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Special Alerts
Health Canada: Labeling Changes for OTC Cough and Cold Preparations - December, 2008
Health Canada has issued an advisory to Canadian consumers regarding upcoming labeling changes for the use of over-the-counter (OTC) cough and cold medicines in children. Specific labeling changes as well as other important information may be found at http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_184-eng.php.
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.
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.
Medication Safety Issues
Sound-alike/look-alike issues:
Dimetapp® may be confused with Dermatop®, Dimetabs®, Dimetane®
Sudafed® may be confused with sotalol, Sudafed PE™, Sufenta®
Pronunciation
(soo doe e FED rin)
U.S. Brand Names
Index Terms
Generic Available
Yes: Liquid, tablet
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Temporary symptomatic relief of nasal congestion due to common cold, upper respiratory allergies, and sinusitis; also promotes nasal or sinus drainage
Use: Dental
Temporary symptomatic relief of nasal congestion due to common cold, upper respiratory allergies, and sinusitis; also promotes nasal or sinus drainage
Pregnancy Risk Factor
C
Pregnancy Considerations
Use during the 1st trimester may be associated with a possible risk of gastroschisis, small intestinal atresia, and hemifacial microsomia due pseudoephedrine's vasoconstrictive effects. However, additional studies are needed to define the magnitude of risk.
Lactation
Enters breast milk/use caution (AAP rates “compatible”)
Breast-Feeding Considerations
Pseudoephedrine is excreted in breast milk. Animal reproduction studies have not been conducted. Some manufacturers contraindicate its use; however, the AAP considers it to be “compatible” with breast-feeding.
Contraindications
Hypersensitivity to pseudoephedrine or any component of the formulation; with or within 14 days of MAO inhibitor therapy; newborns; breast-feeding
Warnings/Precautions
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease).
• Diabetes: Use with caution in patients with diabetes mellitus.
• Increased intraocular pressure/glaucoma: Use with caution in patients with increased intraocular pressure or angle-closure glaucoma.
• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.
• Renal impairment: Use caution in patient with renal impairment; consider dosage adjustments.
• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Special populations:
• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects.
Dosage form specific issues:
• Phenylalanine: Some products may contain phenylalanine.
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. Discontinue and contact healthcare provider if nervousness, dizziness, or sleeplessness occur. Not for OTC use in children <2 years of age.
Adverse Reactions
Frequency not defined.
Cardiovascular: Arrhythmia, hypotension, palpitation, tachycardia
Central nervous system: Chills, confusion, coordination impaired, dizziness, drowsiness, excitability, fatigue, hallucination, headache, insomnia, nervousness, neuritis, restlessness, seizure, transient stimulation, vertigo
Dermatologic: Photosensitivity, rash, urticaria
Gastrointestinal: Anorexia, constipation, diarrhea, dry throat, nausea, vomiting, xerostomia
Genitourinary: Difficult urination, dysuria, polyuria, urinary retention
Hematologic: Agranulocytosis, hemolytic anemia, thrombocytopenia
Neuromuscular & skeletal: Tremor, weakness
Ocular: Blurred vision, diplopia
Otic: Tinnitus
Respiratory: Chest/throat tightness, dry nose, dyspnea, nasal congestion, thickening of bronchial secretions, wheezing
Miscellaneous: Anaphylaxis, diaphoresis
Drug Interactions
Antacids: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Aluminum Hydroxide. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. 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
Carbonic Anhydrase Inhibitors: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Brinzolamide; Dorzolamide. Risk C: Monitor therapy
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination
MAO Inhibitors: May enhance the hypertensive effect of Alpha-/Beta-Agonists (Indirect-Acting). Risk X: Avoid combination
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
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
Ethanol/Nutrition/Herb Interactions
Food: Onset of effect may be delayed if pseudoephedrine is taken with food.
Herb/Nutraceutical: Avoid ephedra, yohimbe (may cause hypertension).
Mechanism of Action
Directly stimulates alpha-adrenergic receptors of respiratory mucosa causing vasoconstriction; directly stimulates beta-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility
Pharmacodynamics/Kinetics
Onset of action: Decongestant: Oral: 15-30 minutes
Duration: Immediate release tablet: 4-6 hours; Extended release: ?12 hours
Absorption: Rapid
Metabolism: Partially hepatic
Half-life elimination: 9-16 hours
Excretion: Urine (70% to 90% as unchanged drug, 1% to 6% as active norpseudoephedrine); dependent on urine pH and flow rate; alkaline urine decreases renal elimination of pseudoephedrine
Dosage
Oral:
Hydrochloride salt: General dosing guidelines:
Children:
<2 years: 4 mg/kg/day in divided doses every 6 hours
2-5 years: 15 mg every 4-6 hours; maximum: 60 mg/24 hours
6-12 years: 30 mg every 4-6 hours; maximum: 120 mg/24 hours
Adults: 30-60 mg every 4-6 hours, sustained release: 120 mg every 12 hours; maximum: 240 mg/24 hours
Tannate salt: Nasofed™ oral suspension:
Children 2-5 years: 1.25-2.5 mL (12.5-25 mg) every 12 hours
Children 6-11 years: 2.5-5 mL (25-50 mg) every 12 hours
Children ?12 years and Adults: 5-10 mL (50-100 mg) every 12 hours
Dosing adjustment in renal impairment: Consider reducing dose
Administration: Oral
Do not crush extended release drug product, swallow whole.
