Butamirate citrate is a centrally acting antitussive. It has an effect on increased stimulation threshold of the cough center located in the medulla oblongatas. This effect is highly selective since butamirate does not affect the activity of other near nervous centers such as the respiratory and cardiovascular centers.

Pharmacokinetics

The oral administration of butamirate citrate is followed by the quick and nearly complete (93 %). Its maximum plasma levels are achieved an hour before. The drug is metabolized in the liver by the action of hydrolases (hydrolytic enzymes). In humans, the main metabolites are excreted by the kidneys, 80 % of them were detected in the first 8 hour-urine. Butamirate citrate is very therapeutically recommended.

Each 100 ml contains:

Butamirate citrate….........………………………................……………   400 mg

Citric acid anhydrous, aspartame, glycerin,

methylparaben, propylparaben,

raspberry essence, neohesperidine,

sodium hydroxide and

deionized water q.s. ………………..………….....................................    100 ml

Spasmodic, irritative, improductive cough.

Drops

Infants younger than a year: 9 drops every 6 hs.

Children 1-3 years old: 18 drops every 6 hours.

Children 3-6 years old: 36 drops every 6 hours.

Hypersensitivity to active ingredients and/or tartrazine. Both the syrup and the drops contain aspartame, that is the reason why it is contraindicated in patients with phenylketonuria.

PRECAUTIONS AND WARNINGS

In patients with pulmonary edema it should be administered with caution. Although no teratogenic effects have been observed the administration is not recommended during the first 3 months of pregnancy.

DOSODOS® syrup contains tartrazine and due to its content of alcohol it should not be administered in patients on disulfiram.

ADVERSE REACTIONS

Exanthema, gastric disturbances, diarrhea or vertigo may be observed in a minimum percentage (1 %) of the patients that were treated with the drug product and they disappeared when the therapy is interrupted.

OVERDOSAGE

As in every case of overdosage, general support measures will be applied. If overdosage is observed, go to the nearest hospital or contact the local poison control center.

Drops: packages containing 15 ml.

STORAGE

Store in its original package at temperatures below 30 °C.

KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN