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Rx Item-Nuzyra omadacycline 150mg tab 6 by Paratek Pharma

RX71715-0002-21Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-Nuzyra omadacycline 150mg tab 6 by Paratek Pharma

$1634.42$1556.59

NDC No. 71715-0002-21 71715-002-21 7171500221 71715000221 UPC/GTIN No. 3-71715-00221-5 371715-002215 371715002215 MPN No.000221 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist,& Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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For: Skin and Structure Infection, Pneumonia

Nuzyra (omadacycline) is an aminomethylcycline tetracycline antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). How Supplied

NUZYRA for Injection

NUZYRA for Injection is supplied as a sterile lyophilized powder in a single-dose colorless glass vial, with each vial containing 100 mg of NUZYRA (equivalent to 131 mg omadacycline tosylate).

They are supplied as follows: 100-mg single-dose vial (NDC 71715-001-02), packaged in cartons of 10.

NUZYRA Tablets

NUZYRA Tablets contains 150 mg of omadacycline (equivalent to 196 mg omadacycline tosylate) in yellow, diamond-shaped, film-coated tablets debossed with OMC on one side and 150 on the other side.

They are supplied as follows:

Blister package of 6 (NDC 71715-002-21)

Unit dose blister package of 14 (NDC 71715-002-23)

Unit dose blister package of 16 (NDC 71715-002-24). These highlights do not include all the information needed to use NUZYRA� safely and effectively. See full prescribing information for NUZYRA.

NUZYRA (omadacycline) for injection, for intravenous use
NUZYRA (omadacycline) tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE

NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms (1):

Community-acquired bacterial pneumonia (CABP) (1.1)
Acute bacterial skin and skin structure infections (ABSSSI) (1.2)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3)
DOSAGE AND ADMINISTRATION

Dosage of NUZYRA in CABP and ABSSSI Adult Patients (2.2, 2.3):

Infection Loading Doses Maintenance Dose
CABP Day 1: 200 mg by intravenous infusion over 60 minutes OR 100 mg by intravenous infusion over 30 minutes twice (2.2) 100 mg by intravenous infusion over 30 minutes once daily OR 300 mg orally once daily (2.2)
ABSSSI Day 1: 200 mg by intravenous infusion over 60 minutes OR 100 mg by intravenous infusion over 30 minutes twice (2.3) OR 100 mg by intravenous infusion over 30 minutes once daily OR 300 mg orally once daily (2.3)
ABSSSI (NUZYRA tablets only) Day 1 and Day 2: 450 mg orally once daily (2.3) 300 mg orally once daily (2.3)

CABP and ABSSSI: Treatment duration is 7 to 14 days. (2.2, 2.3)
Fast for at least 4 hours and then take NUZYRA tablets 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. (2.1)
See full prescribing information for the preparation of NUZYRA IV and other administration instructions. (2.1, 2.5).

DOSAGE FORMS AND STRENGTHS

For Injection: 100 mg of omadacycline (equivalent to 131 mg omadacycline tosylate) as a lyophilized powder in a single dose vial for reconstitution and further dilution before intravenous infusion (3.1)
Tablets: 150 mg omadacycline (equivalent to 196 mg omadacycline tosylate) (3.2)

CONTRAINDICATIONS

Known hypersensitivity to omadacycline, tetracycline-class antibacterial drugs or any of the excipients in NUZYRA (4)

WARNINGS AND PRECAUTIONS

Mortality Imbalance in Patients with CABP: In the CABP trial, mortality rate of 2% was observed in NUZYRA-treated patients compared to 1% in moxifloxacin-treated patients. The cause of the mortality imbalance has not been established. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. (5.1, 6.1)
Tooth Discoloration and Enamel Hypoplasia: The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. (5.2, 8.1, 8.4)
Inhibition of Bone Growth: The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. (5.3, 8.1, 8.4).
Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs. (5.5)

ADVERSE REACTIONS

The most common adverse reactions (incidence ?2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

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)

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding is not recommended during treatment with NUZYRA. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2019

RX71715-0002-21
Rx Item-Nuzyra omadacycline 150mg tab 6
RX71715-0002-21

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-Nuzyra omadacycline 150mg tab 6
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop