- SPL UNCLASSIFIED SECTION
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DESCRIPTION:
Yobine® contains yohimbine with the chemical name 17 alpha-hydroxy-20 alpha-yohimban-16 beta-carboxylic acid methyl ester. Yohimbine hydrochloride has a molecular weight of 390.89, and the molecular formula is C21H26N2O3•HCl. The structural formula is:
Each mL contains: Yohimbine (as the hydrochloride) 2.0 mg, methylparaben 0.9 mg, propylparaben 0.1 mg, citric acid 3.34 mg, and water for injection, pH adjusted with sodium hydroxide.
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- WARNING:
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PRECAUTIONS:
The safety of yohimbine in pregnant dogs or in dogs intended for breeding has not been established.
Careful consideration should be given before administering to dogs known to be epileptic or seizure prone. The drug reverses the analgesic effects of xylazine as well as the sedative effects. If the animal was given xylazine for its analgesic properties, reversal may result in return of normal pain perception.
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PHARMACOLOGY:
Yohimbine is an indolealkylamine alkaloid that acts primarily by blocking central alpha-2 adrenoreceptors that are stimulated by xylazine. Yohimbine is an alpha-2 adrenergic receptor antagonist that easily penetrates the blood-brain barrier. It competitively blocks and antagonizes central nervous system depression or sedation and the bradycardia and respiratory depression caused by xylazine.
Xylazine, an alpha-2 adrenergic agonist with potent sedative, analgesic and muscle relaxant properties, has been used extensively as an analgesic-sedative restraining agent. It has also been used as a preanesthetic agent for many general anesthetics. The central nervous system depressant effect, as well as other pharmacologic effects, is dose dependent.
Yohimbine is useful to counteract the sedation after standard doses of xylazine. The competitive selective blocking of the alpha-2 adrenergic receptor by yohimbine displaces xylazine from these sites and thereby rapidly cancels the effect of the xylazine.
Yohimbine, when used at the prescribed dose, will effectively reverse the effects of xylazine when it is used alone in dogs. Yohimbine abbreviates the anesthesia and chemical restraint of the xylazine.
The reversal of the sedative effects of xylazine by I.V. injection of yohimbine is rapid, usually occurring within one to three minutes, regardless of the route of administration of xylazine.
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REFERENCES:
- Short, C.E., Ed: Principles and Practice of Veterinary Anesthesia, Williams and Wilkens, Baltimore, MD, 1987.
- Hsu, WH. Xylazine-lnduced Depression and Its Antagonism by Alpha Adrenergic Blocking Agents. The Journal of Pharmacology and Experimental Therapeutics. Vol. 218, No. 1, (188-192), 1981.
- Hatch, RC, et al. Antagonism of Xylazine Sedation with Yohimbine, 4-Aminopyridine, and Doxapram in Dogs. American Journal of Veterinary Research. Vol. 46, No. 2, (371-375), 1985.
- Vet-A-Mix Research
AKORN ANIMAL HEALTH
Manufactured by:
Akorn, Inc.
Lake Forest, IL 60045
YO00N Rev. 04/18 -
PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Container Label:
NDC 59399-115-20
Yobine®
INJECTION
(yohimbine injection) 2 mg/mL
Xylazine Reversing Agent and
Antidote for Use in Dogs Only
20 mL
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
NADA #140-866, Approved by FDA
-
PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
NDC 59399-115-20
Yobine®
INJECTION
(yohimbine injection)
2 mg/mL
Xylazine Reversing Agent
and Antidote for Use
in Dogs Only
20 mL
CAUTION: Federal law restricts
this drug to use by or on the
order of a licensed veterinarian.
Akorn Animal Health Logo
NADA #140-866, Approved by FDA
-
INGREDIENTS AND APPEARANCE
YOBINE
yohimbine hydrochloride injection, solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:59399-115 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Yohimbine Hydrochloride (UNII: NB2E1YP49F) (Yohimbine - UNII:2Y49VWD90Q) Yohimbine 2.0 mg in 1 mL Inactive Ingredients Ingredient Name Strength Methylparaben (UNII: A2I8C7HI9T) 0.9 mg in 1 mL Propylparaben (UNII: Z8IX2SC1OH) 0.1 mg in 1 mL Citric Acid Monohydrate (UNII: 2968PHW8QP) 3.34 mg in 1 mL Water (UNII: 059QF0KO0R) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59399-115-20 1 in 1 CARTON 1 20 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA140866 02/25/2015 Labeler - Akorn Animal Health, Inc. (078876357) Establishment Name Address ID/FEI Business Operations Akorn, Inc 603980319 MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL