Overview
11 DESCRIPTION Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8.
Mechanism of Action
12 CLINICAL PHARMACOLOGY Click here to enter Clinical Pharmacology 12.1 Mechanism of Action Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology ( Error! Hyperlink reference not valid. )]. 12.3 Pharmacokinetics 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 (C max ) and area under the curve (AUC) are shown in the chart for the 250 mg to 1000 mg dose range (Table 9). Table 9: Ciprofloxacin C max and AUC Following Administration of Single Doses of Ciprofloxacin Tablets to Healthy Subjects Dose (mg) C max (mcg/mL) AUC (mcg•hr/mL) 250 1.2 4.8 500 2.4 11.6 750 4.3 20.2 1000 5.4 30.
Indications
- 1 INDICATIONS AND USAGE Click here to enter Indications Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: • Skin and Skin Structure Infections ( Error! Hyperlink reference not valid. ) • Bone and Joint Infections ( Error! Hyperlink reference not valid. ) • Complicated Intra-Abdominal Infections ( Error! Hyperlink reference not valid. ) • Infectious Diarrhea ( Error! Hyperlink reference not valid.
Common Doses
- 750 mg
- 500 mg
- 250 mg
- 50 mL
Dosage
2 DOSAGE AND ADMINISTRATION Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables. Adult Dosage Guidelines Infection Dose Frequency Duration Skin and Skin Structure 500 -750 mg every 12 hours 7 to 14 days Bone and Joint 500-750 mg every 12 hours 4 to 8 weeks Complicated Intra-Abdominal 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Gonorrhea 250 mg single dose single dose Inhalational anthrax (post-exposure) 500 mg every 12 hours 60 days...
Black Box Warning
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ( Error! Hyperlink reference not valid. )] including: • Tendinitis and tendon rupture [see Warnings and Precautions ( Error! Hyperlink reference not valid.
Contraindications
- 4 CONTRAINDICATIONS Click here to enter Contraindications • Known hypersensitivity to ciprofloxacin or other quinolones ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. Error! Hyperlink reference not valid. ) • Concomitant administration with tizanidine Error! Hyperlink reference not valid. 4.1 Hypersensitivity Ciprofloxacin tablets are contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see Warnings and Precautions ( Error! Hyperlink reference not...
Side Effects
- 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 [see Warnings and Precautions ( Error! Hyperlink reference not valid. )] • Tendinitis and Tendon Rupture [see Warnings and Precautions ( Error! Hyperlink reference not valid. )] • Peripheral Neuropathy [see Warnings and Precautions ( Error! Hyperlink reference not valid. )] • Central Nervous System Effects [see Warnings and Precautions ( Error! Hyperlink reference not valid.
Interactions
- 7 DRUG INTERACTIONS Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Co-administration of ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the co-administered drug. Table 8: Drugs That are Affected by and Affecting Ciprofloxacin Drugs That are Affected by Ciprofloxacin Drug(s) Recommendation Comments Tizanidine Contraindicated Concomitant administration of tizanidine and ciprofloxacin is contraindicated due to the...