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Gate Pharmaceuticals Drugs
The recommended adult dose is 50 mg as zinc three times daily (See CLINICAL TRIALS).
Since 25 mg t.i.d. is also an effective dose in children 10 years of age or older or in women who are pregnant, it may be advisable to use a dose of zinc to 25 mg three times a day, as long as the patient is compliant with therapy. The dose can be raised to 50 mg t.i.d. if monitoring indicates a lessening of control (see PRECAUTIONS: Monitoring Patients).
Patients should take zinc acetate on an empty stomach, at least one hour before or two to three hours after meals. For additional information, see PRECAUTIONS.
Once a complete hematologic remission is obtained, maintenance therapy is considered essential. Maintenance doses will vary from patient to patient. The usual daily maintenance dose of PURINETHOL is 1.5 to 2.5 mg/kg/day as a single dose. It is to be emphasized that in pediatric patients with acute lymphatic leukemia in remission, superior results have been obtained when PURINETHOL has been combined with other agents (most frequently with methotrexate) for remission maintenance. PURINETHOL should rarely be relied upon as a single agent for the maintenance of remissions induced in acute leukemia.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Dosage with Concomitant Allopurinol
When allopurinol and mercaptopurine are administered concomitantly, the dose of mercaptopurine must be reduced to one third to one quarter of the usual dose to avoid severe toxicity.
Dosage in TPMT-deficient Patients
Patients with inherited little or no thiopurine S-methyltransferase (TPMT) activity are at increased risk for severe PURINETHOL toxicity from conventional doses of mercaptopurine and generally require substantial dose reduction. The optimal starting dose for homozygous deficient patients has not been established. (See CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections.)
Most patients with heterozygous TPMT deficiency tolerated recommended PURINETHOL doses, but some require dose reduction. Genotypic and phenotypic testing of TPMT status are available. (See CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections.)
Dosage in Renal and Hepatic Impairment
It is probably advisable to start with lower dosages in patients with impaired renal function, due to slower elimination of the drug and metabolites and a greater cumulative effect. Consideration should be given to reducing the dosage in patients with impaired hepatic function.
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