Sulfazine EC (Oral)

Sulfasalazine is used to treat and prevent sudden flare-ups of mild to moderate ulcerative colitis. It works in the intestines by helping to decrease inflammation and other symptoms of the condition.

Sulfazine EC (Oral) tablets are used to treat adults and children with rheumatoid arthritis when other medicines (like salicylates or NSAIDs) have not worked or cannot be tolerated.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your or your child's progress at regular visits. This will help your doctor see if the medicine is working correctly. Blood and urine tests will be needed to check for unwanted effects.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be signs of a serious liver problem.

Check with your doctor right away if you or your child have a fever and sore throat, pale skin, unusual bruising or bleeding, or unusual tiredness or weakness. These may be signs of a blood problem.

This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Call your doctor right away if you start to have a cough that would not go away, weight loss, night sweats, fever, chills, runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

Call your doctor right away if you have difficulty breathing or swallowing, a fast heartbeat, itching, rash, or skin redness, or swelling of the face, throat, or tongue. These may be symptoms of an allergic reaction to this medicine.

This medicine may cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

Sulfasalazine may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.

Sulfasalazine may make your skin more sensitive to sunlight than it usually is. Exposure to sunlight, even for short periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you start taking this medicine:

• Stay out of direct sunlight, especially between 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock product with a skin protection factor (SPF) of at least 15. Some patients may need a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sunblock lipstick with an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Your skin or urine may turn an orange or yellow color while you or your child are using this medicine. This is normal and nothing to worry about.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a choice you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how sulfasalazine tablets and enteric-coated tablets affect children younger than 2 years of age who are being treated for ulcerative colitis. Safety and effectiveness have not been established in this age group.

Studies to date have not shown any pediatric-specific issues that would limit the usefulness of sulfasalazine enteric-coated tablets for treating juvenile rheumatoid arthritis in children. However, safety and effectiveness have not been established in children younger than 6 years of age.

Geriatric

Studies performed so far have not shown any specific problems in elderly patients that would limit the usefulness of sulfasalazine.

Breast Feeding

Studies suggest that this medication may affect milk production or its composition. If an alternative to this medication is not given, you should monitor the infant for any side effects and ensure they are getting enough milk.

Interactions with Medicines

While some medicines should not be used together, in other situations, two different medicines may be used together even if an interaction could happen. In these cases, your doctor might adjust the dose, or other precautions may be needed. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are important and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac
• Methenamine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amoxicillin
• Amtolmetin Guacil
• Azathioprine
• Balsalazide
• Bismuth Subsalicylate
• Bromfenac
• Bufexamac
• Capmatinib
• Celecoxib
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Clonixin
• Darolutamide
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Enasidenib
• Encorafenib
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Furosemide
• Ibuprofen
• Indomethacin
• Itraconazole
• Ketoprofen
• Leflunomide
• Leniolisib
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mercaptopurine
• Mesalamine
• Methotrexate
• Midostaurin
• Momelotinib
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olsalazine
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piroxicam
• Porfimer
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tafamidis
• Tenoxicam
• Teriflunomide
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Trolamine Salicylate
• Valdecoxib

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aminolevulinic Acid
• Cyclosporine
• Digoxin
• Eltrombopag
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or consuming certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical issues, especially:

• Allergy to sulfa drugs or salicylates or
• Bowel blockage or
• Porphyria (enzyme issue) or
• Urinary bladder blockage—Should not be used in patients with these conditions.

• Blood or bone marrow problems (e.g., agranulocytosis, aplastic anemia) or
• Heart disease or
• Kidney disease or
• Liver disease or
• Lung or breathing issues (e.g., bronchial asthma)—Use with caution. May worsen these conditions.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary metabolic disorder affecting red blood cells)—May cause hemolytic anemia (blood disorder) in patients with this condition.

• Infection—May reduce your body's ability to fight infection.

