PLATINOL- cisplatin injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

cisplatin (UNII: Q20Q21Q62J) (cisplatin - UNII:Q20Q21Q62J)

Available from:

Corden Pharma Latina S.p.A.

INN (International Name):

cisplatin

Composition:

cisplatin 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PLATINOL (cisplatin for injection, USP) is indicated as therapy to be employed as follows: In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of PLATINOL and cyclophosphamide. PLATINOL, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received PLATINOL therapy. PLATINOL is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy. PLATINOL is contraindicated in patients with preexisting renal impairment. PLATI

Product summary:

PLATINOL® (cisplatin for injection, USP) NDC 61126-003-01—Each amber vial contains 50 mg of cisplatin

Authorization status:

New Drug Application

Summary of Product characteristics

PLATINOL- CISPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CORDEN PHARMA LATINA S.P.A.
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PLATINOL
(CISPLATIN FOR INJECTION, USP)
RX ONLY
WARNING
PLATINOL (cisplatin for injection, USP) should be administered under
the supervision of a
qualified physician experienced in the use of cancer chemotherapeutic
agents. Appropriate
management of therapy and complications is possible only when adequate
diagnostic and treatment
facilities are readily available.
Cumulative renal toxicity associated with PLATINOL is severe. Other
major dose-related
toxicities are myelosuppression, nausea, and vomiting.
Ototoxicity, which may be more pronounced in children, and is
manifested by tinnitus, and/or loss
of high frequency hearing and occasionally deafness, is significant.
_Anaphylactic-like_ reactions to PLATINOL have been reported. Facial
edema, bronchoconstriction,
tachycardia, and hypotension may occur within minutes of PLATINOL
administration.
Epinephrine, corticosteroids, and antihistamines have been effectively
employed to alleviate
symptoms (see WARNINGS and ADVERSE REACTIONS).
EXERCISE CAUTION TO PREVENT INADVERTENT PLATINOL OVERDOSE. Doses
greater than 100
mg/m /cycle once every 3 to 4 weeks are rarely used. Care must be
taken to avoid inadvertent
PLATINOL overdose due to confusion with PARAPLATIN (carboplatin) or
prescribing
practices that fail to differentiate daily doses from total dose per
cycle.
DESCRIPTION
PLATINOL (cisplatin for injection, USP) is a white to light yellow
lyophilized powder. Each vial of
PLATINOL contains 50 mg cisplatin, 450 mg Sodium Chloride, USP, and
500 mg Mannitol, USP.
The active ingredient, cisplatin, is a yellow to orange crystalline
powder with the molecular formula
PtCl
H N , and a molecular weight of 300.1. Cisplatin is a heavy metal
complex containing a central
atom of platinum surrounded by two chloride atoms and two ammonia
molecules in the cis position. It is
soluble in water or saline at 1 mg/mL and in dimethylformamide at 24
mg/mL. It has a melting point of
207° C.
C