Purixan
Generic Name: purixan
Brand Names:
Purixan
11 DESCRIPTION Mercaptopurine, a nucleoside metabolic inhibitor. The chemical name is 1,7-dihydro-6H-purine-6-thione monohydrate. The molecular formula is C 5 H 4 N 4 S•H 2 O and the molecular weight is 170.20. The structural formula is: Mercaptopurine is a yellow, odorless or practically odorless, crystalline powder. It is practically insoluble in water with pKa 7.8, 11.2. PURIXAN (mercaptopurine) oral suspension contains 2,000 mg/100 mL (20 mg/mL) of mercaptopurine.
Overview
11 DESCRIPTION Mercaptopurine, a nucleoside metabolic inhibitor. The chemical name is 1,7-dihydro-6H-purine-6-thione monohydrate. The molecular formula is C 5 H 4 N 4 S•H 2 O and the molecular weight is 170.20. The structural formula is: Mercaptopurine is a yellow, odorless or practically odorless, crystalline powder. It is practically insoluble in water with pKa 7.8, 11.2. PURIXAN (mercaptopurine) oral suspension contains 2,000 mg/100 mL (20 mg/mL) of mercaptopurine.
Uses
1 INDICATIONS AND USAGE PURIXAN is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.( 1.1 ) 1.1 Acute Lymphoblastic Leukemia PURIXAN is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
Dosage
2 DOSAGE AND ADMINISTRATION The recommended starting dosage of PURIXAN is 1.5 mg/kg to 2.5 mg/kg (50 mg/m 2 to 75 mg/m 2 ) orally once daily as part of a combination chemotherapy maintenance regimen. Adjust dose to maintain desirable absolute neutrophil count and for excessive myelosuppression.( 2.1 ) Renal Impairment : Use the lowest recommended starting dose or increase the dosing interval. ( 2.3, 8.6 ) Hepatic Impairment : Use the lowest recommended starting dose. ( 2.3, 8.7 ) 2.1 Recommended Dosage The recommended starting dose of PURIXAN is 1.5 mg/kg to 2.5 mg/kg (50 mg/m 2 to 75 mg/m 2 ) orally once daily as part of combination chemotherapy maintenance regimen. Take PURIXAN either consistently with or without food.
Side Effects
6 ADVERSE REACTIONS The most common adverse reaction (> 20%) is myelosuppression including anemia, neutropenia, lymphopenia and thrombocytopenia. Adverse reactions occurring in 5% to 20% of patients include anorexia, nausea, vomiting, diarrhea, malaise and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc., at 1-844-472-7389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Allopurinol : Reduce the dose of PURIXAN when co-administered with allopurinol. ( 2.4 , 7.1 ) Warfarin : PURIXAN may decrease the anticoagulant effect. ( 7.2 ) See FDA approved patient labeling and
Warnings
5 WARNINGS AND PRECAUTIONS Myelosuppression : Monitor complete blood count (CBC) and adjust the dose of PURIXAN for excessive myelosuppression. Consider testing in patients with severe myelosuppression or repeated episodes of myelosuppression for thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) deficiency. Patients with homozygous-TPMT or homozygous-NUDT15 deficiency may require a dose reduction. ( 2.2, 5.1 ) Hepatotoxicity : Monitor transaminases, alkaline phosphatase and bilirubin. Withhold PURIXAN at onset of hepatotoxicity. ( 5.2 ) Immunosuppression :Response to all vaccines may be diminished and there is a risk of infection with live virus vaccines. Consult immunization guidelines for immunocompromised pediatrics. 4 CONTRAINDICATIONS None None.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING PURIXAN (mercaptopurine) oral suspension is supply as 2,000 mg/100 mL (20 mg/mL) is a pink to brown viscous liquid in amber glass multiple-dose bottles. In addition, a press-in bottle adapter and two oral dispensing syringes (one 1 mL and one 5 mL) are provided. Each carton NDC 62484-0020-2 contains 1 bottle of PURIXAN NDC 62484-0020-1.
Frequently Asked Questions
What is Purixan used for?▼
1 INDICATIONS AND USAGE PURIXAN is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.( 1.1 ) 1.1 Acute Lymphoblastic Leukemia PURIXAN is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
What are the side effects of Purixan?▼
6 ADVERSE REACTIONS The most common adverse reaction (> 20%) is myelosuppression including anemia, neutropenia, lymphopenia and thrombocytopenia. Adverse reactions occurring in 5% to 20% of patients include anorexia, nausea, vomiting, diarrhea, malaise and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc., at 1-844-472-7389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the important warnings for Purixan?▼
5 WARNINGS AND PRECAUTIONS Myelosuppression : Monitor complete blood count (CBC) and adjust the dose of PURIXAN for excessive myelosuppression. Consider testing in patients with severe myelosuppression or repeated episodes of myelosuppression for thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) deficiency. Patients with homozygous-TPMT or homozygous-NUDT15 deficiency may require a dose reduction. ( 2.2, 5.1 ) Hepatotoxicity : Monitor transaminases, alkaline phosphatase and bilirubin. Withhold PURIXAN at onset of hepatotoxicity. ( 5.2 ) Immunosuppression :Response to all vaccines may be diminished and there is a risk of infection with live virus vaccines. Consult immunization guidelines for immunocompromised pediatrics. 4 CONTRAINDICATIONS None None.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.