Felodipine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of felodipine.
Drugs List
Therapeutic Indications
Uses
Prophylaxis of chronic stable angina pectoris
Treatment of essential hypertension
Dosage
Felodipine may be used in combination therapy with beta blocking agents or other antihypertensive agents. However the effects on blood pressure are likely to be additive and combination therapy will usually enhance the anti-hypertensive effect.
Adults
Hypertension
Recommended starting dose is 5mg once daily. Depending on the patient's response, the dose can be decreased to 2.5mg once daily or increased to 10mg once daily. The standard maintenance dose is 5mg once daily. In some cases doses up to 20mg daily may be required.
Angina pectoris
Initial dose is 5mg once daily, increasing if necessary to 10mg once daily.
Elderly
(See Dosage; Adult)
An initial dose of 2.5mg daily should be considered.
Patients with Hepatic Impairment
In patients with impaired hepatic function may have elevated plasma concentrations of felodipine and may respond to lower doses.
Some manufacturers contraindicate the use of felodipine in severe hepatic impairment patients, see product literature.
Contraindications
Children under 18 years
Aortic stenosis
Breastfeeding
Cardiogenic shock
Decompensated cardiac failure
Haemodynamically significant valvular heart disease
Left ventricular outflow obstruction
Pregnancy
Unstable angina
Within 1 month of a myocardial infarction
Precautions and Warnings
Elderly
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Severe left ventricular failure
Tachycardia
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
Some formulations contain castor oil polyoxyl which may cause diarrhoea
Some formulations contain lactose
Some formulations contain propylene glycol
Increased risk of hypotension with diuretics and other antihypertensives
Discontinue if cardiogenic shock develops
Discontinue if ischaemic pain occurs shortly after starting therapy
Consider reducing initial dose in the elderly
Advise patient not to take St John's wort concurrently
Advise patient Seville (sour) orange products may increase plasma level
Grapefruit juice should not be taken simultaneously
Grapefruit prod increase dihydropyridine Ca channel blocker bioavailability
Advise patient of need for high oral hygiene standards
Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis. The enlargement can be avoided or reversed by careful oral hygiene.
Significant hypotension with subsequent tachycardia may result in some patients. In susceptible patients, this may escalate to myocardial ischaemia.
Pregnancy and Lactation
Pregnancy
Felodipine is contraindicated during pregnancy.
Use of felodipine during pregnancy is contraindicated by the manufacturer. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Felodipine is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking felodipine. Available data indicates felodipine is expressed in human breast milk, but the quantity and the effects on exposed infants are unknown.
Side Effects
Abdominal pain
Aggravation of angina
Angioedema
Ankle oedema
Arthralgia
Constipation
Diarrhoea
Dizziness
Dyspnoea
Exanthema
Exfoliative dermatitis
Fatigue
Fever
Flushing
Gingival hyperplasia
Gingivitis
Gynaecomastia
Headache
Hepatic disorders
Hypersensitivity reactions
Hypotension
Impotence
Increases in hepatic enzymes
Leukocytoclastic vasculitis
Menorrhagia
Myalgia
Myocardial ischaemia
Nausea
Palpitations
Paraesthesia
Peripheral oedema
Photosensitivity
Pollakiuria
Pruritus
Rash
Restlessness
Sexual dysfunction
Sweating
Syncope
Tachycardia
Tinnitus
Tremor
Urinary frequency
Urticaria
Vomiting
Weight gain
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: November 2019
Reference Sources
Summary of Product Characteristics: Cardioplen XL 2.5mg prolonged release tablets. Chiesi Ltd. Revised January 2017.
Summary of Product Characteristics: Cardioplen XL 5mg prolonged release tablets. Chiesi Ltd. Revised January 2017.
Summary of Product Characteristics: Cardioplen XL 10mg prolonged release tablets. Chiesi Ltd. Revised January 2017.
Summary of Product Characteristics: Delofine XL 2.5mg Prolonged-Release Tablets. Morningside Healthcare Ltd. January 2022.
Summary of Product Characteristics: Delofine XL 5mg Prolonged-Release Tablets. Morningside Healthcare Ltd. January 2022.
Summary of Product Characteristics: Delofine XL 10mg Prolonged-Release Tablets. Morningside Healthcare Ltd. January 2022.
Summary of Product Characteristics: Felotens XL 2.5mg Prolonged Release tablets. Genus Pharmaceuticals. Revised February 2015.
Summary of Product Characteristics: Felotens XL 5mg Prolonged Release tablets. Genus Pharmaceuticals. Revised February 2015.
Summary of Product Characteristics: Felotens XL 10mg Prolonged Release tablets. Genus Pharmaceuticals. Revised February 2015.
Summary of Product Characteristics: Folpik XL 2.5mg Prolonged Release tablets. Teva UK Ltd. Revised April 2015.
Summary of Product Characteristics: Folpik XL 5mg Prolonged Release tablets. Teva UK Ltd. Revised April 2015.
Summary of Product Characteristics: Folpik XL 10mg Prolonged Release tablets. Teva UK Ltd. Revised April 2015.
Summary of Product Characteristics: Neofel XL 2.5mg Prolonged release tablets. Kent Pharma UK Ltd. Revised May 2020.
Summary of Product Characteristics: Neofel XL 5mg Prolonged release tablets. Kent Pharma UK Ltd. Revised May 2020.
Summary of Product Characteristics: Neofel XL 10mg Prolonged release tablets. Kent Pharma UK Ltd. Revised May 2020.
Summary of Product Characteristics: Parmid XL 2.5mg Prolonged release tablets. Sandoz Ltd. Revised December 2017.
Summary of Product Characteristics: Pinefeld XL (felodipine) 10mg Tablets. Tillomed Laboratories Ltd. Revised December 2018.
Summary of Product Characteristics: Plendil 2.5mg, Plendil 5mg, Plendil 10mg. AstraZeneca UK Ltd. Revised November 2016.
Summary of Product Characteristics: Vascalpha 5mg prolonged release tablets. Actavis UK Ltd. Revised June 2019.
Summary of Product Characteristics: Vascalpha 10mg prolonged release tablets. Actavis UK Ltd. Revised June 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 14 March 2022
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