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INTRODUCTION

FOLITRAX 50MG INJECTION contains Methotrexate which belongs to the group of medicines called Antimetabolites. FOLITRAX 50MG INJECTION is used to treat active rheumatoid arthritis in adults. It is also used to treat its polyarthritic forms (characterized by the involvement of five or more joints) which is severe, active and idiopathic in nature and affects young people (Juvenile Idiopathic Arthritis – JIA). FOLITRAX 50MG INJECTION is also used to treat psoriasis.

In addition, FOLITRAX 50MG INJECTION is also used to treat Crohn’s disease and various cancers such as acute lymphocytic lymphoma, Non-Hodgkin’s Lymphoma, breast cancer, cervical cancer, and bladder cancer etc.

Rheumatoid arthritis is an autoimmune and inflammatory disease, which means that your immune system attacks healthy cells in your body by mistake, causing inflammation (painful swelling) in the affected parts of the body. Psoriasis is a skin condition characterized by itchy scales, that is not responsive to conventional treatment such as phototherapy and retinoids. Crohn’s disease is an inflammatory disease affecting intestine.

Before getting FOLITRAX 50MG INJECTION administered, 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, before receiving FOLITRAX 50MG INJECTION.

Also, FOLITRAX 50MG INJECTION is not recommended for the children less than the age of 3, 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 FOLITRAX 50MG INJECTION. Care must be taken to avoid taking products containing caffeine such as black tea, coffee and cold drinks while receiving FOLITRAX 50MG INJECTION.

The common side effects can be experienced after receiving FOLITRAX 50MG INJECTION are headache, nausea, vomiting, dizziness and altered levels of blood cells. Consult a doctor if any of the above side effect worsens after receiving FOLITRAX 50MG INJECTION.

USES OF FOLITRAX 50MG INJECTION

It is used to treat:

  • active rheumatoid arthritis (adults)
  • severe arthritis occurring due to unknown reasons (idiopathic and juvenile which is non-responsive to conventional painkillers)
  • psoriasis
  • Crohn’s disease
  • polyarthritic forms
  • cancer (acute lymphocytic lymphoma, meningeal leukaemia (a type of cancer of white blood cells, ovary, breast, cervix, lungs, bones and bladder

HOW FOLITRAX 50MG INJECTION WORKS

FOLITRAX 50MG INJECTION contains Methotrexate is a disease-modifying antirheumatic drug (DMARDs) which interferes with the growth of those cells in the body that reproduce quickly. As a result, growth of those cells gets retarded thus serving as an anti-tumour agent. Also, FOLITRAX 50MG 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. As a result, FOLITRAX 50MG INJECTION treats and resolves the symptoms associated with diseases such as rheumatoid arthritis and psoriasis.

DIRECTIONS FOR USE

FOLITRAX 50MG 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 upon your age, body weight and disease condition.

SIDE EFFECTS OF FOLITRAX 50MG INJECTION

COMMON

  • loss of appetite
  • nausea
  • vomiting
  • stomach pain
  • inflammation and ulcers in the mouth and throat
  • increase in the level of liver enzymes
  • decreased count of white and red blood cells
  • decreased count of platelets
  • headache
  • tiredness
  • drowsiness
  • inflammation of the lungs along production of with dry, non-productive cough and shortness of breath
  • fever
  • diarrhea (frequent loose stools)
  • development of itchy, rash and reddening of the skin
  • decreased resistance to infection

UNCOMMON

  • confusion
  • depression
  • fits
  • inflammation of blood vessels
  • liver disorders
  • diabetes
  • sensitivity to light
  • brown skin
  • loss of hair
  • increase of rheumatic nodules
  • viral infection
  • joint or muscle pain
  • porous bones (osteoporosis)
  • painful urination
  • severe allergic reactions
  • development of inflammation and ulcers (vagina)
  • eating disorder resulting in high weight loss (anorexia)
  • pain in chest
  • cough
  • inability to pass urine (dysuria)
  • nose bleeding
  • development of fatty liver
  • red eyes (conjunctivitis)
  • disturbances in the level of electrolytes

RARE

  • inflammation of the sac around the heart along with accumulation of fluid in the sac around the heart
  • severe vision disturbances  
  • mood fluctuations
  • low blood pressure  
  • blood clots
  • asthma (difficult breathing along with production of wheezing sound)
  • changed colour of nails
  • development of acne (pimples)
  • development of red or purple spots due to vessel bleeding
  • kidney problems
  • defective formation of sperm
  • menstruation disorders
  • nodulosis (small tissue growth at the hands and elbows, on Achilles tendons)
  • loss of libido / impotence
  • chills and fever (without any detectable pathogen)
  • immunosuppression
  • decreased resistance to infection
  • abnormal tissue cell changes
  • metabolic disorders
  • development of breasts in men
  • tinnitus (ringing sensation in ears)
  • sweating
  • inflammatory conditions of the heart
  • thromboembolic complications
  • plaque like erosions on skin
  • inflammation of pharynx and gingiva
  • stress fracture

Stop receiving FOLITRAX 50MG INJECTION and consult your doctor immediately if you experience any of the following:  

  • sudden (acute) bleeding from lungs characterized by spitting and/or coughing blood
  • general weakness of muscles, disturbance in the vision, changes in pattern of thinking, memory and orientation that lead to confusion and changes in personality (Progressive Multifocal Leukoencephalopathy)
  • general illness along with dry, irritating cough and shortness of breath, breathlessness during rest, pain in chest or fever, indicative of lung problems
  • severe peeling and/or blisters on skin
  • unusual bleeding and formation of bruises
  • severe, frequent, loose stools (diarrhea)
  • presence of ulcers in mouth
  • black or tar like stools
  • presence of blood in urine and stools
  • yellowing of skin and eyes
  • increased thirst
  • fits (convulsions)
  • blurred and/or decreased vision
  • redness, swelling of the hands, ankles, feet, lips, mouth and throat leading to difficulty in swallowing and/or breathing
  • feeling of fainting
  • symptoms of infection such as fever, body ache and sore throat
  • severe headache along with stiffness in neck, fever, nausea and vomiting, indicative of inflamed membranes of brain (Acute aseptic meningitis)
  • severe skin rash such as blistering of skin indicative of Stevens Johnson syndrome or burned skin syndrome (toxic epidermal necrolysis/Lyell’s syndrome)

HOW TO MANAGE SIDE EFFECTS

Headache:

Stay hydrated and take rest as much possible. Stay away from bright lights and loud sounds. Apply a pain-relieving balm on forehead. If headache persists or worsens, consult your doctor.

Dizziness:

Take 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.

Diarrhea:

Stick to simple meals. Avoid eating heavily rich or spicy food. Drink oral rehydration solution to compensate for the loss of water and minerals. Stay hydrated. Consult your doctor if it persists for 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

FOLITRAX 50MG INJECTION is not recommended for 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 FOLITRAX 50MG INJECTION.

BREASTFEEDING

FOLITRAX 50MG INJECTION is not recommended if you are a nursing mother. Consult your doctor before receiving FOLITRAX 50MG INJECTION.

DRIVING AND USING MACHINES

FOLITRAX 50MG INJECTION is not recommended if you feel tired and/or dizzy after receiving the medicine. Consult your doctor prior to receiving FOLITRAX 50MG INJECTION.

ALCOHOL

FOLITRAX 50MG INJECTION is not recommended if you consume large amount of alcohol. Consult your doctor before receiving FOLITRAX 50MG INJECTION.

KIDNEY

FOLITRAX 50MG INJECTION is not recommended if you are diagnosed with severe kidney disorder. Consult your doctor before receiving FOLITRAX 50MG INJECTION.

LIVER

FOLITRAX 50MG INJECTION is not recommended if you are diagnosed with severe liver disorder. Consult your doctor before receiving FOLITRAX 50MG INJECTION.

ALLERGY

FOLITRAX 50MG INJECTION is not recommended if you are allergic to Methotrexate and/or any other constituent of FOLITRAX 50MG INJECTION. Consult your doctor before receiving FOLITRAX 50MG INJECTION.

