms, particularly when starting or changing treatment and in conjunction with alcohol.

     

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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