Cardene Sr
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Questions & Answers
Side Effects & Adverse Reactions
In short-term, placebo-controlled angina trials with CARDENE (an immediate release oral dosage form of nicardipine), about 7% of patients on CARDENE (compared with 4% of patients on placebo) have developed increased frequency, duration or severity of angina. Comparisons with beta-blockers also show a greater frequency of increased angina, 4% vs 1%. The mechanism of this effect has not been established.
Although preliminary hemodynamic studies in patients with congestive heart failure have shown that CARDENE reduced afterload without impairing myocardial contractility, it has a negative inotropic effect in vitro and in some patients. Caution should be exercised when using the drug in congestive heart failure patients, particularly in combination with a beta-blocker.
CARDENE is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker, preferably over 8 to 10 days.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
CARDENE SR is indicated for the treatment of hypertension. CARDENE SR may be used alone or in combination with other antihypertensive drugs.
History
There is currently no drug history available for this drug.
Other Information
CARDENE® SR 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&C 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.
Sources
Cardene Sr Manufacturers
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Pdl Biopharma, Inc.
![Cardene Sr (Nicardipine Hydrochloride) Capsule, Gelatin Coated [Pdl Biopharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cardene Sr | Pdl Biopharma, Inc.
The dose of CARDENE SR 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 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 beta-blockers (see Drug Interactions). Special Patient Populations Renal InsufficiencyAlthough there is no evidence that CARDENE SR impairs renal function, careful dose titration beginning with 30-mg CARDENE SR bid is advised (see PRECAUTIONS).
Hepatic InsufficiencyCARDENE SR has not been studied in patients with severe liver impairment (see PRECAUTIONS).
Congestive Heart FailureCaution is advised when titrating CARDENE SR dosage in patients with congestive heart failure (see WARNINGS).
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Ekr Therapeutics
Cardene Sr | Ekr Therapeutics
The dose of CARDENE SR 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 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 beta-blockers (see Drug Interactions). Special Patient PopulationsRenal Insufficiency: Although there is no evidence that CARDENE SR impairs renal function, careful dose titration beginning with 30-mg CARDENE SR bid is advised (see PRECAUTIONS).
Hepatic Insufficiency: CARDENE SR has not been studied in patients with severe liver impairment (see PRECAUTIONS).
Congestive Heart Failure: Caution is advised when titrating CARDENE SR dosage in patients with congestive heart failure (see WARNINGS).
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Carilion Materials Management
Cardene Sr | Carilion Materials Management
The dose of CARDENE SR 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 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:
: CARDENE may be safely coadministered with thiazide diuretics. Diuretics
: CARDENE may be safely coadministered with beta-blockers (see ). Beta-BlockersDrug Interactions Special Patient PopulationsAlthough there is no evidence that CARDENE SR impairs renal function, careful dose titration beginning with 30-mg CARDENE SR bid is advised (see ). Renal Insufficiency:PRECAUTIONS
CARDENE SR has not been studied in patients with severe liver impairment (see ). Hepatic Insufficiency:PRECAUTIONS
Caution is advised when titrating CARDENE SR dosage in patients with congestive heart failure (see ). Congestive Heart Failure:WARNINGS
![Cardene Sr (Nicardipine Hydrochloride) Capsule, Extended Release [Ekr Therapeutics]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ce141ca0-d734-11df-8537-0002a5d5c51b&name=cardene-sr-figure-2.jpg)
![Cardene Sr (Nicardipine Hydrochloride) Capsule, Extended Release [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=613c79eb-b34d-4fea-82d0-61b8c4840182&name=68151-0089.jpg)
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