Drug title

Azulfidine (Sulfasalazine)

Drug Class & Mechanism

Azulfidine (Sulfasalazine) is an anti-inflammatory medicine, is prescribed for the treatment of mild to moderate ulcerative colitis (a long-term, progressive bowel disease) and as an added treatment in severe ulcerative colitis (chronic inflammation and ulceration of the lining of large bowel and rectum, the main symptom of which is bloody diarrhea). This medication is also prescribed to decrease severe attacks of ulcerative colitis.

Common uses

Azulfidine 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, Azulfidine is also used to increase the amount of time between attacks. This medication works by reducing irritation and swelling in the large intestines.

Before using

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

• a blockage in your bladder or intestines;
• porphyria (an enzyme disorder that causes blue discoloration of the skin);
• if you are allergic to sulfa drugs (such as Bactrim, Septra, Cotrim, and others); or
• if you are allergic to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

Before using Azulfidine, tell your doctor if you are allergic to any drugs, or if you have:

• asthma;
• glucose-6-phosphate dehydrogenase (G6PD) deficiency;
• kidney disease; or
• liver disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Azulfidine.
FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Azulfidine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Directions

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.

Missed dose

If you miss a dose of Azulfidine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Overdose

Symptoms of overdose may include seizures; severe stomach pain, nausea, or vomiting; unusual or severe drowsiness. Get in touch with your doctor immediately if you suspect overdose.

Storage

Keep at the temperature between 59–86F (15–30 C), away from heat, moisture, light and children.

Cautions

If you have kidney or liver damage or any blood disease, your doctor will check you very carefully before prescribing Azulfidine. Deaths have been reported from allergic reactions, blood diseases, kidney or liver damage, changes in nerve and muscle impulses, and fibrosing alveolitis (inflammation of the lungs due to a thickening or scarring of tissue). Signs such as sore throat, fever, abnormal paleness of the skin, purple or red spots on the skin, or jaundice (yellowing of the skin) may be an indication of a serious blood disorder. Your doctor will do frequent blood counts and urine tests. Use caution taking Azulfidine if you have a severe allergy or bronchial asthma.

If you develop loss of appetite, nausea, or vomiting, report it immediately. The doctor may need to adjust your dosage or change the prescription.

If Azulfidine EN-tabs are eliminated undisintegrated, stop taking the drug and notify your doctor immediately. (You may lack the intestinal enzymes necessary to dissolve this medication.)
Men taking Azulfidine may experience temporary infertility and a low sperm count.

Skin and urine may become yellow-orange in color while taking Azulfidine.
In addition, prolonged exposure to the sun should be avoided.
This drug is generally not prescribed for children under 6. Azulfidine EN-tabs are not recommended for children with the type of juvenile rheumatoid arthritis that affects the whole system, only for children with the type that stays in the joints.

Possible 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, 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.

If you take too much

Any medication taken in excess can have serious consequences. If you suspect an Azulfidine overdose, seek emergency medical attention immediately.

Symptoms of Azulfidine overdose may include: abdominal pain convulsions drowsiness nausea stomach upset vomiting

Additional information

Do not share this medicine with others for whom it was not prescribed.
Do not use this medicine for other health conditions.
If using this medicine for an extended period of time, obtain refills before your supply runs out.