Paclitaxel

[PACK-lih-tax-el] Pregnancy Category: D Taxol (Rx)

Classification: Antineoplastic, miscellaneous

See also Antineoplastic Agents. Action/Kinetics: Naturally occurring antineoplastic agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depol-ymerization. The stabilization results in the inhibition of the normal dynamic reorganization of the microtubule network that is required for vital interphase and mitotic cellular functions. Also induces abnormal "bundles" of microtubules throughout the cell cycle and multiple esters of microtubules during mitosis. Following IV administration, there is a bi-phasic decline in plasma levels. The initial rapid decline is due to distribution to the peripheral compartment and significant elimination, whereas the second phase is due, in part, to a slow efflux of the drug from the peripheral compartment. Metabolized by the liver with small amounts of unchanged drug excreted in the urine. Uses: Metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. Breast cancer after combination chemotherapy has failed or there has been relapse within 6 months of adjuvant chemotherapy (prior therapy must have included an anthracycline unless contra-indicated). Second-line treatment of AIDS-related Kaposi's sarcoma. Non-FDA Approved Uses: Alone or in combination with other chemothera-peutic drugs for advanced head and neck cancer, previously untreated extensive-stage small-cell lung cancer, adenocarcinoma of the upper GI tract, hormone-refractory prostate cancer, advanced non-small-cell lung cancer, and leukemias. Contraindications: Hypersensitiv-ity to paclitaxel, in those with a hyper-sensitivity to products containing polyoxymethylated castor oil (Crem-ophor EL), clients with a baseline neutropenia below 1,500 cells/mm3, and those with AIDS-related Ka-posi's sarcoma with baseline neu-trophil counts below 1,000 cells/mm3. Lactation. Special Concerns: Use with caution in clients with impaired hepatic function. Safety and efficacy have not been determined in children. Side Effects: Hypersensitivity reactions: Severe symptoms usually occur during the first hour of therapy and occur during both the first or second course of therapy despite premedica-tion. Severe symptoms include dyspnea, angioedema, hypotension, or generalized urticaria all of which require immediate cessation of the drug and aggressive treatment therapy. Symptoms not requiring treatment include milder dyspnea, flushing, skin reactions, hypotension, or tachycardia. Hematologic: Neutrope-nia and leukopenia (common), thrombocytopenia, anemia, infections, bleeding, packed cell transfusions, platelet transfusions. CV: Bradycardia and hypotension (including during the infusion), hypertension, severe CV events (including asymptomatic ventricular tachycardia, bigeminy, syncope, completeAVblock), abnormal ECG (including nonspecific repolarization abnormalities, sinus tachycardia, premature beats). Muscu-loskeletal: Peripheral neuropathy (including mild paresthesia), myalgia, arthralgia. Oral: Mucositis. GI: N&V, diarrhea. Miscellaneous: Alopecia, fever associated with severe neutropenia; infections of the urinary tract and upper respiratory tract as well as sepsis due to neutropenia. Drug Interactions Ketoconazole / Inhibition of metabolism of paclitaxel by ketoconazole How Supplied: Injection: 6 mg/mL

Dosage-

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