Patient Medication Information: uses, side effects, how to take - Jamp Sulfasalazine
What the medication is used for:
JAMP Sulfasalazine contains sulfasalazine, which is an anti- inflammatory drug indicated as an adjunctive therapy in the treatment of severe ulcerative colitis (bowel inflammation), proctitis (inflammation of the rectum) or distal ulcerative colitis and Crohn’s disease.
What it does:
The way in which JAMP Sulfasalazine works is unclear and thought to involve three actions:
- anti-inflammatory action, which blocks the production and effect of certain substances in the body (cyclooxygenase, prostaglandins and others), which are involved in producing inflammation;
- bacteriostatic (antibacterial) action, which prevents the growth of several kinds of bacteria which are possibly involved in inflammation;
- immunosuppressive action (which reduces a patient’s overly active immune response, which has been linked to inflammatory diseases).
All of these actions likely work together to reduce symptoms of gut inflammation, diarrhea, swelling and bleeding.
When it should not be used:
Do not use JAMP Sulfasalazine if you have:
- a hypersensitivity (allergic reactions) to sulfasalazine, its metabolites, sulfonamides, salicylates or any other component of this product (see What the non- medicinal ingredients are);
- an intestinal or urinary obstruction;
- porphyria (disease of pigment production in tissues).
- experienced sudden asthmatic attacks, urticaria, rhinitis, or other allergic-type reactions to acetylsalicylic acid or other nonsteroidal anti-inflammatory, as these attacks are serious and can be fatal (see WARNINGS AND PRECAUTIONS PRECAUTIONS in the Product Monograph for a complete list of conditions where JAMP Sulfasalazine should not be used);
- severe kidney (renal) impairment and/or severe liver (hepatic) impairment (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM)
This drug is not to be used in infants under 2 years of age.
What the medicinal ingredient is:
Sulfasalazine
What the non-medicinal ingredients are: JAMP Sulfasalazine tablets contain: colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized starch
What dosage forms it comes in:
JAMP Sulfasalazine is available as:
- JAMP Sulfasalazine tablets: Yellow to orange-colored, round-shaped, biconvex tablet engraved with “500” and a score line on one side and plain on the other side. Supplied in bottles of 100 and 500 tablets.
BEFORE you use JAMP Sulfasalazine talk to your doctor or pharmacist if you:
- have had any allergic reactions to any sulfonamides, furosemide or thiazide diuretics (water pills), dapsone, sulfoxone, oral hypoglycemics (diabetes drugs you take by mouth), glaucoma medicines you take by mouth (for example, acetazolamide, dichlorophenamide, methazolamide), or salicylates (for example, acetylsalicylic acid);
are pregnant or intend to become pregnant while taking this medicine;
- are breastfeeding an infant. Sulfonamides pass into the breast milk in small amounts and may cause unwanted effects in infants with glucose-6-phosphate dehydrogenase (G6PD) deficiency. There have been reports of bloody stools or diarrhea in infants who were breastfeeding from mothers on sulfasalazine.
- intend to father a child (low sperm count);
have any of the following medical problems:
- Blockage of the stomach, intestines, or urinary tract
- Blood problems
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Kidney disease
- Liver disease
- Porphyria
- History of recurring or chronic infections. If you develop a new infection while taking JAMP Sulfasalazine, talk to your doctor.
- are now taking any other medicines (See Interactions with this medicine).
- before having any kind of surgery, including dental surgery, with a general anaesthetic, tell the physician or dentist in charge that you are taking a sulfonamide.
JAMP Sulfasalazine (Sulfasalazine Tablets) Product Monograph 27
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
IMPORTANT: PLEASE READ
Stop taking JAMP Sulfasalazine immediately and tell your doctor if you develop the following symptoms:
- Skin rash, fever, swollen lymph nodes, lesions inside your mouth or nose;
- Sore throat, fever, pallor (pale skin), swollen lymph nodes, purple discolouration of the skin which does not blanch under pressure or jaundice (yellowing of your skin or white portion of your eye).
Do not give this medication to infants under 2 years of age.
