Torbugesic

HORSE:

• As an analgesic: TORBUGESIC is a centrally acting analgesic and may be used for the relief of pain in adult horses and yearlings. Clinical studies in the horse have shown that TORBUGESIC alleviates abdominal pain associated with torsion, impaction, intussusception, spasmodic, tympanic and postpartum pain.

DOG and CAT:

• As an analgesic: TORBUGESIC is used for the relief of moderate to severe pain in dogs and cats. Clinical studies have shown that TORBUGESIC can provide suitable analgesia after a variety of surgical procedures, e.g. orthopaedic and soft tissue surgery. Administered pre-operatively, TORBUGESIC will reduce the amount of analgesia required post-operatively.
• As a sedative: In cats, sedation does not occur with TORBUGESIC alone, but can occur in dogs with TORBUGESIC alone. In both species, profound sedation is achieved using TORBUGESIC in conjunction with DOMITOR (medetomidine hydrochloride), making it suitable for radiography, fracture examination or casting, dematting, ear cleaning, wound management, anal gland flush and other minor procedures.
• As a pre-anaesthetic: Pre-anaesthetic use of TORBUGESIC in dogs has resulted in a dose-related reduction in the dose of thiopentone sodium needed to induce anaesthesia, which will also reduce the risk of anaesthetic respiratory depression. Pre-anaesthetic use in cats provides improved analgesia. Intravenous induction agents should be given to effect.
• As an anaesthetic: TORBUGESIC may be used in combination with DOMITOR (medetomidine hydrochloride) and ketamine hydrochloride as a triple anaesthetic.

• Registered for use in cats, dogs and horses
• Excellent safety profile
• Fast acting, predictable pain relief

Veterinary injection, ready to use solution containing 10 mg butorphanol base per mL as butorphanol tartrate.

Available in 10mL and 50mL glass multi-dose vials.

HORSE:

For analgesia: The recommended dosage is 0.1 mg of butorphanol per kilogram of body weight administered by intravenous injection. This is equivalent to 1 mL of TORBUGESIC for each 100 kg of body weight. 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. The dose may be repeated as required. Butorphanol use should not exceed 48 hours in any one treatment episode.

TORBUGESIC (10 mg/mL) for equine analgesia (IV)
Weight of Horse (kg)	50	100	150	200	250	300	350	400	450	500	550
Dose of Torbugesic (mL)	0.5	1.0	1.5	2.0	2.5	3.0	3.5	4.0	4.5	5.0	5.5

 

Based on a dose rate of 0.1 mg butorphanol per kg body weight.

DOG:

When administering intravenously, inject slowly: do not inject as a bolus. For dogs weighing less than or equal to 10 kg, administration by insulin syringe is recommended to ensure accurate dosing. Due to the low volumes involved, great care should be taken when administering TORBUGESIC to animals weighing under 5 kg.

For analgesia: Administer by intravenous, intramuscular or subcutaneous injection routes using aseptic technique. Dose rate: 0.2 - 0.3 mL per 10 kg (equivalent to 0.2 - 0.3 mg butorphanol per kg) body weight. TORBUGESIC should be administered before terminating anaesthesia to provide analgesia in the recovery phase. Analgesic effects are seen within 15 minutes. For continuous analgesia the dose may be repeated as required.

TORBUGESIC (10 mg/mL) for canine analgesia (IV, IM or SC)
Weight of Dog (kg)	5	10	15	20	25	30	40
Dose of Torbugesic (mL)	0.1‡	0.3‡	0.4	0.5	0.6	0.8	1.0

 

Based on a mean dose rate of 0.25 mg butorphanol per kg body weight.

‡ For animals weighing ≤10 kg body weight, administration by insulin syringe is recommended. Due to the low volumes involved, great care should be taken when administering TORBUGESIC to animals weighing under 5 kg.

For sedation in combination with DOMITOR (medetomidine hydrochloride): TORBUGESIC should be administered at 0.1 mL per 10 kg (equivalent to 0.1 mg butorphanol per kg) together with 10 - 25 µg DOMITOR (medetomidine hydrochloride) per kg body weight¹ depending on the degree of sedation required, both by eitherintramuscular or intravenous injection. Allow 20 minutes for profound sedation to develop before commencing the procedure.

Reversal with 50 - 100 µg ANTISEDAN (atipamezole) per kg body weight² results in sternal recumbency approximately 5 minutes later and standing approximately a further 2 minutes later

TORBUGESIC (10 mg/mL) and DOMITOR (medetomidine hydrochloride) (1 mg/mL) combination for canine sedation (IM or IV)
For sedation and as a premedicant to barbiturate anaesthesia
Weight of Dog (kg)	5	10	15	20	25	30	40
Dose of Torbugesic (mL)	0.05‡	0.10‡	0.15	0.20	0.25	0.30	0.40
Dose of DOMITOR (medetomidine hydrochloride) (mL)	0.05‡	0.10‡	0.15	0.20	0.25	0.30	0.40

 

Based on dose rates of 0.1 mg butorphanol per kg and 10 µg DOMITOR (medetomidine hydrochloride) per kg, respectively.

