Phenylephrine, Pyrilamine, and Dextromethorphan
U.S. Brand Names Codal-DM [OTC]; Codimal DM [OTC]; Codituss DM [OTC]; Viravan-DM
Synonyms Dextromethorphan Tannate, Pyrilamine Tannate, and Phenylephrine Tannate; Pyrilamine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
Therapeutic Category
Antihistamine
Antihistamine/Decongestant/Antitussive
Antitussive
Sympathomimetic
Use Symptomatic relief of cough, nasal congestion, and discharge associated with the common cold, sinusitis, allergic rhinitis, and other respiratory tract conditions
Pregnancy Risk Factor C
Pregnancy Implications Reproduction studies have not been conducted with this combination. Phenylephrine may cause fetal anoxia or bradycardia if administered late in pregnancy or during labor. Sympathomimetics may cause minor malformations when used during the first trimester.
Contraindications Hypersensitivity to phenylephrine, pyrilamine, dextromethorphan, or any component of the formulation; asthma; hypertension or peripheral vascular insufficiency; use with or within 14 days of MAO inhibitors; breast-feeding
Warnings/Precautions Use caution with hypertension, cardiovascular disease, increased intraocular pressure, thyroid dysfunction, prostatic hyperplasia, or diabetes. 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 and/or anticholinergic effects may be increased. Use caution in atopic children. May cause paradoxical excitation in pediatric patients. When used for self-medication (OTC), consult healthcare provider if needed for >7 days or if symptoms include a fever.
Adverse Reactions Frequency not defined.
Cardiovascular: Arrhythmias, hypertension, hypotension, palpitations
Central nervous system: Coordination disturbances, drowsiness, dysphoria, euphoria, headache, insomnia, irritability, nervousness, sedation, seizure
Dermatologic: Photosensitivity, pruritus, rash, urticaria
Gastrointestinal: Constipation, diarrhea, epigastric discomfort, nausea, vomiting, xerostomia
Genitourinary: Difficult urination, urinary frequency
Hematologic: Agranulocytosis, hemolytic anemia, thrombocytopenia
Neuromuscular & skeletal: Tremor, weakness
Ocular: Visual disturbances
Respiratory: Shortness of breath, wheezing
Overdose/Toxicology Symptoms of overdose may vary. CNS stimulation, CNS depression, seizures, mental confusion and respiratory depression may occur.
Drug Interactions Dextromethorphan: Substrate of CYP2B6 (minor), 2C8/9 (minor), 2C19 (minor), 2D6 (major), 2E1 (minor), 3A4 (minor); Inhibits CYP2D6 (weak)
CNS depressants: Sedative effects may be potentiated.
MAO inhibitors: Anticholinergic and sympathomimetic effects may be increased and prolonged; avoid use with and within 14 days of treatment with MAO inhibitors.
Food Interactions
Ethanol: Avoid ethanol (may increase CNS depression).
Mechanism of Action
Phenylephrine hydrochloride is a sympathomimetic agent (primarily alpha), decongestant.
Pyrilamine is an H1-receptor antagonist.
Dextromethorphan, a non-narcotic antitussive, increases cough threshold by its activity on the medulla oblongata.
Usual Dosage Oral: Relief of cough, congestion:
Children 2-6 years (Viravan-DM): 2.5 mL of the suspension or 1/2 tablet every 12 hours
Children 6-12 years: Codimal DM: 5 mL every 4 hours; maximum: 30 mL/24 hours
Viravan-DM: 5 mL of the suspension or 1/2 to 1 tablet every 12 hours
Children >12 years and Adults: Codimal DM: 10 mL every 4 hours; maximum: 60 mL/24 hours
Viravan-DM: 5-10 mL of the suspension or 1-2 tablets every 12 hours
Dosage Forms
Suspension (Viravan-DM): Phenylephrine tannate 12.5 mg, pyrilamine tannate 30 mg, and dextromethorphan tannate 25 mg per 5 mL (480 mL) [contains sodium benzoate; grape flavor]
Syrup: Codal-DM: Phenylephrine hydrochloride 5 mg, pyrilamine maleate 8.33 mg, and dextromethorphan hydrobromide 10 mg (480 mL) [cherry flavor]
Codimal DM: Phenylephrine hydrochloride 5 mg, pyrilamine maleate 8.33 mg, and dextromethorphan hydrobromide 10 mg (120 mL, 480 mL) [alcohol free, dye free, sugar free; contains benzoic acid]
Codituss DM: Phenylephrine hydrochloride 5 mg, pyrilamine maleate 8.33 mg, and dextromethorphan hydrobromide 10 mg (120 mL, 480 mL) [cherry punch flavor]
Tablet, chewable (Viravan-DM): Phenylephrine tannate 25 mg, pyrilamine tannate 30 mg, and dextromethorphan tannate 25 mg [dye free; grape flavor]
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