Sulfasalazine azulfidine

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Sulfasalazine

Sulfasalazine is the generic form of the brand-name drug Azulfidine, which is used to treat symptoms of ulcerative colitis (a condition where the bowel is inflamed).

The medicine is sometimes used to help symptoms of Crohn’s disease (another type of inflammatory bowel disease).

The delayed-release form of sulfasalazine (Azulfidine EN-tabs) is also used to treat rheumatoid arthritis.

Azulfidine is in a class of medicines known as anti-inflammatories. It works by reducing inflammation in the body.

The Food and Drug Administration (FDA) first approved sulfasalazine in 1950. The medicine is manufactured as Azulfidine by Pfizer.

Sulfasalazine Warnings

Before taking sulfasalazine, tell your doctor if you have or have ever had:

  • Asthma
  • Kidney or liver disease
  • Porphyria (a blood disorder)
  • Other blood problems (such as anemia or low white blood cell levels)
  • Rheumatoid arthritis
  • Thyroid problems
  • A glucose-6-phosphate dehydrogenase (G6PD) deficiency (an inherited enzyme condition)
  • An infection or a previous infection that keeps coming back
  • A blockage in your stomach, bowel, or urinary tract
  • Severe allergies or allergies to medications

For men, this medicine may cause temporary infertility. Your fertility will return when you stop taking sulfasalazine.

Elderly people may be more sensitive to the side effects of sulfasalazine. The medicine should be used with caution in those 65 years and older.

Sulfasalazine shouldn’t be used in children younger than 2 years old. Safety and effectiveness haven’t been confirmed in this age group.

This medicine may cause very bad skin conditions such as Stevens-Johnson syndrome or toxic epidermal necrolysis.

Seek medical help right away if you experience symptoms such as:

  • Red, swollen, blistered, or peeling skin
  • Red or irritated eyes
  • Sores in your mouth, throat, eyes, or nose

Sulfasalazine may cause your skin or urine to turn yellowish-orange. This is a harmless effect.

If you have diabetes, sulfasalazine may affect your blood sugar. Check your levels often, and talk to your doctor before changing any doses of your diabetes medicines.

Continue to take sulfasalazine even if you feel well. Don’t stop taking the medicine without first talking to your doctor.

Keep all appointments with your healthcare provider and laboratory while taking sulfasalazine. Your physician may want to perform frequent tests to check your body’s response to the drug.

Pregnancy and Sulfasalazine

Sulfasalazine isn’t likely to harm an unborn baby.

However, tell your doctor if you’re pregnant or might become pregnant before taking this medicine.

The drug can be found in breast milk. You shouldn’t breastfeed while taking sulfasalazine without first talking to your doctor.

What is Sulfasalazine?

Sulfasalazine (Sul-fa-SAL-a-zeen) is an anti-inflammatory agent used to treat rheumatoid arthritis and other inflammatory conditions. It works by suppressing the blood cells that cause inflammation.

How do I take it?

Sulfasalazine is taken twice daily. The pills are 500-mg. each. The usual dose for this drug is 2 to 6 pills daily. You doctor will tell you how many pills to take and how often. Follow your doctor’s directions. For the best results, take these pills at the same time every day. Do not take more or less medicine than ordered. This medicine should be taken with food. You should also drink a full glass of water with each dose.

What about side effects?

In some cases patients have complained of upset stomachs, indigestion, or diarrhea. Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. This medicine can occasionally affect the liver and some blood counts. Blood tests will be done every 2 months to check for problems. If you develop a rash while taking this medicine, stop taking it and call the doctor’s office.

What else should I know?

IF YOU HAVE A KNOWN ALLERGY TO SULFA DRUGS, DO NOT TAKE THIS MEDICINE UNTIL YOU TALK TO YOUR DOCTOR.

What about other medications?

When you are taking Sulfasalazine, it is very important that your doctors know if you are taking any other medicine. This includes prescription and non-prescription medicines as well as birth control pills, vitamins, and herbal supplements.

Sulfasalazine can be taken with other medications, however it is best to have your doctor’s advice before adding another drug to your daily routine.

Sulfasalazine: How Effective is it for Treating Rheumatoid Arthritis?

Hugh Duckworth MD

Doctor of Medicine (M.D.) in 1984 from University of Tennessee School of Medicine

Jan 23, 2019 4 min read

If you are suffering from Rheumatoid Arthritis (RA), you are no stranger to pain. RA is a chronic autoimmune disorder which results in mild to severe joint inflammation and deformity. RA most often affects the hands and feet, though it can affect any other part of the body. Causing pain, swelling, and stiffness, Rheumatoid Arthritis can happen to anyone, but most commonly occurs in women and the average age of onset is in middle age.

While there is as yet no cure for Rheumatoid Arthritis, the progression and the symptoms of this chronic condition can be managed. Goals of the treatment include alleviating pain, slowing and stopping joint damage, reducing swelling, and helping individuals become more active and attain healthier lifestyles. There are multiple types of treatment. Many individuals with Rheumatoid Arthritis will undergo multiple forms of treatment to fully address the pain and symptoms that they are experiencing. Common treatments include:

  • Medicine
  • Lifestyle changes
  • Surgery
  • Alternative therapies

What is Sulfasalazine

With brand names Azulfidine and Sulfazine, Sulfasalazine is a disease-modifying anti-rheumatic drug (DMARD). First discovered and used in RA treatment nearly 70 years ago, Sulfasalazine is normally prescribed for arthritis patients who are not responding to NSAIDs.