If taken with some other medicines, the effects of
JAMP Sulfasalazine or the other medications may change. Please check with your doctor or pharmacist before taking any other medications with JAMP Sulfasalazine such as:
- Anthralin
- Antibiotics
- Anticoagulants, coumarin- or indandione-type (blood thinners)
- Antidiabetic agents, oral (diabetes medicines you take by mouth)
- Azathioprine
- Coal tar
- Dapsone
- Digitalis glycosides (heart medicine)
- Dipyrone
- Diuretics (water pills or high blood pressure medicine)
- Ethotoin
- Folic acid
- Furazolidone
- Mephenytoin
- Methenamine
- Methotrexate
- Methoxsalen
- Nalidixic acid
- Nitrofurantoin
- Other sulfonamides
- Oxyphenbutazone
- Phenothiazines (tranquilizers)
- Phenylbutazone
- Phenytoin
- Primaquine
- Probenecid
- Sulfinpyrazone
- Sulfoxone
- Tetracyclines
- Thiopurine 6-mercaptopurine
- Trioxsalen
- Vitamin K
Drug interactions with antibiotics, anticoagulants, coumarin- or indandione-derivative, anticonvulsants, oral antidiabetic agents, digitalis glycosides or folic acid, methenamine, methotrexate, oxyphenbutazone or phenylbutazone, photosensitizing medications, probenecid, sulfinpyrazone, thiopurine methyltransferase (TPMT) are possible.
Sulfasalazine may interfere with some medical tests. Your healthcare provider will evaluate your results depending on your symptoms.
Usual adult dose:
Take JAMP Sulfasalazine as directed by your doctor, at regular and even intervals over the 24-hour period. If you are taking JAMP Sulfasalazine tablets for an intestinal inflammatory disease, the nighttime dose interval should not exceed 8 hours.
JAMP Sulfasalazine tablets (sulfasalazine) are best taken after meals or with food to lessen stomach upset. If stomach upset continues or is bothersome, check with your doctor.
Each dose of JAMP Sulfasalazine should also be taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water helps prevent unwanted side effects of sulfonamide.
Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.
If your symptoms (including diarrhea) do not improve within a month or two or if they become worse, check with your doctor. It is important that your doctor check your progress at regular visits.
Laboratory and blood tests may be scheduled for you by your doctor before and during treatment.
Overdose:
Missed Dose:
If you do miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, do not take the missed dose or double your next dose. Instead, go back to your regular dosing schedule.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects appear very often, when they do occur they may require medical attention.
Other side effects (than those mentioned in the following table) may occur, which usually do not require medical attention.
These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
If you think you have taken too much JAMP Sulfasalazine, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
IMPORTANT: PLEASE READ
More Common: Diarrhea, dizziness, loss of appetite, nausea or vomiting, headache, itching, skin rash, upset stomach.
Less Common: rash, itching, hives, fever. Rare: blood problems
In some patients this medicine may also cause the urine to become orange-yellow, or may stain contact lenses yellow. This side effect does not require medical attention.
Some people who take sulfonamides may become more sensitive to sunlight than they are normally. When you begin to take this medicine, avoid too much sun or too much use of a sunlamp until you see how you react, especially if you tend to burn easily. You may still be more sensitive to sunlight or sunlamps for many months after you stop taking this medicine. If you have a severe reaction, check with your doctor.
This is not a complete list of side effects. For any unexpected effects while taking JAMP Sulfasalazine, contact your doctor or pharmacist.
Store at room temperature, 15-30°C.
Keep out of reach and sight of children.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||
|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist |
| Only if severe | In all cases | |
| Rare | ||
These symptoms have been associated with sulfasalazine tablets use. | ||
| √ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| More common | Low sperm counts (oligospermia), with infertility, have been observed with men taking sulfasalazine tablets, which is reversible within several months of stopping the medication. | √ | ||
| Increased sensitivity of the skin to sunlight | √ | |||
| Less Common | Aching in joints and muscles, difficulty in swallowing, fever, pale skin, redness, blistering, peeling or loosening of the skin, sore throat, unusual bleeding or bruising, unusual tiredness or weakness, yellowing of the eyes or skin, mouth sores, ringing in the ears | √ | ||
HOW TO STORE IT
IMPORTANT: PLEASE READ
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
|---|
If you want more information about JAMP Sulfasalazine:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-399-9091.
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Last Approved: January 17, 2024