Buscopan: Product Information

BUSCOPAN- butylscopolamine bromide injection
Boehringer Ingelheim Animal Health USA Inc.

NADA 141-228, Approved by FDA

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 is an antispasmodic (spasmolytic) and anticholinergic drug which suppresses spasms of the digestive system.

The chemical name for the active constituent of Buscopan Injectable Solution is N-butylscopolammonium bromide. It is a water soluble, white crystalline substance with a molecular weight of 440.40. Each mL of Buscopan Injectable Solution 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:

Picture of chemical structure.
(click image for full-size original)

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) body weight or 1.5 mL of Buscopan Injectable Solution per 100 kg (220 pounds) body weight.

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 in nursing foals or in pregnant or lactating mares, as safety has not been established. The effects of Buscopan may be potentiated by the concomitant use of other anticholinergic drugs. Studies of concomitant administration of Buscopan with other drugs have not been conducted. Drug compatibility should be monitored closely in patients requiring adjunctive therapy. The safety of Buscopan has not been established for intramuscular (IM) administration. Administration of Buscopan results in heart rate elevation. Heart rate can not be used as a valid indicator of severity of pain for 30 minutes following IV injection.

Adverse Reactions

Transient tachycardia and decreased borborygmal sounds lasted approximately 30 minutes following administration. Transient pupillary dilation may also be observed.

To report suspected adverse reactions, to obtain a Material Safety Data Sheet (MSDS), or for technical assistance, call 1-866-638-2226.

Clinical Pharmacology

Buscopan’s spasmolytic action is based on anticholinergic effects resulting from competitive inhibition of parasympathetic activation (via muscarinic receptors) of smooth muscle cells.1 The major side effect is a mild transient, elevated heart rate.

Pharmacokinetics

Following single IV administration of 14 C-Buscopan (0.4 mg/kg, side chain labeled) in 3 horses, the major route of elimination of total radioactivity was via urine and feces almost equally. The bulk of the radioactivity (>96%) that represents all 14 C-labeled moieties derived from the 14 C-Buscopan dose was eliminated (urine and feces) within the first 48 hours post-dosing. The elimination half-life of total plasma 14 C was estimated to be approximately 6 hours. Therefore, the elimination half-life of the parent drug in plasma is equal to or shorter than 6 hours. The main radioactive component in the urine, which co-chromatographed with Buscopan using thin layer chromatography (TLC), accounted for approximately 85% of the detected radioactivity.

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