tion 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).
As with other calcium antagonists, 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 MOTENS 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.
This product contains 277.25 mg lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Co-administration of lacidipine with other agents recognised to have a hypotensive effect, including anti-hypertensive agents, (e.g. diuretics, beta-blockers or ACE-inhibitors), may have an additive hypotensive effect. However, no specific interaction problems have been identified in studies with common antihypertensive agents (e.g. beta-blockers and diuretics) or with digoxin, tolbutamide or warfarin.
The plasma level of lacidipine may be increased by simultaneous administration of cimetidine.
Lacidipine is highly protein-bound (more than 95%) to albumin and alpha-1-glycoprotein.
As with other dihydropyridines, lacidipine should not be taken with grapefruit juice as bioavailability may be altered.
In clinical studies in patients with a renal transplant treated with cyclosporin, lacidipine reversed the decrease in renal plasma flow and glomerular filtration rate induced by cyclosporin.
Lacidipine is known to be metabolised by cytochrome CYP3A4 and, therefore, significant inhibitors and inducers of CYP3A4 (e.g. rifampicin, itraconazole) administered concurrently may interact with the metabolism and elimination of lacidipine.
Concomitant use of lacidipine and corticoids or tetracosactide might decrease antihypertensive effect.
4.6 Fertility, pregnancy and lactation
Pregnancy:
Although some dihydropyridine compounds have been found to be teratogenic in animals, data in the rat and rabbit for lacidipine provide no evidence of a teratogenic effect. Using doses far above the therapeutic range, in animals lacidipine shows evidence of maternal toxicity resulting in increased pre- and post-implantation losses and possibly delayed ossification. Evidence from experimental animals has indicated that administration of lacidipine results in prolongation of gestational period and prolonged and difficult labour as a consequence of relaxation of uterine muscle.
There are no data on the safety of lacidipine in human pregnancy.
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.
Breastfeeding:
Milk transfer studies in animals have shown that lacidipine (or i
