brompheniramine/phenylephrine

Adult Dosing

Cold/flu/hay fever or other upper respiratory allergies

4 tablets [4 mg/10 mg] or 20 mL [4 mg/10 mg] PO q4 hrs PRN
Max: 6 dose [24 mg/60 mg]/day

Note: Do not cut, crush or chew the tablet

Pediatric Dosing

Safety and effectiveness in pediatric patients <6 yrs of age have not been established

Cold/flu/hay fever or other upper respiratory allergies

6-11 yrs

2 tablets [2 mg/5 mg] or 10 mL [2 mg/5 mg] PO q4 hrs PRN
Max: 6 dose [12 mg/30 mg]/day

>12 yrs

4 tablets [4 mg/10 mg] or 20 mL [4 mg/10 mg] PO q4 hrs PRN
Max: 6 dose/day [24 mg/60 mg]/day

Note: Do not cut, crush or chew the tablet

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Temporary relief of nasal congestion associated with common cold, hay fever or other upper respiratory allergies
Temporarily relieves runny nose, sneezing, itchy watery eyes, and itching of the nose or throat due to hay fever (allergic rhinitis) or other upper respiratory allergies
Temporarily restores freer breathing through the nose

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
To sedate a child
Concomitant use with or within 14 days of treatment with an MAO inhibitor
Coronary artery disease
Patients <2 years
Uncontrolled or severe hypertension
Urinary retention

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

See Supplemental Patient Information

Therapy may cause nervousness, dizziness, or sleeplessness; discontinue the drug if such symptoms occur
Discontinue the drug if symptoms do not improve within 7 days or are accompanied by fever
Children are prone to excitability during therapy

Cautions: Use cautiously in

Renal impairment
Hypertension
Cardiovascular disease
History of bronchial asthma
Increased intraocular pressure
Hyperthyroidism
Prostatic hypertrophy
Geriatric patients
Concomitant CNS depressant use

Supplemental Patient Information

Instruct patients to inform their clinician if they have cardiovascular disease, high blood pressure, thyroid disease, diabetes, difficulty urinating, glaucoma, emphysema, asthma, or chronic bronchitis
Advise patients to inform their physician if they are taking treatment with any other nasal decongestant or stimulant and sedatives or tranquilizers
Inform patients to avoid alcoholic beverages during therapy
Instruct patients to exercise caution when driving a motor vehicle or operating machinery

Interactions ⬆ ⬇

Dimetapp interacts with :

	Aricept
	Aricept ODT
	Donepezil
	Exelon
	Galantamine
	Razadyne
	Razadyne ER
	Rivastigmine

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: No adverse effects are seen in breastfed infants with small, occasional doses of brompheniramine. However, larger doses or more prolonged use can cause effects in the infant or decrease the milk supply, particularly when used with a sympathomimetic such as pseudoephedrine or before lactation is well established. After the last feeding of the day, single bedtime dose may be adequate for many women and will minimize any effects of the drug. The preferred alternatives are nonsedating antihistamines. Phenylephrine is unlikely to reach the infant in large amounts, as the oral bioavailability of phenylephrine is only about 40%. However, oral administration of phenylephrine decreases milk production. As no information is available on the use of oral phenylephrine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 06 July 2011).

Adverse Reactions ⬆ ⬇

CNS: Drowsiness, nervousness, dizziness, excitation (in children)

Clinical Pharmacology ⬆ ⬇

Brompheniramine

Histamine H1 antagonist; non-selectively antagonizes central and peripheral histamine H1 receptors, and also functions as a moderately effective anticholingeric agent
Well absorbed from the GI tract after oral administration
Metabolized by liver; CYP450: None
Renally excreted 40% (5-10% unchanged), feces 2%
Half-life: 12-35 hrs

Phenylephrine

Nasal decongestant; stimulates alpha1-adrenergic receptors in the arterioles of the nasal mucosa, producing vasoconstriction and reducing nasal congestion
Metabolized in intestinal wall and liver
Renally excreted 80% (2.6% unchanged)
Half-life: 2-3 hrs

Brands and Availability ⬆ ⬇

US Trade Name(s)

Children's Dimetapp Cold and Allergy

US Availability

Children's Dimetapp Cold and Allergy (brompheniramine/phenylephrine)

OTC CHEW TABS: 1 mg/2.5 mg
OTC SOLN: [1 mg/2.5 mg]/5 mL

Canadian Trade Name(s)

Cold Liquid
Cold Liquid Grape Flavour
Cold Syrup
Dimetapp
Dimetapp Chewables for Kids
Dimetapp Extra Strength
Extra Strength Cold Syrup

Canadian Availability

Cold Liquid (brompheniramine/phenylephrine)

OTC SOLN: [2 mg/5 mg]/5 mL

Cold Liquid Grape Flavour, Dimetapp (brompheniramine/phenylephrine)

OTC LIQ: [2 mg/5 mg]/5 mL

Cold Syrup (brompheniramine/phenylephrine)

OTC SYRUP: [2 mg/5 mg]/5 mL

Dimetapp Chewables for Kids (brompheniramine/phenylephrine)

OTC CHEW TABS: 1 mg/2.5 mg

Dimetapp Extra Strength (brompheniramine/phenylephrine)

OTC LIQ: [4 mg/10 mg]/5 mL

Extra Strength Cold Syrup (brompheniramine/phenylephrine)

OTC SYRUP: [4 mg/10 mg]/5 mL

UK Trade Name(s)

UK Availability

Australian Trade Name(s)

Dimetapp Elixir Cold & Allergy
Dimetapp Elixir Colour Free Cold & Allergy

Australian Availability

Dimetapp Elixir Cold & Allergy, Dimetapp Elixir Colour Free Cold & Allergy (brompheniramine/phenylephrine)

OTC ELIXIR: [2 mg/5 mg]/5 mL