‡ For animals weighing ≤10 kg body weight, administration or TORBUGESIC by insulin syringe is recommended. Due to the low volumes involved, great care should be taken when administering TORBUGESIC to animals weighing under 5 kg.

TORBUGESIC (10 mg/mL) and DOMITOR (medetomidine hydrochloride) (1 mg/mL) combination for canine sedation (IM or IV)
For profound sedation and as a premedicant to ketamine anaesthesia
Weight of Dog (kg)	5	10	15	20	25	30	40
Dose of Torbugesic (mL)	0.05‡	0.10‡	0.15	0.20	0.25	0.30	0.40
Dose of DOMITOR (medetomidine hydrochloride) (mL)	0.13	0.25	0.38	0.50	0.63	0.75	1.00

 

Based on dose rates of 0.1 mg butorphanol per kg and 25 µg DOMITOR (medetomidine hydrochloride) per kg, respectively.

‡ For animals weighing ≤10 kg body weight, administration of TORBUGESIC by insulin syringe is recommended. Due to the low volumes involved, great care should be taken when administering TORBUGESIC to animals weighing under 5 kg.

For use as a pre-anaesthetic: Used as a pre-anaesthetic, the TORBUGESIC dose should be reduced to 0.1 – 0.2 mL per kg (0.1 – 0.2 mg butorphanol per kg), given 15 minutes prior to induction.

TORBUGESIC (10 mg/mL) for canine analgesia pre-anaesthetic (IV, IM or SC)
Weight of Dog (kg)	5	10	15	20	25	30	40
Dose of Torbugesic (mL)	0.05‡	0.10‡	0.15	0.20	0.25	0.30	0.40

 

Based on dose rate of 0.1 mg butorphanol per kg body weight.

‡ For animals weighing ≤10 kg body weight, administration by insulin syringe is recommended. Due to the low volumes involved, great care should be taken when administering TORBUGESIC to animals weighing under 5 kg.

When using TORBUGESIC as a pre-anaesthetic, the use of an anticholinergic such as atropine will protect the heart against possible narcotic-induced bradycardia.

For anaesthesia in combination with DOMITOR (medetomidine hydrochloride) and ketamine: Administer TORBUGESIC at 0.1 mL per 10 kg (equivalent to 0.1 mg butorphanol per kg) and 25 µg DOMITOR (medetomidine hydrochloride) per kg body weight by intramuscular injection.

Dogs become recumbent in approximately 6 minutes and lose their pedal reflex in approximately 14 minutes.

Ketamine should be administered 15 minutes following the first injection at 5 mg ketamine per kg by intramuscular injection.

The pedal reflex returns approximately 53 minutes following administration of the ketamine injection. Sternal recumbency is attained approximately 35 minutes later followed by standing a further 36 minutes later.

TORBUGESIC (10 mg/mL), DOMITOR (medetomidine hydrochloride) (1 mg/mL) and ketamine hydrochloride (100 mg/mL) for canine anaesthesia (IM)
Weight of Dog (kg)	5	10	15	20	25	30	40
Dose of Torbugesic (mL)	0.05‡	0.10‡	0.15	0.20	0.25	0.30	0.40
Dose of DOMITOR (medetomidine hydrochloride) (mL)	0.13	0.25	0.38	0.50	0.63	0.75	1.00
Wait 15 minutes after first injection before administering ketamine
Dose of ketamine hydrochloride (mL)	0.13‡	0.25‡	0.38	0.50	0.63	0.75	1.00

 

Based on dose rates of 0.1 mg butorphanol, 25 µg DOMITOR (medetomidine hydrochloride) and 5 mg ketamine per kg body weight, respectively.

‡ For animals weighing ≤10 kg body weight, administration of TORBUGESIC and ketamine by separate insulin syringes is recommended. Due to the low volumes involved, great care should be taken when administering TORBUGESIC to animals weighing under 5 kg.

Note: It is NOT advisable to reverse this combination in the dog with ANTISEDAN (atipamezole).

CAT:

Cats should be weighed to ensure that the correct dose is calculated. For cats weighing less than or equal to 10 kg, administer by insulin syringe to ensure accurate dosing. Due to the low volumes involved, great care should be taken when administering TORBUGESIC to animals weighing under 5 kg. Not recommended for intravenous use in cats under 5 kg body weight.