The main ingredients in Sulfasalazine are salicylic acid (the active ingredient in aspirin) and sulfapyridine (an antibiotic). Sulfasalazine provides RA symptom relief by reducing joint inflammation and stopping or slowing down the progression of the disease. Sulfasalazine is most effective in individuals who are experiencing more mild to moderate Rheumatoid Arthritis symptoms; however, it has also been found to be effective in some individuals with more severe cases of RA. In severe cases, Sulfasalazine is more often prescribed in combination with NSAIDs and other DMARDs.

How Do You Take It?

Sulfasalazine is taken orally as a 500mg tablet. Dosage usually begins with one 500mg tablet per day and dosage is eventually increased by 500mg to see how your body reacts to the drug. A common dosage for adults suffering from Rheumatoid Arthritis is about 2000mg to 3000mg per day.

To prevent gastrointestinal issues, Sulfasalazine should be taken with food and water. If you are suffering from stomach upset due to use of this drug, there is an enteric-coated version of the tablet available to ease gastrointestinal symptoms. It is important to note that the enteric-coated tablet should not be crushed or chewed.

It normally takes about 1-3 months for the medication to start seeing the effects of this type of treatment.

Possible Side Effects

When taking Sulfasalazine, reported side effects are usually mild and improve in time. The most common side effects include:

  • Upset stomach
  • Diarrhea
  • Nausea/vomiting
  • Headache
  • Appetite loss
  • Skin sensitivity

Approximately 10% of patients taking Sulfasalazine experience a skin rash. Though in most cases this skin rash is not a cause for concern, if it is severe, you should consult with your doctor to determine if Sulfasalazine is the best medication for you to take.

Clinical Study Results

Significant research about Sulfasalazine’s effects on easing Rheumatoid Arthritis symptoms has been conducted. In comparison to placebos and other RA medications (including other DMARDs, methotrexate, and leflunomide), Sulfasalazine has been found to effectively reduce joint inflammation, other RA symptoms, and slow the progression of joint damage.

Meta-analysis studies examining the effectiveness of Sulfasalazine on RA symptoms found that individuals experienced significant improvements in RA symptoms, including swelling, pain, and inflammation, by week 12 of treatment.

Warnings and Precautions

If you are taking blood thinners, check with your doctor to see if Sulfasalazine should be used in the treatment of RA.

Some males have experienced low sperm counts while taking Sulfasalazine, though levels return to normal upon stopping the drug.

A woman can take Sulfasalazine during pregnancy; however, the drug may lower levels of folate during the pregnancy. If you are breastfeeding, do not take Sulfasalazine.

Check with your doctor if you have/take any of the following to see if Sulfasalazine is the right medication for you:

  • Blood disorders
  • Liver damage
  • Kidney damage
  • Tuberculosis
  • Diabetes
  • Skin rash
  • Severe allergies
  • Bronchial asthma
  • Glaucoma

Azulfidine

Generic Name: sulfasalazine (SUL fa SAL a zeen)
Brand Name: Azulfidine, Azulfidine EN-tabs, Sulfazine

Medically reviewed by Drugs.com on Nov 9, 2018 – Written by Cerner Multum

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What is Azulfidine?

Azulfidine is used to treat ulcerative colitis (UC), and to decrease the frequency of UC attacks. This medicine will not cure ulcerative colitis, but it can reduce the number of attacks you have.

Azulfidine is also used to treat rheumatoid arthritis in children and adults who have used other arthritis medicines that did not work or have stopped working.

Azulfidine may also be used for purposes not listed in this medication guide.

Important Information

You should not use Azulfidine if you have porphyria, a blockage in your bladder or intestines, or if you are allergic to sulfa drugs, aspirin, or similar medicines called salicylates.

Before taking this medicine

You should not use Azulfidine if you are allergic to it, or if you have:

  • a blockage in your bladder or intestines;

  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

  • an allergy to sulfa drugs; or

  • an allergy to aspirin or other salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

  • frequent infections;

  • asthma;

  • low blood cell counts; or

  • liver or kidney disease.

Tell your doctor if you are pregnant. Taking Azulfidine can make it harder for your body to absorb folic acid, and folic acid helps prevent major birth defects of the baby’s brain or spine. You may need to take folic acid supplements if you take this medicine during pregnancy. Follow your doctor’s instructions.

Sulfasalazine can pass into breast milk and may cause diarrhea or bloody stools in a nursing baby. Tell your doctor if you are breast-feeding.

Azulfidine is not approved for use by anyone younger than 2 years old.

How should I take Azulfidine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Azulfidine after a meal.

Swallow the tablet whole and do not crush, chew, or break it.

You will need frequent medical tests.

Drink plenty of liquids to keep your kidneys working properly while you are taking Azulfidine.

