This issue includes reviews of drugs for glaucoma, age-related macular degeneration (AMD), bacterial conjunctivitis, and dry eye disease. Allergic conjunctivitis is reviewed in a separate issue.

Patients who receive pretravel advice can reduce their risk for many travel-related conditions. Vaccines recommended for travelers are reviewed in a separate issue.

View the Expanded Table: Antibiotics for Travelers' Diarrhea

The FDA has approved rifamycin (Aemcolo – Cosmo/ Aries), a minimally absorbed oral antibiotic, for treatment of adults with travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli. It is not recommended for treatment of diarrhea that is complicated by fever and/or bloody stools. Topical and injectable formulations of rifamycin have been used in Europe for other indications for many years.

The FDA has approved a 6% otic suspension formulation of the fluoroquinolone antibiotic ciprofloxacin (Otiprio – Otonomy) for single-dose treatment of acute otitis externa (swimmer's ear) caused by Pseudomonas aeruginosa or Staphylococcus aureus in patients ≥6 months old. Otiprio was approved earlier for prophylaxis in children with bilateral otitis media with effusion who are undergoing tympanostomy tube placement.

The text and tables that follow include recommendations for management of sexually transmitted infections (STIs) other than HIV and viral hepatitis. Some of the indications and dosages recommended here have not been approved by the FDA.

The FDA has approved Otovel (Arbor), a combination of the fluoroquinolone antibiotic ciprofloxacin 0.3% and the corticosteroid fluocinolone acetonide 0.025%, for otic treatment of acute otitis media with tympanostomy tubes (AOMT) in children ≥6 months old. It is the second fluoroquinolone/corticosteroid combination to be approved for this indication; ciprofloxacin 0.3%/dexamethasone 0.1% (Ciprodex) has been available for many years. In December 2015, a suspension of ciprofloxacin 6% (Otiprio) was approved for otic treatment of bilateral otitis media with effusion in children undergoing tympanostomy tube placement.

The FDA has announced that it is requiring changes in the labeling of systemic fluoroquinolones to warn that the risk of serious adverse effects, including tendinitis, peripheral neuropathy and CNS effects, generally outweighs their benefit for the treatment of acute sinusitis, acute exacerbations of chronic bronchitis, and uncomplicated urinary tract infections. For these infections, the new labels will recommend reserving fluoroquinolones for patients with no other treatment options.

The FDA has approved ciprofloxacin 6% otic suspension (Otiprio – Otonomy) for single-dose prophylaxis in children with bilateral otitis media with effusion who are undergoing tympanostomy tube placement. It is the first drug to be approved for this indication in the US. Otic formulations of the fluoroquinolone antibiotics ofloxacin (Floxin Otic, and generics) and ciprofloxacin (plus dexamethasone; Ciprodex) have been available for years for treatment of acute otitis media in children with tympanostomy tubes; an otic suspension containing ciprofloxacin and fluocinolone acetonide (Otovel) has recently been approved for the same indication and will be reviewed in a future issue.

The FDA is requiring new warnings about peripheral neuropathy in the labeling of all oral and injectable fluoroquinolones. The potential for this class of antibiotics to cause peripheral neuropathy was first identified more than 10 years ago and a warning was added to their labels in 2004. The new warnings are based on a recent review of the FDA’s Adverse Event Reporting System (AERS) database.1

The onset of peripheral neuropathy can occur rapidly, often within a few days of starting a fluoroquinolone, and in some patients the disorder may be permanent. Symptoms include pain, tingling, burning, numbness, weakness, and change in sensation to touch, pain, and temperature in the arms and/or legs. If peripheral neuropathy develops in a patient taking a fluoroquinolone, the drug should be stopped and an antibacterial from a different class should be used instead.2

1. FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection. Available at http://www.fda.gov. Accessed November 1, 2013.

2. Drugs for bacterial infections. Treat Guidel Med Lett 2013; 11:65.

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The text that follows reviews some common bacterial infections and their empiric treatment pending the results of culture and susceptibility testing. The recommendations made here are based on the results of susceptibility studies, clinical trials, and the opinions of Medical Letter reviewers. Tables 1 and 2 list the usual dosages of antibacterial drugs.

Drugs for glaucoma, age-related macular degeneration, bacterial conjunctivitis, and dry eyes are reviewed here. Drugs for the treatment of allergic conjunctivitis will be reviewed in a future issue of Treatment Guidelines on Drugs for Allergic Disorders.

Antimicrobial prophylaxis can decrease the incidence of postoperative infection, particularly surgical site infection, after some procedures. Recommendations for such prophylaxis are listed in the table that begins on page 74. Antimicrobial prophylaxis for dental procedures to prevent endocarditis was recently discussed in The Medical Letter.

