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Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

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Manufacturers Voluntarily Change Pediatric OTC Product Labeling – October 7, 2008

Leading manufacturers of over-the-counter (OTC) pediatric cough and cold products, in consultation with the Food and Drug Administration (FDA), have announced that they are voluntarily transitioning product labeling as it relates to children <4 years of age. The decision to change the labeling followed a meeting on October 2, 2008, conducted by the FDA to gather additional information related to the use of these products in children. The safety of the ingredients in these products was not in question. It was found that dosing errors and accidental ingestions were the leading cause of rare adverse events in children. The new product labeling will state "Do not use in children under four years of age." In addition, products with certain antihistamines will warn parents not to use these products to sedate or make a child sleepy. Labeling of adult products will not change. New product labels will be introduced during the 2008-2009 cough and cold season and some products will have the updated labeling by mid-October. Products with the old labeling will not be removed from the market. Prescription products are not affected. It is important to note that these medications have not been shown to be unsafe when used correctly. Pharmacists may continue to see health care practitioners recommending these agents for use in pediatric patients, and should help to ensure that they are being used safely and at appropriate dosages. Parents should be advised that OTC cough and cold products are safe and effective when used as directed, but that they should not be used in children <4 years of age unless instructed to do so by their healthcare provider. Counseling tips from the Consumer Healthcare Products Association (CHPA) also include: Always follow dosing instructions exactly and use measuring devices provided with the medicine. Never give 2 medicines at the same time that contain the same active ingredient. Do not give a medicine intended for use in adults to a child. Additional tips and information related to the labeling changes can be found on the following educational website of the CHPA: http://www.otcsafety.org. The FDA had previously issued a Public Health Advisory reminding patients and caregivers that OTC cough and cold medications should not be used to treat infants and children <2 years of age. This is in response to the Centers for Disease Control and Prevention (CDC) report which noted that during 2004 and 2005, ~1519 children <2 years of age were seen in emergency departments for adverse effects, including overdose, associated with products containing nasal decongestants (eg, pseudoephedrine), antihistamines (eg, carbinoxamine), and cough suppressants (eg, dextromethorphan). In October of 2007, several manufacturers voluntarily removed these products in order to help reduce dosing errors and overdose in this age group.

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For additional information, refer to the following websites: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094913.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116839.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5601a1.htm, Centers for Disease Control, “Infant Deaths Associated with Cough and Cold Medications – Two States, 2005,”MMWR Morb Mortal Wkly Rep, 2007, 56(01):1-4. U.S. BRAND NAMES — All-Nite Multi-Symptom Cold/Flu [OTC]; Vicks® NyQuil® D Cold & Flu Multi-Symptom [OTC] PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
Antitussive
Decongestant
Histamine H1 Antagonist
Histamine H1 Antagonist, First Generation

DOSING: ADULTS — Relief of cold and flu symptoms: Oral: 30 mL every 6 hours (maximum: 120 mL/24 hours)

DOSING: PEDIATRIC — Relief of cold and flu symptoms: Oral: Children ≥ 12 years: Refer to adult dosing.

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Liquid:
All-Nite Multi-Symptom Cold/Flu: Acetaminophen 500 mg, dextromethorphan hydrobromide 15 mg, doxylamine succinate 6.25 mg and pseudoephedrine hydrochloride 30 mg per 15 mL (296 mL) [contains sodium 17 mg/15 mL, ethanol 10%, and propylene glycol] Vicks® NyQuil® D Cold & Flu Multi-Symptom: Acetaminophen 500 mg, dextromethorphan hydrobromide 15 mg, doxylamine succinate 6.25 mg and pseudoephedrine hydrochloride 30 mg per 15 mL (295 mL) [contains sodium 18 mg/15 mL, ethanol 10%, and propylene glycol]

DOSAGE FORMS: CONCISE
Liquid:
All-Nite Multi-Symptom Cold/Flu [OTC]: Acetaminophen 500 mg, dextromethorphan hydrobromide 15 mg, doxylamine succinate 6.25 mg and pseudoephedrine hydrochloride 30 mg per 15 mL
Vicks® NyQuil® D Cold & Flu Multi-Symptom [OTC]: Acetaminophen 500 mg, dextromethorphan hydrobromide 15 mg, doxylamine succinate 6.25 mg and pseudoephedrine hydrochloride 30 mg per 15 mL

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION — Administer orally; only use enclosed dosing cup or tablespoon to administer; do not use other devices.

USE — Temporary relief of common cold and flu symptoms (eg, minor aches and pain, fever, cough, congestion, runny nose, sneezing, sore throat)

ADVERSE REACTIONS SIGNIFICANT — See individual agents.

CONTRAINDICATIONS — Use of MAO inhibitors within 14 days, concurrent use with other products containing acetaminophen

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

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Disease-related concerns: Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. Hepatic impairment: Use caution in patients with hepatic impairment; acetaminophen may cause severe hepatic toxicity with acute overdose.

Concurrent drug therapy issues: Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.

Special populations: Pediatrics: Use with caution in children; may cause excitability. Do not exceed pediatric dosing recommendations. If no recommendations exist on OTC labeling for patient’s age, the product should not be administered without the guidance of a physician.

Dosage form specific issues: Sodium: Some products may contain sodium; use with caution in sodium-restricted patients.

Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>7 days during use, consult a physician. If redness, swelling, or rash occurs or if fever worsens or persists >3 days during therapy, consult a physician. If sore throat is severe, accompanied by fever, nausea/vomiting, headache, swelling or rash, or last >2 days, discontinue use and consult healthcare provider.

DRUG INTERACTIONS
Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Amphetamines: May diminish the sedative effect of Antihistamines. Risk C: Monitor therapy

Antacids: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Aluminum Hydroxide. Risk C: Monitor therapy

Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Paliperidone. Risk C: Monitor therap
y

Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy

Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Risk C: Monitor therapy

Bromocriptine: Alpha-/Beta-Agonists may enhance the adverse/toxic effect of Bromocriptine. Including increased blood pressure, ventricular arrhythmias, and seizure. Risk C: Monitor therapy

Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy

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Carbonic Anhydrase Inhibitors: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Brinzolamide; Dorzolamide. Risk C: Monitor therapy

Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy

CYP2D6 Inhibitors (Moderate): May decrease the metabolism of CYP2D6 Substrates. Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May decrease the metabolism of CYP2D6 Substrates. Risk D: Consider therapy modification

Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination

Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy

MAO Inhibitors: May enhance the serotonergic effect of Dextromethorphan. This may cause serotonin syndrome. Risk X: Avoid combination

MAO Inhibitors: May enhance the hypertensive effect of Alpha-/Beta-Agonists (Indirect-Acting). Risk X: Avoid combination

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy

Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification

QuiNIDine: May decrease the metabolism of Dextromethorphan. Risk D: Consider therapy modification

Selective Serotonin Reuptake Inhibitors: May enhance the adverse/toxic effect of Dextromethorphan. Exceptions: Fluvoxamine. Risk D: Consider therapy modification

Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Risk D: Consider therapy modification

Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Risk D: Consider therapy modification

Sibutramine: May enhance the serotonergic effect of Serotonin Modulators. This may cause serotonin syndrome. Risk X: Avoid combination

Spironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy

ETHANOL / NUTRITION / HERB INTERACTIONS — Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day. DIETARY CONSIDERATIONS
All-Nite Cold contains sodium 17 mg per 15 mL.

Vicks® NyQuil® D Cold & Flu Multi-Symptom contains sodium 18 mg per 15 mL.

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