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What is omadacycline tosylate?

3 min read

In 2018, the FDA approved omadacycline tosylate, a novel aminomethylcycline antibiotic, to combat severe and drug-resistant bacterial infections. This advanced medication was designed to overcome traditional tetracycline resistance mechanisms, offering a new therapeutic option for acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Quick Summary

Omadacycline tosylate is a next-generation tetracycline antibiotic that inhibits bacterial protein synthesis to treat serious infections. It overcomes common resistance and is used for community-acquired pneumonia and skin infections, available in oral and intravenous forms.

Key Points

  • Advanced Tetracycline: Omadacycline tosylate is a next-generation aminomethylcycline designed to overcome common antibiotic resistance mechanisms like efflux pumps and ribosomal protection.

  • Broad-Spectrum Efficacy: It is effective against a wide range of bacteria, including Gram-positive (MRSA, VRE), some Gram-negative, and atypical pathogens.

  • Dual Administration Routes: Available in both intravenous (IV) and oral formulations, offering flexible treatment options for patients.

  • Treats Key Infections: FDA-approved for adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

  • Strict Dosing Requirements: Oral doses must be taken on an empty stomach, with strict timing around food, dairy, and other medications containing polyvalent cations.

  • Specific Precautions: Like other tetracyclines, it can cause photosensitivity and should not be used in children under 8 or pregnant women due to the risk of teeth discoloration and bone growth inhibition.

In This Article

What is Omadacycline Tosylate?

Omadacycline tosylate, marketed as Nuzyra, is a novel antibiotic in the tetracycline class, specifically an aminomethylcycline. It was developed to overcome bacterial resistance mechanisms like efflux pumps and ribosomal protection that affect older tetracyclines. Omadacycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, preventing bacterial growth and replication.

Mechanism of Action: How It Works

Omadacycline's primary function is to inhibit bacterial protein synthesis by binding to the 30S ribosomal subunit. Its modified chemical structure, particularly at the C-7 and C-9 positions, allows it to evade common resistance pathways, including bacterial efflux pumps that expel the drug and ribosomal protection proteins that shield the ribosome from binding.

Approved Indications

Approved by the FDA in 2018, omadacycline is indicated for use in adults for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Community-Acquired Bacterial Pneumonia (CABP). It is effective against a broad range of bacteria known to cause these infections, including resistant strains like MRSA, VRE, and Streptococcus pneumoniae, as well as atypical pathogens.

Administration of Omadacycline

Omadacycline can be administered intravenously (IV) or orally. Treatment plans, including the frequency and amount of medication, are determined by a healthcare professional based on the specific infection and patient needs.

Oral doses must be taken on an empty stomach, with specific time requirements before and after taking the medication regarding food, dairy, and medications containing polyvalent cations like aluminum, calcium, or iron.

Comparison of Omadacycline vs. Other Antibiotics

Feature Omadacycline (Nuzyra) Doxycycline Tigecycline
Class Aminomethylcycline Tetracycline Glycylcycline (Tetracycline-related)
Spectrum Broad-spectrum (Gram+, Gram-, Atypicals, Anaerobes) Broad-spectrum (Gram+, Gram-, Atypicals) Broad-spectrum (Gram+, Gram-, Anaerobes)
Resistance Designed to overcome efflux and ribosomal protection. Susceptible to common efflux and ribosomal resistance mechanisms. Less susceptible to common tetracycline resistance mechanisms.
Formulation Oral and Intravenous (IV). Oral and Intravenous (IV) Intravenous (IV) only.
Administration Frequency and amount are determined by a healthcare provider. Strict food/dairy restrictions. Typically once or twice daily. Food interactions exist. Once or twice daily IV infusion.
Adverse Effects Relatively well-tolerated, lower rates of GI issues than tigecycline. Potential for photosensitivity, teeth staining in children < 8. Generally well-tolerated. Potential for photosensitivity, GI upset, teeth staining. Higher incidence of nausea and vomiting compared to omadacycline.

Potential Side Effects and Precautions

Common side effects of omadacycline include nausea, vomiting, and diarrhea. Important precautions include photosensitivity, risk of permanent teeth discoloration in children under 8, and contraindication during pregnancy and breastfeeding. Rare but serious side effects like Intracranial Hypertension (IH) can occur. Significant drug-food interactions exist, particularly with dairy and products containing polyvalent cations, necessitating strict dietary instructions around the time of taking the medication.

Conclusion

Omadacycline tosylate, a modernized tetracycline, is a valuable antibiotic for treating drug-resistant bacterial infections like ABSSSI and CABP. Its structural modifications help it bypass common resistance mechanisms, making it effective against pathogens such as MRSA and VRE. Available in both IV and oral forms, it offers flexible treatment. However, awareness of its specific administration requirements, potential side effects like photosensitivity and teeth discoloration, and interactions with food and other medications is crucial for its safe and effective use. Ongoing evaluation of its real-world performance is important for optimizing its role in managing infectious diseases.

Disclaimer: This information is for general knowledge and should not be taken as medical advice. Consult with a healthcare professional before starting any new supplement regimen or medication.

Frequently Asked Questions

Omadacycline tosylate is sold under the brand name Nuzyra in the United States.

Yes, omadacycline has been shown to have potent activity against methicillin-resistant Staphylococcus aureus (MRSA).

Oral omadacycline should be taken on an empty stomach. Patients must fast for a specific period before and after taking the dose, as directed by a healthcare professional. Dairy products should also be avoided for a specified time after taking the medication.

Omadacycline works by binding to the 30S ribosomal subunit of bacteria, which inhibits bacterial protein synthesis and prevents their growth.

Omadacycline is not recommended for children under the age of 8, primarily due to the risk of permanent tooth discoloration and impact on bone development, a class-wide effect of tetracyclines.

Common side effects include nausea, vomiting, diarrhea, and constipation. Infusion site reactions can occur with the IV formulation.

Yes, omadacycline's absorption can be reduced by antacids and multivitamins containing polyvalent cations like aluminum, calcium, and iron. It should be taken at a different time than these preparations, as directed by a healthcare professional.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.