LUNGS

FOLITRAX 50MG INJECTION is recommended to be received with caution if you have issues with lung function and are diagnosed with ascites and pleural effusion. Consult your doctor before receiving FOLITRAX 50MG INJECTION.

OTHERS

FOLITRAX 50MG INJECTION is not recommended for use if you:

  • have blood disorders
  • have impaired immune system
  • have severe and/or an existing infection (Ex. Tuberculosis, HIV)
  • have ulcers in the gastro-intestinal tract
  • are receiving vaccinations containing live vaccines
  • have bone marrow suppression
  • have certain immunodeficiency syndromes
  • have scheduled a surgery (requires anaesthesia)
  • have ulcerative colitis characterized by bleeding from bowel
  • are malnourished

Before receiving FOLITRAX 50MG INJECTION, inform your doctor if you:

  • have diabetes mellitus  
  • are overweight
  • have teeth infection such as an abscess in tooth
  • have increased and/or unusual bleeding or bruising
  • suffer folate deficiency of folate
  • are receiving radiotherapy for various conditions such as X-Rays, UV Rays

Use in pediatrics:
FOLITRAX 50MG INJECTION is not recommended in children below the age of 3 years due to lack of safety data. If needed, your doctor will administer the right dose depends on your child’s age, body weight and disease condition. Consult the doctor before receiving FOLITRAX 50MG INJECTION.

Use in geriatrics:
FOLITRAX 50MG INJECTION is recommended to be administered with caution and in lower dosage to elders due to diminished function of liver and kidneys and reduced folate levels in blood in old age. Consult the doctor before receiving FOLITRAX 50MG INJECTION.

INTERACTIONS

A. Drug-Drug Interactions:

Before receiving FOLITRAX 50MG INJECTION, inform your doctor if you are taking any of the following medicine:

  • other medicines used to treat rheumatoid arthritis and psoriasis (Ex. leflunomide, phenylbutazone or amidopyrine)
  • medicines used in organ transplantation to prevent organ rejection (Ex. azathioprine)
  • medicines used to treat skin conditions (Ex. retinoids)
  • medicines used to prevent fits (Ex. phenytoin)
  • medicines used in cancer
  • medicines used to induce sleep (Ex. barbiturates such as phenobarbitone)
  • medicines used to induce calmness and relieve anxiety (Ex. tranquilizers such as diazepam)
  • medicines used for oral contraception (Ex. estrogen)
  • medicines used to treat gout (Ex. probenecid)
  • medicines used to treat bacterial infections (Ex. amoxicillin)
  • medicines used to prevent and treat malaria (Ex. pyrimethamine)
  • medicines used to treat severe heartburn or ulcers (Ex. omeprazole)
  • medicines used to treat asthma (Ex. theophylline)
  • medicines used to suppress hyperactive immune system (Ex. diphenylhydantoin, amidopyrine derivatives)
  • medicines used to treat various infections (Ex. pyrimethamine and cotrimoxazole)
  • medicines used to treat increased cholesterol level (Ex. Cholestyramine)
  • medicines used to treat heart problems (Ex. Amiodarone)
  • medicines used to treat diabetes (Ex. Metformin)

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:
FOLITRAX 50MG INJECTION will be administered only by a doctor or nurse in a hospital, and so it is unlikely to receive an overdose, contact your doctor immediately. However, if you experience any unusual symptoms like easy tendency to bruise or bleed, nausea, vomiting, feeling unusual weakness, along with development of mouth sores, black or bloody stools, coughing up blood and vomit that looks like coffee grounds, decreased urination.

SYNOPSIS

Drug :   Methotrexate
Pharmacological Category :   Anti-metabolites
Therapeutic Indication :   Rheumatoid Arthritis, Psoriasis, Cancer
Dosage Forms :   Injection, Gel, Capsule, Tablet

MORE INFORMATION

  • Keep FOLITRAX 50MG INJECTION out of the reach and sight of children
  • Store FOLITRAX 50MG INJECTION at a temperature below 25°C

FAQs ABOUT FOLITRAX 50MG INJECTION

What is FOLITRAX 50MG INJECTION used for?