Azulfidine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Azulfidine may cause your skin or urine to appear orange-yellow in color. Call your doctor if you also have yellowing of your eyes, brown urine, or stomach pain. These may be signs of liver problems.

If you are treating arthritis, do not stop using any of your other arthritis medicines until your doctor tells you to. Azulfidine may not improve your symptoms right away, and you may still need your other medicines for awhile.

Azulfidine is only part of a complete treatment for rheumatoid arthritis that may also include rest and physical therapy. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include vomiting, stomach pain, drowsiness, or seizure.

What should I avoid while taking Azulfidine?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Azulfidine side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • fever, chills, sore throat;

  • mouth sores, red or swollen gums;

  • pale skin, easy bruising, unusual bleeding; or

  • chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

  • fever with headache, rash, and vomiting;

  • a skin rash, no matter how mild;

  • severe nausea or vomiting when you first start taking Azulfidine;

  • little or no urination, urine that looks foamy;

  • puffy eyes, swelling in your ankles or feet, weight gain; or

  • liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, vomiting, upset stomach, loss of appetite;

  • headache;

  • rash; or

  • low sperm count in men.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Azulfidine?

Other drugs may affect Azulfidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 6.01.

Medical Disclaimer

More about Azulfidine (sulfasalazine)

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  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Pricing & Coupons
  • En Español
  • 3 Reviews
  • Generic Availability
  • Drug class: 5-aminosalicylates

Consumer resources

  • Azulfidine
  • Azulfidine (Advanced Reading)

Other brands: Sulfazine

Professional resources

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  • … +2 more

Other Formulations

  • Azulfidine EN-tabs

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Sulfasalazine Delayed-Release Tablets

Generic Name: Sulfasalazine Delayed-Release Tablets (sul fa SAL a zeen)
Brand Name: Azulfidine EN-tabs

Medically reviewed by Drugs.com. Last updated on Aug 25, 2019.

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Uses of Sulfasalazine Delayed-Release Tablets:

  • It is used to treat rheumatoid arthritis.
  • It is used to treat ulcerative colitis.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Sulfasalazine Delayed-Release Tablets?

  • If you have an allergy to sulfasalazine or any other part of this medicine (sulfasalazine delayed-release tablets).
  • If you have a sulfa allergy.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Bowel block, porphyria, or trouble passing urine.

This is not a list of all drugs or health problems that interact with this medicine (sulfasalazine delayed-release tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (sulfasalazine delayed-release tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Sulfasalazine Delayed-Release Tablets?

  • Tell all of your health care providers that you take this medicine (sulfasalazine delayed-release tablets). This includes your doctors, nurses, pharmacists, and dentists.
  • If you have asthma, talk with your doctor. You may be more sensitive to this medicine (sulfasalazine delayed-release tablets).
  • Be careful if you have G6PD deficiency. Anemia may happen.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have your urine checked as you have been told by your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (sulfasalazine delayed-release tablets).
  • This medicine may change the color of urine or skin to a yellow or orange color. This is not harmful.
  • Very bad and sometimes deadly allergic reactions, infections, heart problems, kidney problems, liver problems, lung problems, and blood problems have happened with this medicine (sulfasalazine delayed-release tablets). Nerve or muscle problems that have not gone away have also happened with this medicine (sulfasalazine delayed-release tablets). Talk with the doctor.
  • Some males have had sperm problems while taking this medicine (sulfasalazine delayed-release tablets). This may affect being able to father a child. This may go back to normal after the drug is stopped. Talk with the doctor.
  • You may see something that looks like the tablet in your stool. If this happens, talk with your doctor.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Sulfasalazine Delayed-Release Tablets) best taken?

Use this medicine (sulfasalazine delayed-release tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take after meals.
  • Swallow whole. Do not chew, break, or crush.
  • Keep taking this medicine (sulfasalazine delayed-release tablets) as you have been told by your doctor or other health care provider, even if you feel well.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Feeling very tired or weak.
  • Pale skin.
  • Any unexplained bruising or bleeding.
  • Swollen gland.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Sulfasalazine Delayed-Release Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Sulfasalazine Delayed-Release Tablets?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (sulfasalazine delayed-release tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about sulfasalazine

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
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  • Drug Interactions
  • Compare Alternatives
  • Support Group
  • Pricing & Coupons
  • En Español
  • 102 Reviews
  • Drug class: 5-aminosalicylates
  • Sulfasalazine
  • Sulfasalazine Tablets
  • Sulfasalazine (Advanced Reading)

Other brands: Azulfidine, Sulfazine, Azulfidine EN-tabs

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PRECAUTIONS

AZULFIDINE Tablets should be given with caution to patients with severe allergy or bronchial asthma. Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation. Patients with glucose-6 phosphate dehydrogenase deficiency should be observed closely for signs of hemolytic anemia. This reaction is frequently dose related. If toxic or hypersensitivity reactions occur, the drug should be discontinued immediately.

Laboratory Tests

Complete blood counts, including differential white cell count and liver function tests, should be performed before starting AZULFIDINE and every second week during the first three months of therapy. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. Urinalysis and an assessment of renal function should also be done periodically during treatment with AZULFIDINE.

