Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.
Inhibits bacterial protein synthesis by binding to the 30S bacterial ribosome.
Reduction in inflammatory lesions.
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)
|PO||unknown||1.5–2 hr||24 hr|
- 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
GI: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), nausea
GU: ↓ fertility (males), vulvovaginal candidiasis
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
- Isotretinoin may ↑ risk of intracranial hypertension; avoid concurrent use.
- Antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, or iron supplements may ↓ absorption.
- May interfere with the bactericidal effects of penicillin ; avoid concurrent use.
- May ↑ effect of and risk of bleeding with warfarin.
- May ↑ levels and risk of toxicity of P-glycoprotein substrates, including digoxin.
Calcium in foods or dairy products may ↓ absorption.
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.
Tablets: 60 mg, 100 mg, 150 mg
- 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.
- 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.
- 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.
Reduction in inflammatory skin lesions.