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Special Alerts
FDA Recommendation: OTC Cough and Cold Medications Should Not Be Used in Infants and Children <2 Years of Age - January, 2008
The Food and Drug Administration (FDA) has issued a Public Health Advisory reminding patients and caregivers that over-the-counter (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 released in January of 2007. The FDA Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee met October 18-19, 2007 to discuss the safety and efficacy of OTC cough and cold products in children <12 years of age. They recommend that these drugs not be used to treat children <2 years of age due to serious and potentially life-threatening side effects related to their use. The review of use of OTC cough and cold products in children 2-12 years is ongoing.
In January 2007, the CDC released a report concerning the use of cough and cold medications in children <2 years of age. Products containing nasal decongestants (eg, pseudoephedrine), antihistamines (eg, carbinoxamine), cough suppressants (eg, dextromethorphan), and expectorants are often used in this age group, however, safety and efficacy data is limited in this population. The CDC notes that during 2004 and 2005, ~1519 children <2 years of age were seen in emergency departments for adverse effects, including overdose, associated with these medications. In October of 2007, several manufacturers voluntarily removed these products in order to help reduce dosing errors and overdose in this age group. The FDA strongly supported this action.
Based on the agencies' review of the safety data, the FDA strongly recommends the following changes for these agents:
- List active ingredients, medication strength, and concentration on the label;
- Remove “Doctor Recommended” and all similar statements from the front panel;
- Remove all pictures of infants, babies, and children from the box;
- Indicate which patients should NOT take the product; and
- State that individuals should not simultaneously be given more than one product with the same ingredient.
For additional information, refer to the following websites:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough
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.
http://www.Otcsafety.org
http://www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4323m1-Final.pdf
Medication Safety Issues
Sound-alike/look-alike issues:
Benylin® may be confused with Benadryl®, Ventolin®
Delsym® may be confused with Delfen®, Desyrel®
Pronunciation
(deks troe meth OR fan)
U.S. Brand Names
Generic Available
Yes: Excludes strip, liquid freezer pop
Pharmacologic Category
Use: Labeled Indications
Symptomatic relief of coughs caused by minor viral upper respiratory tract infections or inhaled irritants; most effective for a chronic nonproductive cough
Use: Unlabeled/Investigational
N-methyl-D-aspartate (NMDA) antagonist in cerebral injury
Pregnancy Risk Factor
C
Contraindications
Hypersensitivity to dextromethorphan or any component of the formulation; do not use with or within 2 weeks of an MAO inhibitor
Warnings/Precautions
Special populations:
• Debilitated patients: Use with caution in patients who are sedated, debilitated or confined to a supine position.
• Pediatrics: Use with caution in atopic children. Not for OTC use in children <2 years of age.
Dosage form specific issues:
• Coconut: Some products may contain coconut oil.
• Tartrazine: Some products may contain tartrazine.
Other warnings/precautions:
• Self-medication (OTC use): When used for self medication (OTC) notify healthcare provider if symptoms do not improve within 7 days, or are accompanied by fever, rash or persistent headache. Do not use for persistent or chronic cough (as with smoking, asthma, chronic bronchitis, emphysema) or if cough is accompanied b excessive phlegm unless directed to do so by healthcare provider.
Adverse Reactions
<1%: Drowsiness, dizziness, coma, respiratory depression, nausea, GI upset, constipation, abdominal discomfort
Metabolism/Transport Effects
Substrate of CYP2B6 (minor), 2C9 (minor), 2C19 (minor), 2D6 (major), 2E1 (minor), 3A4 (minor); Inhibits CYP2D6 (weak)
Drug Interactions
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
MAO Inhibitors: May enhance the serotonergic effect of Dextromethorphan. This may cause serotonin syndrome. Risk X: Avoid combination
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
Sibutramine: May enhance the serotonergic effect of Serotonin Modulators. This may cause serotonin syndrome. Risk X: Avoid combination
Mechanism of Action
Chemical relative of morphine lacking narcotic properties except in overdose; controls cough by depressing the medullary cough center
Pharmacodynamics/Kinetics
Onset of action: Antitussive: 15-30 minutes
Duration: ?6 hours
Dosage
Oral:
Children:
<2 years: Use only as directed by a physician
2-6 years (syrup): 2.5-7.5 mg every 4-8 hours; extended release is 15 mg twice daily (maximum: 30 mg/24 hours)
6-12 years: 5-10 mg every 4 hours or 15 mg every 6-8 hours; extended release is 30 mg twice daily (maximum: 60 mg/24 hours)
Children >12 years and Adults: 10-20 mg every 4 hours or 30 mg every 6-8 hours; extended release: 60 mg twice daily; maximum: 120 mg/day
Dietary Considerations
Delsym® contains sodium 6 mg/5 mL.
Vicks® 44® Cough Relief contains sodium 10 mg/5 mL.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause drowsiness or depression
Mental Health: Effects on Psychiatric Treatment
Use with MAO inhibitors may cause hypertensive crisis; avoid combination
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Gelcap, as hydrobromide:
Robitussin® CoughGels™: 15 mg [contains coconut oil]
Liquid, as hydrobromide:
Creo-Terpin®: 10 mg/15 mL (120 mL) [contains alcohol 25% and tartrazine]
Vicks® 44® Cough Relief: 10 mg/5 mL (120 mL) [contains alcohol, sodium 10 mg/5 mL, sodium benzoate]
Liquid, oral, as hydrobromide [drops]:
PediaCare® Infants' Long-Acting Cough: 7.5 mg/0.8 mL (15 mL) [alcohol free, dye free; contains sodium benzoate; grape flavor] [DSC]
Lozenge, as hydrobromide:
Hold® DM: 5 mg (10s) [cherry or original flavor]
Scot-Tussin DM® Cough Chasers: 5 mg (20s)
Strips, oral, as hydrobromide:
Triaminic® Thin Strips™ Long Acting Cough: 7.5 mg [equivalent to dextromethorphan 5 mg; cherry flavor]
Suspension, extended release:
Delsym®: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (78 mL, 148 mL) [contains sodium 6 mg/5 mL; orange flavor]
Syrup, as hydrobromide:
Babee® Cof Syrup: 7.5 mg/5 mL (120 mL) [alcohol free, dye free; cherry flavor]
Creomulsion® Cough: 20 mg/15 mL (120 mL) [alcohol free; contains sodium benzoate]
Creomulsion® for Children: 5 mg/5 mL (120 mL) [alcohol free; contains sodium benzoate; cherry flavor]
ElixSure® Cough: 7.5 mg/5 mL (120 mL) [cherry bubble gum flavor]
Robitussin® Maximum Strength Cough: 15 mg/5 mL (120 mL, 240 mL) [contains alcohol, sodium benzoate]
Robitussin® Pediatric Cough: 7.5 mg/5 mL (120 mL) [alcohol free; contains sodium benzoate; fruit punch flavor]
Silphen DM®: 10 mg/5 mL (120 mL) [strawberry flavor]
International Brand Names
Lexi-Comp.com
Last full review/revision August 2008
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