INTRODUCTION
BIOTREXATE 500MG INJECTION contains Methotrexate which belongs to the group of medicines called Antimetabolites. It is used to treat various cancers such as acute lymphocytic lymphoma (a type of cancer of blood and bone marrow), meningeal leukaemia (a type of cancer of white blood cells), Non-Hodgkin?s Lymphoma (a type of cancer of lymphatic system), ovary cancer, head and neck region cancer, breast cancer, cervical cancer, lung cancer, bone cancer, cancer of skin-originated T-Cell Lymphoma, bladder cancer and various other cancers that are severe and unmanageable by conventional therapy.
BIOTREXATE 500MG INJECTION is also used to treat psoriasis which is severe and not manageable by other treatments.
Before receiving BIOTREXATE 500MG INJECTION it is recommended to inform the doctor about your medical and family history, including the list of medicines (prescription, non-prescription medicines and herbal medicines) that are being taken.
Also, BIOTREXATE 500MG INJECTION is not recommended to be administered to pregnant and nursing women, women planning pregnancy, those who drink huge amount of alcohol and patients suffering from liver and kidney impairment.
Caution must be exercised by the patients suffering from lung disorders, blood disorders and gastric disorders before receiving BIOTREXATE 500MG INJECTION.
Care must be taken to avoid taking products containing caffeine such as black tea, coffee and cold drinks while receiving BIOTREXATE 500MG INJECTION.
The common side can be experienced after receiving BIOTREXATE 500MG INJECTION are headache, nausea, vomiting, dizziness and altered levels of blood cells. Consult a doctor if any of the above side effects worsen after receiving BIOTREXATE 500MG INJECTION.
USES OF BIOTREXATE 500MG INJECTION
It is used to treat:
Acute lymphocytic lymphoma (ALL)
Meningeal leukaemia ?
Non-Hodgkin?s Lymphoma
Bone cancer (osteogenic sarcoma)
Advanced breast cancer
Recurrent and aggressive cancer of head and neck region
Advanced cancer of urinary bladder
Lungs cancer (bronchogenic carcinoma)
Choriocarcinoma
Severe form of psoriasis
HOW BIOTREXATE 500MG INJECTION WORKS
BIOTREXATE 500MG INJECTION contains Methotrexate which is a disease-modifying antirheumatic drug (DMARDs). It interferes with the growth of those cells in the body that reproduce quickly. As a result, the growth of those cells gets retarded thus serving as an anti-tumour agent. BIOTREXATE 500MG INJECTION decreases the undesired reactions of the body?s own immune-defence mechanism, thereby working as an effective immunosuppressant. In addition, it also exhibits anti-inflammatory effects, thereby reducing the pain, swelling and redness.
DIRECTIONS FOR USE
BIOTREXATE 500MG INJECTION will be administered to you into a muscle (intramuscularly) only by a doctor or a nurse. Your doctor will administer the correct dose and duration for you depending on your age, body weight and disease condition.
SIDE EFFECTS OF BIOTREXATE 500MG INJECTION
COMMON
Nausea
Vomiting
Headache
Fever
Subacute neurotoxicity
Loss of appetite
Inflammation in mouth and throat along with formation of ulcers
Increased levels of liver enzymes
Viral infections (herpes zoster virus)
Decrease in the level of red blood cells, white blood cells and platelets
Drowsiness
Diarrhea
Suppression of the bone marrow
Inflammation of the mucus lining of mouth (ulcerative stomatitis)
Necrotising demyelinating leukoencephalopathy (condition characterized by progressive deterioration along with irritability, confusion and excessive desire to sleep and stay awake (somnolence)
UNCOMMON
Anaphylactic reactions
Feeling confused and depressed
Convulsions
Tumor in lymph tissue
Inflammation of pancreas
Liver disorders
Complications associated with diabetes
Reduced level of protein ?
Hypersensitive skin to sunlight
Brittle bones ?
Pain in bones and muscles ?
RARE
Inflammation of the sac around the heart along with an accumulation of fluid in the sac around the heart
Mood fluctuations
Affected speech
Visual disturbances ?
Thrombosis in the cerebrum and veins of the retina
Hypotension
Asthma (difficulty breathing along with the production of wheezing sound)
Inflammation of the gingiva and small intestine
Malabsorption
Acne
Kidney problems
Abnormal development of mammary glands
Elevated levels (creatinine and urea)
Presence of blood in the urine ?
Stop receiving BIOTREXATE 500MG INJECTION and consult your doctor immediately if you experience any of the following:?
Allergic reactions such as breathlessness, difficulty breathing along with wheezing sound, swelling of face, lips, tongue, rash and itch on the skin
Weakness and/or paralysis on one side of the body
Blood clot in the leg, characterized by pain, swelling, redness and warmth in the leg
Stoke characterized by weakness or paralysis on one side of the body or face, difficulty speaking or swallowing, headache, loss of vision or balance
Temporary blindness
Dry persistent non-productive cough
Shortness of breath, wheezing, difficulty in speaking along with pain chest and coughing out blood
Onset of fits ?
