Dynacirc (Isradipine)
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Dynacirc (Isradipine)

DYNACIRC
(isradipine) Capsules

DRUG DESCRIPTION

DynaCirc® (isradipine) is a calcium antagonist available for oral administration in capsules containing 2.5 mg or 5 mg. The structural formula of isradipine is:

DynaCirc® (isradipine)  Structural Formula Illustration

Chemically, isradipine is 3,5-Pyridinedicarboxylic acid, 4-(4-benzofurazanyl)-1,4-dihydro-2,6-dimethyl-, methyl 1-methylethyl ester. Isradipine is a yellow, fine crystalline powder which is odorless or has a faint characteristic odor. Isradipine is practically insoluble in water ( < 10 mg/L at 37°C), but is soluble in ethanol and freely soluble in acetone, chloroform and methylene chloride.

Active Ingredient: isradipine

Inactive Ingredients: colloidal silicon dioxide, D&C Red No. 7 Calcium Lake, FD&C Red No. 40 (5 mg capsule only), FD&C Yellow No. 6 Aluminum Lake, gelatin, lactose, starch (corn), titanium dioxide and other ingredients.

The 2.5 mg and 5 mg capsules may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, methylparaben, propylparaben, sodium propionate.

What are the possible side effects of isradipine (Dynacirc, Dynacirc CR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling like you might pass out;
  • feeling short of breath, even with mild exertion;
  • swelling in your hands and feet;
  • fast or pounding heartbeats; or
  • chest pain.

Less serious side effects may include:

  • dizziness;
  • warmth, redness, or tingly feeling under your...

Read All Potential Side Effects and See Pictures of Dynacirc »

What are the precautions when taking isradipine (Dynacirc)?

Before taking isradipine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain structural heart problem (aortic stenosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic...

Read All Potential Precautions of Dynacirc »

Last reviewed on RxList: 4/22/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Hypertension

DynaCirc® (isradipine) is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.

DOSAGE AND ADMINISTRATION

The dosage of DynaCirc® (isradipine) should be individualized. The recommended initial dose of DynaCirc® (isradipine) is 2.5 mg b.i.d. alone or in combination with a thiazide diuretic. An antihypertensive response usually occurs within 2-3 hours. Maximal response may require 2–4 weeks. If a satisfactory reduction in blood pressure does not occur after this period, the dose may be adjusted in increments of 5 mg/day at 2-4 week intervals up to a maximum of 20 mg/day. Most patients, however, show no additional response to doses above 10 mg/day, and adverse effects are increased in frequency above 10 mg/day.

The bioavailability of DynaCirc (isradipine) ® (increased AUC) is increased in elderly patients (above 65 years of age), patients with hepatic functional impairment, and patients with mild renal impairment. Ordinarily, the starting dose should still be 2.5 mg b.i.d. in these patients.

HOW SUPPLIED

DynaCirc® (isradipine) Capsules

2.5 mg

White, imprinted twice with the DynaCirc (isradipine) ® logo and "DynaCirc (isradipine) " on one end, and "Reliant" and "2.5" on the other, twice.

Bottles of 100 capsules (NDC 65726-226-25)
Bottles of 60 capsules (NDC 65726-226-15)

5 mg

Light pink, imprinted twice with the DynaCirc (isradipine) ® logo and "DynaCirc (isradipine) " on one end, and "Reliant" and "5"on the other, twice.

Bottles of 100 capsules (NDC 65726-227-25)
Bottles of 60 capsules (NDC 65726-227-15)

Store and Dispense

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-89°F) [see USP Controlled Room Temperature] and dispense in a tight, light-resistant container.

Distributed by: Reliant Pharmaceuticals. Liberty Corner, New Jersey 07938.

Last reviewed on RxList: 4/22/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

In multiple dose U.S. studies in hypertension, 1228 patients received DynaCirc® (isradipine) alone or in combination with other agents, principally a thiazide diuretic, 934 of them in controlled comparisons with placebo or active agents. An additional 652 patients (which includes 374 normal volunteers) received DynaCirc® (isradipine) in U.S. studies of conditions other than hypertension, and 1321 patients received DynaCirc® (isradipine) in non-U.S. studies. About 500 patients received DynaCirc® (isradipine) in long-term hypertension studies, 410 of them for at least 6 months. The adverse reaction rates given below are principally based on controlled hypertension studies, but rarer serious events are derived from all exposures to DynaCirc® (isradipine), including foreign marketing experience.

