Rx Item-Seysara 150 mg Tab 30 Sarecycline Hcl Oral Caplet By Aqua Pharma

Clinical Information
Gen. Code and Des.
79078 sarecycline HCl ORAL TABLET 60 MG
Strength
150 mg
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
8122400 TETRACYCLINE ANTIBIOTICS
Active Ingredients
17780 sarecycline HCl
Inactive Ingredients
10143 yellow dye
11039 sodium bicarbonate 144558
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:

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. (2)
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 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)

ADVERSE REACTIONS
Most common adverse reaction (incidence ≥ 1%) is nausea. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Almirall at 1-866-665-2782 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.


DRUG INTERACTIONS
Oral retinoids: avoid coadministration. (5.4, 7.1)
Antacids and iron preparations: separate dosing of SEYSARA. (7.1)
Penicillin: avoid coadministration. (7.2)
Anticoagulants: decrease anticoagulant dosage as appropriate. (7.2)
P-glycoprotein substrates: monitor for toxicities of drugs that may require dosage reduction. (7.2)
USE IN SPECIFIC POPULATIONS
Sarecycline, like other tetracycline-class drugs, can cause fetal harm when administered to a pregnant woman. (5.1, 8.1)
The use of drugs of the tetracycline class during tooth development may cause permanent discoloration of teeth. (5.1, 8.4)
Lactation: Breastfeeding is not recommended. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2018

SEYSARA 150 MG TAB 30
NDC No.16110-0247-30 16110-247-30 UPC/GTIN No.3-16110-24730-4 MPN No. 24730 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Ph

SEYSARA 60 MG TAB 30 sarecycline HCl ORA
NDC No.16110-0245-30 16110-245-30 UPC/GTIN No.3-16110-24530-0 MPN 24530 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,P

DOXYCYCLINE HYCLATE ORAL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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