INTRODUCTION
GLIOTEM 100MG CAPSULE contains Temozolomide which belongs to the group of medicines called Antineoplastic agents. GLIOTEM 100MG CAPSULE is used to treat specific forms of brain tumors in adults with newly diagnosed glioblastoma multiforme which is used first together with radiotherapy as a concomitant phase of therapy and then used alone as a monotherapy.
It is also used in children (above 3 years) and adults to treat malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma if they return or get worse after standard treatment.
Glioblastoma multiforme is an aggressive type of cancer that affects the brain or spinal cord which is generally characterized by symptoms such as headache, nausea, drowsiness, blurred vision, personality changes and seizures.
Along with this treatment, your doctor might advise you to take liver function tests to assess the hepatotoxicity (injury to liver due to exposure to drug) and function of your liver.?
Before taking GLIOTEM 100MG CAPSULE, inform your doctor if you have or ever had hepatitis B infection (serious liver infection).
GLIOTEM 100MG CAPSULE is not recommended for use if you have certain kinds of blood cells which are severely reduced such as white blood cell and platelet count.
GLIOTEM 100MG CAPSULE should be used with caution during pregnancy only if it is clearly necessary and not recommended for use in breastfeeding women.
It is not recommended for use in children below 3 years of age and should be used with caution in children and adolescents (from 3 to 18 years of age). Consult your doctor before taking GLIOTEM 100MG CAPSULE.
The most common side effects of taking GLIOTEM 100MG CAPSULE are loss of appetite, difficulty while speaking, headache, vomiting, nausea, diarrhea, and constipation. Consult and inform your doctor if any of these symptoms gets worse.
USES OF GLIOTEM 100MG CAPSULE
It is used to treat:
Specific forms of brain tumors in with newly diagnosed glioblastoma multiforme (in adults)
Malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma (in adults and children)
HOW GLIOTEM 100MG CAPSULE WORKS
GLIOTEM 100MG CAPSULE works by damaging the genetic material (DNA and RNA) of the cancer cells inside the brain cells which results in preventing their cell growth and multiplication thereby preventing the spread of the cancer to other parts of the body.
DIRECTIONS FOR USE
Take GLIOTEM 100MG CAPSULE as advised by your physician. Swallow GLIOTEM 100MG CAPSULE with a glass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF GLIOTEM 100MG CAPSULE
COMMON
Loss of appetite
Difficulty while speaking
Headache
Vomiting, nausea
Diarrhea
Constipation
Rash
Hair loss
Tiredness
Infections, oral infections
Feeling sick, extreme tiredness, loss of appetite (signs of neutropenia)
Fever, cough, runny nose (signs of lymphopenia)
Prolonged cuts, bleeding from gums, blood in urine (signs of thrombocytopenia)
Allergic reactions
Memory impairment
Depression, anxiety, confusion, sleeplessness
Difficulty concentrating
Dizziness
Visual disturbances
Deafness, ringing in the ears, earache
Blood clot in lung or legs
High blood pressure
Shortness of breath
Bronchitis
Cough and cold
Inflammation of your sinuses
Stomach or abdominal pain
Dry skin, itching
Muscle damage, muscle aches and pain, muscle weakness
Joint and back pain
Frequent urination
Fever
Flu-like symptoms such as chills, cough, fever, muscle aches
Pain
Fluid retention
Weight gain or loss
Radiation injury such as weakness, hair loss, and bloody vomit
UNCOMMON
New or reactivated cytomegalovirus infections such as chickenpox, herpes simplex
Signs of reactivated hepatitis b virus infections such as abdominal pain, dark urine, fever, and joint pain
Secondary cancers including leukemia (blood cancer)
Reduced blood cell counts such as pancytopenia
Red spots under the skin
Signs of diabetes insipidus
Piles
Dry mouth
Blisters on body or in mouth
Skin peeling, skin eruption, painful reddening of the skin, severe rash with skin swelling
Increased sensitivity to sunlight
Urticaria (red, itchy skin)
Increased sweating
Change in skin color
Vaginal bleeding or irritation
Absent or heavy menstrual periods
Breast pain
Sexual impotence
Shivering
RARE
Stop taking GLIOTEM 100MG CAPSULE and contact your doctor if you experience any of the following side effects:?????????????????? ???? ??????????? ???????????
Signs of a severe allergic (hypersensitive) reaction such as itchy red skin, wheezing or other breathing difficulty
Uncontrolled bleeding
Seizures (fits)
Fever and symptoms of infections such as cough, chills, sweat
Chills
Severe headache ?
HOW TO MANAGE SIDE EFFECTS
Constipation:
Try to eat? high-fiber foods such as vegetables, cereals, fresh fruit, and drink plenty of water. Consult and inform your doctor for receiving alternate treatments for constipation.
Dizziness:
Try to rest and get enough sleep. Try to avoid driving or operating any tools or machines while you feel dizzy. Limit consumption of alcohol, as it can aggravate dizziness. Consult and inform your doctor if the symptom does not improve.
Headache:
If GLIOTEM 100MG CAPSULE causes headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of taking GLIOTEM 100MG CAPSULE. If headaches last more than a week or severe, consult and inform your doctor.
Nausea and Vomiting:
Try to take GLIOTEM 100MG CAPSULE with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if symptom gets worse.
Diarrhea:
Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to treat diarrhea, consult and inform your doctor if the symptom gets worse.