Most adverse reactions were mild and related to the vasodilatory effects of DynaCirc (isradipine) ® (dizziness, edema, palpitations, flushing, tachycardia), and many were transient. About 5% of isradipine patients left studies prematurely because of adverse reactions (vs. 3% of placebo patients and 6% of active control patients), principally due to headache, edema, dizziness, palpitations, and gastrointestinal disturbances.

The following table shows the most common adverse reactions, volunteered or elicited, considered by the investigator to be at least possibly drug related. The results for the DynaCirc® (isradipine) treated patients are presented for all doses pooled together (reported by 1% or greater of patients receiving any dose of isradipine), and also for the two treatment regimens most applicable to the treatment of hypertension with DynaCirc® (isradipine): (1) initial and maintenance dose of 2.5 mg b.i.d., and (2) initial dose of 2.5 mg b.i.d. followed by maintenance dose of 5.0 mg b.i.d.

DynaCirc® (isradipine)

N= All Doses 934 2.5 mg b.i.d. 199 5 mg b.i.d.* 150 10 mg b.i.d. 59 Placebo 297 Active Controls 414
Adverse Experience % % % % % %
Headache 13.7 12.6 10.7 22.0 14.1 9.4
Dizziness 7.3 8.0 5.3 3.4 4.4 8.2
Edema 7.2 3.5 8.7 8.5 3.0 2.9
Palpitations 4.0 1.0 4.7 5.1 1.4 1.5
Fatigue 3.9 2.5 2.0 8.5 0.3 6.3
Flushing 2.6 3.0 2.0 5.1 0.0 1.2
Chest Pain 2.4 2.5 2.7 1.7 2.4 2.9
Nausea 1.8 1.0 2.7 5.1 1.7 3.1
Dyspnea 1.8 0.5 2.7 3.4 1.0 2.2
Abdominal Discomfort 1.7 0.0 3.3 1.7 1.7 3.9
Tachycardia 1.5 1.0 1.3 3.4 0.3 0.5
Rash 1.5 1.5 2.0 1.7 0.3 0.7
Pollakiuria 1.5 2.0 1.3 3.4 0.0 < 1.0
Weakness 1.2 0.0 0.7 0.0 0.0 1.2
Vomiting 1.1 1.0 1.3 0.0 0.3 0.2
Diarrhea 1.1 0.0 2.7 3.4 2.0 1.9
* Initial dose of 2.5 mg b.i.d. followed by maintenance dose of 5.0 mg b.i.d.
Initial dose of 2.5 mg b.i.d. followed by sequential titration to 5.0 mg b.i.d., 7.5 mg b.i.d., and maintenance dose of 10.0 mg b.i.d.
Propranolol, prazosin, hydrochlorothiazide, enalapril, captopril.

Except for headache, which is not clearly drug-related (see previous table), the more frequent adverse reactions listed show little change, or increase slightly, in frequency over time, as shown in the following table:

Incidence Rates for DynaCirc (isradipine) (All Doses) by Week (%)

Week 1 2 3 4 5 6
N 94 906 649 847 432 494
Adverse Reaction            
Headache 6.5 6.1 5.2 5.2 5.8 4.5
Dizziness 1.6 1.9 1.7 2.2 2.3 2.0
Edema 1.2 2.5 3.2 3.2 5.3 5.5
Palpitations 1.2 1.3 1.4 1.9 2.1 1.4
Fatigue 0.4 1.0 1.4 1.2 1.2 1.6
Flushing 1.2 1.3 2.0 1.4 2.1 1.4
Week 7 8 9 10 11 12
N 153 377 261 362 107 105
Adverse Reaction            
Headache 2.0 2.7 1.9 2.8 2.8 3.8
Dizziness 2.0 1.9 2.3 3.9 4.7 3.8
Edema 5.9 5.0 4.6 4.7 3.8 3.8
Palpitations 1.3 0.8 0.8 1.7 1.9 2.9
Fatigue 2.0 2.7 1.5 1.4 0.9 1.9
Flushing 3.3 1.3 1.1 0.8 0.0 0.0

