DRAGBUTEROL® Oral Gel
Bronchodilator.
Dragbuterol® is mainly recommended for the treatment of obstructive diseases of the respiratory tract in horses, such as chronic obstructive pulmonary disease and allergic respiratory diseases. Because of its mucolytic action, it is also recommended as adjuvant in the treatment of infectious diseases such as pneumonia and bronchitis.
Technical Specification
Species
Horses.
Dosage form
Oral gel.
Therapeutic action
Bronchodilator.
Composition
Each 100 mL of gel contains:
Clenbuterol Hydrochloride................ 2.0 mg
Excipients q.s.p..............................100 mL
Indications
Dragbuterol® is mainly recommended for the treatment of obstructive diseases of the respiratory tract in horses, such as chronic obstructive pulmonary disease and allergic respiratory diseases. Because of its mucolytic action, it is also recommended as adjuvant in the treatment of infectious diseases such as pneumonia and bronchitis.
Route od administration and dosage
Oral route.
Dose of the active principle:
- Initial dose: 0.8 μg of Clenbuterol Hydrochloride / Kg of b.w. every 12 hours.
If after 3 days of treatment (6 doses) no improvement is observed, increase the dose according to the following scheme:
- 1.6 μg of Clenbuterol Hydrochloride / Kg of b.w. every 12 hours for 3 days, if there is no improvement,
- 2.4 μg of Clenbuterol Hydrochloride / Kg of b.w. every 12 hours for 3 days, if there is no improvement,
- 3.2 μg of Clenbuterol Hydrochloride / Kg of b.w. every 12 hours for 3 days.
Product dosage:
- Initial dose and mild obstructive symptoms: 4 mL / 100 Kg of b.w., every 12 hours for 30 days.
- Severe broncho-obstructive symptoms: maximum dose of 12-16 mL / 100 Kg of b.w. every 12 hours for 30 days.
If after 3 days of treatment (6 doses) with the initial dose no improvement is observed, increase the dose according to the following scheme:
- 8 mL / 100 Kg of b.w., every 12 hours for 3 days, if there is no improvement,
- 12 mL / 100 Kg b.w., every 12 hours for 3 days, if there is no improvement,
- 16 mL / 100 Kg of b.w., every 12 hours for 3 days.
Once the therapeutic dose is established, continue the treatment for 30 days. If the signs reappear, the treatment can be repeated for a further 30 days, but the determination of the effective dose must be done again in stages.
If after administering the higher dose no effect is observed, it means that the animal is non-responsive to Clenbuterol or that the obstructive condition is not of bronchial origin, then the treatment should be suspended.
Drug interactions
- Concomitant administration with other sympathomimetic amines (for example Terbutaline) can increase the adverse effects of Clenbuterol.
- The use with inhalation anesthetics (eg Halothane, Isofluorane) can predispose to ventricular arrhythmias, particularly in patients with pre-existing heart disease.
- The use with digitalis glycosides may increase the risk of cardiac arrhythmias.
- β-blockers (for example Propanolol) can antagonize the effects of Clenbuterol.
- Clenbuterol can antagonize the effects of Prostaglandin F2 and Oxytocin.
Contraindications
- Do not administer in animals hypersensitive to Clenbuterol Hydrochloride.
- Do not administer in horses with cardiovascular disorders.
- Do not administer in mares in advanced gestation or in lactation period.
- Do not administer to breeding males.
- Do not administer to offspring.
Special precautions for use
- It is not recommended to start treatment with a dose higher than the established starting dose.
- Keep out of the reach of children.
Special precautions for the operator
- Do not handle by people who are hypersensitive to Clenbuterol Hydrochloride.
- Do not handle by pregnant women.
Adverse effects
Adverse effects and adverse reactions:
Moderate tachycardia, sweating, muscle tremors, hives, and restlessness may occur during the first days of treatment. The presence of ataxia is also described, although in low frequency.
Guard period
Do not administer in animals whose meat is intended for human consumption.
Observations
Special precautions for disposal of unused product or waste material:
Empty containers can be disposed of as household waste, without any special precautions. Do not dispose of containers with product remains on the ground or water courses. For expired or unused products, contact the manufacturing laboratory.
Conservation
Store between 15 and 30 °C, protected from light. Once the container is opened, use within 3 days. Discard unused product after that time period.
Condition of sale
Sale with retained Veterinary Medical prescription only.
Presentation
50 mL bottle
Prepared by
Drag Pharma Laboratory.
Records
Reg. SAG No 1866
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