Moxifloxacin Hydrochloride and Prefest

• Generic Name: moxifloxacin
• Dosage Forms: n.a.
• Other Brand Names: Avelox, Avelox IV

Treatment of acute bacterial sinusitis caused by susceptible Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.

Treatment of acute bacterial exacerbations of chronic bronchitis caused by susceptible S. pneumoniae, H. influenzae, H. parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or M. catarrhalis.

Use for treatment of acute bacterial sinusitis or acute bacterial exacerbations of chronic bronchitis only when no other treatment options available. Because systemic fluoroquinolones, including moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient and because acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis may be self-limiting in some patients, risks of serious adverse reactions outweigh benefits of fluoroquinolones for patients with these infections.

Treatment of community-acquired pneumonia (CAP) caused by susceptible S. pneumoniae (including multidrug-resistant strains; MDRSP), S. aureus (methicillin-susceptible [oxacillin-susceptible] strains), K. pneumoniae, H. influenzae, M. catarrhalis, Mycoplasma pneumoniae, or Chlamydophila pneumoniae (formerly Chlamydia pneumoniae). Select regimen for empiric treatment of CAP based on most likely pathogens and local susceptibility patterns; after pathogen is identified, modify to provide more specific therapy (pathogen-directed therapy).

Has been used for treatment of nosocomial pneumonia. Select regimen for empiric treatment of hospital-acquired pneumonia (HAP) not associated with mechanical ventilation or ventilator-associated pneumonia (VAP) based on local susceptibility data. If a fluoroquinolone used for initial empiric treatment of HAP or VAP, IDSA and ATS recommend ciprofloxacin or levofloxacin.

Skin and Skin Structure Infections

Treatment of uncomplicated skin and skin structure infections (abscesses, furuncles, cellulitis, impetigo) caused by susceptible S. aureus (methicillin-susceptible [oxacillin-susceptible] strains) or S. pyogenes (group A β-hemolytic streptococci).

Treatment of complicated skin and skin structure infections caused by susceptible S. aureus (oxacillin-susceptible strains), Escherichia coli, K. pneumoniae, or Enterobacter cloacae.

Intra-abdominal Infections

Treatment of complicated intra-abdominal infections (including polymicrobial infections such as abscess) caused by susceptible Bacteroides fragilis, B. thetaiotaomicron, Clostridium perfringens, Enterococcus faecalis, E. coli, Proteus mirabilis, S. anginosus, S. constellatus, or Peptostreptococcus.

Has been recommended as one of several options for initial empiric treatment of mild to moderate, community-acquired intra-abdominal infections. IDSA states avoid moxifloxacin in patients who received a quinolone within the past 3 months and are likely to harbor B. fragilis since such strains likely to be resistant to the drug.

Endocarditis

Alternative for treatment of endocarditis (native or prosthetic valve or other prosthetic material) caused by fastidious gram-negative bacilli known as the HACEK group (Haemophilus, Aggregatibacter, Cardiobacterium hominis, Eikenella corrodens, Kingella). AHA and IDSA recommend ceftriaxone (or other third or fourth generation cephalosporin), but state that a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) may be considered in patients who cannot tolerate cephalosporins. Consultation with an infectious disease specialist recommended.

GI Infections

Alternative for treatment of campylobacteriosis caused by susceptible Campylobacter. Optimal treatment of campylobacteriosis in HIV-infected patients not identified. Some clinicians withhold anti-infective treatment in those with CD4+ T-cell counts >200 cells/mm3 and mild campylobacteriosis and initiate treatment if symptoms persist for more than several days. In those with mild to moderate campylobacteriosis, treatment with a fluoroquinolone (preferably ciprofloxacin or, alternatively, levofloxacin or moxifloxacin) or azithromycin is reasonable. Modify anti-infective treatment based on results of in vitro susceptibility; resistance to fluoroquinolones reported in 22% of C. jejuni and 35% of C. coli isolates tested in the US.

