CIPRO Film-coated tablet / Oral suspension kit (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bayer HealthCare Pharmaceuticals Inc.

Λέξεις κλειδιά

50419-777 50419-773 50419-758 50419-754

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1. Indications and Usage

1.1 Skin and Skin Structure Infections CIPRO is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, ...

2. Dosage and Administration

CIPRO Tablets and Oral Suspension should be administered orally as described in the appropriate Dosage Guidelines tables. 2.1 Dosage in Adults The determination of dosage and duration for any particular ...

3. Dosage Forms and Strengths

3.1 Tablets 250 mg slightly yellowish, film-coated, round, imprinted with BAYER on one side and CIP 250 on the other 500 mg, slightly yellowish, film-coated, capsule shaped, imprinted with BAYER on one ...

4. Contraindications

4.1 Hypersensitivity CIPRO is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components ...

5. Warnings and Precautions

5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including CIPRO, ...

6. Adverse Reactions

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including CIPRO. Because these reactions are reported voluntarily from a population of uncertain ...

7. Drug Interactions

Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Co-administration of CIPRO with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations ...

8.1. Pregnancy

Risk Summary Prolonged experience with ciprofloxacin in pregnant women over several decades, based on available published information from case reports, case control studies and observational studies on ...

8.2. Lactation

Risk Summary Published literature reports that ciprofloxacin is present in human milk following intravenous and oral administration. There is no information regarding effects of CIPRO on milk production ...

8.4. Pediatric Use

Although effective in clinical trials, CIPRO is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. Quinolones, including CIPRO, ...

8.5. Geriatric Use

Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as CIPRO. This risk is further increased in patients ...

8.6. Renal Impairment

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 alternative ...

8.7. Hepatic Impairment

In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. The pharmacokinetics of ciprofloxacin in patients with ...

10. Overdosage

In the event of acute overdosage, reversible renal toxicity has been reported in some cases. Empty the stomach by inducing vomiting or by gastric lavage. Observe the patient carefully and give supportive ...

11. Description

CIPRO (ciprofloxacin hydrochloride) Tablets and CIPRO (ciprofloxacin) Oral Suspension are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is ...

12.1. Mechanism of Action

Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4)].

12.2. Pharmacodynamics

Absorption The absolute bioavailability of ciprofloxacin when given as an oral tablet is approximately 70% with no substantial loss by first pass metabolism. Ciprofloxacin maximum serum concentrations ...

12.4. Microbiology

Mechanism of Action The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella/Microsome Test (Negative) E. coli DNA Repair Assay (Negative) ...

13.2. Animal Toxicology and/or Pharmacology

Ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested [see Warnings and Precautions (5.13)]. Damage of weight bearing joints was observed ...

14. Clinical Studies

14.1 Complicated Urinary Tract Infection and Pyelonephritis–Efficacy in Pediatric Patients CIPRO administered intravenously and/or orally was compared to a cephalosporin for treatment of cUTI and pyelonephritis ...

15. References

1. 21 CFR 314.510 (Subpart H–Accelerated Approval of New Drugs for Life-Threatening Illnesses). 2. Friedman J, Polifka J. Teratogenic effects of drugs: a resource for clinicians (TERIS). Baltimore, Maryland: ...

16.1. How Supplied

CIPRO (ciprofloxacin hydrochloride) Tablets are available as round, slightly yellowish film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with the word BAYER on one side and ...

16.2. Storage and Handling

CIPRO (ciprofloxacin hydrochloride) Tablets: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. CIPRO Oral Suspension: Store microcapsules ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide) Serious Adverse Reactions Advise patients to stop taking CIPRO if they experience an adverse reaction and to call ...

BOXED WARNING SECTION

RECENT MAJOR CHANGES SECTION WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS ...