September 25, 2016
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Cipro

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Cipro

CIPRO®
(ciprofloxacin hydrochloride) Tablets and Oral Suspension




WARNING

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

  • Fluoroquinolones, including CIPRO®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see WARNINGS AND PRECAUTIONS] including:
    • Tendinitis and tendon rupture [see WARNINGS AND PRECAUTIONS]
    • Peripheral neuropathy [see WARNINGS AND PRECAUTIONS]
    • Central nervous system effects [see WARNINGS AND PRECAUTIONS]
  • Discontinue CIPRO immediately and avoid the use of fluoroquinolones, including CIPRO, in patients who experience any of these serious adverse reactions [see WARNINGS AND PRECAUTIONS].Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis [see WARNINGS AND PRECAUTIONS].
  • Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions [see WARNINGS AND PRECAUTIONS], reserve CIPRO for use in patients who have no alternative treatment options for the following indications:

DRUG DESCRIPTION

CIPRO (ciprofloxacin hydrochloride) Tablets and CIPRO (ciprofloxacin) Oral Suspension 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)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3•HCl•H2O and its chemical structure is as follows:

CIPRO® (ciprofloxacin hydrochloride) Structural Formula Illustration

Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:

CIPRO® (ciprofloxacin hydrochloride) Structural Formula Illustration

CIPRO film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. CIPRO tablets are white to slightly yellowish. The inactive ingredients are cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycol.

CIPRO Oral Suspension is available in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. CIPRO Oral Suspension is a white to slightly yellowish suspension with strawberry flavor which may contain yellow-orange droplets. It is composed of ciprofloxacin microcapsules and diluent which are mixed prior to dispensing [see DOSAGE AND ADMINISTRATION]. The components of the suspension have the following compositions:

  • Microcapsules–ciprofloxacin, povidone, methacrylic acid copolymer, hypromellose, magnesium stearate, and Polysorbate 20.
  • Diluent–medium-chain triglycerides, sucrose, soy-lecithin, water, and strawberry flavor.
  • Five (5) mL of 5% suspension contains approximately 1.4 g of sucrose and 5 mL of 10% suspension contains approximately 1.3 g of sucrose.

What are the possible side effects of ciprofloxacin (Cipro, Cipro XR, Proquin XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ciprofloxacin and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, fainting, fast or pounding heartbeats;
  • sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;
  • diarrhea that is watery or bloody;
  • confusion, hallucinations, depression, unusual...

Read All Potential Side Effects and See Pictures of Cipro »

What are the precautions when taking ciprofloxacin (Cipro)?

Before taking ciprofloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics such as norfloxacin, gemifloxacin, levofloxacin, moxifloxacin, or ofloxacin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (such as recent heart attack), joint/tendon problems (such as tendonitis, bursitis), kidney disease, liver disease, myasthenia gravis, nerve problems (such as peripheral neuropathy), seizures, conditions that increase your risk of seizures (such as brain/head injury, brain tumors, cerebral...

Read All Potential Precautions of Cipro »

Last reviewed on RxList: 8/9/2016
This monograph has been modified to include the generic and brand name in many instances.

Cipro - User Reviews

Cipro User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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