Loading…
PMS-CIPROFLOXACIN XL is a brand name for Ciprofloxacin, supplied as a tablet (immediate and extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-CIPROFLOXACIN XL (ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets) is indicated solely for the treatment of urinary tract infections, caused by susceptible strains of the designated microorganisms, as listed below. pms-CIPROFLOXACIN XL AND CIPROFLOXACIN TABLETS, IMMEDIATE RELEASE FORMULATION…
Verbatim from this product's HC label. Tap a section to expand.
for specific recommendations).
Uncomplicated Urinary Tract Infections (Acute Cystitis) in Females caused by:
Escherichia coli Enterococcus faecalis Proteus mirabilis Staphylococcus saprophyticus In cases of uncomplicated acute bacterial cystitis, limit the use of pms-CIPROFLOXACIN XL to circumstances where no other treatment options are available.
A urine culture should be obtained prior to treatment to ensure ciprofloxacin susceptibility.
Complicated Urinary Tract Infections caused by:
Escherichia coli Klebsiella pneumoniae Enterococcus faecalis Proteus mirabilis Pseudomonas aeruginosa Acute Uncomplicated Pyelonephritis caused by: Escherichia coli THE SAFETY AND EFFICACY OF CIPROFLOXACIN HYDROCHLORIDE AND CIPROFLOXACIN EXTENDED-RELEASE TABLETS IN TREATING INFECTIONS OTHER THAN URINARY TRACT INFECTIONS HAS NOT BEEN DEMONSTRATED.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of pms-CIPROFLOXACIN XL and other antibacterial drugs, pms-CIPROFLOXACIN XL should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to pms-CIPROFLOXACIN XL (ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets) Page 5 of 62 ciprofloxacin.
Therapy with pms-CIPROFLOXACIN XL may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. 1 Pediatrics The safety and efficacy of ciprofloxacin hydrochloride and ciprofloxacin extended -release tablets 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 the creatinine clearance (see 4 DOSAGE AND ADMINISTRATION, Special Populations, Renal Impairment for dose modification based on the creatinine clearance or serum creatinine).
). pms-CIPROFLOXACIN XL (ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets) Page 10 of 62 Aortic Aneurysm and Aortic Dissection Epidemiologic studies report an increased risk of aortic aneurysm and aortic dissection after intake of fluoroquinolones, particularly in the older population.
, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, atherosclerosis). In case of sudden severe abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
g. glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. SEVERE CASES OF HYPOGLYCEMIA RESULTING IN COMA OR DEATH HAVE BEEN REPORTED. If a hypoglycemic reaction occurs, discontinue pms- CIPROFLOXACIN XL immediately and initiate appropriate therapy (see 8 ADVERSE REACTIONS; and
3 Pediatrics). 2 Geriatrics Elderly patients should receive a dose-dependent on the severity of their illness and the creatinine clearance (see 4 DOSAGE AND ADMINISTRATION, Special Populations, Renal Impairment for dose modification based on the creatinine clearance or serum creatinine).
2 CONTRAINDICATIONS pms-CIPROFLOXACIN XL (ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets) is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, or any member of the quinolone class of antibacterial agents, or any of the excipients.
For a complete listing, see the 4 DOSAGE AND ADMINISTRATION section. Concurrent administration of ciprofloxacin and agomelatinea is contraindicated since it may result in an undesirable increase in agomelatine exposure (see 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).
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Fluoroquinolones, including ciprofloxacin hydrochloride and ciprofloxacin extended - release tablets, 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.
a Currently not marketed in Canada pms-CIPROFLOXACIN XL (ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets) Page 6 of 62 Ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets have 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 ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets (see 7 WARNINGS AND PRECAUTIONS, Immune).
pms-CIPROFLOXACIN XL (ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets) is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, or any member of the quinolone class of antibacterial agents, or any of the excipients.
For a complete listing, see the
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ciprofloxacin in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
2 CONTRAINDICATIONS pms-CIPROFLOXACIN XL (ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets) is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, or any member of the quinolone class of antibacterial agents, or any of the excipients.
For a complete listing, see the 4 DOSAGE AND ADMINISTRATION section. Concurrent administration of ciprofloxacin and agomelatinea is contraindicated since it may result in an undesirable increase in agomelatine exposure (see 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).
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Fluoroquinolones, including ciprofloxacin hydrochloride and ciprofloxacin extended - release tablets, 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.
a Currently not marketed in Canada pms-CIPROFLOXACIN XL (ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets) Page 6 of 62 Ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets have 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 ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets (see 7 WARNINGS AND PRECAUTIONS, Immune).
