TOLAZINE- tolazoline hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Tolazoline Hydrochloride (UNII: E669Z6S1JG) (Tolazoline - UNII:CHH9H12AQ3)

Available from:

Akorn Animal Health, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Tolazine should be used in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine.

Product summary:

NDC 59399-113-90 100 mL multiple-dose vial. NADA # 140-994, Approved by FDA

Authorization status:

New Animal Drug Application

Summary of Product characteristics

TOLAZINE- TOLAZOLINE HYDROCHLORIDE INJECTION, SOLUTION
AKORN ANIMAL HEALTH, INC.
----------
TOLAZINE INJECTION
(tolazoline hydrochloride injection)
100 mg Tolazoline per mL
Sterile Solution
Xylazine Reversing Agent and Antagonist For Intravenous Use in Horses
Only
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
DESCRIPTION:
Tolazine contains tolazoline hydrochloride with the chemical name
1H-Imidazole,4,5-dihydro-2-
(phenylmethyl)-monohydrochloride. Tolazoline hydrochloride has a
molecular weight of 196.68 and
the molecular formula is C
H N •HCl. The structural formula is
Each mL contains: tolazoline hydrochloride equivalent to 100 mg base
activity, chlorobutanol 5.0 mg,
tartaric acid 7.8 mg, sodium citrate dihydrate 7.8 mg and water for
injection. The pH is adjusted with
hydrochloric acid and sodium citrate.
INDICATIONS:
Tolazine should be used in horses when it is desirable to reverse the
effects of sedation and analgesia
caused by xylazine.
DOSAGE AND ADMINISTRATION:
The Tolazine dose is 4.0 mg/kg body weight or 1.8 mg/lb (4 mL/100 kg
or 4 mL/220 lb) to reverse the
sedative effects of xylazine. The carefully calculated dose of
Tolazine should be given slowly by
intravenous injection. Administration rate should approximate 1
mL/second.
The table demonstrates the correct injection volume based on body
weight:
Body Weight (kg)
Body Weight (lb)
Tolazine Injection Volume
250 kg
550 lb
10 mL
500 kg
1100 lb
20 mL
®
10
12
2
1,5
WARNING:
Keep out of reach of children. Not for human use.
Do not use in horses intended for human consumption.
Avoid contact with eyes, skin and mucous membranes. In case of eye
contact flush with plenty of water.
Exposed skin should be washed with soap and water. In case of
accidental oral exposure or injection,
seek emergency medical attention.
Users with cardiovascular disease (for example, hypertension or
ischemic heart disease) should take
special precautions to avoid accidental exposure to this product.
To report adverse reactions in user