FOLITRAX 50MG INJECTION contains Methotrexate which belongs to the group of medicines called Antimetabolites. It is used to treat active rheumatoid arthritis in adults. It is also used to treat its polyarthritic forms (characterized by the involvement of five or more joints) which is severe, active and idiopathic in nature and affects young people (Juvenile Idiopathic Arthritis – JIA). FOLITRAX 50MG INJECTION is also used to treat psoriasis, which is a skin condition characterized by itchy scales, that is not responsive to conventional treatment such as phototherapy and retinoids.

Can I receive FOLITRAX 50MG INJECTION in pregnancy?

FOLITRAX 50MG 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 FOLITRAX 50MG INJECTION.

Can I receive FOLITRAX 50MG INJECTION if I am breast feeding?

FOLITRAX 50MG INJECTION is not recommended for nursing mothers due to lack of safety data. Consult your doctor before receiving FOLITRAX 50MG INJECTION.

Can FOLITRAX 50MG INJECTION be received by children?

FOLITRAX 50MG INJECTION is not recommended to be received by children less than 3 years of age. Consult your doctor before receiving FOLITRAX 50MG INJECTION.

Can FOLITRAX 50MG INJECTION be used by elderly?

FOLITRAX 50MG INJECTION is recommended to be administered with caution and in lower dosage to elders due to diminished function of liver and kidneys and reduced folate levels in blood in old age. Consult the doctor before receiving FOLITRAX 50MG INJECTION.

Is there any specific food to avoid while receiving FOLITRAX 50MG INJECTION?

It is recommended to avoid the consumption of drinks containing caffeine such as black tea, coffee, soft drinks along with FOLITRAX 50MG INJECTION to prevent dehydration.

REFERENCES

1. KD. Tripathi. Antirheumatoid and Antigout Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 210.

2. KD Tripathi. Anticancer Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 857. 

3. Brown, P.M., Pratt, A.G. and Isaacs, J.D., 2016. Mechanism of action of methotrexate in rheumatoid arthritis, and the search for biomarkers. Nature Reviews Rheumatology. [Published on 27th October 2016] [Accessed on 21st October 2022] https://www.nature.com/articles/nrrheum.2016.175 

4. Cenexi – Laboratoires Thissen SA. Electronic Medicines Compendium (EMC) U.K. [Revised in February 2022] [Accessed on 21st October 2022] https://www.medicines.org.uk/emc/files/pil.7269.pdf    

5. Hameln Pharmaceuticals Ltd. [Revised on 30th December 2016] [Accessed on 21st October 2022] https://www.ctc.ucl.ac.uk/TrialDocuments/Uploaded/Methotrexate%2025mg_ml%20solution%20for%20Injection%20(hameln)%20-%20SPC%2030.12.2010_15072020_0.pdf    

6. Pfizer Ireland. [Revised on 5th August 2022] [Accessed on 21st October 2022] https://www.medicines.ie/medicines/methotrexate-500-mg-20-ml-injection-32843/spc#tabs   

7. Sandoz Pty Ltd. [Revised in September 2021] [Accessed on 21st October 2022] https://www.medsafe.govt.nz/Consumers/cmi/m/methotrexatesandoz.pdf    

8. Accord Healthcare Limited. [Revised in January 2022] [Accessed on 21st October 2022] https://www.medicines.org.uk/emc/files/pil.4340.pdf

USEFUL DIAGNOSTIC TESTS

  • Liver Function Tests
  • Kidney Function Tests
  • Complete Blood Count

AUTHOR DETAILS

Written By Dr. Janet.C, Pharm.D
Last updated on 09 Nov 2022 | 10:58 PM(IST)

PRODUCT DETAILS

    Net Qty
    1 N
    Shelf Life
    24 months
    Item Weight
    15 g
    Ingredient
    METHOTREXATE 50MG
    Hsn Code
    30049042
DISCLAIMER

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.

Folitrax 50mg Injection 2ml

Folitrax 50mg Injection 2ml Mkt: Ipca Laboratories Ltd

₹ 91.97 MRP ₹ 112.16