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Actifed Plus Extra Strength (Acetaminophen Pseudoephedrine HCl Triprolidine HCl)
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Pharmacology
Information not available
Information not available
Indications
Analgesic Antipyretic Antihistamine Decongestant
Analgesic Antipyretic Antihistamine Decongestant
Contraindications
Hypersensitivity to triprolidine, pseudoephedrine or acetaminophen. Should not be administered to patients receiving MAO inhibitors or who have taken them within preceding 2weeks. Patients with severe hypertension or severe coronary artery disease.
Hypersensitivity to triprolidine, pseudoephedrine or acetaminophen. Should not be administered to patients receiving MAO inhibitors or who have taken them within preceding 2weeks. Patients with severe hypertension or severe coronary artery disease.
Safety Information / Warning
Information not available
Information not available
Precautions
Occupational Hazards: Patients should be cautious not to operate vehicles or hazardous machinery until their response to the drug has been determined.
Since the depressant effects of antihistamines are addictive to those of other drugs affecting the CNS, patients should be cautious against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant antihistaminic therapy.
Hypertension and unconsciousness following the ingestion of 60mg pseudoephedrine by a normotensive individual has been reported and should be regarded as an extremely rare example of pseudoephedrine intolerance.
As with other sympathomimetic agents and decongestants, this product should be used with caution in patients with prostatic enlargement, in hypertensive and diabetic patients, patients with latent or clinically recognized angle closure glaucoma, coronary artery disease, congestive heart failure, hyperthyroidism, and urinary retention. In severe hepatic or renal dysfunction, this product should be given at less than the usual recommended dose and the patient's response used as a guide to the dosage requirement for further administration.
Pregnancy and Lactation: Use with caution. Pseudoephedrine and triprolidine have been reported to be excreted into breast milk of lactating women.
Drug Interactions : Concomitant use of this product with sympathomimetic agents such as decongestants, appetite suppressants, and amphetamine-like psychostimulants or with MAO inhibitors may occasionally cause a rise in blood pressure.
The antibacterial agent, furazolidone, is known to cause a dose-related inhibition of MAO. Although there are no reports of a hypertensive crisis caused by the concurrent administration of pseudoephedrine and furazolidone, they should not be taken together.
Because of its pseudoephedrine component, this product may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, beta and/or alpha adrenergic blocking agents.
Occupational Hazards: Patients should be cautious not to operate vehicles or hazardous machinery until their response to the drug has been determined.
Since the depressant effects of antihistamines are addictive to those of other drugs affecting the CNS, patients should be cautious against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant antihistaminic therapy.
Hypertension and unconsciousness following the ingestion of 60mg pseudoephedrine by a normotensive individual has been reported and should be regarded as an extremely rare example of pseudoephedrine intolerance.
As with other sympathomimetic agents and decongestants, this product should be used with caution in patients with prostatic enlargement, in hypertensive and diabetic patients, patients with latent or clinically recognized angle closure glaucoma, coronary artery disease, congestive heart failure, hyperthyroidism, and urinary retention. In severe hepatic or renal dysfunction, this product should be given at less than the usual recommended dose and the patient's response used as a guide to the dosage requirement for further administration.
Pregnancy and Lactation: Use with caution. Pseudoephedrine and triprolidine have been reported to be excreted into breast milk of lactating women.
Drug Interactions : Concomitant use of this product with sympathomimetic agents such as decongestants, appetite suppressants, and amphetamine-like psychostimulants or with MAO inhibitors may occasionally cause a rise in blood pressure.
The antibacterial agent, furazolidone, is known to cause a dose-related inhibition of MAO. Although there are no reports of a hypertensive crisis caused by the concurrent administration of pseudoephedrine and furazolidone, they should not be taken together.
Because of its pseudoephedrine component, this product may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, beta and/or alpha adrenergic blocking agents.
Side Effects / Adverse Effects
Some patients may exhibit mild sedation or mild stimulation. Sleep disturbances and rarely hallucinations have been reported.
