PROGRAM 6 MONTH FOR CATS- lufenuron injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LUFENURON (UNII: 1R754M4918) (LUFENURON - UNII:1R754M4918)

Available from:

Elanco US Inc.

INN (International Name):

LUFENURON

Composition:

LUFENURON 100 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

PROGRAM 6 Month Injectable for Cats is indicated for use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.

Product summary:

PROGRAM 6 Month Injectable for Cats is available in 0.4 ml and 0.8 ml unit dose syringes, formulated according to the weight of the cat. Unit dose packs are available in packages of 10 syringes per carton.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

PROGRAM 6 MONTH FOR CATS- LUFENURON INJECTION, SUSPENSION
ELANCO US INC.
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_PROGRAM_
_(LUFENURON)_
6 MONTH INJECTABLE FOR CATS
The six-month injection that controls flea populations in cats.
CAUTION
U.S. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
PROGRAM (lufenuron) 6 Month Injectable for Cats is available in two
syringe sizes for
subcutaneous administration to cats and kittens according to their
weight (See Dosage).
Each preloaded syringe is formulated to provide 4.54 mg/pound (10
mg/kg) body weight
of lufenuron. The active ingredient of PROGRAM 6 Month Injectable for
Cats is lufenuron,
a benzoylphenyl-urea derivative with the following chemical
composition: N-[2,5-dichloro-
4-(1,1,2,3,3,3,-hexafluoropropoxy)-phenylaminocarbonyl]-2,6-difluorobenzamide.
Benzoylphenyl-urea compounds, including lufenuron, are classified as
insect
development inhibitors (IDIs).
MODE OF ACTION
Lufenuron, the active ingredient of PROGRAM 6 Month Injectable for
Cats, is an insect
development inhibitor which breaks the flea life cycle by inhibiting
egg development.
Lufenuron's mode of action is interference with chitin synthesis,
polymerization and
deposition. Lufenuron has no effect on adult fleas.
After biting a lufenuron-treated cat, the female flea ingests a blood
meal containing
lufenuron which is subsequently deposited in her eggs. Lufenuron
prevents flea eggs
from hatching and developing into adults and thus controls flea
populations by breaking
the life cycle. (See Efficacy.)
INDICATIONS
PROGRAM 6 Month Injectable for Cats is indicated for use in cats, six
weeks of age and
older, for the control of flea populations.
Lufenuron controls flea populations by preventing the development of
flea eggs and
does not kill adult fleas. Concurrent use of insecticides may be
necessary for adequate
control of adult fleas.
WARNING
DO NOT USE IN DOGS. A SEVERE LOCAL REACTION MAY OCCUR IN DOGS THAT IS
NOT
SEEN IN CATS.
PRECAUTIONS
The safety of PROGRAM 6 Month Injectable for Cats in