TABLE OF CONTENTS Practice Guidelines for the Diagnosis and Management of Cough. and diagnosis of cough type and severity are listed below.

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1 TABLE OF CONTENTS 2006 Practice Guidelines for the Diagnosis and Management of Cough Guidelines for the Treatment of Sexually Transmitted Diseases P & T Committee Formulary Action Practice Guidelines for the Diagnosis and Management of Cough Introduction The Cardiopulmonary and Critical Care Journal (CHEST) published updated cough guidelines in January These guidelines updated information from a consensus panel report published in a 1998 supplement of CHEST. These revised guidelines serve as a template for the diagnosis and management of a variety of cough symptoms. Although the complete mechanisms of acute and chronic cough are unknown, the reflex is controlled by vagal afferent nerves in the visera. Coughing may be triggered by environmental factors, such as air pollution or smoke, or a medical condition, such as asthma. Most cough therapies target these cough triggers or underlying medical conditions in order to prevent or decrease cough symptoms. Depending on the severity of cough, a patient s overall quality of life may be greatly impacted. A summary of the treatment guidelines are presented below and a complete version is available at Diagnosis and Evaluation A patient s symptoms and possible underlying causes should be evaluated when he/she presents with a cough. Complete comprehensive diagnostic criteria do not exist for every cough etiology, so diagnosis may be primarily via exclusion. A history, physical examination, and possibly chest x-ray should be performed during the initial visit. If the cough s origin in undeterminable, the diagnosis may be based on a response, or non-response, to an empiric treatment. The first step in any treatment plan should be to eliminate or reduce exposure if a known respiratory irritant is identified. More specific examinations or diagnostic tests may be performed if a specific etiology, such as asthma or gastroesophageal reflux disease (GERD), is the suspected cause of the cough. Possible diagnostic procedures that may be useful in the evaluation and diagnosis of cough type and severity are listed below. Diagnostic Procedures Specific Etiology Determined Asthma Spirometry, bronchodilator reversibility, bronchial provocation challenge (BCP) Non-asthmatic eosinophilic bronchitis (NAEB) Evaluate for sputum eosinophilia Further Diagnostic Tools 24 hour esophageal ph monitoring Endoscopic or videofluoroscopic swallow evaluation Barium esophagram Sinus imaging High-resolution computed tomography (HRCT) Bronchoscopy Echocardiogram Environmental assessment In addition to the diagnostic procedures listed above, the 9 steps listed below may be utilized to help with the diagnosis process and future treatment. 1) For acute cough, determine if there is an underlying serious illness or a clinical manifestation of a less serious condition or due to environmental exposure. 2) For subacute cough, determine whether or not it is due to a recent infection. If not infectious, treat as if it were just a chronic cough. 3) For chronic cough, utilize empiric treatment in a step-wise sequential fashion targeting the most likely cause of the cough (reference the table below for further treatment recommendations). Initiate therapy using a first generation antihistamine/ decongestant. 1

2 4) For patients whose smoking is the cause of the cough, smoking cessation counseling should be performed. 5) For angiotensin-converting enzyme (ACE) inhibitor induced cough, the ACE inhibitor should be discontinued and replaced. 6) For chronic cough, for patients who fail treatment for upper airway cough syndrome (UACS), asthma should be considered next as the cause of the cough. Either BCP or a trial of an antiasthmatic drug may be used to determine if the patient is truly asthmatic. Ideally, the BCP should be performed before the initiation of oral corticosteroids and if the results of the test are positive, the empiric treatment guidelines found in the table should be initiated. 7) For patients who are negative for UACS and asthma, NAEB should be considered next as the cause for the cough. Either a sputum test for eosinophils or a trial of corticosteroids may be used to test for UACS. 8) For patients negative for UACS, asthma, and NAEB, GERD should be considered next as the cause for the cough. 