Prescription Drug Information: Azithromycin (Page 5 of 5)
15 REFERENCES
- 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-07
Revised: November 2021
Azithromycin tablets, USP 600- 30’s Label
BIONPHARMA
NDC 69452-173-13
Azithromycin Tablets, USP
600 mg
Rx only
30 Tablets
AZITHROMYCIN azithromycin tablet, film coated | ||||||||||||||||||||
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Labeler — Bionpharma Inc. (079637826) |
Registrant — Bionpharma Inc. (079637826) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Bluepharma Indústria Farmacêutica, S.A. | 449909329 | manufacture (69452-173) |
Revised: 12/2023 Bionpharma Inc.
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