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Pronunciation:

(kar bi NOKS a meen, soo doe e FED rin, & deks troe meth OR fan)

U.S. Brand Names:

Andehist DM NR Drops; Carbaxefed DM RF; Decahist-DM; Pediatex™-DM; Rondec®-DM Drops; Sildec-DM; Tussafed®

Synonyms:

Carbinoxamine, Dextromethorphan, and Pseudoephedrine; Dextromethorphan, Carbinoxamine, and Pseudoephedrine; Dextromethorphan, Pseudoephedrine, and Carbinoxamine; Pseudoephedrine, Carbinoxamine, and Dextromethorphan; Pseudoephedrine, Dextromethorphan, and Carbinoxamine

Generic Available:

Yes

Use:

Relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold

Pregnancy Risk Factor:

Pregnancy Implications:

Animal reproduction studies have not been conducted.

Lactation:

Enters breast milk/contraindicated

Contraindications:

Hypersensitivity to carbinoxamine, pseudoephedrine, dextromethorphan, or any component of the formulation; severe hypertension or coronary artery disease; MAO inhibitor therapy; GI or GU obstruction; peptic ulcer disease; narrow-angle glaucoma; avoid use in premature or term infants due to a possible association with SIDS; acute asthma attack

Warnings/Precautions:

Use caution with hypertension, ischemic heart disease, hyperthyroidism, increased intraocular pressure, diabetes mellitus, BPH, and patients >60 years of age. May cause decreased mental alertness; excitation in younger children; paradoxical reactions (manifested by hyperexcitability) in older children. The elderly may be more sensitive to anticholinergic and antihistamine effects and experience increased adverse effects. Use caution in atopic children. Safety and efficacy in children <1 month of age have not been established.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Arrhythmias, cardiovascular collapse, hypertension, pallor, tachycardia

Central nervous system: Anxiety, convulsions, CNS stimulation, dizziness, drowsiness, excitability (children; rare), fear, hallucinations, headache, insomnia, nervousness, restlessness, sedation

Gastrointestinal: Anorexia, diarrhea, dyspepsia, GI upset, nausea, vomiting, xerostomia

Neuromuscular skeletal: Tremors, weakness

Ocular: Diplopia

Renal: Dysuria, polyuria, urinary retention (with BPH)

Respiratory: Respiratory difficulty

Drug Interactions:

Dextromethorphan: Substrate of CYP2B6 (minor), 2C8/9 (minor), 2C19 (minor), 2D6 (major), 2E1 (minor), 3A4 (minor); Inhibits CYP2D6 (weak)

Also see individual monographs for Pseudoephedrine and Dextromethorphan.

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Stability:

Store at 8°C to 30°C (46°F to 86°F). Avoid heat; keep tightly closed.

Mechanism of Action:

Carbinoxamine competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract; pseudoephedrine, 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; dextromethorphan, a non-narcotic antitussive, increases cough threshold by its activity on the medulla oblongata.

Dosage:

Oral:

Drops (Rondec®-DM): Infants and Children:

1-3 months: 1/4 mL 4 times/day

3-6 months: 1/2 mL 4 times/day

6-12 months: 3/4 mL 4 times/day

12-24 months: 1 mL 4 times/day

Liquid (Pediatex™-DM):

Children 18 months to 6 years: 2.5 mL 4 times/day

Children 6-12 years: 5 mL 4 times/day

Children 12 years and Adults: 10 mL 4 times/day

Syrup (Tussafed®):

Children 18 months to 6 years: 2.5 mL 4 times/day

Children >6 years and Adults: 5 mL 4 times/day

Patient Education:

Avoid alcohol and other CNS depressants while taking these products. Take as directed; do not exceed recommended dose. Patients sensitive to antihistamines may experience moderate to severe drowsiness. Patients sensitive to sympathomimetic amines may note mild CNS stimulation. While taking these products, exercise care in driving or operating machinery.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Pseudoephedrine: Xerostomia (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 fatigue, nervousness, or dizziness; may rarely produce depression

Mental Health: Effects on Psychiatric Treatment:

Contraindicated with MAO inhibitors; concurrent use with sedating psychotropics or CNS depressants may produce additive adverse effects

Dosage Forms:

Liquid:

Decahist-DM: Carbinoxamine maleate 2 mg, pseudoephedrine hydrochloride 15 mg and dextromethorphan hydrobromide 15 mg per 5 mL (480 mL) [peach flavor]

Pediatex™-DM: Carbinoxamine maleate 2 mg, pseudoephedrine hydrochloride 15 mg and dextromethorphan hydrobromide 15 mg per 5 mL (480 mL) [alcohol free, dye free, sugar free; cotton candy flavor]

Liquid, oral drops: Carbinoxamine maleate 1 mg, pseudoephedrine hydrochloride 15 mg and dextromethorphan hydrobromide 4 mg per mL (30 mL)

Andehist DM NR: Carbinoxamine maleate 1 mg, pseudoephedrine hydrochloride 15 mg and dextromethorphan hydrobromide 4 mg per mL (30 mL) [alcohol and sugar free; grape flavor]

Carbaxefed DM RF: Carbinoxamine maleate 1 mg, pseudoephedrine hydrochloride 15 mg and dextromethorphan hydrobromide 4 mg per mL (30 mL) [alcohol free; grape flavor]

Rondec® DM: Carbinoxamine maleate 1 mg, pseudoephedrine hydrochloride 15 mg and dextromethorphan hydrobromide 4 mg per mL (30 mL) [alcohol free; contains sodium benzoate; grape flavor]

Sildec-DM: Carbinoxamine maleate 1 mg, pseudoephedrine hydrochloride 15 mg and dextromethorphan hydrobromide 4 mg per mL (30 mL)

Syrup, oral (Tussafed®): Carbinoxamine maleate 4 mg, pseudoephedrine hydrochloride 60 mg, and dextromethorphan hydrobromide 15 mg per 5 mL (480 mL) [alcohol and sugar free]

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