Edema, palpitations, fatigue, and flushing appear to be dose-related, especially at the higher doses of 15-20 mg/day. In open-label, long-term studies of up to two years in duration, the adverse events reported were generally the same as those reported in the short-term controlled trials. The overall frequencies of these adverse events were slightly higher in the long-term than in the controlled studies, but as in the controlled trials most adverse reactions were mild and transient.

The following adverse experiences were reported in 0.5%-1.0% of the isradipine-treated patients in hypertension studies, or are rare. More serious events from this and other data sources, including postmarketing exposure, are shown in italics. The relationship of these adverse events to isradipine administration is uncertain.

Skin: pruritus, urticaria

Musculoskeletal: cramps of legs/feet

Respiratory: cough

Cardiovascular: shortness of breath, hypotension, atrial fibrillation, ventricular fibrillation, myocardial infarction, heart failure

Gastrointestinal: abdominal discomfort, constipation, diarrhea

Urogenital: nocturia

Nervous System: drowsiness, insomnia, lethargy, nervousness, impotence, decreased libido, depression, syncope, paresthesia (which includes numbness and tingling), transient ischemicattack, stroke

Autonomic: hyperhidrosis, visual disturbance, dry mouth, numbness

Miscellaneous: throat discomfort, leukopenia, elevated liver function tests

Read the Dynacirc (isradipine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Nitroglycerin: DynaCirc® (isradipine) has been safely coadministered with nitroglycerin.

Hydrochlorothiazide: A study in normal healthy volunteers has shown that concomitant administration of DynaCirc® (isradipine) and hydrochlorothiazide does not result in altered pharmacokinetics of either drug. In a study in hypertensive patients, addition of isradipine to existing hydrochlorothiazide therapy did not result in any unexpected adverse effects, and isradipine had an additional antihypertensive effect.

Propranolol: In a single dose study in normal volunteers, co-administration of propranolol had a small effect on the rate but no effect on the extent of isradipine bioavailability. Significant increases in AUC (27%) and Cmax (58%) and decreases in tmax (23%) of propranolol were noted in this study. However, concomitant administrationof 5 mg b.i.d. isradipine and 40 mg b.i.d. propranolol to healthy volunteers under steady-state conditions had no relevant effect on either drug's bioavailability. AUC and Cmax differences were < 20% between isradipine given singly and in combination with propranolol, and between propranolol given singly and in combination with isradipine.

Cimetidine: In a study in healthy volunteers, a one-week course of cimetidine at 400 mg b.i.d. with a single 5 mg dose of isradipine on the sixth day showed an increase in isradipine mean peak plasma concentrations (36%) and significant increase in area under the curve (50%). If isradipine therapy is initiated in a patient currently receiving cimetidine, careful monitoring for adverse reactions is advised and downward dose adjustment may be required.

Rifampicin: In a study in healthy volunteers, a six-day course of rifampicin at 600 mg/day followed by a single 5 mg dose of isradipine resulted in a reduction in isradipine levels to below detectable limits. If rifampicin therapy is required, isradipine concentrations and therapeutic effects are likely to be markedly reduced or abolished as a consequence of increased metabolism and higher clearance of isradipine.

Warfarin: In a study in healthy volunteers, no clinically relevant pharmacokinetic or pharmacodynamic interaction between isradipine and racemic warfarin was seen when two single oral doses of warfarin (0.7 mg/kg body weight) were administered during 11 days of multiple-dose treatment with 5 mg b.i.d. isradipine. Neither racemic warfarin nor isradipine binding to plasma proteins in vitro was altered by the addition of the other drug.

Digoxin: The concomitant administration of DynaCirc® (isradipine) and digoxin in a single–dose pharmacokinetic study did not affect renal, nonrenal and total body clearance of digoxin.

