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 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

DRUG: Clarithromycin

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

DRUG: Clarithromycin

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-954 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 CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE 2910 (15 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE

Product Characteristics Color WHITE (white) Score no score Shape OVAL (oval) Size 15mm Flavor Imprint Code W954 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64679-954-01 60 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065266 05/31/2006

CLARITHROMYCIN clarithromycin tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-949 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 CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE 2910 (15 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE

Product Characteristics Color WHITE (white) Score no score Shape OVAL (oval) Size 19mm Flavor Imprint Code W949 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64679-949-01 60 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:64679-949-02 1200 TABLET, FILM COATED in 1 POUCH None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065266 05/31/2006

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.