Wednesday, August 17, 2022

Alternative To Sulfasalazine For Ulcerative Colitis

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TEA: A Better Alternative in Ulcerative Colitis

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Sulfasalazine Which Is Used To Treat Rheumatoid And Other Inflammatory Arthritis Inflammatory Bowel Disease And Other Conditions May Be In Short Supply Heres What To Know About The Issue And What To Do If You Cant Get Your Sulfasalazine Prescription

Are others experiencing inability to get sulfasalazine???

When a CreakyJoints member recently raised this concern with our Facebook community, the response was swift.

Anna L. shared that it took two months to get her prescription filled and she, still couldnt get the enteric-coated sustained release. Katherine N. shared that her mail-order pharmacy has been unable to get it for three months and, several local pharmacies say they have it on back order with no delivery date.

My rheum said it was national shortage, said Kelli D.

According to the drug shortage database from the U.S. Food and Drug Administration , sulfasalazine has been in shortage since April 2020. But the issue seems to be getting worse more recently.

Our clinic first began receiving messages from patients mid-last year that their pharmacies were unable to supply their regularly supplied sulfasalazine prescription, both immediate and delayed-release formulations, says Norman Westervelt, PharmD, a rheumatology specialty pharmacist at the University of Alabama at Birmingham. I would not say it was common enough then to be a major concern or warrant therapy change, but it did require a few patients to seek out another local pharmacy who might have had it in stock. More recently we have had patients who are experiencing much more difficulty.

Walgreens also told CreakyJoints that there is a large supply constraint on this medication that is affecting both versions of sulfasalazine .

Severe Or Fulminant Colitis

Severe or fulminant colitis. Patients need to be hospitalized immediately with subsequent bowel rest, nutrition, and IV steroids. Typical starting choices are hydrocortisone 100 mg IV q8h, prednisolone 30 mg IV q12h, or methylprednisolone 16â20 mg IV q8h. The last two are preferred due to less sodium retention and potassium wasting. 24-hour continuous infusion is preferred than the stated dosing. If the patient has not had any corticosteroids within the last 30 days, IV ACTH 120 units/day as continuous infusion is superior than the IV steroids mentioned above. In either case, if symptoms persist after 2â3 days, Mesalazine or hydrocortisone enemas daily or bid can be given. The use of antibiotics in those with severe colitis is not clear. However, there are those patients who have sub-optimal response to corticosteroids and continue to run a low grade fever with bandemia. Typically they can be treated with IV ciprofloxacin and metronidazole. However, in those with fulminant colitis or megacolon, with high fever, leukocytosis with high bandemia, and peritoneal signs, broad spectrum antibiotics should be given . Abdominal x-ray should also be ordered. If intestinal dilation is seen, patients should be decompressed with NG tube and or rectal tube.

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Warnings For People With Certain Health Conditions

For people with asthma or severe allergies: Tell your doctor if you have asthma. You may be more sensitive to sulfasalazine and have more side effects.

For people with bowel obstructions: Tell your doctor if you have problems with obstruction in your bowel or when urinating. You shouldnt take sulfasalazine because it could make these problems worse.

For people with porphyria: Tell your doctor if you have porphyria. In this disease, your body doesnt process certain chemicals normally. If you take sulfasalazine, you may have an acute attack or flare-up of porphyria.

Understanding The Patients Experience

Ulcerative Colitis Treatment Options

The following views have been expressed by the membership of the National Association for Colitis and Crohns Disease. Patients recognise that desirable goals cannot always be met within resource constraints, but consider that demonstrable efforts should be made to achieve them.

  • Someone with IBD should be seen as an individual and not be defined by their illness.

  • Individuals differ in the way they choose to live with IBD. Views of right and wrong approaches to living with IBD are best avoided.

  • Individuals often develop expertise about their own condition and needs which should be respected.

  • Problems that cannot be solved by the healthcare team are best acknowledged and recognised as being impossible to solve, rather than ignored.

  • Patients place a high value on sympathy, compassion, and interest.

  • There should be equitable access to treatments and services and early referral of complex cases to specialist centres when local expertise is exceeded.

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Cautions With Other Medicines

There are some medicines that can affect the way sulfasalazine works.

Tell your doctor or pharmacist if you’re taking:

  • digoxin, a medicine for heart problems
  • medicines for high blood sugar or diabetes, such as metformin or glibenclamide
  • methenamine, a specific antibiotic sometimes used for treating urinary tract infections
  • folic acid, often taken in first 12 weeks of pregnancy, as it may be less well absorbed so you may need to take a higher dose than usual
  • azathioprine or mercaptopurine, taken for rheumatoid arthritis or to prevent organ rejection after a transplant
  • methotrexate which is usually used to treat rheumatoid arthritis

Impact Of Ibd On Patients And Society24

Patients find symptoms of UC or CD embarrassing and humiliating. IBD can result in loss of education and difficulty in gaining employment or insurance. It can also cause psychological problems and growth failure or retarded sexual development in young people. Medical treatments such as corticosteroids or immunosuppressive drugs cause secondary health problems, and surgery may result in complications such as impotence or intestinal failure.

