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

//medlibrary.org/lib/images-rx/clarithromycin-50/clarithromycin-250-mg-300x83.jpg
(click image for full-size original)

clarithromycin-250-mg.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 500 mg

NDC 62332-345-30
Clarithromycin
Tablets, USP
500 mg
Rx only
30 TabletsAlembic

//medlibrary.org/lib/images-rx/clarithromycin-50/clarithromycin-500-mg-300x83.jpg
(click image for full-size original)
CLARITHROMYCIN clarithromycin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-344
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLARITHROMYCIN (CLARITHROMYCIN) CLARITHROMYCIN 250 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
STARCH, CORN
SILICON DIOXIDE
POVIDONE K30
STEARIC ACID
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
PROPYLENE GLYCOL
TALC
VANILLIN
TITANIUM DIOXIDE
D&C YELLOW NO. 10 ALUMINUM LAKE
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 16mm
Flavor Imprint Code L139
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-344-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62332-344-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:62332-344-91 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210459 02/01/2022
CLARITHROMYCIN clarithromycin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-345
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
SILICON DIOXIDE
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
PROPYLENE GLYCOL
TALC
VANILLIN
TITANIUM DIOXIDE
D&C YELLOW NO. 10 ALUMINUM LAKE
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 18mm
Flavor Imprint Code L140
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-345-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62332-345-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:62332-345-91 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210459 02/01/2022
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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