Sulfasalazine Mylan

Sulfasalazine Mylan Uses, Dosage, Side Effects, Food Interaction and all others data.

The mode of action of Sulfasalazine Mylan is still under investigation, but may be related to the anti inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of Sulfasalazine Mylan, Sulfapyridine and 5-Aminosalyclic Acid have indicated that the major therapeutic action may reside in the 5-Aminosalyclic Acid moiety. The relative contribution of the parent drug and the major metabolites in rheumatoid arthritis is unknown.

Sulfasalazine Mylan is an anti-inflammatory indicated for the treatment of ulcerative colitis and rheumatoid arthritis.

Trade Name Sulfasalazine Mylan
Availability Prescription only
Generic Sulfasalazine
Sulfasalazine Other Names Azopyrin, Salazosulfapiridina, Salazosulfapyridine, Salazosulfapyridinum, Salicylazosulfapyridine, Sulfasalazin, Sulfasalazina, Sulfasalazine, Sulfasalazinum
Related Drugs Lialda, Pentasa, Apriso, Azulfidine, Asacol, Canasa, Delzicol, Asacol HD, Dipentum, Rowasa
Type
Formula C18H14N4O5S
Weight Average: 398.393
Monoisotopic: 398.068490268
Groups Approved
Therapeutic Class Drugs for Irritable Bowel Syndrome, Drugs used for Rheumatoid Arthritis, Ulcerative Colitis
Manufacturer
Available Country Netherlands
Last Updated: September 19, 2023 at 7:00 am
Sulfasalazine Mylan
Sulfasalazine Mylan

Uses

Sulfasalazine Mylan is used for:

  • Rheumatoid arthritis & Juvenile arthritis: In the treatment of patients with rheumatoid arthritis and pediatiric patients with polyarticular-course juvenile rheumatoid arthritis, who have responded inadequately to salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Ulcerative colitis and Crohn's Disease: As adjunct in the treatment of ulcerative colitis with the usual supportive and dietary measures. In the treatment of active Crohn's disease, especially in patients with colonic involvement.

Sulfasalazine Mylan is also used to associated treatment for these conditions: Crohn's Disease (CD), Polyarticular juvenile rheumatoid arthritis, chronic or unspecified, Proctitis, Rheumatoid Arthritis, Severe Ulcerative Colitis, Mild Ulcerative Colitis, Moderate Ulcerative colitis

How Sulfasalazine Mylan works

The mode of action of Sulfasalazine Mylan or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), is still under investigation, but may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of Sulfasalazine Mylan, SP and 5-ASA have indicated that the major therapeutic action may reside in the 5-ASA moiety. The relative contribution of the parent drug and the major metabolites in rheumatoid arthritis is unknown.

Dosage

Sulfasalazine Mylan dosage

The dosage of Sulfasalazine Mylan tablets should be individually adjusted according to the patient's tolerance and response to the treatment and taken in evenly divided doses preferably after meals.

Adult dose for crohn’s disease: 500 mg orally 2 to 4 times a day with food.

Pediatric use (6 years or older) for Ulcerative Colitis: The initial dose 40 to 60 mg/kg/day orally divided into 3 to 6 doses.

Adultdose for rheumatoid arthritis: 2 g daily in two evenly divided doses. It is advisable to initiate therapy with a lower dosage e.g. 0.5 to 1.0 g daily, to reduce possible gastrointestinal intolerance. A suggested dosing schedule is given bellow:

  • First week: One tablet in theevening
  • Secondweek: One tabletin the morning &One tabletin the evening
  • Thirdweek:One tabletin the morning & two tabletin the evening
  • Forthweek: Two tabletin the morning &two tabletin the evening

In case of rheumatoid arthritis 6 years or older: initial dose 10 mg/kg/day orally in 2 equally divided doses.

Juvenile rheumatoid arthritis-polyarticular course: Children 6 years of age and older: 30 to 50 mg/kg/day in two evenly divided doses. Typically the maximum dose is 2 g per day.

For other indications:

Initial therapy:

  • Adults: 3 to 4 g daily in 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.
  • Children 6 years of age and older: 40 to 60 mg/kg/day in to 3 to 6 divided doses.

Maintenance therapy:

  • Adults: 2 g daily.
  • Children 6 years of age and older: 30 mg/kg/day in 4 divided doses.

Side Effects

The common adverse reactions are anorexia, headache, nausea, vomiting, gastric distress, dyspepsia, abdominal pain, dizziness, apparently reversible oligospermia etc.

Precaution

Hepatic/renal impairment, G6PD deficiency, allergic bronchial asthma, lactation.

Interaction

Reduced absorption of folic acid and digoxin has been reported when those agents were administered concomitantly with sulfasalazine.

Food Interaction

  • Drink plenty of fluids. Inadequate fluid intake is associated with crystalluria and stone formation.
  • Take with food.

Volume of Distribution

  • 7.5 ± 1.6 L

Half Life

5-10 hours

Clearance

  • 1 L/h [IV administration]

Elimination Route

The majority of 5-ASA stays within the colonic lumen and is excreted as 5-ASA and acetyl-5-ASA with the feces.

Pregnancy & Breastfeeding use

Use in pregnancy: Pregnancy category B. This drug should be used during pregnancy only if clearly needed.

Use in lactation: Caution should be exercised when sulfasalazine is administered to a nursing mother.

