Chemical Name:Triprolidine HCl Pseudoephedrine HCl
Therapeutic Category:Respiratory tract drugs
Pharmacologic Category:Decongestant - Histamine H1 Antagonist, First Generation
Composition:Triprolidine HCl 2.5mg- Pseudoephedrine HCl 60mg
Triprolidine HCl + Pseudoephedrine HCl
1-MODE OF ACTION:
Triprolidine provides symptomatic relief in conditions believed to depend wholly or partly upon the triggered release of histamine . Pseudoephedrine has direct and indirect sympathomimetic activity and is an effective upper respiratory tract decongestant .
ACT-SMART is indicated for the symptomatic relief of upper respiratory tract disorders which are benefited by a combination of a histamine H1- receptor antagonist and nasal decongestant . These include allergic rhinitis vasomotor rhinitis ،common cold and influenza.
ACT-SMART is contraindicated in individuals who have previously exhibited intolerance to it or to any of its constituents.
ACT-SMART is contraindicated in patients with severe hypertension or severe coronary artery disease.
ACT-SMART is contraindicated in patients who are taking or have taken monoamine oxidase inhibitors within the preceding 2 weeks.
ACT-SMART may cause drowsiness and impair the auditory performance so patients should not drive or operate machinery .
Users of ACT-SMART should avoid the concomitant use of alcohol or other centrally acting sedatives .
ACT-SMART should be used with caution in patients with hypertension، heart disease diabetes، hyperthyroidism ،elevated intraocular pressure, prostatic enlargement and patients taking tricyclic antidepressant .
ACT-SMART should not be given to children below 6 years of age the duration of treatment should not exceed the five days.
5-USE IN PREGNANCY & LACTATION:
There are no specific data on the use of pseudoephedrine and triprolidine during pregnancy, caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing fetus. Pseudoephedrine and triprolidine are excreted in breast milk in small amount but the effect of this on breast – fed infants is not known.
Central nervous system depression or excitation may occur,drowsiness,sleep disturbances, rarely hallucinations, skin rashes with or without irritation, tachycardia, dryness of the mouth,nose and throat, urinary retention and prostatic enlargement could have been an important predisposing factor.
Concomitant use of ACT-SMART with sympatheticomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants, amphetamine like psychostimulants or with monoamine oxidaseinhibitors which interfere with the catabolism of sympatheticomimetic amines may occasionally cause a rise in blood pressure .
Because of its pseudoephedrine content, ACT-SMART may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, bethanidine, guanethidine debrisoquine methyldopa and alpha or beta – adrenergic blocking agents.
8-DOSAGE & ADMINISTRATION:
Adults and children over 12 years: One tablet three times daily.
6-12 years: 5 ml syrup three times daily.
2-5 years: 2.5 ml syrup three times daily.
9-PACKING & COMPOSITION:
ACT-SMART – Tablets: A Pack of 10 tablets. Each tablet contains 2.5mg Triprolidine Hydrochloride + 60 mg Pseudoephedrine Hydrochloride.
ACT-SMART – Syrup: A glass bottle of 100ml. Each 5ml contains 1.25mg Triprolidine Hydrochloride + 30 mg Pseudoephedrine Hydrochloride.
Store ACT-SMART – Tablets and Syrup at temperature below 25°C. Protect from light.