Colosalazine-EC

Trade Name:

Colosalazine-EC

Composition

Active ingredients:

Sulfasalazine 500mg

Inactive ingredients:

Avicel PH 101, Povidone k 25, AC-Di-Sol, Colloidal silicon dioxide, Magnesium stearate, Enteric coat, Eudragit L 100, Talc, Titanium Dl oxide, PEG 6000, Ethyl alcohol , Sun Set yellow

Properties

The mode of action of Sulfasalazine or its metabolites, 5-aminosalicylic acid and sulfapyridine 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.

Indication

the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis

for the prolongation of the remission period between acute attacks of ulcerative colitis

Dosage and administration

The dosage of sulfasalazine tablets should be adjusted to each individual’s response and tolerance.

Initial therapy:

1)Adults 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. In some cases it is advisable to initiate therapy with a smaller dosage to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve desired effects, the increased risk of toxicity should be kept in mind.

Side effects

Stomach upset, nausea, vomiting, loss of appetite, headache, dizziness, or unusual tiredness may occur.

This medication may cause your skin and urine to turn orange-yellow. This effect is harmless and will disappear when the medication is stopped.

Hearing changes (such as ringing in the ears), mental/mood changes, signs of kidney problems (such as change in the amount of urine, painful urination, blood in the urine), new lump/growth in the neck (goiter), numbness/tingling of the hands/feet, signs of low blood sugar (such as hunger, cold sweat, blurred vision, weakness, fast heartbeat).

Contraindications

-Intestinal or urinary obstruction

-Porphyria

-Hypersensitivity to sulfasalazine, its metabolites, sulfonamides or salicylate.

Storage

Store at a temperature not exceeding 30°C in a dry place.

Package:

The carton box contains 2 strips each of 10 enteric coated tablets and inner leaflet.