• Acute bacterial skin and skin structure infections.
• Community-acquired bacterial pneumonia.

Contraindicated in:

• Hypersensitivity (cross-sensitivity within class may exist)
• History of myasthenia gravis (may worsen symptoms including muscle weakness and breathing problems)
• End-stage renal disease (eGFR <15 mL/min)
• Pedi: Use only if no alternatives in children 1–17 yr due to possible arthropathy.

Use Cautiously in:

• Known or suspected CNS disorder
• Severe renal impairment (dose ↓ if eGFR 15–29 mL/min) (IV diluent may accumulate and ↑ SCr) (↑ risk of tendon rupture in renal failure)
• Concurrent use of corticosteroids (↑ risk of tendinitis/tendon rupture)
• Kidney, heart, or lung transplant patients (↑ risk of tendinitis/tendon rupture)
• Patients with or at risk for aortic aneurysms
• Rheumatoid arthritis (↑ risk of tendon rupture)
• OB: Safety not established in pregnancy
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Geri: ↑risk for tendon disorders/rupture and aortic aneurysm/dissection in older adults (within 2 mo following discontinuation).

CV: AORTIC ANEURYSM/DISSECTION.

Endo: hyperglycemia, hypoglycemia.

GI: ↑liver enzymes, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), diarrhea, nausea, vomiting.

MS: arthralgia, myalgia, tendinitis, tendon rupture.

Neuro: agitation, anxiety, attention disturbances, confusion, delirium, depression, disorientation, dizziness , ELEVATED INTRACRANIAL PRESSURE (INCLUDING PSEUDOTUMOR CEREBRI), hallucinations, headache, insomnia, memory impairment, nightmares, paranoia, peripheral neuropathy, SEIZURES, SUICIDAL THOUGHTS/BEHAVIORS, toxic psychosis, tremor.
Misc: (INCLUDING ANAPHYLAXIS, ANGIOEDEMA, AND URTICARIA)HYPERSENSITIVITY REACTIONS .

Drug-Drug:

• Administration with antacids, iron salts, bismuth subsalicylate, sucralfate, and zinc salts↓ absorption; take delafloxacin 2 hr before or 6 hr after these agents.
• May ↑ risk of hypoglycemia when used with antidiabetic agents.

• Lyophilized powder for injection: 300 mg/vial;
• Tablets: 450 mg;

Acute Bacterial Skin and Skin Structure Infections

• IV (Adults): 300 mg every 12 hr for 5–14 days or 300 mg every 12 hr followed by switching to oral regimen (at dose stated below) for a total of 5–14 days.
• PO (Adults): 450 mg every 12 hr for 5–14 days.

Community-Acquired Bacterial Pneumonia

• IV (Adults): 300 mg every 12 hr for 5–10 days or 300 mg every 12 hr followed by switching to oral regimen (at dose stated below) for a total of 5–10 days.
• PO (Adults): 450 mg every 12 hr for 5–10 days.

Baxdela

• Inhibits bacterial DNA synthesis by inhibiting DNA gyrase (topoisomerase II) and topoisomerase IV enzymes.

• Death of susceptible bacteria.

Spectrum:

• Active against gram-positive pathogens, including:
  • Enterococcus faecalis,
  • Staphylococcus aureus(including methicillin-sensitive and methicillin-resistant strains [for skin and skin structure infections only]),
  • Staphylococcus haemolyticus,
  • Staphylococcus lugdunensis,
  • Streptococcus agalactiae,
  • Streptococcus anginosus,
  • Streptococcus pneumoniae,
  • Streptococcus pyogenes
• Gram-negative spectrum notable for activity against:
  • Enterobacter cloacae,
  • Escherichia coli,
  • Haemophilus influenzae,
  • Haemophilus parainfluenzae,
  • Klebsiella pneumoniae,
  • Legionella pneumophila,
  • Pseudomonas aeruginosa.
• Also active against several other pathogens, including:
  • Chlamydia pneumoniae,
  • Mycoplasma pneumoniae,

Therapeutic Classification: anti-infectives

Pharmacologic Classification: Fluoroquinolones

Absorption: 59% absorbed after oral administration; IV administration results in complete bioavailability.

Distribution: Widely distributed.

Metabolism/Excretion: Primarily undergoes glucuronidation. 50–65% excreted unchanged by the kidneys; 28–48% excreted unchanged in feces.

Half-life: 3.7 hr (IV); 4.2–8.5 hr (PO).

(blood levels)

• Instruct patient to take medication as directed at evenly spaced times and to finish drug completely, even if feeling better. Take missed doses as soon as possible, up to 8 hr before next dose. Do not double doses. Advise patient that sharing of this medication may be dangerous. Advise patient to read Medication Guide before starting therapy.
• Advise patient that antacids or medications containing calcium, magnesium, aluminum, iron, or zinc will decrease absorption and should not be taken within 2 hr before and 6 hr after taking this medication.
• May cause dizziness and drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Caution patient to use sunscreen and protective clothing to prevent phototoxicity reactions during and for 5 days after therapy. Notify health care professional if a sunburn-like reaction or skin eruption occurs.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
• Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools).
• Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
• Instruct patient to notify health care professional immediately if signs and symptoms of hepatotoxicity (anorexia, jaundice, dark urine, pruritus, or tender abdomen), rash, signs of hypersensitivity, serious CNS effects (seizures, increased intracranial pressure, and toxic psychosis including: nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, psychotic reactions, suicidal ideations/thoughts), peripheral neuropathy (pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation, and/or motor strength) or tendon (shoulder, hand, Achilles, and other) pain, swelling, inflammation, or if symptoms of tendon rupture (patient hears or feels a snap or pop in a tendon area, bruising right after an injury in a tendon area, or is unable to move affected area or bear weight) occur. If tendon symptoms occur, avoid exercise and use of affected area. Increased risk in >65 yrs old, kidney, heart and lung transplant recipients, and patients taking corticosteroids concurrently. Therapy should be discontinued.
• Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

del-a-FLOKS-a-sin