Contraindication

Hypersensitivity to Sulfasalazine Mylan, its metabolites, sulfonamides or salicylates, patients with intestinal or urinary obstruction and porphyria.

Storage Condition

Store in a cool and dry place, protected from light.

Innovators Monograph

You find simplified version here Sulfasalazine Mylan

Sulfasalazine Mylan contains Sulfasalazine see full prescribing information from innovator Sulfasalazine Mylan Monograph, Sulfasalazine Mylan MSDS, Sulfasalazine Mylan FDA label

FAQ

What is Sulfasalazine Mylan used for?

Sulfasalazine Mylan is used to treat bowel inflammation, diarrhea, rectal bleeding, and abdominal pain in patients with ulcerative colitis, a condition in which the bowel is inflamed.

How safe is Sulfasalazine Mylan?

Sulfasalazine Mylan may cause reversible male infertility, but it is entirely safe for use during pregnancy and lactation. Overall, Sulfasalazine Mylan has a long and impressive safety record, provided the drug is used with an awareness and appreciation of its potential pitfalls.

How does Sulfasalazine Mylan work?

Sulfasalazine Mylan is an anti-inflammatory drug.Sulfasalazine Mylan believed that it affects your immune system and decreases inflammation. Sulfasalazine Mylan work by locally in the colon to decrease inflammation. It also works throughout the body by inhibiting the formation of a chemical known as prostaglandins.

What are the common side effects of Sulfasalazine Mylan?

The more common side effects of Sulfasalazine Mylan are include:

  • decreased appetite
  • headache
  • nausea
  • vomiting
  • stomach upset and pain
  • rash
  • itching
  • decreased sperm count (only while taking the medication)
  • dizziness

Is Sulfasalazine Mylan safe during pregnancy?

Sulfasalazine Mylan does not increase the risk of any complications of pregnancy or the risk of birth defects.

Is Sulfasalazine Mylan safe during breastfeeding?

Sulfasalazine Mylan is considered safe to use while you are breastfeeding, unless the baby is premature or at risk of jaundice.

Can I drink alcohol with Sulfasalazine Mylan?

There's no particular reason to avoid alcohol while on Sulfasalazine Mylan. However, it's recommended that people try to keep well within the recommended limits for alcohol. This limit is 14 units a week for women and men.

How quickly does Sulfasalazine Mylan work?

Sulfasalazine Mylan start to work could be at least 12 weeks before you notice any effects. You shouldn't take Sulfasalazine Mylan if you're known to have an allergy to salicylates.

When is the best time to take Sulfasalazine Mylan?

It is best to take Sulfasalazine Mylan right after meals, at evenly spaced times throughout the day and night. Try not to let more than 8 hours go by between doses, even at night.

Does Sulfasalazine Mylan cause weight gain?

Sulfasalazine Mylan can causes weight gain also with other side effects.

Is Sulfasalazine Mylan a steroid?

No, Sulfasalazine Mylan is not a steroid and is actually considered a "steroid-sparing" medication.

How long can I stay on Sulfasalazine Mylan?

Sulfasalazine Mylan takes time to work. Most patients start to feel the positive effects of at 4-8 weeks, with maximum benefit at 3-6 months.

Who should not take Sulfasalazine Mylan?

If you have or have ever had asthma, kidney or liver disease, porphyria, blood problems, or blockage in your intestine or urinary tract you should not use Sulfasalazine Mylan.

Does Sulfasalazine Mylan cause hair loss?

Sulfasalazine Mylan may not causes hair loss.

Does Sulfasalazine Mylan reduce inflammation?

Sulfasalazine Mylan works inside the bowels by helping to reduce the inflammation and other symptoms of the disease.

Is Sulfasalazine Mylan bad for my liver?

Sulfasalazine Mylan has been linked to cases of acute liver failure, particularly with hepatocellular patterns of injury.

Can Sulfasalazine Mylan affect my eyes?

Sulfasalazine Mylan is generally considered safe and well tolerated. There has been a report of peripheral facial nerve palsy and blurred near vision in association with Sulfasalazine Mylan treatme.

How does Sulfasalazine Mylan affect sperm?

Sulfasalazine Mylan can decrease sperm counts and sperm motility.

How bad is Sulfasalazine Mylan for you?

Sulfasalazine Mylan may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums.

Can Sulfasalazine Mylan cause high blood pressure?

found no effect of Sulfasalazine Mylan on blood pressure, hyperemic response, or arterial diameter.

Can Sulfasalazine Mylan make me infertile?

These studies confirmed the preliminary report and suggest that prolonged treatment with Sulfasalazine Mylan may universally depress semen quality and cause reversible infertility.

What happens if I miss a dose?

If you forget to take a dose of Sulfasalazine Mylan, take Sulfasalazine Mylan as soon as you remember. If it is almost time for your next scheduled dose, take only your next dose. Do not take two doses of Sulfasalazine Mylan at once.

What happens if I overdose of Sulfasalazine Mylan?

Overdose symptoms may include vomiting, stomach pain, drowsiness, or seizure.

How long does it take for Sulfasalazine Mylan to leave my body?

Sulfasalazine Mylan is safe to just stop Sulfasalazine Mylan you do not need to slowly reduce the dose. However, keep in mind, if you were gaining any benefit, it will usually take at least 6 weeks to lose it.

*** Taking medicines without doctor's advice can cause long-term problems.
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