US FDA approved new drug Baxdela that contains delafloxacin as an active pharmaceutical ingredient for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). US FDA also indicated that this drug should only be used when there is no suitable option left behind because delafloxacin therapy is associated with tendon rupture, neuropathy and impaired cartilage growth.
Acute bacterial skin and skin structure infection (ABSSSI) is also know as soft tissue infection such as infection of connective tissues, mucous membrane and cartilage. Some commonly know soft tissue infections are abscesses, cellulitis, furuncles and impetiginous lesions. It has been observed that Staphylococcus aureus and Streptococcus pyogenes are main causative agents for number skin soft tissue infections. In most instances, these infection can not cure via traditional antibiotics due to emergence of resistance.
Complicated type of skin infections include ulcers, gangrene and burns. They may become difficult to treat if they spread to internal layers of skin or reach to systemic circulation. Therefore, ration use of antibiotics is very necessary to mitigate the risk of resistance, secondary infection and to avoid further complications as well.
Baxdela/delafloxacin belongs to a pharmacological class termed as fluoroquinolones that inhibit replication of bacterial DNA. It has been observed during clinical trials that delafloxacin is more active than other agents belongs to this group of antibiotics. Main advantage of delafloxacin over other antibiotics of this group is that it readily deposits inside the bacteria and exerts potent bactericidal activity.
Baxdela/delafloxacin Side effects
According to health authorities this drug exhibit following side effects during clinical trials
- Elevated liver enzymes
- Gastrointestinal discomfort
- Hypersensitivity reactions
Baxdela/delafloxacin Uses/Patient Information
US FDA approved this drug for the treatment of acute Bacterial Skin and Skin Structure Infections
(ABSSSI). FDA also indicated that this drug should be used cautiously because it may cause neuropathy, tendinitis or CNS related problems.
Baxdela is formulated in two types of dosage forms. One is oral dosage form with potency of 450mg per tablet and second is parenteral dosage form with potency of 300mg per vial. However, standard dosage frequency of Baxdela/delafloxacin is 450mg orally after every 12hrs for 7 to 14 days or 300mg intravenously after every 12hrs for 5-14 days for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). In case of renal or hepatic impairment dose titration should be kept in consideration.