Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
cyclosporine (UNII: 83HN0GTJ6D) (cyclosporine - UNII:83HN0GTJ6D)
Elanco US Inc.
CYCLOSPORINE
CYCLOSPORINE 10 mg
ORAL
PRESCRIPTION
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.
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™
New Animal Drug Application
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 Lestu allt skjalið