Product Code: L01AX03
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 What are the Ingredients of Temodar? What does Temodar contain?

Temodal contains the active substance temozolomide, which inhibits the growth of tumor cells, and is used:

- as sole therapy in certain brain tumors (glioblastoma multiforme, anaplastic astrocytoma), which have recurred;

- in combination with radiotherapy for a specific first occurring brain tumor (glioblastoma multiforme).

Treatment with Temodal must be on prescription only and must be monitored regularly.

The active substance of Temodar is Temozolomide.

Titanium dioxide and black iron oxide (E172) are the supporting ingredients. 
What is Temodar used for? What are the Indications of Temodar?
Temodar is advised to the patients, who have recurrent malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma.  Temodar is also suggested for the treatment of people who suffer from metastatic malignant melanoma.

What are the Contraindications of Temodar? 

It is contraindicated in patients with Temodal components or with the patients who faced hypersensitivity reactions to dacarbazine (DTIC) in the past. It is also contraindicated with people living severe myelosuppression.  It is not used in pregnant or nursing women. 

What are the Warnings / Precautions for Temodar?

For the patients facing recurrent malignant glioma with fainting or other disease or infection, the decision should be taken after doing benefit and risk assessment for the patient.  

How is Temodar used for patients with liver or renal dysfunction? 

Temozolomidine pharmacokinetics is comparable for people who have normal hepatic function and people with mild to moderate hepatic dysfunction. No observation was done on use of Temodar in patients with severe hepatic dysfunction or patients with impaired renal function. Due to the pharmacokinetic properties of temozolomide, it is not required to implement dose reduction in patients with severe liver or renal dysfunction. Nevertheless, the patient and the doctor should pay attention after disease is seen.

Patients with severe vomiting (grade 3 or 4) can need antiemetic treatment before starting Temodar.

How Temodar is used in the child patients (Pediatric Use)?

There is no clinical observation of usage of Temodar in kid patients, who are younger than 3 years old. Moreover, the observation for kids older than 3 is also limited. There is no clinical experience with the use of malignant melanoma in patients under the age of eighteen. 

How Temodar is used in old patients?

Patients who are older than 70 are considered to have increased risk of neutropenia and thrombocytopenia compared to younger people. Therefore, the doctor and the patient should be cautious in using Temodar if the patient is older than 70. 

Can Temodar be used during Pregnancy and breastfeeding?

Under normal conditions, Temodar should not be given to the women who are pregnant. The patient should be explained and informed about the potential risks of the fetus. If a women uses Temodar, she is advised to avoid pregnancy untill 6 months after the end of use of Temodar. It should not be used in women who are breastfeeding. The serches do not show whether it can be in the breast milk or not. 

How is Temodar used in Male patients?

Effective contraception is reqired in men receiving Temodar. Temozolomidine can give genotoxic effects. Therefore, male patients who are treated with temozolomide should be advised to freeze their sperm before the treatment starts because of the possibility of irreversible infertility. It is due to the temozolomide treatment during real treatment. The period to await is 6 months after the end of treatment.

Does Temodar have Effects car, vehicle and machine use?

Patients using Temodar feel fatigue and somnolence. Therefore, ability to drive can impair. 

What are the Side effects / Adverse effects of Temodar?

The mostly observed side effect in clinical trials is gastrointestinal disorders suc as nausea (43%) and vomiting (36%). Severe nausea and vomiting are observed at 4% of the patients.  Some other side effects were 
- Fatigue (22%)
- Constipation (17%)
- Headache (14%)
- Anorexia (11%)
- Diarrhea (8%)
- Rash (6%)
- Fever (6%)
- Somnolence (6% each) 
- Asthenia ((between 2% and 5%)
- Abdominal pain and oher pains (between 2% and 5%)
- Dizziness (between 2% and 5%) 
- Weight loss (between 2% and 5%)
- Dyspnea (between 2% and 5%)
- Dyspepsia (between 2% and 5%)
- Alopecia (between 2% and 5%)
- Rigor (between 2% and 5%)

How Temodar is used? 

How Temodar is used in Adult patients?

In patients who have not received prior chemotherapy, Temodar is advised at a dose of 200 mg / m2 once daily for 5 days on a 28 day cycle from oral route. In patients who have already got chemotherapy, the initial dose is 150 mg / m2 once a day and this dose is increased to 200 mg / m2 per day. On the first day of the next cycle, the absolute neutrophil count (MNS) should be equal to or greater than 1.5 x 109 / l and the platelet count should be equal to or greater than 100 x 109 / l.  

How Temodar is used in Pediatric patients (Kids)?

Temodar is delivered in a dose of 200 mg / m2 for 5 days in 28-day cycles on oral route in patients 3 years and older. In patients without prior chemotherapy, initial doses should be 150 mg / m2 once daily for 5 days, and if there is no hematological toxicity, the next cycle should be increased to 200 mg / m2 once a day.  

How Temodar is used in Elderly patients (Old People)?

In spite of the fact that temozolomide clearance age is not affected by pharmacokinetic analyzes, the doctor and the patient should be cautious if the patient is above 70. 

Temodar should be given on an empty stomach at least one hour before taking the meals. Antiemetic treatment can be performed before or after application. If vomiting occurs following the use of Temodar, a second dose should not be given on the same day.  Temodar can be used for 2 years until the disease progresses.  

The capsules should not be opened or chewed but should be swallowed in one piece with a glass of water. 

What happens if Temodar is taken overdose?

At single doses up to 1000 mg / m2, the expected effects of neutropenia and thrombocytopenia were observed. In case of overdose, hematological evaluation and, if necessary, general supportive measures are suggested. 

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