The determination of serum sulfapyridine levels may be useful since concentrations greater than 50 μg/mL appear to be associated with an increased incidence of adverse reactions.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Two-year oral carcinogenicity studies were conducted in male and female F344/N rats and B6C3F1 mice. Sulfasalazine was tested at 84 (496 mg/m²), 168 (991 mg/m²), and 337.5 (1991 mg/m²) mg/kg/day doses in rats. A statistically significant increase in the incidence of urinary bladder transitional cell papillomas was observed in male rats. In female rats, two (4%) of the 337.5 mg/kg rats had transitional cell papilloma of the kidney. The increased incidence of neoplasms in the urinary bladder and kidney of rats was also associated with an increase in the renal calculi formation and hyperplasia of transitional cell epithelium. For the mouse study, sulfasalazine was tested at 675 (2025 mg/m²), 1350 (4050 mg/m²), and 2700 (8100 mg/m²) mg/kg/day. The incidence of hepatocellular adenoma or carcinoma in male and female mice was significantly greater than the control at all doses tested.

Sulfasalazine did not show mutagenicity in the bacterial reverse mutation assay (Ames test) and in L51784 mouse lymphoma cell assay at the HGPRT gene. However, sulfasalazine showed equivocal mutagenic response in the micronucleus assay of mouse and rat bone marrow and mouse peripheral RBC and in the sister chromatid exchange, chromosomal aberration, and micronucleus assays in lymphocytes obtained from humans.

Impairment of male fertility was observed in reproductive studies performed in rats at a dose of 800 mg/kg/day (4800 mg/m²). Oligospermia and infertility have been described in men treated with sulfasalazine. Withdrawal of the drug appears to reverse these effects.

Pregnancy

There are no adequate and well-controlled studies of sulfasalazine in pregnant women. Reproduction studies have been performed in rats and rabbits at doses up to 6 times the human maintenance dose of 2 g/day based on body surface area and have revealed no evidence of impaired female fertility or harm to the fetus due to sulfasalazine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

There have been case reports of neural tube defects (NTDs) in infants born to mothers who were exposed to sulfasalazine during pregnancy, but the role of sulfasalazine in these defects has not been established. However, oral sulfasalazine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation (see DRUG INTERACTIONS) and diminish the effect of periconceptional folic acid supplementation that has been shown to decrease the risk of NTDs.

A national survey evaluated the outcome of pregnancies associated with inflammatory bowel disease (IBD). In a group of 186 women treated with sulfasalazine alone or sulfasalazine and concomitant steroid therapy, the incidence of fetal morbidity and mortality was comparable to that for 245 untreated IBD pregnancies as well as to pregnancies in the general population.1 A study of 1,455 pregnancies associated with exposure to sulfonamides indicated that this group of drugs, including sulfasalazine, did not appear to be associated with fetal malformation.2 A review of the medical literature covering 1,155 pregnancies in women with ulcerative colitis suggested that the outcome was similar to that expected in the general population.3

No clinical studies have been performed to evaluate the effect of sulfasalazine on the growth development and functional maturation of children whose mothers received the drug during pregnancy.

Clinical Considerations

Sulfasalazine and its metabolite, sulfapyridine pass through the placenta. Sulfasalazine and its metabolite are also present in human milk. In the newborn, sulfonamides compete with bilirubin for binding sites on the plasma proteins and may cause kernicterus. Although sulfapyridine has been shown to have a poor bilirubindisplacing capacity, monitor the newborn for the potential for kernicterus.

A case of agranulocytosis has been reported in an infant whose mother was taking both sulfasalazine and prednisone throughout pregnancy.

Nursing Mothers

Sulfonamides, including sulfasalazine, are present in human milk (see Pregnancy, Clinical Considerations). Insignificant amounts of sulfasalazine have been found in milk, whereas levels of the active metabolite sulfapyridine in milk are about 30 to 60 percent of those in the maternal serum. Caution should be exercised when AZULFIDINE is administered to a nursing mother.

There are reports with limited data of bloody stools or diarrhea in human milk fed infants of mothers taking sulfasalazine. In cases where the outcome was reported, bloody stools or diarrhea resolved in the infant after discontinuation of sulfasalazine in the mother or discontinuation of breastfeeding. Due to limited data, a causal relationship between sulfasalazine exposure and bloody stools or diarrhea cannot be confirmed or denied. Monitor human milk fed infants of mothers taking sulfasalazine for signs and symptoms of diarrhea and/or bloody stools.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

1. Mogadam M, et al. Pregnancy in inflammatory bowel disease: effect of sulfasalazine and corticosteroids on fetal outcome. Gastroenterology 1981;80:72-6.

2. Kaufman DW, editor. Birth defects and drugs during pregnancy. Littleton, MA: Publishing Sciences Group, Inc, 1977: 296-313.

3. Jarnerot G. Fertility, sterility and pregnancy in chronic inflammatory bowel disease. Scand J Gastroenterol 1982;17:1-4.

