Source: FDA, National Drug Code (US) Revision Year: 2020
SEYSARA (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections [see Clinical Studies (14)].
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated [see Warnings and Precautions (5.6)].
The recommended dosage of SEYSARA is based on body weight described in Table 1. If there is no improvement after 12 weeks, reassess treatment with SEYSARA.
Table 1. Dosing Table for SEYSARA:
| Body Weight (kg) | Tablet Strength |
|---|---|
| 33 to 54 kg | 60 mg tablet |
| 55 to 84 kg | 100 mg tablet |
| 85 to 136 kg | 150 mg tablet |
Take SEYSARA once daily, with or without food. To reduce the risk of esophageal irritation and ulceration, administer SEYSARA with adequate amounts of fluid.
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.
Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature].
Protect from moisture and excessive heat.
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