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Colic relief within 30 minutes

1

BUSCOPAN

(N-butylscopolammonium bromide)

Injectable Solution

intestinal spasms pain caused by spasmodic colic, flatulent colic or simple impactions

source and severity if pain continues

Used first for fast relief of many types of colic, Buscopan doesn’t prolong the masking of a deteriorating colic situation. Nor does it have adverse effects on gastrointestinal tissue associated with non-steroidal anti-inflammatory drugs (NSAIDs). For more information, call 866-638-2226, or visit www.bi-vetmedica.com

Start colic relief with Buscopan. Buscopan’s major side effect is a mild transient, elevated heart rate. In clinical studies administration of Buscopan resulted in an increased average heart rate of 30% during the first five minutes. By 30 minutes the heart rate did not differ from their pre-treatment values. Therefore, heart rate cannot be used as a valid indicator of severity of pain for 30 minutes after IV injection. Buscopan effects may be potentiated by use with other anticholinergic drugs. For IV use only. Safety for use in nursing foals, pregnant or lactating mares has not been established. See product labeling for complete use information. 1FOI Summary, NADA 141-228 ©2006 Boehringer Ingelheim Vetmedica, Inc. Buscopan is a trademark of Boehringer Ingelheim Vetmedica GmbH D6057-AAEP


Waiting for your Veterinarian to Arrive Once your veterinarian has been contacted, follow his or her instructions concerning what to do until help arrives. These may include: • Removing all feed and water • Keeping the horse as calm and comfortable as possible • Allowing the horse to lie down if it is not at risk of injury • Attempting to walk the horse slowly to prevent rolling Do not administer any medications unless directed to do so by your veterinarian.

Diagnosing Colic Your veterinarian will use a variety of diagnostic methods to determine the nature and severity of your horse’s colic. Depending on the symptoms your horse exhibits, these might include: Physical examination – Temperature, pulse, respiratory rate, abdominal sounds, capillary refill time, and color of the mucous membranes may yield valuable information Passage of a stomach tube – Relieves gas accumulation and may provide information concerning the nature of the problem Rectal examination – To determine the position and contents of digestive organs Other diagnostic procedures – Complete blood counts, blood chemistry, abdominal fluid collection and analysis, ultrasound, gastroscopy, or x-ray may be employed to determine the nature and severity of the problem

370101L-00-0405 NADA 141-228, Approved by FDA Buscopan™ Injectable Solution (N-butylscopolammonium bromide, 20 mg/mL) 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:

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 Dose Body WeightDose Body Weight Dose (nearest 100 pounds)

(mL) nearest 100 pounds)

(mL) (nearest 100 pounds)

(mL)

200 1.4 1000 6.8 1800 12.2 2.0 1100 7.5 1900 12.9 300 400 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: Not for 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 1 800-821-7467. 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 14C-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 14C-labeled moieties derived from the 14C-Buscopan dose was eliminated (urine and feces) within the first 48 hours post-dosing. The elimination half-life of total plasma 14C 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. Effectiveness: A multi-centered, field study was conducted to establish the clinical effectiveness of Buscopan (0.3 mg/kg body weight) for the control of abdominal pain (colic) associated with spasmodic, flatulent and simple impaction colics in horses. A total of 217 cases were randomly assigned to the Buscopan or placebo group; investigators were masked with respect to treatment. Horses underwent a pretreatment colic examination, with repeated exams at 5, 15, and 30 minutes following test article administration. A total colic score was assigned to each case based on 5 individual criteria (sweating, pawing, head and body movement, kicking, and desire to lie down). A general clinical impression was made at the 30-minute post-treatment evaluation. No further evaluations were performed after 30 minutes. Quarter Horses, Arabians, and Thoroughbreds accounted for the majority of the cases. Fifty-three percent of the horses were geldings, 39% were mares and 8% were stal-

