Cipro XR

DRUG DESCRIPTION

CIPRO XR (ciprofloxacin* extended-release tablets) contains ciprofloxacin, a synthetic broad-spectrum 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)-3-quinolinecarboxylic 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 hydrochloride Structural Formula Illustration

Ciprofloxacin betaine is 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(l-piperazinyl)-3-quinolinecarboxylic acid. As a hydrate, its empirical formula is C17H18FN3O33.5 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 HC1 (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 HC1 (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.

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

Stop using ciprofloxacin and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ciprofloxacin and call your doctor at once if you have any of these serious side effects:

  • dizziness, fainting, fast or pounding heartbeat;
  • sudden pain or swelling near your joints (especially in your arm or ankle);
  • diarrhea that is watery or bloody;
  • confusion,...

Read All Potential Side Effects and See Pictures of Cipro XR

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 (e.g., recent heart attack), joint/tendon problems (e.g., tendonitis, bursitis), kidney disease, liver disease, myasthenia gravis, nervous system disorder (e.g., peripheral neuropathy), seizure disorder, conditions that increase your risk of seizures (e.g., brain/head injury, brain tumors,...

Read All Potential Precautions of Cipro XR


Cipro XR Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, diarrhea, dizziness, lightheadedness, headache, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., anxiety, confusion, hallucinations, depression, rare thoughts of suicide), shaking (tremors), skin that sunburns more easily (sun sensitivity).

Ciprofloxacin may rarely cause serious nerve problems that may be reversible if identified and treated early. Seek immediate medical attention if you develop any of the following symptoms: pain/numbness/burning/tingling/weakness in any part of the body, changes in how you sense touch/pain/temperature/body position/vibration.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual bruising/bleeding, severe/persistent headache, signs of a new infection (e.g., new/persistent fever, persistent sore throat), unusual change in the amount of urine, change in color of urine (red/pink urine), signs of liver problems (e.g., unusual tiredness, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine), vision changes.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat, seizures.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 (e.g., recent heart attack), joint/tendon problems (e.g., tendonitis, bursitis), kidney disease, liver disease, myasthenia gravis, nervous system disorder (e.g., peripheral neuropathy), seizure disorder, conditions that increase your risk of seizures (e.g., brain/head injury, brain tumors, cerebral atherosclerosis).

Ciprofloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using ciprofloxacin, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ciprofloxacin safely.

This medication may rarely cause serious changes in blood sugar levels, especially if you have diabetes. Watch for symptoms of high blood sugar including increased thirst and urination. Also watch for symptoms of low blood sugar such as nervousness, shakiness, fast heartbeat, sweating, or hunger. Check your blood sugar regularly as directed by your doctor and report any changes. If you experience symptoms of low blood sugar, you may raise your blood sugar by using glucose tablets/gel or eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this drug in children because they may be more sensitive to its possible side effects (e.g., joint/tendon problems). Discuss the risks and benefits with the doctor.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to its side effects such as tendon problems (especially if they are also taking corticosteroids such as prednisone or hydrocortisone) or heart problems. Discuss the risks and benefits with your doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Cipro XR Patient Information Including Side Effects

Brand Names: Cipro, Cipro XR, Proquin XR

Generic Name: ciprofloxacin (oral) (Pronunciation: SIP roe FLOX a sin)

  • What is ciprofloxacin (Cipro XR)?
  • What are the possible side effects of ciprofloxacin (Cipro XR)?
  • What is the most important information I should know about ciprofloxacin (Cipro XR)?
  • What should I discuss with my healthcare provider before taking ciprofloxacin (Cipro XR)?
  • How should I take ciprofloxacin (Cipro XR)?
  • What happens if I miss a dose (Cipro XR)?
  • What happens if I overdose (Cipro XR)?
  • What should I avoid while taking ciprofloxacin (Cipro XR)?
  • What other drugs will affect ciprofloxacin (Cipro XR)?
  • Where can I get more information?

What is ciprofloxacin (Cipro XR)?

Ciprofloxacin is an antibiotic in a group of drugs called fluoroquinolones (flor-o-KWIN-o-lones). Ciprofloxacin fights bacteria in the body.

Ciprofloxacin is used to treat different types of bacterial infections.

Ciprofloxacin may also be used for other purposes not listed in this medication guide.

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

Stop using ciprofloxacin and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ciprofloxacin and call your doctor at once if you have any of these serious side effects:

  • dizziness, fainting, fast or pounding heartbeat;
  • sudden pain or swelling near your joints (especially in your arm or ankle);
  • diarrhea that is watery or bloody;
  • confusion, hallucinations, depression, unusual thoughts or behavior;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, weakness;
  • urinating less than usual or not at all;
  • easy bruising or bleeding;
  • numbness, tingling, or unusual pain anywhere in your body;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

  • nausea, vomiting;
  • dizziness or drowsiness;
  • blurred vision;
  • feeling nervous, anxious, or agitated;
  • sleep problems (insomnia or nightmares); or
  • increased sensitivity of the skin to sunlight.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ciprofloxacin (Cipro XR)?

You should not use this medication if you are taking tizanidine (Zanaflex), or if you are allergic to ciprofloxacin or similar antibiotics such as levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), norfloxacin (Noroxin), lomefloxacin (Maxaquin), and others.

Do not take ciprofloxacin with dairy products such as milk or yogurt, or with calcium-fortified juice. You may eat or drink dairy products or calcium-fortified juice with a regular meal, but do not use them alone when taking ciprofloxacin. They could make the medication less effective.

Before taking ciprofloxacin, tell your doctor if you have kidney or liver disease, myasthenia gravis, joint problems, diabetes, a history of seizures, low levels of potassium in your blood (hypokalemia), or a personal or family history of "Long QT syndrome."

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 6 hours before or 2 hours after you take ciprofloxacin. These other medicines can make ciprofloxacin much less effective when taken at the same time.

Ciprofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking ciprofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

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