METHOTREXATE injection

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Mylan Institutional LLC

INN (Rahvusvaheline Nimetus):

METHOTREXATE

Koostis:

METHOTREXATE 25 mg in 1 mL

Manustamisviis:

INTRA-ARTERIAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

Parenteral Methotrexate Injection, USP is a preservative free solution supplied in single dose vials. Each 25 mg/mL, 2 mL, 4 mL, 8 mL, 10 mL and 40 mL vial packed individually contains methotrexate sodium equivalent to 50 mg, 100 mg, 200 mg, 250 mg and 1 g methotrexate respectively. NDC 67457-467-21                50 mg in 2 mL     (Individually boxed) NDC 67457-486-04                100 mg in 4 mL   (Individually boxed) NDC 67457-485-08                200 mg in 8 mL   (Individually boxed) NDC 67457-466-10                250 mg in 10 mL (Individually boxed) NDC 67457-467-99                50 mg in 2 mL     (5 individually boxed vials in a carton) NDC 67457-486-99                100 mg in 4 mL   (10 individually boxed vials in a carton) NDC 67457-485-99                200 mg in 8 mL   (10 individually boxed vials in a carton) NDC 67457-480-40                1 g in 40 mL Vial (Individually boxed) Store at 20° to 25° C (68° to77° F). [See USP controlled room temperature.] PROTECT FROM LIGHT  

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

METHOTREXATE- METHOTREXATE INJECTION
MYLAN INSTITUTIONAL LLC
----------
METHOTREXATE INJECTION, USP 40 ML
RX ONLY
WARNINGS
METHOTREXATE SHOULD BE USED ONLY BY PHYSICIANS WHOSE
KNOWLEDGE AND EXPERIENCE INCLUDE THE USE OF ANTIMETABOLITE
THERAPY. BECAUSE OF THE POSSIBILITY OF SERIOUS TOXIC REACTIONS
(WHICH CAN BE FATAL):
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 FORMULATIONS AND DILUENTS CONTAINING PRESERVATIVES
MUST NOT BE USED FOR INTRATHECAL OR HIGH DOSE METHOTREXATE
THERAPY.
1.
2.
3.
4.
5.
6.
7.
8.
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
gastroi