Test Interactions
Interferes with urine detection of amphetamine (false-positive)
Dietary Considerations
Should be taken with water or milk to decrease GI distress. Nasofed™ oral suspension contains phenylalanine 7 mg/5 mL; Sudafed® Children's chewable tablet contains phenylalanine 0.78 mg/tablet.
Patient Education
Take only as prescribed; do not exceed prescribed dose or frequency. Do not chew or crush timed release forms. Maintain adequate hydration unless instructed to restrict fluid intake. You may experience nervousness, insomnia, dizziness, or drowsiness (use caution when driving or engaging in tasks requiring alertness until response to drug is known). Report persistent CNS changes (dizziness, tremor, agitation, or convulsions); respiratory difficulty; chest pain, palpitations, or rapid heartbeat; muscle tremor; or lack of improvement or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.
Geriatric Considerations
Elderly patients should be counseled about the proper use of over-the-counter cough and cold preparations. Elderly are more predisposed to adverse effects of sympathomimetics since they frequently have cardiovascular diseases and diabetes mellitus as well as multiple drug therapies. It may be advisable to treat with a short-acting/immediate-release formulation before initiating sustained-release/long-acting formulations.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
Use with caution since pseudoephedrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response
Mental Health: Effects on Mental Status
Dizziness, drowsiness, nervousness, and insomnia are common; may rarely cause hallucinations
Mental Health: Effects on Psychiatric Treatment
Contraindicated with MAO inhibitors
Nursing: Physical Assessment/Monitoring
Assess effectiveness and interactions of other medications patient may be taking. Monitor effectiveness of therapy and adverse reactions at beginning of therapy and periodically with long-term use. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Caplet, extended release, oral, as hydrochloride:
Sudafed® 12 Hour: 120 mg
Liquid, oral, as hydrochloride: 30 mg/5 mL (120 mL)
Silfedrine Children's: 15 mg/5 mL (120 mL, 480 mL) [alcohol and sugar free; grape flavor]
Sudafed® Children's: 15 mg/5 mL (120 mL) [alcohol and sugar free; contains sodium benzoate; grape flavor]
Liquid, oral, as hydrochloride [drops]:
Kidkare Decongestant: 7.5 mg/0.8 mL (30 mL) [alcohol free; contains benzoic acid and sodium benzoate; cherry flavor]
Suspension, oral, as tannate:
Nasofed™: 50 mg/5 mL (118 mL) [contains phenylalanine 7 mg/5 mL, propylene glycol; strawberry flavor] [DSC]
Syrup, oral, as hydrochloride: 30 mg/5 mL (118 mL, 473 mL)
SudoGest Children's: 15 mg/5 mL (118 mL) [ethanol free, sugar free; contains sodium 5 mg/5 mL, sodium benzoate; grape flavor]
Tablet, oral, as hydrochloride: 30 mg, 60 mg
Genaphed®, Oranyl, Sudafed®, Sudo-Tab®: 30 mg
SudoGest: 30 mg, 60 mg
Tablet, chewable, oral, as hydrochloride:
Sudafed® Children's: 15 mg [sugar free; contains phenylalanine 0.78 mg/tablet; orange flavor]
Tablet, extended release, oral, as hydrochloride:
Sudafed® 24 Hour: 240 mg
Pricing: U.S. (www.drugstore.com)
Tablets (Pseudoephedrine HCl)
60 mg (100): $10.13
References
“American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk,” Pediatrics, 2001, 108(3):776-89.
Pentel P, “Toxicity of Over-the-Counter Stimulants,” JAMA, 1984, 252(14):1898-903.
Salmon J and Nicholson D, “DIC and Rhabdomyolysis Following Pseudoephedrine Overdose,” Am J Emerg Med, 1988, 6(5):545-6.
Simons FE, Gu X, Watson WT, et al, “Pharmacokinetics of the Orally Administered Decongestants Pseudoephedrine and Phenylpropanolamine in Children,” J Pediatr, 1996, 129(5):729-34.
Werler MM, “Teratogen Update: Pseudoephedrine,” Birth Defects Res A Clin Mol Teratol, 2006, 76(6):445-52.
Wezorek C, Dean B, and Krenzelok E, “Pseudoephedrine: A Prospective Study to Establish a Toxic Dose in Children,” Clin Toxicol, 1995, 33(5):554.
Wright S and Tomassoni A, “Acute Myocardial Infarction Following Therapeutic Use of Pseudoephedrine,” Vet Hum Toxicol, 1994, 36:366.
International Brand Names
Lexi-Comp.com
Last full review/revision July 2009
Content last modified July 2009
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