Omadacycline
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From MedlinePlus, U.S. National Library of Medicine
Tetracycline-class Antibacterial
Dosing in kidney impairment
Recommended Dosage Adjustments in Patients with Renal or Hepatic Impairment No dosage adjustment is warranted in patients with renal or hepatic impairment [see Clinical Pharmacology ].
Dosing in liver impairment
Hepatic Impairment No dose adjustment of NUZYRA is warranted in patients with mild, moderate, or severe hepatic insufficiency (Child-Pugh classes A, B, or C) [see Clinical Pharmacology ].
Preparation and administration
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Important Administration Instructions NUZYRA for Injection : Do NOT administer NUZYRA for injection with any solution containing multivalent cations, e.g., calcium and magnesium, through the same intravenous line [see Drug Interactions ] . Co-infusion with other medications has not been studied [see Dosage and Administration ] .
NUZYRA Tablets : Fast for at least 4 hours and then take with water. After oral dosing, no food or drink (except water) is to be consumed for 2 hours and no dairy products, antacids, or multivitamins for 4 hours [see Drug Interactions and Clinical Pharmacology ].
Preparation and Administration of NUZYRA for Injection Intravenous Solution Reconstitution and Dilution : NUZYRA must be reconstituted and then further diluted under aseptic conditions. To prepare the required dose for intravenous infusion, reconstitute and dilute the appropriate number of vials, as determined from Table 3 below.
Reconstitute each 100 mg vial of NUZYRA with 5 mL of Sterile Water, 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, for Injection. Gently swirl the contents and let the vial stand until the cake has completely dissolved and any foam disperses. Do not shake the vial. The reconstituted NUZYRA solution should be yellow to dark orange in color; if not, the solution should be discarded.
Visually inspect the reconstituted NUZYRA solution for particulate matter and discoloration prior to further dilution and administration. If necessary, invert the vial to dissolve any remaining powder and swirl gently to prevent foaming. Immediately (within 1 hour), withdraw 5 mL or 10 mL of the reconstituted solution and further dilute to a 100 mL (nominal volume) of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, bag for injection.
The concentration of the final diluted infusion solution will either be 1 mg/mL or 2 mg/mL in accordance with Table 3 below. Discard any unused portion of the reconstituted solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. [See table below.] Storage of the Diluted Infusion Solution The NUZYRA diluted infusion solution may be used within 24 hours at room temperature (less than or equal to 25°C) or within 7 days when refrigerated (2°C to 8°C).
Do not freeze. Allow the infusion bag to reach room temperature prior to use. Administration After reconstitution and dilution, administer NUZYRA by intravenous infusion, using a total infusion time of 60 minutes for a 200 mg dose, or a total infusion time of 30 minutes for a 100 mg dose [see Dosage and Administration (2.2 , 2.3) ] .
Administer NUZYRA intravenously through a dedicated line or through a Y-site. If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, before and after infusion of NUZYRA. The compatibility of NUZYRA with other drugs and infusion solutions other than 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP has not been established.
| Infection | Loading Doses | Maintenance Dose |
|---|---|---|
| CABP | NUZYRA Injection: Day 1: 200 mg by intravenousinfusion over 60 minutes OR 100 mg by intravenousinfusion over 30 minutes twice ( 2.2) OR NUZYRA Tablets: Day 1: 300 mg orally twice( 2.2) | NUZYRA Injection: 100 mg by intravenousinfusion over 30 minutes once daily OR NUZYRA Tablets: 300 mg orallyonce daily ( 2.2) |
| ABSSSI | NUZYRA Injection: Day 1: 200 mg by intravenous infusion over 60 minutes OR100 mg by intravenousinfusion over 30 minutes twice ( 2.3) OR NUZYRA Tablets: Day 1 and Day 2: 450 mg orallyonce daily ( 2.3) | NUZYRA Injection: 100 mg by intravenousinfusion over 30 minutes once daily OR NUZYRA Tablets: 300 mg orallyonce daily ( 2.3) |
| Loading Doses | Maintenance Dose | Treatment Duration |
|---|---|---|
| NUZYRA Injection: 200 mg by intravenousinfusion over 60 minutes on day 1. OR 100 mg by intravenousinfusion over 30 minutes, twice on day 1. OR | NUZYRA Injection: 100 mg by intravenousinfusion over 30 minutes once daily. OR NUZYRA Tablets: 300 mg orallyonce daily. | 7 to 14 Days |
| NUZYRA Tablets: 300 mg orally twiceon day 1. |
| Loading Doses | Maintenance Dose | Treatment Duration |
|---|---|---|
| NUZYRA Injection: 200 mg by intravenousinfusion over 60 minutes on day 1. OR 100 mg by intravenousinfusion over 30 minutes, twice on day 1. OR | NUZYRA Injection: 100 mg by intravenousinfusion over 30 minutes once daily. OR NUZYRA Tablets: 300 mg orallyonce daily. | 7 to 14 Days |
| NUZYRA Tablets: 450 mg orallyonce a day on day 1 and day 2. |
Drug interactions
Check omadacycline against a medication listLabel text (3 paragraphs)
Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. ( 7.1 ) Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. ( 2.1 , 7.2 )
