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PRODUCT DETAILS

Brand name : Daunotec
Strength : 20mg
Active substance : Daunorubicin
Manufactured by : Cipla Ltd
Pack : 1ml injection in a vial

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Daunotec belongs to the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus.
It is containing as a sterile reddish lyophilized powder in vials for intravenous administration only
Daunotec is a prescription drug provided under the guidance of medical oncologist

INDICATION

Daunotec is indicated for the treatment in patients with Myelogenous leukemia
Daunotec is indicated for the treatment in patients with Lymphoblastic Leukemia
Daunotec is indicated for the treatment in patients with Promyelocytic leukemia

DOSAGE

The Acute Nonlymphocytic Leukemia recommended dose in combination with cytarabine 100mg/m2/day IV for 7 days first course, for 5 days consequent course.
Then, if patient is <60 years old: 45mg/m2 IVP days1,2,3 first course; days 1,2 consequent course.
if patient is >60 years old: 30mg/m2 IVP days1,2,3 first course; days 1,2 consequent course.
Monitor the patients cardiac, renal, hepatic function
The Acute Lymphocytic Leukemia recommended dose is 45mg/m2 IVP days 1,2,3
Monitor the patients cardiac, renal, hepatic function

MECHANISM

Daunorubicin consist of antimitotic and cytotoxic activity through several proposed mechanisms of action: Daunorubicin forms complexes with DNA by intercalation between base pairs, and it inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, preventing the relegation portion of the ligation-relegation reaction that topoisomerase II catalyses.

ADME

The drug Daunotec has protein bound about 50-60% and volume of distribution is 20-39.2L/kg
Daunotec is metabolized in hepatic and the metabolites is Daunorubicinol
The drug excreted via feces 40% and urine 25%
Half-life is 14-20 hr for parent drug, 24-48 for Daunorubicinol

DRUG INTERACTION

When combination with eliglustat will leads increase levels of Daunotec by P- glycoprotein efflux transporter. Avoid the drug
When Daunotec combination with tofacitinib will either raises toxicity of the other by immunosuppressive effects.
The effects of adenovirus types 4 and 7 live reduces by using Daunotec and pharmacodynamic antagonism. Avoid usage of drug

CONTRAINDICATION

Hypersensitivity

MISSED DOSE

If the patients forgot to take a dose, then have the dose as soon as you remember before next dose timing or else skip the missed dose and follow normal schedule.
Consult the doctor

PRECAUTION

• When using the drug Daunotec the risk of serious cardiotoxicity (involving CHF) & myelosuppression
• The Daunotec should use with Caution in hepatic/renal impairment patients
• The drug causes cardiotoxic effects in children may be more sensitive than adults
• Avoid pregnancy
• Secondary leukaemia’s resulted when used in concomitant use with radiation or chemotherapy

STORAGE

• Store the unopened vials at 2℃ to 8℃.
• Store the prepared solution at 20℃ to 25℃.
• Retain in carton until time of use
• Protect the drug from light and moisture

SIDE EFFECTS

Common side effects of Daunotec:
Pain in medication was given site
Urine may appear red-brown or orange
Reduced blood counts
Nausea or vomiting
Mouth sores
Loss of hair on the scalp.
Less common side effect of Daunotec:
Diarrhea
Problems with fertility
Radiation recall
Discoloration of nails beds

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