INTRODUCTION
DERMOTREX 10MG TABLET contains Methotrexate which belongs to the group of medicines called Antimetabolites. DERMOTREX 10MG TABLET is used to treat active rheumatoid arthritis in adults which is a form of severe arthritis occurring due to unknown reasons (idiopathic) and old age and is non-responsive to conventional painkillers (such as Non Steriodal Anti Inflammatory Drugs Ex. aceclofenac). DERMOTREX 10MG TABLET 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).
DERMOTREX 10MG TABLET is also used to treat psoriasis and relapsed (reoccurred) and refractory (unaffected by other conventional treatments) Non-Hodgkin?s Lymphoma which is a type of cancer of lymphatic system.
Psoriasis is a skin condition characterized by itchy scales that is not responsive to conventional treatment such as phototherapy and retinoids.
Before taking DERMOTREX 10MG TABLET, 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, DERMOTREX 10MG TABLET is not recommended to be taken by the pregnant and nursing women, women planning pregnancy, those who drink huge amount of alcohol and patients suffering from liver and kidney impairment.
DERMOTREX 10MG TABLET is not recommended in children for the treatment of psoriasis and rheumatoid arthritis. However, DERMOTREX 10MG TABLET can be used with caution in children to treat polyarticular juvenile idiopathic arthritis which is characterized by the involvement of five or more joints that is of severe, active, juvenile and idiopathic character. Consult the doctor before taking DERMOTREX 10MG TABLET.
In addition, caution must be exercised by the patients suffering from lung disorders, blood disorders and gastric disorders before taking DERMOTREX 10MG TABLET.
Care must be taken to avoid taking products containing caffeine such as black tea, coffee and cold drinks while taking DERMOTREX 10MG TABLET.
The common side effects seen after taking DERMOTREX 10MG TABLET are headache, nausea, vomiting, dizziness and altered levels of blood cells. Consult a doctor if any of the above side effect worsens after taking DERMOTREX 10MG TABLET.
USES OF DERMOTREX 10MG TABLET
It is used to treat:
Active rheumatoid arthritis
Psoriasis ?
Arthritis in patients suffering from psoriasis (psoriatic arthritis)
Relapsed and refractory (unaffected by other conventional treatments) Non-Hodgkin?s Lymphoma
Polyarticular juvenile idiopathic arthritis
HOW DERMOTREX 10MG TABLET WORKS
DERMOTREX 10MG TABLET contains Methotrexate that works by interfering 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, it decreases the undesired reactions of the body?s own immune-defence mechanism, thereby working as an effective immunosuppressant. Additionally, it also exhibits anti-inflammatory effects, thereby reducing the pain, swelling and redness. As a result, it treats and resolves the symptoms associated with diseases such as rheumatoid arthritis and psoriasis.
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DIRECTIONS FOR USE
Take DERMOTREX 10MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew 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 DERMOTREX 10MG TABLET
COMMON
Sore throat due to inflammation
Soreness in mouth and lips
Loss of appetite
Nausea, vomiting
Stomach pain
Increase in the level of liver enzymes
Infections
Diarrhea
Feeling tired and exhausted
Headache
Dizziness
Development of rash and reddening of the skin
Loss of hair
Formation of ulcers in the mouth
UNCOMMON
Fever and general deterioration of the body along with increased level of local infections
Decrease in the number of red blood cells (anaemia)
Decrease in the number of platelets (reduced blood clotting)
Altered blood count
Swelling of the lymph nodes
Development of inflammation and ulcers of the vagina
Decreased serum albumin (type of protein) level
Increased pigmentation of skin
Viral infections of skin such as herpes
Joint or muscle pain
Inflammation and ulcers of the bladder
Fatty liver
Chills
Fits
Sensitivity to light
Brown skin
Loss of hair
Increase of rheumatic nodules
Pain in the lesions associated with psoriasis
RARE
Cramps, swelling in legs, redness, breathlessness and chest pain
Feeling depressed
Feeling weak on one side of the body (hemiparesis)
Diabetes
Decreased blood pressure ?
Inflammation of gums
Acne
Whitening of skin
Painful skin rash such as shingles
Severe disturbances of vision
Mood fluctuations
Inflammatory conditions of the heart ?
Thromboembolic complications
Pericardial tamponade (filling of fluid such as blood around the heart)
Stop taking DERMOTREX 10MG TABLET and consult your doctor immediately if you experience any of the following:?
