Pacli-One 30/Pacli-One 100

Paclitaxel.

Each mL contains: Paclitaxel USP 6 mg; Polyoxyl 35 Castor Oil NF 527 mg; Dehydrated Alcohol USP 49.7% v/v.

Pharmacotherapeutic Group: Antineoplastic Agents.
Pharmacology: Pharmacodynamics: Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions. In addition, Paclitaxel abnormal arrays or bundles of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

The palliative treatment of stage 3 or 4 advanced local carcinoma of the ovary after surgical resection, in combination with Cisplatin.
The palliative management of metastatic carcinoma of the ovary after failure of first line or subsequent chemotherapy.
The treatment of metastatic carcinoma of the breast after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Palliative treatment of advanced non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.

Primary treatment of ovarian carcinoma: a combination regimen consisting of Paclitaxel 135 mg/m³ administered over 24 hours, followed by cisplatin 75 mg, every 3 weeks. Paclitaxel should be administered before cisplatin.
Secondary treatment of ovarian carcinoma: Paclitaxel at a dose of 175 mg/m³ administered intravenously over 3 hours every 3 weeks has been shown to be effective in patients with metastatic carcinoma of the ovary or breast after the failure of first line or subsequent chemotherapy.
Palliative treatment of advanced non-small cell lung carcinoma: the recommended dose of Paclitaxel is 175 mg/m³ administered over a period of 3 hours; followed by a platinum compound, with a 3 week interval between courses.
Paclitaxel should not be readministered until the neutrophil count is at least 1500/mm³ and the platelet count is at least 100 000/mm³. Patients who experience severe neutropenia (neutrophil count <500/mm) or moderate to severe peripheral neuropathy should receive a dose reduction of 20% for subsequent courses. The incidence and severity of neurotoxicity and haematologic toxicity increases with dose. All patients must be premedicated with corticosteroids, antihistamines, and H2 antagonists prior to Paclitaxel administration, e.g., dexamethasone 20 mg orally approximately 12 and 6 hours before Paclitaxel, promethazine 25 IV 30 to 60 minutes before Paclitaxel.
Paclitaxel should be administered through an in-line filter with a microporous membrane not greater that 0.22 micro. Or as prescribed by the physician.

There is no antidote for Paclitaxel overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity and mucositis.

Paclitaxel is contraindicated in patients who have a history of severe hypersensitivity reactions to Paclitaxel or other drugs formulated with polyoxyethylated castor oil.
Paclitaxel should not be used in patients with baseline neutrophils <1500/mm³.

Use in Pregnancy: Paclitaxel has been shown to be embryotoxic foetotoxic and to decrease fertility in animal studies. There is no information on the use of Paclitaxel in pregnant women. Paclitaxel may cause foetal harm when administered to pregnant women. Paclitaxel should not be used during pregnancy. Women of child bearing potential should be advised to avoid becoming pregnant during therapy with Paclitaxel, and to inform the treating physician immediately should this occur.
Use in Lactation: It is not known whether Paclitaxel is excreted in human milk. Breast feeding should be discontinued for the duration of Paclitaxel therapy.

Pregnancy: Paclitaxel has been shown to be embryotoxic foetotoxic and to decrease fertility in animal studies.
There is no information on the use of Paclitaxel in pregnant women. Paclitaxel may cause foetal harm when administered to pregnant women.
Paclitaxel should not be used during pregnancy. Women of child bearing potential should be advised to avoid becoming pregnant during therapy with Paclitaxel, and to inform the treating physician immediately should this occur.
Lactation: It is not known whether Paclitaxel is excreted in human milk. Breast feeding should be discontinued for the duration of Paclitaxel therapy.

Peripheral neuropathy (tingling and numbness in hands and feet due to irritation of nerves), neutropenia (low white blood cell count, greater risk of infection), bone and muscle aches, hair loss, fatigue, nausea, vomiting, mild diarrhea, mucositis (irritated mucous membrane in the mouth), amenorrhea (monthly menstrual cycle stops), changes in nails (brittle or yellowed).

The recommended regimen of Paclitaxel administration of primary treatment of ovarian carcinoma is for Paclitaxel to be given before cisplatin. When Paclitaxel is given before cisplatin, the safety profile of Paclitaxel is consistent with that reported for single agent use. When Paclitaxel was given after cisplatin, patients showed a more profound myelosuppression and an approximately 20% decrease in Paclitaxel clearance.
Medications concomitantly administered with Paclitaxel (e.g., corticosteroids, antihistamines, and H antagonists) did not appear to interact adversely; however, possible interactions of Paclitaxel with concomitantly administered medications have not been formally investigated. The metabolism of Paclitaxel is catalysed by cytochrome P450 isoenzymes CYP2C8 and CYP3A4. In the absence of formal clinical drug interaction studies, caution should be exercised when administering Paclitaxel concomitantly with known substrates or inhibitors of these isoenzymes.

Store at temperatures not exceeding 30°C.
Protect from light. Do not freeze.

Cytotoxic Chemotherapy

L01CD01 - paclitaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.

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