LINCOMYCIN- lincomycin injection

LINCOMYCIN by

Drug Labeling and Warnings

LINCOMYCIN by is a Animal medication manufactured, distributed, or labeled by Sparhawk Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

300 mg/mL 

STERILE LINCOMYCIN INJECTION

Caution:Federal law restricts this drug to use by or on the order of a licenced veterinarian. 

SWINE ANTIBIOTIC

Indicated for the treatment of arthritis caused by susceptible ortanisims and for mycoplasma pneumonia.

Lincomycin Injectable contains lincomycin hydrochloride, an antibiotic produced bySteptomyces lincolnensis var. lincolnensis, which is chemically distinct from all other clinically avaialbel antibiotics and is isolated as a white crystalline solid

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Not for Use in Humans
Keep out of reach of children

INDICATIONS FOR SWINE

Lincomycin injectable is indicated for the treatment of infectious forms of arthritis caused by organisms sensitive to its activity. This includes most of the organisms responsible for the various infectious arthritides in swine, such as staphylococci, streptococci,Erysipelothrix and  Mycoplasma spp.

CONTRAINDICATIONS

As with all drugs, the use of Lincomycin Injectable is contraindicated in animals previously found to be hypersensitive to the drug.

WARNING

Swine intended for human consumption should not be slaughtered within 48 hours of latest treatment. Not for human use.

CAUTION

If no improvement is noted within 48 hours, consult a veterinarian.

ADVERSE REACTIONS

The intramuscular administration to swine may cause a transient diarrhea or loose stools. Although this effect had rarely been reported, one must be alert to the possibility that it may occur. Should this occur, it is important that the necessary steps be taken to prevent the effects of dehydration.

CONTACT INFORMATION 

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Sparhawk Laboratories Inc at 1-800-255-6388 or 1-913-888-7500. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

DOSAGE AND ADMINISTRATION 

For arthritis or mycoplasma pneumonia-5mg per pound of body weight intramuscularly once daily for three to seven days as needed. When using lincomycin injection containing 25 mg/mL, 1 mL/5 lb. body weight will provide 5 mg/lb.
When using lincomycin injection containing 100 mg/mL, 1mL/20lb body weight will provide 5mg/lb. When using lincomycin injection containing 300 mg/mL, 1 mL/60 lb. body weight will provide 5 mg/lb.
For optimal results, initiate treatment as soon as possible. As with any multi-dose vial, practice aseptic techniques in withdrawing each dose. Adequately clean and disinfect the vial closure prior to entry with a sterile needle and syringe. No vial closure should be entered more than 20 times.

HOW SUPPLIED

Lincomycin Injectable is available in three concentrations: 300 mg/mL, 100 mg/mL and 25 mg/mL

300 mg/mL: For use in swine weighing 300 pounds or more. Each mL contains lincomycin hydrochloride equivalent to lincomycin, 300 mg, also Benzyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.

100 mg/mL: Each mL contains lincomycin hydrochloride equivalent to lincomycin, 100 mg; also Benzyl Alcohol, 9,45 mg added as preservative. Supplied in 100 mL vials.

25 mg/mL: Special baby pig concentration. Each mL contains lincomycin hydrochloride equivalent to lincomycin, 25 mg; also Benyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.

STORAGE AND HANDLING

Store at controlled room temperature: 20o to 25oC (68o to 77oF) [see USP]

Lincomycin 300

INGREDIENTS AND APPEARANCE

LINCOMYCIN  
lincomycin injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 58005-636
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)	LINCOMYCIN	300 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58005-636-04	100 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200315	01/21/2004

Labeler - Sparhawk Laboratories, Inc. (147979082)