WARNING & PRECAUTIONS
PREGNANCY
GLIOTEM 100MG CAPSULE should be used with caution in pregnant women only if it is clearly necessary. Women with childbearing potential should use effective contraceptive precautions which should be continued for at least 6 months following the completion of treatment. Consult your doctor before taking GLIOTEM 100MG CAPSULE.
BREASTFEEDING
GLIOTEM 100MG CAPSULE is not recommended for use in breastfeeding women. Consult your doctor before taking GLIOTEM 100MG CAPSULE.
DRIVING AND USING MACHINES
GLIOTEM 100MG CAPSULE may cause tiredness or sleepiness. If you experience any such effects avoid driving and using machines. Consult your doctor before taking GLIOTEM 100MG CAPSULE.
KIDNEY
GLIOTEM 100MG CAPSULE should be used with caution in patients with kidney problems such as severe renal impairment. Consult your doctor for advice before taking GLIOTEM 100MG CAPSULE.
LIVER
GLIOTEM 100MG CAPSULE should be used in patients with mild, moderate, and severe hepatic impairment. Consult your doctor for advice before taking GLIOTEM 100MG CAPSULE.
ALLERGY
Do not take GLIOTEM 100MG CAPSULE is not recommended for use if you are allergic to Temozolomide or any of the other ingredients of this medicine.
LUNGS
GLIOTEM 100MG CAPSULE should be used with caution in patients with lung disease such as pneumocystis jirovecii pneumonia (serious fungal infection of lungs). Consult your doctor before taking GLIOTEM 100MG CAPSULE.
OTHERS
GLIOTEM 100MG CAPSULE is not recommended for use if you:
Have certain kinds of blood cells which are severely reduced such as white blood cell and platelet count
Before taking GLIOTEM 100MG CAPSULE, inform your doctor if you:??? ????? ??????????? ??????????? ??????????????????? ???????????
Have signs of anemia (low red blood cell count)
Have signs of low platelet count
Small risk of other changes in blood cells such as leukemia (blood cancer)
Use in pediatrics:
GLIOTEM 100MG CAPSULE is not recommended for use in children below 3 years of age. There is limited information in patients over 3 years of age who have taken GLIOTEM 100MG CAPSULE. Consult your doctor before taking GLIOTEM 100MG CAPSULE.
Use in geriatrics:
GLIOTEM 100MG CAPSULE should be used with caution in elderly patients (aged 70 years or above). Consult your doctor before taking GLIOTEM 100MG CAPSULE.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking GLIOTEM 100MG CAPSULE, inform your doctor, if you are taking any of the following medicine:
Dacarbazine (used to treat cancer of the lymph system and malignant melanoma (a type of skin cancer)
Overdosage:
If you or anyone else accidentally takes too much of GLIOTEM 100MG CAPSULE, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
Drug :?? Temozolomide
Pharmacological Category :?? Antineoplastic agents
Therapeutic Indication :?? Glioblastoma multiforme, Anaplastic astrocytoma
Dosage Forms :?? Capsule, Tablet, Injection
MORE INFORMATION
Keep the medicine out of reach in children
Store GLIOTEM 100MG CAPSULE at room temperature
FAQs ABOUT GLIOTEM 100MG CAPSULE
What GLIOTEM 100MG CAPSULE is used for?
GLIOTEM 100MG CAPSULE is used to treat specific forms of brain tumors in adults with newly diagnosed glioblastoma multiforme which is used first together with radiotherapy as a concomitant phase of therapy and then used alone as a monotherapy.
How should GLIOTEM 100MG CAPSULE be taken?
Take GLIOTEM 100MG CAPSULE as advised by your physician. Swallow GLIOTEM 100MG CAPSULE with a glass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
What are the side effects of GLIOTEM 100MG CAPSULE?
The most common symptoms of taking GLIOTEM 100MG CAPSULE are loss of appetite, difficulty while speaking, headache, vomiting, nausea, diarrhea, and constipation. Consult and inform your doctor if any of these symptoms gets worse.
What happens if you forget to take GLIOTEM 100MG CAPSULE?
If you forget to take GLIOTEM 100MG CAPSULE at the usual time, take your dose as soon as possible and then continue with your medication at the usual times. Avoid taking a double dose to make up for forgotten individual doses. Consult and inform your doctor before taking GLIOTEM 100MG CAPSULE if you have queries on the missed dose.
Is GLIOTEM 100MG CAPSULE safe to use in children?
GLIOTEM 100MG CAPSULE is not recommended for use in children below 3 years of age. There is limited information in patients over 3 years of age who have taken GLIOTEM 100MG CAPSULE. Consult your doctor before taking GLIOTEM 100MG CAPSULE.
REFERENCES
1. KD. Tripathi. Anticancer Drugs. Seventh edition. 2013. Page ? 858.
2. J.R. Wesolowski, P. Rajdev, and S.K. Mukherji. Temozolomide (Temodar). ?NIH National Library of Medicine, National center for biotechnology information. PMC PubMed Central. September 2010 [Accessed on 15th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7966084/
3. SP Labo N.V. Electronic medicines compendium (EMC). [Revised in August 2021] [Accessed on 15th June 2022] https://www.medicines.org.uk/emc/files/pil.1463.pdf
4. Merck & Co., Inc. TEMODAR. [Revised in November 2019] [Accessed on 15th June 2022] https://www.merck.com/product/usa/pi_circulars/t/temodar_capsules/temodar_pi.pdf
USEFUL DIAGNOSTIC TESTS
Liver function test
PRODUCT DETAILS
Net Qty
1 N
Item Weight
20 g
Ingredient
TEMOZOLOMIDE 100MG
Hsn Code
30049049
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