Azulfidine EN Tablets

Name: Azulfidine EN Tablets

Azulfidine EN Tablets Description

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

AZULFIDINE EN-tabs 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:

Molecular Formula: C18H14N4O5S

Azulfidine EN Tablets Dosage and Administration

The dosage of AZULFIDINE EN-tabs Tablets should be adjusted to each individual's response and tolerance.

Patients should be instructed to take AZULFIDINE EN-tabs in evenly divided doses, preferably after meals, and to swallow the tablets whole.

Initial Therapy

Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. It may be advisable to initiate therapy with a lower dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve the desired therapeutic effect, the increased risk of toxicity should be kept in mind.

Children, six years of age and older: 40 to 60 mg/kg of body weight in each 24-hour period, divided into 3 to 6 doses.

Maintenance Therapy

Adults: 2 g daily.

Children, six years of age and older: 30 mg/kg of body weight in each 24-hour period, divided into 4 doses. The response of acute ulcerative colitis to AZULFIDINE EN-tabs can be evaluated by clinical criteria, including the presence of fever, weight changes, and degree and frequency of diarrhea and bleeding, as well as by sigmoidoscopy and the evaluation of biopsy samples. It is often necessary to continue medication even when clinical symptoms, including diarrhea, have been controlled. When endoscopic examination confirms satisfactory improvement, dosage of AZULFIDINE EN-tabs should be reduced to a maintenance level. If diarrhea recurs, dosage should be increased to previously effective levels.

AZULFIDINE EN-tabs is particularly indicated in patients who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance (e.g., anorexia, nausea). If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) occur after the first few doses of AZULFIDINE EN-tabs, they are probably due to increased serum levels of total sulfapyridine, and may be alleviated by halving the daily dose of AZULFIDINE EN-tabs and subsequently increasing it gradually over several days. If gastric intolerance continues, the drug should be stopped for 5 to 7 days, then reintroduced at a lower daily dose.

Adult Rheumatoid Arthritis

2 g daily in two evenly divided doses. It is advisable to initiate therapy with a lower dosage of AZULFIDINE EN-tabs, e.g., 0.5 to 1.0 g daily, to reduce possible gastrointestinal intolerance. A suggested dosing schedule is given below.

In rheumatoid arthritis, the effect of AZULFIDINE EN-tabs can be assessed by the degree of improvement in the number and extent of actively inflamed joints. A therapeutic response has been observed as early as 4 weeks after starting treatment with AZULFIDINE EN-tabs, but treatment for 12 weeks may be required in some patients before clinical benefit is noted. Consideration can be given to increasing the daily dose of AZULFIDINE EN-tabs to 3 g if the clinical response after 12 weeks is inadequate. Careful monitoring is recommended for doses over 2 g per day.

Suggested Dosing Schedule for Adult Rheumatoid Arthritis:

Week of Number of AZULFIDINE EN-tabs Tablets
Treatment Morning Evening
1 - One
2 One One
3 One Two
4 Two Two

Juvenile Rheumatoid Arthritis - polyarticular course

Children, six years of age and older: 30 to 50 mg/kg of body weight daily in two evenly divided doses. Typically, the maximum dose is 2 g per day. To reduce possible gastrointestinal intolerance, begin with a quarter to a third of the planned maintenance dose and increase weekly until reaching the maintenance dose at one month.

Some patients may be sensitive to treatment with sulfasalazine. Various desensitization-like regimens have been reported to be effective in 34 of 53 patients,8 7 of 8 patients,9 and 19 of 20 patients.10 These regimens suggest starting with a total daily dose of 50 to 250 mg sulfasalazine initially, and doubling it every 4 to 7 days until the desired therapeutic level is achieved. If the symptoms of sensitivity recur, AZULFIDINE EN-tabs should be discontinued. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving sulfasalazine.

