- Approval Id
- f4d187842457e284
- Drug Name
- SALAZOPYRIN EN-TABLET 500 MG
- Product Name
- SALAZOPYRIN EN-TABLET 500 MG
- Approval Number
- SIN01589P
- Approval Date
- 1988-06-01
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- ENTERIC COATED TABLET
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong><u>Tablets and enteric coated tablets</u></strong></p>
<p>The dosage should be adjusted according to the patient’s response to treatment and tolerance to the drug. The tablets should be taken at regular intervals during the day, preferably in connection with meals. Patients not previously treated with Salazopyrin/Salazopyrin EN-tabs are recommended to increase the dose gradually during the first few weeks. The use of enteric coated tablets will reduce the incidence of gastrointestinal side effects. The enteric coated tablets must be swallowed intact, preferably after meals, and should not be crushed or broken.</p>
<p><u>Inflammatory bowel diseases</u></p>
<p><strong><em>Acute attacks:</em></strong><br>
<em>Adults</em><br>
Severe attacks: 2–4 tablets 3–4 times a day may be given in conjunction with steroids as part of an intensive management regime.<br>
Moderate and mild attacks: 2 tablets 3–4 times a day.</p>
<p><em>Children</em><br>
40–60 mg/kg body weight and day, divided into 3–6 doses.</p>
<p><strong><em>Prophylaxis against relapses:</em></strong><br>
<em>Adults</em><br>
In ulcerative colitis in a state of remission a maintenance dose is recommended for keeping the patient free from symptoms, as a rule 2 tablets 2(–3) times a day.<br>
Treatment with this dosage should continue indefinitely, unless adverse effects are observed. In case of deterioration, the dosage is raised to 2(–4) tablets 3–4 times a day.</p>
<p><em>Children</em><br>
20–30 mg/kg body weight and day, divided into 3–6 doses.</p>
<p><strong><u>Enteric coated tablets</u></strong></p>
<p><u>Rheumatoid Arthritis</u></p>
<p>Experience has shown that the clinical effect appears within 1–2 months’ treatment.</p>
<p>Concurrent treatment with analgesics and/or non-steroidal anti-inflammatory agents is recommended at least until the disease-modifying effect of Salazopyrin EN-tabs is apparent. Salazopyrin EN-tabs has been shown effective and well tolerated in long-term treatment.</p>
<p><em>Adults</em><br>
Two enteric coated tablets twice a day, i.e., 2 g a day. The enteric coated tablets should not be crushed or broken. When starting therapy, it is advisable to increase the daily dose according to the following schedule:</p>
<img src="/TGIF/SalazopyrinEN-Table1_130225.png" alt="Salazopyrin EN Dosage Table 1" /><br><br>
<p>If no response has been seen after 2 months’ treatment, the dose may be increased to 3 g per day.</p>
<p><em>Children</em><br>
At present no recommendation regarding treatment with Salazopyrin EN-tabs in juvenile chronic arthritis can be given.</p>
<p><strong><u>Suppositories</u></strong></p>
<p>Individual. 1–2 suppositories in the morning after defecation and in the evening. After 4–5 weeks, the dosage can be reduced by half. The local treatment can be combined with oral therapy with Salazopyrin/Salazopyrin EN tabs.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p><strong><u>Tablets and enteric coated tablets</u></strong></p>
<p><em>Ulcerative colitis</em><br>
In the treatment of mild to moderate ulcerative colitis and as adjunctive therapy in severe ulcerative colitis. For maintenance of remission in ulcerative colitis.</p>
<p><em>Crohn’s disease</em><br>
In the treatment of active Crohn’s disease, especially in patients with colonic involvement.</p>
<p><strong><u>Enteric coated tablets</u></strong></p>
<p><em>Ulcerative colitis and Crohn’s disease.</em></p>
<p><em>Rheumatoid Arthritis.</em></p>
<p><strong><u>Suppositories</u></strong></p>
<p><em>Ulcerative proctitis</em></p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li><p>Known hypersensitivity to sulfasalazine, its metabolites, or any other component of the product as well as sulfonamides, or salicylates.</p></li>
<li><p>Porphyria.</p></li>
</ul>
- Atc Code
- A07EC01
- Atc Item Name
- sulfasalazine
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
- Company Detail Path
- /organization/pfizer-private-limited
