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