Ciprofloxacin Extended-release (Page 8 of 12)

Impaired Hepatic Function:

No dosage adjustment is required with ciprofloxacin extended-release tablets in patients with stable chronic cirrhosis. The kinetics of ciprofloxacin in patients with acute hepatic insufficiency, however, have not been fully elucidated. (See CLINICAL PHARMACOLOGY, Special Populations.)

Children and Adolescents

Dosing in children (less than 18 years of age) with impaired renal or hepatic function has not been studied.

HOW SUPPLIED

Ciprofloxacin Extended-Release Tablets are available as white film-coated, oval-shaped tablets containing 500 mg or 1000 mg ciprofloxacin. The 500 mg tablet is engraved with “ANCHEN 107” on one side and plain on the other side. The 1000 mg tablet is engraved with “ANCHEN 108” on one side and plain on the other side. They are available as follow:

500 mg Tablets
Bottles of 50 NDC # 10370-107-05
Bottles of 100 NDC # 10370-107-10
Bottles of 500 NDC # 10370-107-50
1000 mg Tablets
Bottles of 50 NDC # 10370-108-05
Bottles of 100 NDC # 10370-108-10

Store at 20° to 25°C (68º to 77°F) [see USP Controlled Room Temperature].

ANIMAL PHARMACOLOGY

Ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested. (See WARNINGS.) Damage of weight bearing joints was observed in juvenile dogs and rats. In young beagles, 100 mg/kg ciprofloxacin, given daily for 4 weeks, caused degenerative articular changes of the knee joint. At 30 mg/kg, the effect on the joint was minimal. In a subsequent study in young beagle dogs, oral ciprofloxacin doses of 30 mg/kg and 90 mg/kg given daily for 2 weeks caused articular changes which were still observed by histopathology after a treatment-free period of 5 months. At 10 mg/kg no effects on joints were observed. This dose was also not associated with arthrotoxicity after an additional treatment-free period of 5 months. In another study, removal of weight bearing from the joint reduced the lesions but did not totally prevent them.

Crystalluria, sometimes associated with secondary nephropathy, occurs in laboratory animals dosed with ciprofloxacin. This is primarily related to the reduced solubility of ciprofloxacin under alkaline conditions, which predominate in the urine of test animals; in man, crystalluria is rare since human urine is typically acidic. In rhesus monkeys, crystalluria without nephropathy has been noted after single oral doses as low as 5 mg/kg (approximately 0.1-times the highest recommended therapeutic dose based upon mg/m2. After 6 months of intravenous dosing at 10 mg/kg/day, no nephropathological changes were noted; however, nephropathy was observed after dosing at 20 mg/kg/day for the same duration (approximately 0.4 times the highest recommended therapeutic dose based upon mg/m2).

In dogs, ciprofloxacin administered at 3 and 10 mg/kg by rapid infusion injection (15 sec.) produces hypotensive effects. These effects are considered to be related to histamine release because they are partially antagonized by pyrilamine, an antihistamine. In rhesus monkeys, rapid infusion injection also produces hypotension, but the effect in this species is inconsistent and less pronounced. In mice, concomitant administration of nonsteroidal anti-inflammatory drugs such as phenylbutazone and indomethacin with quinolones has been reported to enhance the CNS stimulatory effect of quinolones.

Ocular toxicity seen with some related drugs has not been observed in ciprofloxacin-treated animals.

CLINICAL STUDIES

Uncomplicated Urinary Tract Infections (acute cystitis)

Ciprofloxacin extended-release tablets were evaluated for the treatment of uncomplicated urinary tract infections (acute cystitis) in a randomized, double-blind, controlled clinical trial conducted in the US. This study compared ciprofloxacin extended-release tablets (500 mg once daily for three days) with ciprofloxacin immediate-release tablets (ciprofloxacin 250 mg BID for three days). Of the 905 patients enrolled, 452 were randomly assigned to the ciprofloxacin extended-release tablets treatment group and 453 were randomly assigned to the control group. The primary efficacy variable was bacteriologic eradication of the baseline organism(s) with no new infection or superinfection at test-of-cure (Day 4 to 11 Post-therapy).

The bacteriologic eradication and clinical success rates were similar between ciprofloxacin extended-release tablets and the control group. The eradication and clinical success rates and their corresponding 95% confidence intervals for the differences between rates (ciprofloxacin extended-release tablets minus control group) are given in the following table:

Ciprofloxacin extended- release 500 mg QD x 3 Days Ciprofloxacin immediate- release 250 mg BID x 3 Days
* n/N = patients with baseline organism(s) eradicated and no new infections or superinfections/ total number of patients
** n/N = patients with specified baseline organism eradicated/patients with specified baseline organism
*** n/N = patients with clinical success /total number of patients
† The presence of a pathogen at a level of ≥ 105 CFU/mL was required for microbiological evaluability criteria, except for S. saprophyticus (≥ 104 CFU/mL).
Randomized Patients 452 453
Per Protocol Patients 199 223
Bacteriologic Eradication at TOC (n/N)* 188/199 (94.5%) 209/223 (93.7%)
CI [-3.5%, 5.1%]
Bacteriologic Eradication(by organism) at TOC (n/N)**
E. coli 156/160 (97.5%) 176/181 (97.2%)
E. faecalis 10/11 (90.9%) 17/21 (81%)
P. mirabilis 11/12 (91.7%) 7/7 (100%)
S. saprophyticus 6/7 (85.7%) 9/9 (100%)
Clinical Response at TOC (n/N)*** 189/199 (95%) 204/223 (91.5%)
CI [-1.1%, 8.1%]

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