Fluoroquinolones

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Oral:
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DOSAGE AND ADMINISTRATION - ADULTS
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.

The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.

The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx ®* (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.

Conversion of I.V. to Oral Dosing in Adults

Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (see CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).

Adults with Impaired Renal Function

Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternate pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:

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Adults: I.V.:
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Bone/joint infections:
Mild to moderate: 400 mg every 12 hours for 4-6 weeks
Severe or complicated: 400 mg every 8 hours for 4-6 weeks
Lower respiratory tract, skin/skin structure infections:
Mild to moderate: 400 mg every 12 hours for 7-14 days
Severe or complicated: 400 mg every 8 hours for 7-14 days
Febrile neutropenia (with piperacillin): 400 mg every 8 hours for 7-14 days
Intra-abdominal infection (with metronidazole): 400 mg every 12 hours for 7-14 days
Nosocomial pneumonia (mild to moderate to severe): 400 mg every 8 hours for 10-14 days
Prostatitis (chronic, bacterial): 400 mg every 12 hours for 28 days
Sinusitis (acute): 400 mg every 12 hours for 10 days
Urinary tract infection:
Mild to moderate: 200 mg every 12 hours for 7-14 days
Severe or complicated: 400 mg every 12 hours for 7-14 days

Elderly: No adjustment needed in patients with normal renal function

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Renal Dosing:
[CRCL >30 ]: no changes .
[5-30 ]: (IV): 200-400mg q18-24h or give 200mg q12h.
(Oral): 250 q12h or, 250-500mg q18 to 24 hours.

Hemodialysis: (IV): 200-400mg q24h or 200mg q12h. Schedule dose after dialysis on dialysis days. (Oral): 250mg q12h or 250-500mg q24h. Schedule dose after dialysis on dialysis days.

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SUPPLIED
Infusion, [premixed in D5W] (Cipro®): 200 mg (100 mL); 400 mg (200 mL) [latex free]
Injection, solution (Cipro®): 10 mg/mL (20 mL, 40 mL, 120 mL)
Microcapsules for oral suspension (Cipro®): 250 mg/5 mL (100 mL); 500 mg/5 mL (100 mL)
Tablet [film coated]: 250 mg, 500 mg, 750 mg
Cipro®: 100 mg, 250 mg, 500 mg, 750 mg

Tablet, extended release [film coated] (Cipro® XR): 500 mg [equivalent to ciprofloxacin hydrochloride 287.5 mg and ciprofloxacin base 212.6 mg]; 1000 mg [equivalent to ciprofloxacin hydrochloride 574.9 mg and ciprofloxacin base 425.2 mg]

Dosing (Adults):
Oral, I.V.:
Note: Sequential therapy (intravenous to oral) may be instituted based on prescriber's discretion.
Chronic bronchitis (acute bacterial exacerbation): 500 mg every 24 hours for at least 7 days

 Inhalational anthrax: 500 mg every 24 hours for 60 days, beginning as soon as possible after exposure
Maxillary sinusitis (acute): 500 mg every 24 hours for 10-14 days

Pneumonia:
Community-acquired: 500 mg every 24 hours for 7-14 days or 750 mg every 24 hours for 5 days (efficacy of 5-day regimen for MDRSP not established)
Nosocomial: 750 mg every 24 hours for 7-14 days

Prostatitis (chronic bacterial): 500 mg every 24 hours for 28 days

Skin infections:
Uncomplicated: 500 mg every 24 hours for 7-10 days
Complicated: 750 mg every 24 hours for 7-14 days

Urinary tract infections:
Uncomplicated: 250 mg once daily for 3 days
Complicated, including acute pyelonephritis: 250 mg every 24 hours for 10 days

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Renal Dosing:
[CRCL >50] No change.
[20-49]: 500 x 1, then 250mg q24h. Complicated skin/structure: 750 mg x 1, then 750mg q48h.
[10-19]: 500mg x 1, 250mg q48h. Complicated skin/structure: 750 mg x 1, then 500mg q48h.
[<10] same as above.
Hemodialysis or PD: 500mg x 1, 250mg q48h. Complicated skin/structure: 750 mg x 1, then 500mg q48h. On dialysis days, schedule dose after dialysis.

