ciprofloxacin

REMS

PO: IV: Treatment of the following infections:
- Skin and skin structure infections,
- Bone and joint infections,
- Complicated intra-abdominal infections (with metronidazole),
- Urinary tract infections (UTIs) (should be used for acute uncomplicated cystitis only when there are no other alternative treatment options),
- Chronic bacterial prostatitis,
- Lower respiratory tract infections (should be used for acute bacterial exacerbations of chronic bronchitis only when there are no other alternative treatment options),
- Acute bacterial sinusitis (should be used only when there are no other alternative treatment options).
Postexposure prophylaxis of inhalational anthrax.
Treatment and prophylaxis of plague.
PO: Treatment of the following infections:
- Infectious diarrhea,
- Typhoid fever,
- Uncomplicated cervical and urethral gonorrhea.
IV: Treatment of the following infections:
- Nosocomial pneumonia,
- Febrile neutropenia (with piperacillin/tazobactam).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity (cross-sensitivity within class may exist);
History of myasthenia gravis (may worsen symptoms including muscle weakness and breathing problems);
Concurrent use with tizanidine;
Patients with or at ↑ risk for aortic aneurysm (use only if no alternatives);
Lactation: Lactation (for all indications other than anthrax);
Pedi: Use only if no alternatives in children 1–17 yr due to possible arthropathy.

Use Cautiously in:

Known or suspected CNS disorder;
Renal impairment;
Concurrent use of corticosteroids (↑ risk of tendinitis/tendon rupture);
Kidney, heart, or lung transplant patients (↑ risk of tendinitis/tendon rupture);
Patients with history of or at risk for QT interval prolongation;
OB: Use during pregnancy only if potential maternal benefit outweighs potential fetal risk;
Lactation: Can be used while breastfeeding for postexposure prophylaxis of anthrax if potential maternal benefit justifies potential risk to infant;
Geri: ↑risk of adverse reactions in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: AORTIC ANEURYSM/DISSECTION, myocardial ischemia

Derm: photosensitivity, rash

Endo: hyperglycemia, hypoglycemia

GI: diarrhea, nausea, ↑liver enzymes , abdominal pain, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), HEPATOTOXICITY

GU: vaginitis

Hemat: eosinophilia

Local: phlebitis at IV site

MS: arthralgia, myalgia, tendinitis, tendon rupture

Neuro: ↑INTRACRANIAL PRESSURE (INCLUDING PSEUDOTUMOR CEREBRI), agitation, confusion, depression, dizziness, drowsiness, hallucinations, headache, insomnia, nightmares, paranoia, peripheral neuropathy, SEIZURES, SUICIDAL THOUGHTS, toxic psychosis, tremor

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

May ↑ tizanidine levels and risk of hypotension and sedation; concurrent use contraindicated.
May ↑ theophylline levels and risk of CNS toxicity; avoid concurrent use; if concurrent use cannot be avoided, closely monitor serum theophylline levels.
Concurrent use with QT interval-prolonging medications may ↑ risk of QT interval prolongation and torsades de pointes; avoid concurrent use.
May ↑ levels and risk of toxicity of CYP1A2 substrates, including ropinirole, clozapine, olanzapine, and zolpidem; avoid concurrent use with zolpidem.
May ↑ risk of hypoglycemia when used with antidiabetic agents.
Antacids, iron salts, bismuth subsalicylate, sucralfate, sevelemer, lanthanum, and zinc salts may ↓ absorption; administer ≥2 hr before or ≥6 hr after any of these medications.
May ↑ the effects of and risk of bleeding from warfarin.
May alter levels and the effects of phenytoin.
Probenecid may ↑ levels and risk of toxicity.
May ↑ risk of nephrotoxicity from cyclosporine.
NSAIDs may ↑ risk of seizures.
Corticosteroids may ↑ risk of tendon rupture.
May ↑ levels and risk of toxicity of methotrexate, sildenafil, and duloxetine.

Drug-Natural Products:

Fennel↓ bioavailability.

Drug-Food:

Absorption is impaired by concurrent enteral feeding (because of metal cations).
Absorption is ↓ by food and/or dairy products; take 1 hr before or 2 hr after.

Availability ⬆ ⬇

(Generic available)

Immediate-release tablets: 250 mg; 500 mg; 750 mg
Oral suspension strawberry flavor: 250 mg/5 mL; 500 mg/5 mL
Premixed infusion: 200 mg/100 mL D5W; 400 mg/200 mL D5W
In combination with: fluocinolone (Otovel); hydrocortisone (Cipro HC) (see Appendix [not included in this PDA edition]).

Route/Dosage ⬆ ⬇

Skin/Skin Structure Infections

PO (Adults ): 500–750 mg every 12 hr for 7–14 days.
IV (Adults ): 400 mg every 8–12 hr for 7–14 days.

Bone and Joint Infections

PO (Adults ): 500–750 mg every 12 hr for 4–8 wk.
IV (Adults ): 400 mg every 8–12 hr for 4–8 wk.

Complicated Intra-Abdominal Infections

PO (Adults ): 500 mg every 12 hr for 7–14 days.
IV (Adults ): 400 mg every 12 hr for 7–14 days.

Infectious Diarrhea

PO (Adults ): 500 mg every 12 hr for 5–7 days.

Typhoid Fever

PO (Adults ): 500 mg every 12 hr for 10 days.

