Brand Name

Azulfidine EN-Tabs {Pfizer}

Generic Name

sulfasalazine, pronounced SUL-fa-SAL-a-zeen

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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Azulfidine EN-Tabs?

Azulfidine EN-Tabs is a medication that treats ulcerative colitis and also helps to increasethe time between attacks of ulcerative colitis. Azulfidine EN-Tabs is a salicylate and works bydecreasing inflammation in your body. You may be prescribed Azulfidine EN-Tabs if you are anadult with rheumatoid arthritis and you have previously responded inadequately to salicylates orother non-steroidal anti-inflammatory medications (NSAIDs). Pediatric patients withpolyarticular-course1 juvenile rheumatoid arthritis may also be prescribed Azulfidine EN Tabs ifprevious treatments with other salicylates and NSAIDs have not been therapeutic.

Azulfidine EN-Tabs may also be prescribed for other reasons not listed in this medicationguide.

Key Facts About Azulfidine EN-Tabs

You should be cautious when administering Azulfidine EN-Tabs to the elderly, as this patientpopulation may be more sensitive to the side effects of this medication.

Azulfidine EN-Tabs should not be given to children younger than 2 years old. Extreme cautionshould be taken when giving children younger than age 10 Azulfidine EN-Tabs if they are sufferingfrom diarrhea or an infection of the bowel or stomach.

You cannot take Azulfidine EN-Tabs tablets if you have folate deficiency anemia.

Tell your doctor immediately if you experience stomach pain that is severe, cramping, bloodydiarrhea or a fever while taking Azulfidine EN-Tabs.

Azulfidine EN-Tabsmay discolor your urine or skin as an orange-yellow color. You should not beconcerned as this is a normal side effect that will not harm you.

While you are taking Azulfidine EN-Tabs tell your doctor right away if you show signs ofjaundice, like a fever, unusually pale skin, dark urine, clay-colored stools, stomach pain,appetite loss, yellowing of your skin or eyes and unusual bruising or bleeding.

Some men who take Azulfidine EN-Tabs have developed a decreased number of sperm and issueswith infertility. These side effects stopped after the discontinuation of Azulfidine EN-Tabs.Talk to your doctor if you are a man taking this medication and concerned about yourfertility.

Tell your doctor if you are pregnant or plan to become pregnant. Azulfidine EN-Tabs is in FDApregnancy category B. Azulfidine EN-Tabs is not known to harm your unborn baby. We know thatAzulfidine EN-Tabs passes into breast milk and may affect your baby if you are nursing. Youshould not take Azulfidine EN-Tabs if you are breastfeeding.

Before You Take Azulfidine EN-Tabs

If you are allergic to sulfasalazine, aspirin or other salicylates like Disalcid, Doan’sPills, Dolobid, Salflex and Tricosal you should not take Azulfidine EN-Tabs.

You may not be a candidate to take Azulfidine EN-Tabs if you have kidney disease, liverdisease, asthma or severe allergies.

If you have rheumatoid arthritis, blood problems such as anemia or a glucose-6-phosphatedehydrogenase deficiency you should inform your doctor before taking Azulfidine EN-Tabs.

Tell your doctor if you are pregnant or have any type of infection before taking AzulfidineEN-Tabs.

Azulfidine EN-Tabs Drug Interactions

You should inform your doctor if you are taking any of the following:

• anticoagulants like warfarin (Coumadin)
• beta-blockers like propranolol
• digoxin
• folic acid
• methenamine

Other drugs you take that are not listed may interact with Azulfidine EN-Tabs. You should tellyour doctor about all of the medications you use. This includes prescription drugs, vitamins,supplements and herbal products, and over the counter medications. You should not begin taking anew medication without telling your doctor first.

Directions for Taking Azulfidine EN-Tabs

Azulfidine EN-Tabs may be taken with or without food. If you are concerned that AzulfidineEN-Tabs may upset your stomach you may take it with food or milk to lessen any potential stomachupset.

You should take Azulfidine EN-Tabs exactly as prescribed by your doctor. Do not takeAzulfidine EN-Tabs in larger or smaller amounts, or for shorter or longer than recommended.Follow the directions on your prescription label.

You should take Azulfidine EN-Tabs with a full (8 oz.) glass of water and drink plenty offluids throughout the day while you are taking this medication.

Do not break, chew or crush the Azulfidine EN-Tabs tablet. Swallow the Azulfidine EN-Tabswhole.

You should take Azulfidine EN-Tabs in evenly spaced doses throughout the day, but do not letmore than eight (8) hours lapse between doses.

Azulfidine EN-Tabs may cause you to sunburn easily, so take care to wear SPF 30 or higher andprotective clothing when you are outdoors.

While taking Azulfidine EN-Tabs you may experience dizziness or drowsiness. Be careful whendriving or doing anything that requires you to be alert until you are sure how you will react tothis medication.

Azulfidine EN-Tabs needs to be stored at room temperature, and away from light, moisture andheat.

If you miss a dose of Azulfidine EN-Tabs you should attempt to take the missed dose as soon asyou remember. However, if it is almost time for your next scheduled dose do not take the misseddose in addition to your regular dose.

Azulfidine EN-Tabs Side Effects

If you experience any of the following adverse effects you should stop taking AzulfidineEN-Tabs and seek emergency medical help immediately:

• allergic reactions such as breathing difficulties, hives or swelling of your face, lips,throat or tongue
• bloody diarrhea
• bluish discoloration of your nails or skin
• bruising that is unusual
• chest pain
• chills
• dizziness that is persistent
• fever
• hearing loss
• severe insomnia
• jaundice symptoms like a fever, unusually pale skin, dark urine, clay-colored stools, stomachpain, appetite loss, yellowing of your skin or eyes and unusual bruising or bleeding.
• mental or mood changes
• muscle pain
• numbness or tingling in your fingers or toes
• rash that includes blistered, red or swollen skin
• shortness of breath
• walking difficulties
• weakness

Less serious side effects of Azulfidine EN-Tabs may include:

• appetite loss
• headache
• nausea
• mild stomach upset or pain
• vomiting

It should be noted that this is not a complete list of possible side effects of AzulfidineEN-Tabs. You should contact your physician for a complete list and medical advice regarding theseeffects.

Azulfidine EN-Tabs Description and Dosing

Azulfidine EN-Tabs is available asa delayed release tablet (enteric-coated), 500mg, for oral administration. The 500 mg tablets are elliptical, gold-colored, film enteric-coatedand monogrammed “102” on one side and “KPh” on the other side.

If you suspect that you have overdosed with Azulfidine EN-Tabs you should seek emergency helpimmediately.

Ingredients in Azulfidine EN-Tabs

Azulfidine EN-Tabs is comprised of the main ingredient sulfasalazine. Additional inactiveingredients include Cellulose Acetate, Povidones, Magnesium Stearate,

Silicon Dioxide, Propylene Glycol, Talc, Carnauba Wax, Glycerol Monostearate, White Wax, Acetoneand Alcohol.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.