CYCLOPHOSPHAMIDE injection powder lyophilized for solution

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

CYCLOPHOSPHAMIDE (UNII: 8N3DW7272P) (CYCLOPHOSPHAMIDE ANHYDROUS - UNII:6UXW23996M)

Disponibbli minn:

Baxter Healthcare Corporation

INN (Isem Internazzjonali):

CYCLOPHOSPHAMIDE

Kompożizzjoni:

CYCLOPHOSPHAMIDE ANHYDROUS 500 mg in 25 mL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

CYCLOPHOSPHAMIDE- CYCLOPHOSPHAMIDE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYCLOPHOSPHAMIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CYCLOPHOSPHAMIDE.
CYCLOPHOSPHAMIDE INJECTION, FOR INTRAVENOUS USE
CYCLOPHOSPHAMIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Cyclophosphamide is an alkylating drug indicated for treatment of:
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DOSAGE AND ADMINISTRATION
MALIGNANT DISEASES: ADULT AND PEDIATRIC PATIENTS (2.1)
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MINIMAL CHANGE NEPHROTIC SYNDROME IN PEDIATRIC PATIENTS(2.2)
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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MALIGNANT DISEASES: malignant lymphomas: Hodgkin’s disease,
lymphocytic lymphoma, mixed-cell type lymphoma,
histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma,
leukemias, mycosis fungoides, neuroblastoma,
adenocarcinoma of ovary, retinoblastoma, breast carcinoma (1.1)
MINIMAL CHANGE NEPHROTIC SYNDROME IN PEDIATRIC PATIENTS: biopsy proven
minimal change nephrotic
syndrome patients who failed to adequately respond to or are unable to
tolerate adrenocorticosteroid therapy (1.2)
Limitations of Use:
The safety and effectiveness for the treatment of nephrotic syndrome
in adults or other renal disease has not been
e stablishe d.
Intravenous: Initial course for patients with no hematologic
deficiency: 40 mg per kg to 50 mg per kg in divided doses
over 2 to 5 days. Other regimens include 10 mg per kg to 15 mg per kg
given every 7 to 10 days or 3 mg per kg to 5
mg per kg twice weekly.
Oral: Usually 1 mg per kg per day to 5 mg per kg per day for both
initial and maintenance dosing.
Recommended oral dose: 2 mg per kg daily for 8 to 12 weeks (maximum
cumulative dose 168 mg per kg). Treatment
beyond 90 days increases the probability of sterility in males.
Injection, lyophilized powder: 500 mg, 1 g, and 2 g (3)
Tablet 25 mg and 50