Butorphanol

For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.

Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Torphadine®

For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.

For subcutaneous injection. Dose may be repeated up to 4 times per day. Do not treat for more than 2 days. Safety for use in pregnant female cats, breeding male cats of kittens less than 4 months of age has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Torbugesic-SA®

For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract.

Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Torbutrol® Injection

TORPHADINE (butorphanol tartrate injection) is indicated for the relief of pain associated with colic in adult horses and yearlings. Clinical studies in the horse have shown that butorphanol tartrate injection alleviates abdominal pain associated with torsion, impaction, intussusception, spasmodic and tympanic colic and postpartum pain.

Torphadine® CIV (butorphanol tartrate injection)

Butorphanol Injection (butorphanol tartrate) is indicated for the relief of pain associated with colic in adult horses and yearlings. Clinical studies in the horse have shown that butorphanol tartrate alleviates abdominal pain, associated with torsion, impaction, intussusception, spasmodic and tympanic colic, and postpartum pain.

Butorphanol CIV(butorphanol tartrate)Injection

Vetorphic (butorphanol tartrate injection) is indicated for the relief of pain associated with colic in adult horses and yearlings. Clinical studies in the horse have shown that butorphanol tartrate alleviates abdominal pain, associated with torsion, impaction, intussusception, spasmodic and tympanic colic, and postpartum pain.

VET OneVetorphicTM CIV(butorphanol tartrate injection)Injection

TORBUGESIC (butorphanol tartrate injection) is indicated for the relief of pain associated with colic in adult horses and yearlings. Clinical studies in the horse have shown that TORBUGESIC alleviates abdominal pain associated with torsion, impaction, intussusception, spasmodic and tympanic colic and postpartum pain.

Torbugesic® (butorphanol tartrate injection)

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Torphadine® CIV (butorphanol tartrate injection)

Comparative Pharmacology In animals, butorphanol has been demonstrated to be 4 to 30 times more potent than morphine and pentazocine (Talwin®-V) respectively.1 In humans, butorphanol has been shown to have 5 to 7 times the analgesic activity of morphine and 20 times that of pentazocine.2,3 Butorphanol has 15 to 20 times the oral antitussive activity of codeine or dextromethorphan in dogs and guinea pigs.4 As an antagonist, butorphanol is approximately equivalent to nalorphine and 30 times more potent than pentazocine.1 Cardiopulmonary depressant effects are minimal after treatment with butorphanol as demonstrated in dogs,5 humans6,7 and horses.8 Unlike classical narcotic agonist analgesics which are associated with decreases in blood pressure, reduction in heart rate, and concomitant release of histamine, butorphanol does not cause histamine release.1 Furthermore, the cardiopulmonary effects of butorphanol are not distinctly dosage related but rather reach a ceiling effect beyond which further dosage increases result in relatively lesser effects. Reproduction: Studies performed in mice and rabbits revealed no evidence of impaired fertility or harm to the fetus due to butorphanol tartrate. In the female rat, parenteral administration was associated with increased nervousness and decreased care for the newborn, resulting in a decreased survival rate of the newborn. This nervousness was seen only in the rat species. Equine Pharmacology Following intravenous injection in horses, butorphanol is largely eliminated from the blood within 3 to 4 hours. The drug is extensively metabolized in the liver and excreted in the urine. In ponies, butorphanol given intramuscularly at a dosage of 0.22 mg/kg was shown to alleviate experimentally induced visceral pain for about 4 hours.9 In horses, intravenous dosages of butorphanol ranging from 0.05 to 0.4 mg/kg were shown to be effective in alleviating visceral and superficial pain for at least four hours, as illustrated in the following figure: Analgesic Effects of Butorphanol Given at Various Dosages in Horses with Abdominal Pain *Pain threshold in butorphanol-treated colicky horses relative to placebo controls A definite dosage-response relationship was detected in that butorphanol dosage of 0.1 mg/kg was more effective than 0.05 mg/kg but not different from 0.2 mg/kg in alleviating deep abdominal pain. Acute Equine Studies Rapid intravenous administration of butorphanol at a dosage of 2.0 mg/kg (20 times the recommended dosage) to a previously unmedicated horse resulted in a brief episode of inability to stand, muscle fasciculation, a convulsive seizure of 6 seconds duration, and recovery within three minutes. The same dosage administered after 10 successive daily 1.0 mg/kg dosages of butorphanol resulted only in transient sedative effects. During the 10 day course of administration at 1.0 mg/kg (10 times the recommended use level) in two horses, the only detectable drug effects were transient behavioral changes typical of narcotic agonist activity. These included muscle fasciculation about the head and neck, dysphoria, lateral nystagmus, ataxia, and salivation. Repeated administration of butorphanol at 1.0 mg/kg (10 times the recommended dose) every four hours for 48 hours caused constipation in one of two horses. Subacute Equine Studies Horses were found to tolerate butorphanol given intravenously at dosages of 0.1, 0.3, and 0.5 mg/kg every 4 hours for 48 hours followed by once daily injections for a total of 21 days. The only detectable drug effects were slight transient ataxia observed occasionally in the high dosage group. No clinical, laboratory, or gross or histopathologic evidence of any butorphanol-related toxicity was encountered in the horses.