For pre-operative analgesia: 0.2 mL TORBUGESIC per 5 kg body weight (equivalent to 0.4 mg butorphanol per kg) should be administered either by subcutaneous or intramuscular injection. Clinical studies have shown that administering the TORBUGESIC dose 5 minutes prior to induction with either acepromazine/ketamine or xylazine/ketamine given intramuscularly will provide analgesia when surgery commences. The arousal time will not be significantly altered. With intravenous induction agents, TORBUGESIC should be administered 15 – 30 minutes prior to the administration of the anaesthetic.

For post-operative analgesia: 0.2 mL TORBUGESIC per 5 kg body weight (equivalent to 0.4 mg butorphanol per kg) should be administered either by subcutaneous or intramuscular injection 15 minutes prior to recovery.

TORBUGESIC (10 mg/mL) for feline analgesia
Weight of Cat (kg)	2.5	3.0	3.5	4.0	4.5	5.0
IM or SC Dose of Torbugesic (mL)	0.10‡	0.12‡	0.14‡	0.16‡	0.18‡	0.20‡
IV Dose of Torbugesic (mL)	Not recommended					0.05‡

 

Based on a mean dose rate of 0.4 mg butorphanol per kg for IM and SC use, and 0.1 mg butorphanol per kg for IV use.

‡ For animals weighing ≤10 kg body weight, administration by insulin syringe is recommended. Due to the low volumes involved, great care should be taken when administering TORBUGESIC to animals weighing under 5 kg.

For sedation in combination with DOMITOR (medetomidine hydrochloride): TORBUGESIC should be administered at 0.2 mL per 5 kg body weight (equivalent to 0.4 mg butorphanol per kg) together with 50 µg DOMITOR (medetomidine hydrochloride) per kg body weight, both by either intramuscular or subcutaneous injection.

Local anaesthetic infiltration should be used for wound suturing. Reversal with 125 µg ANTISEDAN (atipamezole) per kg body weight results in sternal recumbency approximately 4 minutes later and standing 1 minute later.

TORBUGESIC (10 mg/mL) and DOMITOR (medetomidine hydrochloride) (1 mg/mL) combination for feline sedation (IM or SC)
Weight of Cat (kg)	2.5	3.0	3.5	4.0	4.5	5.0
Dose of Torbugesic (mL)	0.10‡	0.12‡	0.14‡	0.16‡	0.18‡	0.20‡
Dose of DOMITOR (medetomidine hydrochloride) (mL)	0.13	0.15	0.18	0.20	0.23	0.25

 

Based on dose rates of 0.4 mg butorphanol per kg and 50 µg DOMITOR (medetomidine hydrochloride) per kg, respectively.

‡ For animals weighing ≤10 kg body weight, administration by insulin syringe is recommended. Due to the low volumes involved, great care should be taken when administering TORBUGESIC to animals weighing under 5 kg.

For anaesthesia in combination with DOMITOR (medetomidine hydrochloride) and ketamine:

a) Intramuscular: Administer TORBUGESIC at 0.2 mL per 5 kg (equivalent to 0.4 mg butorphanol per kg), 80 µg DOMITOR (medetomidine hydrochloride) per kg body weight and ketamine 5 mg per kg. Cats become recumbent in 2-3 minutes following injection. Loss of the pedal reflex occurs in 3 minutes post-injection.

TORBUGESIC (10 mg/mL), DOMITOR (medetomidine hydrochloride) (1 mg/mL) and ketamine hydrochloride (100 mg/mL) for feline anaesthesia (IM)
Weight of Cat (kg)	2.5	3.0	3.5	4.0	4.5	5.0
Dose of Torbugesic (mL)	0.10‡	0.12‡	0.14‡	0.16‡	0.18‡	0.20‡
Dose of DOMITOR (medetomidine hydrochloride) (mL)	0.20	0.24	0.28	0.32	0.36	0.40
Dose of ketamine hydrochloride (mL)	0.13‡	0.15‡	0.18‡	0.20‡	0.23‡	0.25‡

 

Based on dose rates of 0.4 mg butorphanol, 80 µg DOMITOR (medetomidine hydrochloride) and 5 mg ketamine per kg, respectively.

‡ For animals weighing ≤10 kg body weight, administration of TORBUGESIC and ketamine by separate insulin syringes is recommended. Due to the low volumes involved, great care should be taken when administering TORBUGESIC to animals weighing under 5 kg.

Reversal with 200 µg ANTISEDAN (atipamezole) per kg body weight results in return of the pedal reflex 2 minutes later, sternal recumbency 6 minutes later and standing 31 minutes later.

b) Intravenous: Administer TORBUGESIC at 0.05 mL per 5 kg (equivalent to 0.1 mg butorphanol per kg), 40 µg DOMITOR (medetomidine hydrochloride) per kg body weight and ketamine, depending on the depth of anaesthesia required, at a dose rate of 1.25 – 2.5 mg ketamine per kg body weight by intravenous injection. Do not physically mix products in the same syringe.

