Seysara

(Sarecycline Hydrochloride)

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Dosage & Administration

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.

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Seysara Prescribing Information

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.

Limitations of Use

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 ]

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 ]

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.

The use of SEYSARA during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). (
5.1
)
If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) occurs, discontinue SEYSARA. (
5.2
)
Central nervous system side effects, including light-headedness, dizziness or vertigo, have been reported with tetracycline use. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery. These symptoms may disappear during therapy and may disappear when the drug is discontinued. (
5.3
)
SEYSARA may cause intracranial hypertension. Discontinue SEYSARA if symptoms occur. (
5.4
)
Photosensitivity can occur with SEYSARA. Patients should minimize or avoid exposure to natural or artificial sunlight. (
5.5
)

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