Bacterial infections:

Indications for NUZYRA TABLETS:

Susceptible infections including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI).

Adult:

Tabs: Fast for ≥4hrs and take with water. Treatment duration: 7–14 days. ≥18yrs: CABP: Day 1: Initially 200mg IV over 60mins or 100mg IV over 30mins twice; maintenance: 100mg IV over 30mins once daily or 300mg orally once daily. ABSSSI: Day 1: Initially 200mg IV over 60mins or 100mg IV over 30mins twice; maintenance: 100mg IV over 30mins once daily or 300mg orally once daily. ABSSSI (Tabs only): Day 1 and Day 2: 450mg orally once daily; maintenance: 300mg orally once daily.

Children:

<8yrs: not recommended (see full labeling); <18yrs: not established.

Warnings/Precautions:

Mortality imbalance in CABP; closely monitor response esp. those at higher risk (eg, >65yrs, comorbidities). Discontinue if allergic reaction occurs. Evaluate if diarrhea occurs; discontinue if C. difficile-associated diarrhea is suspected or confirmed. Advise females of reproductive potential to use effective contraception during treatment. Pregnancy (during 2nd & 3rd trimester): may cause permanent discoloration of the teeth or reversible inhibition of bone growth. Nursing mothers: not recommended (during and for 4 days after the last dose).

See Also:

Pharmacologic Class:

Tetracycline antibiotic.

Interactions:

May need to reduce concomitant anticoagulant dose. Inj: do not give with multivalent cation-containing solutions (eg, Ca, Mg, Al) through same IV line. Tabs: after dosing, avoid food or drink (except water) for 2hrs; and avoid dairy, antacids, iron preparations, multivitamins for 4hrs.

Adverse Reactions:

Nausea, vomiting, infusion site reactions, AST/ALT/GGT increased, hypertension, headache, diarrhea, insomnia, constipation; hypersensitivity reactions, C. difficile-associated diarrhea, tetracycline class effects (eg, photosensitivity, pseudotumor cerebri, increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis); also Children (up to 8yrs of age): tooth discoloration, enamel hypoplasia, inhibition of bone growth.

Generic Availability:

NO

How Supplied:

Single-dose vials—10; Tabs—6, 14, 16