Approximate time scales when using the triple combination intravenously
Ketamine* Dose (mg/kg)	Time to recumbency	Time to loss of pedal reflex	Time to return of pedal reflex	Time to sternal recumbency	Time to standing
1.25	32 sec	62 sec	26 min	54 min	74 min
2.5	22 sec	39 sec	28 min	62 min	83 min

 

* In conjunction with butorphanol tartrate at 0.1 mg/kg and DOMITOR (medetomidine hydrochloride) at 40 µg/kg.

Dosage chart of 2.5 mg ketamine per kg (duration of anaesthesia approximately 28 minutes):

TORBUGESIC (10 mg/mL), DOMITOR (medetomidine hydrochloride) (1 mg/mL) and ketamine hydrochloride (100 mg/mL) for feline anaesthesia (IV)
Weight of Cat (kg)	2.5	3.0	3.5	4.0	4.5	5.0
Dose of Torbugesic (mL)	Not recommended					0.05‡
Dose of DOMITOR (medetomidine hydrochloride) (mL)	N/A	N/A	N/A	N/A	N/A	0.20
Dose of ketamine hydrochloride (mL)	N/A	N/A	N/A	N/A	N/A	0.13‡

 

Based on dose rates of 0.1 mg butorphanol tartrate, 40 µg DOMITOR (medetomidine hydrochloride) and 2.5 mg ketamine per kg, respectively.

‡ For animals weighing ≤10 kg body weight, administration of TORBUGESIC and ketamine by separate insulin syringes is recommended. Due to the low volumes involved, great care should be taken when administering TORBUGESIC to animals weighing under 5 kg.

Reversal with 100 µg ANTISEDAN (atipamezole) per kg body weight results in return of the pedal reflex 4 minutes later, sternal recumbency 7 minutes later and standing 18 minutes later.

¹ 10 – 25 µg medetomidine hydrochloride is equivalent to 0.1 – 0.25 mL DOMITOR (A6177).

² 50 – 100 µg atipamezole is equivalent to 0.1 – 0.25 mL ANTISEDAN (A6178) per 10 kg body weight.

CONTRAINDICATIONS

Before using any combinations consult the contraindications which appear on the other products’ data sheets.

Horse: TORBUGESIC should not be administered to horses with a history of liver disease. There are no well controlled studies using butorphanol in breeding horses, weanlings or foals. Therefore the drug should not be used in these groups. When used in combination with detomidine hydrochloride, do not use in pregnant animals nor in animals suffering from colic. Routine cardiac auscultation should be performed prior to use of this combination. Do not use the combination in horses with a pre-existing cardiac dysrhythmia or bradycardia.

Dog: Do not use in dogs with a history of liver disease.

Cat: Not recommended for intravenous use in cats under 5 kg body weight.

PRECAUTIONS

TORBUGESIC, a potent analgesic, should be used with caution with other sedative or analgesic drugs as these are likely to produce additive effects.

Transient pain may occur with intramuscular injections.

ADVERSE EFFECTS

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 3 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 behavioural 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 the 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 four 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.

Dog: If respiratory depression occurs, nalorphine may be used as an antidote. (NB Nalorphine is a first schedule prescription human medicine, not a registered veterinary medicine). Transient ataxia, anorexia and diarrhoea have been reported as occurring rarely. When using TORBUGESIC as a pre-anaesthetic the use of an anticholinergic such as atropine will protect the heart against possible narcotic induced bradycardia.

Cat: If respiratory depression occurs, nalorphine may be used as an antidote. Marked sedation does not occur in cats when TORBUGESIC is used as a sole agent. Mydriasis is likely to occur.

Reproduction: Studies performed in mice and rabbits revealed no evidence of impaired fertility or harm to the foetus due to butorphanol tartrate. In the female rat, parenteral administration was associated with increased nervousness and decreased care for the new-born, resulting in a decreased survival rate of the new-born. The nervousness was seen only in the rat species.

WITHHOLDING PERIOD (MEAT)

Horses producing meat and offal for human consumption must not be sold for slaughter either during treatment of within 63 days of cessation of the last treatment.

Zoetis Animal Health New Zealand Limited. Level 5, 8 Mahuhu Crescent, Auckland 1010, New Zealand. Tel: 0800 650 277, Fax: 0800 628 629. TORBUGESIC is a registered trade mark of Zoetis Inc. or its subsidiaries. ACVM Registration No. A7730. RVM; Available only under Veterinary Authorisation.

NZ Technical Services 0800 650 277

• Zoetis Safety Data Sheets
• Zoetis HAZNOTE - TORBUGESIC
• Label: http://www.foodsafety.govt.nz/