Difficulty in speaking writing and understanding language
Onset of fever and chill along with body ache and sore throat
Formation of ulcers and blisters in the mouth resulting in soreness
Formation of cold sores
Severe skin rash such as blistering of skin indicative of Stevens-Johnson Syndrome
Black or tar-like stools
Presence of blood in urine and stools
Painful and frequent urination
Yellowing of skin and eyes
Unexpected bleeding such as bleeding in gums, faeces, urine
HOW TO MANAGE SIDE EFFECTS
Headache:
Stay hydrated and take rest as much as possible. Stay away from bright lights and loud sounds. Apply a pain-relieving balm on the forehead. If the headache persists or worsens, consult your doctor.
Dizziness:
Take an adequate amount of rest and sleep. Stay hydrated and replenish yourself with electrolytes. Also, do not indulge in driving and using heavy machinery as it may prove to be dangerous.
Diarrhoea:
Stick to simple meals. Avoid eating heavily rich or spicy food. Drink an oral rehydration solution to compensate for the loss of water and minerals. Stay hydrated. consult your doctor if it persists for a long or worsens with time.
Nausea or Vomiting:
Stick to simple meals. Avoid eating heavily rich or spicy food. Stay hydrated. Consult your doctor if it persists for long or worsens with time.
WARNING & PRECAUTIONS
PREGNANCY
BIOTREXATE 500MG INJECTION is not recommended if you are pregnant and/or are planning to become pregnant since it can be harmful to the foetus (growing baby) and lead to various malformations. Consult your doctor before receiving BIOTREXATE 500MG INJECTION.
BREASTFEEDING
BIOTREXATE 500MG INJECTION is not recommended if you are a nursing mother. Consult your doctor before receiving BIOTREXATE 500MG INJECTION.
DRIVING AND USING MACHINES
BIOTREXATE 500MG INJECTION is not recommended if you feel tired and/or dizzy after receiving the medicine. Consult your doctor prior to receiving BIOTREXATE 500MG INJECTION.
ALCOHOL
It is not recommended to consume alcohol while receiving BIOTREXATE 500MG INJECTION as it might increase the side effects. Consult your doctor before receiving BIOTREXATE 500MG INJECTION.
KIDNEY
BIOTREXATE 500MG INJECTION is not recommended if you are diagnosed with a severe kidney disorder. Consult your doctor before receiving BIOTREXATE 500MG INJECTION.
LIVER
BIOTREXATE 500MG INJECTION is not recommended if you are diagnosed with severe liver disorder. Consult your doctor before receiving BIOTREXATE 500MG INJECTION.
ALLERGY
BIOTREXATE 500MG INJECTION is not recommended if you are allergic to Methotrexate and/or any other constituent of BIOTREXATE 500MG INJECTION. Consult your doctor before receiving BIOTREXATE 500MG INJECTION.
LUNGS
It is recommended to exercise caution while receiving BIOTREXATE 500MG INJECTION if you are diagnosed with lung disorders. Consult your doctor before receiving BIOTREXATE 500MG INJECTION.
OTHERS
BIOTREXATE 500MG INJECTION is not recommended for use if you:
Have bone marrow diseases
Have blood disorders
Have decreased level of iron in blood ?
Have infections and/or infectious disease
Are receiving vaccinations containing live vaccines, radiation therapy (Ex. X-rays, UV Rays)
Have stomach ulcers
Have ulcerative colitis
Have certain immunodeficiency syndromes
Before receiving BIOTREXATE 500MG INJECTION, inform your doctor if you:
Are receiving treatment in the spine that may cause inflammation in spine
Are diagnosed with conditions that can lead to the retention of fluid in the body organs
Use in pediatrics:
BIOTREXATE 500MG INJECTION is recommended to be used with caution in children. Your doctor will administer the right dose depending on your child?s age, body weight and disease condition. Consult the doctor before receiving BIOTREXATE 500MG INJECTION.
Use in geriatrics:
BIOTREXATE 500MG INJECTION is recommended to be administered with caution and in a lower dosage to elders due to diminished function of liver and kidneys and reduced folate levels in blood. Consult the doctor before receiving BIOTREXATE 500MG INJECTION.
INTERACTIONS
A. Drug-Drug Interactions:
Before receiving BIOTREXATE 500MG INJECTION, inform your doctor if you are taking any of the following medicine:
Medicines used to treat diabetes (Ex. sulphonylureas)
Medicines used to treat various skin and autoimmune diseases (Ex. para aminobenzoic acid)
Medicines used to remove excess fluid and water from the body (Ex. frusemide)
Medicines used to treat epilepsy (Ex. phenytoin)
Medicines used in organ transplantation to prevent organ rejection (Ex. azathioprine)
Medicines used as supplements?
Medicines used to treat pain and inflammations (Ex. aspirin)?
