CHAP 17 PHARMA.pdf

Chronic obstructive pulmonary disease (COPD) is a term that encompasses a group of progressive lung diseases-chronic bronchitis (inflammation of bronchial tubes, which leads to chronic mucus production and a wet cough) and emphysema (destruction of the tiny air sacs at the base of the lungs, diminis...

Chronic obstructive pulmonary disease (COPD) is a term that encompasses a group of progressive lung diseases-chronic bronchitis (inflammation of bronchial tubes, which leads to chronic mucus production and a wet cough) and emphysema (destruction of the tiny air sacs at the base of the lungs, diminishing the capacity and efficiency of the lungs to utilize oxygen, leading to shortness of breath and exercise intolerance). COPD is a progressive disease that worsens with time and has systemic manifestations, including muscle wasting. Cigarette smoking is the primary cause of COPD; less often, it is caused by long-term exposure to lung pollutants. Therapeutic measures for respiratory distress include oxygen therapy, respiratory stimulants, bronchodilators, corticosteroids, mucolytics, expectorants, antitussives, and smoking cessation. Oxygen Therapy indicarody Oxygen is used therapeutically for hypoxia (insufid respiratory system, the sues) and to decrease the workload of the heart and system, pe during distress. Some of the conditions for which oxygen therapy is heart and lung diseases such as COPD, smoke inhalais) conditions with the or nide poisoning, and some central nervous system (CNS) conditions with resp difficulty or failure. Oxygen may be administered cannula, various masks, tents, of hoods. d by endotracheal intubation, Side effects of oxygen delivered at too high a concentration or for prolonged period of time without proper monitoring can include: Hypoventilation (particularly with COPD, may cause CO, retention and acidosis) Confusion, Changes in the alveoli of the lungs Blindness (in premature infants) Cautions or contraindications apply to: Patients with COPD (high O, concentrations may cause hypoventilation or apnea (cessarion of breathing)). Danger of fire when oxygen is used. Oxygen is not flammable but does support combustion. Smoking, matches, cleaning aerosols, and electrical equipment that may spark are not allowed in rooms where oxygen is in use. Respiratory Stimulants Respiratory stimulants include Caffeine citrate in the treatment of neonatal apnea of prematurity (see Theophylline administered IV and orally to stimulate respiration in infants (as an alternative to caffeine Bronchodilators Bronchodilator Administration Bronchodilators by the smooth muscles of the brunchial vee, thereby relieving bronchopu relaxing ating the work of breathing Brunchodilators are used it the symptomaendalment of acute respiratory conditions such as asthma as well as many forrestresum Classifications of bronchodilators include tee sympathomimetics (senergics). The anticholinergics (parasympatholytics) (see Chapter 13. System Drugs), and the xanthine derivatives Bronchodilators can be given orally, parenterally, and by inhalation Theppropriate route of administration inhalation technique Wpreferred to effect of acrosol inhalani inedications minimize adverse systemic effects. Assential to achieve optimal drug delivery and the therapeutic Metered-dose inhalers (MDIs) remain popular because of their coon (CFC) efficacy, and portability, in the past, all MDls contained chlorofluorocarbon (CPC) as the propellant. Because of to detrimental effects on the vaone layer, the use of CPC was phased our by the end of 2013 Some manufacturers Have reformulated their MDIs to contain hydrofluoroalkane (HFA) as the propellant, which has not been linked to depletion of the ozone layer and is nonflammable. Other manufacturers ate discontinuing production of MDIs and utilizing alternative formulations instead. MDs are frequently used, and the use of a spacer or reservoir device can assist in optimizing Drug delivery within the lungs, especially in adolescent patients. (Ser Figure 17-1.) MDls and other inhalers need to be cleaned intermittently to avoid the build-up of medication at the mouthpiece that can inhibit drug delivery. Although it can be done more frequently, it u recommended that MDI inhalers be cleaned at least once per week. The following steps should be followed to ensure proper cleaning: 1. Remove the canister from the actuator. Do not let the canister get wet. 2. Take the cap off the mouthpiece and wash the actuator by running warm water through the top for 30 seconds. 2. Turn the actuator upside down and run warm water through the mouthpiece for 30 seconds. 3. Shake the actuator off to remove as much water as possible, srid allow the actuator to dry overnight. 