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Zinecard
Overview
What is Zinecard?
ZINECARD (dexrazoxane for injection), a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration.
Chemically, dexrazoxane is (S)-4,4'-(1-methyl-1,2-ethanediyl)bis-2,6-piperazinedione. The structural formula is as follows:
Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a whitish crystalline powder that melts at 191° to 197°C. It is sparingly soluble in water and 0.1 N HCl, slightly soluble in ethanol and methanol, and practically insoluble in nonpolar organic solvents. The pKa is 2.1. Dexrazoxane has an octanol/water partition coefficient of 0.025 and degrades rapidly above a pH of 7.0.
Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 25 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0.
Each 500 mg vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 50 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0.
The reconstituted ZINECARD solutions prepared from Sterile Water for Injection, USP, are intended for further dilution with Lactated Ringer's Injection, USP, for rapid intravenous drip infusion. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH .
What does Zinecard look like?
What are the available doses of Zinecard?
250 mg or 500 mg single dose vials as sterile, pyrogen-free lyophilizates. ()
What should I talk to my health care provider before I take Zinecard?
How should I use Zinecard?
ZINECARD is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy .
Administer ZINECARD Injection via intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH.
The recommended dosage ratio of ZINECARD to doxorubicin is 10:1 (e.g., 500 mg/m ZINECARD to 50 mg/m doxorubicin). Do not administer doxorubicin before ZINECARD. Administer doxorubicin within 30 minutes after the completion of ZINECARD infusion.
What interacts with Zinecard?
Sorry No Records found
What are the warnings of Zinecard?
Sorry No Records found
What are the precautions of Zinecard?
Sorry No Records found
What are the side effects of Zinecard?
Sorry No records found
What should I look out for while using Zinecard?
Do not use ZINECARD with non-anthracycline chemotherapy regimens.
What might happen if I take too much Zinecard?
There are no data on overdosage in the cardioprotective trials; the maximum dose administered during the cardioprotective trials was 1000 mg/m every three weeks.
Disposition studies with ZINECARD have not been conducted in cancer patients undergoing dialysis, but retention of a significant dose fraction (>0.4) of the unchanged drug in the plasma pool, minimal tissue partitioning or binding, and availability of greater than 90% of the systemic drug levels in the unbound form suggest that it could be removed using conventional peritoneal or hemodialysis.
There is no known antidote for dexrazoxane. Instances of suspected overdose should be managed with good supportive care until resolution of myelosuppression and related conditions is complete. Management of overdose should include treatment of infections, fluid regulation, and maintenance of nutritional requirements.
How should I store and handle Zinecard?
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].ZINECARD (dexrazoxane for injection) is available in the following strengths as sterile, pyrogen-free lyophilizates.NDC 0013-8717-62250 mg single dose vial with a red flip-top seal, packaged in single vial packs.NDC 0013-8727-89500 mg single dose vial with a blue flip-top seal, packaged in single vial packs.ZINECARD (dexrazoxane for injection) is available in the following strengths as sterile, pyrogen-free lyophilizates.NDC 0013-8717-62250 mg single dose vial with a red flip-top seal, packaged in single vial packs.NDC 0013-8727-89500 mg single dose vial with a blue flip-top seal, packaged in single vial packs.ZINECARD (dexrazoxane for injection) is available in the following strengths as sterile, pyrogen-free lyophilizates.NDC 0013-8717-62250 mg single dose vial with a red flip-top seal, packaged in single vial packs.NDC 0013-8727-89500 mg single dose vial with a blue flip-top seal, packaged in single vial packs.ZINECARD (dexrazoxane for injection) is available in the following strengths as sterile, pyrogen-free lyophilizates.NDC 0013-8717-62250 mg single dose vial with a red flip-top seal, packaged in single vial packs.NDC 0013-8727-89500 mg single dose vial with a blue flip-top seal, packaged in single vial packs.ZINECARD (dexrazoxane for injection) is available in the following strengths as sterile, pyrogen-free lyophilizates.NDC 0013-8717-62250 mg single dose vial with a red flip-top seal, packaged in single vial packs.NDC 0013-8727-89500 mg single dose vial with a blue flip-top seal, packaged in single vial packs.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism by which ZINECARD exerts its cytoprotective activity is not fully understood. Dexrazoxane is a cyclic derivative of EDTA that penetrates cell membranes. Results of laboratory studies suggest that dexrazoxane is converted intracellularly to a ring-opened chelating agent that interferes with iron-mediated free radical generation thought to be responsible, in part, for anthracycline-induced cardiomyopathy.
Non-Clinical Toxicology
Do not use ZINECARD with non-anthracycline chemotherapy regimens.Cyclopropane or halogenated hydrocarbon anesthetics increase cardiac autonomic irritability and may sensitize the myocardium to the action of certain intravenously administered catecholamines, such as dopamine. This interaction appears to be related both to pressor activity and to the beta adrenergic stimulating properties of these catecholamines, and may produce ventricular arrhythmias. Therefore, EXTREME CAUTION should be exercised when administering dopamine HCI to patients receiving cyclopropane or halogenated hydrocarbon anesthetics. Results of studies in animals indicate that dopamine-induced ventricular arrhythmias during anesthesia can be reversed by propranolol.
Because dopamine is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine. Patients who ave been treated with MAO inhibitors within two to three weeks prior to the administration of dopamine should receive an initial dose of Dopamine HCl no greater than one-tenth (1/10) of the usual dose.
Concurrent administration of low-dose dopamine HCI and diuretic agents may produce an additive or potentiating effect on urine flow.
Tricyclic antidepressants may potentiate the cardiovascular effects of adrenergic agents.
Cardiac effects of dopamine are antagonized by beta-adrenergic blocking agents, such as propranolol and metoprolol. The peripheral vasoconstriction caused by high doses of dopamine HCI is antagonized by alpha-adrenergic blocking agents. Dopamine-induced renal and mesenteric vasodilation is not antagonized by either alpha- or beta-adrenergic blocking agents.
Butyrophenones (such as haloperidol) and phenothiazines can suppress the dopaminergic renal and mesenteric vasodilation induced with low-dose dopamine infusion.
The concomitant use of vasopressors, vasoconstrictor agents (such as ergonovine) and some oxytocic drug may result in severe hypertension.
Administration of phenytoin to patients receiving dopamine HCI has been reported to lead to hypotension and bradycardia. It is suggested that in patients receiving dopamine HCI, alternatives to phenytoin should be considered if anticonvulsant therapy is needed.
ZINECARD may add to the myelosuppression caused by chemotherapeutic agents. Obtain a complete blood count prior to and during each course of therapy, and administer ZINECARD and chemotherapy only when adequate hematologic parameters are met.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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