Patients planning to travel to other countries often ask for information about appropriate vaccines and prevention of diarrhea and malaria. More detailed advice for travelers is available from the Centers for Disease Control and Prevention (CDC) at www.cdc.gov/travel. Guidelines are also available from the Infectious Diseases Society of America (IDSA).

A Medical Letter reader has asked us to review the safety of the fluoroquinolone antibiotic levofloxacin (Levaquin – Ortho-McNeil-Janssen), which has just been approved for generic use by the FDA and has been at the center of some recent lawsuits regarding the adequacy of its safety warnings.

Many infections can be transmitted during sexual contact. The text and tables that follow are limited to management of sexually transmitted infections (STIs) other than HIV, viral hepatitis and enteric infections. The drugs of choice, their dosages and alternatives are listed in a table that begins on page 54. A table listing the adverse effects of some of these antimicrobials begins on page 58.

The text below reviews some common bacterial infections and their treatment. The recommendations made here are based on the results of susceptibility studies, clinical trials and the opinions of Medical Letter consultants.

Drugs for glaucoma, age-related macular degeneration, bacterial conjunctivitis, and dry eyes are reviewed here. Ophthalmic drugs can have local and systemic adverse effects. In addition, for some elderly patients, the complexity of self-administering numerous ophthalmic drugs may be the limiting factor in their ability to care for themselves. Drugs for the treatment of allergic conjunctivitis will be reviewed in a future issue of Treatment Guidelines on Drugs for Allergic Disorders.

The FDA has approved the fluoroquinolone besifloxacin 0.6% ophthalmic suspension (Besivance - Bausch & Lomb) for treatment of bacterial conjunctivitis caused by susceptible bacteria. According to the manufacturer, this product was developed specifically for ophthalmic use in a specialized vehicle designed to prolong contact time on the ocular surface. Besifloxacin is not available for systemic use.

Patients planning to travel to other countries often ask physicians for information about appropriate vaccines and prevention of diarrhea and malaria. Guidelines are also available from the Infectious Diseases Society of America (IDSA).

Antimicrobial prophylaxis can decrease the incidence of infection, particularly surgical site infection, after certain procedures. Recommendations for prevention of surgical site infection are listed in the table that begins on page 48. Antimicrobial prophylaxis for dental procedures to prevent endocarditis is discussed in The Medical Letter 2007; 49:99.

The FDA has added a boxed warning to fluoroquinolone package inserts about tendon injuries that may occur as a result of their use. Tendinitis or tendon rupture may occur rarely with systemic use of any fluoroquinolone, either while the drug is being taken or for up to several months afterwards.

Fluoroquinolone-related tendon injury is rare; estimates for its incidence in the general population range from 0.14% to 0.4%. The risk is higher for patients >60 years old and for those taking corticosteroids. For patients with organ transplants, the incidence may be as high as 15%.1 A case-control study in Italy involving 22,194 cases of non-traumatic tendinitis and 104,906 controls found that fluoroquinolone use was significantly associated with tendon disorders in general (OR 1.7; 95% CI 1.4-2.0), tendon rupture (OR 1.3; 95% CI 1.0-1.8), and Achilles tendon rupture (OR 4.1; 95% CI 1.8-9.6). Achilles tendon rupture occurred with fluoroquinolone treatment in one of every 5989 patients in general and in one of every 1638 patients >60 years old.2

Widespread use of fluoroquinolones, particularly for treatment of respiratory infections, has produced substantial bacterial resistance to this class of drugs and has been associated with an increase in the incidence and severity of Clostridium difficile disease.3 Even when bacterial pneumonia is considered a likely possibility, other drugs are generally preferred, at least in non-elderly, otherwise healthy patients.4

1. F Muzi et al. Fluoroquinolones-induced tendinitis and tendon rupture in kidney transplant recipients: 2 cases and a review of the literature.Transplant Proc 2007; 39:1673.
2. G Corrao et al. Evidence of tendinitis provoked by fluoroquinolone treatment: a case-control study. Drug Saf 2006; 29:889.
3. Treatment of Clostridium difficile-associated disease (CDAD). Med Lett Drugs Ther 2006; 48:89.
4. Drugs for community-acquired bacterial pneumonia. Med Lett Drugs Ther 2007; 49:62.

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The most common cause of travelers' diarrhea, usually a self-limited illness without fever lasting several days, is infection with noninvasive enterotoxigenic (ETEC) or enteroaggregative (EAEC) strains of Escherichia coli. Campylobacter, Shigella, Salmonella, Aeromonas, viruses and parasites are less common.

