[Posted 01/13/2011] ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.
BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.
RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.
Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. For more information visit the FDA website at: [Web] and [Web].
Symptomatic relief of rhinorrhea, sneezing, lacrimation, itching eyes, or oronasopharyngeal itching associated with allergic rhinitis (e.g., hay fever) or other upper respiratory allergies.
Allergic Skin Disorders
Management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Common Cold
Self-medication for temporary relief of symptoms associated with the common cold (e.g., rhinorrhea, sneezing).
1.34 mg clemastine fumarate equivalent to 1 mg clemastine.
Individualize dosage according to patient’s response and tolerance.
Pediatric Patients
Allergic Conditions
Allergic Rhinitis
Oral
Children 6 to <12 years of age: Initially, 0.67 mg twice daily (as oral solution). Because single doses of up to 3.02 mg have been well tolerated, may increase dosage as necessary, not to exceed 4.02 mg daily.
Children ≥12 years of age: 1.34 mg every 12 hours (as tablets or oral solution); this is the maximum dosage recommended for self-medication. When used under the direction of a clinician, may increase dosage as necessary, not to exceed 8.04 mg daily.
Allergic Skin Disorders
Oral
Children 6 to <12 years of age: Initially, 1.34 mg twice daily (as oral solution). May increase dosage as necessary, not to exceed 4.02 mg daily.
Children ≥12 years of age: 2.68 mg 1–3 times daily (as tablets or oral solution), not to exceed 8.04 mg daily.
Common Cold
Oral
Self-medication in children ≥12 years of age: Usually, 1.34 mg every 12 hours (as tablets), not to exceed 2.68 mg daily unless otherwise directed by a clinician.
Adults
Allergic Conditions
Allergic Rhinitis
Oral
Initially, 1.34 mg every 12 hours (as tablets or oral solution); this is the maximum dosage recommended for self-medication. When used under the direction of a clinician, may increase dosage as necessary, not to exceed 8.04 mg daily.
Allergic Skin Disorders
Oral
2.68 mg 1–3 times daily (as tablets or oral solution), not to exceed 8.04 mg daily.
Common Cold
Oral
Self-medication: Usually, 1.34 mg every 12 hours (as tablets), not to exceed 2.68 mg daily unless otherwise directed by a clinician.
Prescribing Limits
Pediatric Patients
Allergic Conditions
Allergic Rhinitis
Oral
Children 6 to <12 years of age: Maximum 4.02 mg daily.
Children ≥12 years of age: For self-medication, maximum 1.34 mg every 12 hours. When used under the direction of a clinician, maximum 8.04 mg daily.
Allergic Skin Disorders
Oral
Children 6 to <12 years of age: Maximum 4.02 mg daily.
Children ≥12 years of age: Maximum 8.04 mg daily.
Common Cold
Oral
Children ≥12 years of age: For self-medication, maximum 2.68 mg daily unless otherwise directed by a clinician.
Adults
Allergic Conditions
Allergic Rhinitis
Oral
Self-medication: Maximum 1.34 mg every 12 hours. When used under the direction of a clinician, maximum 8.04 mg daily.
Allergic Skin Disorders
Oral
Maximum 8.04 mg daily.
Common Cold
Oral
Self-medication: Maximum 2.68 mg daily unless otherwise directed by a clinician.
Special Populations
Geriatric Patients
Reduce dosage if mild adverse effects occur. (See Geriatric Use under Cautions.)
Cautions
Contraindications
Use contraindicated in neonates and premature infants. (See Pediatric Use under Cautions.)
Risk of drowsiness. (See CNS Depressants under Interactions and also see Advice to Patients.)
Possible excitability (especially in children). (See Pediatric Use under Cautions.)
Specific Populations
Pregnancy
Category B.
Lactation
Distributed into milk. Some manufacturers recommend discontinuance of nursing or the drug because of potential risk to nursing infants (see Contraindications under Cautions). However, AAP states that the drug may be used with caution during breast-feeding.
Pediatric Use
Contraindicated in neonates and premature infants.
Possible paradoxical excitement (e.g., restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures), especially in children.
Safety and efficacy of tablets not established in children <12 years of age. Safety and efficacy of oral solution not established in children <6 years of age.
Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established. Therefore, FDA recommended not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about . Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.
Geriatric Use
Possible increased risk of dizziness, sedation, and hypotension in patients ≥60 years of age. (See Geriatric Patients under Dosage and Administration.)
Antihistamines do not block the stimulating effect of histamine on gastric acid secretion, which is mediated by H2-receptors of the parietal cells.
Advice to Patients
Risk of drowsiness; avoid alcohol and avoid engaging in hazardous tasks (e.g., operating machinery, driving a motor vehicle) until effects on individual are known.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses. Importance of patients already receiving another CNS depressant (e.g., sedative, tranquilizer) not undertaking self-medication without first consulting a clinician.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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