Oushod Sheba

Oushod Sheba

All category

REUMAZIN

ARISTOPHARMA LTD.


TABLET
500 MG

5.2

Generic Information

Generic name

SULFASALAZINE

Indications

Sulfasalazine is indicated in: 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.

Therapeutic Class

Drugs for Irritable Bowel Syndrome, Drugs used for Rheumatoid Arthritis, Ulcerative Colitis

Pharmacology

Sucralose is an artificial sweetener and sugar substitute. The majority of ingested sucralose is not broken down by the body, so it is noncaloric. In the European Union, it is also known under the E number E955. Sucralose is about 320 to 1,000 times sweeter than sucrose, three times as sweet as aspartame, twice as sweet as saccharin and three times as sweet as acesulfame potassium. It is stable under heat and over a broad range of pH conditions. Therefore, it can be used in baking or in products that require a longer shelf life. The commercial success of sucralose-based products stems from its favorable comparison to other low-calorie sweeteners in terms of taste, stability, and safety.

Dosage & Administration

The dosage of Sulfasalazine 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 crohn8s 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. Adult dose 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 the evening Second week: One tablet in the morning & One tablet in the evening Third week: One tablet in the morning & two tablet in the evening Forth week: Two tablet in the morning & two tablet in 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.

Interaction

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

Contradictions

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

Side Effects

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

Pregnancy & Lactation

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.

Overdose Effects

Precaution & Warnings

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

Storage Conditions

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