Nifedipine
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Extended (24 hour) modified release tablet containing 20mg nifedipine.
Extended (24 hour) modified release tablet containing 30mg nifedipine.
Extended (24 hour) modified release tablet containing 40mg nifedipine.
Extended (24 hour) modified release tablet containing 60mg nifedipine.
Extended (24 hour) modified release capsule containing 30mg nifedipine.
Extended (24 hour) modified release capsule containing 60mg nifedipine.
Drugs List
Therapeutic Indications
Uses
Treatment of all grades of hypertension.
Prophylaxis of chronic stable angina pectoris.
Dosage
Adults
Mild to moderate hypertension
Initial dose - 20mg once daily.
Maintenance dose - If necessary the dosage may be increased according to individual requirements.
Maximum dose - 90mg once daily.
Severe hypertension
Initially dose - 30mg or one 40mg tablet once daily.
Maintenance dose - If necessary the dosage may be increased according to individual requirements.
Maximum dose - 90mg once daily.
Angina prophylaxis
Initially dose - 30mg or one 40mg tablet once daily.
Maintenance dose - If necessary the dosage may be increased according to individual requirements.
Maximum dose - 90mg once daily.
Dosage recommendations by manufacturer may vary.
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.
Children
Not licensed for use in children under 18 years.
Patients with Renal Impairment
Patients with renal impairment should not require adjustment of dosage.
In dialysis patients with malignant hypertension and irreversible renal failure with hypovolaemia, a marked decrease in blood pressure can occur.
Patients with Hepatic Impairment
Some manufacturers do not recommend the use of nifedipine 24 hour modified release preparations in patients with hepatic impairment due to the duration of action. Dose reduction may be required in severe hepatic impairment and alternative formulations may be preferred.
Additional Dosage Information
Patients being switched from other calcium antagonists should initiate nifedipine therapy at 30mg once daily and titrate up to larger doses if required.
Nifedipine may be used as monotherapy or in combination with a beta blocker.
Prescribers should specify the brand to be dispensed.
Administration
For oral administration.
To be swallowed whole with water at the same time each day, either with or without food. Under no circumstances are they to be broken up, bitten or chewed.
Contraindications
Cardiogenic shock
Severe aortic stenosis
Unstable angina
During or within one month of a myocardial infarction
History of gastrointestinal obstruction
Presence or history of oesophageal obstruction
Inflammatory bowel disease
Crohn's disease
Presence or history of decreased gastrointestinal tract lumen diameter
Not to be administered to patients with Kock pouch (ileostomy after proctocolectomy)
Galactosaemia
Children under 18 years
Precautions and Warnings
Prescribe by brand only to ensure consistent bioavailability.
Hepatic impairment (see Dosage - Hepatic Impairment ).
Acute porphyria (see Porphyria ).
Use with caution in patients with cardiac failure, poor cardiac reserve or significantly impaired left ventricular function. Deterioration of heart failure has been observed.
The safety of nifedipine in malignant hypertension has not been established.
In dialysis patients with malignant hypertension and irreversible renal failure with hypovolaemia, a marked decrease in blood pressure can occur.
Cardiac ischaemic pain has been reported in a small proportion of patients shortly after initiating nifedipine therapy. Although a 'steal' effect has not been demonstrated, withdraw treatment if ischaemic pain occurs or existing pain worsens shortly after commencing therapy. Use of nifedipine can lead to increased complaints of angina, if this occurs the physician should be alerted and treatment ceased.
Hypotensive patients should be treated with caution as there is a risk of further reduction in blood pressure. Extreme caution should be taken in patients with systolic pressure less than 90mmHg. Nifedipine may be used in combination therapy with beta blocking agents or other antihypertensive agents. However the potential for an additive effect must be borne in mind as postural hypotension and/or cardiac failure could result.
Transient blindness may occur following an excessive fall in blood pressure.
Diabetic patients may require adjustment of their control. Use with caution in patients with possible hyperglycaemia.
Will not prevent rebound effects of cessation of other antihypertensives therefore their withdrawal should be gradual. Sudden withdrawal may be associated with angina.
Hypersensitivity-type jaundice has been reported.
Grapefruit products increase the bioavailability of dihydropyridine calcium channel blockers. Patients should be advised to avoid grapefruit and grapefruit juice.
Pregnancy (see Pregnancy ).
Breastfeeding (see Lactation ).
May inhibit labour.
In vitro fertilisation treatment: calcium antagonists may adversely affect sperm function and should be considered as a possible cause in men repeatedly unsuccessful in fathering a child via in vitro fertilisation and where no other explanation can be found.
Elderly (see Dosage - Elderly ).
A false positive effect may be seen when performing a barium contrast x-ray.
Nifedipine may increase the spectrophotometric values of urinary vanillylmandelic acid falsely. HPLC measurements, however, are not affected.
In some formulations, the outer membrane of the tablet is not digested and therefore what appears to be a complete tablet may be seen in the toilet or stools. In very rare cases bezoars can occur and may require surgical intervention.
The ability to drive or operate machinery may be affected by side effects of nifedipine such as transient blindness, dizziness and lethargy.
