ZANIDIP 20MG TABLET
Each film-coated tablet contains lercanidipine HCl 10 mg. Each film-coated tablet contains lercanidipine HCl 20 mg equivalent to lercanidipine 18.8 mg. Zanidip also contains the following excipients: Tablet Core: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone K30, magnesium stearate. Film-Coating: Hypromellose, talc, titanium dioxide (E171), macrogol 6000 and ferric oxide (E172).
Indications / Uses :
Treatment of mild to moderate essential hypertension.
10-mg Tab: Some individuals, not adequately controlled on a single antihypertensive agent may benefit form the addition of Zanidip with a ?-adrenoceptor blocking drug, a diuretic or an angiotensin-converting enzyme (ACE) inhibitor.
Should be taken on an empty stomach: Take at least 15 min before meals.
Hypersensitivity to lercanidipine, to any dihydropyridine or to any of the excipients of Zanidip.
Patients with left ventricular outflow tract obstruction, untreated congestive cardiac failure, unstable angina pectoris, severe renal or hepatic impairment or within 1 month of a myocardial infarction. Co-administration with strong inhibitors of CYP3A4, cyclosporine and grapefruit juice (see Interactions).
Special Precautions :
Special care should be exercised when lercanidipine 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 left ventricular (LV) dysfunction. It has been suggested that some short-acting dihydropyridines may be associated with increased cardiovascular risk in patients with ischemic heart disease. Although lercanidipine is long-acting, caution is required in such patients.
Some dihydropyridines may rarely lead to precordial pain or angina pectoris. Very rarely, patients with preexisting angina pectoris may experience increased frequency, duration or severity of these attacks. Isolated cases of myocardial infarction may be observed.
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 usual 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.
Lercanidipine is not recommended for use in patients with severe hepatic impairment or in patients with severe renal impairment (GFR <30 mL/min). Alcohol should be avoided since it may potentiate the effect of vasodilating antihypertensive drugs.
Inducers of CYP3A4-like anticonvulsants (eg, phenytoin, carbamazepine) and rifampicin may reduce lercanidipine’s plasma levels and therefore, the efficacy of lercanidipine may be less than expected.
One (1) tablet contains lactose 60 mg and therefore, should not be administered to patients with Lapp-lactase insufficiency, galactosemia or glucose/galactose malabsorption syndrome.
Effects on the Ability to Drive or Operate Machinery: Clinical experience with lercanidipine indicates that it is unlikely to impair a patient’s ability to drive or use machinery. However, caution should be exercised because dizziness, asthenia, fatigue and rarely, somnolence may occur.
Use in children: Since there is no clinical experience in patients <18 years, use in children is not currently recommended.