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Drug Details

Parmid XL 5 mg Prolonged Release Tablets

• Drug Class Description
  dihydropyridine derivative - ATC-Code:C08C A02
• Generic Name
  felodipine
• Presentation
  Prolonged release tablets Round, light pink, biconvex tablet with imprint 5
• Description
  Each prolonged release tablet contains 5mg of felodipine. Excipient(s) lactose monohydrate (23.95 mg/tablet)
• Indications
  

  Essential hypertension.

• Adult Dosage
  

  The dose should be adjusted to the individual requirements of the patient.

  Parmid XL Tablets should usually be administered as follows:

  The recommended initial dose is 5 mg felodipine once daily.

  If necessary, the dose may be increased to 10 mg felodipine once daily, or another antihypertensive agent added. Dose increases should occur at intervals of at least 2 weeks. The usual maintenance dose is 5-10mg once daily.

  The maximum daily dose is 10 mg felodipine.

  Impaired Renal Function:

  The pharmacokinetics are not significantly affected in patients with mild to impaired renal function. Caution should be taken in patients with severe renal impairment.

  Impaired hepatic function:

  In patients with mild to moderate hepatic impairment, the recommended initial dose should be lowered to the minimal therapeutic effective dose of felodipine. The dose should only be increased after carefully balancing the benefits against the risks. It is contraindicated in patients with severe hepatic impairment.

  Method of administration:

  The prolonged release tablets should be taken in the morning with a sufficient amount of fluid (e.g. a glass of water, but it should NOT be taken with grapefruit juice!). The prolonged release tablets should be swallowed whole and not chewed or crushed.

  The tablets may be taken on an empty stomach or with a light meal. However a high-fat meal should be avoided.

• Child Dosage
  

  Felodipine should not be used in children, as its safety and efficacy in this population has not been established.

• Elderly Dosage
  

  The recommended initial dose should be adapted in the elderly. Subsequent dose increases should be undertaken with particular caution.

• Contra Indications
  

  Felodipine is contra-indicated in patients:

  • With hypersensitivity to felodipine (or other dihydropyridines) or to any of the excipients

  • With cardiogenic shock (as with all other calcium channel blockers, treatment should be discontinued in patients who develop cardiogenic shock)

  • With severe aortic or mitral stenosis

  • With obstructive hypertrophic cardiomyopathy

  • With unstable angina pectoris

  • Who have had an acute myocardial infarction (within 4-8 weeks of a myocardial infarction)

  • With decompensated heart failure

  • With severe hepatic impairment

  • During pregnancy

• Special Precautions
  

  Felodipine should be used with caution in patients with:

  • Conduction disorders, compensated heart failure, tachycardia and aortic or mitral valve stenosis.

  • Mild to moderare hepatic impairment, as the anti-hypertensive effect may be enhanced. Adjustment of the dose should be considered.

  • Severe renal impairment (GFR < 30ml/min).

  • AV block of the second or third degree.

  If treatment with felodipine is discontinued abruptly, a hypertensive crisis may occur in individual cases.

  Felodipine could cause significant hypotension (vasodilation effect) with consecutive tachycardia, leading to myocardial ischaemia in sensitive patients. Therefore predisposed patients may suffer from myocardial infarction.

  Dihydropyridines may cause acute hypotension. In some cases there is a risk of hypoperfusion accompanied by refex tachycardia (paradoxical angor).

  Felodipine is metabolised by CYP3A4 enzymes. Therefore, combination with medicinal products which are potent CYP3A4 inhibitors or inducers should be avoided. Due to the same reason the concomitant intake of grapefruit juice should be avoided.

  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

• Interactions
  

  Felodipine is a CYP3A4 substrate. Drugs that induce or inhibit CYP3A4 will have a large influence on felodipine concentrations.

  The anti-hypertensive effect of felodipine may be enhanced by other anti-hypertensives and tricyclic antidepressants.

  The concomitant intake of felodipine and drugs which inhibit the cytochrome P₄₅₀ isoenzyme 3A4 of the liver such as cimetidine, azole antifungals (itraconazole, ketoconazole), macrolide antibiotics (erythromycin) or HIV protease inhibitors, leads to increased felodipine plasma levels.

  Grapefruit juice results in increased peak plasma levels and bioavailability possibly due to interaction with flavonoids in the fruit juice. Therefore grapefruit juice should not be taken together with felodipine.

  Concomitant treatment with drugs such as carbamazepine, phenytoin and barbituates (e.g. phenobarbital) and rifampicin reduces the plasma levels of felodipine via enzyme induction in the liver (cytochrome P₄₅₀ system). Therefore a dose increase of felodipine may be necessary.

  Hydrochlorthiazide may enhance the anti-hypertensive effect of felodipine.

  Felodipine can induce an increase of Cmax of cyclosporin. Additionally, cyclosporin may inhibit felodipine metabolism which may create a potential risk of felodipine toxicity.

  Blood levels of digoxin increase during concomitant administration of felodipine. Therefore decreasing digoxin dosage should be taken into account when the two drugs are administered concurrently.

• Adverse Drug Reactions
  

  Adverse reactions have been ranked under headings of frequency using the following convention:

  Very common:	1/10
  common:	1/100 to <1/10
  uncommon:	1/1,000 to <1/100
  rare:	1/10,000 to <1/1,000
  very rare including isolated reports:	<1/10,000
  not known:	cannot be estimated from the available data

  Nervous system disorders

  Very common:	Headache, tinnitus
  Uncommon:	Dizziness, paraesthesia, restlessness, tremor, syncope

  Ear and labyrinth disorders

  Very common:

  Tinnitus

  Cardiac disorders

  Common:	Angina pectoris
  Uncommon:	Palpitations, tachycardia, syncope, dyspnoea
  Very rare:	Myocardial infarction

  Vascular disorders

  Very common:	Flushing
  Uncommon:	Hypotension
  Rare:	Leucocytoclastic vasculitis

  Respiratory, thoracic and mediastinal disorders

  Uncommon:

  Dyspnoea

  Gastrointestinal disorders

  Uncommon:

  Gastro-intestinal complaints (e. g. nausea, vomiting, diarrhoea, constipation), gingival hyperplasia and gingivitis

  Hepatobiliary disorders

  Very rare:

  Hepatic function disorders (elevated transaminase levels)

  Skin and subcutaneous tissue disorders

  Uncommon:	Skin and hypersensitivity reactions such as pruritus, urticaria, exanthema, photosensitisation
  Very rare:	Exfoliative dermatitis

  Musculoskeletal and connective tissue disorders

  Uncommon:

  Myalgia, arthralgia

  Renal and urinary disorders

  Uncommon:

  Pollakiuria

  Reproductive system and breast disorders

  Very rare:

  Erection disorders, gynaecomastia, menorrhagia

  General disorders and administration site conditions

  Very common:	Flushing
  Common:	Peripheral oedema
  Uncommon:	Fatigue, weight gain, sweating
  Very rare:	Angiooedema, Ffever

  Investigations

  Uncommon:

  Weight gain

  Flushing, headache or tinnitus may occur, particularly at the beginning of treatment, when the dose is increased or when high doses are administered. Generally, these effects subside on continued treatment

  Particularly at the beginning of treatment, angina pectoris attacks may occur. In patients with pre-existing angina pectoris there may be an increase in the frequency, duration and severity of the attacks.