Alexan Cytosar Cytarabine 50 mg/mL Injection 1000mg
Alexan in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children.
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Buy online Alexan aka Cytarabine or Cytosar 50 mg/mL 1000mg for Injection, for Intravenous, Intrathecal, or Subcutaneous Use Only.
Cytarabine for Injection, commonly known as ara-C, an antineoplastic for intravenous, intrathecal, or subcutaneous administration, contains sterile lyophilized cytarabine (1-β-D-Arabinofuranosylcytosine). Cytarabine is an odorless, white to off-white, crystalline powder which is freely soluble in water and slightly soluble in alcohol and in chloroform. Cytarabine for Injection is available in vials containing 100 mg, 500 mg, 1 g, and 2 g cytarabine. When necessary, the pH of Cytarabine for Injection USP was adjusted with hydrochloric acid and/or sodium hydroxide. Reconstitute with Bacteriostatic Water for Injection USP with benzyl alchohol for intravenous and subcutaneous use only.
Do not use this diluent intrathecally!
Alexan in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. 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 is indicated in the prophylaxis and treatment of meningeal leukemia.
Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, Vincristine, and prednisone with or without cytarabine or procarbazine. Steady-state plasma digitoxin concentrations did not appear to change. Therefore, monitoring of plasma digoxin levels may be indicated in patients receiving similar combination chemotherapy regimens. The utilization of digitoxin for such patients may be considered as an alternative.
An in vitro interaction study between gentamicin and cytarabine showed a cytarabine- related antagonism for the susceptibility of K. pneumoniae strains. This study suggests that in patients on cytarabine being treated with gentamicin for a K. pneumoniae infection, the lack of a prompt therapeutic response may indicate the need for re-evaluation of antibacterial therapy.
Clinical evidence in one patient showed possible inhibition of fluorocytosine efficacy during therapy with cytarabine. This may be due to potential competitive inhibition of its uptake.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]
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Cytarabine is not active orally. The schedule and method of administration varies with the program of therapy to be used. Cytarabine may be given by intravenous infusion or injection, subcutaneously, or intrathecally. 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. This phenomenon is related to the drug’s rapid inactivation and brief exposure of susceptible normal and neoplastic cells to significant levels after rapid injection. Normal and neoplastic cells seem to respond in somewhat parallel fashion to these different modes of administration and no clear-cut clinical advantage has been demonstrated for either.
In the induction therapy of acute non-lymphocytic leukemia, the usual cytarabine dose in combination with other anticancer drugs is 100 mg/m2/day by continuous IV infusion (days 1 to 7) or 100 mg/m2 IV every 12 hours (days 1 to 7).
The literature should be consulted for the current recommendations for use in acute lymphocytic leukemia.
Intrathecal Use In Meningeal Leukemia: Cytarabine has been used intrathecally in acute leukemia in doses ranging from 5 to 75 mg/m2 of body surface area. The frequency of administration varied from once a day for 4 days to once every 4 days. The most frequently used dose was 30 mg/m2 every 4 days until cerebrospinal fluid findings were normal, followed by one additional treatment. The dosage schedule is usually governed by the type and severity of central nervous system manifestations and the response to previous therapy.
If used intrathecally, do not use a diluent containing benzyl alcohol. Many clinicians reconstitute with autologous spinal fluid or preservative-free 0.9% Sodium Chloride Injection USP and use immediately.
Cytarabine given intrathecally may cause systemic toxicity and careful monitoring of the hemopoietic system is indicated. Modification of other anti leukemia therapy may be necessary. Major toxicity is rare. The most frequently reported reactions after intrathecal administration were nausea, vomiting, and fever; these reactions are mild and self-limiting. Paraplegia has been reported. Necrotizing leukoencephalopathy occurred in five children; these patients had also been treated with intrathecal methotrexate and hydrocortisone, as well as by central nervous system radiation. Isolated neurotoxicity has been reported. Blindness occurred in two patients in remission whose treatment had consisted of combination systemic chemotherapy, prophylactic central nervous system radiation and intrathecal cytarabine.
When cytarabine is administered both intrathecally and intravenously within a few days, there is an increased risk of spinal cord toxicity, however, in serious life-threatening disease, concurrent use of intravenous and intrathecal cytarabine is left to the discretion of the treating physician.
Focal leukemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.
The 100 mg vial may be reconstituted for intravenous and subcutaneous use with 5 mL Bacteriostatic Water for Injection USP with benzyl alcohol. The resulting solution contains 20 mg of cytarabine per mL. (Do not use Bacteriostatic Water for Injection USP with benzyl alcohol as a diluent for intrathecal use.
The 500 mg vial may be reconstituted for intravenous and subcutaneous use with 10 mL Bacteriostatic Water for Injection USP with benzyl alcohol. The resulting solution contains 50 mg of cytarabine per mL. (Do not use Bacteriostatic Water for Injection USP with benzyl alcohol as a diluent for intrathecal use.
The 1 g vial may be reconstituted for intravenous and subcutaneous use with 10 mL Bacteriostatic Water for Injection USP with benzyl alcohol. The resulting solution contains 100 mg of cytarabine per mL. (Do not use Bacteriostatic Water for Injection USP with benzyl alcohol as a diluent for intrathecal use.
The 2 g vial may be reconstituted for intravenous and subcutaneous use with 20 mL Bacteriostatic Water for Injection USP with benzyl alcohol. The resulting solution contains 100 mg of cytarabine per mL. (Do not use Bacteriostatic Water for Injection USP with benzyl alcohol as a diluent for intrathecal use.
If used intrathecally many clinicians reconstitute with preservative-free 0.9% Sodium Chloride Injection USP and use immediately.
The pH of the reconstituted solutions is about 5. Solutions reconstituted with Bacteriostatic Water for Injection USP with benzyl alcohol may be stored at controlled room temperature, 15° to 30°C (59° to 86°F), for 48 hours. Discard any solutions in which a slight haze develops.
Solutions reconstituted without a preservative should be used immediately.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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