Sulfasalazine (patient information)

Sulfasalazine (patient information)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]

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Overview

Sulfasalazine (patient information) is a Salicylate that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Sulfasalazine (patient information) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulfasalazine (patient information) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfasalazine (patient information) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Sulfasalazine (patient information) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulfasalazine (patient information) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfasalazine (patient information) in pediatric patients.

Contraindications

There is limited information regarding Sulfasalazine (patient information) Contraindications in the drug label.

Warnings

There is limited information regarding Sulfasalazine (patient information) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Sulfasalazine (patient information) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Sulfasalazine (patient information) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Sulfasalazine (patient information) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Sulfasalazine (patient information) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sulfasalazine (patient information) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sulfasalazine (patient information) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sulfasalazine (patient information) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Sulfasalazine (patient information) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Sulfasalazine (patient information) in geriatric settings.

Gender

There is no FDA guidance on the use of Sulfasalazine (patient information) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sulfasalazine (patient information) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sulfasalazine (patient information) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sulfasalazine (patient information) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sulfasalazine (patient information) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sulfasalazine (patient information) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Sulfasalazine (patient information) Administration in the drug label.

Monitoring

There is limited information regarding Sulfasalazine (patient information) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Sulfasalazine (patient information) and IV administrations.

Overdosage

There is limited information regarding Sulfasalazine (patient information) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Sulfasalazine (patient information) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Sulfasalazine (patient information) Mechanism of Action in the drug label.

Structure

There is limited information regarding Sulfasalazine (patient information) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Sulfasalazine (patient information) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Sulfasalazine (patient information) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Sulfasalazine (patient information) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Sulfasalazine (patient information) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Sulfasalazine (patient information) How Supplied in the drug label.

Storage

There is limited information regarding Sulfasalazine (patient information) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Sulfasalazine (patient information) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Sulfasalazine (patient information) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Sulfasalazine (patient information) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Sulfasalazine (patient information) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Why is this medication prescribed

Sulfasalazine is used to treat bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain in patients with ulcerative colitis, a condition in which the bowel is inflamed. Sulfasalazine delayed-release (Azulfidine EN-tabs) is also used to treat rheumatoid arthritis in adults and children whose disease has not responded well to other medications. Sulfasalazine is in a class of medications called anti-inflammatory drugs. It works by reducing inflammation (swelling) inside the body.

How should this medicine be used

Sulfasalazine comes as regular and delayed-release (enteric-coated) tablets. It usually is taken four times a day in evenly spaced doses throughout the day so that no more than 8 hours separates any two doses, if possible. Take sulfasalazine after a meal or with a light snack, then drink a full glass of water. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sulfasalazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow tablets whole; do not crush or chew them.

Drink plenty of fluids (at least six to eight glasses of water or other beverage per day) while taking sulfasalazine.

Continue to take sulfasalazine even if you feel well. Do not stop taking sulfasalazine without talking to your doctor.

Other uses for this medicine

Sulfasalazine is also used to treat bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain in Crohn's disease. Talk to your doctor about the possible risks of using this drug for your condition.

What special precautions should I follow

Before taking sulfasalazine:

• tell your doctor if you are allergic to sulfasalazine, sulfapyridine, aspirin, choline magnesium trisalicylate (Triosal, Trilisate), choline salicylate (Arthropan), mesalamine (Asacol, Pentasa, Rowasa), salsalate (Argesic-SA, Disalcid, Salgesic, others), sulfa drugs, trisalicylate (Tricosal, Trilisate),or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially digoxin (Lanoxin), folic acid, and vitamins.
• tell your doctor if you have or have ever had asthma, kidney or liver disease, porphyria, blood problems, or blockage in your intestine or urinary tract.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking sulfasalazine, call your doctor.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. *Sulfasalazine may make your skin sensitive to sunlight.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Mild side effects

Sulfasalazine may cause side effects. Sulfasalazine causes temporary infertility in males. Fertility returns when the medicine is stopped. It can also cause your urine or skin to turn yellowish-orange; this effect is harmless.

Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• headache
• loss of appetite
• upset stomach
• vomiting
• stomach pain

Severe side effects

If you have any of the following symptoms, stop taking sulfasalazine and call your doctor immediately:

• skin rash
• itching
• hives
• swelling
• sore throat
• fever
• joint or muscle aches
• pale or yellow skin
• difficulty swallowing
• tiredness
• unusual bleeding or bruising
• weakness

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to sulfasalazine.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Azulfidine®
• Azulfidine® EN-tabs®