Sulfasalazine DR 500 mg Enteric Coated Tablets

Product Summary

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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does NOT assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

SULFASALAZINE – ORAL

(sull-fuh-SAL-uh-zeen)

COMMON BRAND NAME(S): Azulfidine

USES: Sulfasalazine is used to treat a certain type of bowel disease called ulcerative colitis. This medication does not cure this condition, but it helps decrease symptoms such as fever, stomach pain, diarrhea, and rectal bleeding. After an attack is treated, sulfasalazine is also used to increase the amount of time between attacks. This medication works by reducing irritation and swelling in the large intestines. In addition, delayed-release tablets of sulfasalazine are used to treat rheumatoid arthritis. Sulfasalazine helps to reduce joint pain, swelling, and stiffness. Early treatment of rheumatoid arthritis with sulfasalazine helps to reduce/prevent further joint damage so you can do more of your normal daily activities. This medication is used with other drugs, rest, and physical therapy in patients who have not responded to other medications (salicylates, nonsteroidal anti-inflammatory drugs-NSAIDs).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used to treat another type of bowel disease called Crohn’s disease.

HOW TO USE: Take this medication by mouth after meals with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. To prevent stomach upset, your doctor may recommend a slow increase in your dosage when starting treatment. Dosage is based on your medical condition and response to therapy. In children, dosage is also based on weight. If you are taking the delayed-release tablets, swallow them whole. Do not crush, chew, or break the tablets. Doing so may increase the chance of stomach upset. Drink plenty of fluids during treatment with this medication unless otherwise directed by your doctor. This will help prevent kidney stones. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Inform your doctor if your condition does not improve or if it worsens. For the treatment of rheumatoid arthritis, it may take 1-3 months before you notice any improvement in your symptoms.

SIDE EFFECTS: Stomach upset, nausea, vomiting, loss of appetite, mouth sores, headache, dizziness, or unusual tiredness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. This medication may cause your skin and urine to turn orange-yellow. This effect is harmless and will disappear when the medication is stopped. Rarely, delayed-release tablets of sulfasalazine may appear whole or only partly dissolved in your stool. If this occurs, tell your doctor immediately so your treatment can be changed. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may cause temporary male infertility. This effect is reversible when the medication is stopped. Tell your doctor immediately if any of these unlikely but serious side effects occur: sun sensitivity, hearing changes (e.g., ringing in the ears), mental/mood changes, painful urination, blood in the urine, change in the amount of urine, new lump/growth in the neck (goiter), numbness/tingling of the hands/feet, signs of low blood sugar (e.g., hunger, cold sweat, blurred vision, weakness, fast heartbeat). This medication may rarely cause very serious allergic reactions (e.g., Stevens-Johnson syndrome), blood disorders (e.g., agranulocytosis, aplastic anemia), liver damage, and nerve/muscle problems. Seek immediate medical attention if you notice any of the following symptoms: skin rash/blisters/peeling, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest pain, signs of infection (e.g., fever, chills, persistent sore throat), easy bruising/bleeding, severe tiredness, muscle pain/weakness (especially with fever and unusual tiredness), pale or blue skin/lips/nails, new/worsening joint pain, confusion, persistent/severe headache, unexplained neck stiffness, seizures, signs of liver problems (e.g., persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine). This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking sulfasalazine, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs; or to aspirin and related drugs (salicylates, NSAIDs such as ibuprofen); or to mesalamine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: intestinal blockage, urinary blockage, a certain blood disorder (porphyria). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, blood disorders (e.g., aplastic anemia), a certain genetic condition (G6PD deficiency), asthma, severe allergies. This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (e.g., salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (e.g., varicella vaccine), without first consulting a doctor about Reye’s syndrome, a rare but serious illness. During pregnancy, this medication should be used only when clearly needed. Caution is advised if this medication is used near the expected delivery date because similar drugs may cause harm to a newborn. Discuss the risks and benefits with your doctor. If you become pregnant while taking this drug, contact your doctor immediately. This medication may lower your folic acid levels, increasing the risk of spinal cord defects. Therefore, check with your doctor to make sure you are taking enough folic acid. Prenatal care should include tests for spinal cord defects. This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. This drug should not be used with the following medication because very serious interactions may occur: methenamine. If you are currently using the medication listed above, tell your doctor or pharmacist before starting sulfasalazine. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cyclosporine, digoxin, folic acid, PABA taken by mouth, phenytoin. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If an overdose is suspected, contact your local poison control center or emergency room immediately. U.S. residents should call the U.S. National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center. Symptoms of overdose may include: severe stomach/abdominal pain, persistent vomiting, extreme drowsiness, seizures.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., complete blood count, liver and kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2012. Copyright(c) 2012 First Databank, Inc.

