How do you administer this medicine? |
What happens if I overdose Ciprofloxacin?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of ciprofloxacin:
Ciprofloxacin is usually handled and stored by a health care provider. If you are using ciprofloxacin at home, store ciprofloxacin as directed by your pharmacist or health care provider. Keep ciprofloxacin out of the reach of children and away from pets.
Overdose of Ciprofloxacin in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.In the event of acute overdosage, the patient should be carefully observed and given supportive treatment, including monitoring of renal function. Adequate hydration must be maintained. Only a small amount of ciprofloxacin (< 10%) is removed from the body after hemodialysis or peritoneal dialysis.
In mice, rats, rabbits and dogs, significant toxicity including tonic/clonic convulsions was observed at intravenous doses of ciprofloxacin between 125 and 300 mg/kg.
DOSAGE AND ADMINISTRATION
Adults
Ciprofloxacin Injection, USP should be administered to adults by intravenous infusion over a period of 60 minutes at dosages described in the Dosage Guidelines table. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
Ciprofloxacin Injection, USP should be administered by intravenous infusion over a period of 60 minutes.
Conversion of I.V. to
Oral Dosing in Adults
Ciprofloxacin Tablets and ciprofloxacin
Oral Suspension for oral administration are available.
Parenteral therapy may be switched to oral ciprofloxacin when the condition warrants, at the discretion of the physician.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance:
Men: Creatinine clearance (mL/min) = Weight (kg) x (140-age)
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
For patients with changing renal function or for patients with renal impairment and hepatic insufficiency, careful monitoring is suggested.
Pediatrics
Ciprofloxacin Injection, USP should be administered as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed.
Dosing and initial route of therapy (i.e., IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
Preparation of Ciprofloxacin Injection, USP for Administration
Vials (Injection Concentrate)
THIS PREPARATION MUST BE DILUTED BEFORE USE. The intravenous dose should be prepared by aseptically withdrawing the concentrate from the vial of Ciprofloxacin Injection, USP. This should be diluted with a suitable intravenous solution to a final concentration of l-2mg/mL. The resulting solution should be infused over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.
If the Y-type or "piggyback" method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of Ciprofloxacin Injection, USP. If the concomitant use of Ciprofloxacin Injection, USP and another drug is necessary each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.
Flexible Containers
Ciprofloxacin Injection, USP is also available as a 0.2% premixed solution in 5% dextrose in flexible containers of 100 mL or 200 mL. The solutions in flexible containers do not need to be diluted and may be infused as described above.
Compatibility and Stability
Ciprofloxacin Injection 1% (10 mg/mL), when diluted with the following intravenous solutions to concentrations of 0.5 to 2.0 mg/mL, is stable for up to 14 days at refrigerated or room temperature storage.
- 0.9% Sodium Chloride Injection, USP
- 5% Dextrose Injection, USP
- Sterile Water for Injection
- 10% Dextrose for Injection
- 5% Dextrose and 0.225% Sodium Chloride for Injection
- 5% Dextrose and 0.45% Sodium Chloride for Injection
- Lactated Ringer’s for Injection
What should I avoid while taking Ciprofloxacin?
Do not take ciprofloxacin with dairy products such as milk or yogurt, or with calcium-fortified juice. You may eat or drink these products as part of a regular meal, but do not use them alone when taking ciprofloxacin. They could make the medication less effective.
Avoid taking the following medicines 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:
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antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids), or the ulcer medicine sucralfate (Carafate);
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didanosine (Videx) powder or chewable tablets;
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a phosphate binder such as lanthanum carbonate (Fosrenol) or sevelamer (Renagel); or
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vitamin or mineral supplements that contain calcium, iron, or zinc.
Avoid caffeine while you are taking this medicine, because the medication can make the effects of caffeine stronger.
Ciprofloxacin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Avoid exposure to sunlight or tanning beds. Ciprofloxacin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.
Ciprofloxacin warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.Patients should be advised:
· that antibacterial drugs, including Ciprofloxacin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Ciprofloxacin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Ciprofloxacin or other antibacterial drugs in the future.
· that Ciprofloxacin should only be used to treat uncomplicated urinary tract infections (also known as bladder infections). The safety and efficacy of Ciprofloxacin to treat other urinary tract or non-urinary tract infections have not been studied.
· that Ciprofloxacin should be taken with a main meal of the day, preferably the evening meal. The patient should not take more than one Ciprofloxacin tablet per day, even if the patient misses a dose.
· that Ciprofloxacin tablets should be taken whole and never split, crushed, or chewed.
