Azithromycin (Page 6 of 6)

15 REFERENCES

  1. Griffith DE, Aksamit T, Brown-Elliot BA, et al. An official ATS/IDSA statement: Diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med . 2007; 175:367-416.

16 HOW SUPPLIED/STORAGE AND HANDLING

Azithromycin tablets, USP 600 mg are supplied as white, oblong, biconvex, film-coated tablets, debossed with “600” on one side, containing azithromycin dihydrate, USP equivalent to 600 mg azithromycin. These are packaged in bottles of 30 tablets. Azithromycin tablets, USP are supplied as follows:

Bottles of 30 NDC 69452-173-13

Tablets should be stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Azithromycin tablets may be taken with or without food. However, increased tolerability has been observed when tablets are taken with food.

Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously.

The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.

Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant.

Patients should be counseled that antibacterial drugs, including azithromycin tablets, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When azithromycin tablets are prescribed to treat 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 azithromycin tablets or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibacterial which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible.

Distributed by:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Manufactured by:

Bluepharma Indústria Farmacêutica, S.A.

Rua Da Bayer, S. Martinho do Bispo

Coimbra 3045-016 Portugal

FDA-05

Revised: May 2020

Azithromycin tablets, USP 600- 30’s Label

BIONPHARMA

NDC 69452-173-13

Azithromycin Tablets, USP

600 mg

Rx only

30 Tablets

600 mg 30's Label
(click image for full-size original)
AZITHROMYCIN
azithromycin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-173
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 600 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
SODIUM LAURYL SULFATE
HYPROMELLOSES
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape OVAL (oblong, biconvex) Size 19mm
Flavor Imprint Code 600
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-173-13 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209999 12/26/2018
Labeler — Bionpharma Inc. (079637826)
Registrant — Bionpharma Inc. (079637826)
Establishment
Name Address ID/FEI Operations
Bluepharma Indústria Farmacêutica, S.A. 449909329 manufacture (69452-173)

Revised: 06/2020 Bionpharma 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.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.