Nicardia-XL Special Precautions

NICARDIA-XL-30 must be swallowed whole; under no circumstances should they be bitten, chewed or broken up.
Caution should be exercised in patients with hypotension as there is a risk of further reduction in blood pressure and care must be exercised in patients with very low blood pressure (severe hypotension with systolic blood pressure less than 90 mm Hg).
In patients with impaired liver function careful monitoring and, in severe cases, a dose reduction may be necessary.
NICARDIA-XL-30 may be used in combination with beta-blocking drugs and other antihypertensive agents but the possibility of an additive effect resulting in postural hypotension should be borne in mind. NICARDIA-XL-30 will not prevent possible rebound effects after cessation of other antihypertensive therapy.
NICARDIA-XL-30 should be used with caution in patients whose cardiac reserve is poor. Deterioration of heart failure has occasionally been observed with nifedipine.
Diabetic patients taking NICARDIA-XL-30 may require adjustment of their control as elevated blood glucose concentrations in serum (hyperglycaemia) upon taking.
Dialysis patients with severe, life-threatening high blood pressure (malignant hypertension) and irreversible kidney failure with reduced plasma volume (hypovolaemia) may experience particularly great blood pressure reduction through widening of blood vessels (vasodilation).
Nifedipine is metabolised via the cytochrome P450 3A4 system. Drugs that are known to either inhibit or to induce this enzyme system may therefore alter the first pass or the clearance of nifedipine.
Drugs, which are known inhibitors of the cytochrome P450 3A4 system, and which may therefore lead to increased plasma concentrations of nifedipine include, for example: Macrolide antibiotics (e.g., erythromycin); Anti-HIV protease inhibitors (e.g., ritonavir); Azole antimycotics (e.g., ketoconazole); The antidepressants, nefazodone and fluoxetine; quinupristin/dalfopristin; valproic acid; Cimetidine.
Upon co-administration with these drugs, the blood pressure should be monitored and, if necessary, a reduction of the nifedipine dose should be considered.
Treatment of high blood pressure with NICARDIA-XL-30 requires regular monitoring. Due to individually different reactions, alertness may be altered to such an extent that the ability to actively participate in road traffic or to operate machines or to work without a firm support is impaired. This applies especially at the start of treatment, when increasing the dose and when switching medicines as well as in combination with alcohol.