General

Pronunciation:
sar-e-sye-kleen

Trade Name(s)

• Seysara

Ther. Class.

anti-infectives

Pharm. Class.

tetracyclines

Indications

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.

Spectrum:

Active against Propionibacterium acnes.

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)

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

Derm: photosensitivity

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

GU: ↓ fertility (males), vulvovaginal candidiasis

Neuro: dizziness, intracranial hypertension, vertigo

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

Interactions

Drug-Drug

•  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.

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 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 (headache, blurred vision, diplopia, vision loss). Women of reproductive potential who are overweight are at greater risk for developing intracranial hypertension.
• 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 2nd and 3rd trimesters of pregnancy, and from birth to 8 yr. 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.