Advise patients to moderate alcohol intake during nifedipine therapy as it can increase the likelihood of side effects.
Not suitable for secondary prevention of myocardial infarction.
Not suitable for acute attacks of angina or for patients who have had ischaemic pain following previous administration.
Advise patient to avoid taking St. John's Wort.
Some formulations contain lactose, use with caution in patients with lactose intolerance or glucose-galactose malabsorption syndrome.
Use in Porphyria
Many nifedipine brand manufacturers consider nifedipine as being porphyrinogenic. Calcium channel blockers are considered unsafe however nifedipine may be used with caution. The Norwegian Porphyria Centre (NAPOS) classifies nifedipine as being 'probably not porphrinogenic'.
Pregnancy and Lactation
Pregnancy
Use with caution in pregnancy and in women who are planning pregnancy. There is limited information to support the use of calcium blockers in human pregnancy. Studies in sheep with IV infusions of nifedipine indicate a progressive decrease in mean maternal arterial blood pressure. The hypotensive effect resulted in a decrease in uterine blood flow and foetal arterial oxygen content. Reproduction studies in rats and rabbits have shown a teratogenic effect resulting in digital anomalies. Other toxicities were noted in embryos and foetuses of mice, rats and rabbits at doses 3.5-42 times the maximum recommended human dose; these include stunted foetuses, rib deformities, cleft palate, embryo and foetal deaths as well as prolonged pregnancy and decreased neonatal survival. Nifedipine administered intravenously in pregnant rhesus monkeys has been associated with foetal hypoxaemia and acidosis (Briggs, 2011).
In human studies a report of 37 newborns exposed to nifedipine during the first trimester showed two major birth defects (two expected), one of which was a cardiovascular defect (0.5 expected). No abnormalities were observed in five other categories of defects (oral cleft, spina bifida, polydactyly, limb reduction defects and hypospadias). Another human study reported nine hypertensive pregnant women treated in the third trimester with sublingual nifedipine. This showed both maternal arterial blood pressure and uterine artery perfusion pressure significantly lower with nifedipine but no reduction in uteroplacental blood flow detected. Careful monitoring of blood pressure is required when administering nifedipine with IV magnesium sulfate owing to an excessive fall in blood pressure, which could harm the mother and foetus. Nifedipine may inhibit labour. Nifedipine does not appear to pose a major human teratogenic risk (Briggs, 2011).
Nifedipine has been used for tocolysis and as a antihypertensive agent in pregnant women. Nifedipine is one of the preferred first-line calcium channel blockers for the treatment of hypertension in the second or third trimesters. In the first trimester, calcium antagonists are considered to be second-line therapy. Guidelines published by NICE comment that nifedipine is licensed for the treatment of hypertension and is already used widely in UK obstetric practices, however manufacturers advise that it is contraindicated in pregnancy before week 20 and that it should not be administered during pregnancy or in women who may become pregnant. The guidelines from NICE suggest that informed consent on the use of nifedipine in these situations should be obtained and documented. The guidelines also recommend that nifedipine (oral) is one of the drugs that should be used to treat women with severe hypertension who are in critical care during pregnancy or after birth.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Recommended for use in pregnancy, 1st trimester? - as a second-line agent
Recommended for use in pregnancy, 2nd and 3rd trimester? - is a preferred first-line calcium channel blocker for hypertension.
Known human teratogen? - No
Animal data - Nifedipine has been shown to produce embryotoxicity, foetotoxicity and teratogenicity.
Pregnancy-specific adverse effects on the mother - may inhibit labour. Severe reactions when combined with IV magnesium sulfate.
Lactation
Use with caution during breastfeeding
Nifedipine is excreted in breast milk in small amounts, which are considered too small to be harmful. No adverse effects have been reported among a limited number of infants exposed to nifedipine in breast milk.
Nifedipine has also been used to treat painful nipple vasospasm in nursing mothers.
Manufacturers state that nifedipine should not be administered to nursing mothers. However, other organisations considers nifedipine usually compatible with breastfeeding. Guidelines from NICE recommend that women who still need antihypertensive treatment in the postnatal period are told that nifedipine is one of the antihypertensive drugs that has no known side effects on babies receiving breast milk. Schaefer (2007) concluded that nifedipine is one of the calcium antagonists of choice during breastfeeding.
If necessary breastfeeding may be delayed by 3 to 4 hours to significantly reduce the amount of drug ingested by the infant.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Drug excreted in breast milk? - Yes
Considered suitable or recommended by manufacturer? - No
Drug substance licensed in infants? - No
Effects on Ability to Drive and Operate Machinery
The ability to drive or operate machinery may be affected by side effects of nifedipine such as transient blindness, dizziness and lethargy.
Advise patients to moderate alcohol intake during nifedipine therapy as it can increase the likelihood of side effects.
Counselling
Advise patient that grapefruit products increase bioavailability of dihydropyridine calcium channel blockers and should not be taken whilst receiving treatment with nifedipine.
Advise patient that in some formulations, the outer membrane of the tablet is not digested and therefore what appears to be a complete tablet may be seen in the toilet or stools.
