ciprofloxacin hydrochloride

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ciprofloxacin hydrochloride

Cetraxal, Ciloxan, Cipro, Cipro I.V., Ciproxin (UK)

Pharmacologic class: Fluoroquinolone

Therapeutic class: Anti-infective

Pregnancy risk category C

FDA Box Warning

• Fluoroquinolones for systemic use are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in patients usually over age 60, with concomitant use of corticosteroids, and in kidney, heart, and lung transplant recipients.

Action

Inhibits bacterial DNA synthesis by inhibiting DNA gyrase in susceptible gram-negative and gram-positive organisms

Availability

Injection: 200 mg/20 ml, 400 mg/40 ml, 200 mg/100 ml premixed in dextrose 5% in water (D5W), 400 mg/200 ml premixed in D5W, 1,200 mg/120-ml bulk package

Ophthalmic ointment: 3.5-g tube

Ophthalmic solution: 2.5-ml and 5-ml plastic dispensers

Otic solution: 0.2% (0.5 mg in 0.25 ml) in single-use container

Tablets: 250 mg, 500 mg, 750 mg

Indications and dosages

Acute sinusitis

Adults: 500 mg P.O. q 12 hours or 400 mg I.V. q 12 hours for 10 days

Prostatitis

Adults: 500 mg P.O. q 12 hours or 400 mg I.V. q 12 hours for 28 days

Intra-abdominal infections

Adults: 500 mg P.O. q 12 hours or 400 mg I.V. q 12 hours for 7 to 14 days

Febrile neutropenic patients

Adults: 400 mg I.V. q 8 hours for 7 to 14 days

Gonorrhea

Adults: 500 mg P.O. as a single dose

Infectious diarrhea

Adults: 500 mg P.O. q 12 hours for 5 to 7 days

Inhalation anthrax (postexposure)

Adults: 500 mg P.O. q 12 hours for 60 days or 400 mg I.V. q 12 hours for 60 days

Children: 15 mg/kg P.O. q 12 hours for 60 days (not to exceed 500 mg/dose), or 10 mg/kg I.V. q 12 hours for 60 days, not to exceed 400 mg/dose

Infections of lower respiratory tract, skin and skin structures, bones, and joints

Adults: 500 to 750 mg P.O. q 12 hours or 400 mg I.V. q 8 hours for 7 to 14 days. Severe bone and joint infections may necessitate up to 6 weeks of therapy.

Nosocomial pneumonia

Adults: 400 mg I.V. q 8 hours for 10 to 14 days

Typhoid fever

Adults: 500 mg P.O. q 12 hours for 10 days

Urinary tract infections

Adults: 250 to 500 mg P.O. q 12 hours or 200 to 400 mg I.V. q 12 hours for 3 days in acute uncomplicated infection or for 7 to 14 days in acute complicated infection

Complicated urinary tract infections or pyelonephritis

Children ages 1 to 17: 6 to 10 mg/kg I.V. q 8 hours for 10 to 21 days (maximum, 400 mg/dose; not to be exceeded, even in patients weighing more than 51 kg [112 lb]). Or, 10 to 20 mg/kg P.O. q 12 hours for 10 to 21 days (maximum, 750 mg/dose; not to be exceeded, even in patients weighing more than 51 kg).

Acute otitis externa

Adults: Instill contents of one single-use otic solution container (0.5 mg) into affected ear b.i.d. (approximately 12 hours apart) for 7 days

Bacterial conjunctivitis caused by susceptible organisms

Adults: 0.5″ ribbon of ophthalmic ointment applied to conjunctival sac t.i.d. on first 2 days, then 0.5" ribbon b.i.d. for 5 days. Or one to two drops of ophthalmic solution applied to conjunctival sac q 2 hours while awake for 2 days, then one or two drops q 4 hours while awake for 5 days.

Corneal ulcers caused by susceptible organisms

Adults: Two drops of ophthalmic solution instilled into affected eye q 15 minutes for first 6 hours, then two drops into affected eye q 30 minutes for remainder of first day. On second day, two drops of ophthalmic solution hourly; on days 3 through 14, two drops q 4 hours.

Dosage adjustment

• Renal impairment or insufficiency

Off-label uses

• Chancroid
• Cystic fibrosis
• Pseudomembranous colitis caused by anti-infectives

Contraindications

• Hypersensitivity to drug or other fluoroquinolones
• Comcomitant administration of tizanidine

Precautions

Use cautiously in:
• cirrhosis, renal impairment, underlying CNS disease
• concurrent use of theophylline (risk of serious or fatal reactions, such as cardiac arrest, seizures, status epilepticus, and respiratory failure)
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 18 (except for complicated urinary tract infection, pyelonephritis, and postexposure inhalation antrax only).

Administration

• Administer oral drug with or without food but not with dairy products or calcium-fortified juices alone; however, drug may be taken with a meal that contains these products.
• Infuse I.V. dose over at least 1 hour, using pump to ensure 1-hour duration.

Know that too-rapid I.V. infusion increases risk of anaphylaxis and other adverse reactions.

Know that treatment with ophthalmic solution may be continued after 14 days if corneal re-epithelialization hasn't occurred.

