Pseudoephedrine Hydrochloride / Guaifenesin / Dextromethorphan Hydrobromide

Pronunciation: SOO-doe-e-FED-rin HYE-droe-KLOR-ide/gwye-FEN-e-sin/DEX-troe-meth-OR-fan HYE-droe-BROE-mide
Class: Antitussive and expectorant combination

Trade Names

Ambi 40PSE/400 GFN/20 DM
- Tablets, oral dextromethorphan hydrobromide 20 mg, guaifenesin 400 mg, pseudoephedrine hydrochloride 40 mg

Ambi 60 PSE/400 GFN/20 DM
- Tablets, oral dextromethorphan hydrobromide 20 mg, guaifenesin 400 mg, pseudoephedrine hydrochloride 60 mg

Ambifed-G DM
- Tablets, extended-release dextromethorphan hydrobromide 20 mg, guaifenesin 400 mg, pseudoephedrine hydrochloride 20 mg

Ambifed DM
- Tablets, extended-release dextromethorphan hydrobromide 20 mg, guaifenesin 400 mg, pseudoephedrine hydrochloride 30 mg

Bionel
- Liquid dextromethorphan hydrobromide 15 mg, guaifenesin 200 mg, pseudoephedrine hydrochloride 30 mg

Bionel Pediatric
- Liquid dextromethorphan hydrobromide 5 mg, guaifenesin 50 mg, pseudoephedrine hydrochloride 15 mg

BP 8 Cough
- Suspension dextromethorphan hydrobromide 15 mg, guaifenesin 175 mg, pseudoephedrine hydrochloride 30 mg per 5 mL

Capmist DM
- Tablets dextromethorphan hydrobromide 30 mg, guaifenesin 400 mg, pseudoephedrine hydrochloride 30 mg

Donatuss XP
- Suspension dextromethorphan hydrobromide 15 mg, guaifenesin 180 mg, pseudoephedrine hydrochloride 30 mg

Donatussin DM
- Syrup dextromethorphan hydrobromide 15 mg, guaifenesin 150 mg, pseudoephedrine hydrochloride 30 mg

Maxifed DM
- Tablets dextromethorphan hydrobromide 20 mg, guaifenesin 400 mg, pseudoephedrine hydrochloride 40 mg
- Liquid dextromethorphan hydrobromide 10 mg, guaifenesin 200 mg, pseudoephedrine hydrochloride 20 mg per 5 mL

Maxifed DMX
- Tablets dextromethorphan hydrobromide 20 mg, guaifenesin 400 mg, pseudoephedrine hydrochloride 60 mg

Pseudoephedrine Hydrochloride/Guaifenesin/Dextromethorphan Hydrobromide
- Tablets dextromethorphan hydrobromide 20 mg, guaifenesin 400 mg, pseudoephedrine hydrochloride 40 mg
- Tablets dextromethorphan hydrobromide 20 mg, guaifenesin 400 mg, pseudoephedrine hydrochloride 60 mg
- Syrup dextromethorphan hydrobromide 15 mg, guaifenesin 150 mg, pseudoephedrine hydrochloride 30 mg
- Liquid dextromethorphan hydrobromide 15 mg, guaifenesin 175 mg, pseudoephedrine hydrochloride 32 mg

Pseudo Cough
- Liquid dextromethorphan hydrobromide 15 mg, guaifenesin 175 mg, pseudoephedrine hydrochloride 32 mg

Relacon DM NR
- Liquid dextromethorphan hydrobromide 15 mg, guaifenesin 200 mg, pseudoephedrine hydrochloride 32 mg

Relasin DM
- Liquid dextromethorphan hydrobromide 15 mg, guaifenesin 175 mg, pseudoephedrine hydrochloride 32 mg

Robitussin Cough & Cold D
- Liquid dextromethorphan hydrobromide 15 mg, guaifenesin 200 mg, pseudoephedrine hydrochloride 30 mg

TG 45PSE/400GFN/15DM
- Tablets dextromethorphan hydrobromide 15 mg, guaifenesin 400 mg, pseudoephedrine hydrochloride 45 mg

Tusnel
- Liquid dextromethorphan hydrobromide 15 mg, guaifenesin 200 mg, pseudoephedrine hydrochloride 30 mg

Tusnel DM Pediatric
- Drops dextromethorphan hydrobromide 25 mg, guaifenesin 7.5 mg, pseudoephedrine hydrochloride 25 mg

Tusnel Pediatric
- Liquid dextromethorphan hydrobromide 5 mg, guaifenesin 50 mg, pseudoephedrine hydrochloride 15 mg

