Omadacycline (Nuzyra) is a broad-spectrum antibiotic that belongs to the class of drugs called tetracyclines. Other drugs in the same class include doxycycline and tetracycline It has been approved by the FDA in 2018 for skin infections and community-acquired pneumonia.

Omadacycline (Nuzyra) Uses:

• , Community-acquired Pneumonia:

  • Used to treat adult patients with community-acquired bacterial pneumonia (CABP) brought on by sensitive strains of Staphylococcus aureus (methicillin-susceptible isolates), Chlamydophila pneumoniae, Mycoplasma pneumoniae, Haemophilus influenzae, and Klebsiella pneumoniae.

• Skin and skin structure infections:

  • Treatment for adult patients suffering from acute bacterial skin and skin structure infections (ABSSSI) brought on by susceptible strains of Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S.

Omadacycline (Nuzyra) Dose in Adults

Omadacycline (Nuzyra) Dose in the treatment of community-acquired Pneumonia:

• Loading dose:

  • IV: 100 milligrammes twice a day on day 1 or 200 milligrammes as a single dosage on day 1

• Maintenance dose:

  • IV:
    • 100 milligram per day
    • 300 milligram per day
• Duration of therapy:
  • 7-14 days

Omadacycline (Nuzyra) dose in Skin and skin structure infections:

• Loading dose:

  • IV:
    • 100 mg twice daily on day 1 or 200 mg as a single dosage on day 1
  • P/O:
    • Daily 450 mg on days 1 and 2.

• Maintenance dose of Omadacycline (Nuzyra):

  • IV:
    • 100 mg per day
  • P/O:
    • 300 mg per day
  • Duration of therapy:
    • 7-14 days

Use in Children:

Not indicated

Omadacycline (Nuzyra) Pregnancy Risk Category: N (Not assigned)

• Tetracyclines are important in the development of long tubular bone and teeth.
• The teeth may become permanently discoloured (yellow-gray or brown) as a result of in utero exposure. The second and third trimesters, as well as after extended or repeated exposures, are when it is most prone to happen.
• Tetracycline use by mothers in the second and third trimesters may cause reversible suppression of bone formation.
• The company advises women of reproductive potential to use reliable contraception due to the risk of unfavourable pregnancy outcomes with omadacycline therapy.

Omadacycline use during breastfeeding:

• It is unknown if omadacycline can be found in breast milk.
• Tetracyclines are generally avoided by breastfeeding women as they can cause tooth discoloration or inhibit bone growth.
• Breastfeeding is not recommended by the manufacturer because of the risk of adverse events. It is also not recommended for use for the first four days following the last dose.

Dose in Kidney Disease:

• No dosage adjustment is required.

Dose in Liver Disease:

• No dosage adjustment is required.

Common Side Effects of Omadacycline (Nuzyra):

• Gastrointestinal:

  • Nausea
  • Vomiting

Less Common Side Effects of Omadacycline (Nuzyra):

• Cardiovascular:

  • Hypertension
  • Insomnia
  • Atrial Fibrillation
  • Tachycardia

• Central Nervous System:

  • Headache
  • Fatigue
  • Lethargy
  • Vertigo

• Dermatologic:

  • Erythema
  • Hyperhidrosis
  • Pruritus
  • Urticaria

• Endocrine & Metabolic:

  • Increased Gamma-Glutamyl Transferase

• Gastrointestinal:

  • Diarrhea
  • Constipation
  • Abdominal Pain
  • Dysgeusia
  • Dyspepsia
  • Increased Serum Lipase
  • Oral Candidiasis

• Genitourinary:

  • Vulvovaginal Candidiasis

• Hematologic & Oncologic:

  • Anemia
  • Thrombocythemia

• Hepatic:

  • Increased Serum Alanine Aminotransferase
  • Increased Serum Aspartate Aminotransferase
  • Increased Serum Alkaline Phosphatase
  • Increased Serum Bilirubin

• Hypersensitivity:

  • Hypersensitivity Reaction

• Local:

  • Infusion Site Reaction

• Neuromuscular & Skeletal:

  • Increased Creatine Phosphokinase

• Respiratory:

  • Oropharyngeal Pain

Contraindications to Omadacycline (Nuzyra):

• Tetracyclines are important in the development of long tubular bone and teeth.
• Permanent discoloration of the teeth can result from in utero exposure (yellow-gray or brown). This is more common in the second and third trimesters.
• Tetracycline use by mothers in the second and third trimesters may cause reversible suppression of bone formation.
• The company advises women of reproductive potential to use reliable contraception due to the risk of unfavourable pregnancy outcomes with omadacycline therapy.

Omadacycline use during breastfeeding:

• Omadacycline's presence in breast milk is unknown.
• Women who are nursing should generally avoid tetracyclines since they may discolour teeth or slow down bone growth.
• Manufacturers do not recommend breastfeeding due to the potential for adverse events. It is not recommended to be used for the first four days after the last dose.

Monitoring Parameters:

• Periodic renal and hepatic function tests

How to administer Omadacycline (Nuzyra)?

IV:

•  If the diluted infusion solution was kept in the refrigerator, let it come to room temperature before using it.
• Through a dedicated line or Y-site, administer a 200 mg dosage over the course of 60 minutes and a 100 mg dose over the course of 30 minutes.
• If a dedicated line is not available, flush the line both before and after the omadacycline infusion with NS or D5W.

P/O:

• Take the medication on an empty stomach (after fasting for around 4 hours) with water.
• Avoid dairy products and other products with multivalent cations (such as antacids, multivitamins) for 4 hours after administration. After administration, refrain from eating or drinking anything other than water for two hours.

Mechanism of action of Omadacycline (Nuzyra):

• By attaching to the 30S subunit of sensitive bacteria, it prevents protein production.

Absorption:

• Absorption rates and extents of food decrease

Distribution:

• Plasma concentrations are higher in tissues than plasma.

Protein binding:

• 20 percent,
• not concentration-dependent

Metabolism:

• Not metabolized

Bioavailability:

• P/O:
• 34.5 percent following a single 300 mg dose

Half-life elimination:

• IV:
• ~16 hours
• P/O:
• 13.45-16.83 hours

Time to peak: IV:

• ~0.5 hours.
• P/O:
• 2.5 hours.

Excretion: IV:

• Urine (27 percent as unchanged drug)

P/O:

• Feces: (77.5 percent to 84.0 percent).
• Urine: ~14.4 percent (range 10.8 percent to 17.4 percent)

International Brands of Omadacycline:

• Nuzyra

Omadacycline Brand Names in Pakistan:

No Brands Available in Pakistan.