Drug Interaction:
Antineuoplastic agents include- Interferon ALFA 2a, Interferon ALFA -2b, Interferon ALFA -n3, Levamisole, Altretamine, Cladribine, Hydroxyurea, Aldesleukin, Paclitaxel, Docetaxel,Tretinion, Procarbazine,Dacarbazine, Gemcitabine, Mitotane, Asparaginase, Pegaspargase,Porfimer Sodium
In vitro studies have shown that the metabolism of docetaxel may be modified by concomittant administration of compounds that may induce , inhibit or are metabolised by P4502AA, such as terfenadrine, ketoconazole. erythromycin and troleandomycin.
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
104. Docetaxel injection conc. 31-03-08
(Addl indication)
For additional indication -advanced squamous
cell carcinoma of head & neck, Harmone
refractory metastatic prostrate cancer,locally
advanced or metastatic breast cancer
262. Docetaxel Injection concentrate 80mg/2ml 17-12-08
(Addl.Indication)
In combination with Cisplatin and 5-Fluorouracil is
indicated for the induction treatment of patients
with locally advanced squamous cell carcinoma
of head and neck
Antineuoplastic agents include- Interferon ALFA 2a, Interferon ALFA -2b, Interferon ALFA -n3, Levamisole, Altretamine, Cladribine, Hydroxyurea, Aldesleukin, Paclitaxel, Docetaxel,Tretinion, Procarbazine,Dacarbazine, Gemcitabine, Mitotane, Asparaginase, Pegaspargase,Porfimer Sodium
Breast cancer
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Doxetaxel Injection 20-06-1996
In treatment of patients with locally advanced or metastatic breast
cancer and small lungs cancer
2.Doxetaxel Injection Conc 31-03-2008
Addl.Indication
Advanced Gastric adenocarcenoma, locally advanced Squamous
cell carcinoma of head and neck, Hormone Refractory metastatic
prostrate cancer, locally advanced or metastatic cancer
3.Doxetaxel Injection conc. 17-12-2008
80mg/2ml, 20mg/0,5ml
Addl.Indication
In combination with cisplatin and 5-Fluoracil is indicated for the
induction treatment of patients with Locally advanced squamous
cell carcinoma of the head and neck
Approved by FDA on May 14, 1996
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Docetaxel Cancer/Oncolgy Aventis 14-05-2010
Adverse Reaction:
Hypotension, Atrial fibrillation, Deep vein thrombosis, ECG abnormalities, Thrombophlebitis, Pulmonary embolism, Syncope, Tachycardia, Heart failure, Sinus tachycardia. Constipation, Ulcer. Dyspnea, Acute pulomonary edema. Abdominal pain, Diffuse pain, Chest pain, Confusion, Renal insufficiency.
Contra-Indications:
Hyersens sensitivity to the drug.
Special precautions:
Monitoring occurance of mylotoxicity. neuologic symptoms.
Asthenia - severe caes reported
Dosages/ Overdosage Etc:
Approved by FDA on May 14, 1996
Indicatons: Breast cancer
Dosage:
Recommended dose is 60 to 100mg/m2 administered IV over 1 hour every 3 weeks
Pharmacology/ Pharmacokinetics:
Pharmacology:
Doxetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of the yew plant.
Pharmacokinetics:
Docetaxel is eliminated in both urine and feces following oxidative metabolism of tert-butyl ester group.
Pregnancy and lactation:
Pregnancy:
Advise woman of child bearing potential to avoid pregnancy during therapy.
Lactation-
Mothers should discontinue nursing prior to taking the drug.
Manufacturer Details