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Platinol-AQ

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Platinol-AQ

PLATINOL® AQ
(cisplatin) Injection

WARNING

PLATINOL-AQ (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 PLATINOL-AQ 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-AQ have been reported. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of PLATINOL-AQ administration. Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS sections).

Exercise caution to prevent inadvertent PLATINOL-AQ overdose. Doses greater than 100 mg/m2/cycle once every 3 to 4 weeks are rarely used. Care must be taken to avoid inadvertent PLATINOL-AQ overdose due to confusion with PARAPLATINR (carboplatin) or prescribing practices that fail to differentiate daily doses from total dose per cycle.

DRUG DESCRIPTION

PLATINOL® (cisplatin injection) infusion concentrate is a clear, colorless, sterile aqueous solution available in amber vials. Each 50 mL or 100 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 or 100 mL, respectively.

PLATINOL® AQ (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 PtCl2H6N2, 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.

PLATINOL® AQ
  (cisplatin injection) Structural Formula Illustration

What are the possible side effects of cisplatin (Platinol (Restricted Access))?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • hearing problems;
  • trouble with walking or daily activities;
  • numbness, tingling, or cold feeling in your hands or feet;
  • urinating less than usual or not at all;
  • drowsiness, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of...

Read All Potential Side Effects and See Pictures of Platinol-AQ »

What are the precautions when taking cisplatin injection (Platinol-AQ)?

Before using cisplatin, tell your doctor or pharmacist if you are allergic to it; or to carboplatin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia), hearing problems.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: mineral imbalance (low blood levels of sodium, potassium, magnesium, calcium, phosphate), numbness/tingling of the...

Read All Potential Precautions of Platinol-AQ »

Last reviewed on RxList: 1/24/2012
This monograph has been modified to include the generic and brand name in many instances.

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Platinol-AQ - User Reviews

Platinol-AQ User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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