Urinary retention may occasionally occur in male subjects where prostatic enlargement is present. Fixed drug eruption due to pseudoephedrine and lichenoid skin eruption due to triprolidine have been reported but both these reactions should be regarded as rare events.
Some patients may exhibit mild sedation or mild stimulation. Sleep disturbances and rarely hallucinations have been reported.
Urinary retention may occasionally occur in male subjects where prostatic enlargement is present. Fixed drug eruption due to pseudoephedrine and lichenoid skin eruption due to triprolidine have been reported but both these reactions should be regarded as rare events.
Overdose
Symptoms: Insomnia, tremors, tachycardia, difficulty in micturition, irritability, drowsiness, lethargy, dizziness, ataxia, weakness, hypotonicity, respiratory depression, dryness of the skin and mucous membranes, hypertension, hyperpyrexia, hyperactivity and convulsions.
Treatment: There is no specific antidote for triprolidine or pseudoephedrine. General measures to eliminate the drug and reduce its absorption should be undertaken. Gastric lavage should be performed up to 3hours after ingestion if indicated. If desired the elimination of pseudoephedrine can be accelerated by urine acidification. If respiratory depression is severe, intubation and artificial respiration should be used. Convulsions should be treated with diazepam. Maintain blood pressure through fluid replacement and supportive measures. Catheterization of the bladder may be necessary. Hypertension may be controlled with alpha-adrenoceptor blocking drugs and tachycardia with beta-adrenoceptor blocking drugs.
Symptoms: Insomnia, tremors, tachycardia, difficulty in micturition, irritability, drowsiness, lethargy, dizziness, ataxia, weakness, hypotonicity, respiratory depression, dryness of the skin and mucous membranes, hypertension, hyperpyrexia, hyperactivity and convulsions.
Treatment: There is no specific antidote for triprolidine or pseudoephedrine. General measures to eliminate the drug and reduce its absorption should be undertaken. Gastric lavage should be performed up to 3hours after ingestion if indicated. If desired the elimination of pseudoephedrine can be accelerated by urine acidification. If respiratory depression is severe, intubation and artificial respiration should be used. Convulsions should be treated with diazepam. Maintain blood pressure through fluid replacement and supportive measures. Catheterization of the bladder may be necessary. Hypertension may be controlled with alpha-adrenoceptor blocking drugs and tachycardia with beta-adrenoceptor blocking drugs.
Recommended Dosage
Adults and children 12years and over: 1caplet every 4to 6hours. Do not exceed 4doses in 24hours. Children 12years and under: use only as directed by a physician.
Geriatrics: Persons over 65: use only as directed by a physician.
Information for the Patient: See Blue Section--Information for the Patient “Actifed Plus Extra Strength”.
Adults and children 12years and over: 1caplet every 4to 6hours. Do not exceed 4doses in 24hours. Children 12years and under: use only as directed by a physician.
Geriatrics: Persons over 65: use only as directed by a physician.
Information for the Patient: See Blue Section--Information for the Patient “Actifed Plus Extra Strength”.
Supplied / Packaging
Each white caplet, engraved “A” on one side and “WL02” on the other, contains: triprolidine HCl 2.5mg, pseudoephedrine HCl 60mg and acetaminophen 500mg. Nonmedicinal ingredients: cellulose, magnesium stearate and povidone. Packages of 24. Store between 15and 25°C. Protect from light and keep dry.
Each white caplet, engraved “A” on one side and “WL02” on the other, contains: triprolidine HCl 2.5mg, pseudoephedrine HCl 60mg and acetaminophen 500mg. Nonmedicinal ingredients: cellulose, magnesium stearate and povidone. Packages of 24. Store between 15and 25°C. Protect from light and keep dry.
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Brand Name
Actifed Plus Extra Strength
Actifed Plus Extra Strength
General Indications
Analgesic Antipyretic Antihistamine Decongestant
Analgesic Antipyretic Antihistamine Decongestant
