omadacycline
Regulatory sources consulted
Approved indications
- Community-acquired bacterial pneumonia and acute bacterial skin and skin-structure infections in adults.
Contraindications
Absolute
- Hypersensitivity to omadacycline, tetracyclines, or excipients.
Clinical warnings
- Major warning · A mortality imbalance versus comparator was observed in pneumonia; carefully assess response and change treatment if the patient worsens. — DailyMed, set_id 51591524-4703-44c6-8bde-dce3e6a463d1
- Major warning · It may cause tooth discoloration and reversible inhibition of bone growth; avoid during tooth development. — DailyMed, set_id 51591524-4703-44c6-8bde-dce3e6a463d1
- Major warning · It may cause Clostridioides difficile-associated diarrhea, including after completion; stop and treat according to severity. — DailyMed, set_id 51591524-4703-44c6-8bde-dce3e6a463d1
- It may cause photosensitivity. Limit sun/UV exposure and stop for marked erythema. — DailyMed, set_id 51591524-4703-44c6-8bde-dce3e6a463d1
Drug interactions
- ModerateAntacids, iron, calcium, magnesium, zinc, and dairy products
Mechanism: Chelation reduces oral absorption.
Recommendation: Separate doses according to the label and administer with plenty of water.
DailyMed, set_id 51591524-4703-44c6-8bde-dce3e6a463d1
- ModerateAnticoagulants
Mechanism: The tetracycline class may depress prothrombin activity.
Recommendation: Monitor INR and reduce the anticoagulant dose if appropriate.
DailyMed, set_id 51591524-4703-44c6-8bde-dce3e6a463d1
Adverse events
Common (≥1%)
Nausea, vomiting, and infusion-site reactions
Rare but serious
Anaphylaxis, intracranial hypertension, and hepatotoxicity
Pregnancy and lactation
It may cause embryo-fetal harm, including malformations; avoid during pregnancy and tooth development. Breastfeeding is not recommended during treatment.
Recent literature (PubMed)
Tetracyclines constitute a unique class of antibiotic agents, widely prescribed for both community and hospital infections due to their broad spectrum of activity. Acting by disrupting protein synthesis through tight binding to the 30S ribosomal subunit, their interference is typically reversible, rendering them bacteriostatic in action. Resistance to tetracyclines has primarily been associated with changes in pump efflux or ribosomal protection mechanisms. To address this challenge, tetracycline molecules have been chemically modified, resulting in the development of third-generation tetracyclines. These novel tetracyclines offer significant advantages in treating infections, whether used alone or in combination therapies, especially in hospital settings. Beyond their conventional antimicrobial properties, research has highlighted their potential non-antibiotic properties, including their impact on immunomodulation and malignancy. This review will focus on third-generation tetracyclines, namely tigecycline, eravacycline, and omadacycline. We will delve into their mechanisms of action and resistance, while also evaluating their pros and cons over time. Additionally, we will explore their therapeutic potential, analyzing their primary indications of prescription, potential future uses, and non-antibiotic features. This review aims to provide valuable insights into the clinical applications of third-generation tetracyclines, thereby enhancing understanding and guiding optimal clinical use. Omadacycline is a tetracycline-class antibiotic used to treat moderate-to-severe infections including community-acquired pneumonia and acute bacterial skin and skin structure infections caused by susceptible organisms. Omadacycline use has been associated with low rates of serum enzyme elevations during therapy but has not been implicated in cases of clinically apparent acute liver injury.
The progressive increase in antibiotic resistance in recent decades calls for urgent development of new antibiotics and antibiotic stewardship programs to help select appropriate treatments with the goal of minimising further emergence of resistance and to optimise clinical outcomes. Three new tetracycline-class antibiotics, eravacycline, omadacycline, and tigecycline, have been approved within the past 15 years, and represent a new era in the use of tetracyclines. These drugs overcome the two main mechanisms of acquired tetracycline-class resistance and exhibit a broad spectrum of in vitro activity against gram-positive, gram-negative, anaerobic, and atypical pathogens, including many drug-resistant strains. We provide an overview of the three generations of tetracycline-class drugs, focussing on the efficacy, safety, and clinical utility of these three new third-generation tetracycline-class drugs. We also consider various scenarios of unmet clinical needs where patients might benefit from re-engagement with tetracycline-class antibiotics including outpatient treatment options, patients with known β-lactam antibiotic allergy, reducing the risk of Clostridioides difficile infection, and their potential as monotherapy in polymicrobial infections while minimising the risk of any potential drug-drug interaction. KEY MESSAGESThe long-standing safety profile and broad spectrum of activity of tetracycline-class antibiotics made them a popular choice for treatment of various bacterial infections; unfortunately, antimicrobial resistance has limited the utility of the early-generation tetracycline agents.The latest generation of tetracycline-class antibiotics, including eravacycline, tigecycline, and omadacycline, overcomes the most common acquired tetracycline resistance mechanisms.Based on in vitro characteristics and clinical data, these newer tetracycline agents provide an effective antibiotic option in the treatment of approved indications in patients with unmet clinic
Pneumonia, classified as a lower respiratory tract illness, affects different parts of the bronchial system as well as alveoli and can present with varying severities depending on co-morbidities and causative pathogens. It can be broadly classified using the setting in which it was acquired, namely the community or hospital setting, the former being more common and spreading through person-to-person droplet transmission. Community-acquired pneumonia (CAP) is currently the fourth leading cause of death worldwide, and its high mortality makes continual insight into the management of the condition worthwhile. This review explores the literature specifically for severe CAP (sCAP) and delves into the diagnosis, various modalities of treatment, and management of the condition. This condition can be defined as pneumonia requiring mechanical ventilation in the ICU and/or presenting with sepsis and organ failure due to pneumonia. The disease process is characterized by inflammation of the lung parenchyma, initiated by a combination of pathogens and lowered local defenses. Acute diagnosis of the condition is vital in reducing negative patient outcomes, namely through clinical presentation, blood/sputum cultures, imaging modalities such as computed tomography scan, and inflammatory markers, identifying common causative pathogens such as Streptococcus pneumoniae, rhinovirus, Legionella, and viral influenza. Pathogens such as Escherichia coli should also be investigated in patients with chronic obstructive pulmonary disease. The mainstay of treating sCAP includes rapid ICU admission once a diagnosis has been confirmed, initiating sepsis protocol, and treatment with combined empiric antibiotic regimens consisting of beta-lactams and macrolides. Corticosteroid use alongside antibiotics shows promise in reducing inflammation, but its use has to be judged on a case-by-case basis. New drugs such as omadacycline, delafloxacin, and zabofloxacin have shown valid evidence for the treatme