Company: Actavis Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Lercanidipine (HCl), 10mg, 20mg.
Description: Resp. yellow or pink, round, biconvex, 6.5mm or 8.5mm film-coated tablets, scored on one side, marked L on the other.
Presentation: 10mg-28, €8.22; 20mg-28, €13.42.
Indication: Mild to moderate essential hypertension.
Pharmacology: Lercanidipine is a calcium antagonist of the dihydropyridine group and inhibits the transmembrane influx of calcium into cardiac and smooth muscle. The mechanism of its antihypertensive action is due to a direct relaxant effect on vascular smooth muscle thus lowering total peripheral resistance. Despite its short pharmacokinetic plasma half-life, lercanidipine is endowed with a prolonged antihypertensive activity because of its high membrane partition coefficient, and is devoid of negative inotropic effects due to its high vascular selectivity. Since the vasodilatation induced by lercanidipine is gradual in onset, acute hypotension with reflex tachycardia has rarely been observed in hypertensive patients.
Dosage: Adult: 10mg once a day at least 15 minutes before meals; may be increased to 20mg depending on patient’s response. Titrate gradually. Renal or hepatic insufficiency: Caution when increasing to 20mg. Elderly: Caution. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to lercanidipine, to any dihydropyridine or to any of the excipients. Left ventricular outflow tract obstruction. Untreated congestive cardiac failure. Unstable angina pectoris. Within 1 month of myocardial infarction. Severe renal/hepatic impairment. Women of child-bearing potential (unless effective contraception used). Pregnancy, lactation.
Special precautions: Caution: Sick-sinus syndrome, angina pectoris, mild to moderate renal/hepatic dysfunction. Isolated cases of myocardial infarction observed. Contains lactose.
Drug interactions: Contra: Strong CYP3A4 inhibitors, ciclosporin, grapefruit juice. Caution: CYP3A4 inducers, CYP3A4 substrates (digoxin, cimetidine, terfenadine, astemizole, class III antiarrhythmic drugs), β-blockers. Avoid alcohol.
Adverse drug reactions: None common.
Full prescribing information and references available from Actavis Ireland Ltd. Telephone: 1890 333231. Fax: (021) 4619049. E-mail: firstname.lastname@example.org