9) For patients whose cough remains undiagnosed after all of the above steps are followed, a referral to a pulmonologist should be made. Special Populations There are some populations whose cough often requires special attention and unique management strategies. Patients presenting with conditions including: oral-pharngeal dysphagia, habit, tic, psychogenic, unexplained cough (formally idiopathic cough), or cough resulting from peritoneal dialysis should be referred to a physician or specialist to optimally manage their underlying medical symptoms and resultant cough. Immunocompromised patients presenting with cough must be evaluated slightly different than the general population. In addition to the criteria discussed for evaluation, CD4+ lymphocyte counts should be taken to help facilitate treatments decisions. Pediatric patients are another special population whose treatment and diagnosis may be slightly different than the general population. During a child s assessment, more in depth evaluations are often necessary to ensure proper diagnosis. For chronic cough, chest radiograph and spirometry should be performed in older children. The child should be evaluated to see if concurrent disease states such as asthma, cystic fibrosis (CF) or bronchietasis are present that have gone previously undiagnosed. A child will often present with a chronic cough as the first sign of some disease states like asthma. If a child presents with a chronic dry cough and is suspected of having asthma, they should be started on a 2 to 4 week beclomethasone or budesonide trial, and a response to treatment should be evaluated. If a chronic wet cough is observed, a 10 day antimicrobial regimen is recommended. As with adults, if a specific respiratory irritant is identified, it should be withdrawn along with the possibly of starting additional therapies. Other adult treatments (as highlighted in the table) and over-the-counter (OTC) medications are not recommended to be empirically started in children without further evaluation by a healthcare provider. Treatment Treatment is most commonly initiated empirically, based on the cough s presentation. The purpose of treatment is to decrease cough symptoms and, if possible, identify and treat any underlying causes for the condition. Side effects of any therapy should always be minimized while maximizing a patient s quality of life. If an underlying cause for the cough is identified as drug-induced, the offending drug should be discontinued. When the cough is attributed to environmental exposure to agents such as cigarette smoke, life style modifications should be implemented and the offending agent should be removed. Dietary restrictions may provide some relief in patients with GERD and physical therapy, such as chest physiotherapy, may help relive some symptoms in patients with cough secondary to bronchiectasis. In general, antibiotics are not recommended for cough, as cough is seldom of bacterial origin. Conditions which may warrant the use of antibiotics include whooping cough, acute exacerbation of chronic bronchitis, CF, bacterial bronchiolitis, and diffuse panbronchiolitis. Other infections that may cause cough, such as tuberculosis, should be treated following recommendations outlined in the respective treatment guidelines. In conjunction with the antibiotics, additional therapies, as listed in the table, may be utilized to help manage cough symptoms in these patients. For patient s whose cough does not qualify for antibiotic treatment, specific treatment recommendations are listed in the table. Within the table, some therapies are listed as refractive treatments or last-line agents. If listed as refractive, the other agents listed prior to that treatment should be tried first and if the patient is not responsive, then the refractive agent may be initiated. Surgeries are currently available for patients with GERD (antireflux surgery) and some types of bronchiectasis, but these are considered to be the last resort after all other treatments have failed. Additionally, a surgery recommendation may be given to patients with a cough secondary to the diagnosis of a lung tumor. 2

3 Table. Treatment Recommendations for Cough Etiology of Cough Treatment Recommendations Chronic upper airway cough secondary to rhinosinus disease or the common cold asthma GERD or other reflux disorders acute bronchitis chronic bronchitis Chronic cough due to nonasthmatic eosinophilic bronchitis (NAEB) bronchiectasis First generation antihistamine/decongestant: brompheniramine and sustained release pseudoephedrine Inhaled bronchodilator Inhaled corticosteroid (ICS) Leukotriene receptor antagonist (refractive patient) Short course (1 to 2 weeks) of an oral corticosteroids followed by ICS (refractive patient) Anti-reflux (acid suppressive) medications: proton pump inhibitor Life-style and dietary modifications Prokinetic therapy (refractive patient) With wheezing: ß 2 -agonist bronchodilator Short term antitussive agents Acute exacerbation: use of antibiotics is recommended along with short acting ß 2 - agonists and ipratropium bromide; oral corticosteroids may also be given (10-15 days) Stable patients with chronic bronchitis may be treated with: Short acting ß 2 -agonists Ipratropium bromide