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) (PO 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).

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.

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

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

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: ELEVATED INTRACRANIAL PRESSURE (INCLUDING PSEUDOTUMOR CEREBRI), peripheral neuropathy, agitation, confusion, depression, dizziness, drowsiness, hallucinations, headache, insomnia, nightmares, paranoia, 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.
Administration with 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.

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).

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.

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]).

Assessment ⬆ ⬇

Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC; urinalysis; frequency and urgency of urination; cloudy or foul-smelling urine) at beginning of and throughout therapy.
Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
Observe for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue drug and notify health care professional immediately if these problems occur. Keep epinephrine, an antihistamine, and resuscitation equipment close by in case of an anaphylactic reaction.
Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of CDAD. May begin up to several wk following cessation of therapy.

Lab Test Considerations:

May cause ↑ serum AST, ALT, LDH, bilirubin, and alkaline phosphatase.
- May also cause ↑ or ↓ serum glucose.

Implementation ⬆ ⬇

PO: Administer without regard to food and with a full glass of water, at the same time each day. Products or foods containing calcium, magnesium, aluminum, iron, or zinc should not be ingested for 6 hr before and 2 hr after administration.
- If gastric irritation occurs, ciprofloxacin may be administered with meals. Food slows and may slightly ↓ absorption.
- Regular tablets can be crushed for patients unable to swallow.
- To prepare oral suspension open both bottles provided. Pour microcapsules into larger bottle of diluent. Diluent volume varies by dose and concentration. For 250 mg dose, use 5 mL diluent for 250 mg/5 mL (5%) dose or 2.5 mL for 10% 500 mg/5 mL (10%) dose. For 500 mg dose, use 10 mL diluent for 250 mg/5 mL (5%) dose or 5 mL for 500 mg/5 mL (10%) dose. For 750 mg dose, use 15 mL for 250 mg/5 mL (5%) dose or 7.5 mL diluent for 500 mg/5 mL (10%) dose. Do not add water to suspension. Label with expiration date. Solution is stable at room temperature for 14 days. Shake oral suspension vigorously for 15 sec before administering. Administer suspension using the copackaged graduated teaspoon provided for the patient. Do not chew microcapsules in suspension, swallow whole. May follow with water.
- Do not administer 5% or 10% oral solution through an enteral feeding tube or with enteral feedings; may ↓ absorption.

IV Administration:

Intermittent Infusion: Rate: Administer over 60 min into a large vein to minimize venous irritation.

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 patient that sharing of this medication may be dangerous.
Advise patients to notify health care professional immediately if they are taking theophylline.
Encourage patient to maintain a fluid intake of at least 1500–2000 mL/day to prevent crystalluria.
Advise patient that antacids or medications containing calcium, magnesium, aluminum, iron, or zinc will decrease 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, or tender abdomen), rash, signs of hypersensitivity, serious CNS effects (seizures, increased intracranial pressure, and toxic psychosis, including nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, psychotic reactions, suicidal ideations/thoughts), peripheral neuropathy (pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations, including light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength) or tendon (shoulder, hand, Achilles, and other) pain, swelling, or inflammation occur. If tendon symptoms occur, avoid exercise and use of affected area. Increased risk in >65 yr old, kidney, heart and lung transplant recipients and patients taking corticosteroids concurrently. Therapy should be discontinued.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