REMS
Clostridioides difficile
-associated diarrhea (CDAD).Spectrum:
Absorption: 80% absorbed after oral administration. Minimal absorption after topical or vaginal application.
Distribution: Widely distributed into most tissues and fluids, including CSF.
Half-Life: Neonates: 2575 hr; Children and adults: 612 hr.
(PO, IV = plasma concentrations; topical = improvement in rosacea)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
PO | rapid | 13 hr | 8 hr |
PO-ER | rapid | unknown | up to 24 hr |
IV | rapid | end of infusion | 68 hr |
Topical | 3 wk | 9 wk | 12 hr |
Vaginal | unknown | 612 hr | 12 hr |
Contraindicated in:
Use Cautiously in:
Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS (AGEP), DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), rash, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN), urticaria,
topical only
burning, mild dryness, skin irritation, transient rednessEENT: hearing impairment, optic neuropathy, tearing (topical only)
GI: abdominal pain, anorexia, nausea, diarrhea, dry mouth, furry tongue, glossitis, unpleasant taste, vomiting
Hemat: leukopenia
Local: phlebitis at IV site
Neuro: dizziness, headache, aseptic meningitis (IV), encephalopathy (IV), peripheral neuropathy, psychosis, SEIZURES
Misc: superinfection
Drug-drug:
H. pylori
: 250 mg 4 times daily or 500 mg twice daily for 12 wk (with other agents). Antibiotic associatedClostridioides difficile
-associated diarrhea (CDAD): 250500 mg 34 times/day for 1014 days.Clostridioides difficile
-associated diarrhea (CDAD): 30 mg/kg/day divided every 6 hr for 710 days.H. pylori
: 1520 mg/kg/day divided twice daily for 4 wk.Lab Test Considerations:
IV Administration:
NDC Code