More from Oxadel
Other strengths and forms by Square Pharmaceuticals PLC, Pabna
Indications & Uses
Oxadel is indicated for:
Pharmacology
Delafloxacin works by blocking two bacterial enzymes, DNA topoisomerase IV and DNA gyrase (also called topoisomerase II). When these enzymes are blocked, the bacteria can't copy their DNA properly. Normally, positive supercoils build up during the elongation process and have to be relaxed, and delafloxacin stops that from happening. The strain that results prevents any further elongation.
Delafloxacin kills bacteria in a concentration-dependent way, so a higher concentration gives a stronger killing effect. Animal models of infection suggest that its antibacterial activity matches best with the ratio of the area under the concentration-time curve of free delafloxacin to the minimal inhibitory concentration (fAUC/MIC). This holds for Gram-positive organisms such as Staphylococcus aureus and for Gram-negative organisms such as Escherichia coli.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Give 300 mg of Delafloxacin Injection every 12 hours as an intravenous infusion over 60 minutes. The total duration is 5 to 14 days.
Community-Acquired Bacterial Pneumonia (CABP)
Give 300 mg of Delafloxacin Injection every 12 hours as an intravenous infusion over 60 minutes. The total duration is 5 to 10 days.
Hepatic Impairment
Patients with hepatic impairment don't need a dosage adjustment for Delaflox (Delafloxacin).
Renal Impairment
Patients with severe renal impairment (eGFR 15-29 mL/min/1.73m2) need a dosage adjustment. In severe renal impairment or ESRD (eGFR of < 15 mL/min/1.73 m2), the intravenous vehicle sulfobutylether-β-cyclodextrin (SBECD) accumulates. Serum creatinine levels should be monitored carefully in these patients. If serum creatinine rises, consider switching to oral Delafloxacin. Stop Delafloxacin if eGFR falls to < 15 mL/min/1.73 m2.
Side Effects
The most common side effects of Delaflox (Delafloxacin) are nausea, diarrhea, headache, transaminase elevations and vomiting.
Cautions & Contraindications
Warnings & Precautions
Delafloxacin is a fluoroquinolone, and fluoroquinolones have been linked with serious adverse reactions that can disable a person and may not be reversible. The ones seen commonly are tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy and CNS effects (hallucinations, anxiety, depression, insomnia, severe headaches and confusion). Stop the medicine immediately at the first sign or symptom of any serious adverse reaction. Fluoroquinolones carry a higher risk of tendinitis and tendon rupture, and this applies at all ages. It can happen within hours or days of starting the medicine, or even several months after the course is finished. Both sides can be affected. Stop Delafloxacin immediately if the patient has pain, swelling or inflammation in a tendon, or if a tendon ruptures. The risk of peripheral neuropathy is also higher. Sensory or sensorimotor axonal polyneuropathy, affecting small and/or large axons, has been reported in patients taking fluoroquinolones, Delafloxacin included. It causes paresthesias, hypoesthesias, dysesthesias and weakness. Stop the medicine immediately if the patient develops symptoms of peripheral neuropathy. Psychiatric adverse reactions are more likely with fluoroquinolones too, and Delafloxacin is no exception. These may include toxic psychosis, hallucinations or paranoia, depression or suicidal thoughts or acts, delirium, disorientation, confusion or disturbed attention, anxiety, agitation or nervousness, insomnia or nightmares, and memory impairment. Stop the medicine immediately if the patient has any of these symptoms. Fluoroquinolones have also been linked with a higher risk of seizures (convulsions), raised intracranial pressure (including pseudotumor cerebri), dizziness and tremors. Stop the medicine immediately if these symptoms appear. Fluoroquinolones block nerve signals to the muscles to some degree and may cause muscle weakness in people with myasthenia gravis. Avoid Delafloxacin in patients with a known history of myasthenia gravis. Serious and sometimes fatal hypersensitivity (anaphylactic) reactions have been reported in patients on fluoroquinolone therapy. Some of these came with cardiovascular collapse, loss of consciousness, tingling, swelling of the throat or face, dyspnea, urticaria and itching. Stop the medicine at the first appearance of a skin rash or any other sign of hypersensitivity. Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial drugs, Delafloxacin included. It ranges from mild diarrhea to fatal colitis. An increased risk of aortic aneurysm and dissection has been reported within two months of using fluoroquinolones, particularly in elderly patients. Fluoroquinolones have been linked with disturbed blood glucose, including symptomatic hyperglycemia and hypoglycemia. This usually happens in diabetic patients who are also taking an oral hypoglycemic agent or insulin, so their blood glucose should be monitored carefully. Severe hypoglycemia leading to coma or death has been reported with other fluoroquinolones. If a hypoglycemic reaction occurs, stop the medicine immediately. The medicine can make you feel dizzy and lightheaded. Don't drive, operate machinery or do other activities that need mental alertness or coordination until you know how it affects you.
