[The use and safety of butamirate containing drops, syrup and depot tablets in Hungary].

BACKGROUND

Butamirate citrate containing medicines are marketed in Hungary since 1991. Every year several hundred thousands of children and adults are treated with these pharmaceutical products. Aim of the study was to compare the prescription habits with the directions provided in the Summary of Product Characteristics and to get an overview on the safety and efficacy of these products.

METHODS

The study results are based on the evaluation of 3215 questionnaires provided by 276 general practitioners and pulmonologists having medical practice in many regions and the capital of Hungary. Responses were included into the evaluation only if the name of the physician, the address and type of the practice, the therapeutic indication could be precisely identified and if the patient returned for at least one control visit.

RESULTS

The main therapeutic indication of butamirate was cough due to acute lower respiratory tract infections (tracheitis, laryngitis, bronchitis). The treatment interval was usually 1-2 weeks. Depot tablets were prescribed according to the Summary of Product Characteristics. The doses of syrup and drops were frequently and notoriously below the one proposed in the Summary of Product Characteristics. In 14% of the cases the syrup was prescribed for the treatment of children below 3 years of age. All three products were regarded as effective. Adverse events (nausea, vomiting, diarrhoea, skin exanthemas) were reported at 0.5-1% of the patients.

CONCLUSIONS

The prescribed average daily doses of drops between the ages 1 month-12 years and the syrup between the ages 6-12 years were 20-30% below the recommended amounts. In Hungary the butamirate citrate containing medicines are regarded to be effective. The adverse events were rare and non-serious.