The impact of IBD on society is disproportionately high, as presentation often occurs at a young age and has the potential to cause lifelong ill health. A hospital serving a population of 300 000 would typically see 4590 new cases per annum and have 500 under follow up, but many will be followed up in the community. There is a small increase in mortality for both UC and CD , largely dependent on age and distribution of disease.

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Chronic Active And Steroid Dependent Disease4559697191103

Long term treatment with steroids is undesirable. Patients who have a poor response to steroids can be divided into steroid refractory and steroid dependent. Steroid-refractory disease may be defined as active disease in spite of an adequate dose and duration of prednisolone and steroid dependence as a relapse when the steroid dose is reduced below 20 mg/day, or within 6 weeks of stopping steroids. Such patients should be considered for treatment with immunomodulators if surgery is not an immediate consideration.

How To Switch To A Sulfasalazine Alternative

Inflammatory Bowel disease- Ulcerative colitis| Medicine | Dr Jeewat Ram |

If you are interested in switching to a sulfasalazine alternative, you can:

  • Contact your insurance provider if the price is a concern. Ask which sulfasalazine alternatives are covered in your formulary, and what the copay would be for each medication. Be sure to ask if your deductible has been met, or if you are still paying towards your deductible.
  • Reach out to your healthcare provider. You may be asked to make an appointment to talk about your medication regimen. You can review your medical conditions and history, and discuss alternative medicationsas well as potential side effects and drug interactionswith your healthcare provider. If your provider decides to prescribe a sulfasalazine alternative, they can send the prescription to your pharmacy. Tell your pharmacist that you are switching from sulfasalazine to the new medication, so they can update your file.
  • Search SingleCare for coupons. SingleCare customers save up to 80% on prescription prices, and the coupons can be applied to refills, too.

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Medical Management Of Crohns Disease

The severity of CD is more difficult to assess than UC. The general principles are to consider the site , pattern and activity of the disease before treatment decisions are made in conjunction with the patient.

An alternative explanation for symptoms other than active disease should be considered and disease activity confirmed before starting steroids. Individuals with CD have many investigations over their lifetime and imaging should not be repeated unless it will alter management or a surgical decision depends on the result.

Patients should be encouraged to participate actively in the decision to treat with high dose aminosalicylates, different corticosteroids, nutritional therapy, antibiotics, new biological agents, or surgery. Infliximab is considered in section 6.5.

Sulfasalazine May Interact With Other Medications

Sulfasalazine oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs youre taking. To find out how this drug might interact with something else youre taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with sulfasalazine are listed below.

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Fistulating And Perianal Disease72739596

Active perianal disease or fistulae are often associated with active CD elsewhere in the gastrointestinal tract. The initial aim should be to treat active disease and sepsis. For more complex, fistulating disease, the approach involves defining the anatomy, supporting nutrition, and potential surgery. For perianal disease, MRI and examination under anaesthetic are particularly helpful.

  • Metronidazole 400 mg tds and/or ciprofloxacin 500 mg bd are appropriate first line treatments for simple perianal fistulae.

  • Azathioprine 1.52.5 mg/kg/day or mercaptopurine 0.751.5 mg/kg/day are potentially effective for simple perianal fistulae or enterocutaneous fistulae where distal obstruction and abscess have been excluded .

  • Infliximab should be reserved for patients whose perianal or enterocutaneous fistulae are refractory to other treatment and should be used as part of a strategy that includes immunomodulation and surgery .

  • Surgery , including Seton drainage, fistulectomy, and the use of advancement flaps is appropriate for persistent or complex fistulae in combination with medical treatment .

  • Elemental diets or parenteral nutrition have a role as adjunctive therapy, but not as sole therapy .

  • There is insufficient evidence to recommend other agents outside clinical trials or specialist centres.

Newly Developed Alternatives To Sulphasalazine For Use In Inflammatory Bowel Disease

Inflammatory bowel disease.2014

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Surveillance For Colonic Carcinoma24133136

The value of surveillance colonoscopy in UC remains debated. It is important to discuss with individual patients their risk of colorectal cancer, the implications should dysplasia be identified, the limitations of surveillance , and the small, but definable, risks of colonoscopy. A joint decision on the appropriateness of surveillance can then be made, taking the patients views into account.

  • It is advisable that patients with UC should have a colonoscopy after 810 years to re-evaluate disease extent . Whether patients with previously extensive disease whose disease has regressed benefit from surveillance is unknown.

  • For those with extensive colitis opting for surveillance, colonoscopies should be conducted every 3 years in the second decade, every 2 years in the third decade, and annually in the fourth decade of disease .

  • Four random biopsies every 10 cm from the entire colon are best taken with additional samples of suspicious areas .

  • Patients with primary sclerosing cholangitis appear to represent a subgroup at higher risk of cancer, and they should have more frequent colonoscopy .

  • If dysplasia is detected, the biopsies should be reviewed by a second gastrointestinal pathologist and if confirmed, then colectomy is usually advisable .

