Drug: Cardene SR

CARDENE® SR (nicardipine hydrochloride sustained release capsules) is a sustained release formulation of CARDENE®. CARDENE SR capsules for oral administration each contain 30 mg, 45 mg or 60 mg of nicardipine hydrochloride. Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium entry blocker). Nicardipine hydrochloride is a dihydropyridine derivative with the IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6 dimethyl- 4-(m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure: Nicardipine hydrochloride is a greenish-yellow, odorless, crystalline powder that melts at about 169°C. It is freely soluble in chloroform, methanol and glacial acetic acid, sparingly soluble in anhydrous ethanol, slightly soluble in n-butanol, water, 0.01 M potassium dihydrogen phosphate, acetone and dioxane, very slightly soluble in ethyl acetate, and practically insoluble in benzene, ether and hexane. It has a molecular weight of 515.99. CARDENE SR is available in hard gelatin capsules containing 30 mg, 45 mg or 60 mg nicardipine hydrochloride. All strengths contain a two component capsule fill. A powder component containing 25% of total nicardipine hydrochloride dose contains pregelatinized starch and magnesium stearate as inactive ingredients. A spherical granule component containing 75% of total nicardipine hydrochloride dose also contains microcrystalline cellulose, starch, lactose and methacrylic acid copolymer Type C as inactive ingredients. The colorants used in the 30-mg capsules are titanium dioxide, FD& Red No. 40 and red iron oxide, and the colorants used in the 45-mg and 60-mg capsules are titanium dioxide and FD&C Blue No. 2.

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In multiple-dose US and foreign controlled studies, 667 patients received CARDENE SR (nicardipine hydrochloride sustained release capsules) . In these studies adverse events were elicited by nondirected and in some cases directed questioning; adverse events were generally not serious and about 9% of patients withdrew prematurely from the studies because of them. Hypertension The incidence rates of adverse events in hypertensive patients were derived from placebo-controlled clinical trials. Following are the rates of adverse events for CARDENE SR (nicardipine hydrochloride sustained release capsules) (n=322) and placebo (n=140), respectively, that occurred in 0.6% of patients or more on CARDENE SR (nicardipine hydrochloride sustained release capsules) . These represent events considered probably drug related by the investigator. Where the frequency of adverse events for CARDENE SR (nicardipine hydrochloride sustained release capsules) and placebo is similar, causal relationship is uncertain. The only dose-related effect was pedal edema. Percentage of Patients With Probably Drug Related Adverse Events in Placebo-Controlled Studies
Adverse Event CARDENE SR
(n=322) Placebo
(n=140) Headache 6.2 7.1 Pedal Edema 5.9 1.4 Vasodilatation 4.7 1.4 Palpitation 2.8 1.4 Nausea 1.9 0.7 Dizziness 1.6 0.7 Asthenia 0.9 0.7 Postural Hypotension 0.9 0 Increased Urinary Frequency 0.6 0 Pain 0.6 0 Rash 0.6 0 Sweating Increased 0.6 0 Vomiting 0.6 0 Incidence (%) of Discontinuations Due to Any Adverse Event in Placebo-Controlled Studies
Adverse Event CARDENE SR
(n=322) Placebo
(n=140) Headache 2.5 1.4 Palpitation 2.2 0.7 Dizziness 1.9 0.7 Asthenia 1.9 0 Pedal Edema 1.2 0 Nausea 1.2 0 Rash 0.9 0.7 Diarrhea 0.9 0 Tachycardia 0.9 0 Blurred Vision 0.6 0 Chest Pain 0.6 0 Face Edema 0.6 0 Myocardial Infarct 0.6 0 Vasodilatation 0.6 0 Vomiting 0.6 0 Uncontrolled experience in over 300 patients with hypertension treated for up to 27.5 months with CARDENE SR (nicardipine hydrochloride sustained release capsules) has shown no unexpected adverse events or increase in incidence of adverse events compared to the controlled clinical trials. Rare Events The following rare adverse events have been reported in clinical trials or the literature: Body as a Whole: infection, allergic reaction Cardiovascular: hypotension, atypical chest pain, peripheral vascular disorder, ventricular extrasystoles, ventricular tachycardia, angina pectoris Digestive: sore throat, abnormal liver chemistries Musculoskeletal: arthralgia Nervous: hot flashes, vertigo, hyperkinesia, impotence, depression, confusion, anxiety Respiratory: rhinitis, sinusitis Special Senses: tinnitus, abnormal vision, blurred vision Angina Data are available from only 91 patients with chronic stable angina pectoris who received CARDENE SR (nicardipine hydrochloride sustained release capsules) 30 to 60 mg administered twice daily in open-label clinical trials. Fifty-eight of these patients were treated for at least 30 days. The four most frequently reported adverse events thought by the investigators to be probably related to the use of CARDENE SR (nicardipine hydrochloride sustained release capsules) were vasodilatation (5.5%), pedal edema (4.4%), asthenia (4.4%), and dizziness (3.3%). Read the Cardene SR (nicardipine hydrochloride sustained release capsules) Side Effects Center for a complete guide to possible side effectsLearn More »

