BUSCOPAN- n-butylscopolammonium bromide injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUTYLSCOPOLAMINE BROMIDE (UNII: 0GH9JX37C8) (BUTYLSCOPOLAMINE - UNII:2Z3E1OF81V)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

INN (International Name):

BUTYLSCOPOLAMINE BROMIDE

Composition:

BUTYLSCOPOLAMINE BROMIDE 20 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

BUSCOPAN is indicated for the control of abdominal pain (colic) associated with spasmodic colic, flatulent colic, and simple impactions in horses. BUSCOPAN should not be used in impaction colics associated with ileus, or in horses with glaucoma.

Product summary:

BUSCOPAN Injectable Solution is supplied in 50 mL multi-dose vials containing 20 mg N-butylscopolammonium bromide per mL. NDC 0010-3701-01 - 50 mL vial

Authorization status:

New Animal Drug Application

Summary of Product characteristics

BUSCOPAN- N-BUTYLSCOPOLAMMONIUM BROMIDE INJECTION
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
----------
BUSCOPAN® INJECTABLE SOLUTION
(N-BUTYLSCOPOLAMMONIUM BROMIDE, 20 MG/ML)
Approved by FDA under NADA # 141-228
Antispasmodic (spasmolytic) and anticholinergic drug for intravenous
use in horses
only.
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
BUSCOPAN Injectable Solution is an antispasmodic (spasmolytic) and
anticholinergic
drug which suppresses spasms of the digestive system.
The chemical name for the active constituent of BUSCOPAN is
N-butylscopolammonium
bromide. It is a water soluble, white crystalline substance with a
molecular weight of
440.40. Each mL of BUSCOPAN contains 20 mg N-butylscopolammonium
bromide, 1.8
mg methylparaben, 0.2 mg propylparaben, 6.0 mg sodium chloride, and
water for
injection. The chemical structure is:
INDICATIONS:
BUSCOPAN is indicated for the control of abdominal pain (colic)
associated with
spasmodic colic, flatulent colic, and simple impactions in horses.
DOSAGE AND ADMINISTRATION:
Administer a single injection of 0.3 mg/kg body weight (0.14 mg/lb),
slowly IV. This is
equivalent to 30 mg N-butylscopolammonium bromide per 100 kg (220
pounds)
bodyweight or 1.5 mL of BUSCOPAN per 100 kg (220 pounds) bodyweight.
DOSING TABLE (DOSAGE 0.68 ML/100 LBS.)
Body Weight
(nearest 100
pounds)
Dose (mL)
Body Weight
(nearest 100
pounds)
Dose (mL)
Body Weight
(nearest 100
pounds)
Dose (mL)
200
1.4
1000
6.8
1800
12.2
300
2.0
1100
7.5
1900
12.9
400
2.7
1200
8.2
2000
13.6
500
3.4
1300
8.8
2100
14.3
600
4.1
1400
9.5
2200
15.0
700
4.8
1500
10.2
2300
15.6
800
5.4
1600
10.9
2400
16.3
900
6.1
1700
11.6
2500
17.0
CONTRAINDICATIONS:
BUSCOPAN should not be used in impaction colics associated with ileus,
or in horses
with glaucoma.
WARNINGS:
Do not use in horses intended for human consumption. Not for use in
humans. Keep
out of reach of children. If ingested, contact a physician
immediately.
PRECAUTIONS:
BUSCOPAN is not recommended for use i