Sulfasalazine Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 17, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

In Summary

Commonly reported side effects of sulfasalazine include: gastric distress, headache, nausea, oligospermia, vomiting, and anorexia. Other side effects include: fever. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to sulfasalazine: oral tablet, oral tablet enteric coated

Along with its needed effects, sulfasalazine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sulfasalazine:

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
  • troubled breathing with exertion
  • 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
  • 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
  • tightness in the chest
  • 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 of sulfasalazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about 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

  • Abdominal or stomach pain or upset
  • decreased weight

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

For Healthcare Professionals

Applies to sulfasalazine: compounding powder, oral delayed release tablet, oral tablet

General

The most common side effects reported were anorexia, headache, nausea, vomiting, gastric distress, elevated temperature, erythema, pruritus, rash, loss of appetite, and reversible oligospermia. Less common side effects included urticaria, fever, Heinz body anemia, hemolytic anemia, and cyanosis. Frequency of side effects increased with daily doses of 4 g or more, or total serum sulfapyridine levels above 50 mcg/mL.

The use of enteric-coated preparations may decrease gastrointestinal side effects.

Gastrointestinal

Very common (10% or more): Nausea (up to 33%), vomiting (up to 33%), gastric distress (about 33%), dyspepsia (13%)

Common (1% to 10%): Abdominal pain, diarrhea, stomatitis

Frequency not reported: Impaired folic acid absorption, impaired digoxin absorption, neutropenic enterocolitis, hemorrhagic colitis, bloody diarrhea, necrotizing pancreatitis

Postmarketing reports: Pseudomembranous colitis, pancreatitis, worsening ulcerative colitis, parotitis

Nervous system

Transverse myelitis developed in 1 patient after receiving sulfasalazine for 2 years. All symptoms resolved within 2 months after discontinuing sulfasalazine.

Very common (10% or more): Headache (up to 33%)

Common (1% to 10%): Dizziness, taste disorders, tinnitus

Uncommon (0.1% to 1%): Convulsions, vertigo

Frequency not reported: Meningitis, neuropathy, transverse myelitis, transient lesions of the posterior spinal column, cauda equina syndrome, Guillain-Barre syndrome, hearing loss, drowsiness, neurotoxicity, dysphasia, acute encephalopathy, monoparesis, cerebrospinal fluid abnormalities, altered taste, peripheral neuritis

Postmarketing reports: Aseptic meningitis, ataxia, encephalopathy, peripheral neuropathy, smell disorders

Metabolic

Hypoglycemia has been reported rarely in patients using sulfonamides.

Very common (10% or more): Anorexia (about 33%)

Rare (less than 0.1%): Hypoglycemia

Postmarketing reports: Folate deficiency, loss of appetite

Genitourinary

Diuresis has been reported rarely in patients using sulfonamides.

Infertility appeared to be reversible upon drug discontinuation.

Very common (10% or more): Reversible oligospermia (about 33%)

Common (1% to 10%): Proteinuria

Rare (less than 0.1%): Impotence, diuresis

Frequency not reported: Decreased motility, abnormal sperm penetration (sometimes resulted in infertility), urinary tract infections, urine discoloration

Postmarketing reports: Hematuria, crystalluria

Dermatologic

Angioedema was reported during postmarketing experience with the use of products containing or metabolized to mesalamine.

The risk of Stevens-Johnson syndrome or toxic epidermal necrolysis increased largely with the use of sulfonamides; however, these phenomena were rare as a whole.

Very common (10% or more): Rash (up to 13%)

Common (1% to 10%): Pruritus, urticaria

Uncommon (0.1% to 1%): Alopecia

Frequency not reported: Toxic epidermal necrolysis (Lyell’s syndrome), skin discoloration, erythema multiforme, parapsoriasis varioliformis acuta (Mucha-Haberman syndrome), generalized skin eruptions, petechiae

Postmarketing reports: Angioedema, purpura, epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), toxic pustuloderma, erythema, exanthema, exfoliative dermatitis, periorbital edema, lichen planus, photosensitivity

Immunologic

Immunoglobulin suppression was slowly reversible and rarely accompanied by clinical findings.

In most cases of sulfasalazine-induced SLE, patients received the drug for greater than 1 year. Patients most commonly developed arthralgias and pleuritic chest pain. Generally, these patients had a positive ANA, anti-DNA antibody titer, and were slow acetylators of sulfonamides. Symptoms typically resolved over several weeks to several months.

At least 1 case of Kawasaki-like syndrome with hepatic function changes was reported during postmarketing experience with the use of products containing or metabolized to mesalamine.

Very common (10% or more): Immunoglobulin suppression (10%)

Frequency not reported: Drug-induced systemic lupus erythematosus (SLE)

Postmarketing reports: Kawasaki-like syndrome with hepatic function changes, induction of autoantibodies

Hepatic

Common (1% to 10%): Abnormal liver function tests

Uncommon (0.1% to 1%): Elevated liver enzymes

Frequency not reported: Hepatic necrosis

Postmarketing reports: Hepatotoxicity (some cases were fatal), including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, cholestatic hepatitis, cholestasis, possible hepatocellular damage (including liver necrosis and liver failure); Kawasaki-like syndrome with hepatic function changes; fulminant hepatitis; hepatitis; hepatic failure

Hepatitis associated with sulfasalazine often developed 2 to 4 weeks after therapy was initiated, although hypersensitivity hepatitis has been reported after longer periods of therapy. Associated rash usually progressed to desquamation. Liver biopsy has shown necrosis and infiltration with moderate number of inflammatory cells. Noncaseating granulomas have also been seen. Hepatitis generally resolved over several weeks after therapy discontinuation, although some patients progressed to fulminant hepatic failure.

