INTRODUCTION
FOLITRAX 15MG INJECTION contains Methotrexate which belongs to the group of medicines called Antimetabolites. FOLITRAX 15MG 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 15MG INJECTION is also used to treat psoriasis.
In addition, FOLITRAX 15MG 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 15MG 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 15MG INJECTION.
Also, FOLITRAX 15MG 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 15MG INJECTION. Care must be taken to avoid taking products containing caffeine such as black tea, coffee and cold drinks while receiving FOLITRAX 15MG INJECTION.
The common side effects can be experienced after receiving FOLITRAX 15MG 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 15MG INJECTION.
USES OF FOLITRAX 15MG 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 15MG INJECTION WORKS
FOLITRAX 15MG 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 15MG 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 15MG INJECTION treats and resolves the symptoms associated with diseases such as rheumatoid arthritis and psoriasis.
DIRECTIONS FOR USE
FOLITRAX 15MG 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 15MG 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 15MG 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 15MG 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 15MG INJECTION.
BREASTFEEDING
FOLITRAX 15MG INJECTION is not recommended if you are a nursing mother. Consult your doctor before receiving FOLITRAX 15MG INJECTION.
DRIVING AND USING MACHINES
FOLITRAX 15MG INJECTION is not recommended if you feel tired and/or dizzy after receiving the medicine. Consult your doctor prior to receiving FOLITRAX 15MG INJECTION.
ALCOHOL
FOLITRAX 15MG INJECTION is not recommended if you consume large amount of alcohol. Consult your doctor before receiving FOLITRAX 15MG INJECTION.
KIDNEY
FOLITRAX 15MG INJECTION is not recommended if you are diagnosed with severe kidney disorder. Consult your doctor before receiving FOLITRAX 15MG INJECTION.
LIVER
FOLITRAX 15MG INJECTION is not recommended if you are diagnosed with severe liver disorder. Consult your doctor before receiving FOLITRAX 15MG INJECTION.
ALLERGY
FOLITRAX 15MG INJECTION is not recommended if you are allergic to Methotrexate and/or any other constituent of FOLITRAX 15MG INJECTION. Consult your doctor before receiving FOLITRAX 15MG INJECTION.
LUNGS
FOLITRAX 15MG 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 15MG INJECTION.
OTHERS
FOLITRAX 15MG 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 15MG 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 15MG 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 15MG INJECTION.
Use in geriatrics:
FOLITRAX 15MG 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 15MG INJECTION.
INTERACTIONS
A. Drug-Drug Interactions:
Before receiving FOLITRAX 15MG 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 15MG 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 15MG INJECTION out of the reach and sight of children

Store FOLITRAX 15MG INJECTION at a temperature below 25?C

FAQs ABOUT FOLITRAX 15MG INJECTION
What is FOLITRAX 15MG INJECTION used for?
FOLITRAX 15MG 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 15MG 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 15MG INJECTION in pregnancy?
FOLITRAX 15MG 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 15MG INJECTION.
Can I receive FOLITRAX 15MG INJECTION if I am breast feeding?
FOLITRAX 15MG INJECTION is not recommended for nursing mothers due to lack of safety data. Consult your doctor before receiving FOLITRAX 15MG INJECTION.
Can FOLITRAX 15MG INJECTION be received by children?
FOLITRAX 15MG INJECTION is not recommended to be received by children less than 3 years of age. Consult your doctor before receiving FOLITRAX 15MG INJECTION.
Can FOLITRAX 15MG INJECTION be used by elderly?
FOLITRAX 15MG 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 15MG INJECTION.
Is there any specific food to avoid while receiving FOLITRAX 15MG INJECTION?
It is recommended to avoid the consumption of drinks containing caffeine such as black tea, coffee, soft drinks along with FOLITRAX 15MG 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

PRODUCT DETAILS

Net Qty

1 N

Shelf Life

24 months

Item Weight

15 g

Ingredient

METHOTREXATE 15MG

Hsn Code

30049042

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