Modern medicine has evolved so much so that sooner or later every breastfeeding mother needs to take it in one form or other. Medication that is present in mothers blood will transfer into her breast milk to some extent. Most drugs do so at low levels and pose no real risk to infants but then there are some exceptions. In This post will discuss whether Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release is safe in breast-feeding or not.
What is Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release used for?
AZULFIDINE EN-tabs Tablets are indicated: a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; b)for the prolongation of the remission period between acute attacks of ulcerative colitis; c)in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); and d)in the treatment of pediatric patients with polyarticular-course1 juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs. AZULFIDINE EN-tabs is particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance, and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites, e.g., patients experiencing nausea and vomiting with the first few doses of the drug, or patients in whom a reduction in dosage does not alleviate the adverse gastrointestinal effects. In patients with rheumatoid arthritis or juvenile rheumatoid arthritis, rest and physiotherapy as indicated should be continued. Unlike anti-inflammatory drugs, AZULFIDINE EN-tabs does not produce an immediate response. Concurrent treatment with analgesics and/or nonsteroidal anti-inflammatory drugs is recommended at least until the effect of AZULFIDINE EN-tabs is apparent.
Is Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release safe to use while breastfeeding? Can it interfere with growth and development of my kid?
Active ingredient in Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release is Sulfasalazine and based on our analysis of Sulfasalazine it appears that using Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release is safe in breastfeeding. Below is analysis of Sulfasalazine while breastfeeding.
Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers Sulfonamides, including sulfasalazine, are present in human milk (see Pregnancy, Clinical Considerations). Insignificant amounts of sulfasalazine have been found in milk, whereas levels of the active metabolite sulfapyridine in milk are about 30 to 60 percent of those in the maternal serum. Caution should be exercised when AZULFIDINE EN-tabs is administered to a nursing mother. There are reports with limited data of bloody stools or diarrhea in human milk fed infants of mothers taking sulfasalazine. In cases where the outcome was reported, bloody stools or diarrhea resolved in the infant after discontinuation of sulfasalazine in the mother or discontinuation of breastfeeding. Due to limited data, a causal relationship between sulfasalazine exposure and bloody stools or diarrhea cannot be confirmed or denied. Monitor human milk fed infants of mothers taking sulfasalazine for signs and symptoms of diarrhea and/or bloody stools.
Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release Breastfeeding Analsys
SafeCAS Number: 599-79-1
Prodrug of Mesalazine: medication compounded by union of Sulfapyridine and 5-ASA which is degraded into Mesalazine by bacteria in the large intestine. Mesalazine is badly absorbed by the intestine, serum levels are low with scant excretion into breast milk. Inactive metabolite N-acetyl-5-ASA was found in small amount in the milk with a relative infant dose not higher than 10%. No harm effects among breastfed infants from treated mothers have been reported, except for rare cases of diarrhea reported in the 80's with the use of Sulfasalazine. In a review of 121 cases and 121 controls, the authors failed to observe those findings. (Moretti, 1989). Expert consensus supports the compatibility of Mesalazine and/or its prodrugs during breastfeeding. Sulfapyridine released in the large intestine is 60% absorbed with a protein-binding capacity of 90%, both being a reason for low excretion into breast milk. Mesalazine derivatives that not contain Sulfapyridine are recommended by some authors for use while breastfeeding (see alternative drugs).
Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release Breastfeeding Analsys - 2
CAS Number: 599-79-1

Sulfasalazine and its active metabolite mesalamine are poorly excreted into breastmilk. However, rather high levels of the mesalamine metabolite N-acetyl-5-ASA appear in breastmilk and its effects on breastfed infants are unknown. Another sulfasalazine metabolite, sulfapyridine, also appears in milk and infant serum and might cause hemolysis, especially in newborn infants and in those with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The time of greatest risk for hemolysis in fullterm newborns without G6PD deficiency might be as short as 8 days after birth.[1] Bloody diarrhea has occurred in an infant whose mother was taking sulfasalazine and a few cases of diarrhea have been reported in infants exposed to mesalamine in breastmilk, although the rate is not high. Most experts consider mesalamine derivatives to be safe during breastfeeding.[2][3][4][5][6][7] If sulfasalazine is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea. Other mesalamine derivatives that do not contain a sulfonamide are preferred.
I am nursing mother and I have already used Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release, what should I do?
Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release is safe in breastfeeding and should not create any health problem for your baby but in case you feel any health issue associated with Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release you should contact your doctor or health care provider. Be it pregnancy or lactation you shall keep your doctor informed.
My health care provider has asked me to use Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release, what to do?
Definitely, Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release is safe in lactation for baby. No wonder your doctor has recommended it.
If I am using Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release, will my baby need extra monitoring?
No extra baby monitoring required while mother is using Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release
Who can I talk to if I have questions about usage of Azulfidine En-tabs | Sulfasalazine Tablet, Delayed Release in breastfeeding?
US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday
UK
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700
Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week
Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week
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