Nifedipine oral standard release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Standard release formulations of nifedipine.
Drugs List
Therapeutic Indications
Uses
Hypertension
Prophylaxis of chronic stable angina pectoris
Raynaud's syndrome
Unlicensed Uses
Angina
Hiccup in palliative care
Hypertension - crisis
Persistent hyperinsulinaemic hypoglycaemia in children and neonates
Premature labour: postponement
Dosage
Adults
Chronic stable angina, Raynaud's syndrome, hypertension
5mg every 8 hours. Titrate dose according to response to a maximum of 20mg every 8 hours.
Postponement of premature labour (unlicensed)
Initial dose: 20mg
Maintenance dose: 10mg to 20mg three to four times a day.
Adjust according to uterine activity.
Hiccup in palliative care (unlicensed)
10mg three times a day.
Elderly
A slight alteration of the pharmacokinetics of nifedipine may be seen in the elderly therefore caution advised. Lower maintenance doses of nifedipine may be required compared to younger patients (See Dosage; Adult).
Children
Hypertensive crisis; Acute angina in Kawasaki disease or progeria (unlicensed)
Children aged under 18 years
Initial dose: 250 to 500 micrograms/kg (up to a maximum of 10mg). Repeat once if necessary.
May cause severe reduction of blood pressure; close monitoring is recommended. If above dose is ineffective, consider alternative treatment and seek specialist advice.
Hypertension; Angina in Kawasaki disease or progeria (unlicensed)
Children aged 12 to 18 years
5mg to 20mg three times a day.
Maximum dose: 90mg daily.
Children aged 1 month to 12 years
200 to 300 micrograms/kg three times a day.
Maximum dose: 3mg/kg daily or 90mg daily.
Raynaud's syndrome (unlicensed)
Children aged 2 to 18 years
2.5mg to 10mg two to four times a day.
To avoid postural hypotension, start with low doses at night and increase gradually.
Neonates
Persistent hyperinsulinaemic hypoglycaemia (unlicensed)
100 to 200 micrograms/kg (up to a maximum of 600 micrograms/kg) given four times a day.
Patients with Hepatic Impairment
Nifedipine is metabolised primarily in the liver. Patients with hepatic impairment should be carefully monitored and a dose reduction may be necessary.
Additional Dosage Information
For rapid effect in acute angina or hypertensive crisis, capsules can be bitten into and liquid can be swallowed. Use liquid preparation if 5mg or 10mg dose inappropriate.
If liquid unavailable, contents of capsule can be extracted via a syringe and use immediately. Syringe must be covered form light to protect contents from light.
If necessary, capsule contents may be diluted with water.
Contraindications
Cardiogenic shock
Severe aortic stenosis
Unstable angina
Within 1 month of a myocardial infarction
Precautions and Warnings
Children under 18 years
Elderly
Systolic blood pressure < 90mmHg
Breastfeeding
Cardiac failure
Diabetes mellitus
Dialysis patients with malignant hypertension and hypovolaemia
Hepatic impairment
Poor cardiac reserve
Pregnancy
Severe left ventricular failure
Not suitable for secondary prevention of myocardial infarction
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Will not prevent rebound effects of cessation of other antihypertensives
Diabetic control may need adjustment
Monitor antidiabetic drug treatment
Advise patient to report any anginal symptoms
Pregnancy: This medication may inhibit labour
May affect results of some laboratory tests
Abrupt withdrawal may be associated with exacerbation of angina
Discontinue if ischaemic pain occurs shortly after starting therapy
Not licensed for all indications in all age groups
Reduce dose in elderly
Advise patient not to take St John's wort concurrently
Alcohol may enhance side effects
Grapefruit prod increase dihydropyridine Ca channel blocker bioavailability
May reduce sperm count, function, motility or seminal fluid volume
A dose dependent increase in the risk of cardiovascular complications and mortality has been seen in patients treated with fast release forms of nifedipine. This medication should therefore only be used to treat patients with essential hypertension or chronic stable angina if no other treatment is deemed appropriate.
Pregnancy and Lactation
Pregnancy
Use nifedipine with caution during pregnancy.
The manufacturer does not recommend using nifedipine during pregnancy unless the clinical condition of the woman requires treatment. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out. Perinatal asphyxia, caesarean delivery, as well as prematurity and intrauterine growth retardation have been reported.
Lactation
Use nifedipine with caution during breastfeeding.
The manufacturer states nifedipine is present in human breast milk at concentrations similar to maternal levels. It is proposed to delay breastfeeding or milk expression for 3 to 4 hours after drug administration to decrease the nifedipine exposure to the infant.
Side Effects
Abdominal pain
Agranulocytosis
Allergic reaction
Anaphylactic reaction
Anaphylactoid reaction
Angina
Angioedema
Anxiety
Arthralgia
Cardiovascular disturbances
Cerebral ischaemia
Chest pain
Chills
Constipation
Disturbances of sensation
Dizziness
Dry mouth
Dysaesthesia
Dyspepsia
Dyspnoea
Dysuria
Elevation of liver enzymes
Epistaxis
Erectile dysfunction
Erythema multiforme
Eye pain
Flatulence
Gastro-intestinal disturbances
Gastroesophageal sphincter insufficiency
Gingival hyperplasia
Hyperglycaemia
Hypersensitivity reactions
Hypoaesthesia
Hypotension
Impairments of sperm parameters
Jaundice
Joint disorder
Laryngeal oedema
Lethargy
Leucopenia
Malaise
Migraine
Muscle cramps
Myalgia
Myocardial infarction
Myocardial ischaemia
Nasal congestion
Nausea
Oedema
Pain
Palpitations
Paraesthesia
Peripheral oedema
Photosensitivity
Polyuria
Pruritus
Pulmonary oedema
Purpura
Rash
Sleep disturbances
Somnolence
Syncope
Tachycardia
Toxic epidermal necrolysis
Tremor
Urticaria
Vasodilation
Vertigo
Visual disturbances
Vomiting
Effects on Laboratory Tests
Nifedipine may increase the spectrophotometric values of urinary vanillylmandelic acid falsely. HPLC measurements, however, are not affected.
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: August 2019
Reference Sources
Summary of Product Characteristics: Nifedipine 5mg capsules. Relonchem Limited. Revised November 2018.
Summary of Product Characteristics: Nifedipine 10mg capsules. Relonchem Limited. Revised September 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 July 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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