VET OneVetorphicTM CIV(butorphanol tartrate injection)Injection

Comparative Pharmacology In animals, butorphanol has been demonstrated to be 4 to 30 times more potent than morphine and pentazocine (Talwin®-V) respectively.1 In humans, butorphanol has been shown to have 5 to 7 times the analgesic activity of morphine and 20 times that of pentazocine.2,3 Butorphanol has 15 to 20 times the oral antitussive activity of codeine or dextromethorphan in dogs and guinea pigs.4 As an antagonist, butorphanol is approximately equivalent to nalorphine and 30 times more potent than pentazocine.1 Cardiopulmonary depressant effects are minimal after treatment with butorphanol as demonstrated in dogs,5 humans6,7 and horses.8 Unlike classical narcotic agonist analgesics which are associated with decreases in blood pressure, reduction in heart rate, and concomitant release of histamine, butorphanol does not cause histamine release.1 Furthermore, the cardiopulmonary effects of butorphanol are not distinctly dosage related but rather reach a ceiling effect beyond which further dosage increases result in relatively lesser effects. Reproduction: Studies performed in mice and rabbits revealed no evidence of impaired fertility or harm to the fetus due to butorphanol tartrate. In the female rat, parenteral administration was associated with increased nervousness and decreased care for the newborn, resulting in a decreased survival rate of the newborn. This nervousness was seen only in the rat species.

Butorphanol CIV(butorphanol tartrate)Injection

DO NOT USE IN HORSES INTENDED FOR HUMAN CONSUMPTION. NOT FOR HUMAN USE. CAUTION Vetorphic, a potent analgesic, should be used with caution with other sedative or analgesic drugs as these are likely to produce additive effects. There are no well-controlled studies using butorphanol in breeding horses, weanlings, and foals. Therefore, the drug should not be used in these groups.

VET OneVetorphicTM CIV(butorphanol tartrate injection)Injection

DO NOT USE IN HORSES INTENDED FOR HUMAN CONSUMPTION. NOT FOR HUMAN USE. CAUTION Butorphic, a potent analgesic, should be used with caution with other sedative or analgesic drugs as these are likely to produce additive effects. There are no well-controlled studies using butorphanol in breeding horses, weanlings, and foals. Therefore, the drug should not be used in these groups.

Butorphic® CIV(butorphanol tartrate injection)

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DOLOREX® (butorphanol tartrate injection) CIV

DO NOT USE IN HORSES INTENDED FOR HUMAN CONSUMPTION . NOT FOR HUMAN USE.

CovetrusButorphanol Tartrate Injection CIV

In clinical trials in horses, the most commonly observed side effect was slight ataxia which lasted 3 to 10 minutes. Marked ataxia was reported in 1.5% of the 327 horses treated. Mild sedation was reported in 9% of the horses. To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet, contact Dechra Veterinary Products at (866) 933-2472. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Torphadine® CIV (butorphanol tartrate injection)

In clinical trials in horses, the most commonly observed side effect was slight ataxia which lasted 3 to 10 minutes. Marked ataxia was reported in 1.5% of the 327 horses treated. Mild sedation was reported in 9% of the horses.