Z-Cof 8 DM
- Suspension dextromethorphan hydrobromide 15 mg, guaifenesin 175 mg, pseudoephedrine hydrochloride 30 mg per 5 mL

Z-Cof DMX
- Liquid dextromethorphan hydrobromide 15 mg, guaifenesin 200 mg, pseudoephedrine hydrochloride 36 mg

Balminil DM + Decongestant + Expectorant (Canada)
Robitussin Cough & Cold (Canada)
Robitussin Extra Strength Cough & Cold (Canada)

Pharmacology

Pseudoephedrine

Causes vasoconstriction and subsequent shrinkage of nasal mucous membranes by alpha-adrenergic stimulation, which promotes nasal drainage.

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Guaifenesin

May enhance output of respiratory tract fluid by reducing adhesiveness and surface tension, enhancing removal of viscous mucus, and making nonproductive coughs more productive and less frequent.

Dextromethorphan

Suppresses cough by central action on cough center in medulla.

Indications and Usage

Temporary relief of nasal congestion and cough associated with respiratory tract infections and related conditions, such as sinusitis, pharyngitis, bronchitis, and asthma, when these conditions are complicated by tenacious mucus or mucus plugs and congestion; for the relief of eustachian tube congestion; for adjunctive therapy in serious otitis media.

Contraindications

Hypertension; severe coronary artery disease; MAOI therapy; pregnancy; breast-feeding; premature or full-term infants; hypersensitivity to any component of product or idiosyncrasy to sympathomimetic amines, which may manifest as insomnia, dizziness, weakness, tremor, or arrhythmias.

Dosage and Administration

Maximum dose

The following max doses are according to the prescribing information.

Adults and children 12 y and older

Dextromethorphan 120 mg/day; guaifenesin 2,400 mg/day; pseudoephedrine 240 mg/day.

Children 6 to 11 y of age

Dextromethorphan 60 mg/day; guaifenesin 1,200 mg/day; pseudoephedrine 120 mg/day.

Children 2 to 5 y of age

Dextromethorphan 30 mg/day; guaifenesin 600 mg/day; pseudoephedrine 60 mg/day.

Adults Respiratory tract symptoms

For specific dosing by product, refer to the individual manufacturer's prescribing information.

Usual dosage ER tablets

1 or 2 tablets every 12 h.

Medent-DM

1 to 1½ tablets every 12 h or 1 tablet every 8 h.

Suspension

10 mL 2 or 3 times per day.

Syrup

5 to 20 mL every 4 to 12 h.

Tablets

1 or 2 tablets every 4 to 6 h.

Maximum dose

Dextromethorphan 120 mg/day; guaifenesin 2,400 mg/day; pseudoephedrine 240 mg/day.

Children Respiratory tract symptoms

For specific dosing by product, refer to the individual manufacturer's prescribing information.

12 y and older Usual dosage ER tablets

1 or 2 tablets every 12 h.

Medent-DM

1 to 1½ tablets every 12 h or 1 tablet every 8 h.

Suspension

10 mL 2 or 3 times per day.

Syrup

5 to 20 mL every 4 to 12 h.

Tablets

1 or 2 tablets every 4 to 6 h.

Maximum dose

Dextromethorphan 120 mg/day; guaifenesin 2,400 mg/day; pseudoephedrine 240 mg/day.

6 to 11 y of age Usual dosage ER tablets

½ to 1 tablet every 12 h.

Suspension

5 mL 2 or 3 times a day.

Syrup

2.5 to 10 mL every 4 to 12 h.

Tablets

½ to 1 tablet every 4 to 6 h.

Maximum dose

Dextromethorphan 60 mg/day; guaifenesin 1,200 mg/day; pseudoephedrine 120 mg/day.

2 to 5 y of age Usual dosage ER tablets

½ tablet every 12 h.

Drops

2 mL (2 dropperfuls) every 4 to 6 h.

Suspension

2.5 mL 2 or 3 times a day.

Syrup

2.5 to 5 mL every 4 to 12 h.

Maximum dose

Dextromethorphan 30 mg/day; guaifenesin 600 mg/day; pseudoephedrine 60 mg/day.

Younger than 2 y

Safety and efficacy not established.

Elderly

Elderly patients are more likely to exhibit adverse effects, such as confusion or CNS depression.

General Advice

• Tablets may be broken in half for ease of administration. Do not crush or chew tablets or half-tablets.
• Administer without regard to meals. Administer with food if GI upset occurs.
• Measure and administer prescribed dose of syrup using dosing syringe, dosing spoon, or dosing cup.
• Administer with a full glass of water to help loosen mucus in the lungs.

