- 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.
- Kemper CA, et al. Treatment of Myc obacterium avium Complex Bacteremia in AIDS with a Four-Drug Oral Regimen. Ann Intern Med. 1992;116:466-472.
Clarithromycin tablets, USP 500 mg are white, oval-shaped, film-coated tablets, debossed GG C9 on one side and plain on the reverse side, and are supplied as follows:
PACKAGING: 30 in 1 BLISTER PACK
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container as described in the USP. Protect from light.
Provide the following instructions or information about clarithromycin tablets to patients:
Important Administration Instructions
Advise patients that clarithromycin tablets can be taken with or without food and can be taken with milk.
Advise patients that clarithromycin may interact with some drugs; therefore, advise patients to report to their healthcare provider the use of any other medications.
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.
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)].
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 the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.
Repackaged By / Distributed By:
625 Kolter Drive, Indiana, PA 15701
SCORE: No score
SIZE: 19 mm
PACKAGING: 30 in 1 BLISTER PACK
- CLARITHROMYCIN 500mg in 1
- MICROCRYSTALLINE CELLULOSE
- CROSCARMELLOSE SODIUM
- HYPROMELLOSE 2910 (3 MPA.S)
- HYPROMELLOSE 2910 (6 MPA.S)
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL 400
- POLYSORBATE 80
- POVIDONE, UNSPECIFIED
- TITANIUM DIOXIDE
|CLARITHROMYCIN clarithromycin tablet|
|Labeler — REMEDYREPACK INC. (829572556)|
Revised: 10/2022 REMEDYREPACK INC.
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