"The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
(ciprofloxacin) Extended-release Tablets
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
- Fluoroquinolones, including
CIPRO XR, have been associated with disabling and potentially irreversible
serious adverse reactions that have occurred together [see WARNINGS AND
- Tendinitis and tendon rupture [see WARNINGS AND PRECAUTIONS]
- Peripheral neuropathy [see WARNINGS AND PRECAUTIONS]
- Central nervous system effects [see WARNINGS AND PRECAUTIONS]
Discontinue CIPRO XR immediately and avoid the use of fluoroquinolones, including CIPRO XR, in patients who experience any of these serious adverse reactions [see WARNINGS AND PRECAUTIONS]
- Fluoroquinolones, including CIPRO XR, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid CIPRO XR 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 uncomplicated urinary tract infections [see INDICATIONS AND USAGE]
CIPRO XR (ciprofloxacin*) extended-release tablets contain ciprofloxacin, a synthetic antimicrobial agent for oral administration. CIPRO XR tablets are coated, bilayer tablets consisting of an immediate-release layer and an erosion-matrix type controlled-release layer. The tablets contain a combination of two types of ciprofloxacin drug substance, ciprofloxacin hydrochloride and ciprofloxacin betaine (base). Ciprofloxacin hydrochloride is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid hydrochloride. It is provided as a mixture of the monohydrate and the sesquihydrate. The empirical formula of the monohydrate is C17H18FN3O3 • HCl • H2O and its molecular weight is 385.8. The empirical formula of the sesquihydrate is C17H18FN3O3 • HCl • 1.5 H2O and its molecular weight is 394.8. The drug substance is a faintly yellowish to light yellow crystalline substance. The chemical structure of the monohydrate is as follows:
Ciprofloxacin betaine is 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. As a hydrate, its empirical formula is C17H18FN3O3 • 3.5 H2O and its molecular weight is 394.3. It is a pale yellowish to light yellow crystalline substance and its chemical structure is as follows:
CIPRO XR is available in 500 mg and 1000 mg (ciprofloxacin equivalent) tablet strengths. CIPRO XR tablets are nearly white to slightly yellowish, film-coated, oblong-shaped tablets. Each CIPRO XR 500 mg tablet contains 500 mg of ciprofloxacin as ciprofloxacin HCl (287.5 mg, calculated as ciprofloxacin on the dried basis) and ciprofloxacin† (212.6 mg, calculated on the dried basis). Each CIPRO XR 1000 mg tablet contains 1000 mg of ciprofloxacin as ciprofloxacin HCl (574.9 mg, calculated as ciprofloxacin on the dried basis) and ciprofloxacin† (425.2 mg, calculated on the dried basis). The inactive ingredients are crospovidone, hypromellose, magnesium stearate, polyethylene glycol, silica colloidal anhydrous, succinic acid, and titanium dioxide.
* as ciprofloxacin† and
† does not comply with the loss on drying test and residue on ignition test of the USP monograph.
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...
What are the precautions when taking ciprofloxacin extended-release (Cipro XR)?
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...
Last reviewed on RxList: 8/8/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Cipro XR Information
Cipro XR - User Reviews
Cipro XR User Reviews
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