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Cardiovascular Agents

Amlodipin STADA® 5 mg


Pack size:

Box of 3 blisters x 10 capsules.

 

Composition:

Each capsules contains amlodipine (as amlodipine besylate) 5 mg.

 

Shelf-life:

48 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

  • Used alone or in combination with other classes of antihypertensive agents in the management of hypertension.
  • Used for the management of Prinzmetal variant angina and chronic stable angina pectoris. The drug has been used alone or in combination with other antianginal agents.
     
  • Administered orally and may be given without regard to meals.

Hypertension:

  • Adults:
    The usual initial dosage of amlodipine is 2.5 - 5 mg once daily.
    In geriatric and small frail individuals, an initial dosage of 2.5 mg once daily is recommended. Subsequent dosage of amlodipine should be adjusted according to the patient's blood pressure response and tolerance and usually should not exceed 10 mg once daily.
    The usual maintenance dosage of amlodipine for the management of hypertension in adults is 5 –10 mg once daily.
  • Children 6 years of age and older:
    The usual effective dosage of amlodipine is 2.5 - 5 mg once daily.

Angina:

  • The usual adult dosage is 5 –10 mg once daily.
  • In geriatric patients, the lower dosage of 5 mg once daily is recommended.
  • Maintenance dosage is 10 mg daily.


Or as prescribed by physicians.


 

  • Patients who are hypersensitive to amlodipine, to any other calcium antagonist, or to any ingredient of the drug.

     

Common:

  • Ankle oedema, flushing, headache, skin rash, and fatigue.

Uncommon:

  • Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis.
  • Hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.
  • Anorexia, constipation, dyspepsia, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.
  • Allergic reaction, asthenia, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.
  • Arthralgia, muscle cramps, myalgia.
  • Sexual dysfunction (male and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.
  • Dyspnea, epistaxis.
  • Angioedema, erythema multiforme, pruritus, rash, rash erythematous, rash maculopapular.
  • Abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.
  • Micturition frequency, micturition disorder, nocturia.
  • Dry mouth, sweating increased.
  • Hyperglycemia, thirst.
  • Leukopenia, purpura, thrombocytopenia.

Other adverse effects:

  • Myocardial infarction and angina. 

     

  • Amlodipine should be used with caution in patients with hypotension, cardiac reserve is poor, heart failure
  • The drug should not be used in cardiogenic shock, in patients who have suffered a myocardial infarction in the previous 2 to 4 weeks, or in acute unstable angina, in treatment an anginal attack in chronic stable angina.
  • In patients with severe aortic stenosis amlodipine may increase the risk of developing heart failure. Sudden withdrawal of amlodipine might be associated with an exacerbation of angina.
  • The dose may need to be reduced in patients with hepatic impairment.
  • No clinical experience with the preparation in pregnancy or lactation. Accordingly, amlodipine should not be administered during pregnancy, or lactation, or to women of childbearing potential unless effective contraception is used.
  • Amlodipine can have minor or moderate influence on the ability to drive and use machines. If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired. Caution is recommended especially at the start of treatment.
     

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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