Clarithromycin (Page 9 of 9)
15 REFERENCES
- 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 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 supplied as white oval film-coated tablets debossed with W954 on one side and other side plain.
Bottles of 60 Tablets (NDC 64679-954-01)
Clarithromycin tablets, USP 500 mg are supplied as white oval film-coated tablets debossed with W949 on one side and other side plain.
Bottles of 60 Tablets (NDC 64679-949-01)
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a light, light-resistant container as defined in the USP.
17 PATIENT COUNSELING INFORMATION
Provide the following instructions or information about clarithromycin tablets to patients:
- 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 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.
- 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 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 clarithromycin can be taken with or without food and can be taken with milk.
- 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 medication. The potential for these adverse reactions should be taken into account before patients drive or use machines.
- Advise patients 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)].
- 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.
Prilosec® is a registered trademark of AstraZeneca
Prevacid® is a registered trademark of Tap Pharma
Manufactured by:
Wockhardt Limited
L-1, M.I.D.C., Jalgaon Road,
Aurangabad, Maharashtra,
India.
Distributed by
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.
Rev.080518
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
GENERIC: Clarithromycin
DOSAGE: Film-coated Tablets
ADMINSTRATION: Oral
NDC: 64679-954-01
STRENGTH: 250 mg
NDC: 64679-954-01
STRENGTH: 250 mg
COLOR: WHITE
SHAPE: OVAL
SCORE: no score
SIZE: 15mm
IMPRINT: W954
QTY: 60 Tablets
GENERIC: Clarithromycin
DOSAGE: Film-coated Tablets
ADMINSTRATION: Oral
NDC: 64679-949-01
STRENGTH: 500 mg
COLOR: WHITE
SHAPE: OVAL
SCORE: no score
SIZE: 19mm
IMPRINT: W949
QTY: 60 Tablets
CLARITHROMYCIN clarithromycin tablet, film coated | ||||||||||||||||||||||||
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CLARITHROMYCIN clarithromycin tablet, film coated | ||||||||||||||||||||||||
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Labeler — Wockhardt USA LLC. (170508365) |
Registrant — Wockhardt USA LLC. (170508365) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Wockhardt Limited | 916489953 | ANALYSIS (64679-954), ANALYSIS (64679-949), MANUFACTURE (64679-954), MANUFACTURE (64679-949), LABEL (64679-954), LABEL (64679-949), PACK (64679-954), PACK (64679-949) |
Revised: 11/2019 Wockhardt USA LLC.
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