Contraindications
Don't give Delafloxacin to anyone who is known to be hypersensitive to it, or to any other fluoroquinolone antibacterial. If a skin rash appears, or any other sign of hypersensitivity, stop Delafloxacin at once.
Pregnancy & Breastfeeding
There isn't much data on Delafloxacin use in pregnant women, and what exists is not enough to tell whether the medicine carries a risk of major birth defects or miscarriage. For breastfeeding, nothing is known about whether Delafloxacin passes into human milk. The effects on a breast-fed infant and on milk production are also unknown.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Use in children and adolescents
Nobody knows yet whether Delaflox (Delafloxacin) is safe and effective in people under 18 years of age, so it is not recommended for them.
Geriatric use
Older patients have a higher risk of severe tendon disorders, including tendon rupture, when they are treated with a fluoroquinolone. Take care when prescribing Delaflox to elderly patients, especially those who are also on corticosteroids. If any symptom of tendinitis or tendon rupture appears, stopping Delaflox is recommended.
Cases of aortic aneurysm and dissection have been reported within two months of using fluoroquinolones, particularly in elderly patients. So caution is needed when Delaflox is prescribed to elderly patients.
Overdose
If someone takes too much Delaflox, the treatment is observation and general supportive measures. Hemodialysis was found to remove about 19% of Delaflox and 56% of Sulfobutylether-β-cyclodextrin after IV administration of Delaflox.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Delafloxacin at 20°C to 25°C, in a dry place and away from light. Brief excursions between 15°C and 30°C are permitted. Keep all medicines out of reach of children.
Once the vial is reconstituted, you can keep it either in a refrigerator (2°C to 8°C) or at controlled room temperature (20°C to 25°C) for up to 24 hours. Do not freeze it.
After Delafloxacin is diluted into the intravenous bag, the same limits apply. It may be stored in a refrigerator (2°C to 8°C) or at controlled room temperature (20°C to 25°C) for up to 24 hours. Do not freeze it.
Drug Interactions
Common questions about Oxadel 450 mg
What is Oxadel 450 mg Tablet?
Oxadel 450 mg Tablet is a medicine that contains Delafloxacin. It is made by Square Pharmaceuticals PLC, Pabna. It belongs to the 4-Quinolone preparations group of medicines.
What is Oxadel used for?
Oxadel is used for: Pneumonia, Skin and Soft Tissue Infection.
What are the side effects of Oxadel?
The most common side effects of Delaflox (Delafloxacin) are nausea, diarrhea, headache, transaminase elevations and vomiting.
Can I take Oxadel during pregnancy or while breastfeeding?
There isn't much data on Delafloxacin use in pregnant women, and what exists is not enough to tell whether the medicine carries a risk of major birth defects or miscarriage. For breastfeeding, nothing is known about whether Delafloxacin passes into human milk. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Oxadel?
If someone takes too much Delaflox, the treatment is observation and general supportive measures. Hemodialysis was found to remove about 19% of Delaflox and 56% of Sulfobutylether-β-cyclodextrin after IV administration of Delaflox. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Oxadel?
Store Delafloxacin at 20°C to 25°C, in a dry place and away from light. Brief excursions between 15°C and 30°C are permitted.
Can I take other medicines with Oxadel?
Some medicines can interact with Delafloxacin, for example: Magnesium. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Oxadel?
Oxadel is a prescription (Rx) medicine. Take it as your doctor advises.