The FDA has approved a 0.75% ophthalmic solution of the alpha-adrenergic antagonist phentolamine (Ryzumvi – Viatris) for treatment of mydriasis produced by adrenergic agonists such as phenylephrine or parasympatholytic agents such as tropicamide in patients ≥3 years old. Ryzumvi is the first drug to be approved in the US for reversal of pharmacologically induced mydriasis.

The choice of drugs for treatment of allergic rhinitis depends on the severity of symptoms and whether they are intermittent or persistent (see Table 1).

Patients with seasonal allergies often experience nasal itching and congestion, sneezing, rhinorrhea, and itchy, watery eyes. Oral, intranasal, and ophthalmic preparations are widely available over the counter (OTC) for relief of symptoms. Prescription products for management of allergic rhinitis and allergic conjunctivitis are reviewed separately.

Acute cough (<3 weeks in duration) generally does not require pharmacologic treatment, especially in children. Suppression of productive cough may be harmful. Management of patients with cough should include elimination of any precipitating factor (e.g., cigarette smoking) and treatment of any underlying cause such as upper airway cough syndrome, gastroesophageal reflux disease, asthma, or other pulmonary disease.

The FDA has issued new warnings about the use of the opioid analgesics codeine and tramadol in children, particularly those <12 years old, and in breastfeeding women due to concerns about the risk of respiratory depression and death. The FDA previously issued warnings about these drugs in 2013 and 2015.

Allergic rhinitis can be classified as seasonal, perennial, or episodic. It is often associated with allergic conjunctivitis, rhinosinusitis, and asthma.

H₁-ANTIHISTAMINES — Oral – Oral second-generation H₁-antihistamines are the preferred first-line treatment for relief of the itching, sneezing, and rhinorrhea that characterize mild-to-moderate allergic rhinitis. They are less effective for nasal congestion.

In 2007, an FDA advisory committee asked that placebo-controlled, dose-ranging trials be conducted to establish the efficacy of the oral decongestant phenylephrine (Sudafed PE, and others), which is sold over the counter (OTC) as a single agent and in combination with other drugs for treatment of cold and allergy symptoms. Phenylephrine replaced pseudoephedrine (Sudafed, and others) in many OTC formulations when access to pseudoephedrine-containing products was restricted in an effort to reduce their use in the synthesis of methamphetamine.

CLINICAL STUDIES — In a randomized, open-label, dose-ranging trial in 539 patients with seasonal allergic rhinitis, phenylephrine doses up to four times the recommended dose of 10 mg were no more effective than placebo in reducing symptomatic nasal congestion.1 Other recent studies have also found oral phenylephrine no more effective than placebo in reducing nasal congestion.2-4

ALTERNATIVES – Oral pseudoephedrine reduces nasal congestion, but has no effect on other symptoms such as sneezing, itching, or rhinitis, and tolerance to its effects can occur with repeated use. Potential adverse effects include insomnia, excitability, headache, nervousness, anorexia, palpitations, tachycardia, arrhythmias, hypertension, nausea, vomiting, and urinary retention. Pseudoephedrine should be used cautiously in patients with cardiovascular disease, hypertension, diabetes, hyperthyroidism, narrow-angle glaucoma, or bladder neck obstruction.

Intranasal decongestants such as oxymetazoline (Afrin, and others) are effective and less likely than pseudoephedrine to cause systemic adverse effects, but they can cause stinging, burning, sneezing, dryness of the nose and throat, and, if used for more than 3-5 consecutive days, rebound congestion (rhinitis medicamentosa). Intranasal corticosteroids are the most effective drugs available for prevention and relief of nasal congestion and other seasonal allergic rhinitis symptoms.5

CONCLUSION — Oral phenylephrine is not effective for treatment of nasal congestion.

1. EO Meltzer et al. Oral phenylephrine HCl for nasal congestion in seasonal allergic rhinitis: a randomized, open-label, placebo-controlled study. J Allergy Clin Immunol Pract 2015; 3:702.
2. EO Meltzer at al. Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients. Ann Allergy Asthma Immunol 2015 November 7 (epub).
3. F Horak et al. A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber. Ann Allergy Asthma Immunol 2009; 102:116.
4. JH Day et al. Efficacy of loratadine-montelukast on nasal congestion in patients with seasonal allergic rhinitis in an environmental exposure unit. Allergy Asthma Immunol 2009; 102:328.
5. Drugs for allergic disorders. Treat Guidel Med Lett 2013; 11:43.

Download complete U.S. English article

The use of drugs to prevent and control symptoms of allergic disorders can be optimized when patients avoid exposure to specific allergens and/or environmental conditions that trigger or worsen their symptoms.

The main purpose of vasopressors is to raise arterial blood pressure, while that of inotropes is to increase cardiac contractility. The choice of drugs is dictated by the clinical setting. Controlled trials comparing the efficacy and safety of these drugs are generally lacking.

Allergic rhinitis, allergic conjunctivitis, atopic dermatitis, urticaria, anaphylaxis and asthma (reviewed in Treatment Guidelines 2005; 3:33 and not included here), are prevalent worldwide, especially in industrialized countries. Pharmacologic treatment of these disorders continues to improve in efficacy and safety. In addition to using drugs to prevent and control the symptoms of their allergic diseases, patients should also be instructed to avoid, if possible, specific allergens and/or environmental conditions that trigger or worsen their symptoms.

Allergic rhinitis, allergic conjunctivitis, atopic dermatitis, urticaria and anaphylaxis, along with asthma (reviewed in Treatment Guidelines 2002; 1:7 and not included here), have increased in prevalence during the past 30 years and are now epidemic worldwide, especially in industrialized countries. Many safe and effective drugs are currently available for prevention and relief of symptoms in these disorders, but pharmacological treatment alone may not be sufficient. Patients should also be instructed to avoid specific allergens or environmental conditions that trigger their symptoms. Allergen-specific immunotherapy, parenteral administration of gradually increasing doses of the allergen ("allergy shots"), has been effective in allergic rhinitis, allergic conjunctivitis and allergic asthma, and also in prevention of anaphylaxis triggered by stings from bees, yellow jackets, hornets and wasps. It has not been effective in food allergy, atopic dermatitis or urticaria.

Ever-increasing specialization has made it difficult for many physicians to keep up with therapeutic standards in intensive-care units (ICUs). This issue of Treatment Guidelines offers current recommendations for use of cardiovascular drugs in the ICU for treatment of hypertensive emergencies; shock, cardiac arrest or decompensated heart failure; and ventricular arrhythmias.

The US Food and Drug Administration has ordered removal of phenylpropanolamine from over-the-counter cold remedies and weight loss aids. The FDA based its decision on a recent study showing an increased risk of hemorrhagic stroke in young women taking the drug.

Recently, full-page advertisements have appeared in the New York Times and other newspapers promoting the Viralizer (Viral Response Systems, Greenwich, CT), a heated nebulizer-sprayer device marketed for treatment of colds, sore throats, allergy and sinusitis symptoms. The device is available without a prescription for about $30 to $40.