Details for: JAMP-METHOTREXATE
Company: JAMP PHARMA CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02419173 | JAMP-METHOTREXATE | METHOTREXATE (METHOTREXATE SODIUM) | 25 MG / ML | SOLUTION | INTRA-ARTERIAL |
| 02419173 | JAMP-METHOTREXATE | METHOTREXATE (METHOTREXATE SODIUM) | 25 MG / ML | SOLUTION | INTRAMUSCULAR |
| 02419173 | JAMP-METHOTREXATE | METHOTREXATE (METHOTREXATE SODIUM) | 25 MG / ML | SOLUTION | INTRATHECAL |
| 02419173 | JAMP-METHOTREXATE | METHOTREXATE (METHOTREXATE SODIUM) | 25 MG / ML | SOLUTION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Jamp-Methotrexate belongs to a group of medicines known as antimetabolites. It is used in high doses to treat many types of cancers, including breast cancer, Non- Hodgkin's lymphoma and leukemia. At lower doses, it may also be used to treat psoriasis and rheumatoid arthritis.
What it does
Jamp-Methotrexate works by blocking an enzyme needed by body cells to live. This interferes with the growth of some cells, such as skin cells in psoriasis that are growing rapidly. In rheumatoid arthritis, Jamp-Methotrexate acts on the inflammatory cells that cause joint swelling. Jamp-Methotrexate therapy is used to control psoriasis and rheumatoid arthritis but it will not cure them. In cancer, Jamp- Methotrexate works by blocking an enzyme process in cancer cells so that they cannot grow. Some normal cells in the body may be affected as well.
When it should not be used
Do not take Jamp-Methotrexate if you:
- Are allergic to any component of the drug.
- Have severe kidney problems.
- Are on dialysis.
- Are pregnant. Jamp-Methotrexate can cause harm to your unborn baby. Women of childbearing potential should not be started on Jamp-Methotrexate until pregnancy is excluded.
- Are breast-feeding.
- Have psoriasis or rheumatoid arthritis and the following:
- alcoholism (drink excessive alcohol)
- chronic liver disease
- immunodeficiency (resistance to infectious diseases is reduced)
- blood disorders
- Are going to receive a general anesthetic called nitrous oxide. It is also known as laughing gas.
What the medicinal ingredient is
Methotrexate (meth-o-TREX-ate).
What the non-medicinal ingredients are
Hydrochloric acid, sodium chloride, sodium hydroxide and water for injection.
What dosage form it comes in
Jamp-Methotrexate in the following presentations:
25 mg/mL
50 mg / 2 mL (no preservative) as a single use vial
2 mL vials with brown flip-off aluminum seals
1000 mg / 40 mL (no preservatives) as a single use
vial 40 mL vials golden yellow flip-off aluminum
seals
Warnings and precautions
Serious Warnings and Precautions
Jamp-Methotrexate should be prescribed by a doctor who is experienced with the use of antimetabolite therapy.
- Jamp-Methotrexate can cause serious toxic reactions which may result in death.
- Jamp-Methotrexate can cause birth defect (deformed babies) or death of an unborn baby when used in pregnant women. Pregnant women with psoriasis or rheumatoid arthritis should not take Jamp-Methotrexate.
Before you use Jamp-Methotrexate, talk to your doctor or pharmacist if you have any of the following conditions:
- have or have had any unusual or allergic reaction to Jamp-Methotrexate.
- are pregnant or planning to become pregnant. Methotrexate can cause birth defects (deformed babies) or death of an unborn baby. Both male and female patients must use effective birth control methods all the time while taking Jamp-Methotrexate and a few months after the last dose of the drug. Methotrexate may cause sterility (infertility), which could be permanent. Be sure to discuss this with your doctor before taking Jamp-Methotrexate. Tell your doctor right away if you think you have become pregnant while taking Jamp-Methotrexate.
- Are breast-feeding or plan to breast-feed. Methotrexate may cause serious side effects. Do not breastfeed while you are taking the drug
- have kidney problems
- have kidney disease
- are dehydrated or have a lot of vomiting, diarrhea, or sweating
- have or have had liver problems, including hepatitis B or hepatitis C infection
- have lung problems
- have problem with your immune system, or infections
- have gastrointestinal problems such as vomiting, diarrhea, mouth sores or inflammation, ulcer, or colitis (ulcer of the intestines)
- have a skin disease
- have aneurologic disorder
- drink alcohol
Jamp-Methotrexate increases sensitivity to sunlight.
Avoid sun exposure and do not use sunlamp while
taking this drug.
Methotrexate can cause sudden bleeding in the lungs.
This is called Pulmonary alveolar haemorrhage. If
you suddenly spit or cough up blood you must go to the
hospital right away. You will need emergency care.
This occurs in patients with some existing health
problems. Some examples are rheumatic disorder (such
as pain in your joints) or vasculitis such as swelling in
an artery or vein.