Many infections can be transmitted during sexual contact. The text and tables that follow are limited to management of sexually transmitted infections (STIs) other than HIV, viral hepatitis and enteric infections. Guidelines are available from the US Centers for Disease Control and Prevention (CDC) with detailed recommendations for treatment of these diseases.

Information about empirical treatment of bacterial infections, emerging trends in antimicrobial resistance, new drugs and new data about older drugs continue to become available. Usual pathogens and empiric treatment for some common types of infections are summarized in the text and a table listing the drugs of choice and alternatives for each pathogen begins on page 40. The recommendations made here are based on the results of susceptibility studies, clinical trials and the opinions of Medical Letter consultants.

Antimicrobial prophylaxis can decrease the incidence of infection, particularly surgical site infection, after certain procedures. Recommendations for prevention of surgical site infection are listed in this article.

Tuberculosis (TB) is still a problem in the United States, even though the incidence continues to decline in most of the country (MMWR Morbid Mortal Wkly Rep 2004; 53:209). Treatment of TB can be divided into treatment of latent infection diagnosed by a positive PPD and treatment of active clinical TB. Guidelines with detailed management recommendations are available from the US Centers for Disease Control and Prevention (CDC) (MMWR Morbid Mortal Wkly Rep 2003; 52RR-11:1).

Many infections can be transmitted during sexual contact. The text and tables that follow are limited to management of sexually transmitted infections (STIs) other than HIV, viral hepatitis and enteric infections. Guidelines are available from the US Centers for Disease Control and Prevention (CDC) with detailed recommendations for treatment of these diseases (MMWR Recomm Rep 2002; 51, RR-6:1). New guidelines are expected soon.

Rifaximin (Xifaxan - Salix), a non-absorbed oral antibiotic derived from rifampin (Rifadin, and others), has been approved by the FDA for treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in patients 12 years of age or older. It has been available in Europe since 1987.

Patients planning to travel to other countries often ask physicians for advice about immunizations and prevention of diarrhea and malaria. More detailed advice for travelers is available from the Centers for Disease Control (CDC) at 877-FYI-TRIP (877-394-8747) or www.cdc.gov/travel. Recommendations for the treatment of parasitic diseases are available in the public reading room of The Medical Letter's web site.

Antimicrobial prophylaxis can decrease the incidence of infection, particularly surgical site infection, after certain operations, but this benefit must be weighed against the risks of toxic and allergic reactions, emergence of resistant bacteria, adverse drug interactions, superinfection and cost. Medical Letter consultants generally recommend antimicrobial prophylaxis only for procedures with high infection rates, those involving implantation of prosthetic material, and those in which the consequences of infection are likely to be especially serious.

Two new fluoroquinolone solutions, moxifloxacin 0.5% (Vigamox - Alcon) and gatifloxacin 0.3% (Zymar - Allergan) are now available in the US for ophthalmic use in treatment of bacterial conjunctivitis.

New drugs for bacterial infections and new information about older drugs continue to become available. Empirical treatment of some common bacterial infections is discussed in this article. A table listing the drugs of choice and alternatives for each pathogen begins on page 18. These recommendations are based on results of susceptibility studies, clinical trials and the opinions of Medical Letter consultants. Local resistance patterns should be taken into account. Trade names are listed on page 24.

Recently pharmaceutical manufacturers have marketed a stereoisomer of a successful drug nearing patent expiration as a new drug. Examples, such as esomeprazole (Nexium) , levalbuterol (Xopenex), escitalopram (Lexapro) and dexmethylphenidate

Patients planning to travel to other countries often ask physicians for advice about immunizations and prevention of diarrhea and malaria. More detailed advice for travelers is available from the CDC at 877-FYI-TRIP (877-394-8747) or www.cdc.gov/travel.

Superseded by Handbook of Antimicrobial Therapy
The Medical Letter article on Drugs and Vaccines against Biological Weapons, published in the previous issue (October 15, 2001, page 87), included a brief discussion of post-exposure prophylaxis of inhalation anthrax. Recent events call for more detail.

Many infections can be transmitted during sexual contact. The text and tables [in this article] are limited to treatment of non-HIV infections associated primarily with sexual transmission.

Patients planning to travel to other countries often ask pysicians for advice about immunizations and prevention of diarrhea and malaria. Legal requirements for entry and epidemiological conditions in different countries vary from time to time, often unpredictably, but some reasonable recommendations can be made.

