Usual Adult Dose for Pneumonia

IV: 300 mg IV every 12 hours
Oral: 450 mg orally every 12 hours

Total duration of therapy:

• Acute bacterial skin and skin structure infections (ABSSSI): 5 to 14 days
• Community-acquired bacterial pneumonia (CABP): 5 to 10 days

Comments:

• May administer IV formulation OR may administer IV formulation then switch to oral formulation at the physician's discretion OR may administer oral formulation

Uses:

• For the treatment of ABSSSI due to susceptible Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates), S haemolyticus, S lugdunensis, Streptococcus agalactiae, S anginosus Group (including S anginosus, S intermedius, S constellatus), S pyogenes, Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, Pseudomonas aeruginosa
• For the treatment of CABP due to susceptible S pneumoniae, S aureus (methicillin-susceptible isolates only), K pneumoniae, E coli, P aeruginosa, Haemophilus influenzae, H parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae

Usual Adult Dose for Skin and Structure Infection

IV: 300 mg IV every 12 hours
Oral: 450 mg orally every 12 hours

Total duration of therapy:

• Acute bacterial skin and skin structure infections (ABSSSI): 5 to 14 days
• Community-acquired bacterial pneumonia (CABP): 5 to 10 days

Comments:

• May administer IV formulation OR may administer IV formulation then switch to oral formulation at the physician's discretion OR may administer oral formulation

Uses:

• For the treatment of ABSSSI due to susceptible Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates), S haemolyticus, S lugdunensis, Streptococcus agalactiae, S anginosus Group (including S anginosus, S intermedius, S constellatus), S pyogenes, Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, Pseudomonas aeruginosa
• For the treatment of CABP due to susceptible S pneumoniae, S aureus (methicillin-susceptible isolates only), K pneumoniae, E coli, P aeruginosa, Haemophilus influenzae, H parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae

Renal Dose Adjustments

Mild or moderate renal dysfunction (estimated glomerular filtration rate [eGFR] 30 to 89 mL/min/1.73 m2): No adjustment recommended.

Severe renal dysfunction (eGFR 15 to 29 mL/min/1.73 m2):

• IV: 200 mg IV every 12 hours
• Oral: No adjustment recommended.

ESRD (eGFR less than 15 mL/min/1.73 m2): Not recommended.

If eGFR decreases to less than 15 mL/min/1.73 m2 during therapy: Discontinue therapy.

Comments:

• Estimated GFR based on a Modification of Diet in Renal Disease equation.
• For a total duration of therapy of 5 to 14 days for the treatment of ABSSSI and 5 to 10 days for the treatment of CABP
• Severe renal dysfunction (eGFR 15 to 29 mL/min/1.73 m2): May administer IV formulation OR may administer IV formulation then switch to oral formulation (450 mg orally every 12 hours) at the physician's discretion OR may administer oral formulation
• The IV vehicle (sulfobutylether-beta-cyclodextrin) accumulates in patients with severe renal dysfunction or ESRD.
• Serum creatinine levels and eGFR should be closely monitored in patients with severe renal dysfunction using the IV formulation; should consider switching to the oral formulation if serum creatinine level increases
• Insufficient data to provide dosing recommendations for ESRD patients.

Liver Dose Adjustments

No adjustment recommended.

Precautions

US BOXED WARNING:
SERIOUS SIDE EFFECTS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CNS EFFECTS, AND EXACERBATION OF MYASTHENIA GRAVIS:

• Fluoroquinolones have been associated with disabling and potentially irreversible serious side effects that have occurred together (including tendinitis and tendon rupture, peripheral neuropathy, CNS effects). This drug should be discontinued immediately and use of fluoroquinolones (including this drug) should be avoided in patients with any of these serious side effects.
• Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. This drug should be avoided in patients with known history of myasthenia gravis.

CONTRAINDICATIONS:
Known hypersensitivity to the active component, other fluoroquinolones, or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

ESRD (including patients on hemodialysis): Not recommended.

Comments:

• Insufficient data to provide dosing recommendations for ESRD patients on hemodialysis.

Other Comments

Administration advice:

• Administer all IV doses via IV infusion over 60 minutes.
• Do not administer IV formulation with any multivalent cation-containing solution (e.g., calcium, magnesium) through the same IV line; do not co-infuse with other drugs.
• If the same IV line is used for sequential infusion of several drugs, flush the line before and after infusion of this drug with 0.9% Sodium Chloride Injection or 5% Dextrose Injection.
• Administer oral doses with or without food.
• Administer oral formulation at least 2 hours before or 6 hours after aluminum-, magnesium-, iron-, zinc-, or other metal cation-containing products (e.g., antacids, mineral supplements/multivitamins), didanosine buffered tablets for oral suspension/pediatric powder for oral solution, or sucralfate.
• Consult the manufacturer product information regarding missed doses.

Storage requirements:

• Oral tablets and lyophilized powder (prior to reconstitution): Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Reconstituted vials and diluted IV solutions: May store refrigerated at 2C to 8C (36F to 46F) or at controlled room temperature 20C to 25C (68F to 77F) for up to 24 hours; do not freeze.

Reconstitution/preparation techniques:

• IV formulation: This drug must be reconstituted and then further diluted; the manufacturer product information should be consulted.

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection, 5% Dextrose Injection
• Compatibility with other IV drugs, additives, or substances (except those listed above) not established.

General:

• To reduce the development of drug-resistant organisms and maintain effective therapy, this drug should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
• Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.

Monitoring:

• Renal: Serum creatinine levels and eGFR in patients with severe renal dysfunction using the IV formulation

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Avoid missing doses and complete the entire course of therapy.
• Stop this drug immediately and contact healthcare provider if a serious side effect occurs.
• Seek emergency medical care if you have sudden pain in the stomach, chest, or back.
• Stop this drug and contact healthcare provider if tendon pain, swelling, or inflammation develops or you have weakness or are unable to use 1 of your joints; rest and do not exercise.
• Stop this drug at once and contact physician if symptoms of peripheral neuropathy (including pain, burning, tingling, numbness, weakness) develop.
• Contact physician if persistent headache (with or without blurred vision), any symptoms of muscle weakness (including respiratory problems), or watery and bloody stools occur.
• Stop this drug at first sign of skin rash, hives or other skin reactions, rapid heartbeat, problems swallowing or breathing, swelling suggestive of angioedema, or other symptoms of allergic reaction.
• Do not drive, operate machinery, or engage in other tasks that require mental alertness or coordination until you know how the drug affects you.

Frequently asked questions

• What type of antibiotic is Baxdela?