SPORIMUNE- cyclosporine capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYCLOSPORINE (UNII: 83HN0GTJ6D) (Cyclosporine - UNII:83HN0GTJ6D)

Available from:

Dechra Veterinary Products LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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

Product summary:

Sporimune is supplied in packages of 15 unit-dose blisters as follows: 10 mg: oval, off-white capsules imprinted with black "D 10" (NDC 17033-260-15). 25 mg: oval, gray capsules imprinted with black "D 25" (NDC 17033-261-15). 50 mg: oblong, off-white capsules imprinted with black "D 50" (NDC 17033-262-15). 100 mg: oblong, gray capsules imprinted with black "D 100" (NDC 17033-263-15).

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

SPORIMUNE- CYCLOSPORINE CAPSULE
DECHRA VETERINARY PRODUCTS LLC
----------
SPORIMUNE™
(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:
Sporimune (cyclosporine capsules) USP MODIFIED is an oral form of
cyclosporine that
immediately forms a microemulsion in an aqueous environment.
Cyclosporine, the active
ingredient in Sporimune 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-N-
methyl-L-leucyl-L-alanyl-D-ananyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl].
The structural formula is:
INDICATIONS:
Sporimune 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 Sporimune 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 Sporimune 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.
Sporimune 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 × 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 