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|Pseudoephedrine HCl/Guaifenesin/Dextromethorphan HBr

Pseudoephedrine HCl/Guaifenesin/Dextromethorphan HBr

Trade Names:
PanMist-DM
- Syrup 15 mg dextromethorphan HBr, 100 mg guaifenesin, 40 mg pseudoephedrine HCl per 5 mL
- Tablets 32 mg dextromethorphan HBr, 595 mg guaifenesin, 48 mg pseudoephedrine HCl

Mechanism of Action

Pharmacology

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

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.

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.

Contraindications

Hypertension; severe coronary artery disease; MAO inhibitor therapy; pregnancy; nursing; hypersensitivity to any component of product or idiosyncrasy to sympathomimetic amines, which may manifest as insomnia, dizziness, weakness, tremor, or arrhythmias.

Dosage and Administration

PO 1 or 2 tablets q 12 hr (max, 4 tablets in 24 hr) or up to 2 tsp of syrup 3 to 4 times daily.

PO 1 tablet q 12 hr (max, 2 tablets in 24 hr) or up to 1 tsp 3 to 4 times daily, not to exceed 4 mg per kilogram of body weight of pseudoephedrine in 24 hr.

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.

Storage/Stability

Store tablets and syrup at controlled room temperature (59° to 86°F).

Drug Interactions

Ectopic pacemaker activity may be increased by pseudoephedrine.

Antihypertensive effects may be reduced by pseudoephedrine.

May increase pseudoephedrine absorption.

May increase the effects of pseudoephedrine. Dextromethorphan is contraindicated with MAO inhibitors.

Laboratory Test Interactions

Guaifenesin may interfere with the interpretation of the test for urinary 5-hydroxyindoleacetic acid for the diagnosis of carcinoid syndrome.

Adverse Reactions

Cardiovascular

Tachycardia; palpitations; arrhythmias; cardiovascular collapse with hypotension.

CNS

Headache; dizziness; fear; anxiety; nervousness; restlessness; tremor; weakness; insomnia; hallucinations; convulsions; CNS depression.

GI

Nausea.

Genitourinary

Dysuria.

Respiratory

Respiratory difficulty.

Miscellaneous

Pallor.

Precautions

Pregnancy

Category C .

Lactation

Contraindicated in nursing women.

Children

Safety and efficacy in children under 6 yr not established for tablets and in children under 2 yr of age for syrup.

Elderly

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

Special Risk Patients

Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure, diabetes mellitus, prostatic hypertrophy.

Cough

To determine that appropriate therapy for the primary disease is instituted, ascertain underlying cause of cough prior to use of cough suppressants.

Drug abuse

Has abuse potential.

Overdosage

Symptoms

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

Drowsiness, ataxia, nystagmus, opisthotonos, convulsive disorders

Patient Information

• Explain name, dose, action, and potential side effects of drug.
• Advise patient to take prescribed dose every 12 hr as needed.
• 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 these 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.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
• Caution patient to not take any prescription or OTC medications or dietary supplements unless advised by health care provider.