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SUPPLIED:
Infusion [premixed in D5W] (Levaquin®): 250 mg (50 mL); 500 mg (100 mL); 750 mg (150 mL)
Injection, solution [preservative free] (Levaquin®): 25 mg/mL (20 mL, 30 mL)
Solution, oral (Levaquin®): 25 mg/mL (480 mL) [contains benzyl alcohol]
Tablet (Levaquin®): 250 mg, 500 mg, 750 mg
Levaquin® Leva-Pak: 750 mg (5s)

The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, beta-lactams, aminoglycosides, or tetracyclines; therefore, microorganisms resistant to these classes of drugs may be susceptible to moxifloxacin and other quinolones. There is no known cross-resistance between moxifloxacin and other classes of antimicrobials.

INDICATIONS AND USAGE
AVELOX Tablets and I.V. are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.

Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis.

Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae.

* MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin-resistant S. pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 µg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.

Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.

Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species.

Complicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae (See Clinical Studies).

Dosing (Adults):  400 mg orally or IV q24h.

Acute bacterial sinusitis: Oral, I.V.: 400 mg every 24 hours for 10 days.
Chronic bronchitis, acute bacterial exacerbation: Oral, I.V.: 400 mg every 24 hours for 5 days. Note: Avelox® ABC Pack™ (Avelox® Bronchitis Course) contains five tablets of 400 mg each.
Intra-abdominal infections, complicated: Oral, I.V.: 400 mg every 24 hours for 5-14 days (initiate with I.V.).
Legionella(unlabeled use): Oral, I.V.: 400 mg every 24 hours for 10-21 days.
Pneumonia, community-acquired (including MDRSP): Oral, I.V.: 400 mg every 24 hours for 7-14 days.
Skin and skin structure infections: Oral, I.V.:
Complicated: 400 mg every 24 hours for 7-21 days
Uncomplicated: 400 mg every 24 hours for 7 days

Renal Dosing: No adjustment necessary. Hemo: No specific guidelines available.

Supplied: Tablet: 400mg. Avelox® ABC Pack: contains 5 unit dose 400mg tablets. IV (premixed): 400mg/250 ml NS. Ophthalmic soln ( Vigamox ®): 0.5% (3 ml).

"RESPIRATORY QUINOLONE"
Similar to other new-generation fluoroquinolones, such as grepafloxacin, levofloxacin, and trovafloxacin, moxifloxacin exhibits improved activity against pneumococci (S. pneumoniae) and other clinically relevant respiratory pathogens (eg, Haemophilus influenzae, Chlamydia, Mycoplasma), suggesting that it has a role in the treatment of ambulatory community-acquired pneumonia, sinusitis, and acute exacerbations of chronic bronchitis, particularly in older patients with underlying disease and those with resistance to other agents. Until direct comparative data are available, selection of one of these drugs over the other will be guided by mainly by cost. The overall in vitro activity of moxifloxacin is similar to that of trovafloxacin (Woodcock et al, 1997); (Barman et al, 1999). Compared to ciprofloxacin, moxifloxacin is more active against gram-positive organisms and anaerobes, but less active against the Enterobacteriaceae and Pseudomonas spp. Dave's Note: Not indicated for tx of UTI.

Uncomplicated gonorrhea: 800 mg as a single dose (CDC recommends as an alternative regimen to ciprofloxacin or ofloxacin)

Prostatitis: 400 mg every 12 hours for 4 weeks

Dosing interval in renal impairment: Clcr 10-30 mL/minute: Urinary tract infections: Administer 400 mg every 24 hours

Supplied
Tablet: 400 mg

Renal Dosing:
[> 50 ml/min]: no changes.
[20-50]: 200-400mg q24h.
[<20]: 100-200mg q24h (1/2 of usual dose q24h.).
Hemodialysis: Manufacturer states: For CRCL <20 ml/min give 50% of usual dose q24h. No specific info for hemodialysis.