Clarithromycin (Page 10 of 10)

15 REFERENCES

  1. Winkel P, Hilden J, Hansen JF, Kastrup J, Kolmos HJ, Kjøller E, et al. Clarithromycin for stable coronary heart disease increases all-cause and cardiovascular mortality and cerebrovascular morbidity over 10 years in the CLARICOR randomised, blinded clinical trial. Int J Cardiol 2015;182:459-65.
  2. Kemper CA, et al. Treatment of Mycobacterium avium Complex Bacteremia in AIDS with a Four-Drug Oral Regimen. Ann Intern Med. 1992;116:466-472.

16 HOW SUPPLIED/STORAGE AND HANDLING

Clarithromycin Tablets USP, 500 mg are light yellow colored, oval shaped, biconvex film-coated tablets, with D debossed on one side and 63 on the other side.

NDC 68071-5045-2 BOTTLES OF 20

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Provide the following instructions or information about clarithromycin to patients:

Important Administration Instructions

Advise patients that clarithromycin tablets can be taken with or without food and can be taken with milk.

Drug Interactions

Advise patients that clarithromycin may interact with some drugs; therefore, advise patients to report to their healthcare provider the use of any other medications.

Diarrhea

Advise patients that diarrhea is a common problem caused by antibacterials including clarithromycin which usually ends when the antibacterial 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, instruct patients to contact their healthcare provider as soon as possible.

Embryo-Fetal Toxicity

Advise females of reproductive potential that that if pregnancy occurs while taking this drug, there is a potential hazard to the fetus [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1)] .

Antibacterial Resistance

Counsel patients that antibacterial drugs including clarithromycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clarithromycin 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 clarithromycin or other antibacterial drugs in the future.

Potential for Dizziness, Vertigo and Confusion

There are no data on the effect of clarithromycin on the ability to drive or use machines. However, counsel patients regarding the potential for dizziness, vertigo, confusion and disorientation, which may occur with the clarithromycin. The potential for these adverse reactions should be taken into account before patients drive or use machines.

Risk of Mortality in Patients with Coronary Disease Years After Clarithromycin Treatment

Advise patients who have coronary artery disease to continue medications and lifestyle modifications for their coronary artery disease because clarithromycin may be associated with increased risk for mortality years after the end of clarithromycin treatment.
The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. The makers of these brands are not affiliated with and do not endorse Aurobindo Pharma Limited or its products.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India Revised: 01/2019

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

pdp
(click image for full-size original)

CLARITHROMYCIN clarithromycin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-5045(NDC:65862-226)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLARITHROMYCIN (CLARITHROMYCIN) CLARITHROMYCIN 500 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
POVIDONE K30
HYPROMELLOSE 2910 (15 MPA.S)
TITANIUM DIOXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
FERRIC OXIDE YELLOW
PROPYLENE GLYCOL
VANILLIN
SORBIC ACID
Product Characteristics
Color yellow (Light Yellow) Score no score
Shape OVAL (Biconvex) Size 18mm
Flavor Imprint Code D;63
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-5045-2 20 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065489 07/25/2012
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-5045)

Revised: 02/2021 NuCare Pharmaceuticals,Inc.

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