Adverse reactions

CNS: agitation, headache, restlessness, confusion, delirium, peripheral neuropathy, toxic psychosis

CV: orthostatic hypotension, vasculitis

EENT: nystagmus; with ophthalmic use-blurred vision; burning, stinging, irritation, itching, tearing, and redness of eyes; eyelid itching, swelling, or crusting; sensitivity to light

GI: nausea, vomiting, diarrhea, constipation, abdominal pain or discomfort, dyspepsia, dysphagia, flatulence, pancreatitis, pseudomembranous colitis

GU: albuminuria, candiduria, renal calculi

Hematologic: methemoglobinemia, agranulocytosis, hemolytic anemia

Hepatic: jaundice, hepatic necrosis

Metabolic: hyperglycemia, hyperkalemia

Musculoskeletal: myalgia, myoclonus, tendinitis, tendon rupture

Skin: rash, exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme photosensitivity

Other: injection-site reaction, altered taste, anosmia, exacerbation of myasthenia gravis, overgrowth of nonsusceptible organisms, hypersensitivity reactions including anaphylaxis and Stevens-Johnson syndrome

Interactions

Drug-drug.Antacids, bismuth subsalicylate, iron salts, sucralfate, zinc salts: decreased ciprofloxacin absorption

Cyclosporine: transient creatinine increase

Hormonal contraceptives: reduced contraceptive efficacy

Oral anticoagulants: increased anticoagulant effects

Phenytoin: increased or decreased phenytoin blood level

Probenecid: decreased renal elimination of ciprofloxacin, causing increased blood level

Theophylline: increased theophylline blood level, greater risk of toxicity

Tizanidine: significantly elevated tizanidine plasma level

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, cholesterol, glucose, lactate dehydrogenase, potassium, triglycerides: increased levels Prothrombin time: prolonged

Drug-food.Caffeine: interference with caffeine clearance

Concurrent tube feedings, milk or yogurt (when consumed alone with ciprofloxacin): impaired drug absorption

Drug-herbs.Fennel: decreased drug absorption

Patient monitoring

• In patients with renal insufficiency, assess creatinine level before giving first dose and at least once a week during prolonged therapy. Monitor drug blood level closely.

Watch for signs and symptoms of serious adverse reactions, including GI problems, jaundice, tendon problems, and hypersensitivity reactions.

Patient teaching

• Tell patient to take drug with or without food at the same time each day.
• Advise patient not to take drug with dairy products or calcium-fortified juices alone or with caffeinated beverages.
• Advise patient to drink 8 oz of water every hour while awake to ensure adequate hydration.

Instruct patient to stop taking drug and notify prescriber at first sign of burning, numbness, or tingling in hands or feet; yellow eyes or skin; unusual tiredness; persistent diarrhea; rash; or tendon pain, swelling, or inflammation.
• Advise patient to avoid excessive exposure to sun or ultraviolet light and to discontinue drug and notify prescriber if phototoxicity (burning, erythema, exudation, vesicles, blistering, edema) occurs.
• Advise patient taking hormonal contraceptives to use supplemental birth control method, such as condoms, because drug reduces contraceptive efficacy.
• Inform breastfeeding patient that drug is excreted in breast milk and can affect infant's bone growth. Advise her to consult prescriber before using drug.
• Teach patient how to use eye ointment or solution and tell patient not to touch eye dropper tip to any surface, to avoid contamination.
• Instruct patient how to use ear solution and to lie with affected ear upward for at least 1 minute after instilling solution.
• Caution patient with bacterial conjunctivitis not to wear contact lenses.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and herbs mentioned above.

References in periodicals archive ?
BARCELONA, Spain, May 11 /PRNewswire/ -- SALVAT have announced plans to file their CETRAXAL Otic solution, with Its convenient, single-dispensing container (SDC) format, with the FDA.
BARCELONA, Spain -- SALVAT announced that the New Drug Application (NDA) for its CETRAXAL Otic -ciprofloxacin otic- 0.
CETRAXAL Otic, in a single dispensing container, will be the only ciprofloxacin alone solution approved by the FDA for the indication of external otitis, providing high efficacy and more convenience without the risk of steroids, aminoglycosides and preservatives.
BARCELONA, Spain, April 20 /PRNewswire/ -- SALVAT announce plans to file their CETRAXAL Otic solution, with its convenient, single-dispensing container (SDC) format, with the FDA.
BARCELONA, Spain -- SALVAT today announced that it has submitted a new drug application for their CETRAXAL Otic solution, with its convenient, single-dispensing container (SDC) format, with the FDA.
BARCELONA, Spain -- SALVAT announce plans to file their CETRAXAL Otic solution, with its convenient, single-dispensing container (SDC) format, with the FDA.
BARCELONA, Spain, April 18 /PRNewswire/ -- SALVAT announce plans to file their CETRAXAL Otic solution, with its convenient, single-dispensing container (SDC) format, with the FDA.
CETRAXAL eardrops (currently under US-FDA review) and by emphasizing collaborations regarding its pipeline products.
BARCELONA, Spain, June 10 /PRNewswire/ -- SALVAT today announced that it has submitted a new drug application for their CETRAXAL Otic solution, with its convenient, single-dispensing container (SDC) format, with the FDA.