sarecycline

General

Pronunciation:
sar-e-sye-kleen


Trade Name(s)

  • Seysara

Ther. Class.

anti-infectives

Pharm. Class.

tetracyclines

Indications

Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.

Action

Inhibits bacterial protein synthesis by binding to the 30S bacterial ribosome.

Therapeutic Effect(s):

Reduction in inflammatory lesions.

Pharmacokinetics

Absorption: Unknown. Rate and extent of absorption reduced by high-fat, high-calorie food.

Distribution: Widely distributed to tissues.

Metabolism and Excretion: Minimally metabolized by liver. 43% excreted in feces (15% as unchanged drug), 44% in urine (25% as unchanged drug).

Half-life: 21–22 hr.

TIME/ACTION PROFILE (plasma concentrations)

ROUTEONSETPEAKDURATION
POunknown1.5–2 hr24 hr

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity to sarecycline or other tetracycline antibiotics;
  • OB:  Pregnancy (may lead to permanent staining of teeth and inhibition of bone growth in fetus if used during 2nd or 3rd trimester)
  • Lactation:  Lactation
  • Pedi:   Children ≤8 yr (may lead to permanent staining of teeth and ↓ growth).

Use Cautiously in:

Rep:   Women of reproductive potential who are overweight (↑ risk of intracranial hypertension).

Adverse Reactions/Side Effects

CNS: dizziness, intracranial hypertension, vertigo

Derm: photosensitivity

GI: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), nausea

GU: fertility (males), vulvovaginal candidiasis

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

Drug-Food:

Calcium in foods or dairy products may ↓ absorption.

Route/Dosage

PO (Adults and Children ≥9 yr and 85–136 kg): 150 mg once weekly. Reassess treatment if no improvement after 12 wk.

PO (Adults and Children ≥9 yr and 55–84 kg): 100 mg once weekly. Reassess treatment if no improvement after 12 wk.

PO (Adults and Children ≥9 yr and 33–54 kg): 60 mg once weekly. Reassess treatment if no improvement after 12 wk.

Availability

Tablets: 60 mg, 100 mg, 150 mg

Assessment

  • Assess skin lesions before starting and periodically during therapy.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of Clostridioides difficile-associated diarrhea (CDAD). May begin up to several wk following cessation of therapy.

Implementation

  • May cause yellow-brown discoloration and softening of teeth and bones if administered prenatally or during early childhood. Not recommended for children under 8 yr of age or during pregnancy or lactation unless used for the treatment of anthrax.
  • PO Administer once daily without regard to food. Administer full glass of water to decrease risk of esophageal irritation and ulceration.

Patient/Family Teaching

  • Instruct patient to take sarecycline as directed. Advise patient to read  Patient Information  before starting therapy and with each Rx refill in case of changes.
  • May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Instruct patient to notify health care professional immediately if rash, diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.

  • Caution patient to use sunscreen and protective clothing and minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using sarecycline to prevent photosensitivity reactions.
  • Advise patient to report the signs of superinfection (black, furry overgrowth on the tongue; vaginal itching or discharge; loose or foul-smelling stools) or intracranial hypertension (IH) (headache, blurred vision, diplopia, vision loss). Women who are overweight, of childbearing age or have a history of IH are at greater risk for developing IH.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Rep:  May cause fetal harm. May permanently turn a baby or child's teeth yellow-gray-brown during tooth development during the second and third trimesters of pregnancy, and from birth to 8 years of age. May also slow bone growth in infants and children. Advise females of reproductive potential to use a nonhormonal method of contraception and avoid breastfeeding during therapy. Advise patient to notify health care professional promptly if pregnancy is suspected. May reduce fertility in males; avoid use in males attempting to conceive a child.

Evaluation/Desired Outcomes

Reduction in inflammatory skin lesions.