SANDOZ CIPROFLOXACIN

) Caused by: Escherichia coli Pseudomonas aeruginosa Klebsiella pneumoniae Bacteroides fragilis Note: Most anaerobic bacteria, including Bacteroides fragilis, are resistant to ciprofloxacin. Therefore, ciprofloxacin should not be used as single agent therapy for complicated intra- abdominal infections.

Efficacy against Enterococcus sp. in clinical trials has been shown to be only 75%. ) Appropriate culture and susceptibility tests should be performed prior to initiating treatment in order to isolate and identify organisms causing the infection and to determine their susceptibilities to ciprofloxacin.

Therapy with Sandoz Ciprofloxacin and Ciprofloxacin Intravenous Infusion BP (ciprofloxacin injection) may be initiated before results of these tests are known. However, modification of this treatment may be required once results become available or if there is no clinical improvement.

Culture and susceptibility testing performed periodically during therapy will provide information on the possible emergence of bacterial resistance. If anaerobic organisms are suspected to be contributing to the infection, appropriate therapy should be administered.

1 Pediatrics The safety and efficacy of Sandoz Ciprofloxacin and Ciprofloxacin Intravenous Infusion BP (ciprofloxacin injection) in individuals less than 18 years of age has not been established. 3 Pediatrics). 2 Geriatrics Elderly patients should receive a dose dependent on the severity of their illness and their creatinine clearance ( see 4 DOSAGE AND ADMINISTRATION : Special Populations : Impaired Renal Function for dose modification based on creatinine clearance or serum creatinine ).

2 CONTRAINDICATIONS  Sandoz Ciprofloxacin (ciprofloxacin hydrochloride tablets) and Ciprofloxacin Intravenous Infusion BP (ciprofloxacin injection) are contraindicated in patients who have shown hypersensitivity to ciprofloxacin, or other quinolone antibacterial agents or any of the excipients.

For a complete listing, see the 4 DOSAGE AND ADMINISTRATION section. Sandoz Ciprofloxacin and Ciprofloxacin Intravenous Infusion BP Page 9 of 68  Concurrent administration of ciprofloxacin and agomelatinea is contraindicated since it may result in an undesirable increase in agomelatine exposure (se e 9 DRUG INTERACTIONS).

 Concurrent administration of ciprofloxacin and tizanidine is contraindicated since it may result in an undesirable increase in serum tizanidine concentrations. This can be associated with clinically relevant tizanidine-induced side effects (hypotension, somnolence, drowsiness) (see 9 DRUG INTERACTIONS) aCurrently not marketed in Canada 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions  Fluoroquinolones, including Sandoz Ciprofloxacin and Ciprofloxacin Intravenous Infusion BP (ciprofloxacin injection), have been associated with disabling and potentially persistent adverse reactions which to date include, but are not limited to: tendonitis, tendon rupture, peripheral neuropathy and neuropsychiatric effects.

sections of the Ciprofloxacin Product Monograph. Definitive clinical studies have not been completed for severe infections other than in the respiratory tract. The duration of treatment depends upon the severity of infection. Generally, ciprofloxacin should be continued for at least 3 days after the signs and symptoms of infection have disappeared.

The usual duration is 7 to 14 days. However, for severe and complicated infections more prolonged therapy may be required. Bone and joint infections may require treatment for 4 to 6 weeks or longer. Sequential IV/PO Therapy In patients receiving intravenous ciprofloxacin, oral ciprofloxacin may be considered when clinically indicated at the discretion of the physician.

Clinical studies evaluating the use of sequential IV/PO therapy in septicemia, however, have not been completed. Sandoz Ciprofloxacin and Ciprofloxacin Intravenous Infusion BP Page 12 of 68 Special Populations 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 (see 10 CLINICAL PHARMACOLOGY, Detailed Human Pharmacology). This alternate pathway of drug elimination appears to compensate for the reduced renal excretion of patients with renal impairment.

Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides a guideline for dosage adjustment of Sandoz Ciprofloxacin. However, monitoring of serum drug levels provides the most reliable basis for dosage adjustments.

0 Maximum daily doses are not to be exceeded when either creatinine clearance or serum creatinine are in the ranges stated. Hemodialysis Only a small amount of ciprofloxacin (< 10%) is removed from the body after hemodialysis or peritoneal dialysis.

3 Pediatrics). 2 Geriatrics Elderly patients should receive a dose dependent on the severity of their illness and their creatinine clearance ( see 4 DOSAGE AND ADMINISTRATION : Special Populations : Impaired Renal Function for dose modification based on creatinine clearance or serum creatinine ).

2 CONTRAINDICATIONS  Sandoz Ciprofloxacin (ciprofloxacin hydrochloride tablets) and Ciprofloxacin Intravenous Infusion BP (ciprofloxacin injection) are contraindicated in patients who have shown hypersensitivity to ciprofloxacin, or other quinolone antibacterial agents or any of the excipients.

For a complete listing, see the 4 DOSAGE AND ADMINISTRATION section. Sandoz Ciprofloxacin and Ciprofloxacin Intravenous Infusion BP Page 9 of 68  Concurrent administration of ciprofloxacin and agomelatinea is contraindicated since it may result in an undesirable increase in agomelatine exposure (se e 9 DRUG INTERACTIONS).

 Concurrent administration of ciprofloxacin and tizanidine is contraindicated since it may result in an undesirable increase in serum tizanidine concentrations. This can be associated with clinically relevant tizanidine-induced side effects (hypotension, somnolence, drowsiness) (see 9 DRUG INTERACTIONS) aCurrently not marketed in Canada 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions  Fluoroquinolones, including Sandoz Ciprofloxacin and Ciprofloxacin Intravenous Infusion BP (ciprofloxacin injection), have been associated with disabling and potentially persistent adverse reactions which to date include, but are not limited to: tendonitis, tendon rupture, peripheral neuropathy and neuropsychiatric effects.

 Ciprofloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients (see 7 WARNINGS AND PRECAUTIONS: Cardiovascular).  Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving fluoroquinolone therapy, including Sandoz Ciprofloxacin and Ciprofloxacin Intravenous Infusion BP (see 7 WARNINGS AND PRECAUTIONS: Immune).

 Sandoz Ciprofloxacin (ciprofloxacin hydrochloride tablets) and Ciprofloxacin Intravenous Infusion BP (ciprofloxacin injection) are contraindicated in patients who have shown hypersensitivity to ciprofloxacin, or other quinolone antibacterial agents or any of the excipients.

For a complete listing, see the