· that concomitant administration of Ciprofloxacin with aluminum or magnesium-containing antacids, sucralfate, VIDEX (didanosine) chewable buffered tablets or pediatric powder, metal cations such as iron and calcium, and multivitamin preparations containing zinc should be avoided. Ciprofloxacin should be administered at least 4 hours before or 2 hours after these products.
· that Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, since the absorption of ciprofloxacin may be significantly reduced. However, Ciprofloxacin may be taken with a meal that contains these products.
· that ciprofloxacin may be associated with hypersensitivity reactions, even following a single dose, and to discontinue Ciprofloxacin at the first sign of a skin rash or other allergic reaction and contact their physician.
· to avoid excessive sunlight or artificial ultraviolet (UV) light while receiving Ciprofloxacin and to discontinue therapy if phototoxicity occurs.
· that peripheral neuropathies have been associated with ciprofloxacin use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, patients should discontinue treatment and contact their physician.
· that if they experience pain, inflammation, or rupture of a tendon to discontinue treatment, to inform their physician, and to rest and refrain from exercise.
· to contact their doctor if they do not feel better of if they develop fever and back pain while or after taking Ciprofloxacin.
· that Ciprofloxacin may cause dizziness and lightheadedness; therefore, patients should know how they react to this drug before they operate an automobile or machinery or engage in activities requiring mental alertness or coordination.
· that Ciprofloxacin may increase the effects of theophylline and caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones.
· that convulsions have been reported in patients receiving quinolones, including ciprofloxacin, and to notify their physician before taking this drug if there is a history of this condition.
Ciprofloxacin (ciprofloxacin hydrochloride) Extended-Release Tablets PROQUIN® XR (prōkwin) (ciprofloxacin hydrochloride) Extended-Release Tablets, 500 mg This leaflet contains important information about Ciprofloxacin (ciprofloxacin hydrochloride) extended-release tablets and should be read before you begin treatment. This leaflet does not replace talking with your doctor about your medical condition or your treatment. This leaflet does not list all benefits and risks of Ciprofloxacin. Ciprofloxacin can be prescribed only by a doctor. If you have any questions about Ciprofloxacin, talk to your doctor. Only your doctor can tell you if Ciprofloxacin is right for you. What is Ciprofloxacin? Ciprofloxacin is an antibiotic in the class known as "quinolones" that is used to treat adults with simple (uncomplicated) urinary tract infections (also known as "bladder infections") caused by bacteria. It is not known if Ciprofloxacin will treat infections other than bladder infections. Ciprofloxacin, like all other antibiotics, does not kill viruses. You should contact your doctor if you do not feel better or if you develop fever and back pain while or after taking Ciprofloxacin. Ciprofloxacin tablets are blue and contain 500 mg of active drug. How should I take Ciprofloxacin? · Ciprofloxacin should be taken once a day for 3 days shortly after a main meal of the day, preferably the evening meal. Ciprofloxacin does not work as well if you take it without a meal. You should try to take Ciprofloxacin at about the same time each day. · Take Ciprofloxacin for all 3 days, even if you are feeling better. If you stop taking Ciprofloxacin before all 3 doses, Ciprofloxacin may not cure your bladder infection. · Do not split, crush, or chew Ciprofloxacin tablets. Ciprofloxacin tablets must be swallowed whole. Tell your doctor if you cannot swallow tablets whole. Your doctor will prescribe a different medicine for you. · Do not take more than one Ciprofloxacin tablet a day, even if you miss a dose. · Do not take Ciprofloxacin at the same time that you drink milk or juices with added calcium, unless you drink them with a main meal. · Many antacids and multivitamins may interfere with the absorption of Ciprofloxacin if taken at the same time. Take Ciprofloxacin at least 4 hours before or 2 hours after antacids that contain magnesium or aluminum. Ciprofloxacin should also be taken at least 4 hours before or 2 hours after sucralfate, VIDEX® (didanosine) chewable buffered tablets or pediatric powder, iron, calcium, and vitamins that contain zinc. Who should not take Ciprofloxacin? Do not take Proquin XR if you are allergic to or have ever had a severe reaction to ciprofloxacin or to any other "quinolone" antibiotics. Ciprofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. If you are pregnant or planning to become pregnant while taking Ciprofloxacin, talk to your doctor before taking this medication. Ciprofloxacin is not recommended for children. What should I tell my doctor before taking Ciprofloxacin? Tell you doctor about all of your medical conditions, including if you have or ever had seizures (epilepsy), asthma, or liver or kidney problems. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Ciprofloxacin and certain other medicines can affect each other. You may have to adjust the times you take certain other medicines, vitamins, and herbal supplements. Especially, tell your doctor if you take: theophylline, VIDEX® (didanosine) chewable buffered tablets or pediatric powder; warfarin (Coumadin®); glyburide (Glucovance®, Micronase®, DiaBeta®); phenytoin (Dilantin®); sucralfate (Carafate®); or antacids or vitamins that contain magnesium, calcium, aluminum, iron, or zinc. Know the medicines you take. Keep a list of them to show your doctor and pharmacist. What are the possible side effects of Ciprofloxacin? Ciprofloxacin is generally well tolerated. The most common side effects with Ciprofloxacin include vaginal yeast infection and headache. Less common side effects include nausea, diarrhea, dizziness, and abdominal pain. You should be careful about driving or operating machinery until you are sure the Ciprofloxacin is not causing dizziness or lightheadedness. Rare cases of allergic reactions have been reported in patients receiving quinolones, including ciprofloxacin, even after just one dose. Stop taking Ciprofloxacin and call your doctor or get emergency medical attention right away if you develop a rash, hives, swelling of your face or throat, or have trouble breathing. Some patients taking quinolone antibiotics may become more sensitive to sunlight or ultraviolet light such as that used in tanning salons. You should avoid excessive exposure to sunlight or ultraviolet light while taking Ciprofloxacin. Ciprofloxacin has rarely been associated with inflammation of the tendons. Stop taking Ciprofloxacin and call your doctor if you experience pain, swelling, or rupture of a tendon. Convulsions have been reported in patients receiving quinolone antibiotics including ciprofloxacin. Tell your doctor if you have experienced convulsions in the past. Quinolones, including ciprofloxacin, have been rarely associated with other central nervous system events including confusion, tremors, hallucinations, and depression. Stop taking Ciprofloxacin and call your doctor right away if you get any of these symptoms. These are not all the side effects with Ciprofloxacin. For more information, ask your doctor or pharmacist. How should I store Ciprofloxacin? · Store Ciprofloxacin at room temperature, 59° to 86° F (15° to 30° C). · Keep Ciprofloxacin and all medicines out of the reach of children. General information about Proquin XR Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Ciprofloxacin for a condition for which it was not prescribed. Do not give Ciprofloxacin to other people, even if they have the same symptoms you have. It may harm them. Keep this medication out of the reach of children. This leaflet summarizes the most important information about Ciprofloxacin. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Ciprofloxacin that is written for health care professionals. Further information is also provided at: 1-800-206-2945 and www. Proquin.com What are the ingredients in Ciprofloxacin? Active Ingredient: ciprofloxacin hydrochloride Inactive Ingredients: film coating, magnesium stearate, polyethylene oxide, and povidone You should not use this medication if you are allergic to ciprofloxacin, or if: you are also taking tizanidine; or you are allergic to other fluoroquinolones (gemifloxacin, levofloxacin, moxifloxacin, ofloxacin, norfloxacin, and others). You may not be able to use ciprofloxacin if you have a muscle disorder. Tell your doctor if you have a history of myasthenia gravis. To make sure ciprofloxacin is safe for you, tell your doctor if you have: a heart rhythm disorder, especially if you take medication to treat it; a personal or family history of Long QT syndrome; tendon problems, arthritis or other joint problems (especially in children); a muscle or nerve disorder; trouble swallowing pills; liver disease; kidney disease (or if you are on dialysis); seizures or epilepsy; a history of head injury or brain tumor; diabetes (especially if you take oral diabetes medication); low levels of potassium in your blood (hypokalemia); if you use a blood thinner (warfarin, Coumadin) and have "INR" or prothrombin time tests. 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. This can happen during treatment or up to several months after you stop taking ciprofloxacin. Tendon problems may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. FDA pregnancy category C. It is not known whether ciprofloxacin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Ciprofloxacin can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine. Crystals of ciprofloxacin have been observed rarely in the urine of human subjects but more frequently in the urine of laboratory animals, which is usually alkaline. Crystalluria related to ciprofloxacin has been reported only rarely in humans because human urine is usually acidic. Alkalinity of the urine should be avoided in patients receiving ciprofloxacin. Patients should be well hydrated to prevent the formation of highly concentrated urine. Quinolones, including ciprofloxacin, may also cause central nervous system (CNS) events, including: nervousness, agitation, insomnia, anxiety, nightmares or paranoia. Alteration of the dosage regimen is necessary for patients with impairment of renal function.. Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, "V" area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if phototoxicity occurs (see. As with any potent drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic function, is advisable during prolonged therapy. Prescribing ciprofloxacin for oral suspension in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Patients should be advised:Patient Leaflet
What should I discuss with my healthcare provider before taking Ciprofloxacin?