Management Of Ulcerative Colitis

Management of ulcerative colitis involves first treating the acute symptoms of the disease, then maintaining remission. Ulcerative colitis is a form of colitis, a disease of the intestine, specifically the large intestine or colon, that includes characteristic ulcers, or open sores, in the colon. The main symptom of active disease is usually diarrhea mixed with blood, of gradual onset which often leads to anaemia. Ulcerative colitis is, however, a systemic disease that affects many parts of the body outside the intestine.

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B: Maintenance Of Remission

The 16 studies of maintenance therapy involved 2,341 patients. Only 4 were placebo-controlled the remaining 12 studies compared 5-ASA with SASP . Our results are expressed as odds ratios a value of < 1.0 indicates a beneficial effect of 5-ASA treatment over the comparison therapy for the maintenance of remission.

5-ASA versus Placebo

A pooled odds ratio of 0.48 was derived from four studies , comprising 671 patients, that reported the failure to maintain endoscopic or clinical remission . 5-ASA was observed to be significantly more effective than placebo in all dosage subgroups however, a dose-dependent trend was not observed . The pooled odds ratio was similar when calculated exclusively with those trials with endpoints at 12 months . Two of the trials involving olsalazine had a combined odds ratio of 0.54 .

5-ASA versus Sulfasalazine

Two trials involving Asacol had a combined odds ratio of 0.95 three trials involving Claversal had a pooled odds ratio of 1.31 . When the five trials involving olsalazine were pooled, the resulting odds ratio was 1.40 , thus demonstrating that SASP was significantly better than olsalazine in the maintenance of remission.

What To Know About The Sulfasalazine Shortage

USMLE GIT 9: IBD Explained! (Chron’s Disease and Ulcerative Colitis)

According to information on the FDA drug shortage website, some versions of sulfasalazine are expected to be out of shortage by July 2021 others not until Q4 2021.

Greenstone, part of the pharmaceutical company Viatris and formerly a subsidiary of Pfizer, distributes both regular and delayed-release versions of sulfasalazine. However, both are manufactured by a third party. The company shared the following information with CreakyJoints in a statement.

We are working very closely with the manufacturer to improve the supply of both sulfasalazine IR and DR tablets. We anticipate receiving intermittent supply from the third party through the remainder of the year. While we expect to be in an improved supply position in the fourth quarter of 2021, in the interim, we encourage patients to speak to their health care provider about alternatives if they are experiencing an inability to access the product.

Teva Pharmaceuticals manufactures only the regular version of sulfasalazine, though it is unclear whether or to what degree the medication from this company is in shortage. We reached out to Teva but did not hear back by the time this was published.

We will update this article with new information as we receive it.

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What If I Forget To Take It

If you miss a dose of sulfasalazine, take it as soon as you remember, unless it’s nearly time for your next dose. In this case, skip the missed dose and take your next one at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember your medicine.

Drugs That Target Inflammation

Most people with UC take prescription drugs called aminosalicylates that tame inflammation in the gut. These include balsalazide , mesalamine , olsalazine , and sulfasalazine . Which one you take, and whether it is taken by mouth or as an enema or suppository, depend on the area of your colon that’s affected. As long as you avoid your triggers, these may be enough if your disease is mild to moderate.

You may need something else if your condition is more severe or if those standard treatments stop working. Your doctor may consider other medicines. Some people may also need surgery.

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Active Left Sided Or Extensive Uc22283237394776

For the purposes of these guidelines, left sided disease is defined as disease extending proximal to the sigmoid descending junction up to the splenic flexure and extensive UC as extending proximal to the splenic flexure. Disease activity should be confirmed by sigmoidoscopy and infection excluded, although treatment need not wait for microbiological analysis.

For the treatment of active, left sided, or extensive UC:

Part B: Maintenance Of Remission

How effective is Sulfasalazine for Ulcerative colitis?

5-ASA versus Placebo

Only three of four trials provided information regarding adverse events or withdrawals because of adverse events. There was evidence of considerable heterogeneity for both outcomes , and no further analysis was performed. However, in terms of the total number of exclusions/withdrawals , the data from four trials was homogeneous the pooled odds ratio was 1.11 . A dose-dependent trend was observed .

5-ASA versus Sulfasalazine

Seven studies demonstrated similar proportions of patients having adverse events in the 5-ASA and SASP groups overall however, the studies were heterogeneous . Three olsalazine trials that were homogeneous had a pooled odds ratio of 1.35 .

The pooled odds ratio for withdrawals because of adverse events, derived from 10 studies , was 1.31 . In five olsalazine trials , 9.2% of those receiving olsalazine and 6.7% of those receiving SASP were withdrawn because of adverse events the pooled odds ratio was 1.66 . The results from two Claversal trials did not display the same significance the combined odds ratio was 1.10 .

Heterogeneity existed among the 10 trials that reported the total number of exclusions and withdrawals the pooled odds ratio was 1.37 . With regard to the five olsalazine trials , there was a significantly higher proportion of total exclusions/withdrawals because of olsalazine, 17%, than SASP, 12%, as represented by a pooled odds ratio of 1.60 .

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