Sputolysin Powder (Canada)

Company: Boehringer Ingelheim Animal Health

Expectorant for Horses

Dembrexine 5 mg/g

Veterinary Use Only

DIN 00698229

Introduction

Sputolysin^® is a secretolytic for use in respiratory disease in horses. Efficacy has been demonstrated in lung function tests. Clinical use and pharmacological studies in laboratory animals established the following mechanisms of action:

1) pronounced expectorant effects

2) secondary anti-tussive action

3) an increase in the anti-atelectase factor which compensates for decreases in lung surfactant (lowered surface tension in the alveolar region caused by stress and disease)

4) increased lung compliance

Pharmacology

Sputolysin^® is a phenolic benzylamine with the chemical designation: trans-4-[(3,5-dibromo-2-hydrobenzyl) amino] cyclohexanol hydrochloride. It is slightly soluble in water (0.5%) and stable under normal conditions. It alters the constituents and viscosity of abnormal respiratory mucus and improves efficiency of the respiratory tract clearance mechanism. A secondary anti-tussive action has also been demonstrated in laboratory animals. The effect on mucus can change the character and frequency of a cough and alter the consistency and quantity of nasal discharges. Therefore, in some cases, there will be an initial increase in visible nasal discharges and/or frequency of cough prior to clinical improvement.

Description

Sputolysin^® is a palatable white finely grated free flowing powder that is well accepted in the feed. Each gram of powder contains 5 mg of trans-4-[3,5-dibromo-2-hydrobenzyl-amino] cyclohexanol-hydrochloride-monohydrate (dembrexine).

Clinical Experience

In Canadian clinical trials involving positive controls, the effects of Sputolysin^® on clinical response were assessed in 229 horses suffering from a variety of acute, subacute and chronic respiratory conditions. Treated animals responded with improvement in respiration rate, nasal discharges and cough. Animals in the acute and subacute stages of respiratory disease responded favourably more consistently than horses in the chronic category. Chronic cases improved less dramatically but more frequently than the positive control cases (see table).

Sputolysin^® Clinical Field Trials

Results by Category

Side effects were not observed in any of the treated cases. In conditions where concurrent infection existed, supplemental treatment with chemotherapeutic and/or anti-infective agents was instituted.

Sputolysin Powder Indications

Sputolysin^® is recommended as an aid in the treatment of respiratory diseases in the horse where there is difficulty in expectoration and where secretolysis is necessary or desirable.

Dosage

Twice daily administration of 0.33 mg/kg body weight. This is equivalent to one level measure (5 g) per 75 kg body weight (measure enclosed) placed into the grain portion of the feed morning and evening for at least 10 days.

Each level measure (scoop) contains 25 mg dembrexine and weighs 5 g. The 420 g jar contains 84 measures (scoops.

Contraindication

The effect on the fertility of breeding stallions and pregnant mares has not been determined.

Storage

Store at or below 30°C. Protect from light and freezing.

Warning

Horses treated with this drug must not be slaughtered for use in food.

Boehringer Ingelheim Animal Health Canada Inc., 5180 South Service Road, Burlington ON L7L 5H4

Sputolysin^® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.

CPN: 1182194.0