The package insert of the medicine Citarabina

the package insert of the medicine Citarabina.

what For?

Citarabina has its primary indication in the remission of leukemias granulocíticas acute adult, being indicated secondarily in other forms of acute leukemia in adults and children. The responses in other forms of acute leukemia were somewhat comparable to those obtained in the leukemia granulocítica.

Contraindications

When should I not use?

Therapy with citarabina should not be initiated in patients with bone marrow suppression, preexisting, iatrogenically induced, unless the clinician deems to be an alternative treatment to be more promising for the patient.

Dosage

How to use?

Principles: citarabina is not active by the oral route. The majority of researchers administered the drug for infusion or injection intravenous. Subcutaneous administration is satisfactory for the maintenance of remissions; the value of induction therapy in this way is uncertain. In some patients occurred thrombophlebitis at the site of injection or infusion; rarely was noticed the appearance of pain and inflammation at the site of subcutaneous injection. In most cases, the drug has been well tolerated. Patients may tolerate doses higher totals, when they receive the drug by injection in intravenous rapid than when the are given by slow infusion. – dosing regimen: rapid injection: continuous treatment: 2 mg/ kg/day is a starting dose judicious. Administer daily for 10 days. Perform counts hematologic daily. If they are not observed or the effect antileucêmico or toxicity after 10 days, increase the dose to 4 mg/kg/day. Keep the treatment with this dosage until toxicity or therapeutic response are evident. With the continuous treatment, almost all patients can be carried to toxicity with these doses. Infusion: continuous treatment: start with 0.5 to 1.0 mg/kg/day. This dose may be given in infusion, in the duration that you want: 1, 4, 12, or 24 hours. Results with infusions of 1 hour duration were satisfactory and more convenient for most patients. As above, continue the initial dose for 10 days, performing daily counting haematological. If, with this dose, are not observed responses nor therapeutic, not toxic, increase dose to 2 mg/kg/day, continuing the treatment until it shows signs of toxicity or remission.

Side Effects

What are the evils that can cause me?

complete Studies of appropriate duration have revealed the following side effects: in adults leucêmicos: leukopenia, thrombocytopenia, bone marrow suppression, nausea, megaloblastose, vomiting, anemia, diarrhea, inflammation or ulceration of the oral, thrombophlebitis, liver dysfunction and fever. Often much smaller, were observed: renal dysfunction, abdominal pain, anorexia, bleeding, gastrointestinal, sepsis, cellulitis at the injection site, pneumonia, neuritis, or neurotoxicity, rashes, appearance of freckles, esophagitis, bleeding skin and mucous membranes, thoracic pain, joint pain, sore throat, and reduction of reticulócitos. In children: leucopenia (higher incidence), thrombocytopenia, vomiting, nausea, bone marrow suppression, inflammation or ulceration of the oral, anemia, megaloblastose, bleeding (all sites), diarrhea, liver dysfunction, rashes and anorexia. Were still registered, and with less frequency: sepsis, esophagitis or ulceration, esophageal, ulceration of the skin, ulceration of the mucosa, pain at the injection site, thrombophlebitis, urinary retention, fever, jaundice, dizziness, sore throat, purple, reduction of reticulócitos and alopecia. Several principles emerged from these observations. Citarabina is mainly toxic to the bone marrow, producing leukopenia peripheral thrombocytopenia, anemia, and megaloblastose. In addition to producing substantial suppression of the bone marrow, the citarabina also influences deeply the qualitative aspects of the framework of suppression of the spinal bone. Descriptions of the qualitative alterations of the bone marrow induced by citarabina have been published. There is nausea and vomiting, especially after injection in intravenous fast. Liver dysfunction (as indicated by the values of abnormal liver function).

Warnings and Precautions

what should I know before using?

Patients who receive citarabina should be monitored carefully. Count frequent platelets and leukocytes is essential. Must suspend or modify the treatment if depression of the bone marrow, iatrogenically induced, result in values for platelet less than 50,000 or if the count of granulocytes, polymorphonuclear cells for values that are less than 1,000 per mmup4 3. The elements of the blood cells can continue to decrease after the suspension of the drug, and reach lowest values after periods of 5 to 7 days of stopping treatment. If indicated, restart therapy when they appear definitive signs of recovery in spinal cord (highlighted by successive validations of the bone marrow). When the drug is administered rapidly at high doses, via intravenous, patients often have nausea and vomit for several hours after the injection. This problem may be less severe if the drug is administered by infusion. The liver human apparently detoxifies a substantial part of the administered dose, reason for which the drug should be used with caution and in reduced doses in patients with liver function impaired. Periodic assessments of the medullar, liver and kidney should be made in patients under treatment with citarabina. The safety of this drug for use in infants has not yet been established. Like other cytotoxic drugs, the citarabina may induce hyperuricemia after lysis, rapid cell neoplasm. The clinician should observe the levels of uric acid in the blood of the patient and be alert to the use of supportive measures, or pharmacological necessary to work around the problem. – Warnings: citarabina is a potent suppressor of bone marrow. Patients who received this drug should be under strict medical supervision and, during induction therapy, the white blood cell count and platelets should be done on a daily basis. Should be at the disposal of the patient the resources for the treatment of any complications arising from bone marrow suppression (infection resulting from granulocytopenia and other organic immunity impaired, as well as bleeding due to thrombocytopenia). The citarabina is known to teratogênica for some species. Thus, their use in women with pregnancy, proven or probable, should be done only after the proper assessment of the benefits and potential risks for the mother and the child.