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 have not been seen in clinical studies with DynaCirc® (isradipine), an increased volume of circulating fluids might be required if such an interaction were to occur.

Last reviewed on RxList: 4/22/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

None

PRECAUTIONS

General

Blood pressure

Because DynaCirc® (isradipine) decreases peripheral resistance, like other calcium blockers DynaCirc® (isradipine) may occasionally produce symptomatic hypotension. However, symptoms like syncope and severe dizziness have rarely been reported in hypertensive patients administered DynaCirc® (isradipine), particularly at the initial recommended doses (see DOSAGE AND ADMINISTRATION).

Use in Patients with Congestive Heart Failure

Although acute hemodynamic studies in patients with congestive heart failure have shown that DynaCirc® (isradipine) reduced afterload without impairing myocardial contractility, it has a negative inotropic effect at high doses in vitro, and possibly in some patients. Caution should be exercised when using the drug in congestive heart failure patients, particularly in combination with a beta-blocker.

Carcinogenesis, mutagenesis, impairment of fertility

Treatment of male rats for 2 years with 2.5, 12.5, or 62.5 mg/kg/day isradipine admixed with the diet (approximately 6, 31, and 156 times the maximum recommended daily dose based on a 50 kg man) resulted in dose dependent increases in the incidence of benign Leydig cell tumors and testicular hyperplasia relative to untreated control animals. These findings, which were replicated in a subsequent experiment, may have been indirectly related to an effect of isradipine on circulating gonadotropin levels in the rats; a comparable endocrine effect was not evident in male patients receiving therapeutic doses of the drug on a chronic basis. Treatment of mice for two years with 2.5, 15, or 80 mg/kg/day isradipine in the diet (approximately 6, 38, and 200 times the maximum recommended daily dose based on a 50 kg man) showed no evidence of oncogenicity. There was no evidence of mutagenic potential based on the results of a battery of mutagenic tests. No effect on fertility was observed in male and female rats treated with up to 60 mg/kg/day isradipine.

Pregnancy

Pregnancy Category C

Isradipine was administered orally to rats and rabbits during organogenesis. Treatment of pregnant rats with doses of 6, 20, or 60 mg/kg/day produced a significant reduction in maternal weight gain during treatment with the highest dose (150 times the maximum recommended human daily dose) but with no lasting effects on the mother or the offspring. Treatment of pregnant rabbits with doses of 1,3, or 10 mg/kg/day (2.5, 7.5, and 25 times the maximum recommended human daily dose) produced decrements in maternal body weight gain and increased fetal resorption at the two higher doses. There was no evidence of embryotoxicity at doses which were not maternotoxic and no evidence of teratogenicity at any dose tested. In a peri/postnatal administration study in rats, reduced maternal body weight gain during late pregnancy at oral doses of 20 and 60 mg/kg/day isradipine was associated with reduced birth weights and decreased peri and postnatal pup survival.

There are no adequate and well controlled studies in pregnant women. The use of DynaCirc® (isradipine) during pregnancy should only be considered if the potential benefit outweighs potential risks.

Nursing mothers

It is not known whether DynaCirc® (isradipine) is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for adverse effects of DynaCirc® (isradipine) on nursing infants, a decision should be made as to whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use

Safety and effectiveness in pediatric patients have not been established.

Last reviewed on RxList: 4/22/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Drug Abuse And Dependence

Minimal empirical data are available on DynaCirc® (isradipine) overdosage. Three individual suicide attempts with dosages of isradipine reported to be from 20 mg up to 100 mg resulted in lethargy, sinus tachycardia and, in the case of the person ingesting 100 mg, transient hypotension which responded to fluid therapy. A foreign report of the ingestion of 200 mg of isradipine with ethanol resulted only in flushing, tachycardia with ST depression on ECG, and hypotension, all of which were reversible. The ingestion of 5 mg of isradipine by a 22-month old child and the accidental ingestion of 100 mg of isradipine by a 58-year old female did not result in any sequelae.