Precautions While Using This Medicine
- Do not take Jamp-Methotrexate daily or more than the dose prescribed. Methotrexate can cause serious toxic reactions which may result in death.
- Do not drink alcohol.
- Do not drive a car or operate machinery until you know how Jamp-Methotrexate affects you since the drug may cause dizziness and fatigue.
- Drink extra fluid to prevent kidney problems.
- Have regular blood tests to reduce the risk of infection or bleeding. Methotrexate can lower the number of white blood cells and there is an increased risk of infection or bleeding.
Talk to your doctor if you need a vaccination. Live vaccines may cause severe infections. Live vaccines or contact with any individual who has had a live vaccination should be avoided, since your ability to fight an infection (immune system) is decreased while taking Jamp-Methotrexate.
Interactions with this medication
Talk to your healthcare professional about all the medicines you take or have recently taken, including any drugs, vitamins, minerals, natural supplements or alternative medicines. Jamp- Methotrexate may interact with the following drugs:
Do not take JAMP-METHOTREXATE if you are going to receive a general anesthetic called nitrous oxide. It is also known as laughing gas. When used together, they can cause
- Myelosuppression (a condition in which the bone marrow cannot make enough blood cells),
- Mouth sores,
- Inflammation of the mouth,
- Inflammation of the kidneys
- Damage to the nervous system.
- Non-steroidal anti-inflammatory drugs (NSAIDs) and acetyl salicyclate (acetylsalicyclic acid or (ASA) and other pain killers
- Disease Modifying Antirheumatic drugs (DMARDs), such as gold, penicillamine, hydroxychloroquine, or sulfasalazine
- Drugs that may cause harm to the liver (leflunomide, azathioprine, sulfasalazine, retinoid)
- Phenylbutazone.
- Phenytoin (to treat seizures)
- Probenecid
- Amphotericine B (may cause harm to kidneys)
- Certain antibiotics such as penicillins, tetracycline, vancomycin, nystatin, neomycin, trimethoprim/ sulfamethoxazole, ciprofloxacin, pristinamycin, chloramphenicol
- Theophylline
- Mercaptopurine
- Folic acid or folinic acid
- Cytarabine and other chemotherapy agents
- Radiotherapy
- L-asparagine, a drug used to treat cancer.
- Proton pump inhibitors (PPI), They are drugs used to treat acid-related stomach problems.Some PPIs are omeprazole,esomeprazole ,and pantoprazole.
- Pyrimethamine, an anti-parasitic drug
- Nitrous oxide, an inhaled gas used to prevent pain during medical procedures.
- Amiodarone, a drug used to treat abnormal heart rhythms
- Sulfonylureas, drugs used to lower blood sugar levels, aminobenzoic acid, sulfonamides, also known as “sulfa drugs”
- Packed red blood cells, used for blood transfusions
- PUVA therapy, a type of ultraviolet light treatment for severe skin conditions
- Triamterene, a drug used to reduce blood pressure and decrease swelling
Proper use of this medication
Jamp-Methotrexate Injection is for single-use only.
Any unused product should be discarded by trained
personnel.
Take Jamp-Methotrexate o n l y as directed by
your doctor. Do not take more or less of it, and do
not take it more often than your doctor ordered. The
exact amount of medicine you need has been
carefully worked out. Taking too much may
increase the chance of side effects, while taking
too little may not improve your condition. You should
check with your doctor if you are not certain how to
take the medication.
- In most cases, Jamp-Methotrexate i s taken once weekly; the prescribed dose is taken on a single day of the week.
- In some cases, your healthcare professional may instruct you to take Jamp-Methotrexate e v e r y 12 hours for 3 doses; you should only do this once a week, and should not take more than 3 doses each week.
- It should never be taken every day of the week When used to treat psoriasis or rheumatoid arthritis. As well, in most cases of cancer, Jamp-Methotrexate should not be taken every day of the week.
- Taking Jamp-Methotrexate daily, or in a dose larger than prescribed can result in serious complications, often requiring hospitalization, and sometimes resulting in death. Taking even small doses of Jamp-Methotrexate daily for less than a week can result in serious consequences, including death.
- Select a day of the week when you are most likely to remember to take Jamp-Methotrexate and take it on that same day each week.
- Each time you refill your prescription, check to see whether the dose you need to take has changed.
Jamp-Methotrexate is often given together with
certain other medicines. If you are using a
combination of medicines, make sure that you
take each one at the proper time and do not mix
them. Ask your doctor or pharmacist to help you
plan a way to remember to take your medicines at
the right times.
While you are using Jamp-Methotrexate, your
doctor may want you to drink extra fluids so that
you will pass more urine. This will help the drug
to pass from the body, and will prevent kidney
problems and keep your kidneys working well.
If you vomit shortly after taking a dose of Jamp-Methotrexate, check with your doctor. You will be told
whether to take the dose again or to wait until
the next scheduled dose.
