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Drug Details

Amlodipine 10mg Tablets

• Drug Class Description
  Selective calcium channel blockers with mainly vascular effects; Dihydropyridine derivatives - ATC code: C 08 CA 01
• Generic Name
  amlodipine besilate
• Presentation
  Tablet White or almost white, flat, bevelled edges, round tablet debossed with "C" on one side and "59" on the other side.
• Description
  Each tablet contains Amlodipine besilate equivalent to 10 mg of amlodipine.
• Indications
  

  Essential hypertension.

  Chronic stable and vasospastic angina pectoris.

• Adult Dosage
  

  For oral use.

  The tablets should be taken with a glass of liquid (e.g. a glass of water) with or without food.

  In adults

  For the treatment of hypertension and angina pectoris, the starting dose is 5 mg once daily. If the desired therapeutic effect cannot be achieved within 2-4 weeks, the dose can be increased to a maximum of 10 mg daily (given as a single dose) depending on the individual response of the patient. Amlodipine can be used as monotherapy or in combination with anti-anginal medication in patients suffering from angina pectoris.

  Patients with renal impairment

  The normal dosage is recommended. Amlodipine is not dialyzable. Amlodipine should be administered with particular caution to patients undergoing dialysis.

  Patients with hepatic impairment

  In patients with hepatic impairment, no dosage regimen has been defined, therefore amlodipine should be administered with caution

• Child Dosage
  

  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 5 mg tablets as these tablets are not manufactured to break into two equal halves.

• Elderly Dosage
  

  For elderly patients, the normal dose is recommended; however, caution is advised when the dose is increased.

• Contra Indications
  

  Amlodipine is contraindicated in patients with:

  - hypersensitivity to amlodipine, other dihydropyridines or any of the excipients

  - severe hypotension

  - shock (including cardiogenic shock)

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

  - haemodynamically unstable heart failure after acute myocardial infarction

• Special Precautions
  

  The safety and efficacy of amlodipine in hypertensive crisis has not been established.

  Patients with cardiac failure:

  Patients with heart failure should be treated with caution. In a long-term, placebo controlled study in patients with severe heart failure (NYHA class 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 associated with worsening of the heart failure.

  Use in patients with impaired hepatic function:

  The half life of amlodipine 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 elderly patients, caution is advised when the dosage is increased.

  Use in renal failure

  Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialyzable

• Interactions
  

  Effects of other medicinal products on amlodipine

  CYP3A4 inhibitors: With concomitant use with the CYP3A4 inhibitor erythromycin in young patients and diltiazem in elderly patients respectively the plasma concentration of amlodipine increased by 22% and 50 % respectively. However, the clinical relevance of this finding is uncertain. It cannot be ruled out that strong inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent than diltiazem. Amlodipine should be used with caution together with CYP3A4 inhibitors. However, no adverse events attributable to such interaction have been reported.

  CYP3A4 inducers: There is no data available regarding the effect of CYP3A4 inducers on amlodipine. The concomitant use of CYP3A4 inducers (e.g. rifampicin, hypericum perforatum) may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with 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

  The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other antihypertensive agents.

  In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, ethanol (alcohol), warfarin or cyclosporin.

  There is no effect of amlodipine on laboratory parameters.

• Adverse Drug Reactions
  

  The following undesirable effects have been observed and reported during treatment with amlodipine with the following frequencies: Very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to 1/100); rare (1/10,000 to 1/1,000); very rare (1/10,000).

  System Organ Class	Frequency	Undesirable effects
  Blood and the lymphatic system disorders	Very Rare	Leukocytopenia, thrombocytopenia
  Immune system disorders	Very Rare	Allergic reactions
  Metabolism and nutrition disorders	Very Rare	Hyperglycaemia
  Psychiatric disorders	Uncommon	Insomnia, mood changes (including anxiety), depression
  	Rare	Confusion
  Nervous system disorders	Common	Somnolence, dizziness, headache (especially at the beginning of the treatment)
  	Uncommon	Tremor, dysgeusia, syncope, hypoesthesia, paresthesia
  	Very Rare	Hypertonia, peripheral neuropathy
  Eye disorders	Uncommon	Visual disturbance (including diplopia)
  Ear and labyrinth disorders	Uncommon	Tinnitus
  Cardiac disorders	Uncommon	Palpitations
  	Very Rare	Myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation)
  Vascular disorders	Common	Flushing
  	Uncommon	Hypotension
  	Very Rare	Vasculitis
  Respiratory, thoracic and medicinal disorders	Uncommon	Dyspnoea, rhinitis
  	Very Rare	Cough
  Gastrointestinal disorders	Common	Abdominal pain, nausea
  	Uncommon	Vomiting, dyspepsia, altered bowel habits (including diarrohea and constipation), dry mouth
  	Very Rare	Pancreatitis, gastritis, gingival hyperplasia
  Hepato-biliary disorders	Very Rare	Hepatitis, jaundice, hepatic enzymes increased*
  Skin and subcutaneous tissue disorders	Uncommon	Alopecia, purpura, skin discolouration, hyperhydrosis, pruritus, rash, exanthema
  	Very Rare	Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity
  Musculoskeletal, connective tissue and bone disorders	Common	Ankle swelling
  	Uncommon	Arthralgia, myalgia, muscle cramps, back pain
  Renal and urinary disorders	Uncommon	Micturition disorder, nocturia, increased urinary frequency
  Reproductive system and breast disorders	Uncommon	Impotence, gynecomastia
  General disorders and administration site conditions	Common	Oedema, fatigue
  	Uncommon	Chest pain, asthenia, pain, malaise
  Investigations	Uncommon	Weight increase, weight decrease

  *mostly consistent with cholestatis