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Updated On: 22-04-2025

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Mitoxantrone - @ - Antibiotic- (March 1989)

Drug Name:
Mitoxantrone - @ - Antibiotic- (March 1989)

List Of Brands:

ONCOTRON INJ

Indication Type Description:

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation

Drug Interaction:

Not known

Indication:

Carcinoma of breast

Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

Mitoxantrone Hcl Anti-cancer March 1989

Adverse Reaction:

Chest pain, asymptomatic decreases in LVEF; tachycardia;

ECG changes, myleosuppression, hypotension, urticaria, dyspena, rashes.

Contra-Indications:

Hypersensity to the drug Abnormal cardiac function from prior antthracytic exposure

Severe myelosuppression

Lactation

Special precautions:

Monitoring of hematological and chemical laboratory parameters.

Hyperuricemia may occur. Monitor serum uric acid levels. Hepatotoxicity, elevation of AST and ALT. Pre-exising cardiac disease

Monitor blood counts and cardiac function

Concurrent cytotoxic therapy Pregnancy

Dosages/ Overdosage Etc:

Indication-

Carcinoma of breast

Dosage-

Initially 14mg/m2 as single iv dose Repeat at 21 day interval

Patient Information:

Ref - USP PDI Vol II 17th Edition (1997)

1.Allergies-

Tell your doctor if you have ever had any unusual or allergic reaction to

mitoaxtrone.

2.Pregnancy-

Tell your doctor if you are pregnant or intent to have children. There is a chance

that this medicine may cause birth defects if either the male or female is taking it

at the time of conception or it is taken during pregnancy.

Mitoraxantrone has been reported to cause low birth weight and slow growth of the

kidney in rats and premature birth defects in rabbits. Although sterility has not been

reported with this medicine, this possibility should be kept in mind

3. Breast-feeding-

Breast feeding is not generally recommended while while you are receiving it.

4.Children-

There is no specific information comparing use of mitoxantrone in children

with use in other age groups.

5.Older adults-

There is no specific information comparing use of mitoxantrone in the elderly with use

in other age groups

6. Other medicines-

Tell your doctor if you are using any of the following -

Amphotericin B

Antityroid agents or

Azathioprine or

Chloramphenicol or

Colchicine or

Ganciclovir or

Pilamycin or

Zidovudine or

If you have treated with radiation or cancer medicines - Mitoxantrone

may increase effects of these medicines or radiation on the blood

Probenecid or

Sulfinpyrazone - mitoxantrone may increase the concentration of uric

acid in the blood. Since these medicines are used to lower uric acid

levels, they may not work as well in patients receiving mitoxantrone

7. Other medical problems-

Make sure you tell your doctor if you have any other medical problems

especially-

Chicken pox or

Herpes zosyter - risk of severe disease affecting other parts of the body

Gout or

Kidney stones -mitoxantrone may increase levels of uric acid in the body,

which can cause gout or kidney stones

Heart disease -risk of heart problems caused by mitoxantrone may be increased

Infection- mitoxantrone may decrease your body ability to fight infection

Liver disease- effects of mitoxantrone may be increased because of slower

removal from the body

Pharmacology/ Pharmacokinetics:

Pharmacology:

Mitoxanthrone is a synthetic anthracenedione for IV use. Although the mechanism of action is not clearly understood, mitoxanthrone is a DNA reactive reagent. It has cytocidal effect on poliferating and non-proliferating cultured human cells., suggesting lack of cell cylcle phase specificity.

Pharmacokinetics:

Elimination is slow with an apparent mean terminal plasma half-life of 5.8 days. Excretion is via the renal and hepatobiliary systems.

Pregnancy and lactation:

Pregnancy:

May cause fetal harm when administerd to pregnant women. Use with caution. Advise women of child bearing potential to avoid pregnancy, while on treatment

Lactation:

Not known whether this drug is excreted in breast milk. Because of the potential for serious adverse reactions, discontinue breast feeding before starting treatment.

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Disclaimer: Every effort has been made to ensure that the information provided in this Database is authentic and accurate. Commissions or omissions in the database, if any, are purely inadvertent and the site owner shall not accept any liability whatsoever for any adverse consequences of any nature arising to any individual or third party, as a result of usage of this information.