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Delaflox
The ACME Laboratories Ltd.
Generic: Delafloxacin
Medicine Overview of Delaflox 300mg/vial Injection
বাংলা
English
Indication
Acute bacterial skin and skin structure infections
Administration
IV Preparation Reconstitute 300-mg vial with10.5 mL D5W or 0.9% NaCl, resulting in 300 mg/12 mL (25 mg/mL) Shake vial vigorously until contents are completely dissolved; solution should appear clear yellow to amber colored Further dilute reconstituted solution to a total volume of 250 mL with D5W or 0.9% NaCl to achieve a final concentration of 1.2 mg/mL prior to administration IV Administration Infuse IV via volume control set or piggyback container Infuse IV over 60 minutes Oral Administration May take with or without food Missed dose: Take as soon as possible within 4 hr of missed dose; if >4...
... Show moreAdult Dose
Skin and Skin Structure Infections
Parenteral
300 mg IV q12hr for 5-14 days, OR
300 mg IV q12hr, then switch to a 450-mg tablet PO q12hr for 5-14 days, OR
Oral
450 mg PO q12hr for 5-14 days
Hepatic impairment
No dosage adjustment needed
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
IV
CrCl 30-89 mL/min: No dosage adjustment needed
CrCl 15-29 mL/min: 200 mg IV q12hr OR 200 mg IV q12hr, then switch to 450 mg PO q12hr
CrCl <15 mL/min: Not recommended
PO
CrCl 15-89 mL/min: No dosage adjustment needed
CrCl <15mL/min: Not recommended
Contraindication
Documented hypersensitivity to delafloxacin or its components or other fluoroquinolones
Mode of Action
Fluoroquinolone antibiotic; inhibits both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes, which are required for bacterial DNA replication, transcription, repair, and recombination
Precaution
Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions from different body systems, including tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and CNS effects (eg, hallucinations, anxiety, depression, insomnia, severe headaches, confusion) Risk of tendinitis and tendon rupture in all ages; the Achilles tendon is most frequently involved, but rupture has also been reported with the rotator cuff, hand, biceps, thumb, and other tendons Fluoroquinolones are associated with increased risk of peripheral neuropathy; sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported (see Black Box Warnings) Increased risk of...
... Show moreSide Effect
1-10% Nausea (8%) Diarrhea (8%) Headache (3%) Transaminase elevations (3%) Vomiting (2%) Cardiac disorders: Sinus tachycardia, palpitations, bradycardia (<2%) Ear and labyrinth disorders: Tinnitus, vertigo (<2%) Eye disorders: Vision blurred (<2%) General disorders and administration site conditions: Infusion site extravasation, infusion site bruise, discomfort, edema, erythema, irritation, pain, phlebitis, swelling, thrombosis (<2%) Gastrointestinal disorders: Abdominal pain, dyspepsia (<2%) Immune system disorders: Hypersensitivity (<2%) Infections and infestations: Clostridium difficile infection, fungal infection, oral candidiasis, vulvovaginal candidiasis (<2%) Laboratory Investigations: Blood alkaline phosphatase increased, blood creatinine increased, blood creatine phosphokinase increased (<2%) Metabolism and nutrition disorders: Hyperglycemia, hypoglycemia (<2%) Musculoskeletal and connective...
... Show morePregnancy Category Note
Pregnancy
Data are limited regarding use in pregnant women and are insufficient to inform a drug-associated risk of major birth defects and miscarriages
Lactation
Unknown if distributed in human breast milk
Excreted in the breast milk of rats
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interaction
Fluoroquinolones form chelates with alkaline earth and transition metal cations
Delafloxacin PO administration with antacids containing aluminum or magnesium, with sucralfate, with metal cations (eg, iron), or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations (eg, didanosine buffered tablets for oral suspension or the pediatric powder for oral solution), may substantially interfere with the absorption and decrease systemic exposure
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