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The dose of CARDENE SR (nicardipine hydrochloride sustained release capsules) should be individually adjusted according to the blood pressure response beginning with 30 mg two times daily. The effective doses in clinical trials have ranged from 30 mg to 60 mg two times daily. The maximum blood pressure lowering effect at steady-state is sustained from 2 hours until 6 hours after dosing. When initiating therapy or upon increasing dose, blood pressure should be measured 2 to 4 hours after the first dose or dose increase, as well as at the end of a dosing interval. The total daily dose of immediate release nicardipine (CARDENE) may not be a useful guide to judging the effective dose of CARDENE SR. Patients currently receiving immediate release nicardipine may be titrated with CARDENE SR (nicardipine hydrochloride sustained release capsules) starting at their current total daily dose of immediate release nicardipine and then reexamined to assess the adequacy of blood pressure control. Concomitant Use With Other Antihypertensive Agents
  • Diuretics: CARDENE may be safely coadministered with thiazide diuretics.
  • Beta-Blockers: CARDENE may be safely coadministered with betablockers (see DRUG INTERACTIONS).
Special Patient Populations Renal Insufficiency: Although there is no evidence that CARDENE SR (nicardipine hydrochloride sustained release capsules) impairs renal function, careful dose titration beginning with 30-mg CARDENE SR (nicardipine hydrochloride sustained release capsules) bid is advised (see PRECAUTIONS). Hepatic Insufficiency: CARDENE SR (nicardipine hydrochloride sustained release capsules) has not been studied in patients with severe liver impairment (see PRECAUTIONS). Congestive Heart Failure: Caution is advised when titrating CARDENE SR (nicardipine hydrochloride sustained release capsules) dosage in patients with congestive heart failure (see WARNINGS).

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Beta-Blockers In controlled clinical studies, adrenergic beta-receptor blockers have been frequently administered concomitantly with CARDENE. The combination is well tolerated. Cimetidine Cimetidine increases CARDENE plasma levels. Patients receiving the two drugs concomitantly should be carefully monitored. Digoxin Some calcium blockers may increase the concentration of digitalis preparations in the blood. CARDENE usually does not alter the plasma levels of digoxin; however, serum digoxin levels should be evaluated after concomitant therapy with CARDENE is initiated. Fentanyl Anesthesia Severe hypotension has been reported during fentanyl anesthesia with concomitant use of a beta-blocker and a calcium channel blocker. Even though such interactions were not seen during clinical studies with CARDENE, an increased volume of circulating fluids might be required if such an interaction were to occur. Cyclosporine Concomitant administration of nicardipine and cyclosporine results in elevated plasma cyclosporine levels. Plasma concentrations of cyclosporine should therefore be closely monitored, and its dosage reduced accordingly, in patients treated with nicardipine. When therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine or naproxen were added to human plasma (in vitro), the plasma protein binding of CARDENE was not altered. Read the Cardene SR Drug Interactions Center for a complete guide to possible interactions Learn More »

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CARDENE SR (nicardipine hydrochloride sustained release capsules) is indicated for the treatment of hypertension. CARDENE SR may be used alone or in combination with other antihypertensive drugs.

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CARDENE is contraindicated in patients with hypersensitivity to the drug. Because part of the effect of CARDENE is secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. Reduction of diastolic pressure by any means in these patients may worsen rather than improve myocardial oxygen balance.Last reviewed on RxList: 6/19/2009
This monograph has been modified to include the generic and brand name in many instances.

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Three overdosages with CARDENE or CARDENE SR (nicardipine hydrochloride sustained release capsules) have been reported. Two occurred in adults, 1 of whom ingested 600 mg of CARDENE and the other 2160 mg of CARDENE SR (nicardipine hydrochloride sustained release capsules) . Symptoms included marked hypotension, bradycardia, palpitations, flushing, drowsiness, confusion, and slurred speech. All symptoms resolved without sequelae. The third overdosage occurred in a 1-year-old child who ingested half of the powder in a 30-mg CARDENE capsule. The child remained asymptomatic. Based on results obtained in laboratory animals, overdosage may cause systemic hypotension, bradycardia (following initial tachycardia) and progressive atrioventricular conduction block. Reversible hepatic function abnormalities and sporadic focal hepatic necrosis were noted in some animal species receiving very large doses of nicardipine. For treatment of overdose standard measures (for example, evacuation of gastric contents, elevation of extremities, attention to circulating fluid volume, and urine output) including monitoring of cardiac and respiratory functions should be implemented. The patient should be positioned so as to avoid cerebral anoxia. Frequent blood pressure determinations are essential. Vasopressors are clinically indicated for patients exhibiting profound hypotension. Intravenous calcium gluconate may help reverse the effects of calcium entry blockade.

