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Drug details for : ZANIDIP 10 mg tablets
| Drug class description : | Selective calcium channel blockers with mainly vascular effects |
| Generic Name : | Lercanidipine |
| Drug description : | Film-coated tablet. Yellow, circular, biconvex tablets, scored on one side. |
| Presentation : | One tablet contains 10 mg of lercanidipine hydrochloride, which is equivalent to 9.4 mg of lercanidipine. |
| Indications : | ZANIDIP is indicated for the treatment of mild to moderate essential hypertension. |
| Adult Dosage : | The recommended dosage is 10 mg orally once a day at least 15 minutes before meals; the dose may be increased to 20 mg depending on the individual patient's response. Dose titration should be gradual, because it may take about 2 weeks before the maximal antihypertensive effect is apparent. Some individuals, not adequately controlled on a single antihypertensive agent, may benefit from the addition of ZANIDIP to therapy with a beta-adrenoceptor blocking drug (atenolol), a diuretic (hydrochlorothiazide) or an angiotensin converting enzyme inhibitor (captopril or enalapril). Since the dose-response curve is steep with a plateau at doses between 20-30 mg, it is unlikely that efficacy will be improved by higher doses; whereas side effects may increase. Use in renal or hepatic dysfunction: special care should be exercised when treatment is commenced in patients with mild to moderate renal or hepatic dysfunction. Although the usually recommended dose schedule may be tolerated by these subgroups, an increase in dose to 20 mg daily must be approached with caution. The antihypertensive effect may be enhanced in patients with hepatic impairment and consequently an adjustment of the dosage should be considered. ZANIDIP is not recommended for use in patients with severe hepatic impairment or in patients with severe renal impairment (GFR < 30 ml/min). |
| Child Dosage : | Use in children: since there is no clinical experience in patients under the age of 18 years, use in children is not currently recommended. |
| Elderly Dosage : | Use in the elderly: although the pharmacokinetic data and clinical experience suggest that no adjustment of the daily dosage is required, special care should be exercised when initiating treatment in the elderly. |
| Contra Indications : | • Hypersensitivity to the active substance “lercanidipine“, to any dihydropyridine or to any of the excipients of the medicinal product. • Pregnancy and lactation (See Interactions). • Women of child-bearing potential unless effective contraception is used. • Left ventricular outflow tract obstruction. • Untreated congestive cardiac failure. • Unstable angina pectoris. • Severe renal or hepatic impairment. • Within 1 month of a myocardial infarction. • Co-administration with: o strong inhibitors of CYP3A4 (See Interactions), o ciclosporin (See Interactions), o grapefruit juice (See Interactions). |
| Special Precautions : | Special care should be exercised when ZANIDIP is used in patients with sick sinus syndrome (if a pacemaker is not in situ). Although hemodynamic controlled studies revealed no impairment of ventricular function, care is also required in patients with LV dysfunction. It has been suggested that some short-acting dihydropyridines may be associated with increased cardiovascular risk in patients with ischaemic heart disease. Although ZANIDIP is long-acting caution is required in such patients. Some dihydropyridines may rarely lead to precordial pain or angina pectoris. Very rarely patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these attacks. Isolated cases of myocardial infarction may be observed (See Adverse Reactions). Use in renal or hepatic dysfunction: special care should be exercised when treatment is commenced in patients with mild to moderate renal or hepatic dysfunction. Although the usually recommended dose schedule may be tolerated by these subgroups, an increase in dose to 20 mg daily must be approached with caution. The antihypertensive effect may be enhanced in patients with hepatic impairment and consequently an adjustment of the dosage should be considered. ZANIDIP is not recommended for use in patients with severe hepatic impairment or in patients with severe renal impairment (GFR < 30 ml/min) (See Adult Dosage). Alcohol should be avoided since it may potentiate the effect of vasodilating antihypertensive drugs (See Interactions). Inducers of CYP3A4 like anticonvulsants (e.g. phenytoin, carbamazepine) and rifampicin may reduce lercanidipine's plasma levels and therefore the efficacy of lercanidipine may be less than expected (See Interactions). 1 tablet contains 30 mg lactose and therefore should not be administered to patients with Lapp lactase insufficiency, galactosaemia or glucose/galactose malabsorption syndrome. |
| Interactions : | Lercanidipine is known to be metabolised by the CYP3A4 enzyme and, therefore, inhibitors and inducers of CYP3A4 administered concurrently may interact with the metabolism and elimination of lercanidipine. Co-prescription of ZANIDIP with inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, ritonavir, erythromycin, troleandomycin) should be avoided (see 4.3). An interaction study with a strong CYP3A4 inhibitor, ketoconazole, has shown a considerable increase in plasma levels of lercanidipine (a 15-fold increase of the AUC and an 8-fold increase of the Cmax for the eutomer S-lercanidipine). Ciclosporin and lercanidipine should not be administered together (See Contraindications). Increased plasma levels of both lercanidipine and ciclosporin have been observed following concomitant administration. A study in young healthy volunteers has shown that when ciclosporin was administered 3 hours after the lercanidipine intake, the plasma levels of lercanidipine did not change, while the AUC of ciclosporin increased by 27%. However, the co-administration of ZANIDIP with ciclosporin has caused