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PMS-CIPROFLOXACIN is a brand name for Ciprofloxacin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-CIPROFLOXACIN (ciprofloxacin tablets) may be indicated for the treatment of patients with the following infections caused by susceptible strains of the indicated microorganisms: Respiratory Tract Infections Acute exacerbation of chronic bronchitis caused by: Haemophilus influenzae Moraxella catarrhalis Acute…
Verbatim from this product's HC label. Tap a section to expand.
Special Populations:
Impaired Renal Function for dose modification based on creatinine clearance or serum creatinine). 2 CONTRAINDICATIONS pms-CIPROFLOXACIN 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. 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 pms-CIPROFLOXACIN 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.
pms-CIPROFLOXACIN 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 pms- CIPROFLOXACIN (see 7 WARNINGS AND PRECAUTIONS: Immune).
a Currently not marketed in Canada pms-CIPROFLOXACIN (Ciprofloxacin Tablets USP) Page 8 of 59 Fluoroquinolones including pms-CIPROFLOXACIN 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).
Fluroquinolones including pms-CIPROFLOXACIN may exacerbate muscle weakness in persons with myasthenia gravis. Avoid using pms- CIPROFLOXACIN 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 pms-CIPROFLOXACIN.
). 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. , 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 immediately and initiate appropriate therapy (see 8 ADVERSE REACTIONS and
, Tendinitis and Tendon Rupture 11/2020 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not liste d. TABLE OF CONTENTS ............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION................................................................. 4 1 INDICATIONS ...............................................................................................................
1 Pediatrics ..................................................................................................................... 2 Geriatrics......................................................................................................................
7 2 CONTRAINDICATIONS...................................................................................................... 7 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 7 4 DOSAGE AND ADMINISTRATION.....................................................................................
1 Dosing Considerations ................................................................................................ 2 Recommended Dose and Dosage Adjustment ........................................................... 4 Administration ...........................................................................................................
5 Missed Dose............................................................................................................... 10 5 OVERDOSAGE ................................................................................................................
11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING............................. 11 7 WARNINGS AND PRECAUTIONS ................................................................................... 1 Special Populations ...................................................................................................
pms-CIPROFLOXACIN 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
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ciprofloxacin in Canada.
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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.
pms- CIPROFLOXACIN 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 pms-CIPROFLOXACIN (see 7 WARNINGS AND PRECAUTIONS: Hepatic / Biliary / Pancreatic).
1 Dosing Considerations 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-defence mechanisms, and the status of renal function.
pms-CIPROFLOXACIN may be taken before or after meals. Absorption is faster on an empty stomach. Patients should be advised to drink fluids liberally and avoid taking dairy products or antacids containing magnesium or aluminum. 2 Recommended Dose and Dosage Adjustment Adults The recommended oral dosages for pms-CIPROFLOXACIN are: Table 1: Recommended Oral Dosages pms-CIPROFLOXACIN (Ciprofloxacin Tablets USP) Page 9 of 59 Location of Infection Type / Severity Unit Dose Frequency Daily Dose Urinary Tract Mild / Moderate 250 mg q12h 500 mg Urinary Tract Severe / Complicated 500 mg q12h 1000 mg Chronic Bacterial Prostatitis Asymptomatic / Mild / Moderate 500 mg q12h 1000 mg Respiratory Tract Bone & Joint Skin & Soft Tissue Mild / Moderate 500 mg q12h 1000 mg Respiratory Tract Bone & Joint Skin & Soft Tissue Severeb / Complicated 750 mg q12h 1500 mg Infectious Diarrhea Mild / Moderate / Severe 500 mg q12h 1000 mg Urogenital and Extragenital Gonorrhea Uncomplicated 500 mg once 500 mg Typhoid Fever Mild / Moderate 500 mg q12h 1000 mg Neisseria meningitidis Nasopharyngeal Colonization Carrier State 750 mg once 750 mg Acute Sinusitis Moderate 500 mg q12h 1000 mg b eg, hospital-acquired pneumonia, osteomyelitis Depending on the severity of the infections, as well as the clinical and bacteriological responses, the average treatment period should be approximately 7 to 14 days.
Generally, treatment should last 3 days beyond the disappearance of clinical symptoms or until cultures are sterile. Patients with osteomyelitis may require treatment for a minimum of 6 to 8 weeks and up to 3 months. With acute cystitis in females a 3- to 5-day treatment may be sufficient.
With infectious diarrhea a five- day treatment may be sufficient. Typhoid fever should be treated for 14 days. Acute sinusitis should be treated for 10 days with 500 mg q12h. Chronic bacterial prostatitis should be treated for 28 days with 500 mg q12h.
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 pms- CIPROFLOXACIN. However, monitoring of serum drug levels provides the most reliable basis for dosage adjustments. 73m2 Maximum Daily Oral Dose Serum […]
1 Pregnant Women ....................................................................................................... 2 Breast-feeding............................................................................................................
3 Pediatrics ................................................................................................................... 4 Geriatrics....................................................................................................................
17 8 ADVERSE REACTIONS ................................................................................................... 1 Adverse Reaction Overview ......................................................................................
2 Clinical Trial Adverse Reactions ............................................................................... 3 Less Common Clinical Trial Adverse Reactions....................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...................................................................................................................
5 Post-Market Adverse Reactions ................................................................................ 20 9 DRUG INTERACTIONS ....................................................................................................
2 Drug Interactions Overview ....................................................................................... 3 Drug-Behavioural Interactions .................................................................................. 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions.............................................................................................. 6 Drug-Herb Interactions ..............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 27 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action .................................................................................................
3 Pharmacokinetics ...................................................................................................... 27 11 STORAGE, STABILITY AND DISPOSAL........................................................................ 34 12 SPECIAL HANDLING INSTRUCTIONS ..........................................................................
34 PART II: SCIENTIFIC INFORMATION .................................................................................... 35 13 PHARMACEUTICAL INFORMATION ............................................................................. 35 14 CLINICAL TRIALS..........................................................................................................
3 Comparative Bioavailability Studies ......................................................................... 36 15 MICROBIOLOGY ............................................................................................................
36 16 NON-CLINICALTOXICOLOGY ....................................................................................... 40 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 43 PATIENT MEDICATION INFORMATION ................................................................................
44 pms-CIPROFLOXACIN (Ciprofloxacin Tablets USP) Page 4 of 59 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS pms-CIPROFLOXACIN […]