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CARDENE® SR (nicardipine hydrochloride sustained release capsules) 30-mg capsules are available in opaque pink-pink hard gelatin capsules. The capsule cap is printed with CARDENE SR (nicardipine hydrochloride sustained release capsules) 30 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 (NDC 67286-0813-2) and bottles of 200 (NDC 67286-0813-1). CARDENE® SR (nicardipine hydrochloride sustained release capsules) 45-mg capsules are available in opaque powder bluepowder blue hard gelatin capsules. The capsule cap is printed with CARDENE SR 45 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 (NDC 67286-0813-4) and bottles of 200 (NDC 67286-0813-3). CARDENE® SR (nicardipine hydrochloride sustained release capsules) 60-mg capsules are available in opaque light blue-white hard gelatin capsules. The capsule cap is printed with CARDENE SR (nicardipine hydrochloride sustained release capsules) 60 mg and the capsule body is printed with PDL BioPharma. These are supplied in bottles of 60 (NDC 67286-0813-5). Store bottles at 15° to 30°C (59° to 86°F) and dispense in light-resistant containers, such as the manufacturer's original container. For questions of a medical nature or to report an adverse event, call 1-866-437-7742. Marketed by: PDL BioPharma, Inc., Redwood City, CA 94063. Revised: January 2007. Last reviewed on RxList: 6/19/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Blood Pressure Because CARDENE decreases peripheral resistance, careful monitoring of blood pressure during the initial administration and titration of CARDENE is suggested. CARDENE, like other calcium channel blockers, may occasionally produce symptomatic hypotension. Caution is advised to avoid systemic hypotension when administering the drug to patients who have sustained an acute cerebral infarction or hemorrhage. Use in Patients With Impaired Hepatic Function Since the liver is the major site of biotransformation and since CARDENE is subject to firstpass metabolism, CARDENE should be used with caution in patients having impaired liver function or reduced hepatic blood flow. Patients with severe liver disease developed elevated blood levels (fourfold increase in AUC) and prolonged half-life (19 hours) of CARDENE. Use in Patients With Impaired Renal Function When 45-mg CARDENE SR (nicardipine hydrochloride sustained release capsules) bid was given to hypertensive patients with moderate renal impairment, mean AUC and Cmax values were approximately 2-fold to 3-fold higher than in patients with mild renal impairment. Doses in these patients must be adjusted. Mean AUC and Cmax values were similar in patients with mildly impaired renal function and normal volunteers (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). Carcinogenesis, Mutagenesis, Impairment of Fertility Rats treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of 5, 15 or 45 mg/kg/day) for 2 years showed a dose-dependent increase in thyroid hyperplasia and neoplasia (follicular adenoma/carcinoma). One- and 3-month studies in the rat have suggested that these results are linked to a nicardipine-induced reduction in plasma thyroxine (T4) levels with a consequent increase in plasma levels of thyroid stimulating hormone (TSH). Chronic elevation of TSH known to cause hyperstimulation of the thyroid. In rats on an iodine deficient diet, nicardipine administration for 1 month was associated with thyroid hyperplasia that was prevented by T4 supplementation. Mice treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of up to 100 mg/kg/day) for up to 18 months showed no evidence of neoplasia of any tissue and no evidence of thyroid changes. There was no evidence of thyroid pathology in dogs treated with up to 25 mg nicardipine/kg/day for 1 year and no evidence of effects of nicardipine on thyroid function (plasma T4 and TSH) in man. There was no evidence of a mutagenic potential of nicardipine in battery of genotoxicity tests conducted on microbial indicator organisms, in micronucleus tests in mice and hamsters, or in a sister chromatid exchange study in hamsters. No impairment of fertility was seen in male or female rats administered nicardipine at oral doses as high as 100 mg/kg/day (50 times the maximum recommended daily dose in man, assuming a patient weight of 60 kg). Pregnancy Pregnancy Category C Nicardipine was embryocidal when administered orally to pregnant Japanese White rabbits, during organogenesis, at 150 mg/kg/day (a dose associated with marked body weight gain suppression in the treated doe) but not at 50 mg/kg/day (25 times the maximum recommended dose in man). No adverse effects on the fetus were observed when New Zealand albino rabbits were treated, during organogenesis, with up to 100 mg nicardipine/kg/day (a dose associated with significant mortality in the treated doe). In pregnant rats administered nicardipine orally at up to 100 mg/kg/day (50 times the maximum recommended human dose) there was no evidence of embryolethality or teratogenicity. However, dystocia, reduced birth weights, reduced neonatal survival and reduced neonatal weight gain were noted. There are no adequate and well-controlled studies in pregnant women. CARDENE SR (nicardipine hydrochloride sustained release capsules) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Studies in rats have shown significant concentrations of nicardipine in maternal milk following oral administration. For this reason it is recommended that women who wish to breastfeed should not take this drug. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Pharmacokinetic parameters did not differ significantly between elderly hypertensive subjects (mean age: 70 years) and younger hypertensive subjects (mean age: 44 years) after 1 week of treatment with CARDENE SR (see CLINICAL PHARMACOLOGY: Geriatric Pharmacokinetics). Clinical studies of nicardipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Last reviewed on RxList: 6/19/2009
This monograph has been modified to include the generic and brand name in many instances.

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