Adult Dosing

Nasal congestion, sinus congestion and pressure

Disophrol

• 6 mg/120 mg PO bid, then following initial improvement, one tab daily to control symptoms

Drixoral

• 6 mg/120 mg PO bid, in some cases 6 mg/120 mg PO q8hrs

Note:

• Do not chew, crush, or dissolve the tablet

Pediatric Dosing

Nasal congestion, sinus congestion and pressure

Disophrol

• 12yrs: 6 mg/120 mg PO bid, then following initial improvement, one tab daily to control symptoms

Drixoral

• 12yrs: 6 mg/120 mg PO bid, in some cases 6 mg/120 mg PO q8hrs

Note:

• Do not chew, crush, or dissolve the tablet

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relief of symptoms of upper respiratory mucosal congestion in seasonal and perennial allergies, eustachian tube congestion blockage and secretory otitis media, acute rhinitis and rhinosinusitis

• Hypersensitivity to any of the ingredients of the product
• Patients receiving MAO inhibitors more than 2 weeks
• Children < 12 years of age

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Inform physicians before initiating therapy about preexisting illnesses such as asthma, emphysema, diabetes, glaucoma, heart problems, high blood pressure, kidney problems, liver disease, seizures, stomach/intestinal problems, enlarged prostate, and seizures
• Limit alcoholic beverages. Therapy may cause dizziness or drowsiness. Instruct patient not to drive or use machinery that requires alertness
• Use cautiously in diabetic patients, alcohol dependence, liver disease, phenylketonuria (PKU) or any other condition that requires avoiding phenylalanine
• Use cautiously in children as it may cause excitation and agitation
• Not recommended for nursing or pregnant women

Pregnancy Category:NR

Breastfeeding: 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.Pseudoephedrine: A small amount of pseudoephedrine is excreted in breastmilk and is unlikely to harm the nursing infant, occasionally causes 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 11 December 2012). Manufacturer advises do not breastfeed while using this drug.

• CV: Chest pain, irregular heartbeat, tightness of chest
• NEURO: Involuntary trembling, loss of coordination
• CNS: Dizziness, drowsiness, light-headedness, fainting, seizure
• PSYCHIATRIC: Nervousness, restlessness, confusion, hallucinations, mental or mood changes
• GI: Dry mouth, nausea, vomiting, constipation, diarrhea, stomach upset
• METABOLIC: Loss of appetite
• DERM: Hives, rash, itching
• GU: Difficulty urinating or inability to urinate
• EENT: Blurred vision

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)

• Disophrol
• Drixoral

US Availability

dexbrompheniramine/pseudoephedrine (generic)

• OTC ETABS: 6 mg/120 mg

Disophrol (dexbrompheniramine/pseudoephedrine)

• ETABS: 6 mg/120 mg

Drixoral (dexbrompheniramine/pseudoephedrine)

• ETABS: 6 mg/120 mg

Canadian Trade Name(s)

• Drixoral cold & sinus

Canadian Availability

Drixoral cold & sinus (dexbrompheniramine/pseudoephedrine)

• ETABS: 6 mg/120 mg

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