- Approval Id
- 83e5aa7e046c9fe3
- Drug Name
- SALAGEN TABLET 5 MG
- Product Name
- SALAGEN TABLET 5 MG
- Approval Number
- SIN11683P
- Approval Date
- 2001-09-28
- Registrant
- PHARMAFORTE SINGAPORE PTE LTD
- Licence Holder
- PHARMAFORTE SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION:</strong></p>
<p><u>Head & Neck Cancer Patients:</u></p>
<p>The recommended initial dose of SALAGEN® Tablets is one tablet (5 mg) taken three times a day. Dosage should be titrated according to therapeutic response and tolerance. The usual dosage range is up to 3–6 tablets or 15–30 mg per day (Not to exceed 2 tablets per dose). Although early improvement may be realized, at least 12 weeks of uninterrupted therapy with SALAGEN® Tablets may be necessary to assess whether a beneficial response will be achieved. The incidence of the most common adverse events increases with dose. The lowest dose that is tolerated and effective should be used for maintenance.</p>
<p><u>Sjögren's Syndrome Patients:</u></p>
<p>The recommended dose of SALAGEN® Tablets is one tablet (5 mg) taken four times a day. Efficacy was established by 6 weeks of use.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS AND USAGE:</strong> SALAGEN® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjögren's syndrome.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS:</strong> SALAGEN® Tablets are contraindicated in patients with uncontrolled asthma, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.</p>
- Atc Code
- N07AX01
- Atc Item Name
- pilocarpine
- Pharma Manufacturer Name
- PHARMAFORTE SINGAPORE PTE LTD
- Company Detail Path
- /organization/pharmaforte-singapore-pte-ltd
