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Azulfidine EN-tabs (Generic Sulfasalazine)

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Why is this medication prescribed?

Sulfasalazine is used to treat ulcerative colitis, a disorder that results in swelling and ulcers on the rectum and colon (large intestine) lining, as well as to maintain symptom relief. Adults with rheumatoid arthritis who have not responded well to conventional drugs or who could not tolerate them are also treated with sulfasalazine delayed-release (Azulfidine EN-tabs). In children who have not responded to other medications, sulfasalazine delayed-release (Azulfidine EN-tabs) is also used to treat polyarticular juvenile idiopathic arthritis (PJIA), a type of childhood arthritis that affects five or more joints during the first six months of the condition and causes pain, swelling, and loss of function. Sulfasalazine belongs to the group of pharmaceuticals known as anti-inflammatory drugs. It reduces swelling and inflammation inside the body.

How should this medicine be used?

Both standard and delayed-release sulfasalazine tablets are available; the latter releases the drug in the intestine rather than the stomach, preventing stomach discomfort and enabling the drug to exert its effects there. It is often taken 3 to 6 times a day, evenly spaced out throughout the day so that, wherever possible, no more than 8 hours pass between any two doses. Sulfasalazine delayed-release tablets are often given twice daily in doses spread equally throughout the day to treat polyarticular juvenile idiopathic arthritis or rheumatoid arthritis. Sulfasalazine should be taken with a meal or light snack and followed by a full glass of water.Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Sulfasalazine should be taken as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not crush or chew delayed-release pills; instead, swallow them whole.

Be sure to stay hydrated while taking sulfasalazine.

Even if you feel well, keep taking the sulfasalazine medication. Without consulting your doctor, do not stop taking sulfasalazine.

Other uses for this medicine

Sulfasalazine is also used to treat Crohn’s disease-related stomach pain, colon inflammation, diarrhoea (frequent stools), and rectal bleeding. Discuss the potential dangers of using this medication for your illness with your doctor.

What special precautions should I follow?

Before taking sulfasalazine,

  • Inform your doctor if you have any allergies to sulfasalazine, sulfapyridine, salicylate pain relievers like aspirin, choline magnesium trisalicylate, diflunisal, or magnesium salicylate (Doan’s, among others), balsalazide (Colazal), mesalamine (Asacol, Pentasa, Rowasa, among others), olsalazin Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: Methotrexate, folic acid, and digoxin (Lanoxin) (Trexall, Xatmep).
  • Inform your doctor if you have or have ever had porphyria, a urinary obstruction (a blockage of urine coming out of the bladder), or an intestinal obstruction (a blockage in the intestines) (condition in which abnormal substances build up in the blood and cause problems with the skin or nervous system). Most likely, your doctor will advise against taking sulfasalazine.
  • If you have an infection or have ever had one that keeps coming back, let your doctor know. Asthma, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency (an inherited blood illness), kidney stones, blood issues, kidney or liver disease, and asthma are other conditions to mention to your doctor.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you become pregnant while taking sulfasalazine.
  • You should be aware that this drug may reduce male fertility. Usually, once the medication is stopped, fertility returns. Ask your doctor about the dangers of sulfasalazine use.
  • You need to be informed that this medication can lower male fertility. Fertility usually returns after the medicine is stopped. Find out from your doctor whether using sulfasalazine is dangerous.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If your next dose is approaching, skip the missed one and carry on with your regular dosing schedule. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There could be side effects from sulfasalazine.

If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Urine or skin colour that is yellow or orange
  • Diarrhea
  • Headache
  • Reduced appetite
  • Uneasy stomach
  • Vomiting
  • Abdominal pain

Call your doctor right away and stop taking sulfasalazine if you have any of the following symptoms:

  • Rash, hives, itchy, blistered, or peeling skin
  • Eye, face, lip, tongue, mouth, or throat swelling
  • Breathing or swallowing challenges
  • Enlarged glands
  • Fever, chills, sore throat, cough, night sweats, and other infection-related symptoms
  • Pale complexion, exhaustion, or shortness of breath
  • Muscle or joint pain
  • The skin or eyes turning yellow
  • Stomach pain in the right upper portion
  • Urine that is cloudy, discolored, or bloody, or that is painful or difficult to urinate
  • Chest pain
  • A new or worsening cough
  • Tiredness
  • Uncommon bruising or bleeding
  • Weakness
  • Seizures

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Nausea
  • Vomiting
  • Stomach discomfort
  • Tiredness
  • Seizures

What other information should I know?

Keep all of your appointments with your physician and the lab. To determine how you are responding to sulfasalazine, your doctor may request specific lab tests.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Azulfidine®
  • Azulfidine® EN-tabs®
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