Along with its intended effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Aching of joints
• fever
• headache (continuing)
• increased sensitivity of the skin to sunlight
• skin rash or itching
• vomiting

Less common

• Back, leg, or stomach pains
• bleeding gums
• bluish color of the fingernails, lips, skin, palms, or nail beds
• chills
• dark urine
• difficulty breathing
• fever
• general body swelling
• headache
• loss of appetite
• nausea
• nosebleeds
• pale skin
• sore throat
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellowing of the eyes or skin

Less common or rare

• Aching of muscles
• black, tarry stools
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• bloody diarrhea
• bluish fingernails, lips, or skin
• chest pain or tightness
• constipation
• cough
• difficulty with swallowing
• dizziness
• fainting spells
• fast heartbeat
• general feeling of discomfort or illness
• general tiredness and weakness
• hives
• indigestion
• inflammation of the joints
• irregular heartbeat
• light-colored stools
• muscle aches
• muscle cramps or spasms
• muscle pain or stiffness
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• redness, blistering, peeling, or loosening of the skin
• sores, ulcers, or white spots in the mouth or on the lips
• swollen or painful glands
• upper right abdominal or stomach pain

Incidence not known

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Decreased weight
• stomach upset

Less common

• Welts

Less common or rare

• Discoloration of the skin or urine
• hair loss or thinning of the hair
• swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Azulfidine
• Azulfidine Entabs
• Sulfazine
• Sulfazine EC

In Canada

• alti-sulfaSALAzine
• Salazopyrin

Available Dosage Forms:

• Tablet
• Tablet, Enteric Coated

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Salicylate, Non-Aspirin

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

It is best to take this medicine right after meals, at evenly spaced times throughout the day and night. Try not to let more than 8 hours go by between doses, even at night.

Swallow the enteric-coated tablet whole. Do not crush, break, or chew it.

Drink extra fluids so you will pass more urine while you are using this medicine. This may help prevent kidney problems.

Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

While using this medicine, part of the enteric-coated tablet may pass into your stools. This is normal and is nothing to worry about.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of ulcerative colitis: For oral dosage form (enteric-coated tablets): Adults—At first, 500 to 1000 milligrams (mg) every 6 to 8 hours per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 4000 mg per day. Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 40 to 60 milligrams (mg) per kilogram (kg) of body weight per day, divided into 3 to 6 doses. Children 2 to 5 years of age—Dose must be determined by your doctor. Children younger than 2 years of age—Use and dose must be determined by your doctor. For oral dosage form (tablets): Adults—At first, 500 to 1000 milligrams (mg) every 6 to 8 hours per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 4000 mg per day. Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 40 to 60 milligrams (mg) per kilogram (kg) of body weight per day, divided into 3 to 6 doses. Children 2 to 5 years of age—Dose must be determined by your doctor. Children younger than 2 years of age—Use and dose must be determined by your doctor.
• For maintenance treatment of ulcerative colitis: For oral dosage form (enteric-coated tablets): Adults—2000 milligrams (mg) per day. Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 30 milligrams (mg) per kilogram (kg) of body weight per day, divided into 4 doses. Children 2 to 5 years of age—Dose must be determined by your doctor. Children younger than 2 years of age—Use and dose must be determined by your doctor. For oral dosage form (tablets): Adults—2000 milligrams (mg) per day. Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 30 milligrams (mg) per kilogram (kg) of body weight per day, divided into 4 doses. Children 2 to 5 years of age—Dose must be determined by your doctor. Children younger than 2 years of age—Use and dose must be determined by your doctor.
• For treatment of rheumatoid arthritis: For oral dosage form (enteric-coated tablets): Adults—At first, 500 mg to 1000 milligrams (mg) per day, divided into 2 doses. Your doctor may increase your dose as needed. However, the dose is usually not more than 3000 mg per day. Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 30 to 50 milligrams (mg) per kilogram (kg) of body weight per day, divided into 2 doses. Your doctor may increase your dose as needed. However, the dose is usually not more than 2000 mg per day. Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.