Cipla-Doxorubicin Solution

    Cipla-Doxorubicin Solution

    S4

    API: Doxorubicin | Company: Cipla

    1. What CIPLA-DOXORUBICIN is and what it is used for.

    CIPLA-DOXORUBICIN is indicated for the treatment of a variety of cancers, including the following:

    • Acute leukaemias (blood cancer), lymphomas (cancer of lymph glands or spleen) and a number of solid tumours.
    • Cancer of the breast that has spread to other organs, bladder cancer, cancer of the airways and cancers of nerve or brain tissue.
    • Thyroid cancer that has spread to other organs, cancer of the lining of the womb, cancers of the testes, prostate, cervix (neck of womb), and head and neck cancers, and certain types of white blood cell cancers.
    • Cancer of the ovary if given in combination with other chemotherapeutic (anticancer) medicines (cisplatin and cyclophosphamide).
    • Cancer of the breast and small (oat) cell cancer of the lung when given concurrently with other chemotherapeutic medicines.
    • Cancers arising in connective tissue (called sarcomas) that may involve bone tissue or other soft tissues.
    • Hodgkin's disease, a cancer of lymph tissue (lymphoma), if given with other chemotherapeutic agents.
    • Non-Hodgkin's lymphomas if administered concurrently with other chemotherapeutic medicines.

    Your doctor will decide whether or not you qualify for treatment with CIPLA-DOXORUBICIN.

    2. What you need to know before you take/use CIPLA-DOXORUBICIN.

    Do not receive CIPLA-DOXORUBICIN if you:

    • Are known to be hypersensitive (allergic) to CIPLA-DOXORUBICIN, other medicines belonging to the same class (anthracyclines) or to any components of the formulation.
    • Have low white blood cell or red blood cell counts or low platelet counts.
    • Have impairment of liver function.
    • Have heart failure or any other heart disease.
    • Recently suffered a heart attack (myocardial infarction).
    • Suffer from abnormal heart rhythm.
    • Have already received treatment with maximum cumulative doses of doxorubicin or other similar compounds. Your doctor will be able to tell you if this is the case.
    • Are pregnant or breast feeding.

    Take special care with CIPLA-DOXORUBICIN:

    CIPLA-DOXORUBICIN should be given only under supervision of a doctor experienced in cancer chemotherapy. Females are advised to use reliable contraception if they are of child-bearing age, since treatment with CIPLA-DOXORUBICIN may harm their unborn babies.

    3. How to take/use CIPLA-DOXORUBICIN.

    CIPLA-DOXORUBICIN is administered intravenously (into a vein) over a period of 3 to 5 minutes. Your doctor will decide the appropriate dosage and times of administration. He/she may decide to alter your dose should you develop any side-effects, such as low white cell counts or liver or heart function abnormalities. Your doctor will also tell you how long treatment with CIPLA-DOXORUBICIN will last.

    If you have the impression that CIPLA-DOXORUBICIN is too strong or too weak for you, please discuss this with your treating doctor.

    4. Possible side effects.

    CIPLA-DOXORUBICIN may have unintended or undesirable effects. One of the most serious, and potential life-threatening, side-effects associated with CIPLA-DOXORUBICIN therapy is low white blood cell counts. White blood cells are necessary to maintain a healthy immune system and to fight infections. You should immediately report to your doctor if you develop fever or chills, cough or hoarseness, lower back or flank pain, painful or difficult urination or a sore throat.

    Other serious side-effects, which you should report to your doctor as a matter of urgency, include:

    • Allergic reactions, presenting with swelling of the face, lips, or throat, skin rash or hives, and difficulty breathing. Severe allergic reactions may result in death if not treated promptly.
    • Swelling of the feet or legs, or shortness of breath accompanied by an inability to lie down or coughing of pink-coloured sputum, as these symptoms may be indicative of heart failure.
    • Palpitations, as this may indicate heart damage.
    • Ulcers in the mouth.
    • Any bleeding complications, including vomiting of blood or blood per rectum.
    • Severe foul-smelling diarrhoea accompanied by stomach cramps and fever as this may indicate infection or inflammation of the large bowel.
    • Fever and/or chills.

    Other side-effects with CIPLA-DOXORUBICIN that you should report to your doctor as soon as possible include:

    • Secondary infections.
    • Low red blood cell counts (presenting with tiredness or shortness of breath) and low platelet counts (presenting with easy bruising, pinpoint red spots on the skin, or bleeding from the gums).
    • High blood uric acid levels causing attacks of gout, which usually presents with severe pain, swelling and redness of a joint, such as those of the big toe or knee. This occurs most commonly during initial treatment of patients with leukaemia or lymphoma as a result of rapid cell breakdown that leads to elevated blood uric acid concentrations.
    • Painful red eyes with formation of pus (yellow discharge) or any reduction in vision.
    • Pain, swelling or red streaks at the injection site.
    • Nausea and vomiting (which may be severe).
    • Heartburn or regurgitation or pain with eating, as this may indicate inflammation of the lining of the oesophagus or stomach or a stomach ulcer.
    • Diarrhoea.
    • Suppression of testicular or ovarian function. This may interfere with the production of sperm in men and the menstrual cycle in women.

    Other side-effects with CIPLA-DOXORUBICIN that you should report to your doctor if they continue or become bothersome include:

    • Tearing of the eyes.
    • Hot flushes.
    • Stomach pain.
    • Loss of appetite.
    • Redness with inflammation and pain of skin previously exposed to radiation therapy (radiation recall reactions).
    • Hives (urticaria) occurring on sun-exposed skin.
    • Skin rash or darkening of the nails, palms or soles.
    • Reddening of the skin covering fingers, toes, ears and other peripheral parts.
    • Generally feeling unwell and tiredness.

    Other side-effects with CIPLA-DOXORUBICIN include:

    • Dehydration.
    • Darkening of the membrane inside the mouth.
    • Changes in liver enzyme levels.
    • Hair loss.
    • Red discolouration of urine for 1 to 2 days after administration.
    • Severe drop in blood pressure.

    Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen while taking CIPLA-DOXORUBICIN, please consult your doctor, pharmacist or other healthcare professional for advice. If you notice any side-effects not mentioned in this leaflet, please inform your doctor or pharmacist.

    5. How to store CIPLA-DOXORUBICIN.

    Freeze-dried powder: Store at or below 25 ºC. Protect from light. Vials should not be frozen. Keep vial in the outer carton until required for use. KEEP OUT OF REACH OF CHILDREN.

    Reconstituted solution: The reconstituted solution is stable for 24 hours at room temperature below 25 ºC or for 48 hours in a refrigerator between 2 – 8 ºC. Protect from light. KEEP OUT OF REACH OF CHILDREN.

    Important Disclaimer

    The Cipla-Doxorubicin Solution professional information leaflet below is the property of Cipla and is provided on Somayeza exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Somayeza serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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