Theophylline ICS with long acting ß 2 - agonists Short term, centrally acting antitussives (dextromethorphan or codeine) ICSs Oral corticosteroids (refractive to ICS) Bronchodilators Antibiotics for acute exacerbations Chronic cough due to nonbronchiectatic suppurative airway disease Post infectious cough lung tumor Chronic cough due to chronic interstitial pulmonary disease Antibiotics for bacterial causes Oral corticosteroids and ICS for patients with inflammatory bowel disease Inhaled ipratropium Inhaled corticosteroids (refractive to ipratropium) Short term prednisone (severe patients) Centrally acting antitussives: codeine or dextromethorphan (when all other therapies fail) Centrally acting antitussives: such as hydrocodone Limited oral corticosteroids on an individual basis ICS therapy should follow oral corticosteroid therapy in patients with cough secondary to sarcoidosis Reference: American College of CHEST Physicians. Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest 2006;129(suppl):1S-22S. Guidelines for the Treatment of Sexually Transmitted Diseases In August 2006, the Centers for Disease Control and Prevention (CDC) published an update to the 2002 practice guidelines on the treatment of sexually transmitted diseases (STDs). Sexually transmitted diseases are among the most frequently reported infectious diseases in the United States. These guidelines are meant to assist physicians and health care professionals in their treatment and diagnosis, as well as improve prevention strategies. A summary of the recommended treatment regimens for common STDs is presented below. Genital Herpes Herpes Simplex Virus (HSV)-Type 1 and Type 2: Painful vesicular or ulcerative lesions on the genitals First episode: Acyclovir 400 mg PO TID for 7-10 days; or Acyclovir 200 mg PO five times daily for 7-10 days; or Famciclovir 250 mg PO TID for 7-10 days; or Valacyclovir 1 g PO BID for 7-10 days Suppressive therapy for recurrent infection: Acyclovir 400 mg PO BID; or Famciclovir 250 mg PO BID; or 3

4 Valacyclovir 500 mg PO daily; or Valacyclovir 1 g PO daily Episodic therapy for recurrent infection: Acyclovir 400 mg PO TID for 5 days; or Acyclovir 800 mg PO BID for 5 days; or Acyclovir 800 mg PO TID for 2 days; or Famciclovir 125 mg PO BID for 5 days; or Famciclovir 1g PO BID for 1 day; or Valacyclovir 500 mg PO BID for 3 days; or Valacyclovir 1 g PO daily for 5 days Symptomatic sex partners should be treated with the same regimens as above. Asymptomatic sex partners should receive typespecific serologic testing for HSV infection. Genital Warts Human Papilloma Virus Type 6 and 11: Flat, papular growths on the genital mucosa Majority of infections are asymptomatic External genital warts: Podofilox 0.5% solution or gel, applied BID for 3 days, followed by 4 days of no therapy. This cycle may be repeated up to 4 times; or Imiquimod 5% cream, applied at bedtime, 3 times per week for up to 16 weeks. Examination to assess the presence of genital warts Syphilis Systemic disease caused by T. pallidum Primary infection: ulcer or chancre at infection site Secondary infection: skin rash, mucocutaneous lesions, or swelling of lymph nodes Tertiary infection: cardiac or ophthalmic complications, auditory abnormalities, or gummatous lesions Latent infection: positive serologic tests without clinical symptoms Neurosyphilis: cognitive dysfunction, motor or sensory deficits, ophthalmic or auditory symptoms, cranial nerve palsies, and signs or symptoms of meningitis Primary and secondary syphilis: Benzathine penicillin G 2.4 million units IM in a single dose Tertiary syphilis: Benzathine penicillin G 7.2 million units, divided into 3 doses of 2.4 million units IM, each administered at 1- week intervals Early latent syphilis without CSF involvement: Benzathine penicillin G 2.4 million units IM in a single dose Late latent syphilis or latent syphilis of unknown duration: Same regimen as tertiary syphilis Neurosyphilis: Aqueous crystalline penicillin G million units IV per day, administered in 3 divided doses every 4 hours or continuous infusion, for days Treat presumptively if sexual contact occurred within 90 days of diagnosis of primary, secondary, or early latent syphilis. Treat presumptively when sexual contact occurred > 90 days of diagnosis of primary, secondary, or early latent syphilis and serologic tests are not available immediately or opportunity for follow-up is uncertain. Chancroid H. ducreyi infection Painful genital ulcer, negative HSV test and no evidence of T.pallidum in ulcer exudate, swelling of the glands or lymph nodes in the groin region Ceftriaxone 250 mg IM in a single dose; or Ciprofloxacin 500 mg PO BID for 3 days; or Erythromycin base 500 mg PO TID for 7 days Treat if sexual contact occurred within 10 days of onset of symptoms in partner. Nongonococcal Urethritis C. trachomatis, U. urealyticum, or