Felodipine

Registered South African indications:

• Hypertension

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Cardiogenic shock
• Acute myocardial infarction
• Uncompensated heart failure
• Unstable angina pectoris

South African recommendations

Caution in the following patient groups

• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Risk of myocardial ischaemia

• Felodipine may precipitate significant hypotension with tachycardia which, in susceptible individuals, may result in myocardial ischaemia

Effects on ability to drive and use machines

• Felodipine is not likely to affect the ability to drive or use machines

Forms avail. in SA and covered in this monograph: srt

South African registered indications and dosages

Hypertension

• Oral (srt): Initial: 5mg, dly; Maintenance: 5-10mg, dly

The dose should be adjusted according to the individual requirements of the patient. For dose titration purposes a 2.5mg tablet is available

Felodipine may be used in combination with beta-blockers, ACE-inhibitors or diuretics. The effects on blood pressure are likely to be additive and combination therapy will usually enhance the antihypertensive effect. Care should be taken to avoid hypotension

Method of administration

The tablets should be taken in the morning, swallowed with water, and must not be divided, crushed or chewed. Should not be administered after a meal rich in fat or carbohydrates

Not established for use in children

Pregnancy

South African recommendations

• Contraindicated
• Felodipine should not be given during pregnancy

Breastfeeding

South African recommendations

• Caution
• Felodipine is detected in breast milk. When taken in therapeutic doses by the nursing mother it is, however, not likely to affect the infant

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no dose sdjustment recommended
  The pharmacokinetics of felodipine is not significantly affected in patients with impaired renal function

South African recommendations

• Caution; no dose adjustment recommended
  Patients with impaired liver function should generally not exceed a daily felodipine dose of 10mg

South African recommendations

• Caution; dose adjustment recommended
  Consider initial treatment with 2.5mg daily. Elderly patients should generally not exceed a daily felodipine dose of 10mg

Central Nervous System Disorders

• Headache
• Dizziness
• Paraesthesia
• Fatigue

Cardiovascular Disorders

• Tachycardia
• Palpitations
• Myocardial ischaemia
• Flushing
• Hypotension
• Syncope
• Aggravation of angina
• Peripheral oedema

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain
• Gingival hyperplasia
• Gingivitis

Hepatobiliary Disorders

• Increased liver enzymes

Genitourinary Disorders

• Pollakisuria
• Impotence
• Sexual dysfunction

Musculoskeletal Disorders

• Arthralgia
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Urticaria
• Photosensitivity reactions
• Leukocytoclastic vasculitis

Immune, Blood and Lymphatic System Disorders

• Ankle swelling
• Hypersensitivity reactions
  - Angioedema
  - Fever

• CYP3A4 inhibitors
• Cimetidine
• Erythromycin
• Itraconazole
• Ketoconazole
• Anti-HIV/protease inhibitors
• Ritonavir
• CYP3A4 inducers
• Phenytoin
• Carbamazepine
• Phenobarbital
• Rifampicin
• Barbiturates
• Efavirenz
• Nevirapine
• Tacrolimus

Other interactions

• St John's wort (Hypericum Perforatum)
• Grapefruit juice

• Blood pressure
• Heart rate

Felodipine is a vascular-selective calcium antagonist, which lowers arterial blood pressure by decreasing systemic vascular resistance. Due to the high degree of selectivity for smooth muscle in the arterioles, felodipine in therapeutic doses has no direct effect on cardiac contractility or conduction. Because there is no effect on venous smooth muscle or adrenergic vasomotor control, felodipine is not associated with orthostatic hypotension. Felodipine possesses a mild natriuretic/diuretic effect and generalized fluid retention does not occur.

Tablet xr 2.5mg 

• Plendil (AstraZeneca) originator

Tablet xr 5mg

• Plendil (AstraZeneca) originator

Tablet sr 5mg

• Felodipine-Hexal (Sandoz)

Tablet sr 10mg

• Felodipine-Hexal (Sandoz)