METHOTREXATE injection, powder, lyophilized, for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1)

Dostupné s:

Hikma Pharmaceuticals USA Inc.

INN (Mezinárodní Name):

METHOTREXATE

Složení:

METHOTREXATE 1 g

Podání:

INTRA-ARTERIAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is also indicated in the treatment of meningeal leukemia. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin’s lymphomas. Methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection

Přehled produktů:

Methotrexate for Injection, USP (preservative free) is supplied in a 1 gram, single-dose vial of lyophilized powder containing 1 gram methotrexate as the base in the following package strength: NDC 0143-9830-01                   1 gram Vial (individually boxed) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light . To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

METHOTREXATE- METHOTREXATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
METHOTREXATE FOR INJECTION, USP
METHOTREXATE FOR INJECTION, USP
RX ONLY
WARNINGS
WARNINGS
FOR INTRATHECAL AND HIGH-DOSE THERAPY, USE THE PRESERVATIVE-
FREE FORMULATION OF METHOTREXATE. DO NOT USE THE PRESERVED
FORMULATION FOR INTRATHECAL OR HIGH-DOSE THERAPY BECAUSE
IT CONTAINS BENZYL ALCOHOL.
METHOTREXATE SHOULD BE USED ONLY IN LIFE THREATENING NEOPLASTIC
DISEASES, OR IN PATIENTS WITH PSORIASIS OR RHEUMATOID ARTHRITIS
WITH SEVERE, RECALCITRANT, DISABLING DISEASE WHICH IS NOT
ADEQUATELY RESPONSIVE TO OTHER FORMS OF THERAPY.
DEATHS HAVE BEEN REPORTED WITH THE USE OF METHOTREXATE IN THE
TREATMENT OF MALIGNANCY, PSORIASIS, AND RHEUMATOID ARTHRITIS.
PATIENTS SHOULD BE CLOSELY MONITORED FOR BONE MARROW, LIVER,
LUNG AND KIDNEY TOXICITIES. (See PRECAUTIONS.)
PATIENTS SHOULD BE INFORMED BY THEIR PHYSICIAN OF THE RISKS
INVOLVED AND BE UNDER A PHYSICIAN’S CARE THROUGHOUT THERAPY.
THE USE OF METHOTREXATE HIGH-DOSE REGIMENS RECOMMENDED FOR
OSTEOSARCOMA REQUIRES METICULOUS CARE. (See DOSAGE AND
ADMINISTRATION.) HIGH-DOSE REGIMENS FOR OTHER NEOPLASTIC DISEASES
ARE INVESTIGATIONAL AND A THERAPEUTIC ADVANTAGE HAS NOT BEEN
ESTABLISHED.
Methotrexate has been reported to cause fetal death and/or congenital
anomalies. Therefore, it is not recommended for women of childbearing
potential unless there is clear medical evidence that the benefits can
be
expected to outweigh the considered risks. Pregnant women with
psoriasis or
rheumatoid arthritis should not receive methotrexate (See
CONTRAINDICATIONS).
Methotrexate elimination is reduced in patients with impaired renal
functions,
ascites, or pleural effusions. Such patients require especially
careful monitoring
for toxicity, and require dose reduction or, in some cases,
discontinuation of
methotrexate administration.
Unexpectedly severe (sometimes fatal) bone marrow suppression,
aplastic
anemia, and gastrointestinal toxicity have been reported with
concomitant
administrat