Hepatitis has been reported in patients with sulfasalazine hypersensitivity. Some of these cases were fatal.

Side effects listed as postmarketing reports were reported during postmarketing experience with the use of products containing or metabolized to mesalamine.

Hematologic

Agranulocytosis has generally occurred during the first 1 to 3 months of therapy. Patients often presented with fever and sore throat. A few also presented with a rash. Bone marrow hypoplasia or aplasia was usually confined to the myeloid series, but may be accompanied by erythroid hypoplasia and marrow plasmacytosis. In one review of 62 cases of sulfasalazine-induced agranulocytosis, 6.5% of patients died. Recovery of granulocytes was generally seen within 1 to 2 weeks after drug discontinuation, and leukocyte counts and differential returned to normal in 1 to 3 weeks. Some cases of agranulocytosis were treated with colony stimulating factor, which appeared to increase the time to recovery.

Common (1% to 10%): Hemolytic anemia, Heinz body anemia, leukopenia

Uncommon (0.1% to 1%): Thrombocytopenia

Frequency not reported: Red cell aplasia, congenital neutropenia, myelodysplastic syndrome

Postmarketing reports: Pseudomononucleosis, lymphadenopathy, macrocytosis, neutropenia, pancytopenia, agranulocytosis, aplastic anemia, hypoprothrombinemia, methemoglobinemia, megaloblastic (macrocytic) anemia

Respiratory

Common (1% to 10%): Cough

Uncommon (0.1% to 1%): Dyspnea

Frequency not reported: Pulmonary infiltrates (frequently accompanied by eosinophilia), pneumonitis (with or without eosinophilia), pleuritis, bronchiolitis obliterans, lung toxicity (may mimic Wegener’s granulomatosis)

Postmarketing reports: Oropharyngeal pain, fibrosing alveolitis, eosinophilic infiltration, interstitial lung disease

Patients often presented after several weeks or months of therapy with fever, malaise, shortness of breath, and nonproductive cough. Eosinophilic infiltrates have been seen. Respiratory changes generally resolved over a few weeks, however, fatal reactions involving fibrosing alveolitis have been reported.

Cardiovascular

Common (1% to 10%): Cyanosis

Uncommon (0.1% to 1%): Vasculitis

Frequency not reported: Tachycardia

Postmarketing reports: Myocarditis, allergic myocarditis, pallor, polyarteritis nodosa, pericarditis

Psychiatric

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Depression

Frequency not reported: Confusion, vivid dreams

Postmarketing reports: Hallucinations

Musculoskeletal

Common (1% to 10%): Arthralgia

Frequency not reported: Myopathy, rhabdomyolysis, Sjogren’s syndrome

Postmarketing reports: Systemic lupus erythematosus

Other

Common (1% to 10%): Fever

Uncommon (0.1% to 1%): Facial edema

Frequency not reported: Malaise, false positive c-ANCAs, elevated temperature, petechiae and drug fever, LE phenomenon

Postmarketing reports: Yellow discoloration of skin and body fluids

Ocular

Common (1% to 10%): Conjunctival and scleral injection

Frequency not reported: Diplopia, blurred vision, corneal damage

Hypersensitivity

The following side effects have been reported as hypersensitivity reactions: erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, epidermal necrolysis (Lyell’s syndrome) with corneal damage, drug rash with eosinophilia and systemic symptoms (DRESS), anaphylaxis, serum sickness syndrome, pneumonitis (with or without eosinophilia), vasculitis, fibrosing alveolitis, pleuritis, pericarditis (with or without tamponade), allergic myocarditis, polyarteritis nodosa, lupus erythematosus-like syndrome, hepatitis and hepatic necrosis (with or without immune complexes), fulminant hepatitis (sometimes leading to liver transplantation), parapsoriasis varioliformis acuta (Mucha-Haberman syndrome), rhabdomyolysis, photosensitization, arthralgia, periorbital edema, conjunctival and scleral injection, alopecia, and interstitial lung disease.

Anaphylaxis was reported during postmarketing experience with the use of products containing or metabolized to mesalamine.

Frequency not reported: Hypersensitivity reactions, drug-induced rash, lupus erythematosus-like syndrome, anaphylactoid reactions

Postmarketing reports: Anaphylaxis, serum sickness

Renal

Frequency not reported: Toxic nephrosis with oliguria and anuria, nephritis, hemolytic uremic syndrome, bilateral renal calculi composed of acetylsulfapyridine, proteinase 3-ANCA positive necrotizing glomerulonephritis

Postmarketing reports: Nephrolithiasis, nephrotic syndrome, interstitial nephritis

At least 1 patient developed bilateral renal calculi composed of acetylsulfapyridine, a metabolite of sulfasalazine.

Endocrine

Rare (less than 0.1%): Goiter production

Goiter production has been reported rarely in patients using sulfonamides.

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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

Salazopyrin

How does this medication work? What will it do for me?