Usual Dose
The dose of Jamp-Methotrexate will be different for
different patients. The dose that is used may depend on
a number of things, including what the medicine is
being used for, the patient's size, whether the medicine
is being given by mouth or by injection, and whether or
not other medicines are also being taken. If you are
taking or receiving Jamp-Methotrexate at home, follow
your doctor's orders or the directions on the label. If
you have any questions about the proper dose of Jamp-Methotrexate, ask your doctor.
The doctor may decrease your dose if you have
problems with your kidneys.
Overdose
For management of a suspected drug overdose, contact your regional Poison Control Centre immediately
- Do this even if you have no signs of discomfort.
Missed Dose
- If you missed a scheduled dose, contact your doctor for instruction
Side effects and what to do about them
Along with their needed effects, medicines like
Jamp- Methotrexate can sometimes cause unwanted
effects. Also, because of the way these medicines
act on the body, there is a chance that they might
cause other unwanted effects that may not
occur until months or years after the medicine is
used. These delayed effects may include certain
types of cancer, such as leukemia. Discuss these
possible effects with your doctor.
Jamp- Methotrexate commonly causes nausea and
vomiting. Even if you begin to feel ill, do not stop
using this medicine without first checking with your
doctor. Ask your doctor for ways to lessen these
effects.
The most common side effects include:
- Upset stomach, stomach pain, vomiting, nausea, loss of appetite, dizziness, chills and fever, diarrhea or sores on lips or mouth.
- A fall in the number of white blood cells. This may reduce your resistance to infection and increase your chance of cold sores, blood poisoning or swelling of blood vessels.
- Tiredness (fatigue)
Less common side effects are:
- Headaches, hair loss, mood changes, confusion, ringing in the ears, sore eyes, skin rashes, increased sensitivity to sunlight or unexplained weight loss.
- A fall in the number of other blood cells. This may increase your chances of bruising, bleeding or tiredness.
- Damage to the lungs.
- Harm to the unborn baby.
- Convulsions
Rarely, Jamp-Methotrexate can cause other side effects including:
- Liver damage, kidney damage, pain or difficulty urinating, lower back or side pain, blood in urine or stools, dark urine
- Drowsiness, weakness
- Hoarseness
- Bloody vomit, black tarry stools or pin-point red spots on the skin
- Reddening or whitening of the skin, acne, boils, itching yellow skin or eyes
- Impotence or loss of interest in sex, decreased fertility, abortion
- Diabetes, thinning of the bones, painful muscles and joints
- Low blood pressure
- Gastrointestinal ulcers
More rarely, it can cause:
- Skin rash and other skin disorders.
- Cancer of lymph glands, sudden death
- Severe allergic reactions
- Leukoencephalopathy
- Damage to heart
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Diarrhea, vomiting, abdominal pain, or mouth ulcers | ✔ | ||
| Sore throat, fever, chills, or swelling of glands | ✔ | ||
| Inflammation of the lungs: Persistent dry, non-productive cough, shortness of breath and fever. | ✔ | ||
| Less common | |||
| Chest pain, cough, shortness of breath or fever | ✔ | ||
| Unusual bleeding or bruising | ✔ | ||
| Severe headaches | ✔ | ||
| Rare | |||
| Signs of severe allergic reaction: Skin rash, itching, chest tightness, wheezing, dizziness, hives, faintness, rapid heartbeat, shortness of breath, and/or a swollen face, lips or tongue | ✔ | ||
| Pain or difficulty urinating, lower back or side pain, blood in urine or stools, dark urine | ✔ | ||
| Yellow colour of eyes or skin | ✔ | ||
|
Renal Failure/
kidney damage
(inability of the
kidneys to work
properly):
Swelling of the hands, ankles or feet. Nausea, vomiting. Blood in the urine. Changes in frequency or amount of urine. |
✔ | ||
| Unknown | |||
| Gastrointestinal
Related:
Severe abdominal pain, tenderness, chills, fever, nausea, vomiting, extreme thirst, difficulty passing urine or bowel movement |
✔ | ||
| Central
Nervous System
Related: Behaviour changes, decreased consciousness, headache, weakness, numbness, vision loss or double vision, seizures, vomiting, loss of memory |
✔ | ||
| DRESS
(allergic
reactions): Fever, rash, hives, swelling of eyes, lips or tongue |
✔ | ||
| Pulmonary
alveolar
haemorrhage: suddenly spit or cough up blood |
✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Jamp-Methotrexate , contact your doctor or pharmacist.
How to store
To store this medicine:
- Keep out of the reach of children.
- Store it between 15°C to 25°C and away from heat.
- Protect from light. Avoid freezing Jamp-Methotrexate
- Jamp-Methotrexate should not be used beyond the labeled expiry date.
- Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting ( https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph prepared
for health professionals can be found by contacting Jamp
Pharma Corporation at 1-866-399-9091
The leaflet was prepared by Jamp Pharma Corporation
Jamp Pharma Corporation
1310 rue Nobel
Boucherville, Québec
Canada J4B 5H3
Date of Revision: September 25, 2019