Adult Dosing

Relief of fever and minor aches and pains

• 500 mg/3 mg/60 mg PO every 4, 6, 8, or 12 hours PRN

Note:

• Do not crush, break, or chew extended-release tablets

Pediatric Dosing

Relief of fever and minor aches and pains

• >12 yrs: 500 mg/3 mg/60 mg PO every 4, 6, 8, or 12 hours PRN

Note:

• Do not crush, break, or chew extended-release tablets

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of fever, minor aches and pains

• Hypersensitivity to any of the ingredients of the product
• Patients receiving MAO inhibitors for more than 2 weeks

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Liver cirrhosis: Dose adjustments not defined

• Inform physicians before initiating therapy about preexisting illnesses such as heart disease, high blood pressure, seizure disorders, asthma, emphysema, diabetes, glaucoma, or an overactive thyroid
• Consult a clinician if symptoms last more than 7 days or are accompanied by severe sore throat, fever, or thick yellow or green mucus
• Therapy may contain phenylalanine and should be avoided or must be use cautiously in patients with phenylketonuria
• Advise patients to avoid driving a motor vehicle or operating machinery, as therapy may cause side effects such as drowsiness or restlessness which may impair thinking
• Keep out of the reach of children
• Instruct women of childbearing potential to inform their clinician if they are pregnant, breastfeeding, or planning to become pregnant during course of therapy

Pregnancy Category:NR

Breastfeeding: Acetaminophen: Safe; Good choice for analgesia and fever reduction in nursing mothers. Amounts excreted in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 December 2012).Maternal medication is usually compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting the compound. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 17 December 2012). Manufacturer advises to consult a health professional. Dexbrompheniramine: Small, occasional doses of dexbrompheniramine may not cause any adverse effects in breastfed infants. Larger doses or prolonged use may cause effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. Single bedtime doses after the last feeding of the day may be adequate for many women and will minimize any effects of the drug. The nonsedating antihistamines are preferred alternatives. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 December 2012)Pseudoephedrine: Small amount of pseudoephedrine is excreted in breastmilk and are unlikely to harm the nursing infant, occasionally cause irritability. A single dose of pseudoephedrine decreases milk production acutely and repeated use interferes with lactation. Mothers of newborns or who are having difficulties producing sufficient milk should not receive pseudoephedrine. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 December 2012)). Maternal medication is usually compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting the compound. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 17 December 2012). Manufacturer advises do not breastfeed while using this drug.

• CV: Chest tightness, dyspnea, palpitation
• CNS: Severe headache
• GI: Stomach pain, vomiting, dry mouth, nausea, hemoptysis, melena
• GU: Dysuria
• DERM: Pruritus, hives
• EENT: Tinnitus
• MISC: Edema of face and hands, swelling or tingling on mouth or throat

Acetaminophen

• Analgesic, antipyretic; acts primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis; reduces fever through direct action on hypothalamic heat-regulating centers
• Rapid and almost complete absorption
• Metabolized in the liver; CYP450: CYP2E1, CYP1A2
• Excreted in urine (5-10% unchanged)
• Half-life: 2-4 hrs

Dexbrompheniramine

• Antihistamine: Binds to the histamine H1-receptor and blocks the action of endogenous histamine, leading to temporary relief of the negative symptoms brought on by histamine
• Metabolized by liver
• Excretion: Unknown
• Half-life: 25 hrs

Pseudoephedrine

• Nasal decongestant; acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, causing vasoconstriction and by stimulating beta2-adrenergic receptors relaxes bronchial smooth muscle
• Metabolized by liver
• Renally excreted (55-75% unchanged)
• Half-life: 9-16 hrs (depends on urine pH)

US Trade Name(s)

• Drixoral Plus

US Availability

Drixoral Plus (acetaminophen/dexbrompheniramine/pseudoephedrine)

• OTC ETABS: 500 mg/3 mg/60 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

ENT

Upper Respiratory Combinations