Sputolosin Oral Powder 5 mg/g

Composition

Each gram contains:

Active substance

Dembrexine hydrochoride monohydrate 5 mg

(Equivalent to 4.372 mg of dembrexine per g.)

For a full list of excipients, see section 6.1.

6.1 List of excipients

Lactose, fine

Lactose, coarse

3

Pharmaceutical form

Oral powder. Fine, white and free-flowing

3

Pharmacological properties

Dembrexine is a benzylamine with mucolytic properties.

ATCvet code : QR05CB90

5.1 Pharmacodynamic properties

Dembrexine reduces the viscosity of respiratory mucus by fragmenting the sputum fibre network, and increasing pulmonary surfactant and respiratory compliance.

5.2 Pharmacokinetic particulars

Absorption:

Absorption of dembrexine from the gut in the horse is practically complete as evident from the large percentage excreted in the urine. Following oral administration of dembrexine the absolute bioavailability of unchanged drug is about 30% (see also the information under the subheading "Metabolism" below).Steady state concentrations of dembrexine in plasma are reached within 2 days after repeated twice daily oral administration. At that time mean maximum plasma concentrations of 0.15 ng dembrexine/ml are observed about 1 hour post dose.

Distribution:

There is a linear relationship between the dose administered and the plasma concentration observed in the therapeutic dose range. The volume of distribution is approximately 5 l/kg.

Metabolism:

The parent compound trans-dembrexine occurs in plasma, liver and kidneys. Due to a first pass isomerization the stereoisomer of trans-dembrexine, i.e. cis-dembrexine, can also be found. Further metabolites occur as conjugates of dembrexine and there is also some highly polar material. Both trans- and cis-dembrexine are pharmacologically active.

Elimination:

Dembrexine is eliminated with a half life in the order of 8 hours. Approximately 85% of the administered dose is excreted via urine and the remainder via faeces.

3

Target species

Horses

3

Indications

The product is indicated for the symptomatic treatment of acute, sub-acute and chronic respiratory disease of the upper and lower respiratory tract, where an abnormal amount of mucus of increased viscosity is present..

3

Dosage

For oral administration in the food at a dose rate of 0.3 mg dembrexine per kg bodyweight twice daily: for example, for a 500kg horse, 30 g (6 level measures) of powder twice daily.

For small horses, ponies and foals the dose is administered pro rata according to the bodyweight, i.e. at a rate of 2 level measures per 170 kg bodyweight.

Add to the feed immediately prior to administration. Discard any remaining medicated feed.

An improvement in clinical signs is usually seen within five days. Treatment should be continued until complete remission occurs (usually a total period of 12 to 14 days) but should not exceed 28 days. The horse's condition should be reassessed after this period before any further treatment is proposed.

In cases complicated by the presence of micro-organisms or where pyrexia is present, the simultaneous use of suitable chemotherapeutic agent is recommended.

3

Contraindications

Do not use in animals known to be hypersensitive to the active substance.

3

Adverse reactions

None known.

3

Warnings

(i) Special precautions for use in animals

None known.

(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

Care/precautions should be taken when using this product to avoid skin contact, eye contact and/or inhalation of the dust. Medical advice should be sought if you feel unwell after using this product.

3

Use during pregnancy, lactation or lay

Sputolosin has not been tested in pregnant mares, however, reproduction studies using dembrexine in laboratory animals show no teratogenic effect. Where Sputolosin has been administered to pregnant mares, no adverse effects have been reported.

3

Interactions

None known.

3

Overdose

None known. Dosages up to 15 times the therapeutic dose did not cause any adverse reactions

3

Special warnings

None known.

3

Withdrawal period

Meat and offal: 1 day

3

Incompatibilities

None known.

3

Immediate packaging

The product is packaged in a polyethylene container with a push-fit polyethylene cap and a measuring spoon (5 g powder). The container is filled with 420 g powder.

3

Storage

Do not store above 25°C. Store in a dry place.

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Add to feed immediately prior to administration. Discard any remaining medicated feed.

3

Disposal of unused product

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

3

Additional information

Vm 08327/5065

9 DATE OF FIRST AUTHORISATION

30 July 1985

10 DATE OF REVISION OF THE TEXT

August 2025

Gavin Hall Approved: 28 August 2025

3

Registration holder

Boehringer Ingelheim Animal Health UK Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

3