AZITHROMYCIN (Page 5 of 5)

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 to off white, oval shaped, film-coated tablet debossed with “592” on one side and “L” on the other side containing azithromycin dihydrate equivalent to 600 mg of azithromycin, USP.

These are packaged in bottles and blister cards as follows:

NDC 46708-253-30 bottle of 30 tablets

NDC 46708-253-10 carton of 100 (10 x 10) unit dose tablets

Tablets should be stored at 25°C (77°F); excursions permitted to 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, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When azithromycin is 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 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:

Alembic Pharmaceuticals Limited

(Formulation Division),

Village Panelav, P. O. Tajpura,

Near Baska, Taluka-Halol,

Panchmahal 389350, Gujarat, India.

Revised: 05/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46708-253-30
Azithromycin
Tablets, USP
600 mg
Rx only
30 TabletsAlembic

30 Tablets
(click image for full-size original)
AZITHROMYCIN azithromycin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-253
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (70000 WAMW)
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (5 MPA.S)
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 592;L
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-253-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:46708-253-10 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (46708-253-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211793 01/28/2020
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-253)

Revised: 01/2023 Alembic Pharmaceuticals Limited

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