Storage/Stability

Store between 59° and 86°F.

Drug Interactions

Beta-adrenergic blockers, MAOIs (eg, isocarboxazid)

May increase the effects of pseudoephedrine. Dextromethorphan is contraindicated with MAOIs. Do not use concurrently or for 2 wk after stopping an MAOI.

Digitalis

Ectopic pacemaker activity may be increased by pseudoephedrine.

Guanethidine, mecamylamine, methyldopa, reserpine, veratrum alkaloids

Antihypertensive effects may be reduced by pseudoephedrine.

Kaolin

May increase pseudoephedrine absorption.

Laboratory Test Interactions

Guaifenesin may interfere with the interpretation of the test for urinary 5-hydroxyindoleacetic acid for the diagnosis of carcinoid syndrome and may falsely elevate the vanillylmandelic acid (VMA) test for catechols. It may also increase renal clearance for urate and thereby lower serum uric acid levels.

Adverse Reactions

Cardiovascular

Arrhythmias, CV collapse with hypotension, hypertension, palpitations, tachycardia.

CNS

Anxiety; CNS depression; convulsions; dizziness; drowsiness; excitability; fear; hallucinations; headache; insomnia; nervousness; restlessness; tremor; tenseness; weakness; disturbed coordination, irritability, euphoria, dysphoria.

Dermatologic

Drug rash, photosensitivity, pruritus, urticaria.

EENT

Dryness of mouth, nose, and throat; visual disturbances.

GI

Anorexia, constipation; diarrhea, nausea, stomach pain, vomiting.

Genitourinary

Dysuria, urinary frequency.

Hematologic

Agranulocytosis, hemolytic anemia, thrombocytopenia.

Miscellaneous

Pallor, respiratory difficulty.

Precautions

Pregnancy

Category C .

Lactation

Contraindicated in breast-feeding women. Pseudoephedrine and dextromethorphan are excreted in breast milk.

Children

Safety and efficacy in children younger than 2 y of age not established ( Relasin DM , Touro CC-LD , Z-Cof 8 DM ). Consult a health care provider for use in children younger than 2 y of age ( Bionel Pediatric , Relacon-DM NR , Tusnel Pediatric , Z-Cof 12 DM ). Not recommended for use in children younger than 6 y of age ( Medent DM , Robitussin Cough and Cold D ). Consult a health care provider for use in children younger than 6 y of age ( Ambifed DM , Ambifed-G DM , Bionel , BP 8 , Donatussin DM , Maxifed DM , Maxifed DMX , TidaFen DM , Tusnel ). Consult a doctor for use in children younger than 12 y of age ( Capmist DM ).

Elderly

Geriatric patients are more likely to exhibit adverse reactions, such as confusion or CNS depression.

Special Risk Patients

Use with caution in patients with hypertension, heart disease, asthma, increased IOP, diabetes mellitus, peripheral vascular disease, prostatic hypertrophy, thyroid disease, difficulty in urination due to enlargement of prostate gland, sedated or debilitated patients, or patients confined to a supine position; atopic children.

Cough

Ascertain underlying cause of cough prior to use of cough suppressants. Do not use for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where excessive secretions accompany cough.

Phenylketonurics

Bionel , Bionel Pediatric , Tusnel , Tusnel Pediatric , Z-Cof 8 DM , and Z-Cof 12 DM contain phenylalanine.

Overdosage

Symptoms

Pseudoephedrine

Arrhythmias, circulatory collapse, convulsions, delirium, excessive CNS stimulation (eg, excitement, insomnia, restlessness, tremor), hallucinations, hyperglycemia, hyperpnea, hypertension, hypokalemia, hypotension, mydriasis, pallor, tachycardia, tachypnea, urinary retention.

Dextromethorphan

Ataxia, central excitement, convulsive disorders, drowsiness, mental confusion, nystagmus, opisthotonos, respiratory depression, toxic psychosis.

Patient Information

• Advise patient to take with food if GI upset occurs.
• Advise patient that if a dose is missed to take as soon as remembered unless it is nearing time for the next dose. Caution patient not to double the dose to catch up.
• Instruct patient to discontinue use and report any of the following symptoms to health care provider: nervousness, dizziness, sleeplessness.
• Advise patient that if symptoms are not controlled, not to increase the dose of medication but to inform health care provider.

Copyright © 2009 Wolters Kluwer Health.