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 are supplied as white to off-white oval film-coated tablets in the following packaging sizes:

500 mg tablets: (debossed with the “S4” on one side)
Unit dose packages of 30 (3 x 10) NDC 60687-435-21

Store clarithromycin tablets, USP at controlled room temperature 20° to 25°C (68° to 77°F).

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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 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 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 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.

* All trademark names are the property of their respective owners.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Lannett Company, Inc. as follows:
(500 mg / 30 UD) NDC 60687-435-21 packaged from NDC 0527-1932

Distributed by:
American Health Packaging Columbus, OH 43217

8443521/0420

Package/Label Display Panel – Carton – 500 mg

500 mg Clarithromycin Tablets Carton
(click image for full-size original)

NDC 60687- 435 -21

Clarithromycin
Tablets, USP

500 mg

30 Tablets (3 x 10)               Rx Only

Each Film-Coated Tablet Contains:
Clarithromycin ……………………………………………….. 500 mg

Usual Dosage: See package insert for full prescribing
information.

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

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 0527-1932, Lannett Company, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

743521 0443521/0619

Package/Label Display Panel – Blister – 500 mg

500 mg Clarithromycin Tablet Blister
(click image for full-size original)

Clarithromycin Tablet, USP

500 mg

CLARITHROMYCIN clarithromycin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-435(NDC:0527-1932)
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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color white Score no score
Shape OVAL Size 19mm
Flavor Imprint Code S;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-435-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-435-11)
1 NDC:60687-435-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-435-21)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203584 01/29/2020
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-435)

Revised: 12/2020 American Health Packaging

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