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CHAPTER 63  Therapeutic & Toxic Potential of Over-the-Counter Agents        1127


                    TABLE 63–2  Ingredients of known efficacy for selected over-the-counter (OTC) classes. (Continued)

                                    Generic Name
                     OTC Category   (Brand Example)  Labeled Use   Warnings                 Considerations
                     Sleep aids     Diphenhydramine   Reduces      Avoid use in: children <12 years   •  Insomnia persisting for >2 weeks may
                                    (Nytol, Sominex)  difficulty in   of age; combination with   be a sign of a serious underlying medical
                                                     falling asleep.  alcohol, other antihistamines,   condition.
                                    Doxylamine (Unisom)            or sedatives; individuals with
                                                                   angle-closure glaucoma; men
                                                                   with trouble urinating due to
                                                                   an enlarged prostate gland.
                                                                   Use caution when driving or
                                                                   operating machinery.
                                                                   Adverse effects include:
                                                                   dizziness, constipation, and dry
                                                                   mouth.
                     Smoking        Nicotine polacrilex   Reduces with-  Avoid use in: children   •  Nicotine replacement products in addition
                     cessation aids  gum (Nicorette)  drawal symp-  <18 years of age; women who   to behavioral support approximately
                                                     toms (including   are pregnant or breastfeeding;   double the long-term cessation rates
                                    Nicotine polacrilex   nicotine craving)   individuals with temporoman-  compared with placebo.
                                    lozenge (Nicorette)  associated   dibular joint disease (gum only);   •  Nicotine replacement products can be
                                    Nicotine transdermal   with quitting   individuals with allergies to   used in combination to improve long-term
                                    patch (Nicoderm CQ)  smoking.  adhesive tape (patch only). Use   abstinence rates.
                                                                   patch with caution in patients
                                                                   with a history of dermatologic   •  The patch may aid in improved adherence
                                                                   conditions (eczema, psoriasis,   (once-daily dosing).
                                                                   ectopic dermatitis).   •  Do not use lozenge if allergic to soya (soy
                                                                                            beans).
                                                                   Gum
                                                                   Adverse effects include: jaw
                                                                   soreness, hiccups, dyspepsia,
                                                                   throat and mouth irritation,
                                                                   nausea, vomiting,
                                                                   lightheadedness.
                                                                   Lozenge
                                                                   Adverse effects include: mouth
                                                                   irritation, nausea, hiccups,
                                                                   cough, heartburn, headache,
                                                                   sore throat, dizziness.
                                                                   Transdermal patch
                                                                   Adverse effects include: local
                                                                   skin reactions (erythema, itch-
                                                                   ing, burning), headache, and
                                                                   sleep disturbances (insomnia,
                                                                   abnormal/vivid dreams).



                    The recommendations listed in  Table 63–2 are based on the   appropriate based on the patient’s symptoms, underlying
                    efficacy of the ingredients and on the principles set forth in the   health conditions, and whatever is known about the medica-
                    following paragraphs.                                  tions the patient is already taking. Many products with the
                                                                           same brand name contain different ingredients that are
                    1. Select the product that is simplest in formulation; in general,
                      single-ingredient products are preferred. Combination products   labeled for different uses. For example, multiple products
                      may contain effective doses of some ingredients and subthera-  (with different active ingredients) carry the Allegra name,
                      peutic doses of others. Furthermore, there may be differing   including Allegra Allergy (fexofenadine), Allegra-D (fexofena-
                      durations of action among the ingredients, and there is always   dine and pseudoephedrine), and Allegra Anti-Itch Cream
                      a possibility that the clinician or patient is unaware of the   (allantoin and diphenhydramine).
                      presence of certain active ingredients in the product.  4. Recommend a generic product if one is available.
                    2. Select a product that contains a therapeutically effective dose.  5. Be wary of claims of specific superiority over similar products.
                    3. Consumers and providers should carefully read the “Drug   6. For children, the dose, dosage form, and palatability of the
                      Facts” label (Figure 63–1) to determine which ingredients are   product are prime considerations.
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