Introduction

FDAH

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Dopram-V Solution for Injection is presented in multi-dose vials containing 20 ml of sterile solution for parenteral and topical sublingual use. Each ml contains Doxapram Hydrochloride 20 mg. It also contains Chlorbutanol 5 mg/ml as an antimicrobial preservative. Dopram-V (doxapram hydrochloride) is a potent respiratory stimulant. It differs from the analeptic agents in having greater specificity of action on the respiratory centre.

Metabolism:

The metabolism of doxapram has been studied in the dog and man. Doxapram is extensively metabolised; the metabolites and unchanged doxapram are excreted in the bile and urine. The pharmacokinetic properties of doxapram can be described by a multi-compartmental model. Due to rapid redistribution the pharmacological effects of an intravenous injection of doxapram are terminated within 15-20 minutes following administration.

Uses

Respiratory stimulant

For dogs, cats and horses:

1.To stimulate respiration during and after general anaesthesia.

2.To speed awakening and return of reflexes after anaesthesia, when this is considered beneficial.

For neonatal puppies, kittens, calves and lambs:

1.To initiate respiration following dystocia or Caesarean section.

2.To stimulate respiration following dystocia or Caesarean section.

Dosage and administration

To ensure adequate dosing an insulin-type syringe must be used for administration to low bodyweight animals.

Post-anaesthetic use

For intravenous use only.

Dogs and cats: Following intravenous anaesthesia 2–5 mg/kg (0.1–0.25 ml/kg) depending on response.

Following inhalation anaesthesia 1–2 mg/kg (0.05–0.1 ml/kg) depending on response.

Dosage should be adjusted for depth of anaesthesia and degree of respiratory depression. Dosage can be repeated in 15 to 20 minutes if necessary.

Horses: Following intravenous or inhalation anaesthesia 0.5–1.0 mg/kg (2.5–5.0 ml/100 kg) depending on response. Dosage should be adjusted for depth of anaesthesia and degree of respiratory depression.

Neonatal use

For intravenous or subcutaneous injection and for topical sublingual use.

Puppies: 1–5 mg (0.05–0.25 ml) depending on size of neonate and degree of respiratory depression.

Kittens: 1–2 mg (0.05–0.1 ml) depending on size of neonate and degree of respiratory depression.

Calves: For intravenous, intramuscular, subcutaneous or sublingual use.

40–100 mg (2.0–5.0 ml) depending on size of neonate and degree of respiratory depression.

Lambs: For intravenous, subcutaneous or sublingual use.

5–10 mg (0.25–0.5 ml) depending on size of neonate and degree of respiratory depression.

The action of Dopram-V is rapid, usually beginning in a few seconds. The duration and intensity of response depends upon the dose, the condition of the animal at the time the drug is administered, and depth of anaesthesia. Repeated doses should not be given until the effects of the first dose have passed, and the condition of the patient requires it.

However, the therapeutic ratio (convulsive dose: respirogenic dose) is very high. In trials carried out on conscious cats to determine the total dose required to initiate hyperventilation compared to the total dose required to produce convulsions, the convulsive dose to respirogenic dose was calculated to be 38:1.

Contra-indications, warnings, etc

Dopram-V Injection is contra-indicated for use in food producing animals with the exception of neonatal calves and lambs, and horses.

Withdrawal period

Not intended for use in animals producing milk for human consumption. For horses and neonatal calves and lambs, the meat withdrawal period is 28 days from last administration.

Warnings

Dosage of Dopram-V should be adjusted to meet the requirements of the situation. Adequate, but not excessive, doses should be used. A patent airway is essential. Reflexes should be checked periodically.

Excessive doses may produce hyperventilation which may be followed by reduced carbon dioxide tension in the blood, cerebral vasoconstriction, hypoxia, and possible brain damage.

Excessive doses administered to animals during, or following anaesthesia with cyclopropane or halogenated hydrocarbon anaesthetics may precipitate cardiac arrhythmias.

Dopram-V Injection should be administered with extreme caution in dogs which have been sedated with morphine. Administration of Dopram-V Injection at a dose of 10 mg/kg to such animals may be followed by convulsions.

Operator warning

Avoid self injection with the product. Avoid direct contact with skin and eyes. In the event of contact, wash with plenty of water. If irritation or other symptoms persist, seek medical advice. Do not smoke, eat or drink when using the product. Wash hands after use.

For animal treatment only. Keep out of the reach and sight of children.

Disposal

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Pharmaceutical precautions

Keep container in outer carton.

Following withdrawal of the first dose, use the product within 28 days.

When the container is broached for the first time, using the in-use shelf-life which is specified on this datasheet, the date on which any product remaining in the container should be discarded should be worked out. The discard date should be written in the space provided on the label. Discard any unused material. Should any apparent growth or discolouration occur the product should be discarded.

Dopram-V Injection is incompatible with alkaline solutions such as aminophylline, frusemide, and thiopentone. Do not store above 25°C. Protect from freezing. Protect from light.

Legal category

POM-V

Packaging Quantities

20 ml multi-dose vials.

Further information

Dopram-V Injection has been used extensively in the treatment of exotic species. Doses of 1 mg/kg have been used; the dose being adjusted according to response and the overall condition of the animal. It has been found to be of particular use in the treatment of respiratory failure associated with lungworm infestation in pinnipeds, respiratory depression produced by barbiturate poisoning in felines and in the anaesthetic management of the giraffe.

Dopram-V is also available in 5 ml dropper bottles for topical sublingual use.