EMILOX (Doxorubicin hydrochloride)

EMILOX (Doxorubicin hydrochloride)

EMILOX (Doxorubicin hydrochloride)

EMILOX (Doxorubicin hydrochloride)

EMILOX (Doxorubicin hydrochloride)

EMILOX

EMILOX

Description

Emilox (doxorubicin) belongs to the group of anthracyclines - a class of drugs used in cancer chemotherapy derived from Streptomyces bacterium Streptomyces peucetius var. caesius.  
Experimental  evidence  indicates  that  doxorubicin  forms  a  complex  with  the  DNA  by intercalation of its planar rings between nucleotide base pairs. The consequences of this intercalation are serious disturbances of DNA synthesis, DNA-dependent RNA synthesis and protein synthesis. More recent experimental   evidence   seems   to   indicate   that   DNA   intercalation   triggers   DNA   cleavage   by topoisomerase-II, yielding serious disturbances in the tertiary structure of DNA. Doxorubicin is also known to be involved in oxidation/reduction reactions: a number of NADPH-dependent cellular reductases are able to reduce doxorubicin to semiquinone free radicals, which can in turn react with molecular oxygen to generate highly reactive cytotoxic compounds such as superoxide, hydroxyl radicals and hydrogen peroxide. Free radical formation has been implicated in doxorubicin cardiotoxicity. A further site of action for doxorubicin may be at the cell membrane level: the drug can bind to cell membrane lipids and affect a variety of functions. Cytotoxicity and/or antiproliferative activity of doxorubicin may result as a consequence of any mentioned mechanisms and there may be others. 
Cell kinetic studies have shown that doxorubicin is active throughout the cell cycle, including the interphase. Rapidly proliferating tissues such as tumour tissues (but also bone marrow, gastrointestinal and oral mucosa, hair follicles) are therefore the most sensitive to the antiproliferative effects of doxorubicin.

Indications

Emilox (doxorubicin)  has  produced  significant  therapeutic  responses  in  a  number  of  solid  tumours  and haematologic malignancies, and is commonly used in the treatment of the following tumours: carcinoma of the breast, carcinoma of the lung, carcinoma of the ovary, transitional cell bladder cancer, neuroblastoma, Wilm's tumour, soft tissue sarcomas, osteosarcoma, acute lymphocytic - lymphoblastic leukaemia, acute myelogenous leukaemia, non-Hodgkin's lymphoma, Hodgkin's disease, carcinoma of the thyroid, carcinoma of the endometrium, carcinoma of the head and neck, carcinoma of the stomach, primary hepatocellular carcinoma, non-seminomatous carcinoma of the testis, carcinoma of the prostate, Ewing's sarcoma, rhabdomyosarcoma sarcoma, multiple myeloma, chronic leukaemias. 

Contraindications 

Situations in which patients should not be treated with IV intravenous Emilox are:
- Persisting myelosuppression or severe stomatitis from previous cytotoxic treatments.
- Presence of generalized infections.
- Marked liver function impairment.
- Severe arrhythmias, myocardial insufficiency, previous myocardial infarction.
- Previous treatment with anthracyclines up to their maximum cumulative dose.
- Hypersensitivity to doxorubicin or to other anthracyclines; or anthracenediones.
Contraindications for intravesical use are:
- Invasive tumours that have penetrated the bladder wall.
- Urinary infections.
- Inflammation of the bladder.
- Catheterization problems (e.g. due to massive intravesical tumours).
- Haematuria

STORAGE, SHELF-LIFE AND PACKING UNITS

STORAGE: at 2 to 8°C (Refrigerate.  Do not freeze).  Protect from light and use within 24 hours, in line with good pharmaceutical practice. 
SHELF LIFE:  24 months from manufacturing date.
PACKAGE:  
          Strength                                                          Pack size
10 milligrams/5 mL   vial                                              1
50 milligrams/25 mL   vial                                            1

 

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