Chlorpheniramine and Pseudoephedrine

Pronunciation

(klor fen IR a meen & soo doe e FED rin)

U.S. Brand Names

Allerest® Maximum Strength Allergy and Hay Fever [OTC]; A.R.M® [OTC]; Chlor-Trimeton® Allergy D [OTC]; C-Phed Tannate; Deconamine®; Deconamine® SR; Histade™; Histex™; Kronofed-A®; Kronofed-A®-Jr; LoHist-D; PediaCare® Cold and Allergy [OTC]; Rescon-Jr.; Sudafed® Sinus & Allergy [OTC]; Sudal® 12; Tanafed® [DSC]; Triaminic® Cold and Allergy [OTC]

Synonyms

Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride; Chlorpheniramine Tannate and Pseudoephedrine Tannate; Pseudoephedrine and Chlorpheniramine

Generic Available

Yes: Tablet, extended release capsule, suspension

Canadian Brand Names

Triaminic® Cold & Allergy

Use

Relief of nasal congestion associated with the common cold, hay fever, and other allergies, sinusitis, eustachian tube blockage, and vasomotor and allergic rhinitis

Pregnancy Risk Factor

C

Pregnancy Implications

Reproduction studies have not been conducted with this combination product. See individual agents.

Lactation

Excretion in breast milk unknown/contraindicated

Contraindications

Hypersensitivity to chlorpheniramine, pseudoephedrine, or any component of the formulation; severe hypertension; severe cardiovascular disease; use with or within 2 weeks of discontinuing MAO inhibitor; narrow-angle glaucoma; urinary retention; peptic ulcer disease; breast-feeding

Warnings/Precautions

Use caution with hypertension, diabetes, cardiovascular disease, hyperthyroidism, increased intraocular pressure, or prostatic hyperplasia. Causes sedation, caution must be used in performing tasks which require alertness (eg, operating machinery or driving). Sedative effects of CNS depressants or ethanol are potentiated. Use caution in elderly patients, risk of CNS depression may be increased. When used for self-medication (OTC), should not exceed more than 4 doses in 24 hours, use for more than 7 days, or use in the presence of a fever; not labeled for OTC use in children <6 years of age.

Adverse Reactions

See individual agents.

Drug Interactions

Chlorpheniramine: Substrate of CYP2D6 (minor), 3A4 (major); Inhibits CYP2D6 (weak)

Also see individual agents.

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may increase CNS depression).

Mechanism of Action

Chlorpheniramine competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract.

Pseudoephedrine is a sympathomimetic amine and isomer of ephedrine; acts as a decongestant in respiratory tract mucous membranes with less vasoconstrictor action than ephedrine in normotensive individuals.

Pharmacodynamics/Kinetics

See individual agents.

Dosage

General dosing guidelines; consult specific product labeling. Rhinitis/decongestant: Oral:

Children:

2-6 years:

Chlorpheniramine maleate 1 mg and pseudoephedrine hydrochloride 15 mg every 4-6 hours

Tanafed®: Chlorpheniramine tannate 4.5 mg and pseudoephedrine tannate 75 mg: 2.5-5 mL every 12 hours (maximum: 10 mL/24 hours)

6-12 years:

Chlorpheniramine maleate 2 mg and pseudoephedrine hydrochloride 30 mg every 4-6 hours (immediate release products)

Rescon-Jr: Chlorpheniramine maleate 4 mg and pseudoephedrine hydrochloride 60 mg every 12 hours

Tanafed®: Chlorpheniramine tannate 4.5 mg and pseudoephedrine tannate 75 mg: 5-10 mL every 12 hours (maximum: 20 mL/24 hours)

Children 12 years and Adults:

Chlorpheniramine maleate 4 mg and pseudoephedrine hydrochloride 60 mg every 4-6 hours (immediate release products)

Deconamine® SR, Kronofed-A®: Chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg every 12 hours

Tanafed®: Chlorpheniramine tannate 4.5 mg and pseudoephedrine tannate 75 mg: 10-20 mL every 12 hours (maximum: 40 mL/24 hours)

Administration

Swallow sustained release formulations whole, do not crush or chew.

