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Dristan (Phenylephrine HCl Chlorpheniramine Maleate Acetaminophen)
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Pharmacology
Information not available
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Indications
Decongestant Antihistamine Analgesic
Decongestant Antihistamine Analgesic
Contraindications
Hypersensitivity to any of the components. Patients receiving MAO inhibitors.
Hypersensitivity to any of the components. Patients receiving MAO inhibitors.
Safety Information / Warning
Information not available
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Precautions
Use with caution on elderly patients or patients with allergy to acetaminophen, chronic alcoholism, serious liver or kidney disease, diabetes, heart or thyroid disease, high blood pressure, chronic lung disease, glaucoma, difficulty in urination due to enlarged prostate, or pregnant or nursing, or taking antidepressants, other antihistamines, tranquilizers, or sedating drugs.
Occupational Hazards: Patients should be cautioned not to operate vehicles or hazardous machinery until their response to the drug has been determined. Since the depressant effects of antihistamines are additive to those of other drugs affecting the CNS, patients should be cautioned against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant effects during antihistamine therapy.
Pregnancy and Lactation: Caution should be exercised before giving to women who are pregnant or nursing a baby.
Use with caution on elderly patients or patients with allergy to acetaminophen, chronic alcoholism, serious liver or kidney disease, diabetes, heart or thyroid disease, high blood pressure, chronic lung disease, glaucoma, difficulty in urination due to enlarged prostate, or pregnant or nursing, or taking antidepressants, other antihistamines, tranquilizers, or sedating drugs.
Occupational Hazards: Patients should be cautioned not to operate vehicles or hazardous machinery until their response to the drug has been determined. Since the depressant effects of antihistamines are additive to those of other drugs affecting the CNS, patients should be cautioned against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant effects during antihistamine therapy.
Pregnancy and Lactation: Caution should be exercised before giving to women who are pregnant or nursing a baby.
Side Effects / Adverse Effects
Slight to moderate drowsiness may occur. Other possible adverse reactions may include restlessness, dry mouth, nervousness, visual disturbances, dermatitis, weakness and nausea.
In therapeutic doses, acetaminophen is relatively non-toxic. Chronic use of large doses of acetaminophen may produce more significant toxicity.
Renal: Nephropathy, including papillary renal failure has been reported following consumption of large amounts of acetaminophen. Renal tubular necrosis has been associated occasionally with hepatic injury produced by acetaminophen overdose.
Hematologic: Neutropenia and thrombocytopenia purpura have been reported and rarely agranulocytosis.
Hypersensitivity: Laryngeal edema, angioedema and anaphylactoid reactions may occur rarely.
Hepatic: Hepatic toxicity has been associated with acetaminophen in overdose. Chronic use of high doses, e.g., ³5g daily for several weeks in adults or 150mg/kg/day for 2to 4days in children, has also been associated with hepatotoxicity. Alcoholics, patients with liver disease, the malnourished and patients taking drugs that induce hepatic microsomal enzymes, may be at increased risk for hepatic toxicity.
Respiratory: May aggravate bronchospasm in patients sensitive to ASA or other analgesics.
Slight to moderate drowsiness may occur. Other possible adverse reactions may include restlessness, dry mouth, nervousness, visual disturbances, dermatitis, weakness and nausea.
In therapeutic doses, acetaminophen is relatively non-toxic. Chronic use of large doses of acetaminophen may produce more significant toxicity.
Renal: Nephropathy, including papillary renal failure has been reported following consumption of large amounts of acetaminophen. Renal tubular necrosis has been associated occasionally with hepatic injury produced by acetaminophen overdose.
Hematologic: Neutropenia and thrombocytopenia purpura have been reported and rarely agranulocytosis.
Hypersensitivity: Laryngeal edema, angioedema and anaphylactoid reactions may occur rarely.
Hepatic: Hepatic toxicity has been associated with acetaminophen in overdose. Chronic use of high doses, e.g., ³5g daily for several weeks in adults or 150mg/kg/day for 2to 4days in children, has also been associated with hepatotoxicity. Alcoholics, patients with liver disease, the malnourished and patients taking drugs that induce hepatic microsomal enzymes, may be at increased risk for hepatic toxicity.
Respiratory: May aggravate bronchospasm in patients sensitive to ASA or other analgesics.
Overdose
Information not available
Information not available
Recommended Dosage
Dristan: Adults: 2tablets every 4hours not to exceed 8tablets daily. Children 6to 12years: 1tablet every 4hours, not to exceed 4tablets daily. Children under 6years: Consult a physician.
Dristan: Adults: 2tablets every 4hours not to exceed 8tablets daily. Children 6to 12years: 1tablet every 4hours, not to exceed 4tablets daily. Children under 6years: Consult a physician.
Supplied / Packaging
Each yellow and white layered regular strength tablet contains: phenylephrine HCl 5mg, chlorpheniramine maleate 2mg and acetaminophen 325mg. Nonmedicinal ingredients: calcium stearate, cellulose, croscarmellose sodium, crospovidone, D&C yellow No.10, FD&C yellow No.6, polyethylene glycol, povidone, pregelatinized starch and stearic acid. Energy: 0.19kJ (0.05kcal). Blister packages of 24, 48 and 72.
Each yellow and white layered regular strength tablet contains: phenylephrine HCl 5mg, chlorpheniramine maleate 2mg and acetaminophen 325mg. Nonmedicinal ingredients: calcium stearate, cellulose, croscarmellose sodium, crospovidone, D&C yellow No.10, FD&C yellow No.6, polyethylene glycol, povidone, pregelatinized starch and stearic acid. Energy: 0.19kJ (0.05kcal). Blister packages of 24, 48 and 72.
