New Revised MRP, 100% GST benefit passed Zexate 15mg Injection 3ml
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INTRODUCTION ABOUT ZEXATE 15MG INJECTION
ZEXATE 15MG INJECTION contains Methotrexate, which belongs to the group of medicines called Antimetabolites. ZEXATE 15MG INJECTION is used to manage active rheumatoid arthritis in adults. It is also used to manage polyarthritic forms (characterized by the involvement of five or more joints), which are severe, active, and idiopathic in nature and affect young people (Juvenile Idiopathic Arthritis, or JIA). ZEXATE 15MG INJECTION is also used to manage psoriasis.
In addition, ZEXATE 15MG INJECTION is also used to manage Crohn’s disease and various cancers such as acute lymphocytic lymphoma, Non-Hodgkin’s Lymphoma, breast cancer, cervical cancer, 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 managements such as phototherapy and retinoids. Crohn’s disease is an inflammatory disease affecting the intestine.
Before getting ZEXATE 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 ZEXATE 15MG INJECTION.
Also, ZEXATE 15MG INJECTION is not recommended for children less than the age of 3, pregnant and nursing women, women planning pregnancy, those who drink huge amounts of alcohol, and patients suffering from liver and kidney impairment.
Caution must be exercised by patients suffering from lung disorders, blood disorders, and gastric disorders before receiving ZEXATE 15MG INJECTION. Care must be taken to avoid taking products containing caffeine, such as black tea, coffee, and cold drinks, while receiving ZEXATE 15MG INJECTION.
The common side effects that can be experienced after receiving ZEXATE 15MG 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 ZEXATE 15MG INJECTION.
USES OF ZEXATE 15MG INJECTION
It is used to manage:
- 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 leukemia) (a type of cancer of white blood cells in the ovary, breast, cervix, lungs, bones, and bladder
HOW ZEXATE 15MG INJECTION WORKS
ZEXATE 15MG INJECTION contains Methotrexate, a disease-modifying antirheumatic drug (DMARDs) which 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. Also, ZEXATE 15MG INJECTION decreases the undesired reactions of the body’s own immune-defense mechanism, thereby working as an effective immunosuppressant. In addition, it also exhibits anti-inflammatory effects, thereby reducing pain, swelling, and redness. As a result, ZEXATE 15MG INJECTION manages the symptoms associated with diseases such as rheumatoid arthritis and psoriasis.
DIRECTIONS FOR USE
ZEXATE 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 on your age, body weight, and disease condition.
SIDE EFFECTS OF ZEXATE 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 with the production of a dry, non-productive cough and shortness of breath
- fever
- diarrhea (frequent loose stools)
- development of itching, 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 in 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 the 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 the accumulation of fluid in the sac around the heart
- severe vision disturbances
- mood fluctuations
- low blood pressure
- blood clots
- asthma (difficult breathing along with the production of wheezing sounds)
- 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 or 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 the ears)
- sweating
- inflammatory conditions of the heart
- thromboembolic complications
- plaque-like erosions on the skin
- inflammation of the pharynx and gingiva
- stress fracture
Stop receiving ZEXATE 15MG INJECTION and consult your doctor immediately if you experience any of the following:
- sudden (acute) bleeding from the 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 a dry, irritating cough and shortness of breath, breathlessness during rest, pain in the chest, or fever, indicative of lung problems
- severe peeling and/or blisters on the skin
- unusual bleeding and the formation of bruises
- severe, frequent, loose stools (diarrhea)
- presence of ulcers in the mouth
- black or tar-like stools
- presence of blood in urine and stools
- yellowing of the 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 swallowing and/or breathing
- feeling of fainting
- symptoms of infection such as fever, body ache, and sore throat
- severe headache along with stiffness in the neck, fever, nausea, and vomiting, indicative of inflamed membranes of the 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
Diarrhea
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 time or worsens with time.
Dizziness Or Drowsiness
Take an adequate amount of rest and sleep. Stay hydrated and replenish yourself with electrolytes. Also, do not indulge in driving or using heavy machinery, as it may prove to be dangerous.