Advise patient that the ability to drive or operate machinery may be affected by side effects of nifedipine such as transient blindness, dizziness and lethargy.
Advise patients to moderate alcohol intake during nifedipine therapy as it can increase the likelihood of side effects.
Advise patients not to take St. John's Wort.
Side Effects
Headache
Flushing
Dizziness
Lethargy
Tachycardia
Palpitations
Increased frequency of micturition
Gingival hyperplasia
Depression
Telangiectasia
Jaundice
Visual disturbances
Tremor
Myalgia
Urticaria
Gynaecomastia in older men
Hypotension
Fever
Paraesthesia
Dyspepsia
Mood changes
Photosensitivity
Allergic reaction
Liver function disturbances
Sweating
Dysuria
Epistaxis
Hyperaesthesia
Sleep disturbances
Dyspnoea
Nocturia
Polyuria
Chills
Eructation
Gingivitis
Vomiting
Arthralgia
Joint disorder
Pain
Abdominal pain
Syncope
Dry mouth
Nervousness
Vertigo
Dysphagia
Gastro-intestinal ulceration
Leucopenia
Hyperglycaemia
Weight loss
Muscle cramps
Pemphigoid reaction
Blindness (temporary)
Postural hypotension
Agranulocytosis
Oedema
Cardiovascular disturbances
Myocardial ischaemia
Cerebral ischaemia
Cholestasis
Erythema multiforme
Exfoliative dermatitis
Gastro-intestinal bezoars (concretions)
Intestinal obstruction
Anorexia
Migraine
Nasal congestion
Anxiety
Hypersensitivity reactions
Angioedema
Impairments of sperm parameters
Vasodilation
Peripheral oedema
Chest pain
Malaise
Myocardial infarction
Gastro-intestinal disturbances
Aggravation of angina
Exacerbation of myasthenia gravis
Asthenia
Erectile dysfunction
Toxic epidermal necrolysis
Hypoaesthesia
Dysaesthesia
Somnolence
Angina
Rash
Purpura
Pruritus
Nausea
Gastroesophageal sphincter insufficiency
Flatulence
Eye pain
Diarrhoea
Constipation
Skin disorder
Anaphylactic reaction
Anaphylactoid reaction
Elevation of liver enzymes
Pulmonary oedema
Effects on Laboratory Tests
A false positive test may be experienced with some modified release formulations when performing a barium contrast x-ray.
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 ).
Shelf Life and Storage
Storage conditions differ between brands. Consult product literature for more information.
Further Information
Last Full Review Date: January 2013
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Medications and Mothers' Milk, 14th Edition (2010) Hale,T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Adalat LA 20mg prolonged-release tablets. Bayer plc. Revised August 2016.
Summary of Product Characteristics: Adalat LA 30mg prolonged-release tablets. Bayer plc. Revised November 2020.
Summary of Product Characteristics: Adalat LA 60mg prolonged-release tablets. Bayer plc. Revised August 2016.
Summary of Product Characteristics: Adanif XL 30mg tablets. Focus Pharmaceuticals Ltd. Revised May 2010.
Summary of Product Characteristics: Adanif XL 60mg tablets. Focus Pharmaceuticals Ltd. Revised May 2010.
Summary of Product Characteristics: Adipine XL 30mg & 60mg tablets. Chiesi Ltd. Revised September 2012.
Summary of Product Characteristics: Coracten XL Joint SPC 30mg, 60mg. UCB Pharma Ltd. Revised April 2009.
Summary of Product Characteristics: Fortipine LA 40mg tablets. Goldshield Pharmaceuticals Ltd. Revised September 2012.
Summary of Product Characteristics: Neozipine XL 30mg tablets. Kent Pharma UK Limited. Revised January 2021.
Summary of Product Characteristics: Neozipine XL 60mg tablets. Kent Pharma UK Limited. Revised January 2021.
Summary of Product Characteristics: Nimodrel XL 30mg & 60mg tablets. Chiesi Ltd. Revised September 2012.
Summary of Product Characteristics: Nidef 30 mg Prolonged Release Tablets. Morningside Heathcare Ltd. Revised March 2017.
Summary of Product Characteristics: Nidef 60 mg Prolonged Release Tablets. Morningside Heathcare Ltd. Revised March 2017.
Summary of Product Characteristics: Valni XL 30mg prolonged-release tablets. Winthrop Pharmaceuticals UK Ltd. Revised February 2011.
Summary of Product Characteristics: Valni XL 60mg prolonged-release tablets. Winthrop Pharmaceuticals UK Ltd. Revised February 2011.
NAPOS: The Norwegian Porphyria Centre
Available at: https://www.drugs-porphyria.org/languages/UnitedKingdom/selsearch.php?l=gbr
Drug: Nifedipine. Last accessed: January 11, 2013
NICE clinical guideline 107: Hypertension in pregnancy, the management of hypertensive disorders during pregnancy
Available at: https://www.nice.org.uk/nicemedia/live/13098/50418/50418.pdf
Issue date: August 2010
Last accessed: January 11, 2013
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 August 2017
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Nifedipine. Last revised: February 02, 2012
Last accessed: January 11, 2013
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