SEYSARA- sarecycline hydrochloride tablet, coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

SARECYCLINE HYDROCHLORIDE (UNII: 36718856JR) (SARECYCLINE - UNII:94O110CX2E)

Beschikbaar vanaf:

Almirall, LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 (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)] . SEYSARA is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. Risk Summary SEYSARA, like tetracycline class drugs, may cause fetal harm, permanent discoloration of teeth, and reversible inhibition of bone growth when administered during pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)] . The limited available human data are not sufficient to inform a drug-associated

Product samenvatting:

How Supplied Storage 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]. Handling Protect from moisture and excessive heat.

Autorisatie-status:

New Drug Application

Productkenmerken

SEYSARA- SARECYCLINE HYDROCHLORIDE TABLET, COATED
ALMIRALL, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEYSARA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEYSARA .
SEYSARA (SARECYCLINE) TABLETS FOR ORAL USE.
INITIAL U.S. APPROVAL: 2018
INDICATIONS AND USAGE
SEYSARA is a tetracycline-class drug indicated for the treatment of
inflammatory lesions of non-nodular
moderate to severe acne vulgaris in patients 9 years of age and older.
(_1_)
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. 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)]._
DOSAGE AND ADMINISTRATION
The recommended dosage of SEYSARA is once daily with or without food
(_2_):
60 mg for patients who weigh 33-54 kg,
100 mg for patients who weigh 55-84 kg,
150 mg for patients who weigh 85-136 kg.
DOSAGE FORMS AND STRENGTHS
Tablets: 60 mg, 100 mg, 150 mg (_3_)
CONTRAINDICATIONS
SEYSARA is contraindicated in persons who have shown hypersensitivity
to any of the tetracyclines. (_4_)
WARNINGS AND PRECAUTIONS
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 hyp