Headache
Stay hydrated and take as much rest as possible. Stay away from bright lights and loud sounds. Apply a pain-relieving balm to the forehead. If the headache persists or worsens, consult your doctor.
Nausea And Vomiting
Stick to simple meals. Avoid eating heavily rich or spicy food. Stay hydrated. Consult your doctor if it persists for a long time or worsens with time.
WARNING & PRECAUTIONS
PREGNANCY
ContraindicatedZEXATE 15MG 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 ZEXATE 15MG INJECTION.
BREASTFEEDING
ContraindicatedZEXATE 15MG INJECTION is not recommended if you are a nursing mother. Consult your doctor before receiving ZEXATE 15MG INJECTION.
DRIVING AND USING MACHINES
ContraindicatedZEXATE 15MG INJECTION is not recommended if you feel tired and/or dizzy after receiving the medicine. Consult your doctor prior to receiving ZEXATE 15MG INJECTION.
ALCOHOL
ContraindicatedZEXATE 15MG INJECTION is not recommended if you consume large amounts of alcohol. Consult your doctor before receiving ZEXATE 15MG INJECTION.
KIDNEY
ContraindicatedZEXATE 15MG INJECTION is not recommended if you are diagnosed with a severe kidney disorder. Consult your doctor before receiving ZEXATE 15MG INJECTION.
LIVER
ContraindicatedZEXATE 15MG INJECTION is not recommended if you are diagnosed with a severe liver disorder. Consult your doctor before receiving ZEXATE 15MG INJECTION.
ALLERGY
ContraindicatedZEXATE 15MG INJECTION is not recommended if you are allergic to methotrexate and/or any other constituent of ZEXATE 15MG INJECTION. Consult your doctor before receiving ZEXATE 15MG INJECTION.
LUNGS
Use with CautionZEXATE 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 ZEXATE 15MG INJECTION.
USE IN PEDIATRICS
ContraindicatedZEXATE 15MG INJECTION is not recommended for children below the age of 3 years due to a lack of safety data. If needed, your doctor will administer the right dose depending on your child’s age, body weight, and disease condition. Consult the doctor before receiving ZEXATE 15MG INJECTION.
USE IN GERIATRICS
Use with CautionZEXATE 15MG 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 in old age. Consult the doctor before receiving ZEXATE 15MG INJECTION.
OTHERS
ZEXATE 15MG INJECTION is not recommended for use if you:
- have blood disorders
- have an impaired immune system
- have a severe and/or 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 (which requires anesthesia)
- have ulcerative colitis characterized by bleeding from the bowel
- are malnourished
Before receiving ZEXATE 15MG INJECTION, inform your doctor if you:
- have diabetes mellitus
- are overweight
- have a tooth infection, such as an abscess in a tooth
- have increased and/or unusual bleeding or bruising
- suffer folate deficiency of folate
- are receiving radiotherapy for various conditions, such as X-rays and UV-rays
INTERACTIONS
A. Drug-Drug Interactions:
Before receiving ZEXATE 15MG INJECTION, inform your doctor if you are taking any of the following medicines:
- other medicines used to manage rheumatoid arthritis and psoriasis (Ex. leflunomide, phenylbutazone, or amidopyrine)
- medicines used in organ transplantation (Ex. azathioprine)
- medicines used to manage skin conditions (Ex. retinoids)
- medicines used to manage 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 manage gout (Ex. probenecid)
- medicines used to manage bacterial infections (Ex. amoxicillin)
- medicines used to manage malaria (Ex. pyrimethamine)
- medicines used to manage severe heartburn or ulcers (Ex. omeprazole)
- medicines used to manage asthma (Ex. theophylline)
- medicines used to suppress hyperactive immune system (Ex. diphenylhydantoin, amidopyrine derivatives)
- medicines used to manage various infections (Ex. pyrimethamine and cotrimoxazole)
- medicines used to manage increased cholesterol levels (Ex. Cholestyramine)
- medicines used to manage heart problems (Ex. Amiodarone)
- medicines used to manage diabetes (Ex. Metformin)
B. Drug-food interactions:
It is recommended to avoid the consumption of drinks containing caffeine, such as black tea, coffee, and soft drinks, to manage dehydration.
