triprolidine + pseudoephedrine




Apex Pharma Marketing
Full Prescribing Info
Triprolidine hydrochloride, pseudoephedrine hydrochloride
FC tablet: Each tablet contains: Triprolidine HCl 2.5 mg; Pseudoephedrine HCl 60 mg.
Syrup: Each 5ml contains: Triprolidine HCl 1.25 mg; Pseudoephedrine HCl 30 mg (contains Sodium Benzoate).
Pharmacology: Triprolidine hydrochloride acts as an antagonists of the H1 histamine receptor. Pseudoephedrine acts as an indirect sympathomimetic agent by stimulating sympathetic nerve endings to release noradrenaline. Noradrenaline in turn stimulates alpha and beta receptors throughout the body. The action of pseudoephedrine hydrochloride is apparently more specific for the blood vessels of the upper respiratory tract and less specific for the blood vessels of the systemic circulation. The vasoconstriction elicited at these sites results in the shrinkage of swollen tissues in the sinuses and nasal passages.
It is indicated in nasal and respiratory congestion, common cold, acute sinusitis, and allergic rhinitis.
Dosage/Direction for Use
Oral administration.
FC tablet
: Adults and children 12 years and older: 1 tablet three times daily.
Syrup: Adults and children over 12 years: 10ml three times daily.
Children 6 to 12 years: 5ml three times daily.
Children 2 to 5 years: 2.5ml three times daily.
Overdosage with triprolidine may produce reactions varying from depression to stimulation of the Central Nervous System: the later is particularly likely in children. Atropine-like signs and symptoms (dry mouth, fixed dilated pupils, flushing, tachycardia, hallucination, convulsions, urinary retention, cardiac arrthymias and coma) may occur. Overdosage with pseudoephedrine can cause excessive CNS stimulation resulting in excitement, nervousness, anxiety, tremor, restlessness and insomnia. Other effects include tachycardia, hypertension, pallor, mydriasis, hyperglycaemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, hallucinations, convulsions, or delirium, but in some individuals there may be CNS depression with somnolence, stupor, or respiratory depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Severe hypotension can occur probably due to compartmental shift rather than depletion of potassium. Gastric emptying and/or lavage is recommended as soon as possible after ingestion even if the patient has vomited spontaneously. Either isotonic or half isotonic saline may be used for lavage. Administration of activated charcoal as a slurry is beneficial after lavage and or emesis, if less than four hours have passes since ingestion. Saline cathartics, such as milk of magnesia, help to dilute the concentration of the drugs in the bowels by drawing water into the gut, thereby hastening drug elimination.
Adrenergic receptor blocking agents are antidotes to pseudoephedrine. In practice, the most useful is the beta-blocker propranolol, which is indicated when there are signs of cardiac toxicity. There are no specific antidotes to triprolidine. Histamine should not be given.
The combination of triprolidine and pseudoephedrine is contraindicated under the following condition: Hypersensitivity to pseudoephedrine or sympathomimetic amines.
Patients taking MAO inhibitors.
Severe hypertension.
Severe coronary artery disease.
Not recommended for children below 2 years. Use with caution and on doctor's/pharmacist's advice in children 2 to 6 years of age.
Special Precautions
It should be used with considerable caution in patients with increased intraocular pressure, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bladder neck obstruction, hypertension, diabetes mellitus, ischemic heart disease and hyperthyroidism. It should be prescribed with caution for certain special risk patients, such as the elderly or debilitated and for those with severe impairment of renal or hepatic function, gall bladder disease or gallstones, respiratory impairment, cardiac arrhythmias, history of bronchial asthma, prostatic hypertrophy or urethral stricture and in patients known to be taking other antihistamines or decongestant preparations.
Patients should be cautioned about engaging in activities requiring mental alertness. This preparation should not be used by persons intolerant to sympathomimetics used for the relief of nasal or sinus congestion. This product may cause drowsiness. If affected do not drive or operate machinery.
Use In Pregnancy & Lactation
As there are no adequate data on its use in pregnant women, it should be used only if clearly needed. The components of the combination are excreted in breast milk in small amounts and because of the potential for serious adverse reaction in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug.
Side Effects
The most frequent side effects include dryness of mouth, nose and throat, sedation, sleepiness, dizziness and disturbed coordination. Other side effects include urticaria, excessive perspiration, tachycardia, headache, hypotension, anxiety, vertigo, tinnitus, nausea, vomiting, diarrhoea, epigastric pain, irritability, anorexia, tightness of chest and wheezing.
Drug Interactions
Concomitant use of DECONDINE with other sympathomimetic agents such as decongestants, tricyclic antidepressants and amphetamine-like psychostimulants or MOA inhibitors which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure and may diminish the antihypertensive effects of guanethidine, bethanidine, methyldopa and reserpine.
Store at or below 30°C. Protect from light.
Shelf-life: FC tablet: 5 years.
Syrup: 3 years.
ATC Classification
R01BA52 - pseudoephedrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
FC tab (round, standard convex, white, film-coated with single score) 100 x 10's. Syr (clear, yellow; vanilla-flavoured) 3.6 L.
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