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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:
Chlor-Trimeton® may be confused with Chloromycetin®
Pronunciation
(klor fen IR a meen)
U.S. Brand Names
Index Terms
Generic Available
Yes: Syrup, tablet
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Perennial and seasonal allergic rhinitis and other allergic symptoms including urticaria
Use: Dental
Treatment of histamine-induced allergic symptoms
Pregnancy Risk Factor
C
Pregnancy Considerations
Reproduction studies have not been conducted with chlorpheniramine tannate.
Lactation
Excretion in breast milk unknown/not recommended
Contraindications
Hypersensitivity to chlorpheniramine maleate or any component of the formulation; narrow-angle glaucoma; bladder neck obstruction; symptomatic prostate hypertrophy; during acute asthmatic attacks; stenosing peptic ulcer; pyloroduodenal obstruction. Avoid use in premature and term newborns due to possible association with SIDS.
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).
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease).
• Increased intraocular pressure: Use with caution in patients with increased intraocular pressure.
• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.
• Respiratory disease: Use with caution in patients with asthma or other chronic breathing disorders.
• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Concurrent drug therapy issues:
• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations:
• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects.
• Pediatrics: Antihistamines may cause excitation in young children. Not for OTC use in children <2 years of age.
Adverse Reactions
>10%:
Central nervous system: Slight to moderate drowsiness
Respiratory: Thickening of bronchial secretions
1% to 10%:
Central nervous system: Headache, excitability, fatigue, nervousness, dizziness
Gastrointestinal: Nausea, xerostomia, diarrhea, abdominal pain, appetite increase, weight gain
Genitourinary: Urinary retention
Neuromuscular & skeletal: Arthralgia, weakness
Ocular: Diplopia
Renal: Polyuria
Respiratory: Pharyngitis
Metabolism/Transport Effects
Substrate of CYP2D6 (minor), 3A4 (major); Inhibits CYP2D6 (weak)
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
Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Paliperidone. Risk C: Monitor therapy
Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Risk D: Consider therapy modification
Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
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
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may increase CNS depression).
Storage
Protect from light.
Mechanism of Action
Competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract
Pharmacodynamics/Kinetics
Half-life elimination, serum: 20-24 hours
Dosage
Children: Oral: 0.35 mg/kg/day in divided doses every 4-6 hours
2-6 years: 1 mg every 4-6 hours, not to exceed 6 mg in 24 hours
6-12 years: 2 mg every 4-6 hours, not to exceed 12 mg/day or sustained release 8 mg at bedtime
Children >12 years and Adults: Oral: 4 mg every 4-6 hours, not to exceed 24 mg/day or sustained release 8-12 mg every 8-12 hours, not to exceed 24 mg/day
Elderly: Oral: 4 mg once or twice daily. Note: Duration of action may be 36 hours or more when serum concentrations are low.
Hemodialysis: Supplemental dose is not necessary
Administration: Oral
Timed release oral forms are to be swallowed whole, not crushed or chewed.
Dietary Considerations
May be taken with food or water.
Geriatric Considerations
Anticholinergic action may cause significant confusional symptoms, constipation, or problems voiding urine. If an antihistamine is indicated, a second generation nonsedating antihistamine would be a more appropriate choice.
Additional Information
Not effective for nasal stuffiness.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation). Chronic use of antihistamines will inhibit salivary flow, particularly in elderly patients; this may contribute to periodontal disease and oral discomfort.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
Drowsiness is common; may cause excitability, nervousness, fatigue, or depression
Mental Health: Effects on Psychiatric Treatment
Dry mouth and sedation may be exacerbated by concurrent psychotropic use
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, extended release, oral, as maleate: 8 mg, 12 mg
CPM-12: 12 mg
Suspension, oral, as tannate:
PediaTan™: 8 mg/5 mL (480 mL) [sugar free; contains sodium benzoate; bubble gum flavor]
P-Tann: 8 mg/5 mL (473 mL) [sugar free; contains sodium benzoate; bubblegum flavor]
Suspension, oral, as tannate [drops]:
Ed Chlorped: 2 mg/mL (60 mL)
Syrup, as maleate:
Aller-Chlor®: 2 mg/5 mL (120 mL) [contains alcohol 5%]
Diabetic Tussin® Allergy Relief: 2 mg/5 mL (120 mL) [alcohol free, dye free, sugar free]
Tablet, as maleate: 4 mg
Aller-Chlor®: 4 mg
Chlor-Trimeton® Allergy: 4 mg
Chlorphen: 4 mg
Teldrin® HBP: 4 mg
Tablet, extended release, oral, as maleate:
Chlor-Trimeton® Allergy: 12 mg
Tablet, extended release, oral, as tannate:
Ed-Chlor-Tan: 8 mg
Tablet, long acting, as tannate [scored]:
Ahist™: 12 mg
International Brand Names
Lexi-Comp.com
Last full review/revision June 2009
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