Presentation

Askorel SR tablet: Each sustained release tablet contains Butamirate Citrate INN 50 mg.

Askorel syrup: Each 5 ml syrup contains Butamirate Citrate INN 7.5 mg.

Askorel paediatric drops: Each ml drop contains Butamirate Citrate INN 5 mg.

Description

Butamirate Citrate belongs to the anti-cough medicines of central action. It exerts expectorant, moderate bronchodilating and anti-inflammatory action. Butamirate Citrate also increases the spirometery indexes and blood oxygenation. It is safe and non-sedating which is neither chemically nor pharmacologically related to opium alkaloids. The active metabolites of Butamirate Citrate have also antitussive action.

Indications

Askorel is indicated in acute cough of any etiology, suppression of pre-& post-operative cough in surgery & bronchoscopy and suppression of whooping cough.

Dosage & Administration

Dosage form Age Dose

SRTablet Adolescents over 12 years 1-2 tablets daily

Adults 2-3 tablets daily at 8-12 hoursinterval

Syrup Infants (2 months – 1 year) 1.5 ml four times daily

Infants (1 – 3 years) 2.5 ml four times daily

Children 3-5 years of age 7.5 ml three times daily

> 6 years and adults 15 ml three times daily

Paediatricdrops Infants (2 months – 1 year) 10 drops four times daily

Infants (1 – 3 years) 15 drops four times daily

Side Effects

Tolerance of Butamirate Citrate is good. Adverse reactions such as rash, nausea, diarrhea and vertigo have been observed in a few rare cases, resolving after dose reduction or treatment withdrawal.

Precautions

Not applicable

Use in Pregnancy & Lactation

Butamirate Citrate should not be used during the first trimester of pregnancy. During the remainder of pregnancy, it can be used if indicated by a physician but with caution. As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, the benefits of Butamirate Citrate administration during breast feeding should be carefully weighed against the risks.

Over Dose

Accidental overdose with Butamirate Citrate can cause the following symptoms: drowsiness, nausea, vomiting, diarrhea, loss of balance and hypotension. Standard emergency procedures should be followed: activated charcoal, saline laxatives and standard cardio-respiratory resuscitation.

Storage

Do not store above 30 0 C. Keep away from light and out of the reach of children.

Commercial Pack

Askorel SR tablet: Each box contains 3 Alu-Alu blister strips of 10 tablets.

Askorel syrup: Each box contains 1 PET bottle containing 100 ml Syrup & 20 ml measuring cup. Askorel pediatric drops: Each box contains 1 amber glass bottle containing 15 ml pediatric drops and one 1.25 ml dropper