Sulfasalazine

Salazopyrin (sulfasalazine) tablets are indicated in the treatment of acute episodes and maintenance of remission of ulcerative colitis, as well as in the treatment of Crohn's disease.

The active substance in Salazopyrina 500 mg tablets is sulfasalazine. Sulfasalazine belongs to a group of medicines called intestinal anti-inflammatory agents that show anti-inflammatory, immunosuppressive, and antibacterial activity. It is used to inhibit inflammatory conditions, particularly those related to the intestinal mucosa.

The mechanism of action of sulfasalazine medication in the treatment of ulcerative colitis and Crohn's disease is not exactly known. After oral administration, most of it reaches the colon unchanged, splitting into sulfapyridine and 5-aminosalicylic acid. One possible mechanism is that sulfasalazine serves as a vehicle to deliver sulfapyridine and 5-aminosalicylic acid to the colon in concentrations higher than can be achieved by oral administration of these metabolites alone. When these products reach the colon, the therapeutic effect appears to be due to the antibacterial action of sulfapyridine and/or the topical anti-inflammatory action of 5-aminosalicylic acid. Other mechanisms that may explain the activity of sulfasalazine are related to changes in the intestinal flora, reduction of Clostridium and Escherichia coli in the feces, inhibition of prostaglandin synthesis, alteration in the secretion and absorption of fluids and electrolytes by the colon, and/or immunosuppression.

Sulfasalazine is a drug with intestinal anti-inflammatory, immunosuppressive and antibacterial action. Sulfasalazine tablet uses include being indicated to treat acute episodes of ulcerative colitis as well as to maintain remission maintenance. It is also used in active Crohn's disease and rheumatoid arthritis.

Follow exactly the instructions for the administration of Salazopyrina indicated by your doctor. Ask your doctor or pharmacist if you have doubts.

The doses of this gastrointestinal medication will be adjusted according to the response to the treatment and the tolerability of the product by the patient. The tablets should be taken at regular intervals throughout the day, preferably after meals. They can be swallowed whole or dissolved in water or another liquid as long as a complete tablet is dissolved.

In the case of patients who have not been previously treated with Salazopyrina, it is recommended to gradually increase the doses during the first weeks.

Acute attacks:

Use in adults:

Severe attacks: 1,000 ¿2,000 mg (2-4 tablets) divided into 3-4 doses per day.

Moderate and mild attacks: 1,000 mg (2 tablets) divided into 3-4 doses per day.

Use in the elderly:

No dose adjustment is necessary, using the same doses as in adults.

Use in children (from 6 years):

40-60 mg / kg / day divided into 3-6 doses.

This dose can be administered as long as it can be dosed as complete tablets.

Relapse prophylaxis:

Use in adults:

Ulcerative colitis in remission: 1,000 mg (2 tablets) divided into 2-3 doses per day is the recommended maintenance dose to keep the patient symptom-free. Treatment with this dose should continue indefinitely unless side effects appear. In case of worsening, the dose rises to 1,000 - 2,000 mg (2-4 tablets) divided into 3-4 doses per day.

Use in the elderly:

No dose adjustment is necessary, using the same doses as in adults.

Use in children (from 6 years):

20-30 mg / kg / day divided into 3-6 doses a day.

This dose can be administered as long as it can be dosed as complete tablets.

Like all medicines, Salazopyrina can have side effects, although not everybody gets them.

The most common side effects associated with Salazopyrin therapy are nausea, loss of appetite, gastric disturbances, and occasionally slight increases in body temperature. In most cases, treatment can be continued by reducing the dose or after a few days without treatment.

The frequency of occurrence of sulfasalazine side effects during clinical trials and in post-marketing experience was:

Very common side effects (in more than 1 in 10 patients):

• Gastric discomfort, nausea.

Common side effects (between 1 and 10 of every 100 patients):

• Decreased white blood cell count (leukopenia), loss of appetite, dizziness, headache, altered taste, ringing in the ears (tinnitus), cough, abdominal pain, itching, joint pain, presence of protein in urine, fever.

Uncommon side effects (between 1 and 10 of every 1000 patients):

• Decreased platelet count (thrombocytopenia), depression, shortness of breath, hair loss, hives, facial edema, increased liver enzymes.

Rare side effects (1 to 10 in 10,000 patients):

• Inflammation of the meninges of the brain (aseptic meningitis), pseudomembranous colitis, decreased white blood cells (agranulocytosis), decreased number of red blood cells in the blood (aplastic, hemolytic, megaloblastic anemia), increased large red blood cells (macrocytosis), decreased of all types of blood cells (pancytopenia), hypersensitivity reaction (serum sickness), brain disorder (encephalopathy), tingling, burning, tightening or numbness in the feet and hands, altered smell, bluish skin color and mucosa, inflammation of the lining of the heart, eosinophilic infiltration, infiltration of the alveoli of the lung, worsening of chronic inflammatory bowel disease, inflammation of the pancreas, of the liver, severe cutaneous adverse reactions (epidermal necrolysis, exfoliative dermatitis, or Stevens-Johnson) erythema, rash, recurrent itching inflammatory lesion (lichen flat), abnormal skin response to light, purulent skin infection, yellowing of the skin and body fluids, destruction of the glands that produce tears and saliva (Sjogren's syndrome), chronic connective tissue disease (systemic lupus erythematosus), presence of crystals and blood in urine, inflammation of the kidneys (interstitial nephritis), increased protein in the blood, decreased number of reversible sperm and induction of autoantibodies.

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