Label: MILBEMITE- milbemycin oxime solution
- NDC Code(s): 58198-8602-5
- Packager: Elanco US Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated December 13, 2023
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- SPL UNCLASSIFIED SECTION
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Description:
MILBEMITE OTIC Solution is available in plastic dispensing tubes. Each plastic tube contains 0.25 mL of MILBEMITE OTIC Solution as a 0.1% solution of milbemycin oxime. Milbemycin oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A4 (C32H45NO7, MW 555.71) and 20% A3 (C31H43NO7, MW 541.68).
- Indications:
- Human Warnings:
- Precautions:
- Adverse Reactions:
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Dosage:
MILBEMITE OTIC Solution should be administered topically into the external ear canal as the entire contents of a single-dose tube per ear. The volume delivered will be approximately 0.2 mL, with 0.05 mL residual volume remaining in dispensing tube. Repeat the treatment one time if necessary, based upon the ear mite life cycle and the response to treatment.
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Administration:
MILBEMITE OTIC Solution should be administered as one tube per ear as a single treatment. Each foil pouch contains two tubes of solution, one for each ear. Open the tube by pressing cap down firmly to break seal. Remove cap and check to be sure tip of tube is open. Squeeze the tube to administer the contents of one tube into each external ear canal. Massage the base of the ear for optimal distribution. In clinical field trials, ears were not cleaned and many animals still had debris in their ears at the end of the study. Cleaning of the external ear canal prior to treatment may be performed, but is not necessary to provide effectiveness.
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Effectiveness:
The clinical effectiveness of milbemycin oxime 0.1% solution was evaluated in a placebo-controlled clinical field trial of client-owned cats. Otodectes cynotis infestation was diagnosed by direct microscopic visualization of ear swab debris. Test or placebo treatment was administered to both ears of the cat following the pre-treatment examination. Cats’ ears were examined by ear swab microscopy at multiple intervals throughout the life cycle of the mite (up to day 30). Ninety-nine percent (99%) of the milbemycin oxime-treated group were ear mite negative at the microscopic exams.
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Safety:
A study was conducted using otic doses of 0.1, 0.3 or 0.5% milbemycin oxime solutions administered once weekly for six applications in kittens that were 4 weeks of age at the initiation of the study. Otic doses of 0.1 and 0.3% did not produce adverse systemic or local effects. One kitten treated with 0.5% was lethargic 8 hours after the second treatment. The kitten was offered milk replacer and by 10 hours post-treatment it appeared normal. In this kitten, lethargy was not observed after subsequent treatments. A study was conducted to evaluate the safety of a 0.1% milbemycin oxime solution in adult cats. Topical doses at 1X, 3X or 5X the recommended dose applied in one ear did not produce adverse effects.
- Storage Conditions:
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How Supplied:
MILBEMITE OTIC Solution is supplied in individual white polypropylene tubes, paired in a foil overlay pouch. The product is packaged in a box of 10 pouches of 2 tubes of 0.25 mL each.
Product of Japan
Manufactured for: Elanco US Inc.
Greenfield, IN 46140, USAApproved by FDA under NADA # 141-163
Milbemite, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2022 Elanco or its affiliates
Revision Date: May 2022
PA103718X
ElancoTM
- Principal Display Panel - Carton Label
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Principal Display Panel - Pouch Label
MilbeMite™
OTIC Solution (0.1% milbemycin oxime)
For the treatment of ear mite (Otodectes cynotis)
infestations in cats and kittens.FOR USE IN CATS & KITTENS FOUR WEEKS OF
AGE AND OLDERNet Contents: 2 tubes of 0.25 mL each
HUMAN WARNINGS:
Not for human use. Keep this and all drugs out
of the reach of children.CAUTION: Federal (USA) law restricts this drug
to use by or on the order of a licensed veterinarian. -
INGREDIENTS AND APPEARANCE
MILBEMITE
milbemycin oxime solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-8602 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Milbemycin oxime (UNII: 0502PUN0GT) (Milbemycin oxime - UNII:0502PUN0GT) Milbemycin oxime 1 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-8602-5 10 in 1 BOX 1 2 in 1 POUCH 1 0.25 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141163 11/01/2015 Labeler - Elanco US Inc. (966985624)