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Baxdela

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Overview

What is Baxdela?

BAXDELA (delafloxacin) for Injection and BAXDELA (delafloxacin) Tablets contain meglumine salt of delafloxacin, a fluoroquinolone antibacterial. Delafloxacin meglumine is identified chemically as 1-Deoxy-1-(methylamino)-D-glucitol, 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-7-(3-hydroxyazetidin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylate (salt), the chemical structure of which is shown below. The meglumine salt has a molecular weight of 635.97 g/mol, whereas the molecular weight of the delafloxacin free acid is 440.76 g/mol.

Figure 1 Chemical Structure

BAXDELA is intended for intravenous infusion or oral administration. BAXDELA is supplied as a sterile, lyophilized powder for injection and oral tablets as follows:



What does Baxdela look like?



What are the available doses of Baxdela?

What should I talk to my health care provider before I take Baxdela?

Renal Impairment: Closely monitor serum creatinine levels in patients with severe renal impairment (eGFR 15-29 mL/min/1.73 m) receiving intravenous delafloxacin. If serum creatinine level increases occur, consider changing to oral delafloxacin. Discontinue BAXDELA if eGFR decreases to <15 mL/min/1.73 m ().

How should I use Baxdela?

BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following:

Gram-positive organisms:

Staphylococcus aureus

Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae

Streptococcus anginosus

Streptococcus anginosus

Streptococcus intermedius

Streptococcus constellatus

Streptococcus pyogenes

Enterococcus faecalis

Gram-negative organisms:

Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae,

Pseudomonas aeruginosa.

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 for 5 to 14 days total duration. ()

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


What interacts with Baxdela?

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What are the warnings of Baxdela?

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What are the precautions of Baxdela?

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What are the side effects of Baxdela?

Sorry No records found


What should I look out for while using Baxdela?

BAXDELA is contraindicated in patients with known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs, or any of the components of BAXDELA [].

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

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

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


What might happen if I take too much Baxdela?

Treatment of overdose with BAXDELA should consist of observation and general supportive measures. Hemodialysis removed about 19% of delafloxacin and 56% of SBECD (Sulfobutylether β cyclodextrin) after intravenous administration of BAXDELA. []


How should I store and handle Baxdela?

BAXDELA Tablets and BAXDELA for Injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [].The reconstituted powder may be stored for up to 24 hours under refrigerated or controlled room temperature and then further diluted for intravenous infusion. The reconstituted solution in the infusion bag may be stored under refrigerated or controlled room temperature conditions for up to 24 hours []. BAXDELA Tablets and BAXDELA for Injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [].The reconstituted powder may be stored for up to 24 hours under refrigerated or controlled room temperature and then further diluted for intravenous infusion. The reconstituted solution in the infusion bag may be stored under refrigerated or controlled room temperature conditions for up to 24 hours []. Product: 50436-4630NDC: 50436-4630-1 30 CAPSULE in a BOTTLEProduct: 50436-4630NDC: 50436-4630-1 30 CAPSULE in a BOTTLE


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

BAXDELA is an antibacterial drug [].

Non-Clinical Toxicology
BAXDELA is contraindicated in patients with known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs, or any of the components of BAXDELA [].

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

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

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

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions could occur within hours to weeks after starting a fluoroquinolone. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [].

Discontinue BAXDELA immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including BAXDELA, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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