CISPLATIN- cisplatin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alvogen Inc.

INN (International Name):

cisplatin

Composition:

cisplatin 50 mg in 50 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 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 pre-existing renal i

Product summary:

CISplatin Injection (1 mg/mL) is supplied as follows: The above products are multiple dose vials packaged individually. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Do not refrigerate. Protect from light. This container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CISPLATIN- CISPLATIN INJECTION, SOLUTION
ALVOGEN INC.
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CISPLATIN INJECTION
(FOR INTRAVENOUS USE)
WARNINGS
Cisplatin 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).
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 is a clear, colorless, sterile aqueous solution.
Each 100 mL amber vial of Cisplatin
Injection contains: 1 mg/mL cisplatin USP, 9 mg/mL sodium chloride,
hydrochloric acid and/or sodium
hydroxide to adjust pH, and water for injection USP to a final volume
of 50 mL and 100 mL,
respectively. The pH range of Cisplatin Injection is 3.8 to 5.9.
Cisplatin Injection must be further diluted prior to administration
(see DOSAGE AND
ADMINISTRATION, ALL PATIENTS).
The active ingredient, cisplatin USP, is a yellow to orange
crystalline powder. Cisplatin is a heavy
metal complex containing a central atom of platinum surrounded by two
chloride atoms and two ammonia
molecules i