Torbugesic® (butorphanol tartrate injection)

0.2 milligram of butorphanol base activity per pound of body weight (0.4 milligrams per kilogram), using 2 milligrams per milliliter solution. For subcutaneous injection.

Subcutaneous

Dose may be repeated up to 4 times per day. Do not treat for more than 2 days. Safety for use in pregnant female cats, breeding male cats of kittens less than 4 months of age has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian

Butorphanol Tartrate Injection

Administer 0.4 mg of butorphanol per kilogram body weight (0.2 mg/lb). This is equivalent to 1.0 mL solution per 10 lbs body weight.

Subcutaneous

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Butorphine™

0.2 milligram of butorphanol base activity per pound of body weight (0.4 milligrams per kilogram)

Subcutaneous

For subcutaneous injection. Dose may be repeated up to 4 times per day. Do not treat for more than 2 days. Safety for use in pregnant female cats, breeding male cats of kittens less than 4 months of age has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Torbugesic-SA®

0.05 milligram of butorphanol per pound of body weight (0.1 milligram per kilogram of body weight). Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours.

Intravenous

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Butorphic™ Injection

0.05 milligram of butorphanol base activity per pound of body weight (0.1 milligram/kilogram) using 10 milligrams per milliliter solution. For intravenous use.

Intravenous

Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Torphadine®

0.025 milligram of butorphanol base activity per pound of body weight (equivalent to 0.5 milliliter per 10 pounds), using 0.5 milligram per milliliter solution. For subcutaneous injection.

Subcutaneous

Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Torbutrol® Injection

0.25 milligram of butorphanol base activity per pound of body weight.

Oral

For oral use in dogs only. Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Torbutrol® Tablets

The recommended dosage in the horse is 0.1 mg of butorphanol per kilogram of body weight (0.05 mg/lb) by intravenous injection. This is equivalent to 5 mL of TORPHADINE for each 1000 lbs body weight. The dose may be repeated within 3 to 4 hours but treatment should not exceed 48 hours. Pre-clinical model studies and clinical field trials in horses demonstrate that the analgesic effects of butorphanol tartrate injection are seen within 15 minutes following injection and persist for about 4 hours. Use within 6 months of first puncture.

INTRAVENOUS

Torphadine® CIV (butorphanol tartrate injection)

The recommended dosage in the horse is 0.1 mg of butorphanol per kilogram of body weight (0.05 mg/lb) by intravenous injection. This is equivalent to 5 mL of TORBUGESIC for each 1000 lbs body weight. The dose may be repeated within 3 to 4 hours but treatment should not exceed 48 hours. Use contents within 4 months of first puncture. Pre-clinical model studies and clinical field trials in horses demonstrate that the analgesic effects of TORBUGESIC are seen within 15 minutes following injection and persist for about 4 hours.

INTRAVENOUS

Torbugesic® (butorphanol tartrate injection)

The recommended dosage in the horse is 0.1 mg of butorphanol per kilogram of body weight (0.05 mg/lb) by intravenous injection. This is equivalent to 5 mL of Butorphanol Tartrate Injection for each 1000 lbs body weight. The dose may be repeated within 3 to 4 hours but treatment should not exceed 48 hours. Pre-clinical model studies and clinical field trails in horses demonstrate that the analgesic effects of butorphanol tartrate are seen within 15 minutes following injection and persist for about 4 hours.

INTRAVENOUS

CovetrusButorphanol Tartrate Injection CIV

The recommended dosage in the horse is 0.1 mg butorphanol per kilogram of body weight (0.05 mg/lb) by intravenous injection. This is equivalent to 5 mL DOLOREX for each 1000 lb body weight. The dose may be repeated within 3 to 4 hours but treatment should not exceed 48 hours. Preclinical model studies and clinical field trials in horses demonstrate that the analgesic effects of butorphanol are seen within 15 minutes following injection and persist for about 4 hours.

INTRAVENOUS

DOLOREX® (butorphanol tartrate injection) CIV