Phenylpropanolamine HCl/Guaifenesin

A to Z Drug Facts

 Action FDA Recommendation: The Food and Drug Administration (FDA) has issues a public health advisory for phenylpropanolamine (PPA) ans has asked all manufacturers of products containing PPA to voluntarily discontinue marketing any drug products containing PPA, or to reformulate to remove PPA, if applicable. Studies suggest PPA increases the risk of hemorhagic stroke. The FDA plans to initiate rulemaking to classify PPA as a nonmonograph (not generally recognized as safe and effective) for OTC use and to remove it from prescription drugs products. For more information, please visit the FDA's web site at www.fda.gov

Phenylpropanolamine, a sympathomimetic amine, causes constriction and shrinkage of mucous membranes, resulting in less nasal stuffiness and improved drainage and ventilation. Guaifenesin enhances output of respiratory tract fluid by reducing adhesiveness and surface tension of viscous mucus.

 Indications Symptomatic relief of respiratory conditions characterized by nasal congestion and dry, nonproductive cough in presence of mucus in respiratory tract.

 Contraindications Hypersensitivity or idiosyncrasy to sympathomimetic amines manifested by insomnia, dizziness, weakness, tremor or arrhythmias; hypersensitivity to guaifenesin; MAO inhibitor therapy during or within 14 days of administration; severe hypertension and coronary artery disease.

 Route/Dosage

ADULTS: PO 25 mg phenylpropanolamine/100 to 400 mg guaifenesin q 4 hr (immediate release tablets) or 75 mg phenylpropanolamine/100 to 600 mg guaifenesin q 12 hr (sustained release tablets). CHILDREN: PO 6.25 to 12.5 mg phenylpropanolamine/50 to 200 mg guaifenesin q 4 hr.

 Interactions

Guanethidine: May inhibit effect of decongestant and reverse hypotension action of guanethidine. MAO inhibitors, furazolidone: May result in severe headache, hypertension and hyperpyrexia, possibly resulting in hypertensive crisis. Methyldopa: May cause hypertension.

 Lab Test Interferences May cause color interference with certain laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

 Adverse Reactions

CV: Arrhythmias and cardiovascular collapse with hypotension; palpitations; tachycardia; transient hypertension; bradycardia. CNS: Fear; anxiety; tenseness; restlessness; headache; lightheadedness; dizziness; drowsiness; tremor; insomnia; hallucinations; psychological disturbances; prolonged psychosis (paranoia, terror, delusions); convulsions; CNS depression; anorexia; weakness. DERM: Pallor; sweating; rash; urticaria. EENT: Blepharospasm (ocular irritation, tearing, photophobia); nasal dryness. GI: Nausea; vomiting; dry mouth. GU: Dysuria. RESP: Respiratory difficulty. OTHER: Orofacial dystonia.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Elderly: May be more likely to experience adverse reactions. Special-risk patients: Administer drug with caution to patients with hyperthyroidism, diabetes mellitus, cardiovascular disease, coronary artery disease, ischemic heart disease, increased IOP, or prostatic hypertrophy. Hypertension: Avoid administering drug to patients with hypertension. Persistent cough: Not indicated for cough associated with smoking, asthma, or emphysema. If cough persists for > 1 wk, is recurring, or is accompanied by high fever, rash, or persistent headache, notify physician. Sulfite sensitivity: Some of these products contain sulfites, which can cause allergic-like reactions.

 Administration/Storage

• Patient should be withdrawn from MAO inhibitor therapy 2 wk before taking this drug.
• Do not crush or allow patient to chew sustained-release preparations.
• Give each dose of expectorant with glass of water or fluid.
• Store at room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Encourage patient to increase fluid intake. Provide room humidification to liquefy secretions.
• Evaluate patient's cough for the following: Type, frequency, character (including sputum).

 Patient/Family Education

• Teach patient the importance of adequate fluid intake to help to liquify mucus. Recommend use of humidifier.
• Advise patient that this product is not for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema unless prescribed by physician.
• Instruct patient to notify physician if symptoms persist for > 1 wk, tend to recur, or are accompanied by fever, rash, or persistent headache.
• Advise patient that drug may cause drowsiness, and to use caution while driving or performing other tasks requiring mental alertness.
• Caution patient to avoid smoking, smoke-filled rooms, perfume, dust, environmental pollutants, and cleansers.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts