AnaSed 100 Injection

Name: AnaSed 100 Injection

Description

AnaSed® is supplied in 50 mL multiple-dose vials as a sterile solution.

EACH ML CONTAINS: Xylazine hydrochloride equivalent to 100 mg of base activity, methylparaben 0.9 mg, propylparaben 0.1 mg, sodium citrate dihydrate 5.0 mg and water for injection. pH adjusted with citric acid and sodium citrate.

Protect from heat. Do not store over 30° C (86° F).

Pharmacology

Xylazine, a non-narcotic compound, is a sedative and analgesic as well as a muscle relaxant. Its sedative and analgesic activity is related to central nervous system depression. Its muscle-relaxant effect is based on inhibition of the intraneural transmission of impulses in the central nervous system. The principal pharmacological activities develop within 10 to 15 minutes after intramuscular injection in horses and Cervidae, and within 3 to 5 minutes following intravenous administration in horses.

A sleeplike state, the depth of which is dose-dependent, is usually maintained for 1 to 2 hours, while analgesia lasts from 15 to 30 minutes. The centrally acting muscle-relaxant effect causes relaxation of the skeletal musculature complementing sedation and analgesia.

In horses and Cervidae under the influence of xylazine, the respiratory rate is reduced as in natural sleep. Following treatment with xylazine, the heart rate is decreased and a transient change in the conductivity of the cardiac muscle may occur, as evidenced by a partial atrioventricular block. This resembles the atrioventricular block often observed in normal horses.1,2,3,4 Although a partial A-V block may occasionally occur following intramuscular injection of xylazine, the incidence is less than when it is administered intravenously. Intravenous administration of xylazine causes a transient rise in blood pressure, followed by a slight decrease.

Xylazine has no effect on blood clotting time or other hematologic parameters.

Dosage and Administration

  1. Dosage
    Horses:
    Intravenous — 0.5 mL/100 lb body weight (0.5 mg/lb or 1.1 mg/kg).
    Intramuscular — 1.0 mL/100 lb body weight (1 mg/lb or 2.2 mg/kg).
    Cervidae:
    Administer intramuscularly, by either hand syringe or syringe dart, in the heavy muscles of the croup or shoulder.
    Fallow Deer (Dama dama) — 2.0 to 4.0 mL/100 lbs body weight (2.0 to 4.0 mg/lb or 4.4 to 8.8 mg/kg).
    Mule Deer (Odocoileus hemionus) — 1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb or 2.2 to 4.4 mg/kg).
    Sika Deer (Cervus nippon) — 1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb or 2.2 to 4.4 mg/kg).
    White-Tailed Deer (Odocoileus virginianus) — 1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb or 2.2 to 4.4 mg/kg).
    Elk (Cervus canadensis) — 0.25 to 0.5 mL/100 lbs body weight (0.25 to 0.5 mg/lb or 0.55 to 1.1 mg/kg).
    Following injection of xylazine, the animal should be allowed to rest quietly until the full effect has been reached.
    These dosages produce sedation which is usually maintained for 1 to 2 hours, and analgesia which lasts for 15 to 30 minutes.
  2. Preanesthetic to Local Anesthesia
    Xylazine at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine.
  3. Preanesthetic to General Anesthesia
    Xylazine at the recommended dosage rates produces an additive effect to central nervous system depressants such as pentobarbital sodium, thiopental sodium and thiamylal sodium. Therefore, the dosage of such compounds should be reduced and administered to the desired effect. In general, only 1/3 to 1/2 of the calculated dosage of the barbiturates will be needed to produce a surgical plane of anesthesia. Post-anesthetic or emergence excitement has not been observed in animals preanesthetized with xylazine.

Xylazine has been used successfully as a preanesthetic agent for pentobarbital sodium, thiopental sodium, thiamylal sodium, nitrous oxide, ether, halothane, glyceryl guaiacolate and methoxyflurane anesthesia.

Safety

Xylazine has been tested in horses at 5 times the recommended dose, and at doses above the recommended range in Cervidae. However, doses of this magnitude may produce convulsions and long periods of sedation in horses and muscle tremors and long periods of sedation in Cervidae.

References

  1. Detweiler, D. K.: The Diagnosis and Significance of Cardiac Arrhythmias in Progress in Equine Practice. Edited by E. J. Catcott and J. F. Smithcors. American Veterinary Publications, Inc., Santa Barbara, California and Wheaton, Illinois, (1966), 280-281.
  2. Glazier, D. B.: Atrioventricular Heart Block. Irish Vet. J., Vol. 12 (1958): 194-198.
  3. Holmes, J. R., Alps, B. J.: Observations on Partial Atrioventricular Heart Block in the Horse. Can. Vet. J., Vol. 7, No. 12, (1966), 280-290.
  4. Smetzer, D. L, Smith, C. R., Senta, T: Second Degree Atrioventricular Block in the Horse. Am. J. Vet. Res., Vol. 30, No. 6, (1969), 933-946.

AKORN
Animal Health
Manufactured by:
Akorn, Inc.
Lake Forest, IL 60045
XYA0N       Rev. 07/14
U.S. Pat. No. 4,614,798

Principal Display Panel Text for Container Label:

NDC 59399-111-50

AnaSed®

INJECTION

Xylazine 100 mg/mL

Sedative and Analgesic

For Horses and Cervidae

50 mL

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Do not use in Cervidae less than 15 days

before or during the hunting season.

NADA #139-236, Approved by FDA

Principal Display Panel Text for Carton Label:

NDC 59399-111-50

AnaSed®

INJECTION

Xylazine 100 mg/mL

Sedative and Analgesic

For Horses and Cervidae

50 mL

CAUTION: Federal law restricts this drug

to use by or on the order of a

licensed veterinarian.

Do not use in Cervidae less than 15 days

before or during the hunting season.

Akorn Animal Health Logo

NADA #139-236, Approved by FDA

ANASED 
xylazine hydrochloride injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:59399-111
Route of Administration INTRAVENOUS, INTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Xylazine Hydrochloride (UNII: NGC3S0882S) (Xylazine - UNII:2KFG9TP5V8) Xylazine 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Trisodium Citrate Dihydrate (UNII: B22547B95K)  
Water (UNII: 059QF0KO0R)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59399-111-50 1 in 1 CARTON
1 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA139236 03/03/2015
Labeler - Akorn Animal Health, Inc. (078876357)
Establishment
Name Address ID/FEI Business Operations
Akorn, Inc 063434679 PACK, LABEL
Establishment
Name Address ID/FEI Business Operations
Akorn, Inc. 155135783 MANUFACTURE, ANALYSIS, STERILIZE
Revised: 3/2015 Document Id: fb3db47f-e3e1-4527-b1e3-a6c99af102f4 Set id: d994cde8-cf50-49c4-8a1b-e558620d8b28 Version: 1 Effective Time: 20150303   Akorn Animal Health, Inc.
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