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Drug Information For:
ADRIAMYCIN 20MG INJ, 1 VIAL
Ingredient Name:DOXORUBICIN (dox-oh-ROO-bi-sin)
Drug Manufacturer:BEDFORD LABORATORIES
Common Uses:This medicine is an antineoplastic antibiotic used to treat certain types of cancer.
Before Using This Medicine:WARNING: This medicine may cause severe tissue, skin, or muscle damage if it leaks from the vein. Notify your doctor immediately if you have any redness, burning, pain, swelling, blisters or sores, or leaking of fluid at or around the injection site. THIS MEDICINE MAY CAUSE SEVERE AND POSSIBLY LIFE-THREATENING HEART PROBLEMS (eg, heart failure). These problems may occur during therapy or sometimes months to years after receiving this medicine. In some cases, heart problems are irreversible. The risk may be increased if you are using certain medicines that may affect heart function (eg, trastuzumab), or have a history of heart problems, radiation treatment to the chest area, or previous therapy with other anthracyclines (eg, epirubicin). The risk of developing heart problems varies depending on your dose and condition, although it can occur at any dose whether or not you are at risk. You will need to have your heart function checked before, during, and after treatment. Notify your doctor immediately if you develop cough; fast heartbeat; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; or unusual tiredness or weakness. ANOTHER TYPE OF CANCER (acute myelogenous leukemia [AML]) and a certain blood problem (myelodysplastic syndrome [MDS]) have been reported in patients treated with anthracyclines, including this medicine. The risk varies depending on your dose and other medicines and/or radiation therapy. Discuss any questions or concerns with your doctor. THIS MEDICINE MAY CAUSE BONE MARROW SUPPRESSION. This may lead to severe and sometimes deadly health problems (eg, infections, bleeding). Notify your doctor immediately if you develop easy bruising or bleeding, unusual tiredness or weakness, or signs of an infection (eg, fever, chills, persistent sore throat). Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you have taken or will be taking palifermin within 24 hours before or after using this medicine. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (eg, warfarin), cyclosporine, paclitaxel, verapamil, phenobarbital, phenytoin, St John's wort, medicines that may harm the liver (eg, acetaminophen, mercaptopurine, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection), or medicines that may affect heart function (eg, cyclophosphamide, trastuzumab). Ask your doctor if you are unsure if any of your medicines may affect heart function or might harm the liver. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of heart problems (eg, irregularheartbeat), liver problems, allergies, pregnancy or if you are able to become pregnant, or breast-feeding. Tell your doctor if you are receiving radiation therapy or plan to receive radiation to the chest, or if you have previously received this medicine or similar medicines (eg, epirubicin, daunorubicin). USE OF THIS MEDICINE IS NOT RECOMMENDED if you have certain bone marrow problems (eg, low blood platelet levels, low red blood cell levels, or low white blood cell levels) with prior chemotherapy, severe liver problems, severe heart problems, or recent heart attack. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
How to Use This Medicine:Follow the directions for using this medicine provided by your doctor. An extra patient leaflet is available with this medicine. Talk to your pharmacist if you have questions about this information. This medicine is usually administered as an injection at your doctor's office or a clinic. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. DO NOT USE THIS MEDICINE if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. DRINKING EXTRA FLUIDS while you are taking this medicine is recommended. Check with your doctor or nurse for instructions. Your doctor may also prescribe medicine to help decrease the nausea and vomiting that this medicine can cause. Discuss any questions with your doctor. DO NOT GET THIS MEDICINE ON YOUR SKIN. If this medicine comes in contact with your skin, wash it off immediately with soap and water. STORE THIS MEDICINE as directed on the prescription label. Do not freeze. KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and pets. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor immediately.
Cautions:DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it, to any ingredient in this product, or to similar medicines (eg, epirubicin). Laboratory and/or medical tests may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are being treated with this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are taking this medicine. THIS MEDICINE MAY LOWER YOUR RESISTANCE to infection. To prevent infection, avoid contact with people who have colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. THIS MEDICINE MAY REDUCE THE NUMBER OF BLOOD CELLS NEEDED FOR CLOTTING. To prevent bleeding, avoid situations where bruising or injury may occur. DO NOT RECEIVE A LIVE VACCINE (eg, measles, mumps) while you are taking this medicine. Talk with your doctor before you receive any vaccine. THIS MEDICINE MAY CAUSE THE URINE TO TURN RED. This is harmless and should go away in 1 to 2 days after receiving a dose of this medicine. Contact your doctor if this continues or if you notice blood in your urine. THIS MEDICINE MAY CAUSE increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period. THIS MEDICINE MAY CAUSE A SERIOUS AND POSSIBLY FATAL condition called tumor lysis syndrome (TLS). Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN CHILDREN because they may be more sensitive to the effects of the medicine, especially heart problems (eg, heart failure). WOMEN WHO MAY BECOME PREGNANT and men who use this medicine must use an effective form of birth control while they take this medicine and for at least 6 months after treatment is stopped. Talk to your doctor about birth control methods. If you or your partner becomes pregnant, tell your doctor right away. THIS MEDICINE MAY CAUSE infertility that is sometimes permanent. Discuss any questions or concerns with your doctor. FOR MEN: THIS MEDICINE MAY DAMAGE SPERM. Use effective birth control methods (eg, condoms) while using this medicine and for 6 months after treatment is stopped. Discuss any questions or concerns with your doctor. FOR WOMEN: WOMEN TAKING THIS MEDICINE may develop absence of menstrual periods or early menopause. THIS MEDICINE HAS BEEN SHOWN TO CAUSE HARM to the humanfetus. AVOID BECOMING PREGNANT while you are taking it. If you are able to become pregnant, talk with your doctor about using an effective form of birth control. IF YOU THINK YOU MAY BE PREGNANT, contact your doctor right away. THIS MEDICINE IS FOUND IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.
Possible Side Effects:SIDE EFFECTS that may occur while using this medicine include diarrhea, hair loss, nausea, or vomiting. If they continue or are severe, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience absence of menstrual cycle; black, bloody, or tarry stools; chest pain; darkening of nails or separation of nails from the nail bed; fainting; fast, slow, or irregular heartbeat; pain, redness, burning, stinging, swelling, or open sores at the injection site; redness, pain, swelling, peeling, tingling, or blistering of the palms of the hands and the soles of the feet; severe or persistent diarrhea, nausea, or vomiting; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; swelling or soreness of the mouth or tongue; symptoms of dehydration (eg, dry mouth or eyes, decreased urination, fast heartbeat, sluggishness, unusual thirst); symptoms of infection (eg, fever, chills, cough, sore throat, burning or painful urination); unusual bruising or bleeding; or unusual tiredness or weakness. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; dizziness; flushed face; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose:If overdose is suspected, contact your local poison control center or emergency room immediately. .
Additional Information:DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2014 Wolters Kluwer Health, Inc.