lions. Body weights ranged from 300-1700 lb (136-772 kg), with a mean of 968 lb (440 kg). Ages ranged between 4 months and 35 years, with an average of 10.6 years. Total colic scores decreased throughout the 30-minute post-treatment observation period for both Buscopan and placebo. Scores were significantly lower (p≤0.001) for the Buscopan treated horses. Also, 88% of the Buscopan cases were rated as a “success” (excellent, good, or moderate). This was significantly greater (p≤0.0001) than the 42% success rate for the placebo group. The effectiveness of Buscopan was also supported by the overall improvement in the behavioral attitudes of the horses. A significantly higher percentage of Buscopan treated horses were rated as “alert/calm” at 15 and 30 minutes post-treatment (p≤0.005 and 0.0058, respectively), and a significantly (p≤0.006) greater proportion of placebo treated horses were “nervous/restless.” A comparable number of cases for both the Buscopan and placebo groups were classified as “violent” or “drowsy/depressed” at all time points. Post-treatment heart rates were significantly elevated (p≤0.0001) for Buscopan treated horses at 5 and 15 minutes, compared to the placebo treated horses, as expected due to Buscopan’s parasympatholytic effects. By 30 minutes post-treatment, the heart rates for the Buscopan group did not differ significantly from their pre-treatment heart rates. The intensity and frequency of borborygmi in all four abdominal quadrants was decreased for the Buscopan group at most post-treatment evaluation points (p≤0.02). Animal Safety: Target animal safety was evaluated in several studies, including dose tolerance, target animal safety, hemodynamics, and field safety. There were no signs of toxicity or adverse reactions. The pharmacological effects seen in these studies were consistent with those of anticholinergic drugs (see above). In a target animal safety study, Buscopan was evaluated in two phases. In the first phase, the drug was administered intravenously at dosages of 1, 3, and 5 times the recommended level (30, 90 and 150 mg per 100 kg body weight) once daily for three consecutive days. In the second phase it was given at the recommended therapeutic dosage (30 mg per kg body weight) at hourly intervals for three consecutive hours. Horses receiving Buscopan tended to have transient, reduced intensity of auscultated borborygmi, which can be attributed to the intended therapeutic effect of the drug. There was no evidence of gut stasis or colic. No other clinically significant effects were found. Though a transient effect on heart rate was noted in other studies, observations in this study (1-4 hours after drug administration) were made after the primary pharmacological activity for this drug had passed. Neither was there a significant association of dosage with pupil / pupillary light response as has been noted in other studies. Pupillary dilation is an expected pharmacological response to this class of drug (anticholinergic). The lack of a clinical response in this study is also likely related to the longer time after treatment at which the initial observations were made. In any event, this study shows that any effect on pupillary light response is indeed transient. There were no drug associated findings with respect to blood analyses, nor were there any effects evident at necropsy and histopathology. In a tolerance study, four horses were administered 10 times the recommended Buscopan dosage (300 mg/100 kg) and were examined at 10 minutes and then at 1, 2, 3, 4, 24, and 72 hours post injection. All horses temporarily experienced dilated and fixed pupils at 10 minutes post injection. Normal pupillary light reflex returned in two horses at 4 hours and in the other two horses at 24 hours. Heart rates were increased at 10 and 60 minutes, but had returned to normal at 2 hours. Oral mucous membranes were dry at 10 minutes, but were normal at 2 hours. Gut motility, as judged by auscultated borborygmi, was absent at 10 minutes post injection, but had returned to baseline frequency and intensity by 3 hours in 2 horses and by 4 hours in the remaining horses. There were two incidences of colic, with one horse showing mild colic at 1 hour, and another with mild colic at 11 hours. Both colic episodes were transient and required no medication. There were no drug associated changes in CBC, blood coagulation, or serum chemistry. Neither were there any drug-related gross or histopathological changes. In a study of hemodynamic parameters, Buscopan decreased right atrial pressure, while cardiac output was maintained. The hemodynamic changes which occurred following Buscopan administration were of little clinical significance, being qualitatively similar to those reported for low doses of other anticholinergics such as atropine. Storage: Store at controlled room temperature, 59-86°F (15-30°C). How Supplied: Buscopan Injectable Solution is supplied in 50 mL multi-dose vials containing 20 mg N-butylscopolammonium bromide per mL. References: 1 Roelvinck, M.E.J., et al. 1991. Analgesic and spasmolytic effects of dipyrone, hyoscine-N-butylbromide and a combination of the two in ponies. Veterinary Record 129:379380 Manufactured by: Boehringer Ingelheim Vetmedica, Inc. St. Joseph, MO 64506 Buscopan™ is a trademark of Boehringer Ingelheim Pharma GmbH & Co. KG and used under license. 370101L-00-0405 Code 370111 Revised 05/2004

