Finished product reference
Cytarabine
Injection, Solution · Parenteral · 20 mg/1mL · 5 mL
- List code
- 375
- Pharmacologic class
- Nucleoside Metabolic Inhibitor
WARNING Only physicians experienced in cancer chemotherapy should use cytarabine injection. For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity.
What it is and how it works
Mechanism class: Nucleic Acid Synthesis Inhibitors
Indications
INDICATIONS AND USAGE Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION Cytarabine injection is not active orally. The schedule and method of administration varies with the program of therapy to be used. Cytarabine injection may be given by intravenous infusion or injection, subcutaneously, or intrathecally (preservative free preparation only). Thrombophlebitis has occurred at the site of drug injection or infusion in some patients, and rarely patients have noted pain and inflammation at subcutaneous injection sites. In most instances, however, the drug has been well tolerated. Patients can tolerate higher total doses when they receive the drug by rapid intravenous injection as compared with slow infusion.
Contraindications
CONTRAINDICATIONS Cytarabine is contraindicated in those patients who are hypersensitive to the drug.
Warnings and precautions
WARNINGS (See boxed WARNING ) Cytarabine is a potent bone marrow suppressant. Therapy should be started cautiously in patients with pre-existing drug-induced bone marrow suppression. Patients receiving this drug must be under close medical supervision and, during induction therapy, should have leucocyte and platelet counts performed daily. Bone marrow examinations should be performed frequently after blasts have disappeared from the peripheral blood.
Pregnancy
6. Pregnancy See WARNINGS .
Storage and supply
Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). Protect from light. Retain in carton until time of use. Discard unused portion. Isotonic Solution Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
Source: Cytarabine (Cytarabine) — US FDA prescribing information, 2022-01-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
- Injection, Powder, for Solution · Parenteral · 1 g1454
- Injection, Powder, for Solution · Parenteral · 100 mg52393
- Injection, Solution · Parenteral · 100 mg/1mL · 1 mL52791
- Injection, Solution · Parenteral · 100 mg/1mL · 10 mL52394
- Injection, Solution · Parenteral · 20 mg/1mL · 25 mL53362
- Injection, Solution · Parenteral · 20 mg/1mL · 50 mL52404
- Injection, Solution · Parenteral · 50 mg/1mL · 20 mL50464
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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