Delameg Injection
Delafloxacin
300 mg/vial
Incepta Pharmaceuticals Ltd.
| Pack size | 1's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 1700.00 AED |
Indications
Delameg Injection is used for:
Acute bacterial skin and skin structure infections, Community-Acquired Bacterial Pneumonia
Adult Dose
Skin and Skin Structure Infections
Parenteral
Acute Bacterial Skin and Skin Structure Infections
300 mg IV over 60 minutes, every 12 hours for 5-14 days
Community-Acquired Bacterial Pneumonia
300 mg IV over 60 minutes, every 12 hours for 5-10 days
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,
CrCl <15 mL/min: Not recommended
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 hr since missed dose, wait until next scheduled dose
Contra Indications
Documented hypersensitivity to delafloxacin or its components or other fluoroquinolones
Precautions
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 CNS reactions (eg, convulsions and increased intracranial pressure [including pseudotumor cerebri]; toxic psychosis); may also cause CNS reactions of nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or acts
Fluoroquinolones elicit neuromuscular blocking activity and may exacerbate muscle weakness with myasthenia gravis
Serious and occasional fatal hypersensitivity reactions (including after first dose) reported
Clostridium difficile-associated diarrhea (CDAD) reported with use of nearly all systemic antibiotics
Prescribing an antibiotic in the absence of proven or strongly suspected bacterial infection is unlikely to provide benefit and increases risk developing drug-resistant bacteria
Hypersensitivity Reactions: May occur after first or subsequent doses of Delafloxacin. Discontinue Delafloxacin at the first sign of a skin rash or any other sign of hypersensitivity.
Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs.
Pregnancy-Lactation
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
Interactions
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.
Contraindicated (0)
Serious (3)
fexinidazole
microbiota oral
selinexor
Adverse Effects
Side effects of Delafloxacin :
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 tissue disorders: Myalgia (<2%)
Nervous system disorders: Dizziness, hypoesthesia, paraesthesia, dysgeusia, presyncope, syncope (<2%)
Psychiatric disorders: Anxiety, insomnia, abnormal dreams (<2%)
Renal and urinary: Renal impairment, renal failure (<2%)
Skin and subcutaneous tissue disorders: Pruritus, urticaria, dermatitis, rash (<2%)
Vascular disorders: Flushing, hypotension, hypertension, phlebitis (<2%)
Mechanism 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
Note
Delameg 300 mg/vial Injection manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Delafloxacin. Delameg is availble in Bangladesh.
Farmaco BD drug index information on Delameg Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.