Formation of scar tissue in the lungs (pulmonary fibrosis), development of pneumonia indicated by shortness of breath along with thick mucus
Severe allergic reactions characterized by tightness in the chest, swelling of the face, throat, hands, along with difficulty in breathing
Severe toxic reactions of skin resulting in the formation of vesicles as seen in Stevens Johnson Syndrome, toxic epidermal necrolysis (Lyell?s syndrome)
Decreased white blood cells characterized by fever and general deterioration of the body along with increased level of local infections
Painful urination
Kidney damage
Inflammation and/or damage of liver characterized by yellowing of skin and eyes along with fever, itchy skin and swollen/tender stomach
Ulcer and/or bleeding in stomach characterized by black tar like stools, vomiting blood, and stomach pain
Formation of blood clot characterized by cramps, swelling in legs, redness, breathlessness and chest pain
Decreased formation of urine
Fever, chills, shivering along with rapid heartbeat, breathing
Presence of blood in urine
Fits (convulsions)
Spitting/ coughing blood
Disorders of brain such as encephalopathy
Easy tendency to bleed and bruise, persistent bleeding
Loss of coordination
Loss of ability to speak and/or understand speech
Weakness and inability to move one side of the body or the whole body
Miscarriage and/or damage to foetus (in women)
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.
Diarrhoea:
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
DERMOTREX 10MG TABLET is not recommended for use 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 taking DERMOTREX 10MG TABLET.
BREASTFEEDING
DERMOTREX 10MG TABLET is not recommended if you are a nursing mother. Consult your doctor before taking DERMOTREX 10MG TABLET.
DRIVING AND USING MACHINES
DERMOTREX 10MG TABLET is not recommended if you feel tired or dizzy after taking the medicine. Consult your doctor before taking DERMOTREX 10MG TABLET.
ALCOHOL
It is recommended to avoid the consumption of alcohol while taking DERMOTREX 10MG TABLET as it may increase the risk of liver damage. Consult your doctor before taking DERMOTREX 10MG TABLET.
KIDNEY
DERMOTREX 10MG TABLET is not recommended if you have or had kidney disorder and/or are receiving any dialysis treatment. Consult your doctor before taking DERMOTREX 10MG TABLET.
LIVER
DERMOTREX 10MG TABLET is not recommended if you have liver disorder. Consult your doctor before taking DERMOTREX 10MG TABLET.
ALLERGY
DERMOTREX 10MG TABLET is not recommended if you are allergic to Methotrexate and/or any other constituent of DERMOTREX 10MG TABLET. Consult your doctor before taking DERMOTREX 10MG TABLET.
LUNGS
DERMOTREX 10MG TABLET is recommended to be taken with caution if you have issues with lung function and are diagnosed with pleural effusion. Consult your doctor before taking DERMOTREX 10MG TABLET.
OTHERS
DERMOTREX 10MG TABLET is not recommended for use if you:
Have bone marrow disorders
Have blood disorders
Have impaired immune system
Have severe and/or an existing infection (Ex. Tuberculosis, HIV)
Have ulcers in the gastro-intestinal tract
Have inflammation and ulcers of mouth
Are receiving vaccinations containing live vaccines
Before taking DERMOTREX 10MG TABLET, inform your doctor if you:
Have diabetes ?
Are overweight
Suffer from diarrhea
Ulcers in the colon (ulcerative colitis)
Are receiving radiotherapy for various conditions such as X-Rays, UV Rays
Have folate deficiency ?
Have lactose and/or galactose intolerance
Have mental illness
Use in pediatrics:
DERMOTREX 10MG TABLET is not recommended in children for the treatment of psoriasis and rheumatoid arthritis. However, DERMOTREX 10MG TABLET can be used with caution in children to treat polyarticular juvenile idiopathic arthritis. Your doctor will prescribe the right dose depends on your child?s age, body weight and health condition. Consult your doctor for advice before taking DERMOTREX 10MG TABLET.
Use in geriatrics:
DERMOTREX 10MG TABLET 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. Also, it is recommended to closely monitor the elderly, taking DERMOTREX 10MG TABLET for the identification of possible side effects. Consult the doctor before taking DERMOTREX 10MG TABLET.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking DERMOTREX 10MG TABLET, inform your doctor if you are taking any of the following medicine:
Medicines used to treat bacterial infections (Ex. amoxicillin, ciprofloxacin)
Medicines used to increase urine excretion (Ex. frusemide)
Medicines used to treat increased sugar level (Ex. metformin)
Medicines used to prevent fits and treat epilepsy (Ex. phenytoin)
Medicines used to treat increased cholesterol level(Ex. cholestyramine)
Medicines used to treat gout (Ex. probenecid)
Medicines to treat reduced folic acid levels (Ex. folic acid preparations)
Medicines used to treat severe heartburn or ulcers (Ex. omeprazole)
Other medicines used to treat rheumatoid arthritis (Ex. leflunomide)
Medicines that can be harmful to liver (Ex. sulfasalazine)
Medicines used in the treatment of cancer (Ex. doxorubicin, cisplatin, mercaptopurine)
Medicines used to treat pain (Ex. ibuprofen, naproxen, diclofenac)
Other medicines used to treat rheumatoid arthritis and psoriasis (Ex. leflunomide, phenylbutazone or amidopyrine)
Medicines used to treat asthma (Ex. theophylline)
Medicines used in organ transplantation to prevent organ rejection (Ex. cyclosporin, azathioprine)
Medicines used to induce sleep (Ex. phenobarbitone)
Medicines used to induce calmness and relieve anxiety (Ex. diazepam)
Medicines used for oral contraception (Ex. estrogen)
Medicines used to treat skin conditions (Ex. retinoids)
Medicines used to prevent and treat malaria (Ex. pyrimethamine)
Medicines that contain live vaccine (Ex. MMR Vaccine)
Medicines used for general anesthesia and pain relief (Ex. nitrous oxide)
Medicines used to treat heart problems (Ex. amiodarone)
Medicines used to treat heart failure (Ex. digoxin)
Medicines used for treatment of various inflammatory conditions like skin diseases, allergic reactions (Ex. hydrocortisone)
B. Drug-Food Interactions:
It is recommended to avoid the consumption of drinks containing caffeine such as black tea, coffee, soft drinks along with DERMOTREX 10MG TABLET to prevent dehydration.
