Phenylpropanolamine HCl

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

Causes appetite suppression; stimulates adrenergic receptors and smooth muscle (reducing nasal congestion).

 Indications Short-term (8 to 12 wk) adjunct to diet plan to reduce weight; relief of nasal congestion. Unlabeled use(s): Treatment of stress incontinence in women.

 Contraindications Hypersensitivity to sympathomimetic amines; cardiovascular disease; hypertension; hyperthyroidism; kidney disease; diabetes; glaucoma; depression; during or within 14 days following MAO inhibitor use.

 Route/Dosage

Appetite Suppressant

ADULTS: PO 25 mg tid ½ hr before meals (immediate-release tablets) or 75 mg in morning (sustained release capsules).

ORAL SPRAY

25 mg (4 sprays) 4 hours before meals (75 mg/day maximum).

Nasal Decongestant

ADULTS: PO 25 mg q 4 hr (maximum 150 mg/day) or PO 75 mg (sustained-release capsules) q 12 hr. CHILDREN 6 to 12 YR: PO 12.5 mg q 4 hr (maximum 75 mg/day). CHILDREN 2 to 6 YR: PO 6.25 mg q 4 hr.

 Interactions

Guanethidine: May decrease hypotensive effect. Indomethacin: May cause severe hypertensive episode. MAO inhibitors, furazolidone: May cause hypertensive crisis and intracranial hemorrhage. Methyldopa: May cause hypertension.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Palpitations; tachycardia; arrhythmias; hypertensive crisis and possible renal failure that may include rhabdomyolysis. CNS: Restlessness; dizziness; insomnia; tremor; headache; bizarre behavior. EENT: Nasal dryness. GI: Dry mouth; nausea. GU: Dysuria.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy as anorexiant not established. Special-risk patients: Patients with hypertension or other cardiovascular diseases, hyperthyroidism, diabetes mellitus, prostatic hypertrophy or increased intraocular pressure should use these products only with medical advice. Cardiovascular effects: Acute BP elevation may occur. Tartrazine sensitivity: Some products contain tartrazine, which may cause allergic-type reactions in susceptible individuals.

 Administration/Storage

• Do not crush or allow patient to chew sustained-release or precision-release capsules.
• Administer immediate-release tablets for appetite suppression ½ hr before meals.
• Administer sustained-release capsules once a day in the morning. Administer precision-release capsules once a day after breakfast.
• Store in tightly closed, light-resistant container.
• Shake oral spray well before using.
• First time use: Prime oral spray pump by depressing pump » 5 strokes to expel liquid.
• Spray directly onto tongue and swallow immediately.
• Use of oral spray should be discontinued after 3 months.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• If drug is administered as diet aid, monitor patient's weight and nutritional intake.
• If drug is administered as nasal decongestant, assess nasal congestion periodically.

 Patient/Family Education

• Caution patient not to take medication immediately before bedtime to avoid insomnia.
• Warn patient not to exceed recommended dosage.
• When drug is prescribed as diet aid, remind patient that drug must be used in conjunction with restricted-calorie diet to be effective.
• Advise patient to avoid excessive intake of caffeine-containing foods and beverages.
• Instruct patient to discontinue drug and notify physician if rapid pulse, dizziness, nervousness, insomnia, weakness, tremor, or palpitations occur.
• Advise patient to notify physician if no improvement in symptoms or if high fever occurs.
• Instruct patient not to take otc medications without consulting physician.

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