Buscopan: Product Information
BUSCOPAN- butylscopolamine bromide injection
Boehringer Ingelheim Animal Health USA Inc.
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.
| 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 Safety Data Sheet (SDS), or for technical assistance, call 1-888-637-4251.
For additional information about adverse drug experience reporting for animal drugs, contact FDA by telephone 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.
Clinical Pharmacology:
The spasmolytic action of BUSCOPAN 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.
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