Guide to

Colic relief for the horse owner

A major problem for you as a horse owner is identifying the signs of colic. That’s because signs can vary and may depend on the severity of the pain. Some of the more common signs of colic include: • Pawing at the ground • Sweating • Lip curling • Elevated pulse rate • Absence of digestive sounds • Turning the head toward the flank • Kicking or biting • Rolling, especially violently Your veterinarian may need to see a horse showing signs of colic as soon as possible. If the cause of the colic is not identified and relieved quickly, the affected horse may injure itself, or complicate the colic by rolling violently in response to the severe pain.

What Causes Colic?

B USCOPAN (N-butylscopolammonium bromide) ™

Injectable Solution

1-866-638-2226 www.bi-vetmedica.com ©2007 Boehringer Ingelheim Vetmedica, Inc. Buscopan is a trademark of Boehringer Ingelheim Vetmedica GmbH D6058 QXM BI 3701-14

Signs of Colic

Relax... Relieve... Assess... 2/07

Colic is not a disease in itself but a general term that refers to abdominal pain. A number of digestive tract disorders result in colic. In the early stages the mild, non-life threatening cases of colic caused by temporary gas accumulation or simple impactions are difficult to distinguish from more serious colic caused by severe twisted bowel or severe impactions. All cases of abdominal pain should be treated as potentially serious medical emergencies. Contact your veterinarian immediately if your horse shows signs of abdominal pain.


To quickly relax the smooth muscles of the gastro-intestinal tract, your veterinarian’s first treatment for colic may be BuscopanTM (N-butylscopolammonium bromide) Injectable Solution. Buscopan Injectable Solution is the only anti-spasmodic labeled for control of abdominal pain associated with spasmodic colic, flatulent colic and simple impactions. Your veterinarian may choose to use this drug first in the treatment regimen for colic, prior to administration of analgesics, sedatives, or other drugs.

Buscopan is a good drug to use first for colic. The effect it has on colicky horses is quite profound; it’s quick and you can visibly see the horse relax as soon as you give it.

Colic relief within 30 minutes in 88% of cases 1

BUSCOPAN

(N-butylscopolammonium bromide)

Injectable Solution

intestinal spasms pain caused by spasmodic colic, flatulent colic or simple impactions

source and severity if pain continues

Bart Barber, DVM, Rood & Riddle, Lexington, KY

Buscopan works fast. I’ve had horses that people are walking in circles to keep them from rolling. I give them a shot and in two minutes they are fine. At least 70 percent of my colic cases are taken care of with Buscopan…it does a nice job.

If after 30 minutes the horse continues to have pain, your veterinarian can assess the source and severity to determine if additional medical treatments may be necessary.

• Studies have shown 88% of colic horses were judged by veterinarians to be successfully relieved of colic spasms within 30 minutes1. • No prolonged masking of a deteriorating colic situation. • Further assessment is possible by your attending veterinarian in about 30 minutes. • Expect a mild transient, elevated heart rate within the first 5 minutes that returns to normal within approximately 30 minutes.

