Zolomide - Capsule Temozolomide Hydrochloride - 100mg 1 Capsule(s) / Capsule EDCL Introduction: Zolomide is used in the treatment of a specific type of cancer of the brain. It is used to treat brain tumors if they return or get worse after standard treatment. It may be also used to treat other conditions, as determined by the doctor. Zolomide should be taken empty stomach and at same time each day to make sure it has the best effect. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should... Uses of Zolomide: Brain tumor Side effects of Zolomide: NauseaVomitingConstipationHeadacheFatigueConvulsionCoordination disorderDiarrheaDizzinessFeverHair lossHemiparesis (weakness on one side of the body)Insomnia (difficulty in sleeping)Loss of appetiteMemory lossRashViral infectionWeakness How to use Zolomide: Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Zolomide is to be taken empty stomach. How Zolomide works: Zolomide is an anti-cancer medication. It enters the brain tissues and works by damaging the genetic material (DNA and RNA) of the cancer cells. This stops their growth and multiplication. What if you forget to take Zolomide?: If you miss a dose of Zolomide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Indication: Glioblastoma multiforme, Malignant gliomas, Metastatic melanoma Administration: Should be taken on an empty stomach. Take on an empty stomach at least 1 hr before meals. Swallow capsules whole with a full glass of water on an empty stomach or at bedtime. Do not take a 2nd dose if capsules are vomited. Adult Dose: Oral Glioblastoma multiforme Adult: 75 mg/m2 once daily for 42 days with focal radiotherapy (concomitant phase). Do not reduce dose during concomitant phrase but interrupt or discontinue therapy depending on toxicity. Continue if absolute neutrophil count (ANC)> 1.5x109/L, thrombocyte count >100x109/L and Common Toxicity Criteria (CTC) non-haematological toxicity 1.5x109/L, thrombocyte count >100x109/L and CTC non-haematological toxicity for cycle 1 is 1500 mm³ and platelets >100,000 mm³ Infuse IV over 90 minutes Dosage modifications Measure ANC and platelet on days 22 & 29 (day 1 of next cycle); modify dose for following cycle if: ANC 1000-1500/mm³ or platelet 50,000-100,000/mm³: Postpone treatment... Child Dose: Oral Recurrent or progressive malignant gliomas Child: >3 yr: Previously untreated with chemotherapy: 200 mg/m2 once daily for 5 days, followed by a 23 day break (1 cycle). Previously treated with chemotherapy: 150 mg/m2 daily for 5 days followed by 23 day break (1 cycle) increased to 200 mg/m2 for the 2nd cycle if there is no haematological toxicity. Contraindication: Hypersensitivity to dacarbazine. Severe myelosupression. Pregnancy. Mode of Action: Temozolomide, a triazene, is an inactive prodrug. It is chemically hydrolysed to 3-methyl-(triazen-1-yl) imidazole-4-carboxamide (MTIC), the active metabolite of dacarbazine. The cytotoxicity of MTIC is believed to be due alkylation of DNA, mainly at the O6 and N7 positions of guanine. Precaution: Severe hepatic and renal impairment. Elderly >70 yr, children. Women of child bearing potential should avoid becoming pregnant during therapy. Males should be advised not to father a child up to 6 mth after treatment and to consider cryoconservation of sperms due to possibility of irreversible infertility. May impair ability to drive or operate machinery. Monitor CBC wkly during concomitant therapy and on day 22 of each 28 day treatment cycle, followed by wkly blood count until recovery. Hepatitis screening and prophylactic therapy with antiviral agents as clinically indicated to be considered. Prophylaxis for Pneumocystis jiroveci (or Pneumocystis carinii) pneumonia... Side Effect: >10% Alopecia (55-69%),Lymphopenia (55%),Nausea (53%),Vomiting (42%),Headache (41%),Fatigue (34%),Constipation (33%),Anorexia (9-27%),Convulsions (23%),Thrombocytopenia (19%),Rash (8-19%),Hemiparesis (18%),Diarrhea (16%),Neutropenia (14%),Fever (13%),Asthenia (13%),Dizziness (12%),Peripheral edema (11%),Viral infections (11%) 1-10% (selected) Amnesia (10%),Insomnia (10%),Abdominal pain (5-9%),Ataxia (8%),Back pain (8%),Paresis (8%),URI (8%),Urinary incontinence (8%),UTI (8%),Abnormal vision (5-8%),Pruritus (5-8%),Breast pain (6%),Depression (6%),Confusion (5%),Myalgia (5%),Weight gain (5%),Anemia (4%),Erythema (1%) Interaction: Valproic acid, other myelosuppressive agents.