Other medicines used to treat Rheumatoid arthritis and psoriasis (Ex. leflunomide, phenylbutazone or amidopyrine)
Medicines used to treat gout (Ex. Probenecid, allopurinol)
Medicines used to treat asthma (Ex. theophylline)
Medicines used to treat increased cholesterol level (Ex. cholestyramine)
Medicines used to treat heart problems (Ex. amiodarone)
Medicines used to treat Crohn?s disease (Ex. sulfasalazine)
Medicines used to treat severe heartburn or ulcers (Ex. omeprazole)
Medicines used to treat skin conditions (Ex. acitretin)
Medicines used to treat malaria (Ex. pyrimethamine)
Medicines used to treat severe conditions such as psoriasis along with ultraviolet light in PUVA Therapy (Ex. methoxsalen)
Medicines used to treat infections (Ex. amoxicillin, ciprofloxacin)
Medicines used as vaccination (Ex. live vaccines such as MMR vaccine)
B. Drug- Food Interactions:
It is recommended to avoid the consumption of drinks containing caffeine such as black tea, coffee, soft drinks to prevent dehydration.
Overdosage:
BIOTREXATE 500MG INJECTION will be administered only by a doctor or nurse in a hospital, and so it is unlikely to receive an overdose, if you experience any unusual reactions, contact your doctor immediately. Symptoms of overdosage with BIOTREXATE 500MG INJECTION are nausea, vomiting, along with the development of mouth sores, black tarry or bloody stools and severe infections.
SYNOPSIS
Drug :?? Methotrexate
Pharmacological Category :?? Anti-metabolites
Therapeutic Indication :?? Cancers and Severe Psoriasis
Dosage Forms :?? Injection, Gel, Capsule, Tablet
MORE INFORMATION
Keep BIOTREXATE 500MG INJECTION out of the reach and sight of children
Store BIOTREXATE 500MG INJECTION at a temperature below 25?C
FAQs ABOUT BIOTREXATE 500MG INJECTION
What is BIOTREXATE 500MG INJECTION used for?
BIOTREXATE 500MG INJECTION is used to treat various cancers such as acute lymphocytic lymphoma (ALL), meningeal leukaemia, Non-Hodgkin?s Lymphoma, cancer of the ovary,? cancer of head and neck region, breast cancer, cancer of cervix, cancer of lungs, cancer of bones, cancer of skin-originated T-Cell Lymphoma, cancer of the bladder and various other cancers that are severe and unmanageable by conventional therapy. BIOTREXATE 500MG INJECTION is also used to treat psoriasis that is not manageable by other treatments and is very severe.
Can I receive BIOTREXATE 500MG INJECTION in pregnancy?
BIOTREXATE 500MG INJECTION is not recommended for use in pregnant women and/or in women who are planning pregnancy because it can be harmful for the foetus (growing baby in the womb). Consult your doctor before receiving BIOTREXATE 500MG INJECTION.
Can I receive BIOTREXATE 500MG INJECTION if I am breastfeeding a baby?
BIOTREXATE 500MG INJECTION is not recommended for nursing mothers due to a lack of safety data. Consult your doctor before receiving BIOTREXATE 500MG INJECTION.
Can BIOTREXATE 500MG INJECTION be used by children?
BIOTREXATE 500MG INJECTION is recommended to be used with caution in children. Consult the doctor before receiving BIOTREXATE 500MG INJECTION.
Can BIOTREXATE 500MG INJECTION be used by the elderly?
BIOTREXATE 500MG INJECTION is recommended to be administered with caution and in a lower dosage to elders due to diminished function of the liver and kidneys and reduced folate levels in the blood. Consult the doctor before receiving BIOTREXATE 500MG INJECTION.
Is there any specific food to avoid while receiving BIOTREXATE 500MG INJECTION?
It is recommended to avoid the consumption of drinks containing caffeine such as black tea, coffee, soft drinks along with BIOTREXATE 500MG INJECTION to prevent dehydration.
REFERENCES
1. KD Tripathi. Anticancer Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page ? 857.
2. Hao, F., Lee, R.J., Yang, C., Zhong, L., Sun, Y., Dong, S., Cheng, Z., Teng, L., Meng, Q., Lu, J. and Xie, J., 2019. Targeted Co-delivery of siRNA and methotrexate for tumor therapy via mixed micelles. Pharmaceutics. [Published on 21st February 2019] [Accessed on 27th October 2022] https://www.mdpi.com/1999-4923/11/2/92
3. Sandoz Pty Ltd. [Revised in July 2022] [Accessed on 27th October 2022] https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2012-CMI-01899-3&d=20221026172310101
4. Sandoz Pty Ltd. [Revised on 8th July 2022]? [Accessed on 27th October 2022] https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2011-PI-03245-3&d=20221020172310101
5. Taj Pharmaceuticals Limited. [Revised on N.A] [Accessed on 27th October 2022] https://tajpharma.in/portfolio-item/methotrexate-injection-ip-1000mg-10ml-imutaj-taj-pharma/
USEFUL DIAGNOSTIC TESTS
Liver Function Tests
Kidney Function Tests
Complete Blood Count
PRODUCT DETAILS
Net Qty
1 N
Ingredient
METHOTREXATE SODIUM 500MG
Hsn Code
30049042
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