CISPLATIN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

WG Critical Care, LLC

INN (International Name):

cisplatin

Composition:

cisplatin 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cisplatin Injection 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 Cisplatin Injection and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy. Cisplatin Injection 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. Cisplatin is contraindicated in patients with preexistin

Product summary:

Cisplatin Injection is available as follows: NDC 44567-509-01 Each multidose vial contains 50 mg of cisplatin NDC 44567-510-01 Each multidose vial contains 100 mg of cisplatin NDC 44567-511-01 Each multidose vial contains 200 mg of cisplatin

Authorization status:

New Drug Application

Summary of Product characteristics

CISPLATIN- CISPLATIN INJECTION, SOLUTION
WG CRITICAL CARE, LLC
----------
CISPLATIN INJECTION
RX ONLY
WARNING
Cisplatin Injection 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 cisplatin 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 cisplatin have been reported. Facial
edema,
bronchoconstriction, tachycardia, and hypotension may occur within
minutes of
cisplatin administration. Epinephrine, corticosteroids, and
antihistamines have been
effectively employed to alleviate symptoms (see WARNINGS and ADVERSE
REACTIONS sections).
EXERCISE CAUTION TO PREVENT INADVERTENT CISPLATIN OVERDOSE. Doses
greater
than 100 mg/m /cycle once every 3 to 4 weeks are rarely used. Care
must be
taken to avoid inadvertent cisplatin overdose due to confusion with
carboplatin or
prescribing practices that fail to differentiate daily doses from
total dose per cycle.
DESCRIPTION
Cisplatin Injection infusion concentrate is a clear, colorless,
sterile aqueous solution
available in amber vials. Each 50 mL, 100 mL or 200 mL amber vial of
infusion
concentrate contains: 1 mg/mL cisplatin, 9 mg/mL sodium chloride,
hydrochloric acid
and sodium hydroxide to approximate pH of 4.0, and water for injection
to a final
volume of 50 mL, 100 mL or 200 mL respectively.
Cisplatin Injection infusion concentrate must be further diluted prior
to administration
(see DOSAGE AND ADMINISTRATION, ALL PATIENTS).
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