Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Brand Name : Ciproxin Descriptions 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. 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 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 tablets 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. Pregnancy Information about this ciprofloxacin-oral-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breastfeeding Studies in women suggest that this medication poses minimal risk to the infant when used during 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 • Amifampridine • Cisapride • Dronedarone • Lomitapide • Mesoridazine • Pimozide • Piperaquine • Sparfloxacin • Thioridazine • Tizanidine 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. • Acarbose • Acecainide • Acetohexamide • Alfuzosin • Alosetron • Amiodarone • Amitriptyline • Amoxapine • Apomorphine • Arsenic Trioxide • Artemether • Asenapine • Astemizole • Azimilide • Azithromycin • Bendamustine • Benfluorex • Bosutinib • Bretylium • Chlorpromazine • Chlorpropamide • Citalopram • Clarithromycin • Clomipramine • Clozapine • Crizotinib • Dasatinib • Desipramine • Disopyramide • Dofetilide • Dolasetron • Domperidone • Droperidol • Eltrombopag • Erythromycin • Fentanyl • Fingolimod • Flecainide • Fluconazole • Fluoxetine • Gatifloxacin • Gemifloxacin • Gliclazide • Glimepiride • Glipizide • Gliquidone • Glyburide • Granisetron • Guar Gum • Halofantrine • Haloperidol • Hydrocodone • Ibrutinib • Ibutilide • Iloperidone • Imipramine • Insulin • Insulin Aspart, Recombinant • Insulin Glulisine • Insulin Lispro, Recombinant • Ivabradine • Lapatinib • Levofloxacin • Lopinavir • Lumefantrine • Lurasidone • Mefloquine • Metformin • Methadone • Mifepristone • Miglitol • Moricizine • Moxifloxacin • Nilotinib • Norfloxacin • Nortriptyline • Octreotide • Ofloxacin • Ondansetron • Paliperidone • Pazopanib • Perflutren Lipid Microsphere • Pomalidomide • Posaconazole • Procainamide • Prochlorperazine • Promethazine • Propafenone • Protriptyline • Quetiapine • Quinidine • Quinine • Ranolazine • Salmeterol • Saquinavir • Sematilide • Simeprevir • Simvastatin • Sodium Phosphate • Sodium Phosphate, Dibasic • Sodium Phosphate, Monobasic • Solifenacin • Sorafenib • Sotalol • Sunitinib • Tedisamil • Telavancin • Telithromycin • Terfenadine • Tetrabenazine • Theophylline • Tolazamide • Tolbutamide • Toremifene • Trazodone • Trifluoperazine • Trimipramine • Troglitazone • Vandetanib • Vardenafil • Vemurafenib • Vilanterol • Vinflunine • Voriconazole • Warfarin • Ziprasidone 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. • Aluminum Carbonate, Basic • Aluminum Hydroxide • Aluminum Phosphate • Betamethasone • Calcium • Chloroquine • Corticotropin • Cortisone • Cosyntropin • Cyclosporine • Deflazacort • Dexamethasone • Diclofenac • Didanosine • Dihydroxyaluminum Aminoacetate • Dihydroxyaluminum Sodium Carbonate • Dutasteride • Erlotinib • Fludrocortisone • Fluocortolone • Fosphenytoin • Hydrocortisone • Itraconazole • Lanthanum Carbonate • Magaldrate • Magnesium Carbonate • Magnesium Hydroxide • Magnesium Oxide • Magnesium Trisilicate • Methylprednisolone • Mycophenolate Mofetil • Olanzapine • Paramethasone • Phenytoin • Prednisolone • Prednisone • Probenecid • Rasagiline • Rifapentine • Ropinirole • Ropivacaine • Sevelamer • Sildenafil • Sucralfate • Triamcinolone • Zolpidem 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 Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: • Bradycardia (slow heartbeat) or • Diabetes or • Diarrhea or • Heart attack, history of or • Heart disease (eg, heart failure) or • Heart rhythm problems (eg, prolonged QT interval), or family history of or • Hypokalemia (low potassium in the blood), uncorrected or • Hypomagnesemia (low magnesium in the blood), uncorrected or • Liver disease or • Seizures (epilepsy), history of or • Stroke, history of—Use with caution. May make these conditions worse. • Brain disease (eg hardening of the arteries) or • Kidney disease, severe or • Organ transplant (eg, heart, kidney, or lung), history of or • Tendon disorder (eg, rheumatoid arthritis), history of—Use with caution. May cause side effects to become worse. Myasthenia gravis (severe muscle weakness)—Should not be used in patients with this condition. 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 taking it as soon as possible after you are exposed to anthrax. 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 taking 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 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 complicated urinary tract infections: Adults—1000 milligrams (mg) once a day. Children—Use and dose must be determined by your doctor. For acute uncomplicated pyelonephritis: Adults—1000 milligrams (mg) once a day. Children—Use and dose must be determined by your doctor. • For oral dosage forms (suspension or tablets): For infections: Adults—250 to 750 milligrams (mg) two times a day, taken every 12 hours. Children—Use and dose must be determined by your doctor. For urinary tract or serious kidney infections: Adults—250 to 500 milligrams (mg) two times a day, taken every 12 hours. 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. However, the dose is usually not more than 750 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 anthrax infection (post-exposure): Adults—500 milligrams (mg) two times a day, taken every 12 hours. 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. However, the dose is usually not more than 500 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. Do not take more than one extended-release tablet each day. 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. 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 risks 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. 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 breathing, trouble 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. Sometimes serious side effects can occur without warning. However, possible warning signs are including 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, and/or lower legs, unusual bleeding or bruising, unusual weight gain, or yellow skin or eyes. Stop taking this medicine and 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, abdominal or stomach pain, or yellow eyes or skin. These maybe symptoms of a serious liver problem. 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. 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. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. 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, stop taking ciprofloxacin and check with your doctor right away: • Symptoms of low blood sugar can include: Anxious feeling, 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. 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 or discomfort • chest tightness or heaviness • chills or fever • clumsiness or unsteadiness • confusion • continuing ringing or buzzing or other unexplained noise in the ears • coughing or spitting up blood • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position • fast, irregular, pounding, or racing heartbeat or pulse • headache, severe and throbbing • hearing loss • hives or welts • joint stiffness • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs • light-colored stools • muscle pain or stiffness • nausea and vomiting • 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 abdominal or stomach pain, cramping, or burning • shakiness in the legs, arms, hands, or feet • skin rash • 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 • white patches in the mouth and/or on the tongue • yellow eyes or skin Incidence not known • Acid or sour stomach • 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 to pain • increased sensitivity to touch • irregular or slow heart rate • mood changes • nosebleeds • rapid heart rate • red skin lesions, often with a purple center • sores, ulcers, or white spots on the lips or in the mouth • 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 nose • sneezing • stuffy nose 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.