Trovafloxacin (Trovan - Pfizer) and its prodrug alatrofoxacin (Trovan IV) are new fluroroquinolones marketed for an unusually wide variety of infections, including oral and intravenous treatment of nosocomial and community-acquired pneumonia, acute ecerbations of chronic bronchitis, acute sinusitis, complicate intra-abdominal and pelvic infections, diabetic foot infection, uncomplicated urinary tract infection, prostatitis, cervicitis and uncomplicated gonorrhea.

Grepafloxacin (Raxar - Glaxo Wellcome), a once-daily oral fluoroquinolone, is now being marketed for treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, uncomplicated gonorrhea, and nongonococcal urethritis and cervicitis.

Fosfomycin, a broad-spectrum antibiotic used parenterally in Europe for many years, has been approved by the US Food and Drug Administration (FDA) as fosfomycin tromethamine (Monurol - Forest) for single-dose oral treatment of uncomplicated urinary tract infections in women.

Sparfloxacin (Zagam - Rh ne-Poulenc Rorer) and levofloxacin (Levaquin - Ortho-McNeil) are the newest fluoroquinolone antimicrobials to be approved by the US Food and Drug Administration. Sparfloxacin in a once-daily oral preparation is being marketed for treatment of community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis. Levofloxacin, which is the active stereoisomer of ofloxacin (Floxin), is available for either oral or parenteral use; it is approved for oncedaily treatment of community-acquired pneumonia, acute exacerbations of chronic bronchitis, sinusitis, skin and skin structure infections and complicated urinary tract infections.

Patients planning to travel to other countries often ask physicians for advice about immunizations and prevention of diarrhea and malaria. More detailed advice for travelers is available from the CDC at 877-FYI-TRIP (877-394-8747) or www.cdc.gov/travel.

Tuberculosis (TB) continues to be a major problem in the United States, particularly in areas where drug resistance is common (Morbid Mortal Weekly Rep, 44:387, May 26, 1995). Since poor compliance is the most important cause of treatment failure and is associated with emergence of drug resistence, some experts now recommend that all patients take drugs for TB under direct observation (SE Weis et al, N Engl J Med, 330:1179, 1994; R Bayer and D Wilkinson, Lancet, 345:1545, June 17, 1995).

The rising incidence of tuberculosis (TB) has been accompanied by a dramatic increase in drug resistance in some areas of the USA (TR Frieden et al, N Engl J Med, 328:521, 1993). Since poor compliance is the most important cause of treatment failure and associated with emergence of drug resistance, some experts now recommend that patients with TB take their drugs under direct obeservation (MD Iseman et al, N Engl J Med, 329:576, 1993).

Cefpodoxime proxetil (Vantin - Upjohn), a new third-generation oral cephalosporin, has been approved for marketing by the US Food and Drug Administration. It is available for twice-daily treatment of pharyngitis, upper and lower respiratory infections, otitis media, urinary tract infections, skin and soft tissue infections, and for single-dose treatment of uncomplicated gonorrhea in men or women and anorectal gonorrhea in women.

Enoxacin (en ox' a sin; Penetrex - Rh ne-Poulenc Rorer), a fluoroquinolone antimicrobial for oral use, has now been marketed in the USA for treatment of urinary tract infections and uncomplicated urethral or cervical gonorrhea.

Temafloxacin (Omniflox - Abbott) and lomefloxacin (Maxaquin - Searle) are the latest fluoroquinolone antimicrobial agents to be approved by the US Food and Drug Administration (FDA) for oral treatment of various infections. Previously marketed include norfloxacin (Noroxin - Medical Letter, 29:25, 1987), ciprofloxacin (Cipro - Medical Letter, 30:11, 1988), and ofloxacin (Floxin - Medical Letter, 33:71, 1991). Norfloxacin is marketed only for treatment of urinary tract infections, and lomefloxacin only for treatment of urinary tract infections and bronchitis known to be caused by Haemophilus influenzae or Moraxella catarrhalis. Ciprofloxacin and ofloxacin are also available in parenteral formulations.

After many years of decline in the USA, the incidence of tuberculosis (TB) has recently increased, partly because the disease occurs more frequently in patients with human immunodeficiency virus (HIV) infection and in the homeless (PF Barnes et al, N Engl J Med, 324:1644, 1991; Morbid Mortal Weekly Rep, 40:869, Dec 20, 1991).

Ofloxacin (Floxin - McNeil, Ortho), a new fluoroquinolone antibacterial agent, was recently marketed in the USA for oral treatment of various infections caused by susceptible microorganisms. Ofloxacin is the third fluoroquinolone to become available in this country. Norfloxacin (Noroxin - Medical Letter, 29:25, 1987) is marketed only for treatment of urinary tract infections. Ciprofloxacin (Cipro - Medical Letter, 30:11, 1988), like ofloxacin, is approved for use in a variety of infections.