ATOPICA- cyclosporine capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

cyclosporine (UNII: 83HN0GTJ6D) (cyclosporine - UNII:83HN0GTJ6D)

Available from:

Elanco US Inc.

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

ATOPICA is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. ATOPICA is contraindicated for use in dogs with a history of neoplasia. Do not use in dogs with a hypersensitivity to cyclosporine.

Product summary:

ATOPICA soft gelatin capsules (cyclosporine capsules) USP MODIFIED are supplied in packages of 15 unit-dose blisters as follows: Manufactured for: Elanco US Inc. Greenfield, IN 46140, USA Approved by FDA under NADA # 141-218 Revision Date: July 2020 Atopica, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. A161259 Elanco™

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ATOPICA- CYCLOSPORINE CAPSULE, GELATIN COATED
ELANCO US INC.
----------
ATOPICA™
(cyclosporine capsules) USP MODIFIED
CAUTION:
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
Keep this and all drugs out of reach of children.
DESCRIPTION:
ATOPICA (cyclosporine capsules) USP MODIFIED is an oral form of
cyclosporine that
immediately forms a microemulsion in an aqueous environment.
Cyclosporine, the active
ingredient in ATOPICA, is a cyclic polypeptide, immune modulating
agent consisting of 11
amino acids. It is produced as a metabolite by the fungal species
_Beauveria nivea_.
Chemically, cyclosporine A is designated
Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-
2(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-
Nmethyl-L-leucyl-L-alanyl-D-ananyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl].
The structural formula is:
INDICATIONS:
ATOPICA is indicated for the control of atopic dermatitis in dogs
weighing at least 4 lbs.
(1.8 kg) body weight.
DOSAGE AND ADMINISTRATION:
The initial dose of ATOPICA is 5 mg/kg/day (3.3-6.7 mg/kg/day) as a
single daily dose for
30 days. Following this initial daily treatment period, the dose of
ATOPICA may be
tapered by decreasing the frequency of dosing to every other day or
twice weekly, until
a minimum frequency is reached which will maintain the desired
therapeutic effect.
ATOPICA should be given at least one hour before or two hours after a
meal. If a dose is
missed, the next dose should be administered (without doubling) as
soon as possible,
but dosing should be no more frequent than once daily.
DOSE ADMINISTRATION
DOG BODY WEIGHT (LBS)
DOG BODY WEIGHT (KG)
DOSE 5 MG/KG
4 – 6.5 lbs
2 – 2.9 kg
10 mg capsule
6.6 – 9 lbs
3 – 3.9 kg
2 x 10 mg capsules
9.1 – 16 lbs
4 – 7.9 kg
25 mg capsule
16.1 – 33 lbs
8 – 14.9 kg
50 mg capsule
33.1 – 64 lbs
15 – 28.9 kg
100 mg capsule
64.1 – 79 lbs
29 – 35.9 kg
100 mg capsule
+50 mg capsule
79.1 – 121 lbs
36 – 55.9 kg
2 x 100 mg capsules
CO