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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (D's) » Doxorubicin



DESCRIPTION

WARNINGS

  • Experience with Doxil® (doxorubicin HCl liposome injection) at high cumulative doses is too limited to have established its effects on the myocardium. It should therefore be assumed that Doxil will have myocardial toxicity similar to conventional formulations of doxorubicin HCl. Irreversible myocardial toxicity leading to congestive heart failure often unresponsive to cardiac supportive therapy may be encountered as the total dosage of doxorubicin HCl approaches 550 mg/m 2 . Prior use of other anthracyclines or anthracenediones will reduce the total dose of doxorubicin HCl that can be given without cardiac toxicity. Cardiac toxicity also may occur at lower cumulative doses in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy. Doxil should be administered to patients with a history of cardiovascular disease only when the benefit outweighs the risk to the patient.
  • Acute infusion-associated reactions (flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension) have occurred in about 5% to 10% of patients treated with Doxil . In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction has resolved with slowing of the infusion rate. Doxil should be administered at an initial rate of 1 mg/min to minimize the risk of infusion reactions. (See WARNINGS - Infusion Reactions.)
  • Severe myelosuppression may occur. (See WARNINGS - Myelosuppression.)
  • Dosage should be reduced in patients with impaired hepatic function. (See DOSAGE AND ADMINISTRATION.)
  • Accidental substitution of Doxil for doxorubicin HCl has resulted in severe side effects. Doxil should not be substituted for doxorubicin HCL on a mg per mg basis. (See DESCRIPTION and DOSAGE AND ADMINISTRATION.)
  • Doxil should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.

    Doxil (doxorubicin HCl liposome injection) is doxorubicin hydrochloride (HCl) encapsulated in STEALTH® liposomes for intravenous administration.

    Note: Liposomal encapsulation can substantially affect a drugs functional properties relative to those of the unencapsulated drug. In addition, different liposomal drug products may vary from one another in the chemical composition and physical form of the liposomes. Such differences can substantially affect the functional properties of liposomal drug products. DO NOT SUBSTITUTE.

    Doxorubicin is a cytotoxic anthracycline antibiotic isolated from Streptomyces peucetius var. caesius.

    Doxorubicin HCl, which is the established name for 8S,10S)-10-[(3-amino-2,3,6-trideoxy-a-L-lyxo-hexopyranosyl)oxy] -8-glycolyl-7,8,9,10-tetrahydro-6,8,11- trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride.

    The molecular formula of the drug is C27H29NO11HCl; its molecular weight is 579.99.

    Doxil is provided as a sterile, translucent, red liposomal dispersion in 10-mL glass, single use vials. Each vial contains 20 mg doxorubicin HCl at a concentration of 2 mg/mL and a pH of 6.5. The STEALTH liposome carriers are composed of N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero- 3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and cholesterol, 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 2 mg; histidine as a buffer; hydrochloric acid and/or sodium hydroxide for pH control; and sucrose to maintain isotonicity. Greater than 90% of the drug is encapsulated in the STEALTH liposomes.





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