Linezolid (Page 7 of 7)

17 PATIENT COUNSELING INFORMATION

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

Patients should be advised that:

  • Linezolid 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. 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 HCl or phenylpropanolamine HCl, 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.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Camber Pharmaceuticals, Inc. as follows:
(600 mg / 30 UD) NDC 60687-309-21 packaged from NDC 31722-749

Distributed by:
American Health Packaging Columbus, OH 43217

8430921/1120

Package/Label Display Panel – Carton – 600 mg

600 mg Linezolid Tablets Carton
(click image for full-size original)

NDC 60687- 309 -21

Linezolid
Tablets

600 mg

30 Tablets (3 x 10)                Rx Only

Each Film Coated Tablet Contains:
Linezolid………………………………………………………………….. 600 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 # 31722-749, Camber Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

730921 0430921/1120

Package/Label Display Panel – Blister – 600 mg

600 mg Linezolid Tablet Blister
(click image for full-size original)

Linezolid Tablet

600 mg

LINEZOLID linezolid tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-309(NDC:31722-749)
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
CARNAUBA WAX
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off white) Score no score
Shape OVAL (OVAL) Size 18mm
Flavor Imprint Code I;22
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-309-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-309-11)
1 NDC:60687-309-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-309-21)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204239 02/07/2018
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-309)

Revised: 10/2022 American Health Packaging

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