Linezolid (Page 14 of 14)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.2 Tablets

Linezolid Tablets are available containing 600 mg of linezolid.

The 600 mg tablets are yellow, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and L77 on the other side. They are available as follows:

NDC 42292-008-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each).

16.4 Storage

Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light.

17 PATIENT COUNSELING INFORMATION

Patients should be counseled that antibacterial drugs including linezolid tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When linezolid 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 linezolid tablets or other antibacterial drugs in the future.

Patients should be advised that:

  • Linezolid tablets may be taken with or without food.
  • They should inform their physician if they have a history of hypertension.
  • Large quantities of foods or beverages with high tyramine content should be avoided while taking linezolid tablets. Foods high in tyramine content include those that may have undergone protein changes by aging, fermentation, pickling, or smoking to improve flavor, such as aged cheeses, fermented or air-dried meats, sauerkraut, soy sauce, tap beers, and red wines. The tyramine content of any protein-rich food may be increased if stored for long periods or improperly refrigerated.
  • They should inform their physician if taking medications containing pseudoephedrine hydrochloride or phenylpropanolamine hydrochloride, such as cold remedies and decongestants.
  • They should inform their physician if taking serotonin re-uptake inhibitors or other antidepressants.
  • They should inform their physician if they experience changes in vision.
  • They should inform their physician if they have a history of seizures.
  • Diarrhea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic. If this occurs, patients should contact their physician as soon as possible.
  • Inform patient, particularly those with diabetes mellitus that hypoglycemic reactions, such as diaphoresis and tremulousness, along with low blood glucose measurements may occur when treated with linezolid. If such reactions occur, patients should contact a physician or other health professional for proper treatment.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-12268 R1
10/17

PRINCIPAL DISPLAY PANEL – 600 mg

NDC 42292-008-03

Linezolid
Tablets
600 mg

30 Tablets (3 x 10)

Each film-coated tablet contains:
Linezolid 600 mg

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Rx only

S-12269

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Linezolid 600 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
LINEZOLID
linezolid tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42292-008(NDC:0378-7077)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LINEZOLID (LINEZOLID) LINEZOLID 600 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color yellow Score no score
Shape OVAL Size 19mm
Flavor Imprint Code MYLAN;L77
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42292-008-03 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42292-008-01)
1 NDC:42292-008-01 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (42292-008-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078845 12/16/2015 05/31/2019
Labeler — Mylan Institutional Inc. (039615992)

Revised: 12/2018 Mylan Institutional Inc.

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