Carbotin-450mg

Carbotin 450 Carton

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Product Description

Description
Carbotin® (Carboplatin BP), injection is supplied as lyophilized powder. After reconstitution, the solution will contain 10 mg/mL carboplatin. Carbotin is a platinum coordination compound. Its chemical name is platinum, diammine[1,1-cyclobutanedicarboxyl to(2-)-O,O′]-, (SP-4-2). Carbotin is a crystalline powder with the
molecular formula of C6H12N2O4Pt. Its molecular weight is 371.25 and is soluble in water and the following structural formula is:
Composition
Each vial contains Carboplatin BP 150 mg and 450 mg lyophilized powder for injection.
Mechanism of action
Carbotin® causes inter and intra strand crosslink of the DNA double helix and inhibits the process of cell division by forming covalent bond.
Pharmacokinetics
Bioavailability Complete Protein binding Very low

Metabolism Hepatic
Half-life 1.1-2 hours
Excretion Hepatic
Indications
Carbotin® is indicated for the treatment of sub optimally debulked ovarian cancer, non-small cell lung cancer, extensive stage small cell lung cancer, head and neck cancer.
10 Inj.
Carboplatin BP 150 mg & 450 mg 11
Dosage and administration
Area- under- the- curve (AUC) dosing is generally preferred. Target AUC is commonly 4 to 6, depending on previous treatment andm other drugs to be used. Administration dose (mg) = (target AUC) x ([creatinine clearance] + 25). Administration dose is given by I.V. infusion over 15 to 60 min and repeated every 3 to 4 weeks. 300 to 400 mg/m2 I.V. by infusion over 15 to 60 min or longer, repeated every 3 to 4 weeks. Higher doses up to 1600 mg/m2 divided over several days have been used followed by stem cell rescue.
Possible side effects
Bone marrow suppression, gastrointestinal effects, nephrotoxicity, nervous system, ototoxicity, allergic reactions, alopecia, mucositis.
Contraindications
Carboplatin injection should not be employed in patients with severe bone marrow depression or significant bleeding. It is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum containing compounds.
Drug interactions
Administration of a liver vaccine may be dangerous during treatment with carboplatin. The renal effects of nephrotoxic compounds may be potentiated by carboplatin.
Special precautions
Much less renal toxicity than cisplatin so no need for a vigorous hydration schedule or forced diuresis. If AUC dosing is not used, dose should be reduced to 250 mg/m2 for creatinine clearance of 41 to 59 mL/min and to 200 mg/m2 for clearance of 16 to 40 mL/min. Corticosteroids & antihistamines are employed to alleviate symptoms.
Reconstitution
Carboplatin 450 mg injection should be reconstituted with 45 mL of sodium chloride solution (0.9%) or water for injection. The reconstituted solution should be diluted by 300 mL (for 150 mg) & 900 mL (for 450 mg) of 5% glucose for injection or 0.9% sodium
chloride solution for infusition.
Stability
Reconstituted solution is stable for 8 hours at controlled room temperature 25oC. Reconstituted solution does not contain any preservative, unused solution must be discarded 8 hours after reconstitution.
Storage
Product should be stored at controlled room temperature 25oC and protected from light.
Presentations
Carbotin® 450 mg injection: Each vial contains lyophilized power of Carboplatin BP

450 mg.

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