Cyclophosan

Each vial contains: Cyclophosphamide Monohydrate equivalent to Cyclophosphamide Anhydrous 200 mg and 1,000 mg.

Pharmacology: Cyclophosphamide is an antineoplastic agent which has alkylating effect. Its active ingredient is beta-chloroethyl, linked to a cyclic phosphamide group. The compound as such is inert but phosphamidase enzymes occurring in high amounts in neoplastic tissue are capable of accomplishing the cleavage of the active group.

Malignant tumours such as pulmonary carcinoma, mammary carcinoma, ovarian carcinoma. Malignant lymphogranulomatosis, lymphosarcoma, reticulum cell sarcoma, leukemias and multiple myeloma.

Dosage: The dosage regimen should be tolerated to the individual requirements of the patient, depending on his general condition, concurrent therapy, the type and state of tumour, and the patient's response.
Three sample regimens may serve as guides: Low dose: 80 to 240 mg/m² body surface (2 to 6 mg/kg body weight), as a single dose weekly i.v. or in divided doses orally.
Medium dose: 400 to 600 mg/m² body surface (10 to 15 mg/kg body weight), as a single dose weekly i.v.
High dose: 800 to 1,600 mg/m² body surface (20 to 40 mg/kg body weight), as a single dose i.v. at 10-20 day intervals.
Higher doses should be used only at the discretion of a physician experienced in cytotoxic chemotherapy.
Direction for Use: Reconstitute with 10 mL sterile water for injection for 200 mg of Cyclophosphamide. Shake vigorously. Do not warm.
Concentration after Reconstitution: Each mL contains 21.4 mg Cyclophosphamide Monohydrate equivalent to 20 mg Cyclophosphamide Anhydrous.

Bone marrow disorders; Hypersensitivity and haemorrhagic cystitis; Patients who are pregnant or mothers who are breast feeding.

Cyclophosphamide should be given cautiously to patients with any of the following conditions: Leukopenia; Thrombocytopenia; Tumour cell infiltration on bone marrow; Previous X-ray therapy; Previous therapy with other cytotoxic agents; Impaired hepatic function; Impaired renal function.
Cyclophosphamide may induce permanent sterility in children.

Nausea and vomiting may occur. Loss of hair is relatively common. The most serious side effect is bone marrow depression (leukopenia, thrombocytopenia). Because of this, the white blood cell count (and possibly also the number of thrombocytes) should be controlled sufficiently often during the treatment. Usually a control performed once a week or once every two weeks is adequate. With a small dosage, a control performed less frequently may be sufficient, if the white blood cell count is stable. The control of thrombocytes is necessary only when the number of leukocytes is low.
Other possible side effects include amenorrhea, azospermia and sterile haemorrhagic cystitis. Cystitis can be avoided by large amounts of liquid.
Alopecia; Bladder fibrosis and carcinoma have been reported after long term use of cyclophosphamide; Liver disfunction; Hyperpigmentation; Oral ulceration.

Store between 2°C-8°C. Away from light and heat.
After reconstitution the solution stable for 2-3 hours at temperature below 25°C.

Cytotoxic Chemotherapy

L01AA01 - cyclophosphamide ; Belongs to the class of alkylating agents, nitrogen mustard analogues. Used in the treatment of cancer.

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