CYCLOPHOSPHAMIDE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Baxter Healthcare Corporation

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Cyclophosphamide Tablets is indicated for the treatment of: Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. Cyclophosphamide Tablets is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. Limitations of Use: The safety and effectiveness of Cyclophosphamide Tablets for the treatment of nephrotic syndrome in adults or other renal disease has not been established. Cyclophosphamide Tablets are contraindicated in patients with: Risk Summary Based on its mechanism of action and published reports of effects in pregnant patients or animals, Cyclophosphamide Tablets can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)]. Exposure to cyclophosphamide during pregnancy may cause fetal malformations

Proizvod sažetak:

Tablets: Store tablets at 20°C to 25°C (68°F to77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Cyclophosphamide is an antineoplastic product. Follow special handling and disposal procedures.1

Status autorizacije:

New Drug Application

Svojstava lijeka

CYCLOPHOSPHAMIDE- CYCLOPHOSPHAMIDE TABLET
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYCLOPHOSPHAMIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CYCLOPHOSPHAMIDE
TABLETS.
CYCLOPHOSPHAMIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1959
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Cyclophosphamide Tablets is an alkylating drug indicated for treatment
of:
•
•
Limitations of Use:
The safety and effectiveness for the treatment of nephrotic syndrome
in adults or other renal disease has
not been established. (1.2)
DOSAGE AND ADMINISTRATION
During or immediately after the administration, administer adequate
amounts of fluid to reduce the risk of
urinary tract toxicity (2.1).
MALIGNANT DISEASES: ADULT AND PEDIATRIC PATIENTS
•
MINIMAL CHANGE NEPHROTIC SYNDROME IN PEDIATRIC PATIENTS
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
Dosage and Administration, Hydration and Important Administration
Instructions (2.1) 08/2020
Warnings and Precautions, Embryo Fetal Toxicity (5.7) 08/2020
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)
Oral: Usually 1 mg per kg to 5 mg per kg once daily for both initial
and maintenance dosing. (2.2)
Recommended oral dose: 2 mg per kg once daily for 8 to 12 weeks
(maximum cumulative dose 168
mg per kg). Treatment beyond 90 days increases the probability of
sterility in males. (2.3)
Tablets: 25 mg and 50 mg (3)
Hypersensitivity to cyclophosphamide (4)
Urinary outflow obstruction