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Cardiovascular Agents

Nebivolol STADA® 5 mg

 

Pack size:

Box of 3 blisters x 10 tablets.

 

Composition:

Each tablet contains nebivolol 5 mg

(as nebivolol hydrochloride)

 

Shelf-life:

36 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 oral administration in treatment of hypertension.
     
  • Adults: 
    One tablet (5 mg) daily, preferably at the same time of the day.
    The blood pressure lowering effect becomes evident after 1 - 2 weeks of treatment. Occasionally, the optimal effect is reached only after 4 weeks.
  • Patients with renal insufficiency:
    The recommended starting dose is 2.5 mg daily. If needed, the daily dose may be increased to 5 mg.
  • Elderly:
    In patients over 65 years, the recommended starting dose is 2.5 mg daily. If needed, the daily dose may be increased to 5 mg.
     

Or as prescribed by physicians.

 

  • Hypersensitivity to the active substance or to any ingredient of the drug.
  • Liver insufficiency or liver function impairment.
  • Acute heart failure, cardiogenic shock or episodes of heart failure decompensation  requiring i.v. inotropic therapy.
  • Sick sinus syndrome, including sino-atrial block.
  • Second and third degree heart block (without a pacemaker).
  • History of bronchospasm and bronchial asthma.
  • Untreated phaeochromocytoma.
  • Metabolic acidosis.
  • Bradycardia (heart rate < 60 bpm prior to start therapy).
  • Hypotension (systolic blood pressure < 90 mmHg).
  • Severe peripheral circulatory disturbances.

     

Most common:

  • Headache
  • Dizziness
  • Paresthesia
  • Dyspnea
  • Constipation
  • Nausea
  • Diarrhea
  • Ttiredness
  • Edema.

     

  • Continuation of beta-blockade reduces the risk of arrhythmias during induction and intubation. If beta-blockade is interrupted in preparation for surgery, the beta-adrenergic antagonist should be discontinued at least 24 hours beforehand. Caution should be observed with certain anesthetics that cause myocardial depression. The patient can be protected against vagal reactions by intravenous administration of atropine.
  • In general, beta-adrenergic antagonists should not be used in patients with untreated congestive heart failure, unless their condition has been stabilised.
    In patients with ischemic heart disease, treatment with a beta-antagonist should be discontinued gradually, i.e. over 1 - 2 weeks. If necessary replacement therapy should be initiated at the same time, to prevent exacerbation of angina pectoris.
    Beta-adrenergic antagonists may induce bradycardia: If the pulse rate drops below 50 - 55 bpm at rest and/or the patient experiences symptoms that are suggestive of bradycardia, the dosage should be reduced.
  • Beta-adrenergic antagonists should be used with caution. In patients with peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication), as aggravation of these disorders may occur; In patients with first degree heart block, because of the negative effect of beta-blockers on conduction time; In patients with Prinzmetal's angina due to unopposed alpha receptor mediated coronary artery vasoconstriction: beta-adrenergic antagonists may increase the number and duration of angina attacks.
  • Nebivolol does not affect glucose levels in diabetic patients. Care should be taken in diabetic patients however, as nebivolol may mask certain symptoms of hypoglycemia (tachycardia, palpitations).
  • In patients with chronic obstructive pulmonary disorders, beta-adrenergic antagonists should be used with caution as airway constriction may be aggravated.
  • Nebivolol has pharmacological effects that may cause harmful effects on pregnancy and/or the fetus/newborn. Nebivolol should not be used during pregnancy unless clearly necessary. If treatment with nebivolol is considered necessary the uteroplacental blood flow and the fetal growth should be monitored.
  • It is not known whether this drug is excreted in human milk. Therefore, breastfeeding is not recommended during administration of nebivolol.
  • No studies on the effects on the ability to drive and use machines have been performed. Pharmacodynamic studies have shown that nebivolol does not affect psychomotor function. When driving vehicles or operating machines it should be taken into account that dizziness and fatigue may occasionally occur.

     

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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