Fluoroquinolones, including ciprofloxacin hydrochloride and ciprofloxacin extended- release tablets, are associated with an increased risk of tendinitis and tendon rupture in all ages. The risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal).
Fluoroquinolones, including ciprofloxacin hydrochloride and ciprofloxacin extended- release tablets, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid using pms-CIPROFLOXACIN XL in patients with a known history of myasthenia gravis (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal).
Seizures and toxic psychoses may occur with fluoroquinolone therapy. Convulsions, increased intracranial pressure (including pseudotumor cerebri) and toxic psychoses have been reported in patients receiving fluoroquinolones, including ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets.
pms-CIPROFLOXACIN XL should be used with caution in patients with known or suspected CNS disorders which may predispose them to seizures or lower the seizure threshold (see 7 WARNINGS AND PRECAUTIONS, Neurologic). Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
1 Dosing Considerations pms-CIPROFLOXACIN XL AND CIPROFLOXACIN TABLETS, IMMEDIATE RELEASE FORMULATION ARE NOT INTERCHANGEABLE. pms-CIPROFLOXACIN XL should be administered once daily, as described in the table below: […]
Fluoroquinolones, including ciprofloxacin hydrochloride and ciprofloxacin extended- release tablets, are associated with an increased risk of tendinitis and tendon rupture in all ages. The risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal).
Fluoroquinolones, including ciprofloxacin hydrochloride and ciprofloxacin extended- release tablets, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid using pms-CIPROFLOXACIN XL in patients with a known history of myasthenia gravis (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal).
Seizures and toxic psychoses may occur with fluoroquinolone therapy. Convulsions, increased intracranial pressure (including pseudotumor cerebri) and toxic psychoses have been reported in patients receiving fluoroquinolones, including ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets.
pms-CIPROFLOXACIN XL should be used with caution in patients with known or suspected CNS disorders which may predispose them to seizures or lower the seizure threshold (see 7 WARNINGS AND PRECAUTIONS, Neurologic). Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
1 Dosing Considerations pms-CIPROFLOXACIN XL AND CIPROFLOXACIN TABLETS, IMMEDIATE RELEASE FORMULATION ARE NOT INTERCHANGEABLE. 2 Recommended Dose and Dosage Adjustment Table 1: Recommended Dosage Indication Unit Dose pms-CIPROFLOXACIN XL Frequency Recommended Duration Uncomplicated Urinary Tract Infection (Acute Cystitis) in Females 500 mg q 24 h 3 Days Complicated Urinary Tract Infection 1,000 mga q 24 h 7-14 Days Acute Uncomplicated Pyelonephritis 1,000 mga q 24 h 7-14 Days a For severely renally impaired patients see DOSAGE AND ADMINISTRATION, Special Populations, Renal Impairment below.
Special Populations Renal Impairment pms-CIPROFLOXACIN XL 500 mg Based on pharmacokinetic data, no dosage adjustment is required with pms-CIPROFLOXACIN XL 500 mg (see 10 CLINICAL PHARMACOLOGY, Detailed Human Pharmacology, Special Populations, Renal Impairment).
Ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets 1,000 mg For complicated urinary tract infections or acute uncomplicated pyelonephritis, where 1,000 mg is the appropriate dose, the dosage of ciprofloxacin hydrochloride and ciprofloxacin extended- release tablets should be reduced to 500 mg pms-CIPROFLOXACIN XL once daily in patients with creatinine clearance below 30 mL/min.
This recommendation is based on pharmacokinetic modeling. Clinical studies with ciprofloxacin hydrochloride and ciprofloxacin extended -release tablets have not been performed in patients with impaired renal function. For patients on hemodialysis or peritoneal dialysis, administer ciprofloxacin hydrochloride and ciprofloxacin extended-release tablets after the dialysis procedure is completed (see 10 CLINICAL PHARMACOLOGY, Detailed Human Pharmacology, Special Populations, Renal Impairme nt).
Hepatic Impairment Based on pharmacokinetic data, no dosage adjustment is required with pms-CIPROFLOXACIN XL in patients with stable chronic cirrhosis (with mild to moderate hepatic impairment). The kinetics of ciprofloxacin in patients with acute hepatic insufficiency and stable chronic cirrhosis (with severe hepatic impairment), however, have not been elucidated (see 10 CLINICAL PHARMACOLOGY, […]