4. Replace the canister in the actuator and shake well, spray two sprays -Dry-powder inhalers (DPIs) provide medication (especially corticosметод and long-acting beta, agonists) only under the pressure of spontaneous inspiration to generate sufficient inspiratory effort on their own to deliver the medication, and 17-2.) This option is helpful for patients who are unable to coordinate inspiration With actuation of conventional MDI Small-solutie nebultzees (SVNs) create an aerosol mist of a drug solution tha can then be shhaled the the lungs through a mouthpiece or a mask. The arrosol created by either compressed air or oxygen gas, and the a slow, deep breath with a sustained breath hold: an 8-12 min period. (See Figure 17-3) e optimal breathing pattern the aerosol should be delivered over Sympathomimetics Sympathomimetics (adrenergics) are potent bronchodilators that increase vital capacity and decrease airway resistance. The adrenergics work on the smooth muscle in the lungs to cause relaxation. Examples include albuterol, epinephrine, and salmeterol. An important classification system is differentiating between short-acting beta agonists (SABAs) and long-acting beta agonists (LABAs). SABAs, such as albuterol, are the drug of choice for managing acute exacerbations of asthma. LABAs, such as salmeterol, are used for prophylactic treatment. SABAs are also known as reicue medications versus the LABAs, which are known as maintenance medications. Side effects of the increased risk of adrenergics include potentiation of theophylline effects with Gastrointestinal (GI) (nausea, vomiting and decreased appetite) toxicity, especially Cough, throar intanon, hoarseriess, and sinusitis with inhaled preps CNS stimulacion (nervousness, tremor, dizziness, and headache) Cardiac irrepilarities (tachycardia, palpitations, arrhythmias, and angina) an isomer of albuterol, may cause less cardiac stimulation andopenincidence of certain systemic adverse reactions such as tremor and nervousness compared these small differences is unknown) to albuterol; the clinical significance of Hypertension Hyperglycemia and hypokalemia (caution with loop or thiazide diuretics) Cautions or contraindications for the adrenergics apply to: First administration, which should be observed by medical personnel for hyper- sensitivity reactions, Contacting the physician if decreased effectiveness occurs, Close monitoring, if administering oral inhaled adrenergics with other oral in- haled bronchodilators, for cardiovascular effects Patients with cardiovascular or kidney disorders, diabetes, seizure disorders, or hyperthyroidism Because of a prolonged onset of action, long-acting beta, agonists (such as salmeterol) should not be used to treat an acute asthma attack or bronchospasm; these are indicated only for asthma prophylaxis in combination with an asthma controller medication such as an inhaled corticosteroid. A short-acting beta, agonist (such as albuterol) should always be available for the rescue treatment of an acute attack. Warn patients that increasing use of rescue inhalers is a sign of deteriorating asthma control. In addition, long-acting beta, agonists have been associated with an increased risk of severe asthma exacerbations and asthma-related deaths. Clinical Application Rescue Inhaler Use Rescue inhalers, which are most commonly albuterol (SABA)-based MDI inhalers, are an effective way for patients who have asthma, COPD, or other bronchospastice diseases to manage acute respiratory distress. These noes of medications act very quickly, but also provide only temporary relief to patients. Overuse of SABAS can result in tachycardia, jitteriness, anxiousness, and mnia. The recommended maximum dose for inhaled albuterol MDis is 12 inhalations in any 24-h period Patients should be counseled that their rescue inhaler is intended for “as-needed” use, and should not be taken if symptoms are not present. Even if a patient is not exceeding the max daily dose, it is important as a health Care practitioner to limit rescue inhaler use, as frequent use can be a sign of poor disease state control, Ideally. Patients should only require the use of the rescue inhaler 2 days per week or less. If patients are using the rescue relief more frequently, there is a need for maintenance therapy initiation, adjustment, or addition of new medications. Maintenance medications for respiratory diseases include inhaled corticosteroids, LABAs, oral corticosteroids, and leukotriene inhibitors. The use of these medications can vary based on patient age, disease severity, and other factors. Additionally, patients can be instructed to limit activities or avoid environments that exacerbate their condition. Anticholinergics (parasympatholytics), for example, Achospasm. Lation by decreasing the chemical that promotes bronchospasm. Block the parasympathetic nervous system and can dito avoiding of pulmonary secretions. Adequate hydration should be encouraged to copd mucus plugging Inhaled anticholinergics are the first-line therapy for COPD once symptoms become persistent. Side effects of anticholinergics can include: Cardiac effects (changes in heart rate and palpitations) CNS stimulation (headache, drowsiness, dizziness, confusion, and agitation) Thickened secretions and mucus plugging; dry mouth and metallic taste Constipation and