M. genitalium infection Urethral inflammation, mucopurulent or purulent discharge, painful urination, or urethral itching Asymtomatic infections are common Nongonococcal urethritis: Doxycycline 100 mg PO BID for 7 days Recurrent and persistent urethritis: Metronidazole 2 g PO in a single dose + azithromycin 1 g PO in a single dose Evaluate and treat if sexual contact occurred within 60 days preceding diagnosis in partner. Testing for gonorrhea and chlamydia is encouraged. Cervicitis Typically C. trachomatic or N. gonnorhoeae infection; however, in a majority of cases no organism is isolated Purulent or mucopurulent cervical discharge, and intermenstrual vaginal bleeding Presumptive treatment: Doxycycline 100 mg PO BID for 7 days Test for gonorrhea, chlamydia, and trichomoniasis and treat accordingly if infection is present. Partner and patient should refrain from sexual intercourse for 7 days. 4

5 Chlamydia C. trachomatis infection Asymptomatic infections are common in males and females Sequelae include pelvic inflammatory disease, ectopic pregnancy, and infertility Doxycycline 100 mg PO BID for 7 days Evaluate and treat if sexual contact occurred within 60 days preceding onset of symptoms and diagnosis. If sexual contact occurred >60 days prior to onset of symptoms and diagnosis, treat only recent partner. Gonococcal Infections N. gonnorhoeae infection Asymptomatic infections are common among women Uncomplicated gonococcal infections of the cervix, urethra, and rectum*: Ceftriaxone 125 mg IM in a single dose; or Cefixime 400 mg PO in a single dose; or Ciprofloxacin 500 mg PO in a single dose; or Ofloxacin 400 mg PO in a single dose; or Levofloxacin 250 mg PO in a single dose Uncomplicated gonococcal infection of the pharynx*: Ceftriaxone 125 mg IM in a single dose; or Ciprofloxacin 500 mg in a single dose *If chlamydial infection is not ruled out, all regimens should include concomitant treatment for chlamydia. Gonococcal conjunctivitis: Ceftriaxone 1 g IM in a single dose Gonococcal bacteremia: Ceftriaxone 1 g IM or IV every 24 hours, up to 48 hours after improvement begins. Therapy may be switched to one of the following regimens to complete 1 week of antibiotic treatment: Cefixime 400 mg PO BID; or Ciprofloxacin 500 mg PO BID; or Ofloxacin 400 mg PO BID; or Levofloxacin 500 mg PO daily Gonococcal meningitis: Ceftriaxone 1-2 g IV Q12 for days Gonococcal endocarditis: Ceftriaxone 1-2 g IV Q12 for 4 weeks Evaluate and treat for gonorrhea and chlamydia if sexual contact occurred within 60 days preceding onset of symptoms and diagnosis. Always treat most recent partner, even if sexual contact occurred > 60 days preceding onset of symptoms Bacterial Vaginosis Thin, white vaginal discharge with a fishy odor Metronidazole 500 mg PO BID for 7 days; or Metronidazole gel, 0.75%, one full applicator (5 g) intravaginally, once daily for 5 days; or Clindamycin cream, 2%, one full applicator (5 g) intravaginally daily at bedtime for 7 days Treatment not recommended. Trichomoniasis T. vaginalis infection Females: may be asymptomatic or present with diffuse, foul-smelling, yellow-green vaginal discharge with vulvar irritation Males: may be asymptomatic or present with urethral inflammation, mucopurulent or purulent discharge, painful urination, or urethral itching Metronidazole 2 g PO in a single dose Treat with either of the above regimens. Instruct patient and partner to avoid sexual intercourse until therapy is completed or symptoms are resolved. Pelvic Inflammatory Disease Infection may be caused by any one of the following organisms: N. gonorrhoeae, C. trachomatis, G. vaginalis, H. influenzae, S. agalactiae, cytomegalovirus, M. hominis, U. urealyticum, or M. genitalium Abnormal bleeding, pelvic or lower abdominal pain, painful sexual intercourse, abnormal vaginal discharge, and fever Women may also be asymptomatic Parenteral Treatment: Cefotetan 2 g IV Q12 for 24 hours + doxycycline 100 mg PO or IV Q12 for 14 days; or Ceftoxitin 2 g IV Q6 for 24 hours + doxycycline 100 mg PO or IV Q12 for 14 days; or Oral Treatment: Levofloxacin 500 mg PO daily for 14 days + metronidazole 500 mg PO BID for 14 days; or Ofloxacin 400 mg PO BID for 14 days + metronidazole 500 mg PO BID for 14 days Treat if sexual contact occurred within 60 days preceding the onset of symptoms Reference: Centers for Disease Control and Prevention; Sexually transmitted diseases treatment guidelines: MMWR Recomm Rep 2006;55:

6 P&T Committee Formulary Action Additions Sildenafil - Restricted to treatment of pulmonary hypertension Deletions Varicella Zoster Immuneglobulin Diatrizoate meglumine (Hypaque) Triamcinolone diacetate (Aristocort) Papain-urea-chlorophyllin copper complex (Panafil) topical spray Authors: Megan Szmajda, PharmD candidate, class of 2008; Lauryn Tierney, PharmD candidate, class of 2008 Editor: Maria G. Tanzi, PharmD 6