Ciprofloxacin precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
General
Central Nervous System
Renal Impairment
Photosensitivity/Phototoxicity
Information for Patients
Drug Interactions
Tizanidine
In a pharmacokinetic study, systemic exposure of tizanidine (4 mg single dose) was significantly increased (Cmax 7-fold, AUC 10-fold) when the drug was given concomitantly with ciprofloxacin (500 mg BID for 3 days). The hypotensive and sedative effects of tizanidine were also potentiated. Concomitant administration of tizanidine and ciprofloxacin is contraindicated.
Theophylline
As with some other quinolones, concurrent administration of ciprofloxacin with theophylline may lead to elevated serum concentrations of theophylline and prolongation of its elimination half-life. This may result in increased risk of theophylline-related adverse reactions. If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.
Other Xanthine Derivatives
Some quinolones, including ciprofloxacin, have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and a prolongation of its serum half-life. On concurrent administration of ciprofloxacin and caffeine or pentoxifylline containing products, elevated serum concentrations of these xanthine derivatives were reported.
Chelation Complex Formation
Concurrent administration of a quinolone, including ciprofloxacin, with multivalent cation-containing products such as magnesium/aluminum antacids, polymeric phosphate binders (for example. sevelamer, lanthanum carbonate) sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder, other highly buffered drugs, or products containing calcium, iron, or zinc may substantially decrease its absorption, resulting in serum and urine levels considerably lower than desired.
Histamine H2-receptor antagonists appear to have no significant effect on the bioavailability of ciprofloxacin.
Omeprazole
Concomitant administration of a single tablet dose of 500 mg ciprofloxacin and once-daily administration of 20 mg omeprazole pretreatment for 4 days resulted in a 16%reduction of mean Cmax and mean AUC of ciprofloxacin
Phenytoin
Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant ciprofloxacin. To avoid the loss of seizure control associated with decreased phenytoin levels, and to prevent phenytoin overdose-related undesirable effects when ciprofloxacin is discontinued in patients receiving both agents, monitoring of phenytoin therapy, including phenytoin serum concentration measurements, is recommended during and shortly after co-administration of ciprofloxacin with phenytoin.
Oral Antidiabetic Agents
Hypoglycemia has been reported when ciprofloxacin and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. The concomitant administration of ciprofloxacin with glyburide has, on rare occasions, resulted in severe hypoglycemia. Fatalities have been reported.
Metronidazole
The serum concentrations of ciprofloxacin and metronidazole were not altered when these two drugs were given concomitantly.
Cyclosporine
Some quinolones, including ciprofloxacin, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
Oral Anti-coagulants
Simultaneous administration of ciprofloxacin with an oral anticoagulant may augment the effect of the anticoagulant. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of ciprofloxacin to the increase in INR (international normalized ratio) is difficult to assess. Prothrombin time and INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with an oral anticoagulant (for example, warfarin).
Probenecid
Probenecid interferes with renal tubular secretion of ciprofloxacin and produces an increase in the level of ciprofloxacin in the serum. This should be considered if patients are receiving both drugs concomitantly.
Methotrexate
Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin potentially leading to increased plasma levels of methotrexate. This might increase the risk of methotrexate associated toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant ciprofloxacin therapy is indicated.
Metoclopramide
Metoclopramide significantly accelerates the absorption of oral ciprofloxacin resulting in shorter time to reach maximum plasma concentrations. No significant effect was observed on the bioavailability of ciprofloxacin.
Duloxetine
In clinical studies it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme such as fluvoxamine, may result in a 5-fold increase in mean AUC and a 2.5-fold increase in mean Cmax of duloxetine. Although no clinical data are available on a possible interaction with ciprofloxacin, similar effects can be expected upon concomitant administration.
NSAIDs
Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies.
Ropinirole
In a study conducted in 12 patients with Parkinson's disease who were administered 6 mg ropinirole once daily with 500 mg ciprofloxacin twice-daily, the mean Cmax and mean AUC of ropinirole were increased by 60% and 84%, respectively. Monitoring for ropinirole-related side effects and appropriate dose adjustment of ropinirole is recommended during and shortly after co-administration with ciprofloxacin.
Lidocaine
In a study conducted in 9 healthy volunteers, concomitant use of 1.5 mg/kg IV lidocaine with 500 mg ciprofloxacin twice daily, resulted in an increase of lidocaine Cmax and AUC by 12% and 26%, respectively. Although lidocaine treatment was well tolerated at this elevated exposure, a possible interaction with ciprofloxacin and an increase in side effects related to lidocaine may occur upon concomitant administration.
