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 Myc obacterium 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 white, oval-shaped, film-coated tablets, debossed GG C9 on one side and plain on the reverse side, and are supplied as follows:

NDC: 70518-2773-00

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.

17 PATIENT COUNSELING INFORMATION

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.

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 the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

Repackaged By / Distributed By:

RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

DRUG: Clarithromycin

GENERIC: Clarithromycin

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2773-0

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 19 mm

IMPRINT: GG;C9

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CLARITHROMYCIN 500mg in 1

INACTIVE INGREDIENT(S):

  • MICROCRYSTALLINE CELLULOSE
  • CROSCARMELLOSE SODIUM
  • HYPROMELLOSE 2910 (3 MPA.S)
  • HYPROMELLOSE 2910 (6 MPA.S)
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL 400
  • POLYSORBATE 80
  • POVIDONE, UNSPECIFIED
  • TALC
  • TITANIUM DIOXIDE
MM1
(click image for full-size original)
CLARITHROMYCIN clarithromycin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2773(NDC:0781-1962)
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
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 19mm
Flavor Imprint Code GG;C9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2773-0 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065136 06/09/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 10/2022 REMEDYREPACK INC.

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