omadacycline

Inhibits bacterial protein synthesis by binding to the 30S bacterial ribosome.

Therapeutic effects:

Bacteriostatic action against susceptible bacteria.

Spectrum:

Includes activity against some gram-positive pathogens:
- Enterococcus faecalis,
- Staphylococcus aureus(including methicillin-sensitive and methicillin-resistant strains),
- Staphylococcus lugdunensis,
- Streptococcus anginosus,
- Streptococcus constellatus,
- Streptococcus intermedius,
- Streptococcus pneumoniae,
- Streptococcus pyogenes.
Active against some gram-negative pathogens:
- Enterobacter cloacae,
- Haemophilus influenzae,
- Haemophilus parainfluenzae,
- Klebsiella pneumoniae.
Also active against several other pathogens, including:
- Chlamydophila pneumoniae
- Legionella pneumophila,
- Mycoplasma pneumoniae.

Pharmacokinetics ⬆ ⬇

Absorption: 35% absorbed following oral administration (high-fat meal ↓ rate and extent of absorption); IV administration results in complete bioavailability.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Does not undergo metabolism in the liver. Primarily excreted in feces (78–84%), with 14% excreted in urine (27% as unchanged drug).

Half-Life: 15–16 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	0.5 hr	24 hr
PO	unknown	2.5 hr	24 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to omadacycline or other tetracycline derivatives;
OB: Pregnancy (may lead to permanent staining of teeth and inhibition of bone growth in fetus if used during 2nd or 3rd trimester);
Lactation: Lactation;
Pedi: Children 8 yr (may lead to permanent staining of teeth and growth).

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children;
Geri: risk of mortality in older adults, especially those with multiple comorbidities.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension

Derm: photosensitivity

GI: nausea, vomiting, ↑liver enzymes, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), constipation, diarrhea

GU: ↓fertility

Local: injection site reactions

Neuro: headache, insomnia, intracranial hypertension

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

May ↑ effect of warfarin.
Medications containing aluminum, calcium, or magnesium may ↓ absorption of oral tablets; separate administration by ≥4 hr.

Dairy products may ↓ absorption of oral tablets; separate administration by ≥4 hr.

Route/Dosage ⬆ ⬇

Community-Acquired Bacterial Pneumonia

IV PO (Adults ): Loading dose: 200 mg IV as single dose on Day 1 or 100 mg IV twice daily on Day 1 or 300 mg orally twice daily on Day 1. Maintenance dose: 100 mg IV once daily for additional 6–13 days or 300 mg orally once daily for additional 6–13 days.

Acute Bacterial Skin and Skin Structure Infections

IV PO (Adults ): Loading dose: 200 mg IV as single dose on Day 1 or 100 mg IV twice daily on Day 1 or 450 mg orally once daily on Days 1 and 2. Maintenance dose: 100 mg IV once daily for additional 6–13 days or 300 mg orally once daily for additional 6–13 days.

Availability ⬆ ⬇

Tablets: 150 mg
Lyophilized powder for injection: 100 mg/vial

Assessment ⬆ ⬇

Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and during therapy, especially in geriatric patients.
Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of Clostridioides difficile-associated diarrhea (CDAD). May begin up to several wk following cessation of therapy.
Monitor for signs and symptoms of hypersensitivity reactions (rash, hives, swelling of face or throat) during therapy.

Implementation ⬆ ⬇

May cause yellow-brown discoloration and softening of teeth and bones if administered prenatally or during early childhood. Not recommended for children under 8 yr of age or during pregnancy or lactation.
PO: Fast for at least 4 hr and then take with water. After oral dosing, consume no food or drink (except water) for 2 hr and no dairy products, antacids, or multivitamins for 4 hr.

IV Administration:

Intermittent Infusion: Reconstitution: Reconstitute each 100-mg vial with 5 mL of sterile water for injection, 0.9% NaCl, or D5W. Gently swirl and let vial stand until cake has completely dissolved and any foam disperses. Do not shake. Solution is yellow to dark orange; do not administer solutions that are discolored or contain particulate matter. Diluent: Within 1 hr, withdraw 5–10 ml of reconstituted solution and further dilute in 100 mL 0.9% NaCl or D5W.Concentration: 1 mg/mL or 2 mg/mL. Discard unused solution. Solution is stable for 12 hr at room temperature or 7 days if refrigerated. Allow solution to reach room temperature before administration.
Rate: Infuse through a dedicated line or a Y-site over 60 min for 200-mg dose, or 30 min for a 100-mg dose. If line used for other infusions, flush with 0.9% NaCl or D5W before and after infusion.
Y-Site Incompatibility: Solutions containing calcium and magnesium.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication and to finish the drug completely as directed, even if feeling better. Instruct patient to fast 4 hr before and 2 hr after taking omadacycline and not to consume dairy products, antacids, or multivitamins for 4 hr after taking dose.
Instruct patient to notify health care professional immediately if rash, diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
Advise patient to report the signs of superinfection (black, furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools) to health care professional.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: May cause fetal harm. May permanently turn a baby or child's teeth yellow-gray-brown during tooth development during the second and third trimesters of pregnancy, and from birth to 8 years of age. May also slow bone growth in infants and children. Advise females of reproductive potential to use a nonhormonal method of contraception and avoid breast feeding during and for 4 days after last dose of therapy. Advise patient to notify health care professional promptly if pregnancy is suspected. May impair fertility in females and males.

Evaluation/Desired Outcomes ⬆ ⬇

Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

71715- Paratek Pharmaceuticals, Inc.
- 71715-001- NUZYRA
  - 71715-001-02- 10 VIAL, GLASS in 1 CARTON (71715-001-02) > 10 mL in 1 VIAL, GLASS (71715-001-01)

71715- Paratek Pharmaceuticals, Inc.
- 71715-002- NUZYRA
  - 71715-002-21- 1 BLISTER PACK in 1 CARTON (71715-002-21) > 6 TABLET, FILM COATED in 1 BLISTER PACK

71715- Paratek Pharmaceuticals, Inc.
- 71715-002- NUZYRA
  - 71715-002-23- 14 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-23)

71715- Paratek Pharmaceuticals, Inc.
- 71715-002- NUZYRA
  - 71715-002-24- 16 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-24)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