Stadlacil 4

Rx

Indications

• Stadlacil 4 is indicated for the treatment of hypertension either alone or in combination with other antihypertensive agents, including β-adrenoceptor antagonists, diuretics, and ACE-inhibitors.

Dosage

Adults

• The treatment of hypertension should be adapted to the severity of the condition, and according to the individual response.
• The recommended initial dose is 2 mg once daily. The dose may be increased to 4 mg (and then, if necessary, to 6 mg) after adequate time has been allowed for the full pharmacological effect to occur. In practice, this should not be less than 3 to 4 weeks.
• Daily doses above 6 mg have not been shown to besignificantly more effective.
• Lacidipine should be taken at the same time each day, preferably in the morning.
• Treatment with lacdipine may be continued indefinitely.

Patients with hepatic impairment

• Lacidipine is metabolised primarily by the liver and therefore in patients with hepatic impairment, the bioavailability of lacidipine may be increased and the hypotensive effect enhanced. These patients should be carefully monitored, and in severe cases, a dose reduction may be necessary.

Patients with kidney disease

• As lacidipine is not cleared by the kidneys, the dose does not require modification in patients with kidney disease.

Paediatric

• No experience has been gained with lacidipine in children.

Usage

• Orally administered.

• Hypersensitivity to lacidipine or to any of the excipients.
• Lacidipine should only be used with great care in patients with a previous allergic reaction to another dihydropyridine because there is a theoretical risk of cross-reactivity.
• As with other calcium antagonists, lacidipine should be discontinued in patients who develop cardiogenic shock and unstable angina. In addition, dihydropyridines have been shown to reduce coronary arterial blood-flow in patients with aortic stenosis and in such patients lacidipine is contraindicated.
• Lacidipine should not be used during or within one month of a myocardial infarction.

Common

• Dizziness, headache,
• Palpitations, tachycardia,
• Flushing,
• Abdominal discomfort, nausea,
• Rash, erythema, pruritus,
• Polyuria,
• General and administration site conditions: Asthenia, oedema,
• Blood alkaline phosphatase increased.

• Lacidipine should be used with caution in patients with pre-existing abnormalities in the activity of the SA and AV nodes.
• Lacidipine should be used with caution in patients with congenital or documented acquired QT prolongation. Lacidipine should also be used with caution in patients treated concomitantly with medications known to prolong the QT interval such as class I and III antiarrhythmics, tricyclic antidepressants, some antipsychotics, antibiotics (e.g. erythromycin) and some antihistamines (e.g. terfenadine).
• Lacidipine should be used with caution in patients with poor cardiac reserve.
• There is no evidence that lacidipine is useful for secondary prevention of myocardial infarction.
• The efficacy and safety of lacidipine in the treatment of malignant hypertension has not been established.
• Lacidipine should be used with caution in patients with impaired liver function because antihypertensive effect may be increased.
• There is no evidence that lacidipine impairs glucose tolerance or alters diabetic control.
• Stadlacil contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Lacidipine should only be used in pregnancy when the potential benefits for the mother outweigh the possibility of adverse effects in the foetus or neonate. The possibility that lacidipine can cause relaxation of the uterine muscle at term should be considered.
• Lacidipine should only be used during breastfeeding when the potential benefits for the mother outweigh the possibility of adverse effects in the foetus or neonate.
• Lacidipine may cause dizziness. Patients should be warned not to drive or operate machinery if they experience dizziness or related symptoms.