abdominal pain Cautions: Anticholinergics are not indicated for patients with unstable cardiac status, history of heart attacks, glaucoma, drug sensitivity, or prostatic hypertrophy. Tiotropium (Spiriva), which is structurally similar to ipratropium (Atrovent), is administered daily as a maintenance drug in a dry-powder inhaler (versus three to four times daily for ipratropium). It is more efficient than ipratropium for the main- tenance treatment of COPD and may lead to a reduction in the use of sympathomi- metics for rescue therapy. Xanthines The xanthine derivative theophylline, listed in Table 17-1, relaxes the smooth muscle of the bronchial airways and pulmonary blood vessels and may possess anti inflammatory actions. Xanthines are no longer a first-line treatment because of their modest clinical effectiveness, the need for serum monitoring, their many adverse effects, and their drug interactions. Theophylline is generally reserved for patients with COPD who do not respond to or cannot take inhaled long-acting bronchodilators. When used, xanthines are usually administered as sustained-release formulations with other respiratory system drugs such as adrenergics and anticholinergics for additive effects on symptom relief And breathing functions. Side effects of theophyllines can be mild or severe with acute toxicity, including: GI distress (nausea, vomiting, epigastric pain, abdominal cramps, anorexia, or diarrhea; to reduce gastric irritation, take with meals) CNS stimulation (nervousness, insomnia, irritability, headache, tremors, and seizures; can be fatal) Cardiac effects fatipitation, tachycardia, arrhythmias, especially with rapid IV administration) Urinary frequency (mild diuresis) Hyperglycemia Cautions and contraindications cations when administering theophylline apply to: Sudden cessation of tobacco smoking (may result in reduced clearance of the- ophylline and increased serum theophylline concentrations) Cardiovascular, kidney, pulmonary, or liver dysfunction Diabetes, peptic ulcer, or glaucoma Children and older adults (more prone to toxicity) IV injection (must be done slowly see cardiac side effects) Patients undergoing influenza immunization or who have influenza Pregnancy and lactation Interactions occur with: Cimetidine, allopurinol, erythromycins, quinolones, oral contraceptives, calcium channel blockers, and beta-blockers (increase theophylline levels) Smoking, barbiturates, phenytoin, and rifampin (decrease theophylline effectiveness) Roflumilast or PDE-4 inhibitor Corticosteroids Bronbetic corticosteroids are used to relieve inflaromation, reduce swelling, decrease bronchial hyper- chronic reactive be administered -responsiveness to triggers, and suppress symptoms in acute and systemically (oral and injectable forms) for short-term “bursts” during exacerbations and callasionally at the beginning of treatment until symptoms are controlled. Comparatively. Inhaled corticosteroids are used chronically for pro phylaxis, and are not used as acute bronchospasm treatment. Inhaled corticosteroids (SVN aerosol. DPI, and MDI) are considered a preferred drug therapy in long-term prophylactic management of persistent asthma of vari ous severities. Regular long-term treatment reduces exacerbations, improves control of symptoms and lung function, and reduces hospital admissions and deaths from asthma. Inhaled corticosteroids with long-acting beta agonists are also used on a reg ular, long-term, scheduled basis in patients with COPD to improve symptoms and quality of life. Inhaled corticosteroids have fewer systemic side effects than oral or injectable administration. They are often used in combination with LABAs. Parients should be counseled to rinse their mouth out with water after use and to not swal low medication. Failure to follow these instructions could result in oral thrush or irritation of the esophageal passage. Intranasal Nasal corticosteroids are increasingly considered first-line therapy for most nenin fectious types of thinitis and reduce congestion, edema, and inflammation. They should be started before symptoms occur and taken regularly throughout the period of exposure. Aerosol corticosteroid preparations seem to be more irritating (burning, sneezing) to the nasal mucosa. Aqueous preparations may drip into the throat resulting in reduced deposition of drug in the nasal mucosa. Side effects of inhaled corticosteroids: Throat irritation and dry mouth Oral fungal infections (patient should be encouraged to rinse mouth with Hoarseness mouthwash or water after administration) Increased susceptibility to pneumonia Cautions or contraindications with corticosteroids apply to: Viral, bacterial, or fungal infections Hypertension or congestive heart failure Diabetes Hypothyroidism or cirrhosis Renal failure Asthma Prophylaxis Loukotriene Inhibitors Zalilukuu (Accolare) and montelukan (Singulair) are oral leukotriene receptor antagonists for asth sthus prophylaxis, prevention striction, and treatm of exercise-induced bronchocon- of chronic asthma. Leukotriene