References

  1. van Rossum MAJ, et al. Sulfasalazine in the treatment of juvenile chronic arthritis: a randomized, double-blind, placebo-controlled, multicenter study. Arth Rheum 1998;41:808–816.
  2. Mogadam M, et al. Pregnancy in inflammatory bowel disease: effect of sulfasalazine and corticosteroids on fetal outcome. Gastroenterology 1981;80:726.
  3. Kaufman DW, editor. Birth defects and drugs during pregnancy. Littleton, MA: Publishing Sciences Group, Inc., 1977:296–313.
  4. Jarnerot G. Fertility, sterility and pregnancy in chronic inflammatory bowel disease. Scand J Gastroenterol 1982;17:1–4.
  5. Imundo LF, Jacobs JC. Sulfasalazine therapy for juvenile rheumatoid arthritis. J Rheumatol 1996;23:360–366.
  6. Hertzberger-ten Cate R, Cats A. Toxicity of sulfasalazine in systemic juvenile chronic arthritis. Clin Exp Rheumatol 1991;9:85–8.
  7. Farr M, et al. Immunodeficiencies associated with sulphasalazine therapy in inflammatory arthritis. British Jnl Rheum 1991;30:413–417.
  8. Korelitz B, et al. Desensitization to sulfasalazine in allergic patients with IBD: an important therapeutic modality. Gastroenterology 1982;82:1104.
  9. Holdworth CG. Sulphasalazine desensitization. Br Med J 1981;282:110.
  10. Taffet SL, Das KM. Desensitization of patients with inflammatory bowel disease to sulfasalazine. Am J Med 1982;73:520–4.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB-0237-9.0

June 2016

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label

NDC 0013-0102-01

Pfizer

Azulfidine EN-tabs®

sulfasalazine delayed release

500 mg

tablets, USP

100 Enteric-coated Tablets
Rx only

AZULFIDINE   EN-TABS
sulfasalazine tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0013-0102
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFASALAZINE (SULFASALAZINE) SULFASALAZINE 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE ACETATE  
POVIDONE, UNSPECIFIED  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
PROPYLENE GLYCOL  
TALC  
CARNAUBA WAX  
GLYCERYL MONOSTEARATE  
WHITE WAX  
ACETONE  
ALCOHOL  
Product Characteristics
Color YELLOW (Gold) Score no score
Shape OVAL (elliptical convex) Size 18mm
Flavor Imprint Code 102;KPh
Contains     
Packaging
# Item Code Package Description
1 NDC:0013-0102-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE
2 NDC:0013-0102-20 300 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA007073 06/20/1950
Labeler - Pharmacia and Upjohn Company LLC (618054084)
Establishment
Name Address ID/FEI Operations
Kemwell AB 774341221 ANALYSIS(0013-0102), API MANUFACTURE(0013-0102), MANUFACTURE(0013-0102), PACK(0013-0102)
Revised: 06/2017   Pharmacia and Upjohn Company LLC

In Summary

Common side effects of Azulfidine EN-tabs include: gastric distress, headache, nausea, oligospermia, vomiting, and anorexia. Other side effects include: fever. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to sulfasalazine: oral tablet, oral tablet enteric coated

Along with its needed effects, sulfasalazine (the active ingredient contained in Azulfidine EN-tabs) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sulfasalazine:

More common
  • Aching of joints
  • fever
  • headache (continuing)
  • increased sensitivity of the skin to sunlight
  • skin rash or itching
  • vomiting
Less common
  • Back, leg, or stomach pains
  • bleeding gums
  • bluish color of the fingernails, lips, skin, palms, or nail beds
  • chills
  • dark urine
  • difficulty breathing
  • fever
  • general body swelling
  • headache
  • loss of appetite
  • nausea
  • nosebleeds
  • pale skin
  • sore throat
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellowing of the eyes or skin
Less common or rare
  • Aching of muscles
  • black, tarry stools
  • blistering, peeling, or loosening of the skin
  • bloating
  • blood in the urine or stools
  • bloody diarrhea
  • bluish fingernails, lips, or skin
  • chest pain
  • constipation
  • cough
  • difficulty with swallowing
  • dizziness
  • fainting spells
  • fast heartbeat
  • general feeling of discomfort or illness
  • general tiredness and weakness
  • hives
  • indigestion
  • inflammation of the joints
  • irregular heartbeat
  • light-colored stools
  • muscle aches
  • muscle cramps or spasms
  • muscle pain or stiffness
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness, blistering, peeling, or loosening of the skin
  • sores, ulcers, or white spots in the mouth or on the lips
  • swollen or painful glands
  • tightness in the chest
  • upper right abdominal or stomach pain
Incidence not known
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects of sulfasalazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain or upset
  • decreased weight
Less common
  • Welts
Less common or rare
  • Discoloration of the skin or urine
  • hair loss or thinning of the hair
  • swelling or inflammation of the mouth

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