7.1 Anticoagulant Drugs Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while also taking NUZYRA.
7.2 Antacids and Iron Preparations Absorption of oral tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron containing preparations [see Dosage and Administration (2.1) ].
Supplement interactions
Dietary supplement interactions
2 noted- Magnesium can form insoluble complexes with tetracyclines, such as demeclocycline (Declomycin) and doxycycline (Vibramycin), and with quinolone antibiotics, such as ciprofloxacin (Cipro) and levofloxacin (Levaquin). These antibiotics should be taken at least 2 hours before or 4 to 6 hours after a magnesium-containing supplement.
- Both quinolone antibiotics (such as Cipro) and tetracycline antibiotics (such as Achromycin and Sumycin) might interact with zinc in the gastrointestinal tract, which could inhibit the absorption of both zinc and the antibiotic if they are taken at the same time. Taking the antibiotic at least 2 hours before or 4 to 6 hours after the zinc supplement minimizes this interaction.
Contraindications
4 CONTRAINDICATIONS NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients [see Warnings andPrecautions (5.3) and Adverse Reactions (6.1) ]. Known hypersensitivity to omadacycline, tetracycline class antibacterial drugs or any of the excipients in NUZYRA ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for omadacycline. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary NUZYRA, like other tetracycline class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy [see Warnings and Precautions ( 5.1 , 5.2) , Data, Use in Specific Populations ( 8.4 )]. The limited available data of NUZYRA use in pregnant women is insufficient to inform drug associated risk of major birth defects and miscarriages.
Animal studies indicate that administration of omadacycline during the period of organogenesis resulted in fetal loss and/or congenital malformations in pregnant rats and rabbits at 7 times and 3 times the mean AUC exposure, respectively, of the clinical intravenous dose of 100 mg and the oral dose of 300 mg. Reductions in fetal weight occurred in rats at all administered doses (see Data ). In a fertility study, administration to rats during mating and early pregnancy resulted in embryo loss at 20 mg/kg/day; systemic exposure based on AUC was approximately equal to the clinical exposure level [see Nonclinical Toxicology ( 13.1) ] .
Results of studies in rats with omadacycline have shown tooth discoloration. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15-20%. Data Animal Data Intravenous infusion of omadacycline to pregnant rats during organogenesis (gestation days 6-17) at doses of 5 to 80 mg/kg/day resulted in maternal lethality at 80 mg/kg/day.
Increased embryo-fetal lethality and fetal malformations (whole body edema) occurred at 60 mg/kg/day (7 times the clinical AUC), dose-dependent reductions in fetal body weight occurred at all doses, and delayed skeletal ossification occurred at doses as low as 10 mg/kg/day (Systemic exposure based on AUC at a similar dose in unmated female rats in a separate study was approximately half the clinical exposure). In pregnant rabbits, intravenous infusion of 5, 10 or 20 mg/kg/day during organogenesis (gestation days 7-18) resulted in maternal lethality and body weight loss at 20 mg/kg/day.
Embryo-fetal lethality, congenital malformations of the skeleton, and reduced fetal weight also occurred at 20 mg/kg/day (7 times the clinical AUC). Cardiac and lung malformations were present in dose-related incidence at 10 and 20 mg/kg/day. The fetal…
Breastfeeding (LactMed)
No information is available on the use of omadacycline during breastfeeding. It is unknown how much omadacycline is excreted into breastmilk, but the drug is only about 35% absorbed orally under optimal circumstances, and is probably less from milk because of its calcium content. Although the manufacturer recommends avoiding breastfeeding during administration of omadacycline and for 4 days after the last dose, short-term use of omadacycline is probably acceptable in nursing mothers. If an infant is breastfed, monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (e.g., thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis. As a theoretical precaution, avoid prolonged or repeat courses during nursing.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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