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INTRODUCTION

TEMZOL 20MG CAPSULE contains Temozolomide which belongs to the group of medicines called Antineoplastic agents. TEMZOL 20MG 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 TEMZOL 20MG CAPSULE, inform your doctor if you have or ever had hepatitis B infection (serious liver infection).

TEMZOL 20MG 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.

TEMZOL 20MG 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 TEMZOL 20MG CAPSULE.

The most common side effects of taking TEMZOL 20MG 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 TEMZOL 20MG 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 TEMZOL 20MG CAPSULE WORKS

TEMZOL 20MG 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 TEMZOL 20MG CAPSULE as advised by your physician. Swallow TEMZOL 20MG 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 TEMZOL 20MG 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 TEMZOL 20MG 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 TEMZOL 20MG 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 TEMZOL 20MG CAPSULE. If headaches last more than a week or severe, consult and inform your doctor.

Nausea and Vomiting:

Try to take TEMZOL 20MG 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

TEMZOL 20MG 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 TEMZOL 20MG CAPSULE.

BREASTFEEDING

TEMZOL 20MG CAPSULE is not recommended for use in breastfeeding women. Consult your doctor before taking TEMZOL 20MG CAPSULE.

DRIVING AND USING MACHINES

TEMZOL 20MG CAPSULE may cause tiredness or sleepiness. If you experience any such effects avoid driving and using machines. Consult your doctor before taking TEMZOL 20MG CAPSULE.

KIDNEY

TEMZOL 20MG CAPSULE should be used with caution in patients with kidney problems such as severe renal impairment. Consult your doctor for advice before taking TEMZOL 20MG CAPSULE.

LIVER

TEMZOL 20MG CAPSULE should be used in patients with mild, moderate, and severe hepatic impairment. Consult your doctor for advice before taking TEMZOL 20MG CAPSULE.

ALLERGY

Do not take TEMZOL 20MG CAPSULE is not recommended for use if you are allergic to Temozolomide or any of the other ingredients of this medicine.

LUNGS

TEMZOL 20MG 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 TEMZOL 20MG CAPSULE.

OTHERS

TEMZOL 20MG 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 TEMZOL 20MG 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:

TEMZOL 20MG 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 TEMZOL 20MG CAPSULE. Consult your doctor before taking TEMZOL 20MG CAPSULE.

Use in geriatrics:

TEMZOL 20MG CAPSULE should be used with caution in elderly patients (aged 70 years or above). Consult your doctor before taking TEMZOL 20MG CAPSULE.

INTERACTIONS

A. Drug-Drug Interactions:

Before taking TEMZOL 20MG 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 TEMZOL 20MG 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 TEMZOL 20MG CAPSULE at room temperature

FAQs ABOUT TEMZOL 20MG CAPSULE

What TEMZOL 20MG CAPSULE is used for?

TEMZOL 20MG 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 TEMZOL 20MG CAPSULE be taken?

Take TEMZOL 20MG CAPSULE as advised by your physician. Swallow TEMZOL 20MG 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 TEMZOL 20MG CAPSULE?

The most common symptoms of taking TEMZOL 20MG 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 TEMZOL 20MG CAPSULE?

If you forget to take TEMZOL 20MG 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 TEMZOL 20MG CAPSULE if you have queries on the missed dose.

Is TEMZOL 20MG CAPSULE safe to use in children?

TEMZOL 20MG 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 TEMZOL 20MG CAPSULE. Consult your doctor before taking TEMZOL 20MG 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

AUTHOR DETAILS

Written By Dr. Janet.C, Pharm.D
Last updated on 12 Nov 2022 | 05:57 PM(IST)

PRODUCT DETAILS

    Net Qty
    1 N
    Ingredient
    TEMOZOLOMIDE 20 mg
    Hsn Code
    30049095
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The contents of this website are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. Do not disregard professional medical advice or delay in seeking it because of something you have read on this website.