Treatment of Salmonella gastroenteritis. CDC, NIH, and HIV Medicine Association of IDSA recommend ciprofloxacin as initial drug of choice for treatment of Salmonella gastroenteritis (with or without bacteremia) in HIV-infected adults; other fluoroquinolones (levofloxacin, moxifloxacin) also likely to be effective, but data limited. Depending on in vitro susceptibility, alternatives are co-trimoxazole and third generation cephalosporins (ceftriaxone, cefotaxime). Role of long-term anti-infective treatment (secondary prophylaxis) against Salmonella in HIV-infected individuals with recurrent bacteremia or gastritis not well established; weigh benefits of such prophylaxis against risks of long-term anti-infective therapy.

Treatment of shigellosis caused by susceptible Shigella. Anti-infectives may not be required for mild infections, but generally indicated in addition to fluid and electrolyte replacement for treatment of patients with severe shigellosis, dysentery, or underlying immunosuppression. Empiric treatment regimen can be used initially, but in vitro susceptibility testing indicated since resistance is common. Fluoroquinolones (preferably ciprofloxacin or, alternatively, levofloxacin or moxifloxacin) have been recommended for treatment of shigellosis in HIV-infected adults, but consider that fluoroquinolone-resistant Shigella reported in the US, especially in international travelers, the homeless, and men who have sex with men (MSM). Depending on in vitro susceptibility, other drugs recommended for treatment of shigellosis include co-trimoxazole, ceftriaxone, azithromycin (not recommended in those with bacteremia), or ampicillin.

Anthrax

Alternative for postexposure prophylaxis of anthrax following suspected or confirmed exposure to aerosolized Bacillus anthracis spores (inhalational anthrax). CDC, AAP, US Working Group on Civilian Biodefense, and US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommend oral ciprofloxacin and oral doxycycline as initial drugs of choice for prophylaxis following such exposures, including exposures that occur in the context of biologic warfare or bioterrorism. Other oral fluoroquinolones (levofloxacin, moxifloxacin, ofloxacin) are alternatives when ciprofloxacin or doxycycline cannot be used.

Treatment of uncomplicated cutaneous anthrax (without systemic involvement) that occurs in the context of biologic warfare or bioterrorism. CDC states that preferred drugs for such infections include ciprofloxacin, doxycycline, levofloxacin, or moxifloxacin.

Alternative to ciprofloxacin for use in multiple-drug parenteral regimen for initial treatment of systemic anthrax (inhalational, GI, meningitis, or cutaneous with systemic involvement, head or neck lesions, or extensive edema) that occurs in the context of biologic warfare or bioterrorism. For initial treatment of systemic anthrax with possible or confirmed meningitis, CDC and AAP recommend a regimen of IV ciprofloxacin in conjunction with another IV bactericidal anti-infective (preferably meropenem) and an IV protein synthesis inhibitor (preferably linezolid). If meningitis excluded, these experts recommend an initial regimen of IV ciprofloxacin in conjunction with an IV protein synthesis inhibitor (preferably clindamycin or linezolid).

Has been suggested as possible alternative to ciprofloxacin for treatment of inhalational anthrax when a parenteral regimen not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).

Meningitis and Other CNS Infections

Alternative for treatment of meningitis caused by certain susceptible gram-positive bacteria (e.g., S. pneumoniae). Fluoroquinolones have been recommended as alternatives for treatment of meningitis caused by some gram-negative bacteria (e.g., Neisseria meningitidis, H. influenzae, E. coli, Ps. aeruginosa).

Limited data from animal studies indicate moxifloxacin has been effective for treatment of experimental meningitis caused by S. pneumoniae or E. coli. Fluoroquinolones (ciprofloxacin, moxifloxacin) should be considered for treatment of meningitis only when the infection is caused by multidrug-resistant gram-negative bacilli or when the usually recommended anti-infectives cannot be used or have been ineffective.

Tuberculosis

Alternative (second-line) agent for use in multiple-drug regimens for treatment of active tuberculosis caused by Mycobacterium tuberculosis.

