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SANDOZ FELODIPINE is a brand name for Felodipine, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
Felodipine is contraindicated in: 1. Patients with a known hypersensitivity to felodipine or any other components of Sandoz Felodipine. 2. Patients with a known hypersensitivity to other dihydropyridines. 3. In women of childbearing potential, in pregnancy, and during lactation.
Fetal malformations and adverse effects on pregnancy have been reported in animals. 4 to 4 times the maximum recommended human dose on a mg/m2 basis) showed digital anomalies consisting of reduction in size and degree of ossification of the terminal phalanges in the fetuses.
The frequency and severity of the changes appeared dose-related and were noted even at the lowest dose. These changes have been shown to occur with other members of the dihydropyridine class. Similar fetal anomalies were not observed in rats given felodipine.
In a teratology study in Cynomolgus monkeys, no reduction in the size of the terminal phalanges was observed but an abnormal position of the distal phalanges was noted in about 40 percent of the fetuses. 6 mg/kg/day and above. 2 mg/kg/day.
This effect occurred only in pregnant rabbits and regressed during lactation. Similar changes in the mammary glands were not observed in rats or monkeys. WARNINGS Congestive Heart Failure The safety and efficacy of felodipine in patients with heart failure has not been established.
Caution should, therefore, be exercised when using felodipine in hypertensive patients with compromised ventricular function, particularly in combination with a beta-blocker. Acute hemodynamic studies in a small number of patients with New York Heart Association Class II or III heart failure treated with felodipine have not demonstrated negative inotropic effects.
Hypotension, Myocardial Ischemia Felodipine may, occasionally, precipitate symptomatic hypotension and rarely syncope. It may Sandoz Felodipine Page 6 of 35 lead to reflex tachycardia which, particularly in patients with severe obstructive coronary artery disease, may result in myocardial ischaemia.
Careful monitoring of blood pressure during the initial administration and titration of felodipine is recommended. Care should be taken to avoid hypotension especially in patients with a history of cerebrovascular insufficiency, and in those taking medications known to lower blood pressure.
Beta-Blocker Withdrawal Felodipine gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be a gradual reduction of the dose of beta-blockers. Outflow Obstruction Felodipine should be used with caution in the presence of left ventricular outflow obstruction.
Dermatologic Lesion Along with leucocytoclastic vasculitis, other dermatologic events have been observed. These include rash and flush. All cases of dermatologic lesions should be carefully diagnosed and monitored. Concomitant Use With Strong Inhibitors of CYP3A4 Use of felodipine with drugs that result in strong inhibition of CYP3A4, such as ketoconazole, clarithromycin, ritonavir, may lead to increased plasma levels of felodipine and associated serious adverse events (see DRUG INTERACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Such concomitant use should be avoided. I. 06)]. PRECAUTIONS Peripheral Edema Mild to moderate peripheral edema was the most common adverse event in the clinical trials. The incidence of peripheral edema was dose-dependent. Frequency of peripheral edema ranged from about 10 percent in patients under 50 years of age taking 5 mg daily to about 30 percent in those over 60 years of age taking 20 mg daily.
This adverse effect generally occurs within 2-3 weeks of the initiation of treatment. Care should be taken to differentiate this peripheral edema from the effects of increasing left ventricular dysfunction. Use in Elderly Patients Patients over 65 years of age may have elevated plasma concentrations of felodipine and, therefore, may require lower doses of felodipine (see ACTION AND CLINICAL PHARMACOLOGY - Pharmacokinetics).
These patients should have their blood pressure monitored closely during initial administration and after dosage adjustment of felodipine. A dosage of 10 mg daily should not be exceeded (see DOSAGE AND ADMINISTRATION - Sandoz Felodipine Page 7 of 35 Use in the Elderly).
Use in Patients with Impaired Liver Function Patients with impaired liver function may have elevated plasma concentrations of felodipine and, therefore, may require lower doses of felodipine (see ACTION AND CLINICAL PHARMACOLOGY - Pharmacokinetics).
These patients should have their blood pressure monitored closely during initial administration and after dosage adjustment of felodipine. A dosage of 10 mg daily should not be exceeded (see DOSAGE AND ADMINISTRATION - Use in Patients with Impaired Liver Function).
Gingival Hyperplasia Felodipine can induce gingival enlargement in patients with pronounced gingivitis and periodontitis. However, such changes may be avoided or reversed by measures of good oral hygiene and mechanical debridement of the teeth.
In very rare instances, felodipine has also caused gingivitis. Pregnancy and Lactation See CONTRAINDICATIONS. Use in Children Felodipine is not recommended in children since the safety and efficacy in […]