Uncomplicated Urethral and Cervical Gonorrhea

PO (Adults ): 250 mg as a single dose.

Inhalational Anthrax (Postexposure)

PO (Adults ): 500 mg every 12 hr for 60 days.
PO (Children ): 15 mg/kg (max = 500 mg/dose) every 12 hr for 60 days.
IV (Adults ): 400 mg every 12 hr for 60 days.
IV (Children ): 10 mg/kg (max = 400 mg/dose) every 12 hr for 60 days.

Plague

PO (Adults ): 500–750 mg every 12 hr for 14 days.
PO (Children ): 15 mg/kg (max = 500 mg/dose) every 8–12 hr for 14 days.
IV (Adults ): 400 mg every 8–12 hr for 14 days.
IV (Children ): 10 mg/kg (max = 400 mg/dose) every 8–12 hr for 10–21 days.

Chronic Bacterial Prostatitis

PO (Adults ): 500 mg every 12 hr for 28 days.
IV (Adults ): 400 mg every 12 hr for 28 days.

Lower Respiratory Tract Infections

PO (Adults ): 500–750 mg every 12 hr for 7–14 days.
IV (Adults ): 400 mg every 8–12 hr for 7–14 days.

Nosocomial Pneumonia

IV (Adults ): 400 mg every 8 hr for 10–14 days.

Febrile Neutropenia

IV (Adults ): 400 mg every 8 hr for 7–14 days.

Urinary Tract Infections

PO (Adults ): Complicated UTI or acute pyelonephritis: 250–500 mg every 12 hr for 7–14 days; Acute uncomplicated cystitis: 250 mg every 12 hr for 3 days.
PO (Children 1–17 yr): Complicated UTI or pyelonephritis: 10–20 mg/kg (max = 750 mg/dose) every 12 hr for 10–21 days.
IV (Adults ): 200–400 mg every 8–12 hr for 7–14 days.
IV (Children 1–17 yr): Complicated UTI or pyelonephritis: 6–10 mg/kg (max = 400 mg/dose) every 8 hr for 10–21 days.

Acute Bacterial Sinusitis

PO (Adults ): 500 mg every 12 hr for 10 days.
IV (Adults ): 400 mg every 12 hr for 10 days.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: 250–500 mg every 12 hr; CCr 5–29 mL/min: 250–500 mg every 18 hr; Hemodialysis or peritoneal dialysis: 250–500 mg every 24 hr (give dose after dialysis session).

Renal Impairment

IV (Adults ): CCr 5–29 mL/min: 200–400 mg every 18–24 hr.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits bacterial DNA synthesis by inhibiting DNA gyrase enzyme.

Therapeutic effects:

Death of susceptible bacteria.

Spectrum:

Active against gram-positive pathogens, including:
- Staphylococcus aureus,
- Staphylococcus epidermidis,
- Staphylococcus saprophyticus,
- Streptococcus pyogenes,
- Streptococcus pneumoniae,
- Enterococcus faecalis,
- Bacillus anthracis (anthrax).
Gram-negative spectrum notable for activity against:
- Escherichia coli,
- Klebsiella pneumoniae,
- Enterobacter cloacae,
- Salmonella typhi,
- Shigella spp,
- Proteus mirabilis,
- Proteus vulgaris,
- Providencia stuartii,
- Providencia rettgeri,
- Morganella morganii,
- Pseudomonas aeruginosa,
- Serratia marcescens,
- Haemophilus influenzae,
- Moraxella catarrhalis,
- Campylobacter jejuni,
- Yersinia pestis.

Classifications ⬆ ⬇

Therapeutic Classification: anti-infectives

Pharmacologic Classification: Fluoroquinolones

Pharmacokinetics ⬆ ⬇

Absorption: 70% absorbed after oral administration; IV administration results in complete bioavailability.

Distribution: Widely distributed. High tissue and urinary levels are achieved

Metabolism/Excretion: 15% metabolized by the liver; 40–50% excreted unchanged by the kidneys.

Half-Life: 4 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	1–2 hr	12 hr
IV	rapid	end of infusion	12 hr

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed at evenly spaced times and to finish drug completely, even if feeling better. Take missed doses as soon as possible, unless within 6 hr of next dose. Do not double doses.
Advise patients to notify health care professional immediately if they are taking theophylline.
Encourage patient to maintain a fluid intake of ≥1500–2000 mL/day to prevent crystalluria.
Advise patient that antacids or medications containing calcium, magnesium, aluminum, iron, or zinc will ↓ absorption and should not be taken within 4 hr before and 2 hr after taking this medication.
May cause dizziness and drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Caution patient to use sunscreen and protective clothing to prevent phototoxicity reactions during and for 5 days after therapy. Notify health care professional if a sunburn-like reaction or skin eruption occurs.
Instruct patients being treated for gonorrhea that partners also must be treated.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools).
Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
Instruct patient to notify health care professional immediately if signs and symptoms of hepatotoxicity (anorexia, jaundice, dark urine, pruritus, tender abdomen); rash; signs of hypersensitivity; serious CNS effects (seizures, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, suicidal ideations/thoughts); peripheral neuropathy (pain, burning, tingling, numbness, weakness, other alterations in sensation); or tendon (shoulder, hand, Achilles, other) pain, swelling, or inflammation occur. If tendon symptoms occur, avoid exercise and use of affected area.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy and for 2 days after last dose unless being treated for inhalation anthrax.

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Indications ⬇