Paraplatin

DRUG DESCRIPTION

PARAPLATIN® (carboplatin aqueous solution) INJECTION is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin. Carboplatin is a platinum coordination compound. The chemical name for carboplatin is platinum, diammine[1,1-cyclobutanedicarboxylato(2-)-O,O?]-, (SP-4-2), and carboplatin has the following structural formula:

PARAPLATIN®
   (carboplatin) Structural Formula Illustration

Carboplatin is a crystalline powder with the molecular formula of C6H12N2O4Pt and a molecular weight of 371.25. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide.

What are the possible side effects of carboplatin (Paraplatin)?

If you experience any of the following serious side effects from carboplatin, contact your doctor immediately or seek emergency medical attention:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • kidney damage (little or no urine production, blood in the urine);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of...

Read All Potential Side Effects and See Pictures of Paraplatin »

What are the precautions when taking carboplatin (Paraplatin)?

Before using carboplatin, tell your doctor or pharmacist if you are allergic to it, or to cisplatin; 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: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, mineral imbalance (low blood levels of sodium, potassium, magnesium, calcium).

Do not have immunizations/vaccinations without the...

Read All Potential Precautions of Paraplatin »


Paraplatin Consumer (continued)

SIDE EFFECTS: Stomach pain, body aches/pain, diarrhea, constipation, weakness, nausea, and vomiting may occur. Nausea and vomiting can be severe in some patients but usually go away within 24 hours of treatment. Drug therapy may be needed to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: numbness or tingling in the hands/feet, mouth sores, yellowing eyes/skin, dark urine, unusual tiredness, change in the amount of urine, pain/swelling/redness at the injection site, hearing problems (e.g., ringing in the ears, hearing loss), easy bruising/bleeding, blood in the urine, black/bloody stools, fast/irregular heartbeat.

Rarely, temporary vision loss may occur with high doses of carboplatin. Normal vision usually returns within several weeks after the end of treatment. Consult your doctor or pharmacist for more details and report this side effect immediately if it occurs.

This medication can lower your body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using carboplatin, tell your doctor or pharmacist if you are allergic to it, or to cisplatin; 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: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, mineral imbalance (low blood levels of sodium, potassium, magnesium, calcium).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.

Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.

Wash your hands well to prevent the spread of infections.

The elderly may be more sensitive to the side effects of this drug, especially to bleeding problems and numbness/tingling of the hands/feet.

Children may be at greater risk for hearing loss when carboplatin is used at higher-than-recommended doses in combination with other medications that may affect hearing.

This medication is not recommended for use during pregnancy. It may cause harm to an unborn baby. Women of childbearing age should use reliable form(s) of birth control during treatment and for some time afterwards. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Paraplatin Patient Information Including Side Effects

Brand Names: Paraplatin

Generic Name: carboplatin (Pronunciation: car bo PLAH tin)

  • What is carboplatin (Paraplatin)?
  • What are the possible side effects of carboplatin (Paraplatin)?
  • What is the most important information I should know about carboplatin (Paraplatin)?
  • What should I discuss with my healthcare provider before using carboplatin (Paraplatin)?
  • How should I use carboplatin (Paraplatin)?
  • What happens if I miss a dose (Paraplatin)?
  • What happens if I overdose (Paraplatin)?
  • What should I avoid while using carboplatin (Paraplatin)?
  • What other drugs will affect carboplatin (Paraplatin)?
  • Where can I get more information?

What is carboplatin (Paraplatin)?

Carboplatin is an antineoplastic medication. Carboplatin interferes with the growth of cancer cells and slows their growth and spread in the body.

Carboplatin is used to treat ovarian cancer and many other types of cancer.

Carboplatin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of carboplatin (Paraplatin)?

If you experience any of the following serious side effects from carboplatin, contact your doctor immediately or seek emergency medical attention:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • kidney damage (little or no urine production, blood in the urine);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • severe nausea, vomiting, and loss of appetite; or
  • blurred vision, altered color perception, temporary blindness, and other visual problems.

Other, less serious side effects may be more likely to occur. Continue taking carboplatin and talk to your doctor if you experience:

  • hearing loss or ringing in the ears;
  • numbness or tingling;
  • weakness;
  • mild to moderate nausea, vomiting, or loss of appetite; or
  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about carboplatin (Paraplatin)?

Carboplatin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of carboplatin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); kidney damage (little or no urine production, blood in the urine); hearing loss or ringing in the ears; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with carboplatin.

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