Overdosage:
If you or some else accidentally takes too DERMOTREX 10MG TABLET, it is recommended to consult your doctor immediately. Symptoms of overdosage with DERMOTREX 10MG TABLET are easy tendency to bruise or bleed, nausea, vomiting, unusual weakness, along with development of mouth sores and ulcers.
SYNOPSIS
Drug :?? Methotrexate
Pharmacological Category :?? Anti-metabolites
Therapeutic Indication :?? Rheumatoid Arthritis, Psoriasis, Cancer? ? ? ? ? ?
Dosage Forms :?? Injection, Gel, Capsule, Tablet
MORE INFORMATION
Keep DERMOTREX 10MG TABLET out of the reach and sight of children
Store DERMOTREX 10MG TABLET at a temperature below 25?C
FAQs ABOUT DERMOTREX 10MG TABLET
What is DERMOTREX 10MG TABLET used for?
It is used to treat active rheumatoid arthritis in adults which is a form of severe arthritis occurring due to unknown reasons (idiopathic) and old age and is non-responsive to conventional painkillers (such as Non Steriodal Anti Inflammatory Drugs Ex. aceclofenac). DERMOTREX 10MG TABLET 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).
Can I take DERMOTREX 10MG TABLET in pregnancy?
DERMOTREX 10MG TABLET 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 taking DERMOTREX 10MG TABLET.
Can I take DERMOTREX 10MG TABLET if I am breast feeding a baby?
DERMOTREX 10MG TABLET is not recommended for nursing mothers due to lack of safety data. Consult your doctor before taking DERMOTREX 10MG TABLET.
Can DERMOTREX 10MG TABLET be taken by children?
DERMOTREX 10MG TABLET is not recommended in children for the treatment of psoriasis and rheumatoid arthritis. However, DERMOTREX 10MG TABLET can be used with caution in children to treat polyarticular juvenile idiopathic arthritis. Your doctor will prescribe the right dose depends on your child?s age, body weight and health condition. Consult your doctor for advice before taking DERMOTREX 10MG TABLET.
Can DERMOTREX 10MG TABLET be used by elderly?
DERMOTREX 10MG TABLET 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. Also, it is recommended to closely monitor the elderly, taking DERMOTREX 10MG TABLET for the identification of possible side effects. Consult the doctor before taking DERMOTREX 10MG TABLET.
Is there any specific food to avoid while taking DERMOTREX 10MG TABLET?
It is recommended to avoid the consumption of drinks containing caffeine such as black tea, coffee, soft drinks along with DERMOTREX 10MG TABLET 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. Hospira UK Limited. Electronic Medicines Compendium (EMC) U.K [Revised in March 2022] [Accessed on 29th October 2022]?https://www.medicines.org.uk/emc/files/pil.6790.pdf
5. Cipla. Methotrexate. [Revised on 13th April 2020] [Accessed on 29th October 2022]?https://www.cipla.com/sites/default/files/Methotrexate%202.5%20mg%20%E2%80%93%20Patient%20Card%20-%20Risk%20Minimisation%20Information%20for%20Patients.pdf
6.?Accord Healthcare Inc. U.S.A. [Revised in December 2021] [Accessed on 29th October 2022]?https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=874c7f43-a3be-4236-89cc-24c44e3c5813&type=display#section-9
7.?Teva Women?s Health, Inc. [Revised in April 2021] [Accessed on 29th October 2022]?https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&type=display#section-9
8.?Pfizer Healthcare Ireland. [Revised in September 2020] [Accessed on 29th October 2022] http://www.hpra.ie/img/uploaded/swedocuments/Licence_PA0822-206-005_23092020105544.pdf
9. Pfizer Australia Pty Ltd. [Revised in August 2021] [Accessed on 29th October 2022]?https://www.nps.org.au/assets/medicines/152212ff-3721-4bba-b3cc-a53300ff0e7d.pdf
10.?Imutaj. Taj Pharma. [Accessed on 29th October 2022]?https://tajpharma.in/portfolio-item/methotrexate-tablets-ip-5mg-imutaj-taj-pharma/
USEFUL DIAGNOSTIC TESTS
Liver Function Test
Kidney Function Test
Complete Blood Count
PRODUCT DETAILS
Net Qty
1 N
Item Weight
17.5 g
Ingredient
METHOTREXATE 10MG
Hsn Code
30049099
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