Ciprofloxacin (oral route)

Brand Name

US Brand Name

Cipro

Description

Ciprofloxacin is used to treat bacterial infections in many different parts of the body. Ciprofloxacin oral liquid and tablets are also used to treat anthrax infection after inhalational exposure. This medicine is also used to treat and prevent plague (including pneumonic and septicemic plague). Ciprofloxacin may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Ciprofloxacin extended-release tablets are only used to treat urinary tract infections, including acute uncomplicated pyelonephritis.

Proquin® XR tablets are only used to treat uncomplicated or simple urinary tract infections (acute cystitis).

Ciprofloxacin belongs to the class of drugs known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Powder for Suspension
Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ciprofloxacin in children. However, because of this medicine's toxicity, it should be used with caution, after other medicines have been considered and found ineffective. Ciprofloxacin oral liquid or tablet may be used in children to prevent anthrax infection after possible exposure, and to treat serious kidney infections.

Appropriate studies have not been performed on the relationship of age to the effects of ciprofloxacin extended-release tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ciprofloxacin in the elderly. However, elderly patients are more likely to have age-related kidney or heart problems, or develop severe tendon problems (including tendon rupture), which may require caution in patients receiving ciprofloxacin.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Agomelatine
Bepridil
Cisapride
Dronedarone
Fezolinetant
Flibanserin
Levoketoconazole
Lomitapide
Mesoridazine
Pimozide
Piperaquine
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Tizanidine
Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acalabrutinib
Acarbose
Acecainide
Adagrasib
Albiglutide
Alfentanil
Alfuzosin
Alogliptin
Alosetron
Alprazolam
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Anagrelide
Apomorphine
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Artemether
Asenapine
Astemizole
Atazanavir
Avapritinib
Azimilide
Azithromycin
Bedaquiline
Bendamustine
Benzhydrocodone
Betamethasone
Bosutinib
Bretylium
Brigatinib
Budesonide
Buprenorphine
Bupropion
Buserelin
Canagliflozin
Capivasertib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aceclofenac
Aluminum Carbonate, Basic
Aluminum Hydroxide
Aluminum Phosphate
Aminolevulinic Acid
Amlodipine
Calcium
Chloroquine
Diclofenac
Didanosine
Dihydroxyaluminum Aminoacetate
Dihydroxyaluminum Sodium Carbonate
Dutasteride
Fosphenytoin
Iron
Lanthanum Carbonate
Levothyroxine
Magaldrate
Magnesium Carbonate
Magnesium Hydroxide
Magnesium Oxide
Magnesium Trisilicate
Patiromer
Phenytoin
Probenecid
Rifapentine
Ropinirole
Ropivacaine
Sevelamer
Sildenafil
Sucralfate

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine
Dairy Food

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take one dose a day, try to take it at the same time each day.

If you need to take this medicine for anthrax infection, your doctor will want you to begin using it as soon as possible after you are exposed to anthrax.

You may swallow the Cipro® tablet whole or break it in half at the score line. Do not crush or chew it. Tell your doctor if you have trouble swallowing the tablet.

Swallow the extended-release tablet whole. Do not crush, split, or chew it.

Shake the oral liquid for at least 15 seconds just before each use. The oral liquid has small microcapsules floating in it. These microcapsules may look like bubbles or small beads. Do not chew the microcapsules when you take the oral liquid. Measure the oral liquid with the marked measuring spoon that comes with the bottle.

You may take this medicine with or without food. However, Proquin® XR tablets should be taken with a main meal, preferably the evening meal.

Drink plenty of fluids while you are using this medicine. Drinking extra water will help prevent some unwanted effects of ciprofloxacin.

Do not take this medicine alone with milk, yogurt, or other dairy products. Do not drink any juice with calcium added when you take this medicine. It is okay to have dairy products or juice as part of a larger meal when you take this medicine.

If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, didanosine (Videx®), lanthanum carbonate (Fosrenol®), sevelamer (Renagel®), sucralfate (Carafate®), or any products containing calcium or zinc, do not take them at the same time that you take this medicine. It is best to take these medicines at least 2 hours before or 4 to 6 hours after taking ciprofloxacin. These medicines may keep ciprofloxacin from working properly.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (extended-release tablets):
- For acute uncomplicated pyelonephritis:
  - Adults—1000 milligrams (mg) once a day.
  - Children—Use and dose must be determined by your doctor.
- For complicated urinary tract infections:
  - Adults—1000 milligrams (mg) once a day.
  - Children—Use and dose must be determined by your doctor.
- For uncomplicated urinary tract infections (acute cystitis):
  - Adults—500 milligrams (mg) once a day for 3 days.
  - Children—Use and dose must be determined by your doctor.
For oral dosage forms (suspension or tablets):
- For anthrax infection (post-exposure):
  - Adults—500 milligrams (mg) 2 times a day, taken every 12 hours for 60 days.
  - Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligram (mg) per kilogram (kg) of body weight every 12 hours for 60 days. However, the dose is usually not more than 500 mg per day.
- For gonorrhea:
  - Adults—250 milligrams (mg) taken as a single dose.
  - Children—Use and dose must be determined by your doctor.
- For other infections:
  - Adults—250 to 750 milligrams (mg) 2 times a day, taken every 12 hours.
  - Children—Use and dose must be determined by your doctor.
- For plague:
  - Adults—500 to 750 milligrams (mg) 2 times a day, taken every 12 hours for 14 days.
  - Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligram (mg) per kilogram (kg) of body weight every 8 to 12 hours for 14 days. However, the dose is usually not more than 500 mg per day.
- For urinary tract or serious kidney infections:
  - Adults—250 to 500 milligrams (mg) 2 times a day, taken every 12 hours for 7 to 14 days.
  - Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 10 to 20 milligrams (mg) per kilogram (kg) of body weight every 12 hours for 10 to 21 days. However, the dose is usually not more than 750 mg per day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of the oral liquid or tablet and it is 6 hours or more until your next regular dose, take the missed dose as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 6 hours until your next regular dose, skip the missed dose and take your next dose at the regular time.

