NUZYRA (Page 7 of 7)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 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)
Blister package of 30 (5 blister cards of 6 tablets each) NDC 71715-002-27
16.2 Storage and Handling
NUZYRA for Injection and NUZYRA Tablets should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] [see Dosage and Administration (2.5)]. Do not freeze.
17 PATIENT COUNSELING INFORMATION
Nausea and Vomiting
Advise patients that nausea and vomiting can be an adverse reaction to NUZYRA. Advise patients that a greater proportion of patients who received the oral loading dose of NUZYRA for treatment of ABSSSI experienced nausea and vomiting.
Allergic Reactions
Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious allergic reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to NUZYRA, or other tetracycline class antibacterials [see Warnings and Precautions (5.4)].
Administration with Food
Instruct patients to fast 4 hours before and 2 hours after taking NUZYRA tablets and not to consume dairy products, antacids, or multivitamins for 4 hours after taking NUZYRA tablets [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].
Tooth Discoloration and Inhibition of Bone Growth
Advise patients that NUZYRA, like other tetracycline-class drugs, may cause permanent tooth discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment [see Warnings and Precautions (5.1, 5.2) and Use in Specific Populations (8.1, 8.4)].
Lactation
Advise women not to breastfeed during treatment with NUZYRA and for 4 days after the last dose [see Use in Specific Populations (8.2)]
Diarrhea
Advise patients that diarrhea is a common problem caused by antibacterial drugs, including NUZYRA, which usually ends when the antibacterial drugs is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery or bloody stools (with or without stomach cramps and fever). If this occurs, patients should contact their physician as soon as possible.
Tetracycline Class Adverse Reactions
Inform patients that NUZYRA is similar to tetracycline-class antibacterial drugs and may have similar adverse reactions [see Warnings and Precautions (5.6)].
Antibacterial Resistance
Advise patients that antibacterial drugs including NUZYRA should only be used to treat bacterial infections. They do not treat viral infections (e.g. , the common cold). When NUZYRA is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by NUZYRA or other antibacterial drugs in the future.
Distributed by:
Paratek Pharmaceuticals, Inc.
Boston, MA, USA
PARATEK® and the hexagon logo are registered trademarks of Paratek Pharmaceuticals, Inc.
NUZYRA® and its design logo are registered trademarks of Paratek Pharmaceuticals, Inc.
For patent information: www.paratekpharma.com/products/patent.
© 2021 Paratek Pharmaceuticals, Inc. All rights reserved.
PRINCIPAL DISPLAY PANEL — 10 Vial Carton
NDC 71715-001-02
Contains 10 of NDC 71715-001-01
RX ONLY
NUZYRA®
(omadacycline)
for injection
100 mg per single-dose vial.
Must be reconstituted
and further diluted.For intravenous infusion only.
100 mg
Contains 10 vials
PRINCIPAL DISPLAY PANEL — 6 Tablet Blister Pack Carton
NDC 71715-002-21
RX ONLY
once-daily
NUZYRA®
(omadacycline)150 mg tablets
Contains 6 tablets
PRINCIPAL DISPLAY PANEL — 30 Tablet Blister Pack Carton
NDC 71715-002-27
RX ONLY
once-daily
NUZYRA®
(omadacycline)
150 mg tablets
Contains 30 tablets(5 blister cards of 6 tablets each)
NUZYRA omadacycline injection, powder, lyophilized, for solution | ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
|
NUZYRA omadacycline tablet, film coated | |||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||
|
Labeler — Paratek Pharmaceuticals, Inc. (076333934) |
Establishment | |||
Name | Address | ID/FEI | Operations |
CIPAN | 449040773 | API MANUFACTURE (71715-001), API MANUFACTURE (71715-002), ANALYSIS (71715-001), ANALYSIS (71715-002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Carbogen Amcis AG (Carbogen) | 481385565 | API MANUFACTURE (71715-001), API MANUFACTURE (71715-002), ANALYSIS (71715-001), ANALYSIS (71715-002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Carbogen Amcis AG (Carbogen NE) | 480029695 | ANALYSIS (71715-001), ANALYSIS (71715-002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Conframa France (Confarma) | 492738125 | ANALYSIS (71715-001), ANALYSIS (71715-002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Solvias AG (Solvias) | 480739627 | ANALYSIS (71715-001), ANALYSIS (71715-002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Finorga (Novasep) | 276669694 | API MANUFACTURE (71715-001), API MANUFACTURE (71715-002), ANALYSIS (71715-001), ANALYSIS (71715-002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Alcami Carolinas Corporation (Alcami) | 831351445 | ANALYSIS (71715-001), ANALYSIS (71715-002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Almac Pharma Services Limited (Almac) | 233170864 | MANUFACTURE (71715-002), ANALYSIS (71715-002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Patheon Italia S.p.A. (Patheon) | 434078638 | MANUFACTURE (71715-001), ANALYSIS (71715-001) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Almac Pharma Services LLC (Almac Audubon) | 078607239 | PACK (71715-001), PACK (71715-002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Sharp Corporation (Sharp) | 143696495 | PACK (71715-001), PACK (71715-002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Sharp Corporation (Sharp) | 002346625 | PACK (71715-002) |
Revised: 06/2021 Paratek Pharmaceuticals, Inc.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.