Available data suggest that, as with other dihydropyridines, overdosage with DynaCirc® (isradipine) might result in excessive peripheral vasodilatation with subsequent marked and probably prolonged systemic hypotension, and tachycardia. Emesis, gastric lavage, administration of activated charcoal followed in 30 minutes by a saline cathartic would be reasonable therapy. Isradipine is highly protein-bound and not removed by hemodialysis. Overdosage characterized by clinically significant hypotension should be treated with active cardiovascular support including monitoring of cardiac and respiratory function, elevation of lower extremities, and attention to circulating fluid volume and urine output. A vasoconstrictor (such as epinephrine, norepinephrine, or levarterenol) may be helpful in restoring a normotensive state, provided that there is no contraindication to its use.

Refractory hypotension or AV conduction disturbances may be treated with intravenous calcium salts, or glucagon. Cimetidine should be withheld in such instances due to the risk of further increasing plasma isradipine levels.

Significant lethality was observed in mice given oral doses of over 200 mg/kg and rabbits given about 50 mg/kg of isradipine. Rats tolerated doses of over 2000 mg/kg without effects on survival.

CONTRAINDICATIONS

DynaCirc® (isradipine) is contraindicated in individuals who have shown hypersensitivity to any of the ingredients in the formulation.

Last reviewed on RxList: 4/22/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Isradipine is a dihydropyridine calcium channel blocker. It binds to calcium channels with high affinity and specificity and inhibits calcium flux into cardiac and smooth muscle. The effects observed in mechanistic experiments in vitro and studied in intact animals and man are compatible with this mechanism of action and are typical of the class.

Except for diuretic activity, the mechanism of which is not clearly understood, the pharmacodynamic effects of isradipine observed in whole animals can also be explained by calcium channel blocking activity, especially dilating effects in arterioles which reduce systemic resistance and lower blood pressure, with a small increase in resting heart rate. Although like other dihydropyridine calcium channel blockers, isradipine has negative inotropic effects in vitro, studies conducted in intact anesthetized animals have shown that the vasodilating effect occurs at doses lower than those which affect contractility. In patients with normal ventricular function, isradipine's afterload reducing properties lead to some increase in cardiac output.

Effects in patients with impaired ventricular function have not been fully studied.

Clinical Effects

Dose-related reductions in supine and standing blood pressure are achieved within 2-3 hours following single oral doses of 2.5 mg, 5 mg, 10 mg, and 20 mg DynaCirc® (isradipine), with a duration of action (at least 50% of peak response) of more than 12 hours following administration of the highest dose.

DynaCirc® (isradipine) has been shown in controlled, double-blind clinical trials to be an effective antihypertensive agent when used as monotherapy, or when added to therapy with thiazide-type diuretics. During chronic administration, divided doses (b.i.d.) in the range of 5–20 mg daily have been shown to be effective, with response at trough (prior to next dose) over 50% of the peak blood pressure effect. The response is dose-related between 5-10 mg daily. DynaCirc® (isradipine) is equally effective in reducing supine, sitting, and standing blood pressure.

On chronic administration, increases in resting pulse rate averaged about 3-5 beats/min. These increases were not dose-related.

Hemodynamics

In man, peripheral vasodilation produced by DynaCirc® (isradipine) is reflected by decreased systemic vascular resistance and increased cardiac output. Hemodynamic studies conducted in patients with normal left ventricular function produced, following intravenous isradipine administration, increases in cardiac index, stroke volume index, coronary sinus blood flow, heart rate, and peak positive left ventricular dP/dt. Systemic, coronary, and pulmonary vascular resistance was decreased. These studies were conducted with doses of isradipine which produced clinically significant decreases in blood pressure. The clinical consequences of these hemodynamic effects, if any, have not been evaluated.

Effects on heart rate are variable, dependent upon rate of administration and presence of underlying cardiac condition. While increases in both peak positive dP/dt and LV ejection fraction are seen when intravenous isradipine is given, it is impossible to conclude that these represent a positive inotropic effect due to simultaneous changes in preload and afterload. In patients with coronary artery disease undergoing atrial pacing during cardiac catheterization, intravenous isradipine diminished abnormalities of systolic performance. In patients with moderate left ventricular dysfunction, oral and intravenous isradipine in doses which reduce blood pressure by 12%-30%, resulted in improvement in cardiac index without increase in heart rate, and with no change or reduction in pulmonary capillary wedge pressure. Combination of isradipine and propranolol did not significantly affect left ventricular dP/dt max. The clinical consequences of these effects have not been evaluated.

Electrophysiologic Effects

In general, no detrimental effects on the cardiac conduction system were seen with the use of DynaCirc® (isradipine).

Electrophysiologic studies were conducted on patients with normal sinus and atrioventricular node function. Intravenous isradipine in doses which reduce systolic blood pressure did not affect PR, QRS, AH* or HV* intervals.

No changes were seen in Wenckebach cycle length, atrial, and ventricular refractory periods. Slight prolongation of QTC interval of 3% was seen in one study. Effects on sinus node recovery time (CSNRT) were mild or not seen.

In patients with sick sinus syndrome, at doses which significantly reduced blood pressure, intravenous isradipine resulted in no depressant effect on sinus and atrioventricular node function.

Pharmacokinetics and Metabolism

Isradipine is 90%-95% absorbed and is subject to extensive first-pass metabolism, resulting in a bioavailability of about 15%-24%. Isradipine is detectable in plasma within 20 minutes after administration of single oral doses of 2.5-20 mg, and peak concentrations of approximately 1 ng/mL/mg dosed occur about 1.5 hours after drug administration. Administration of DynaCirc® (isradipine) with food significantly increases the time to peak by about an hour, but has no effect on the total bioavailability (area under the curve) of the drug. Isradipine is 95% bound to plasma proteins. Both peak plasma concentration and AUC exhibit a linear relationship to dose over the 0-20 mg dose range. The elimination of isradipine is biphasic with an early half-life of 1½-2 hours, and a terminal half-life of about 8 hours. The total body clearance of isradipine is 1.4 L/min and the apparent volume of distribution is 3 L/kg. Isradipine is completely metabolized prior to excretion, and no unchanged drug is detected in the urine. Six metabolites have been characterized in blood and urine, with the mono acids of the pyridine derivative and a cyclic lactone product accounting for > 75% of the material identified. Approximately 60%-65% of an administered dose is excreted in the urine and 25%–30% in the feces. Mild renal impairment (creatinine clearance 30-80 mL/min) increases the bioavailability (AUC) of isradipine by 45%. Progressive deterioration reverses this trend, and patients with severe renal failure (creatinine clearance < 10 mL/min) who have been on hemodialysis show a 20%-50% lower AUC than healthy volunteers. No pharmacokinetic information is available on drug therapy during hemodialysis. In elderly patients, Cmax and AUC are increased by 13% and 40%, respectively; in patients with hepatic impairment, Cmax and AUC are increased by 32% and 52%, respectively (see DOSAGE AND ADMINISTRATION).

REFERENCES

* AH = conduction time from low right atrium to His bundle deflection, or AV nodal conduction time;
* HV = conduction time through His bundle and the bundle branch-Purkinje system.

Last reviewed on RxList: 4/22/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 4/22/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 4/22/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Dynacirc Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ISRADIPINE - ORAL

(is-RAD-i-peen)

COMMON BRAND NAME(S): Dynacirc

USES: Isradipine is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Isradipine is called a calcium channel blocker. It works by relaxing blood vessels so blood can flow more easily.

HOW TO USE: Take this medication by mouth, usually twice daily with or without food or as directed by your doctor.

Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details.

The dosage is based on your medical condition and response to treatment. Your doctor may gradually increase your dose. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. It may take 2 to 4 weeks before you get the full benefit of this drug.

Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings remain high or increase).

Disclaimer

Dynacirc Consumer (continued)

SIDE EFFECTS: Dizziness, nausea, headache, tiredness, flushing, and swelling of the ankles/feet may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/irregular/pounding heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Dynacirc (isradipine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking isradipine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain structural heart problem (aortic stenosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are taking this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Dynacirc Consumer (continued)

DRUG INTERACTIONS: See also the How to Use section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Other medications can affect the removal of isradipine from your body, which may affect how isradipine works. Examples include cimetidine, azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Cimetidine is a nonprescription drug that is commonly used to treat extra stomach acid. Because cimetidine may interact with isradipine, ask your pharmacist about other products to treat stomach acid.

