Sulfasalazin HEXAL

Sulfasalazin HEXAL Uses, Dosage, Side Effects, Food Interaction and all others data.

The mode of action of Sulfasalazin HEXAL 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 Sulfasalazin HEXAL, 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.

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

Trade Name Sulfasalazin HEXAL
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 Germany
Last Updated: September 19, 2023 at 7:00 am
Sulfasalazin HEXAL
Sulfasalazin HEXAL

Uses

Sulfasalazin HEXAL 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.

Sulfasalazin HEXAL 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 Sulfasalazin HEXAL works

The mode of action of Sulfasalazin HEXAL 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 Sulfasalazin HEXAL, 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

Sulfasalazin HEXAL dosage

The dosage of Sulfasalazin HEXAL 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 Sulfasalazin HEXAL, 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 Sulfasalazin HEXAL

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

FAQ

What is Sulfasalazin HEXAL used for?

Sulfasalazin HEXAL 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 Sulfasalazin HEXAL?

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

How does Sulfasalazin HEXAL work?

Sulfasalazin HEXAL is an anti-inflammatory drug.Sulfasalazin HEXAL believed that it affects your immune system and decreases inflammation. Sulfasalazin HEXAL 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 Sulfasalazin HEXAL?

The more common side effects of Sulfasalazin HEXAL are include:

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

Is Sulfasalazin HEXAL safe during pregnancy?

Sulfasalazin HEXAL does not increase the risk of any complications of pregnancy or the risk of birth defects.

Is Sulfasalazin HEXAL safe during breastfeeding?

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

Can I drink alcohol with Sulfasalazin HEXAL?

There's no particular reason to avoid alcohol while on Sulfasalazin HEXAL. 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 Sulfasalazin HEXAL work?

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

When is the best time to take Sulfasalazin HEXAL?

It is best to take Sulfasalazin HEXAL 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 Sulfasalazin HEXAL cause weight gain?

Sulfasalazin HEXAL can causes weight gain also with other side effects.

Is Sulfasalazin HEXAL a steroid?

No, Sulfasalazin HEXAL is not a steroid and is actually considered a "steroid-sparing" medication.

How long can I stay on Sulfasalazin HEXAL?

Sulfasalazin HEXAL 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 Sulfasalazin HEXAL?

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 Sulfasalazin HEXAL.

Does Sulfasalazin HEXAL cause hair loss?

Sulfasalazin HEXAL may not causes hair loss.

Does Sulfasalazin HEXAL reduce inflammation?

Sulfasalazin HEXAL works inside the bowels by helping to reduce the inflammation and other symptoms of the disease.

Is Sulfasalazin HEXAL bad for my liver?

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

Can Sulfasalazin HEXAL affect my eyes?

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

How does Sulfasalazin HEXAL affect sperm?

Sulfasalazin HEXAL can decrease sperm counts and sperm motility.

How bad is Sulfasalazin HEXAL for you?

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

Can Sulfasalazin HEXAL cause high blood pressure?

found no effect of Sulfasalazin HEXAL on blood pressure, hyperemic response, or arterial diameter.

Can Sulfasalazin HEXAL make me infertile?

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

What happens if I miss a dose?

If you forget to take a dose of Sulfasalazin HEXAL, take Sulfasalazin HEXAL 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 Sulfasalazin HEXAL at once.

What happens if I overdose of Sulfasalazin HEXAL?

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

How long does it take for Sulfasalazin HEXAL to leave my body?

Sulfasalazin HEXAL is safe to just stop Sulfasalazin HEXAL 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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