Tigecycline (Page 8 of 8)
16 HOW SUPPLIED/STORAGE AND HANDLING
Tigecycline for Injection, USP is an orange lyophilized cake or powder, and is supplied as follows:
NDC | Tigecycline for Injection, USP | Package Factor |
71288-019 -11 | 50 mg tigecycline lyophilized powder for reconstitution in a 10 mL glass Single-Dose Vial | 10 vials per carton |
Prior to reconstitution, Tigecycline for Injection, USP should be stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] The reconstituted solution of Tigecycline for Injection, USP may be stored at room temperature (not to exceed 25°C/77°F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag) [see Dosage and Administration (2.5)].
The container closure is not made with natural rubber latex.
17 PATIENT COUNSELING INFORMATION
Tooth Discoloration and Inhibition of Bone Growth
Advise pregnant women that tigecycline may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.7, 5.8) and Use in Specific Populations (8.1, 8.4)].
Lactation
Advise a woman not to breastfeed for longer than 3 weeks while taking tigecycline because of the lack of data on effects due to prolonged breastfeeding, and the theoretical risk of dental discoloration and inhibition of bone growth. Women may also consider reducing infant exposure through pumping and discarding breastmilk during and for 9 days after the last dose of tigecycline [see Use in Specific Populations (8.2)].
Diarrhea
Advise patients, their families, or caregivers that diarrhea is a common problem caused by antibacterial drugs, including tigecycline. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, advise patients to contact his or her healthcare provider [see Warnings and Precautions (5.9)].
Development of Resistance
Patients should be counseled that antibacterial drugs including tigecycline should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When tigecycline 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 tigecycline or other antibacterial drugs in the future.
This product’s label may have been updated. For current full prescribing information, please visit www.meithealpharma.com.
meitheal®
Mfd. for Meitheal Pharmaceuticals
Chicago, IL 60631 (USA)
©2021 Meitheal Pharmaceuticals Inc.
Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.Nanjing, China 210061
March 2021
810083-00
Principal Display Panel – Tigecycline for Injection, USP 50 mg Vial Label
NDC 71288-019 -10
Rx only
Tigecycline for Injection, USP
50 mg per vial
For Intravenous Infusion Only
Single-Dose Vial
Principal Display Panel – Tigecycline for Injection, USP 50 mg Carton
NDC 71288-019 -11
Rx only
Tigecycline for Injection, USP
50 mg per vial
For Intravenous Infusion Only
RECONSTITUTED SOLUTION MUST BE FURTHER DILUTED FOR INTRAVENOUS INFUSION
10 Single-Dose Vials
TIGECYCLINE tigecycline injection, powder, lyophilized, for solution | |||||||||||||||||
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Labeler — Meitheal Pharmaceuticals Inc. (080548348) |
Revised: 05/2021 Meitheal Pharmaceuticals Inc.
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