receptor antagonists pri marily help to conued of chlammatory process of sathma caused by le They can production, thus helps inflarem ustuna symptoms and cure stack broded as monotherapy to prodd-on therapy in patients whose persistent mild to moderate u in Inadequately kast can be used in as 2 years old and has fewer drug interactums compared to safiriukan controlled with inhaled corticosteroids. Side effects of Singular include Headache Dizzines Nausta or dyspepsia Pain Fatigue Respiratory infections and fever Behavior or mood thanges, sleep disturbances, and suicidal ideation Cautions or contraindications apply to Hepatotoxicity (zahrlukast) Pregnancy or lactation Treatment of acute episodes of asthma (these are not rescue medications) Drug interactions occur with: Aspirin (increased levels of zafirlukast) Erythromycin and theophylline (decreased levels of zafirlukast) Warfarin and zafirlukast (increased prothrombin time) Phenobarbital and rifampin (decreased levels of montelukast) Mast Cell Stabilizers The rupture or degranulation of mast cells and the subsequent spilling of their chemical mediator contents cause an inflammatory response that can lead to asthma. Stabilizing the mast cell membrane has anti-inflammatory actions that modify the release of mediators from mast cells and eosinophils. A prophylactic for asthma, cromolyn was one of the first classified mast cell stabilizers. Cromolyn has no value in the treatment of acute attacks of asthma. Has also been used in the prevention of exercise-induced bronchospasm. Cromolyn is available as a solution for inhalation or a nasal solution (to treat seasonal allergic rhinitis) for use in adults and children as young as 2 years old. To be effective, the Manufacturer’s directions must be followed carefully. (acetylcysteine) Mucolytics Side effects of cromolyn can include: Throat irritation, cough, and bronchospasm Nose burning, stinging, and sneezing (with nasal solution) Caution applies to: Those with cardiovascular disorders Mucolytics and Expectorants Mucolytick, such a as scetylcysteine. Decrease the hypersecretion of and liquefy obstmonary can be a problem in patients with obote effive lung disease, but there is little evidence that inhaled acetylcysteine is mote effective chan adeq hate hydration for thinning of increasing the clearance of secretions Contraindications Asthma (IV administration or inhalation may result in acute bronchospasm for mucolytics apply to or anaphylaxis) Respiratory insuficiency, inadequate cough mechanism, or gag reflex depression (liquefied pulmonary secretions can occlude the airway if t adequately clear the the patient is unable to Cautions or contraindications Secretions) [Expectorants, such as guaifeneun (the only agent approved for use as an expec torant), inctease secretions, reduce viscosity, and help to expel sputum but like mucolytics offer little dinical benefit for patients with obstructive lung disease. Ade quate fluid intake is important to maintain normal fluid volume, but excessive fluid intake is of no value. Guaifenesinis commonly combined in cough syrups for the symptomatic management of productive (“wet”) coughs associated with upper respiratory tract infections, bronchitis, pharyngitis, influenza, and measles or coughs provoked by sinusitis, but evidence of benefit is lacking. It is also commonly used in combi nation with a cough suppressant, dextromethorphan, to reduce the incidence of dry cough, but still loosen mucus in the respiratory tract to allow for productive cough Expectorants should not be used for self-medication for persistent or chronic coughs such as those associated with smoking or COPD. A persistent cough may be indicative of a serious condition. If the cough persists for more than a week, is recur rent, or is accompanied by a fever, a physician, should be consulted. Side effects of the expectorants are infrequent, usually not serious at recommended doses, and can include: Nausea and vomiting, and diarrhea Drowsiness, dizziness, and headache Cautions or contraindications for expectorants apply to: Persistent or chronic cough Some asthmatics (prone to bronchospasm) Cardiovascular disease and hypertension, diabetes, glaucoma, hyperthyroidism. And prostatic hypertrophy, especially with combination products Pregnancy or lactation Antitussives Antitussives are medications to prevent coughing in patients not producing a pro ductive cough. Coughing, a reflex mechanism, helps eliminate secretions from the respiratory tract. A dry, nonproductive cough can cause fatigue; insomnia; and, in some cases, pain to the patient (e.g., pleurisy and fractured ribs). Most antitus- sives produce cough suppression by acting centrally on the cough center located in the brainstem. Cough suppressants are divided into narcotic preparations such as codeine and hydrocodone and non-narcotic preparations such as dextromethorphan Codeine, a narcotic antitussive, is widely used as a cough suppressant owing to its reduced incidence of side effects (respiratory depressant action and bronchial con- striction) at antitussive doses as compared to morphine. In some states, codeine is available behind the pharmacy counter as an OTC cough medication. Hydroco. Done another narcotic cough suppressant, has slightly greater antitussive activity compared to codeine but is more sedating. With the recent change from Drug Enforcement Agency (DEA) Schedule III to DEA Schedule II. Hydrocodone is pre scribed less frequently aEA antitussive, but liquid formulations are still available for severe coughing Non-narcotic antitussiver)(e-g. Dextromethorphan) are used more frequently because they do not depine respirations, do not cause dependence, and have few side effects at recommended doses. They are considered to have a similar antitus sive effect as codeine atide same dose. Dextromethorphan should not be used in patients under the age of 4 years (caution in age less than 6 years) because of the cough center in the bra of dot being fully developed. Benzonatate (Tessalon), chemi cally related to the local anesthetic tetracaine, suppresses cough peripherally by anes thetizing receptors in the alveoli of the lungs, the bronchi, and the pleura; it also acts centrally like the other antitussives/Diphenhydramine (Benadryl), a firs-generation antihistamine, is also used as a cough suppressant and is described in detail later in this chapter. Side effects of antitussives can include: Respiratory depression (large doses or e )-only narcotic antitussives excessive use)- Constipation-only narcotic antitussives Urinary retention-only narcotic antitussives Sedation and dizziness-only narcotic antitussives Nausea and vomiting Cautions or contraindications for antitussives apply to: Addiction-prone patients (refer also to the discussion on dextromethorphan Abuse in Chapter 20) Asthma; COPD Other CNS depressants (refer to Chapter 19, “Central Nervous System Drugs: Analgesics, Sedatives, and Hypnotics,” for opioid interactions) Caution for antitussives with children can include: Some CNS side effects, behavioral disturbances, and respiratory depression reported, especially with large doses Ester-type anesthetic (e.g., tetracaine) hypersensitivity with benzonatate Interactions with dextromethorphan can include: Triptans used for migraine headache Monoamine oxidase inhibitors (MAOIs), resulting in serotonin syndrome (applies to benzonatate as well) The SSRIs fluoxetine and paroxetine (reduce dextromethorphan dose) Memantine (Namenda) The American College of Chest Physicians practice guidelines do not recom- mend the use of cough suppressants for coughs associated with upper respiratory infection (URI) because of their limited efficacy. It is recommended that patients experiencing a cough associated with the common cold or postnasal drip associated with a URI use a first- generation antihistamine and a decongestant to treat cough Antihistamines Antihistamines competitively action, the antihistamines antagonize the histamine, receptor sites. Through this combat the increased capillary permeability and edema, inflammation, cold by sudden histamine release. Antihistamines are used to treat the symptoms of allergies (e.g. rhinitis, conjunctivitis, and rash). Please see Figure 17-4. However, when antihistamines are used to common cold, the consequent reduce nasal secretions in thickening of bronchial secretions may result the in fur ther airway in those with COPD and asthma. H-blockers are grouped into two categories: first-generation agents and second-generation agents. First Generation These antihistamines, such as diphenhydramine (Benadryl), were the first group of medications available to tich symptoms of allergies. Diphenhydramine is also approved as an antitussive, nighttime sleep aid (see also hypnotics in Chapter 19), and antiemetic. It is also used as an adjunctive treatment of anaphylactic reactions after the acute symp toms (eg, laryngeal edema and shock) have been controlled with epinephrine and corticosteroids or used as monotherapy for minor local allergic reactions or irritation from things like insect mings and bites. Some antihistamines are used in the symp tomatic treatment of vertigo associated with pathology of the middle eat or in the pre- vention and treatment of motion sickness (see Chapter 16, “Gastrointestinal Drugs”). First-generation antihistamines tend to have more side effects than second-generation antihistamines because they are not selective for the histamine, receptors Side effects of the five generation antihistamines are primarily anticholinergic in action and include Drying of secretions, capecially of the eyes, cars, nose, and throat Sedation, disines, tachycardia, and hypotension, especially in older adul Muscular weaknes and decreased coordination; cognitive impairment Urinary retention and constipation Visual disorders Paradionical effeco-nausc Gl cament Insomnia, and tremors, especially in children vomiting, and anorexia Nasal unitarion, epistasis, and bitter taste with nasal spray Cautions or contraindications for first-generation antihistamines apply to: COPD and asthana Persons operating machinery or driving a car Older adult patients (extended half-life with sedation) Closed-angle glaucoma Cardiovascular disorders Benign prostatic hyperplasia (BPH) Children under the age of 6 years Pregnancy and lactation Seizure disordern Interactions of fust-generation antihistamines may occur with: Porentiation of CNS depression with tranquilizers, analgesics, hypnotics, alcohol, and muscle relaxants Second Generation The second-generation antihistamines include fexofenadine (Allegra), cetirizine (Zyrtec), levocetirizine (Xyzal), and loratadine (Claritin). These drugs are selective (have greater specificity for) histamine, -receptor antagonists and have fewer CNS effects, for example, less sedation, and fewer anticholinergic effects compared to the first-generation antihistamines. Although these agents cause little or no seda tion, it is important to note that the incidence of sedation is not zero. They are used to provide symptomatic relief of seasonal allergic rhinitis, for example, hay fever. The second generation antihistamines are not effective in the treatment of cough Decongestants Several adrenergic drugs, for example, phenylephrine (Neo-Synephrine) and pseudo- Ephedrine (Sudafed), act as decongestants. These drugs constrict blood vessels in the respiratory tract, resulting in the shrinkage of swollen mucous membranes (because of colds or allergies) and helping to open nasal airway passages. Given orally, they are less effective than topical decongestants and have the potential for systemic side effects, especially increasing blood pressure. However, these drugs, both oral and nasal, should be used only on a short-term hasis because rebound congestion may occur within a few days. Decongestants are frequently combined with antihistamines, analgesics, caffeine, and/or antitussives. Many of these products are available OTC, and by combining several drugs, the possibility of adverse side effects is increased, especially without adequate medical supervision. As mentioned in Chapter 20, the Combat Methamphetamine Epidemic Act of 2005 (which took effect in 2006) banned OTC sales of ingredients commonly used to make methamphetamine. Psuedoephedrine (PSE), a popular and effective oral nasal decongestant, was the primary target of the act. PSE can now be stored and sold only in limited quantities under special conditions (behind the counter) by pharmacies in an attempt to limit its sale in large quantities. Purchasers are limited to 3.6 g (15 days of the max daily dose) of PSE per day and 9 g per month. Pharmacies Are limited in the amount that can be sold per day as well. Newer formulations of PSE have been marketed as an abuse deterrent and have now become the primary single-source PSE product that pharmacies choose to stock. Nexafed and Zephrex-D, when taken correctly, supply the intended amount of PSE Nenedient, but both formulations make it very difficult to extract PSE by crush ing, dissolving, and so on. This makes it much more difficult to abuse. Side effects of decongestants can include: Note: Saline nasal spray (eg. Ocean) is a safe, effective treatment option for hasal congestion Anxiety, nervousness, insomnia, tremor, and seizures Palpitations, rachycardia, hypertension, headache, and cerebral hemorrhage Reduced cardiac output and reduced urine output Burning, stinging, sneezing, and dryness with nasal preparations Cautions or contraindications for decongestants apply to: Cardiovascular disorders Hyperthyroid or diabetes Older adults especially those with glaucoma or BPH Pregnancy or lactation Interactions may occur with: Potentiation of adverse side effects with other adrenergics, ergot, tricyclics, MAOIS Safety of Cough–Cold-Allergy Products Many prescription and OTC cough and cold formulations are available that combine several drugs-for example, antitussives with expectorants, antihistamines, and decongestants to treat two or more simultaneous symptoms. Combination formulations should be used only if the corresponding symptom is present and each individual component is available in the proper strength and dosing interval a patient may need. Patients should be cautioned to seek advice from a health care professional familiar with each ingredient. The health care professional should Thoroughly assess each patient’s use of similar products (both OTC and Rx) to avoid duplication of therapy and the potential for inadvertent overdose. Some ingredients are contraindicated in certain medical conditions, as detailed earlier. In 2011, the FDA required removal of many prescription cough, cold, and allergy products from the market that were never approved by the FDA. Many of the unapproved drug products covered by the 2011 action contained the same ingredients as the OTC cough and cold preparations that were the subject of a 2008 public health advisory. The FDA’s Nonprescription Drugs and the Pediatric Advisory Committee found there was no proof that these medications eased cold symptoms in children, whereas there were reports that they caused serious adverse effects, overdose, and even deaths. At that time, many manufacturers voluntarily removed from the market cough and cold products labeled for use in children under 2 years old, and some products were relabeled to state that they were not for use in children under 4 years old. In addition to product labeling changes, new child-resistant packaging and measuring devices for the products were introduced. With the changing status of cough and cold medications, a website (https://www.fda.gov/drugs/understanding- over-counter- medicines/tips-parents-about-safe-use-over-counter-otc-medicine) is available for parents seeking information on the use of these medicines in children. Smoking-Cessation Aids Cigarette smoking is the leading cause of preventable disease and death in the United States. Most smokers fail to quit on their first try, and after experiencing how dif ficult quitting is, many will never try again. All smoking-cessation aids have been shown to help twice as many smokers quit versus quitting “cold turkey” when used properly and in conjunction with nonpharmacologic therapies (behavioral modifica tion and social support system). Nicotine Replacement Therapy Nicotine replacement Products (Table 17-7), including Nicorette gum, Commit basan ses, the Nicoderm CQ patch (see Figure 17-5), and the Nicotrol inhaler and nasal spray, help to lessen withdrawal symptoms by slowly lowering the level of nicotine in the body. They let the smoker focus on breaking the social habits of nic- otine and participating in a behavior modification program for smoking cessation without battling the withdrawal symptoms at the same time. The most effective method is for patients to use one long-acting nicotine replacement method (e.g patch) and one “rescue” nicotine replacement method (e.g. gum) for breakthrough cravings. Electronic cigarettes (or e-cigarettes) are battery-powered devices that heat liquid nicotine into an inhaled vapor (“vaping”), which simulates tobacco smoking. E-cigarettes should theoretically have fewer toxic effects (because of fewer toxic chemicals) than traditional cigarettes, but concrete evidence is lacking. Although e-cigarettes have not yet been linked to any serious health issues, they have been in widespread use for such a short period of time that there is no basis for determining if there are long-term risks. Side effects of nicotine replacement products (which could also be related to nicotine withdrawal symptoms) can include: Mechanical problems with chewing gum, especially if the patient has dentures Cardiac irritability Chewing too quickly (may cause lightheadedness, nausea, heartburn, vomiting, and throat and mouth irritation) Skin reaction at the application site Cautions or contraindications for nicotine replacement products apply to: Dental problems that might be exacerbated by chewing gum Drug abuse and/or overdependence Overdosage-studies have shown that combination therapy (nicotine patch plus One other form of nicotine replacement) is more effective if unable to quit using a single agent, but there is little safety data on this, and combination therapy may increase the risk of nicotine overdose Pregnancy and lactation Unstable cardiovascular disease Patients should be warned not to smoke Proper disposal to avoid accidental ingestion by children and pets Bupropion An oral drug (Wellbutrin) that is also prescribed Bupropioning cessation (mat keted as Zyban) and has been associated with decre in cravings Link cigarettes and lessening of nicotine withdrawal. Zyban is also ind in combination with nicotine patches for treating the symptoma of cated for use in nicotine withdrawal (Refer to Chapter 20 for information on bupropion) Varenicline (chantix) Prescription-only partial nicotine receptor antagonist given orally and indicated for adults as an aid in smoking cessation. L alleviates the symptoms of nicotine craving and withdrawal through its agonise activity while inhibiting the effects of repeated nicotine exposure by its antagoni activity, thus eliminating the pleasurable feelings associated with smoking. Mild to moderare nausea and vomiting, sleep disturbance, and abnormal dreams are the most common side effects, with nausea and vomiting occurring in nearly one-third of patients (it should be taken after a meal with fluids). To date, no clinically significant drug interactions have been identified. There have been reports of serious neuropsychiatric symptoms, such as changes in behavior, agitation, depressed mood, and suicidal ideation and behavior associated with varenicline. There is some controversy as to whether these were caused by complications owing to nicotine withdrawal or by the drug itself. The safety and efficacy of varenicline in patients with serious psychiatric disorders such as schizophrenia, bipolar disorder, and major depression have not been established Patients and caregivers should be aware of the need to monitor for these symptoms and report them immediately to the physician.