Sarecycline

Indications

Sarecycline is used for: Acne Vulgaris

Adult Dose

Acne Vulgaris Indicated for treatment of inflammatory lesions of non-nodular moderate-to-severe acne <54 kg: 60 mg PO qDay 55-84 kg: 100 mg PO qDay 85-136 kg: 150 mg PO qDay If improvement after 12 weeks not observed, reassess treatment

Child Dose

Acne Vulgaris Indicated for treatment of inflammatory lesions of non-nodular moderate-to-severe acne in patients aged ?9 yr <9 years: Safety and efficacy not established >9 years 33-54 kg: 60 mg PO qDay 55-84 kg: 100 mg PO qDay 85-136 kg: 150 mg PO qDay If improvement after 12 weeks not observed, reassess treatment

Renal Dose

Administration

Take with or without food

Contra Indications

Hypersensitivity to any tetracyclines

Precautions

Clostridium difficile-associated diarrhea (CDAD) reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis; if CDAD is suspected or confirmed, consider discontinuing ongoing antibacterial drug use not directed against C difficile and initiating treatment-appropriate measures CNS adverse effects (eg, light-headedness, dizziness, vertigo) reported with tetracycline use Intracranial hypertension in adults and adolescents associated with tetracycline use; clinical manifestations include headache, blurred vision, and papilledema Photosensitivity manifested by an exaggerated sunburn reaction observed with tetracyclines; instruct patients to minimize or avoid exposure to natural or artificial sunlight Bacterial resistance to tetracyclines may develop; because of this, use only as indicated

Pregnancy-Lactation

Pregnancy Like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during second and third trimesters of pregnancy Pregnant women should discontinue sarecycline as soon as pregnancy is recognized Animal data Crosses placenta and is found in fetal plasma; sarecycline induced skeletal malformations in fetuses when administered PO to pregnant rats during the period of organogenesis at a dose 1.4 times the maximum recommended human dose (MRHD) of 150 mg/day (based on AUC comparison) Infertility Based on animal studies, can lead to impaired spermiation and sperm maturation, resulting in abnormal sperm morphology and poor motility Avoid use in males who are attempting to conceive a child Lactation Tetracyclines are excreted in human milk Because of the potential for serious adverse reactions on bone and tooth development in nursing infants, sarecycline is not recommended in breastfeeding women Animal studies When dosing with sarecycline continued through the period of lactation, decreases in offspring survival, offspring body weight, and implantation sites and viable embryos in offspring females occurred at a dose 3 times the MRHD

Interactions

Avoid coadministration with oral retinoids; may have additive effects on increasing intracranial pressure Coadministration with antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations decrease tetracycline absorption, which may decrease efficacy; separate doses May interfere with bacteriocidal action of penicillin; avoid coadministration May depress plasma prothrombin activity, which may increase bleeding risk in patients who are on anticoagulant therapy May increase serum concentration of P-gp substrates; monitor for toxicities if P-gp substrates coadministered

Adverse Effects

Side effects of Sarecycline : 1-10% Nausea (3.1%) <1% Vulvovaginal mycotic infection Vulvovaginal candidiasis

Mechanism of Action

Tetracycline-derived antibiotic; narrow spectrum of activity targeting acne-specific pathogens (ie, Propionibacterium acnes, Staphylococcus aureus) Elicits limited activity against aerobic gram-negative gastrointestinal organisms compared with minocycline and doxycycline