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 Vial Label
(click image for full-size original)

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

Principal Display Panel – Tigecycline for Injection, USP 50 mg Carton
(click image for full-size original)
TIGECYCLINE tigecycline injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71288-019
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tigecycline (Tigecycline) Tigecycline 50 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate 100 mg in 5 mL
hydrochloric acid
sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71288-019-11 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (71288-019-10)
1 NDC:71288-019-10 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (71288-019-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214020 05/13/2021
Labeler — Meitheal Pharmaceuticals Inc. (080548348)

Revised: 05/2021 Meitheal Pharmaceuticals Inc.

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