Amlodipine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of amlodipine.
Drugs List
Therapeutic Indications
Uses
Prinzmetal angina
Prophylaxis of chronic stable angina pectoris
Treatment of essential hypertension
Dosage
Adults
Initial dose: 5mg once daily.
Titrate to a maximum dose of 10mg once daily if desired therapeutic effect cannot be achieved within two to four weeks.
Children
Hypertension
Children aged 6 to 18 years
Initial dose: 2.5mg once daily.
Titrate up to 5mg once daily if blood pressure goal is not achieved after four weeks.
The following alternative dosing schedule may be suitable:
Hypertension
Children aged 12 to 18 years
Initial dose: 5mg once daily.
Titrate up to a maximum dose of 10mg once daily (unlicensed) if necessary, adjusted at intervals of one to two weeks.
Children aged 1 month to 12 years (unlicensed)
Initial dose: 100 micrograms/kg to 200 micrograms/kg once daily.
Titrate up to a maximum dose of 400 micrograms/kg once daily if necessary, adjusted at intervals of one to two weeks (up to a maximum of 10mg once daily).
Patients with Hepatic Impairment
In patients with hepatic impairment, amlodipine should be initiated the lower end of the dosing range. Slow dose titration and careful monitoring may be required in patients with severe hepatic impairment.
Additional Dosage Information
Amlodipine may be used either as monotherapy or in combination with other antianginal drugs in patients with angina which is refractory to nitrates an/or adequate doses of beta blockers. In hypertensive patients, amlodipine has been used in combination with a thiazide diuretic, alpha blocker, beta blocker or an angiotensin converting enzyme inhibitor.
Contraindications
Neonates under 1 month
Breastfeeding
Cardiac failure within 1 month of a myocardial infarction
Cardiogenic shock
Left ventricular outflow obstruction
Pregnancy
Severe aortic stenosis
Severe hypotension
Unstable angina - excluding Prinzmetal's angina
Precautions and Warnings
Children aged 1 month to 6 years
Elderly
Cardiac failure
Hepatic impairment
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Pregnancy: This medication may inhibit labour
Abrupt withdrawal may be associated with exacerbation of angina
Not licensed for all indications in all age groups
Advise patient not to take St John's wort concurrently
Grapefruit prod increase dihydropyridine Ca channel blocker bioavailability
Pregnancy and Lactation
Pregnancy
Amlodipine is contraindicated during pregnancy.
The manufacturer does not recommend using amlodipine during pregnancy unless there is no safer alternative or when the disease carries a greater risk. Animal studies have shown reproductive toxicity. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Amlodipine is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues amlodipine or discontinues breastfeeding. Amlodipine is present in human breast milk at an estimated interquartile range of 3%-7%, with a maximum of 15%. Effects on exposed infants are unknown.
Side Effects
Abdominal pain
Abnormal liver function tests
Allergic reaction
Alopecia
Angioedema
Ankle oedema
Anxiety
Arrhythmias
Arthralgia
Asthenia
Atrial fibrillation
Back pain
Bradycardia
Chest pain
Confusion
Constipation
Cough
Depression
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspepsia
Dyspnoea
Erythema multiforme
Exanthema
Exfoliative dermatitis
Extrapyramidal effects
Fatigue
Flushing
Gastritis
Gastro-intestinal disturbances
Gingival hyperplasia
Gynaecomastia
Headache
Hepatitis
Hyperglycaemia
Hyperhidrosis
Hypersensitivity reactions
Hypertonia
Hypoaesthesia
Hypotension
Impotence
Increased urinary frequency
Increases in hepatic enzymes
Jaundice
Leucopenia
Liver function disturbances
Malaise
Micturition disorders
Mood changes
Muscular cramps
Myalgia
Myocardial infarction
Nausea
Nocturia
Oedema
Pain - generalised
Palpitations
Pancreatitis
Paraesthesia
Peripheral neuropathy
Photosensitivity
Pruritus
Purpura
Quincke's oedema
Rash
Rhinitis
Skin discolouration
Sleep disturbances
Somnolence
Stevens-Johnson syndrome
Syncope
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Tremor
Urinary abnormalities
Urticaria
Vasculitis
Ventricular tachycardia
Visual disturbances
Vomiting
Weight changes
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2020
Reference Sources
Summary of Product Characteristics: Amlodipine 10mg tablets. Accord UK Limited. Revised August 2022.
Summary of Product Characteristics: Amlodipine 5mg tablets. Actavis UK Limited. Revised July 2018.
Summary of Product Characteristics: Amlodipine 10mg tablets. Actavis UK Limited. Revised July 2018.
Summary of Product Characteristics: Amlodipine 2.5mg tablets. Bristol Laboratories Ltd. Revised April 2019.
Summary of Product Characteristics: Amlodipine 5mg tablets. Dr Reddy's Laboratories. Revised October 2018.
Summary of Product Characteristics: Amlodipine 10mg tablets. Dr Reddy's Laboratories. Revised October 2018.
Summary of Product Characteristics: Amlodipine 1mg/1ml oral suspension. Essential Pharmaceuticals Limited. Revised August 2018.
Summary of Product Characteristics: Amlodipine 1mg/1ml oral suspension. Rosemont Pharmaceuticals Limited. Revised February 2018.
Summary of Product Characteristics: Amlodipine 2mg/1ml oral suspension. Rosemont Pharmaceuticals Limited. Revised February 2018.
Summary of Product Characteristics: Amlodipine 5mg tablets. TEVA UK Limited. Revised February 2018.
Summary of Product Characteristics: Amlodipine 10mg tablets. TEVA UK Limited. Revised February 2018.
Summary of Product Characteristics: Amlodipine 5mg tablets. Wockhardt UK Ltd. Revised April 2018.
Summary of Product Characteristics: Amlodipine 10mg tablets. Wockhardt UK Ltd. Revised April 2018.
Summary of Product Characteristics: Istin 5mg tablets. Pfizer Limited. Revised January 2018.
Summary of Product Characteristics: Istin 10mg tablets. Pfizer Limited. Revised January 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 24 February 2020
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last revised: 13 April, 2010
Last accessed: 3 July, 2015
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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