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Drug Details

Amlodipine 5mg Tablets

• Presentation
  Tablet The tablets are white to off-white, round biconvex and embossed with “5” on one side.
• Description
  Each tablet contains 5 mg amlodipine (as amlodipine mesilate monohydrate).
• Indications
  

  Essential hypertension.

  Chronic stable and vasospastic angina pectoris.

• Adult Dosage
  

  In adults

  For treatment of both hypertension and angina pectoris the usual initial dose is 5 mg once daily. If the desired therapeutic effect cannot be achieved within 2-4 weeks this dose may be increased to a maximum dose of 10 mg daily (as single dose) depending on the individual patient's response.

  Children with hypertension from 6 years to 17 years of age.

  The recommended antihypertensive oral dose in pediatric patients ages 6-17 years is 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily have not been studied in pediatric patients. The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.

  The 2.5 mg dose cannot be obtained with Amlodipine tablets 5 mg as these tablets are not manufactured to break into two equal halves

  In the elderly

  Normal dosage regimens are recommended in the elderly, however, increase of the dosage should take place with care. 

  In patients with renal impairment

  Amlodipine is not dialysable. In these patients amlodipine can be used in the normal dosage

  In patients with hepatic impairment

  A dosage regimen for patients with hepatic impairment has not been established , therefore amlodipine should be administered with caution.

  The tablets should be taken with a glass of water independently from meals.

• Contra Indications
  

  Amlodipine is contra-indicated in patients with:

  • severe hypotension

  • shock, including cardiogenic shock

  • hypersensitivity to dihydropyridine derivatives, amlodipine or any of the excipients

  • heart failure after acute myocardial infarction (during the first 28 days)

  • obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis)

  • unstable angina pectoris

• Special Precautions
  

  Amlodipine should be administered with caution to patients with low cardiac reserve. There are no data to support the use of amlodipine alone, during or within one month of myocardial infarction. The safety and efficacy of amlodipine in hypertensive crisis has not been established.

  Patients with cardiac failure

  Patients with cardiac failure should be treated with caution In a long-term study including patients suffering from severe heart failure (NYHA grade III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group, but this was not indicating an aggravation of the heart failure.

  Use in patients with impaired hepatic function

  Amlodipine's half-life is prolonged in patients with impaired liver function; dosage recommendations have not been established. Amlodipine should therefore be administered with caution in these patients.

  Use in elderly patients

  In the elderly, increase of the dosage should take place with care.

  Use in children (under 18 years of age)

  Amlodipine should not be given to children due to insufficient clinical experience.

• Interactions
  

  Effects of other medicinal products on amlodipine

  CYP3A4 inhibitors: A study of elderly patients has shown that diltiazem inhibits metabolism of amlodipine, probably via CYP3A4, since plasma concentration increases by approx. 50% and the effect of amlodipine is increased. It cannot be excluded that stronger inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) increase the plasma concentration of amlodipine to a greater extent than diltiazem. Caution should be exercised in combination of amlodipine and CYP3A4 inhibitors.

  CYP3A4 inducers: There is no information available on the effect of CYP3A4 inducers (i.e. rifampicin, St. John's wort) on amlodipine. Co-administration may lead to reduced plasma concentration of amlodipine. Caution should be exercised in combination of amlodipine and CYP3A4 inducers.

  In clinical interaction studies grapefruit juice, cimetidine, aluminium/magnesium (antacid) and sildenafil did not affect the pharmacokinetics of amlodipine.

  Effects of amlodipine on other medicinal products

  Amlodipine may potentiate the effect of other antihypertensive agents, such as beta-adrenoceptor blocking agents, ACE-inhibitors, alpha-1-blockers and diuretics. In patients with an increased risk (for example after myocardial infarction) the combination of a calcium channel blocker with a beta-adrenoceptor blocking agent may lead to heart failure, to hypotension and to a (new) myocardial infarction.

  In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.

  There is no effect of amlodipine on laboratory parameters.

• Adverse Drug Reactions
  

  Very common: Common: Uncommon: Rare: Very rare:

  >1/10 >1/100 and <1/10 >1/1000 and <1/100 >1/10 000 and <1/1000 <1/10 000 including isolated cases

   

  Blood and lymphatic system disorders:
  Very rare:	Leukocytopenia, thrombocytopenia.
  Endocrine disorders:
  Uncommon:	Gynaecomastia.
  Metabolism and nutrition disorders:
  Very rare:	Hyperglycaemia.
  Nervous system disorders:
  Common:	Headache (especially at the beginning of the treatment), fatigue, dizziness, asthenia
  Uncommon:	Malaise, dry mouth, tremor paraesthesia, increased sweating
  Very rare:	Peripheral neuropathy.
  Eye disorders:
  Uncommon:	Visual disturbances.
  Psychiatric disorders:
  Uncommon:	Sleep disorder, irritability, depression
  Rare:	Confusion, mood changes including anxiety.
  Cardiac disorders:
  Common:	Palpitations
  Uncommon:	Syncope, tachycardia, chest pain, at the beginning of treatment aggravation of angina pectoris may happen, isolated cases of myocardial infarction and arrhythmias (including extrasystole, ventricular tachycardia, bradycardia and atrial arrhythmias) and chest pain have been reported in patients with coronary artery disease, but a clear association with amlodipine has not been established
  Vascular disorders:
  Uncommon:	Hypotension.
  Very rare:	Vasculitis.
  Respiratory, thoracic and mediastinal disorders:
  Uncommon:	Dyspnoea, rhinitis.
  Very rare:	Cough.
  Gastrointestinal disorders:
  Common:	Nausea, dyspepsia, abdominal pain
  Uncommon:	Vomiting, diarrhoea, constipation, gingival hyperplasia
  Very rare:	Gastritis.
  Hepato-biliary disorders:
  Rare:	Elevated liver enzymes, jaundice, hepatitis
  Very rare:	Pancreatitis
  Skin and subcutaneous tissue disorders:
  Very common:	Ankle swelling
  Common:	Facial flushing with heat sensation, especially at the beginning of the treatment
  Uncommon:	Exanthema, pruritus, urticaria, alopecia, skin discolouration
  Very rare:	Angioedema, isolated cases of allergic reactions including pruritus, rash and erythema exsudativum multiforme, exfoliative Dermatitis, Stevens Johnson syndrome and Quincke oedema have been reported.
  Musculoskeletal, connective tissue and bone disorders:
  Uncommon:	Muscle cramps, back pain, myalgia and arthralgia.
  Renal and urinary disorders:
  Uncommon:	Increased micturition frequency.
  Reproductive system and breast disorders:
  Uncommon:	Impotence.
  General disorders and administration site conditions:
  Uncommon:	Increase or decrease of weight.
  Special senses
  Uncommon:	Tinnitus