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Trepar

Trepar Adverse Reactions

dactinomycin

Manufacturer:

Korea United Pharma

Distributor:

Qualimed
Full Prescribing Info
Adverse Reactions
Dermatological Problems: Alopecia, skin eruptions, acne and flare-up of erythema or increased pigmentation of previously irradiated skin.
Gastrointestinal disturbances: Anorexia, nausea & vomiting, abdominal pain, diarrhea, stomatitis, proctitis, gastrointestinal ulceration, liver toxicity including ascites, hepatomegaly, hepatitis and liver function test abnormalities. Nausea and vomiting, which occur during the first few hours after administration may be alleviated by giving antiemetics.
Toxic effects (except nausea and vomiting) usually do not become apparent until two to four days after a course of therapy is stopped.
Renal Problems:
Renal abnormalities and rarely, increase of BUN may occur.
Hematological Problems: Anemia, even to the point of aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia and reticulopenia may occur. Platelet and white cell counts should be done daily to detect severe hemopoietic depression. If either count markedly decreases, the drug should be withheld to allow marrow recovery. This often takes up to three weeks.
Hepatic Abnormalities: Hepatotoxicity including ascites, hepatomegaly, hepatitis, liver function test abnormalities and occasionally, jaundice may occur.
Hypersensitivity Reactions: Occasionally, dyspnea and anaphylaxis may occur.
Neurotoxicity: Hypernoia, headache, heaviness in head, malaise, fatigue, debility, occasionally, numbness of extremities, convulsion, dizziness, apprehension and rarely, lethargy may occur.
Local: Phlebitis at IV site.
Others: Nasal hemorrhage, fever, occasionally malaise, myalgia, flush, sputum cruentum, hematochezia, compression of pectus, blepharedema, pharyngitis, proctitis and hypocalcemia may occur.
Dactinomycin is extremely corrosive. If extravasation occurs during intravenous use, severe damage to soft tissues will occur. In at least one instance, this has led to contracture of the arms.
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