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Sudafed Cold & Flu (Pseudoephedrine HCl Dextromethorphan HBr Acetaminophen Guaife)
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Pharmacology
Information not available
Information not available
Indications
Nasal Decongestant Antitussive Analgesic Expectorant
Nasal Decongestant Antitussive Analgesic Expectorant
Contraindications
Sensitivity to pseudoephedrine or any of the other components. Patients receiving or having received MAO inhibitors in the preceding 2weeks; known hypersensitivity to pressor amines. Patients with severe hypertension or severe coronary artery disease.
Dextromethorphan: Pre-existing respiratory depression.
Sensitivity to pseudoephedrine or any of the other components. Patients receiving or having received MAO inhibitors in the preceding 2weeks; known hypersensitivity to pressor amines. Patients with severe hypertension or severe coronary artery disease.
Dextromethorphan: Pre-existing respiratory depression.
Safety Information / Warning
Massive acetaminophen overdose can be toxic and potentially fatal. In adults, hepatotoxicity from acetaminophen is unlikely to occur with overdoses of less than 10g ingested at one time and fatalities are unlikely to occur with overdoses of less than 15g ingested at one time.
Massive acetaminophen overdose can be toxic and potentially fatal. In adults, hepatotoxicity from acetaminophen is unlikely to occur with overdoses of less than 10g ingested at one time and fatalities are unlikely to occur with overdoses of less than 15g ingested at one time.
Precautions
As pseudoephedrine is a sympathomimetic amine, it should be used with caution in hypertensive and diabetic patients; patients with latent or clinically recognized angle closure glaucoma, coronary artery disease, congestive heart failure, prostatic hypertrophy, hyperthyroidism, urinary retention.
Geriatrics: The elderly (60years and older) are more likely to have adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death.
In severe hepatic or renal dysfunction, a single dose should be given and the patient's response used as a guide to the dosage requirement for further administration.
Hypertension and unconsciousness following the ingestion of one Sudafedtablet by a normotensive individual has been reported and should be regarded as an extremely rare example of pseudoephedrine intolerance.
Pregnancy and Lactation: Use with caution. Pseudoephedrine has been reported to be excreted into breast milk of lactating women. Consult a physician before using these products.
Drug Interactions : Concomitant use of pseudoephedrine with other sympathomimetic agents, such as decongestants, appetite suppressants, and amphetamine-like psychostimulants or with MAO inhibitors, which interfere with the catabolism of sympathomimetic amines, 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.
The effect of antihypertensive drugs which interfere with sympathetic activity may be partially reversed by pseudoephedrine (e.g., bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, beta and/or alpha- adrenergic-blocking agents).
As pseudoephedrine is a sympathomimetic amine, it should be used with caution in hypertensive and diabetic patients; patients with latent or clinically recognized angle closure glaucoma, coronary artery disease, congestive heart failure, prostatic hypertrophy, hyperthyroidism, urinary retention.
Geriatrics: The elderly (60years and older) are more likely to have adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death.
In severe hepatic or renal dysfunction, a single dose should be given and the patient's response used as a guide to the dosage requirement for further administration.
Hypertension and unconsciousness following the ingestion of one Sudafedtablet by a normotensive individual has been reported and should be regarded as an extremely rare example of pseudoephedrine intolerance.
Pregnancy and Lactation: Use with caution. Pseudoephedrine has been reported to be excreted into breast milk of lactating women. Consult a physician before using these products.
Drug Interactions : Concomitant use of pseudoephedrine with other sympathomimetic agents, such as decongestants, appetite suppressants, and amphetamine-like psychostimulants or with MAO inhibitors, which interfere with the catabolism of sympathomimetic amines, 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.
The effect of antihypertensive drugs which interfere with sympathetic activity may be partially reversed by pseudoephedrine (e.g., bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, beta and/or alpha- adrenergic-blocking agents).
Side Effects / Adverse Effects
Pseudoephedrine: As with other sympathomimetic amines, headache, dizziness, insomnia, tremor, confusion, CNS stimulation, muscular weakness, dry mouth, nausea, vomiting, difficulty in micturition, palpitations, tightness in the chest and syncope may be encountered. Fixed drug eruption has been reported and rarely hallucinations.
