Ciprofloxacin

CIPROFLOXACIN- ciprofloxacin hydrochloride tablet, film coated
Golden State Medical Supply, Inc.

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

  • Fluoroquinolones, including ciprofloxacin tablets have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1)] including:

o Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]

o Peripheral neuropathy [see Warnings and Precautions (5.3]

o Central nervous system effects [see Warnings and Precautions (5.4)]

  • Discontinue ciprofloxacin tablets immediately and avoid the use of fluoroquinolones, including ciprofloxacin tablets, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1)]. Fluoroquinolones, including ciprofloxacin tablets, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid ciprofloxacin tablets in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5)].
  • Because fluoroquinolones, including ciprofloxacin tablets , have been associated with serious adverse reactions [see Warnings and Precautions (5.15.16)], reserve ciprofloxacin tablets for use in patients who have no alternative treatment options for the following indications:

o Acute exacerbation of chronic bronchitis [see Indications and Usage ( 1.10)]

o Acute uncomplicated cystitis [ see Indications and Usage ( 1.11)]

o Acute sinusitis [see Indications and Usage ( 1.12)]

1 INDICATIONS AND USAGE

1.1 Skin and Skin Structure Infections

Ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

1.2 Bone and Joint Infections

Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

1.3 Complicated Intra-Abdominal Infections

Ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

1.4 Infectious Diarrhea

Ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli ( enterotoxigenic isolates ), Campylobacter jejuni, Shigella boydii †, Shigella dysenteriae, Shigella flexneri or Shigella sonnei when antibacterial therapy is indicated .

Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients .

1.5 Typhoid Fever (Enteric Fever)

Ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever (enteric fever ) caused by Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.

1.6 Uncomplicated Cervical and Urethral Gonorrhea

Ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [see Warnings and Precautions (5.17)].

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