a 3-fold increase of the plasma levels of lercanidipine and a 21% increase of the ciclosporin AUC. Lercanidipine should not be taken with grapefruit juice (See Contraindications). As for other dihydropyridines, lercanidipine is sensitive to inhibition of metabolism by grapefruit juice, with a consequent rise in its systemic availability and increased hypotensive effect. When concomitantly administered at a dose of 20 mg with midazolam p.o. to elderly volunteers, lercanidipine's absorption was increased (by approximately 40%) and the rate of absorption was decreased (tmax was delayed from 1.75 to 3 hours). Midazolam concentrations were not modified. Caution should be exercised when ZANIDIP is co-prescribed with other substrates of CYP3A4, like terfenadine, astemizole, class III antiarrhythmic drugs such as amiodarone, quinidine. Co-administration of ZANIDIP with CYP3A4 inducers like anticonvulsants (e.g. phenytoin, carbamazepine) and rifampicin should be approached with caution since the antihypertensive effect may be reduced and blood pressure should be monitored more frequently than usual. When ZANIDIP was co-administered with metoprolol, a ß-blocker eliminated mainly by the liver, the bioavailability of metoprolol was not changed while that of lercanidipine was reduced by 50%. This effect may be due to the reduction in the hepatic blood flow caused by ß-blockers and may therefore occur with other drugs of this class. Consequently, lercanidipine may be safely administered with beta-adrenoceptor blocking drugs, but dose adjustment may be required. An interaction study with fluoxetine (an inhibitor of CYP2D6 and CYP3A4), conducted in volunteers of an age of 65 ± 7 years (mean ± s.d.), has shown no clinically relevant modification of the pharmacokinetics of lercanidipine. Concomitant administration of cimetidine 800 mg daily does not cause significant modifications in plasma levels of lercanidipine, but at higher doses caution is required since the bioavailability and the hypotensive effect of lercanidipine may be increased. Co-administration of 20 mg lercanidipinein patients chronically treated with b-methyldigoxin showed no evidence of pharmacokinetic interaction. Healthy volunteers treated with digoxin following dosing with 20 mg lercanidipine given fasted showed a mean increase of 33% in digoxin Cmax, while AUC and renal clearance were not significantly modified. Patients on concomitant digoxin treatment should be closely monitored clinically for signs of digoxin toxicity. When a dose of 20 mg of ZANIDIP was repeatedly co-administered with 40 mg of simvastatin, the AUC of lercanidipine was not significantly modified, while simvastatin's AUC increased by 56% and that of its active metabolite ß-hydroxyacid by 28%. It is unlikely that such changes are of clinical relevance. No interaction is expected when lercanidipine is administered in the morning and simvastatin in the evening, as indicated for such drug. The co-administration of 20 mg lercanidipine to healthy volunteers given fasted did not alter the pharmacokinetics of warfarin. ZANIDIP has been safely administered with diuretics and ACE inhibitors. Alcohol should be avoided since it may potentiate the effect of vasodilating antihypertensive drugs (See Special Precautions). Pregnancy and lactation: Data for lercanidipine provide no evidence of a teratogenic effect in the rat and the rabbit and reproductive performance in the rat was unimpaired. Nevertheless, since there is no clinical experience with lercanidipine in pregnancy and lactation, and other dihydropyridine compounds have been found teratogenic in animals, ZANIDIP should not be administered during pregnancy or to women with child-bearing potential unless effective contraception is used. Because of high lipophilicity of lercanidipine, distribution in milk may be expected. Therefore, it should not be administered to nursing mothers. |
| Adverse Reactions : | About 1.8% of treated patients experienced adverse reactions. The table below shows the incidence of adverse drug reactions, at least possibly causally related, grouped by WHO-ART Body System classification, and ranked by frequency (uncommon, rare). As shown in the table, the most commonly occurring adverse drug reactions reported in controlled clinical trials are headache, dizziness, peripheral oedema, tachycardia, palpitations, flushing, each occurring in less than 1% of patients. Skin And Appendages Disorders Rare (>1/10,000 <1/1000) rash Musculo-Skeletal System Disorders Rare (>1/10,000 <1/1000) myalgia Central & Peripheral Nervous System Disorders Uncommon (>1/1000 <1/100) headache; dizziness Psychiatric Disorders Rare (>1/10,000 <1/1000) somnolence Gastro-Intestinal System Disorders Rare (>1/10,000 <1/1000) nausea; dyspepsia; diarrhoea; abdominal pain; vomiting Cardiovascular Disorders, General Uncommon (>1/1000 <1/100) oedema peripheral Myo-, Endo- Pericardial & Valve Disorders Rare (>1/10,000 <1/1000) angina pectoris Heart Rate And Rhythm Disorders Uncommon (>1/1000 <1/100) tachycardia; palpitations Vascular (Extracardiac) Disorders Uncommon (>1/1000 <1/100) flushing Urinary System Disorders Rare (>1/10,000 <1/1000) polyuria Body As A Whole - General Disorders Rare (>1/10,000 <1/1000) asthenia; fatigue In post-marketing experience, from spontaneous reports the following undesirable effects were reported very rarely ( <1/10,000): gingival hypertrophy, reversible increases in serum levels of hepatic transaminases, hypotension, urinary frequency and chest pain. Some dihydropyridines may rarely lead to precordial pain or angina pectoris. Very rarely patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these attacks. Isolated cases of myocardial infarction may be observed. Lercanidipine does not appear to influence adversely blood sugar or serum lipid levels. |
| Manufacturer : | Recordati Pharmaceuticals Limited |
| Drug Availability : | (POM) |
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