Check the labels on all your medicines (such as cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs for pain/fever reduction) because they may contain ingredients that could increase your blood pressure (such as pseudoephedrine, phenylephrine, ibuprofen, naproxen). Ask your pharmacist about using these products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Talk with your doctor about making changes to your lifestyle that may help this medication work better (such as stress reduction programs, exercise, and dietary changes).

Laboratory and/or medical tests (such as liver function tests, blood pressure, electrocardiograms) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

There are different types of this medication available. They may not have the same effects. Do not change types without consulting your doctor or pharmacist.

Have your blood pressure checked regularly while taking this medication. Discuss with your doctor how to monitor your own blood pressure.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Dynacirc Patient Information Including Side Effects

Brand Names: Dynacirc, Dynacirc CR

Generic Name: isradipine (Pronunciation: is RAD i peen)

What is isradipine (Dynacirc)?

Isradipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

Isradipine is used to treat high blood pressure (hypertension). It is sometimes given with other blood pressure medications.

Isradipine may also be used for purposes other than those listed in this medication guide.

Dynacirc 2.5 mg

white, imprinted with S 2.5, DynaCirc

Isradipine 2.5 mg-ABR

beige, imprinted with ABRIKA 108

Isradipine 2.5 mg-COB

pink, imprinted with LOGO, IS 2.5

Isradipine 5 mg-ABR

yellow, imprinted with ABRIKA 109

Isradipine 5 mg-COB

yellow, imprinted with LOGO, IS 5

What are the possible side effects of isradipine (Dynacirc)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling like you might pass out;
  • feeling short of breath, even with mild exertion;
  • swelling in your hands and feet;
  • fast or pounding heartbeats; or
  • chest pain.

Less serious side effects may include:

  • dizziness;
  • warmth, redness, or tingly feeling under your skin;
  • headache;
  • weakness, tired feeling;
  • nausea, vomiting, diarrhea, upset stomach; or
  • skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Dynacirc (isradipine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about isradipine (Dynacirc)?

You should not take this medication if you are allergic to isradipine.

Before taking isradipine, tell your doctor if you have kidney or liver disease, congestive heart failure, or a narrowing or blockage in your digestive tract.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

Isradipine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Some tablet forms of isradipine are made with a shell that is not absorbed or melted in the body. Therefore, you may see what looks like part of a tablet in your stool. This is a normal side effect of isradipine and will not make the medication less effective.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms, so you may not know when your blood pressure is high. You may need to use blood pressure medication for the rest of your life.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

Side Effects Centers

Dynacirc Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking isradipine (Dynacirc)?

You should not take this medication if you are allergic to isradipine.

Before taking isradipine, tell your doctor if you are allergic to any drugs, or if you have:

  • kidney disease;
  • liver disease;
  • congestive heart failure; or
  • a narrowing or blockage in your digestive tract.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take isradipine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Isradipine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take isradipine (Dynacirc)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

Some tablet forms of isradipine are made with a shell that is not absorbed or melted in the body. Therefore, you may see what looks like part of a tablet in your stool. This is a normal side effect of isradipine and will not make the medication less effective.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms, so you may not know when your blood pressure is high. You may need to use blood pressure medication for the rest of your life.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

Store isradipine at room temperature away from moisture, heat, and light.

Side Effects Centers

Dynacirc Patient Information including If I Miss a Dose

What happens if I miss a dose (Dynacirc)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Dynacirc)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include fast heart rate, sluggish feeling, or feeling like you might pass out.

What should I avoid while taking isradipine (Dynacirc)?

Isradipine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What other drugs will affect isradipine (Dynacirc)?

Before taking isradipine, tell your doctor if you are using any of the following drugs:

  • cimetidine (Tagamet, Tagamet HB);
  • fentanyl (Duragesic, Ionsys, Actiq); or
  • rifampin (Rifadin, Rimactane, Rifater).

This list is not complete and there may be other drugs that can interact with isradipine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about isradipine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.11. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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