Dextromethorphan: drowsiness, dizziness, constipation, nausea, vomiting and confusion.
Guaifenesin: Nausea, gastrointestinal upset and drowsiness occur infrequently.
Pseudoephedrine: As with other sympathomimetic amines, headache, dizziness, insomnia, tremor, confusion, CNS stimulation, muscular weakness, dry mouth, nausea, vomiting, difficulty in micturition, palpitations, tightness in the chest and syncope may be encountered. Fixed drug eruption has been reported and rarely hallucinations.
Dextromethorphan: drowsiness, dizziness, constipation, nausea, vomiting and confusion.
Guaifenesin: Nausea, gastrointestinal upset and drowsiness occur infrequently.
Overdose
Symptoms: Pseudoephedrine: Increase in pulse and respiratory rate, CNS stimulation, disorientation, headache, dry mouth, nausea and vomiting.
Dextromethorphan: In severe cases, there may be respiratory depression due to the dextromethorphan component.
Treatment: Pseudoephedrine: Gastric lavage, repeated, if necessary. Acidify the urine and institute general supportive measures. If CNS excitement is prominent, a short-acting barbiturate may be used. Catheterization of the bladder may be necessary. Alpha-adrenergic blockade may be required to treat hypertensive crises and beta-adrenergic blockade for the control of supraventricular dysrhythmias. Elimination may be accelerated by dialysis.
Dextromethorphan: In severe cases of acute poisoning, where the respiratory depressive effects of dextromethorphan may be apparent, the following may be indicated: naloxone; Adults: 400µg s.c. Children: 5 to 10µg/kg s.c. Depending on the patient's response, the dose can be repeated at 2to 3minute intervals.
Symptoms: Pseudoephedrine: Increase in pulse and respiratory rate, CNS stimulation, disorientation, headache, dry mouth, nausea and vomiting.
Dextromethorphan: In severe cases, there may be respiratory depression due to the dextromethorphan component.
Treatment: Pseudoephedrine: Gastric lavage, repeated, if necessary. Acidify the urine and institute general supportive measures. If CNS excitement is prominent, a short-acting barbiturate may be used. Catheterization of the bladder may be necessary. Alpha-adrenergic blockade may be required to treat hypertensive crises and beta-adrenergic blockade for the control of supraventricular dysrhythmias. Elimination may be accelerated by dialysis.
Dextromethorphan: In severe cases of acute poisoning, where the respiratory depressive effects of dextromethorphan may be apparent, the following may be indicated: naloxone; Adults: 400µg s.c. Children: 5 to 10µg/kg s.c. Depending on the patient's response, the dose can be repeated at 2to 3minute intervals.
Recommended Dosage
Cold & Flu: Adults and children 12years and over: 2capsules every 4hours. Maximum daily dose: 8 capsules. Persons over 65 or under 12years: use only as directed by a physician.
Cold & Flu: Adults and children 12years and over: 2capsules every 4hours. Maximum daily dose: 8 capsules. Persons over 65 or under 12years: use only as directed by a physician.
Supplied / Packaging
Cold & Flu Regular Strength: Each liquid filled gel cap, imprinted “SMS”, contains: acetaminophen 250mg, dextromethorphanHBr 10mg, guaifenesin 100mg and pseudoephedrineHCl 30mg. Nonmedicinal ingredients: D&C yellow No.10, FD&C red No.40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol and water. Blister packages of10.
Cold & Flu Regular Strength: Each liquid filled gel cap, imprinted “SMS”, contains: acetaminophen 250mg, dextromethorphanHBr 10mg, guaifenesin 100mg and pseudoephedrineHCl 30mg. Nonmedicinal ingredients: D&C yellow No.10, FD&C red No.40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol and water. Blister packages of10.
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Brand Name
Sudafed Cold & Flu
Sudafed Cold & Flu
General Indications
Nasal Decongestant Antitussive Analgesic Expectorant
Nasal Decongestant Antitussive Analgesic Expectorant
