BUTADYNE

Table of Contents

BUTORPHANOL (AS THE TARTRATE)

VETERINARY MEDICINE

Wildlife Pharmaceuticals specialises in the local and international distribution of scheduled veterinary medicines

SCHEDULING STATUS

S6

COMPOSITION

Each ml contains:    50 mg butorphanol (as tartrate)

Preservative:             Benzethonium chloride 0,02 % m/v

Other ingredients:      Trisodium citrate, citric acid anhydrous, sodium chloride, water for injection (sodium hydroxide or hydrochloric acid for pH adjustment)

CATEGORY AND CLASS OF MEDICINE

C 1.3.1 Opioid agonist

PHARMACOLOGICAL ACTION

Butorphanol is a synthetic narcotic agonist-antagonist. It is centrally acting with activity at µ- and κ-opioid receptors. In mammals, butorphanol has potent analgesic and antitussive properties. Its partial antagonistic µ-receptor activity reverses the effects of more potent opioids while its agonistic κ-receptor activity accounts for its strong analgesic effect. Butorphanol lightens the plane of anaesthesia, alleviates opioid-induced respiratory depression and stimulates respiratory drive through its agonistic σ-receptor activity.

PHARMACOKINETIC AND PHARMACODYNAMIC PROPERTIES

The onset of the analgesic effect of butorphanol is approximately 15 minutes after IM administration, with duration of action ranging from 1-3 hours and an elimination half-life of 1,8-2,5 hours. Pharmacokinetic properties vary between species, type and/or intensity of pain, dose and route of injection. Butorphanol is metabolised in the liver by hydroxylation and its metabolites do not retain any analgesic activity. Butorphanol is primarily excreted in the urine, with a small portion excreted in bile and eliminated in the faeces.

Butorphanol inhibits transmission of nociceptive stimulation in the dorsal horn of the spinal cord. This activates descending inhibitory pathways, inhibits supraspinal afferent pathways and reduces the release of neurotransmitters in the spinal cord.

INDICATIONS

BUTADYNE 50 is indicated for use in wildlife animals for:

  • Pain control (including perioperative and visceral pain)
  • Sedation
  • Reversal of opioid-induced respiratory depression
  • Partial reversal of opioid anaesthesia in larger species to allow walking under heavy sedation
  • Anaesthesia and neuroleptanalgesia when used in combination with α2-adrenergic agonists and/or more potent opioids

Controlled clinical trials with BUTADYNE 50 have only been conducted in blue wildebeest and blesbok.

CONTRAINDICATIONS

None recorded.

WARNINGS

Caution should be taken when using BUTADYNE 50 in combination with other sedatives or analgesics as these may produce additive effects. BUTADYNE 50 should not be administered in wildlife animals treated with opioid antagonists within the past 24 hours.

BUTADYNE 50 is not recommended for somatic analgesia. When used alone, BUTADYNE 50 causes apathetic sedation that may allow arousal when the animal is stimulated – a potential risk when working with dangerous species. In wildlife animals with respiratory disease associated with increased mucous production, due to its antitussive properties, BUTADYNE 50 should only be used when the benefit outweighs the risk.

The safety of Butadyne 50 in pregnant and lactating wildlife animals has not been established.

BUTADYNE 50 residue studies have not been conducted in wildlife animals. Carcasses of animals treated with BUTADYNE 50 within 90 days of slaughter should be discarded and are not considered safe for human or predator consumption.

DOSAGE AND DIRECTIONS FOR USE

BUTADYNE 50 dosing is dependent on species, body mass, condition of the wildlife animal being treated and the indication for use. Administration by intramuscular or intravenous injection is recommended. Refer to the table for BUTADYNE 50 doses.

The effects of BUTADYNE 50 may be reversed by administering TREXONIL (naltrexone HCl) at a ratio of 2 mg of TREXONIL for every 1 mg of BUTADYNE 50 used.

SIDE EFFECTS AND SPECIAL PRECAUTIONS FOR USE

Common side effects of BUTADYNE 50 include lack of appetite and general sedation.  BUTADYNE 50 may decrease intestinal motility. Pain on injection, mydriasis, disorientation, swallowing/licking and sedation have also been reported.

Due to its high concentration, accidental exposure to BUTADYNE 50 could have serious effects on humans. Veterinarians are advised to take the following precautions when handling BUTADYNE 50:

  • Do not work with the product when unaccompanied.
  • Avoid using the product in devices where the solution is pressurised e.g. blowpipes.
  • Wear gloves when handling the product.
  • Discard used needles in an appropriate sharps container immediately after use.
  • In the event of topical exposure, rinse the affected area with copious amounts of water. Monitor for signs of toxicity including dizziness and vomiting.

Should accidental injection occur, administer the antidote (naloxone) and seek medical attention immediately. Severe exposure may result in respiratory depression, coma, and death. Monitor the airways and initiate CPR if needed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT 

Symptoms of toxicity in wildlife animals have not been established. Management is symptomatic and supportive.

IDENTIFICATION

A clear, colourless sterile solution free from visible particulates.

PRESENTATION

BUTADYNE 50 is supplied in a 10 ml amber glass vial (filled to 5 ml) with a grey rubber stopper and a white plastic cap. Each vial is contained in an outer carton.

STORAGE INSTRUCTIONS

Store at or below 25 °C. Do not refrigerate.
Protect from light. 
KEEP OUT OF REACH OF CHILDREN AND UNINFORMED PERSONS.

REGISTRATION NUMBER

19/1.3.1/14

NAME AND BUSINESS ADDRESS OF HOLDER OF CERTIFICATE OF REGISTRATION

Wildlife Pharmaceuticals (Pty) Ltd. 38 Wilkens Street, Rocky Drift, White River,1240, South Africa.

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