Clarithromycin (Page 9 of 9)
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, 250 mg are yellow oval film-coated tablets debossed with ‘L139’ on one side and plain on the other side.
NDC 62332-344-30 Bottle of 30 tablets
NDC 62332-344-60 Bottle of 60 tablets
NDC 62332-344-91 Bottle of 1000 tablets
Clarithromycin tablets USP, 500 mg are yellow oval film-coated tablets debossed with ‘L140’ on one side and plain on the other side.
NDC 62332-345-30 Bottle of 30 tablets
NDC 62332-345-60 Bottle of 60 tablets
NDC 62332-345-91 Bottle of 1000 tablets
Store 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 tablets to patients:
Important Administration Instructions
Advise patients that clarithromycin tablets and oral suspension can be taken with or without food and can be taken with milk; however, clarithromycin extended-release tablets should be taken with food. Do not refrigerate the suspension.
Drug Interactions
Advise patients that clarithromycin tablet 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 tablets 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 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 tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clarithromycin tablets are 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 tablets or other antibacterial drugs in the future.
Potential for Dizziness, Vertigo and Confusion
There are no data on the effect of clarithromycin tablets 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 tablets. 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 Tablets Treatment
Advise patients who have coronary artery disease to continue medications and lifestyle modifications for their coronary artery disease because clarithromycin tablets may be associated with increased risk for mortality years after the end of clarithromycin tablets treatment.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For more information, call Alembic Pharmaceutical Limited at 1-866-210-9797.
Manufactured by:
Alembic Pharmaceuticals Limited
(Formulation Division),
Panelav 389350, Gujarat, India
Manufactured for:
Alembic Pharmaceuticals, Inc.
Bedminster, NJ 07921, USA
Revised: 05/2023
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 250 mg
NDC 62332-344-30
Clarithromycin
Tablets, USP
250 mg
Rx only
30 Tablets Alembic
clarithromycin-250-mg.jpg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 500 mg
NDC 62332-345-30
Clarithromycin
Tablets, USP
500 mg
Rx only
30 TabletsAlembic
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CLARITHROMYCIN clarithromycin tablet, film coated | ||||||||||||||||||||||||||||
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Labeler — Alembic Pharmaceuticals Inc. (079288842) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Alembic Pharmaceuticals Limited | 650574671 | MANUFACTURE (62332-344), MANUFACTURE (62332-345) |
Revised: 05/2023 Alembic Pharmaceuticals Inc.
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