Baxdela

(Delafloxacin Meglumine)

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Dosage & Administration

* For ABSSSI and CABP: Administer BAXDELA for injection 300 mg by intravenous infusion over 60 minutes, every 12 hours, or a 450 mg BAXDELA tablet orally every 12 hours.
* Recommended duration of treatment:
* ABSSSI: 5 to 14 days
* CABP: 5 to 10 days

* Dosage for patients with renal impairment is based on the estimated glomerular filtration rate (eGFR)

Estimated Glomerular Filtration Rate (eGFR)(mL/min/1.73m²)Estimate of GFR based on a Modification of Diet in Renal Disease (MDRD) equation.	Recommended Dosage Regimen for BAXDELAFor a total treatment duration of 5 to 14 days for the treatment of ABSSSI and 5 to 10 days for the treatment of CABP.
	Oral	IntravenousAll intravenous doses of BAXDELA are administered over 60 minutes.
30-89	No dosage adjustment	No dosage adjustment
15-29	No dosage adjustment	200 mg every 12 hours
End Stage Renal Disease (ESRD) (< 15 including hemodialysis)	Not RecommendedNot recommended due to insufficient information to provide dosing recommendations.

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Baxdela Prescribing Information

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together (5.1), including:

Tendinitis and tendon rupture (5.2)
Peripheral neuropathy (5.3)
Central nervous system effects (5.4)

Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions (5.1)

Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid BAXDELA in patients with known history of myasthenia gravis. (5.5)

BAXDELA is a fluoroquinolone antibacterial indicated for the treatment of adults with the following infections caused by designated susceptible bacteria:

Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Community-Acquired Bacterial Pneumonia (CABP)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

For ABSSSI and CABP: Administer BAXDELA for injection 300 mg by intravenous infusion over 60 minutes, every 12 hours, or a 450 mg BAXDELA tablet orally every 12 hours.
Recommended duration of treatment:
- ABSSSI: 5 to 14 days
- CABP: 5 to 10 days
Dosage for patients with renal impairment is based on the estimated glomerular filtration rate (eGFR)

Estimated Glomerular Filtration Rate (eGFR)(mL/min/1.73m²)Estimate of GFR based on a Modification of Diet in Renal Disease (MDRD) equation.	Recommended Dosage Regimen for BAXDELAFor a total treatment duration of 5 to 14 days for the treatment of ABSSSI and 5 to 10 days for the treatment of CABP.
	Oral	IntravenousAll intravenous doses of BAXDELA are administered over 60 minutes.
30-89	No dosage adjustment	No dosage adjustment
15-29	No dosage adjustment	200 mg every 12 hours
End Stage Renal Disease (ESRD) (< 15 including hemodialysis)	Not RecommendedNot recommended due to insufficient information to provide dosing recommendations.

Baxdela

Dosage & Administration

Baxdela Prescribing Information

Baxdela Prior Authorization Resources

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Baxdela PubMed™ News