Dietary Considerations

Triaminic® Cold and Allergy chewable tablet contains coconut oil, phenylalanine 17.6 mg/tablet, and sodium 5 mg/tablet.

Patient Education

May cause drowsiness. Alcohol may worsen this effect. Use caution while driving or operating machinery.

Additional Information

Chlorpheniramine maleate is ~70% chlorpheniramine; chlorpheniramine tannate is ~44% chlorpheniramine.

Pseudoephedrine hydrochloride is ~82% pseudoephedrine; pseudoephedrine tannate is ~29% pseudoephedrine.

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment:

Chlorpheniramine: Prolonged use will cause significant xerostomia (normal salivary flow resumes upon discontinuation).

Pseudoephedrine: Xerostomia (prolonged use worsens; normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

Use with caution since pseudoephedrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response

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

[DSC] = Discontinued product

Caplet (A.R.M.®): Chlorpheniramine maleate 4 mg and pseudoephedrine hydrochloride 60 mg

Capsule, extended release: Chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg

Histade™: Chlorpheniramine maleate 12 mg and pseudoephedrine hydrochloride 120 mg

Capsule, sustained release:

Deconamine® SR, Kronofed-A®: Chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg

Kronofed-A®-Jr, Rescon-Jr: Chlorpheniramine maleate 4 mg and pseudoephedrine hydrochloride 60 mg

Liquid:

Histex™: Chlorpheniramine maleate 2 mg and pseudoephedrine sulfate 30 mg per 5 mL (480 mL) [peach flavor]

PediaCare® Cold and Allergy: Chlorpheniramine maleate 1 mg and pseudoephedrine sulfate 15 mg per 5 mL (120 mL) [alcohol free; contains sodium benzoate; bubble gum flavor]

Triaminic® Cold and Allergy: Chlorpheniramine maleate 1 mg and pseudoephedrine sulfate 15 mg per 5 mL (120 mL) [contains benzoic acid; orange flavor]

Suspension: Chlorpheniramine tannate 4.5 mg and pseudoephedrine tannate 75 mg per 5 mL (120 mL, 480 mL)

C-Phed Tannate: Chlorpheniramine tannate 4.5 mg and pseudoephedrine tannate 75 mg per 5 mL (120 mL, 480 mL) [alcohol free; strawberry-banana flavor]

Tanafed®: Chlorpheniramine tannate 4.5 mg and pseudoephedrine tannate 75 mg per 5 mL (120 mL, 480 mL) [contains sodium benzoate; strawberry-banana flavor] [DSC]

Suspension, sustained release (Sudal®12): Chlorpheniramine maleate 6 mg and pseudoephedrine hydrochloride 30 mg per 5 mL (480 mL)

Syrup: Chlorpheniramine maleate 2 mg and pseudoephedrine hydrochloride 30 mg per 5 mL (480 mL)

Deconamine®: Chlorpheniramine maleate 2 mg and pseudoephedrine sulfate 30 mg per 5 mL (480 mL) [alcohol free, dye free; contains sodium benzoate; grape flavor]

LoHist-D: Chlorpheniramine maleate 2 mg and pseudoephedrine hydrochloride 30 mg per 5 mL (480 mL) [alcohol free, dye free; peach flavor]

Tablet: Chlorpheniramine maleate 4 mg and pseudoephedrine hydrochloride 60 mg

Allerest® Maximum Strength Allergy and Hay Fever: Chlorpheniramine maleate 2 mg and pseudoephedrine hydrochloride 30 mg

Chlor-Trimeton® Allergy D, Sudafed® Sinus & Allergy: Chlorpheniramine maleate 4 mg and pseudoephedrine hydrochloride 60 mg

Deconamine®: Chlorpheniramine maleate 4 mg and pseudoephedrine hydrochloride 60 mg [dye free]

Tablet, chewable: Chlorpheniramine maleate 2 mg and pseudoephedrine sulfate 15 mg

Triaminic® Cold and Allergy: Chlorpheniramine maleate 1 mg and pseudoephedrine sulfate 15 mg [contains coconut oil; phenylalanine 17.6 mg/tablet, sodium 5 mg/tablet; orange flavor]

International Brand Names

Triaminic® Cold & Allergy (CA)