Overdosage:
ZEXATE 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 an easy tendency to bruise or bleed, nausea, vomiting, or feeling unusual weakness, along with the development of mouth sores, black or bloody stools, coughing up blood and vomiting that looks like coffee grounds, or decreased urination.
SYNOPSIS
| Drug | : | Methotrexate |
| Pharmacological Category | : | Anti-metabolites |
| Therapeutic Indication | : | Rheumatoid Arthritis, Psoriasis, Cancer |
| Dosage Forms | : | Injection, Gel, Capsule, Tablet |
MORE INFORMATION
- Keep ZEXATE 15MG INJECTION out of the reach and sight of children
- Store ZEXATE 15MG INJECTION at a temperature below 25°C
FAQs ABOUT ZEXATE 15MG INJECTION
Q: What is ZEXATE 15MG INJECTION used for?
A: ZEXATE 15MG INJECTION contains Methotrexate, which belongs to the group of medicines called Antimetabolites. It is used to manage active rheumatoid arthritis in adults. It is also used to manage polyarthritic forms (characterized by the involvement of five or more joints), which are severe, active, and idiopathic in nature and affect young people (Juvenile Idiopathic Arthritis, or JIA). ZEXATE 15MG INJECTION is also used to manage psoriasis, which is a skin condition characterized by itchy scales that is not responsive to conventional management such as phototherapy and retinoids.
Q: Can I receive ZEXATE 15MG INJECTION during pregnancy?
A: ZEXATE 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 (a growing baby in the womb). Consult your doctor before receiving it.
Q: Can I receive ZEXATE 15MG INJECTION if I am breastfeeding?
A: ZEXATE 15MG INJECTION is not recommended for nursing mothers due to a lack of safety data. Consult your doctor before receiving it.
Q: Can ZEXATE 15MG INJECTION be received by children?
A: ZEXATE 15MG INJECTION is not recommended to be received by children less than 3 years of age. Consult your doctor before receiving ZEXATE 15MG INJECTION.
Q: Can ZEXATE 15MG INJECTION be used by the elderly?
A: ZEXATE 15MG 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 in old age. Consult the doctor before receiving it.
Q: Is there any specific food to avoid while receiving ZEXATE 15MG INJECTION?
A: It is recommended to avoid the consumption of drinks containing caffeine, such as black tea, coffee, and soft drinks, along with ZEXATE 15MG INJECTION, to manage dehydration.
REFERENCES
1. KD. Tripathi. Antirheumatoid and Antigout Drugs, Anticancer Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page- 210, 857.
2. 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 5th February 2024] https://www.nature.com/articles/nrrheum.2016.175
3. Cenexi – Laboratoires Thissen SA. Electronic Medicines Compendium (EMC) U.K.[Revised in February 2022] [Accessed on 5th February 2024] https://www.medicines.org.uk/emc/files/pil.7269.pdf
4. Hameln Pharmaceuticals Ltd. [Revised on 30th December 2016] [Accessed on 5th February 2024] https://www.ctc.ucl.ac.uk/TrialDocuments/Uploaded/Methotrexate%2025mg_ml%20solution%20for%20Injection%20(hameln)%20-%20SPC%2030.12.2010_15072020_0.pdf
5. Pfizer Ireland. [Revised on 5th August 2022] [Accessed on 5th February 2024] https://www.medicines.ie/medicines/methotrexate-500-mg-20-ml-injection-32843/spc#tabs
6. Sandoz Pty Ltd. [Revised in September 2021] [Accessed on 5th February 2024] https://www.medsafe.govt.nz/Consumers/cmi/m/methotrexatesandoz.pdf
7. Hospira Australia Pty Ltd. Electronic Medicines Compendium (EMC). [Revised in October 2023] [Accessed on 5th February 2024] https://www.medicines.org.uk/emc/files/pil.1404.pdf
USEFUL DIAGNOSTIC TESTS
- Complete Blood Count (CBC)/ Hemogram
- Liver Function Test (LFT)
- Kidney Function Test (KFT)
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