If you miss a dose of the extended-release tablet and it is 8 hours or more until your next regular dose, take the missed dose as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 8 hours until your next regular dose, skip the missed dose and take your next dose at the regular time.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store the oral liquid at room temperature or in the refrigerator. Do not freeze the bottle. Do not keep the mixed oral liquid for more than 14 days. Throw away any unused liquid after 14 days.

Precautions

It is very important that your doctor check your or your child's progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Do not use this medicine if you are also taking tizanidine (Zanaflex®). Tell your doctor if you or your child are also using theophylline (Theo-Dur®) or other products that contain caffeine (eg, coffee, soda, chocolate). Using these medicines together may increase the risk for more serious side effects.

Ciprofloxacin may rarely cause inflammation (tendinitis) or tearing of a tendon (the cord that attaches muscles to bones). This can occur while you are taking the medicine or after you finish taking it. The risk of having tendon problems may be increased if you are over 60 years of age, are using steroid medicines (eg, dexamethasone, prednisolone, prednisone, Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or if you have received an organ transplant (eg, heart, kidney, or lung). Check with your doctor right away if you have sudden pain or swelling in a tendon after exercise (eg, ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or are unable to bear weight or move the affected area. Refrain from exercise until your doctor says otherwise.

Tell your doctor right away if you have feeling anxious, confused, or depressed, seeing, hearing, or feeling things that are not there, seizures, severe headache, trouble sleeping, or unusual thoughts or behaviors. These may be symptoms of serious mental problems.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hives, hoarseness, trouble or swallowing, or any swelling of your hands, face, mouth, or throat after you take this medicine.

Serious side effects can occur during treatment with this medicine and can sometimes occur without warning. However, possible warning signs include: black, tarry stools, blistering, peeling, or loosening of the skin, bloody or cloudy urine, chills, decreased urination, diarrhea, fever, joint or muscle pain, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, or yellow skin or eyes. Check with your doctor immediately if you or your child notice any of these warning signs.

Check with your doctor right away if you have dark urine, clay-colored stools, stomach pain, or yellow eyes or skin. These maybe symptoms of a serious liver problem.

Ciprofloxacin may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Ciprofloxacin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you or your child stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Check with your doctor right away if you or your child start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.

This medicine may increase your risk for aortic aneurysm (bulge in the wall of the largest artery). Check with your doctor right away if you have sudden chest, stomach, or back pain, trouble breathing, cough, or hoarseness.

Some people who take ciprofloxacin may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn, skin rash, redness, itching, or discoloration. When you begin using this medicine:

Stay out of direct sunlight, especially between the hours of 10:00 AM and 3:00 PM, if possible.
Wear protective clothing, including a hat and sunglasses.
Apply a sun block product that has a sun protection factor (SPF) of at least 15. Some people may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Ciprofloxacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these reactions are especially bothersome, check with your doctor.

If you are a diabetic patient taking diabetes medicine by mouth: Ciprofloxacin may cause hypoglycemia (low blood sugar) in some patients. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. If you experience symptoms of low blood sugar, check with your doctor right away.

Symptoms of low blood sugar can include: anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty with concentrating, drowsiness, excessive hunger, headache, nausea, nervousness, rapid heartbeat, shakiness, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Diarrhea

Rare

Bloody or black, tarry stools
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
changes in skin color
changes in urination
chest pain, discomfort, tightness, or heaviness
chills
clumsiness or unsteadiness
confusion
continuing ringing or buzzing or other unexplained noise in the ears
coughing or spitting up blood
dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
fast, irregular, pounding, or racing heartbeat or pulse
fever
headache, severe and throbbing
hearing loss
hives or welts, skin rash
joint stiffness
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
light-colored stools
muscle pain or stiffness
nausea
nightmares
numbness of the hands
pain in the joints
pain or discomfort in the arms, jaw, back, or neck
painful, red lumps under the skin, mostly on the legs
pounding in the ears
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness of the face, neck, arms, and occasionally, upper chest
seizures
severe stomach pain, cramping, or burning
shakiness in the legs, arms, hands, or feet
swelling of the face, feet, or lower legs
swollen, painful, or tender lymph glands in the neck, armpit, or groin
thick, white vaginal discharge with no odor or with a mild odor
unsteadiness, trembling, or other problems with muscle control or coordination
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
vomiting
white patches in the mouth or on the tongue
yellow eyes or skin

Incidence not known

Blistering, peeling, or loosening of the skin
bluish-colored lips, fingernails, or palms
bone pain
diarrhea, watery and severe, which may also be bloody
difficulty with breathing, chewing, or talking
double vision
excessive muscle tone
feeling of discomfort
feeling, seeing, or hearing things that are not there
increased sensitivity of the skin to sunlight
increased sensitivity to pain or touch
irregular or slow heart rate
loss of sense of smell
mood changes
nosebleeds
rapid heart rate
red skin lesions, often with a purple center
seeing, hearing, or feeling things that are not there
sensation of skin burning
severe sunburn
sores, ulcers, or white spots on the lips or in the mouth
uncontrolled eye movements
unusual bleeding or bruising
unusual excitement, nervousness, or restlessness
vaginal yeast infection

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Runny or stuffy nose
sneezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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