Sulfasalazine belongs to the class of medications called anti-inflammatories. It is used to treat inflammatory bowel disease such as ulcerative colitis, proctitis or distal ulcerative colitis, and Crohn’s disease. It helps control symptoms by reducing chronic inflammation in the bowel. The enteric-coated tablets can be used to treat rheumatoid arthritis when treatment with other medications has not helped. It may take 1 to 2 months before you see any results.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Tablets
Each yellow-orange, round, convex tablet, engraved with “KPh” on one side with “101” and a score on the other side, contains sulfasalazine 500 mg. Nonmedicinal ingredients: silicon dioxide, starch, and magnesium stearate. This medication does not contain tartrazine.

EN-tabs
Each yellow-orange, elliptical, convex, enteric-coated tablet, engraved with “KPh” on one side and “102” on the other side, contains sulfasalazine 500 mg. Nonmedicinal ingredients: beeswax, carnauba wax, cellulose acetate phthalate, glyceryl monostearate, polyethylene glycol, propylene glycol, and talc. This medication does not contain tartrazine.

How should I use this medication?

The dose of sulfasalazine varies widely according to the condition being treated and the needs of the person. The dose is usually started at a low dose and increased to the dose that is most effective. Side effects are more likely to occur with total daily doses of 4 g (4,000 mg) daily or more. Doses of sulfasalazine should be taken at regular and even intervals over the 24 hour daily period. If you are taking sulfasalazine for an intestinal inflammatory disease, the night-time dose interval should not be longer than eight hours. Doses for children are calculated on the basis of body weight.

The uncoated tablets should be taken with a meal if possible. The enteric-coated tablets must not be chewed or crushed; they should be swallowed whole.

While taking sulfasalazine, drink an adequate amount of fluids to minimize the risk of crystals in the urine and the forming of kidney stones.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones given here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take sulfasalazine if you:

  • are allergic to sulfasalazine or any ingredients of the medication
  • are allergic to sulfonamides or salicylates (e.g., ASA or aspirin)
  • have a liver condition called porphyria as this type of medication has been reported to bring on an attack
  • have had acute asthmatic attacks, hives, rhinitis, or other allergic symptoms that are brought on by ASA or other nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen)
  • have an intestinal or urinary blockage
  • have severely decreased kidney function

Do not give this medication to children under 2 years of age.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • diarrhea
  • dizziness
  • headache
  • increased sensitivity of skin to sunlight
  • itchiness
  • loss of appetite
  • nausea
  • orange-yellow colour of urine
  • upset stomach
  • vomiting

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • aching joints and muscles
  • difficulty swallowing
  • headache (continuing)
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
  • signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • skin rash
  • symptoms of anemia (such as weakness, paleness, and fatigue)
  • symptoms of arthritis (such as joint pain, stiffness)
  • symptoms of infection (such as fever, chills, or a general feeling of being ill)
  • yellow stain to contact lenses

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of interstitial lung disease (e.g., shortness of breath or difficulty breathing)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergies: Some people who are allergic to furosemide, thiazide water pills, or carbonic anhydrase inhibitors also experience allergic reactions to this medication. Before you take sulfasalazine, inform your doctor about any previous adverse reactions you have had to medications, especially water pills or sulfonamide antibiotics. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing or swelling of the face and throat.

Anemia: Sulfasalazine may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Asthma: Sulfasalazine can cause breathing difficulty to increase for people with asthma. If you have asthma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Bleeding: Sulfasalazine may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Fertility: Infertility has been observed for some men treated with sulfasalazine. Stopping the medication appears to reverse these effects.

Glucose-6-phosphate dehydrogenase enzyme deficiency: People without the G6PD enzyme should discuss with their doctor how this medication may affect the dosing and effectiveness of this medication.

Infection: Sulfasalazine can reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor immediately if you notice more frequent signs of infections, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney disease: This medication can reduce kidney function. If you have kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You will probably need to have regular tests while taking this medication to make sure that your kidneys are working properly. People who have severe kidney problems should not use this medication.

Liver disease: Sulfasalazine may reduce liver function and can cause liver failure. If you have liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You will probably need to have regular liver tests while taking this medication. People with severe liver disease or very poor liver function should not take sulfasalazine.

Staining: Sulfasalazine may produce an orange-yellow colour in the urine. Similar discoloration of the skin and yellow staining of soft contact lenses have occasionally been reported.

Tablets in stool: If you notice intact enteric-coated tablets in your stool, contact your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking sulfasalazine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: This medication is not recommended for children with juvenile rheumatoid arthritis.

What other drugs could interact with this medication?

There may be an interaction between sulfasalazine and any of the following:

  • antibiotics
  • azathioprine
  • celecoxib
  • chicken pox vaccine
  • cyclosporine
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • digoxin
  • folic acid
  • heparin
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • medications that increase sensitivity to the sun
  • mercaptopurine
  • methotrexate
  • methylfolate
  • nitric oxide
  • non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
  • olsalazine
  • phenytoin
  • prilocaine
  • probenecid
  • other salicylates (e.g., ASA, salsalate)
  • sodium nitrite
  • sulfinpyrazone
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Salazopyrin

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