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Cardiovascular Agents

Felodipin STADA® 5 mg retard

 

Pack size:

Box of 10 blisters x 10 retard film-coated tablets.


Composition:

Each retard film-coated tablet contains felodipine 5 mg.


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
  • Dosage and Administration

  • Management of hypertension
    The initial adult dosage is 5 mg once daily. The dosage should be adjusted according to the patient's blood pressure response and tolerance, generally at intervals of not less than 2 weeks. Depending on the patient's response, the dosage can be decreased to 2.5 mg daily or increased to 10 mg daily. If necessary another antihypertensive agent such as beta-blockers may be added.
    The usual maintenance dosage is 2.5 to 10 mg given once daily in the morning.
  • Prophylaxis of stable angina pectoris
    Treatment should be started with 5 mg once daily and if needed be increased to 10 mg once daily.
  • Children:
    Felodipine should not be used in children because safety and efficacy have not been established.
  • In hepatic or renal impairment and in geriatric patients:
    The usual initial dosage is 2.5 mg daily, should be adjusted carefully and blood pressure response should be closely monitored with each dosage adjustment. In clinical trials, the risk of peripheral edema was increased substantially in geriatric patients receiving dosages exceeding 10 mg daily.
     
  • Administered orally before breakfast at least 30 minutes. The drug should be swallowed intact with water and should not be chewed or crushed. Only use this drug on an empty stomach.


Or as prescribed by physicians.
 

  • Known hypersensitivity to felodipine or to any of ingredient of the drug.
  • Unstable angina pectoris.
  • Uncompensated heart failure.
  • Acute myocardial infarction.
  • Patients with hereditary galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
  • Felodipine should be discontinued in patients who develop cardiogenic shock.
  • As the drug contains lactose excipient, it is contraindicated in patients with congenital galactosemia, glucose-galactose malabsorption, or the Lapp lactase deficiency.

     

Common

  • The most common adverse effects of felodipine are associated with its vasodilator action. They include flushing, headache, dizziness. Most of these reactions appear at the start of treatment and diminish with time.
  • As with other dihydropyridines, dose-dependent ankle swelling which results from precapillary vasodilatation can occur in patients treated with felodipine.

Uncommon

  • Mild gingival enlargement has been reported in patients with pronounced gingivitis/ periodontitis. The enlargement can be avoided or reversed by careful dental hygiene.

Rare

  • Nausea, fatigue, skin reactions, arrhythmia, palpitations.
  • In patients with coronary artery disease, felodipine may cause chest pain about 15 - 20 minutes after use.

     

  • Due to hypotensive effect of calcium channel blockers, the drug can cause hypotension, syncope or reflex tachycardia leading to activate angina pectoris.
  • Use this drug after meals may be at risk of excessive hypotension due to food increases the maximum concentration (Cmax) of the drug in the blood.
  • Felodipine should be used with caution in the elderly because they are sensitive to its effect at usual dosage.
  • The elderly and patients with severe hepatic impairment: The maximum dose is 5 mg daily.
  • Besides patients who have just suffered a myocardial infarction, felodipine could be used in extremely necessary case as left ventricular function starts decreasing but without any signs of uncompensated heart failure.
  • Felodipine should be discontinued if angina pectoris occurs, or existing pain worsens or having cardiogenic shock after initiating treatment.
  • The drug should not be used with grapefruit juice.
  • There is no special precaution in patients with renal failure.
  • Because of the slow onset of hypertensive effect with extended-release tablets containing felodipine, these dosage forms are not suitable for use as acute therapy in rapidly reducing blood pressure in patients with severe hypertension.Felodipine should not be used during known or suspected pregnancy and lactation.
  • Felodipine is not likely to affect the ability to drive and use machines.

     

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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