Gary Fouts, DVM, Equine Veterinary Hospital of Northern Indiana, Bremen, IN

1-866-638-2226 www.bi-vetmedica.com 1FOI

Summary, NADA 141-228

Buscopan has been an excellent product for Equine Sports Medicine in treating for gas and spasmodic colic. I’ll treat about 20 colic cases per month and Buscopan usually is the only treatment administered in 80 percent of the cases. Dr. Brian T. Saathoff, DVM, Equine Sports Medicine, Cypress, CA

Buscopan is fast acting with very fast pain relief. It’s becoming our first treatment for all horses with initial signs of colic. I estimate 80 to 90 percent of colic horses respond with only Buscopan…for horses that don’t respond completely with Buscopan in half an hour, they need immediate and more aggressive treatment in the clinic.

Many useful drugs are available to treat equine colic. Early in the course of the colic episode, analgesics and/or sedatives are often used to relieve the horse’s pain. While the horse appears to feel better, these drugs may disguise the worsening signs of colic without doing anything to relieve the cause of the colic. This can complicate the diagnostic and prognostic attempts of the veterinarian.

When used first for fast relief of many types of colic, Buscopan quickly addresses the cause and doesn’t mask a deteriorating colic situation. This allows your veterinarian to more quickly and accurately diagnose the condition of your horse. Time is critical when treating colic. Buscopan is administered I.V. and begins working to relax intestinal spasms within 5 to 10 minutes1. Buscopan relieves pain caused by spasmodic colic, flatulent colic or simple impactions. The effects of Buscopan last about 30 minutes. Studies have shown that 88 percent of colic horses were judged by veterinarians to be successfully relieved of colic spasms within 30 minutes1.

Treatment of Colic

Joe Carter, DVM, Oklahoma Equine Hospital, Washington, OK

Buscopan’s major side effect is a mild transient, elevated heart rate. In clinical studies administration of Buscopan resulted in an increased average heart rate of 30% during the first five minutes. By 30 minutes the heart rate did not differ from their pre-treatment values. Therefore, heart rate cannot be used as a valid indicator of severity of pain for 30 minutes after IV injection. Buscopan effects may be potentiated by use with other anticholinergic drugs. For IV use only. Safety for use in nursing foals, pregnant or lactating mares has not been established.


Colic relief

within 30 minutes in 88% of cases1

BUSCOPAN

Injectable Solution

(N-butylscopolammonium bromide)

Start colic relief with Buscopan. Buscopan

• Studies have shown that 88% of colic horses were judged by veterinarians to be successfully relieved of colic spasms within 30 minutes1

Administration

IV

Antispasmodic Relaxes gastrointestinal smooth muscles Fast initial response — 5-10 min. in most horses1 Controls colic pain associated with spasmodic colic Short duration of effect — 30 min. in most horses1 Prolonged masking of a deteriorating colic situation

YES YES YES YES YES NO

866-638-2226

www.bi-vetmedica.com

• In horses pre-treated with NSAIDS and analgesics that were non-responsive, Buscopan was shown to be 87% successful in achieving a postive clinical response within 30 minutes.1 • Behavioral attitude scores relative to “alert/calm” parameters improved from 13% pre-treatment to 67% at 15 minutes post-treatment, and 73% at 30 minutes post-treatment.1 • Total colic scores (based upon a pre-treatment colic examination and evaluation of clinics signs) decreased from 6.5 pre-treatment to 2.4 post-treatment at 15 minutes and fell to a score of 2.1 post-treatment at 30 minutes.1

Buscopan’s major side effect is a mild transient, elevated heart rate. In clinical studies administration of Buscopan resulted in an increased average heart rate of 30% during the first five minutes. By 30 minutes the heart rate did not differ from their pre-treatment values. Therefore, heart rate cannot be used as a valid indicator of severity of pain for 30 minutes after IV injection. Buscopan effects may be potentiated by use with other anticholinergic drugs. For IV use only. Safety for use in nursing foals, pregnant or lactating mares has not been established. FOI Summary, NADA 141-228

1

©2007 Boehringer Ingelheim Vetmedica, Inc. Buscopan is a trademark of Boehringer Ingelheim Vetmedica GmbH D6059 BI 3701-12 02/07

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