Although potential role of fluoroquinolones and optimal length of therapy not fully defined, ATS, CDC, IDSA, and others state that use of fluoroquinolones as alternative (second-line) agents can be considered for treatment of active tuberculosis in patients intolerant to certain first-line agents and in those with relapse, treatment failure, or M. tuberculosis resistant to certain first-line agents. If a fluoroquinolone used in multiple-drug regimens for treatment of active tuberculosis, ATS, CDC, IDSA, and others recommend levofloxacin or moxifloxacin.

Consider that fluoroquinolone-resistant M. tuberculosis reported and there are increasing reports of extensively drug-resistant tuberculosis (XDR tuberculosis). XDR tuberculosis is caused by M. tuberculosis resistant to rifampin and isoniazid (multiple-drug resistant strains) that also are resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial (capreomycin, kanamycin, amikacin).

Consult most recent ATS, CDC, and IDSA recommendations for treatment of tuberculosis and other mycobacterial infections for more specific information.

Other Mycobacterial Infections

Has been used in multiple-drug regimens for treatment of disseminated infections caused by Mycobacterium avium complex (MAC). ATS and IDSA state that role of fluoroquinolones in treatment of MAC infections not established. If a fluoroquinolone is included in treatment regimen (e.g., for macrolide-resistant MAC infections), moxifloxacin or levofloxacin may be preferred, although many strains are resistant in vitro. Treatment of MAC infections is complicated and should be directed by clinicians familiar with mycobacterial diseases; consultation with a specialist is particularly important when the patient cannot tolerate first-line drugs or when the infection has not responded to prior therapy or is caused by macrolide-resistant MAC.

Treatment of M. kansasii infections in conjunction with other antimycobacterials. ATS and IDSA recommend a multiple-drug regimen of isoniazid, rifampin, and ethambutol for treatment of pulmonary or disseminated infections caused by M. kansasii. If rifampin-resistant M. kansasii are involved, ATS and IDSA recommend a 3-drug regimen based on results of in vitro susceptibility testing, including clarithromycin (or azithromycin), moxifloxacin, ethambutol, sulfamethoxazole, or streptomycin.

Consult most recent ATS, CDC, and IDSA recommendations for treatment of other mycobacterial infections for more specific information.

Nongonococcal Urethritis

Alternative for treatment of nongonococcal urethritis (NGU). CDC recommends azithromycin or doxycycline; alternatives are erythromycin, levofloxacin, or ofloxacin. For persistent or recurrent NGU in men compliant with previous treatment who have not been reexposed to an untreated sexual partner(s), CDC recommends that those initially treated with azithromycin be retreated with moxifloxacin.

Plague

Treatment of plague, including pneumonic and septicemic plague, caused by Yersinia pestis. Streptomycin (or gentamicin) historically has been considered regimen of choice for treatment of plague; alternatives are doxycycline (or tetracycline), chloramphenicol (a drug of choice for plague meningitis), fluoroquinolones (ciprofloxacin [a drug of choice for plague meningitis], levofloxacin, moxifloxacin), or co-trimoxazole (may be less effective than other alternatives). Regimens recommended for treatment of naturally occurring or endemic bubonic, septicemic, or pneumonic plague also recommended for plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism.

Postexposure prophylaxis following high-risk exposure to Y. pestis (e.g., household, hospital, or other close contact with an individual who has pneumonic plague; laboratory exposure to viable Y. pestis; confirmed exposure in the context of biologic warfare or bioterrorism). Drugs of choice for such prophylaxis are doxycycline (or tetracycline) or a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin).

• Generic Name: estradiol / norgestimate
• Dosage Forms: tablets
• Other Brand Names: Prefest, Ortho-Prefest

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Norgestimate is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Prefest is a combination medicine used to treat menopause symptoms such as hot flashes and vaginal changes, and to prevent osteoporosis (bone loss) in menopausal women.

Prefest may also be used for purposes not listed in this medication guide.