Azulfidine EN-Tabs

DRUG DESCRIPTION

AZULFIDINE EN-tabs Tablets contain sulfasalazine, formulated in a delayed release tablet (enteric-coated), 500 mg, for oral administration.

AZULFIDINE EN-tabs (sulfasalazine delayed release tablets) Tablets are film coated with cellulose acetate phthalate to retard disintegration of the tablet in the stomach and reduce potential irritation of the gastric mucosa.

Therapeutic Classification: Anti-inflammatory agent and/or immunomodulatory agent.

Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid.

Chemical Structure:

Azulfidine EN-tabs® (sulfasalazine) Structural Formula Illustration

Molecular Formula: C18H14N4O5S

What are the possible side effects of sulfasalazine oral (Azulfidine, Azulfidine EN-tabs, Sulfazine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sulfasalazine and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, or other flu symptoms;
  • pale skin, easy bruising;
  • dark urine, jaundice (yellowing of the skin or eyes);
  • pain or burning when you urinate;
  • urinating less than usual...

Read All Potential Side Effects and See Pictures of Azulfidine EN-Tabs »

What are the precautions when taking sulfasalazine delayed release tablets (Azulfidine EN-Tabs)?

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...

Read All Potential Precautions of Azulfidine EN-Tabs »


Azulfidine EN-Tabs Consumer (continued)

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.


Azulfidine EN-Tabs Patient Information Including Side Effects

Brand Names: Azulfidine, Azulfidine EN-tabs, Sulfazine

Generic Name: sulfasalazine (Pronunciation: SUL fa SAL a zeen)

  • What is sulfasalazine oral (Azulfidine EN-Tabs)?
  • What are the possible side effects of sulfasalazine oral (Azulfidine EN-Tabs)?
  • What is the most important information I should know about sulfasalazine oral (Azulfidine EN-Tabs)?
  • What should I discuss with my healthcare provider before taking sulfasalazine oral (Azulfidine EN-Tabs)?
  • How should I take sulfasalazine oral (Azulfidine EN-Tabs)?
  • What happens if I miss a dose (Azulfidine EN-Tabs)?
  • What happens if I overdose (Azulfidine EN-Tabs)?
  • What should I avoid while taking sulfasalazine oral (Azulfidine EN-Tabs)?
  • What other drugs will affect sulfasalazine oral (Azulfidine EN-Tabs)?
  • Where can I get more information?

What is sulfasalazine oral (Azulfidine EN-Tabs)?

Sulfasalazine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Sulfasalazine is used to treat moderate to severe ulcerative colitis. It is also used to treat rheumatoid arthritis in children and adults who have received other arthritis medications without successful treatment of symptoms.

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

What are the possible side effects of sulfasalazine oral (Azulfidine EN-Tabs)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sulfasalazine and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, or other flu symptoms;
  • pale skin, easy bruising;
  • dark urine, jaundice (yellowing of the skin or eyes);
  • pain or burning when you urinate;
  • urinating less than usual or not at all;
  • the appearance of a whole tablet in your stool; or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, upset stomach;
  • loss of appetite;
  • headache, ringing in your ears;
  • dizziness, spinning sensation;
  • white patches or sores inside your mouth or on your lips;
  • sleep problems (insomnia); or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sulfasalazine oral (Azulfidine EN-Tabs)?

You should not use this medication if you have porphyria, a blockage in your bladder or intestines, or if you are allergic to sulfasalazine, sulfa drugs, aspirin, or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

Before using sulfasalazine, tell your doctor if you have asthma, kidney or liver disease, or glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Also tell your doctor about all other medications you use, especially digoxin (digitalis, Lanoxin), folic acid (Folicin, FA-8), or vitamin or mineral supplements that contain folic acid.

Do not crush, break, or chew a sulfasalazine tablet. Swallow the pill whole. The enteric-coated tablet has a special coating to protect your stomach. Breaking the pill could damage this coating.

For best results, keep using the medication as directed. Sulfasalazine will not cure ulcerative colitis, but it can reduce the number of attacks you have.

If you are treating arthritis, do not stop using any of your other arthritis medications until your doctor tells you to.

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