Clozapine
Following concomitant administration of 250 mg ciprofloxacin with 304 mg clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Careful monitoring of clozapine associated adverse effects and appropriate adjustment of clozapine dosage during and shortly after co-administration with ciprofloxacin are advised..
Sildenafil
Following concomitant administration of a single oral dose of 50 mg sildenafil with 500 mg ciprofloxacin to healthy subjects, the mean Cmax and mean AUC of sildenafil were both increased approximately two-fold. Therefore, sildenafil should be used with caution when co-administered with ciprofloxacin.
Drugs Known To Prolong QT Interval
Precaution should be taken when using ciprofloxacin concomitantly with drugs known to prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) as ciprofloxacin may have an additive effect on the QT interval.
CARCINOGENESIS, MUTAGENESIS & IMPAIRMENT OF FERTILITY
Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below:
Salmonella/Microsome Test (Negative)
E. coli DNA Repair Assay (Negative)
Mouse Lymphoma Cell Forward Mutation Assay (Positive)
Chinese Hamster V79 Cell HGPRT Test (Negative)
Syrian Hamster Embryo Cell Transformation Assay (Negative)
Saccharomyces cerevisiae Point Mutation Assay (Negative)
Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative)
Rat Hepatocyte DNA Repair Assay (Positive)
Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results:
Rat Hepatocyte DNA Repair Assay
Micronucleus Test (Mice)
Dominant Lethal Test (Mice)
Long-term carcinogenicity studies in rats and mice resulted in no carcinogenic or tumorigenic effects due to ciprofloxacin at daily oral dose levels up to 250 and 750 mg/kg to rats and mice, respectively (approximately 1.7- and 2.5- times the highest recommended therapeutic dose based upon mg/m2).
Results from photo co-carcinogenicity testing indicate that ciprofloxacin does not reduce the time to appearance of UV-induced skin tumors as compared to vehicle control. Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 78 weeks while concurrently being administered ciprofloxacin. The time to development of the first skin tumors was 50 weeks in mice treated concomitantly with UVA and ciprofloxacin (mouse dose approximately equal to maximum recommended human dose based upon mg/m2), as opposed to 34 weeks when animals were treated with both UVA and vehicle. The times to development of skin tumors ranged from 16 to 32 weeks in mice treated concomitantly with UVA and other quinolones.5
In this model, mice treated with ciprofloxacin alone did not develop skin or systemic tumors. There are no data from similar models using pigmented mice and/or fully haired mice. The clinical significance of these findings to humans is unknown.
Fertility studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg (approximately 0.7-times the highest recommended therapeutic dose based upon mg/m2) revealed no evidence of impairment.
Pregnancy
Teratogenic Effects. Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother. An expert review of published data on experiences with ciprofloxacin use during pregnancy by TERIS – the Teratogen Information System – concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data=fair), but the data are insufficient to state that there is no risk.9
A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation.10 In utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations. The reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1 to 5%). Rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the ciprofloxacin exposed children.
Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures).11 There were 70 ciprofloxacin exposures, all within the first trimester. The malformation rates among live-born babies exposed to ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. No specific patterns of congenital abnormalities were found. The study did not reveal any clear adverse reactions due to in utero exposure to ciprofloxacin.
No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy.9,10 However, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses. Reproduction studies have been performed in rats and mice using oral doses up to 100 mg/kg (0.6 and 0.3 times the maximum daily human dose based upon body surface area, respectively) and have revealed no evidence of harm to the fetus due to ciprofloxacin. In rabbits, oral ciprofloxacin dose levels of 30 and 100 mg/kg (approximately 0.4- and 1.3-times the highest recommended therapeutic dose based upon mg/m2) produced gastrointestinal toxicity resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose level. After intravenous administration of doses up to 20 mg/kg (approximately 0.3-times the highest recommended therapeutic dose based upon mg/m2) no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed.
Nursing Mothers
Ciprofloxacin is excreted in human milk. The amount of ciprofloxacin absorbed by the nursing infant is unknown. Because of the potential risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking ciprofloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Ciprofloxacin, like other quinolones, causes arthropathy and histological changes in weight-bearing joints of juvenile animals resulting in lameness.
Inhalational Anthrax (Post-Exposure)
Ciprofloxacin is indicated in pediatric patients for inhalational anthrax (post-exposure). The risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate. For information regarding pediatric dosing in inhalational anthrax (post-exposure), see and.
Complicated Urinary Tract Infection and Pyelonephritis
Ciprofloxacin is indicated for the treatment of complicated urinary tract infections and pyelonephritis due to Escherichia coli. Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to the controls, including events related to joints and/or surrounding tissues. The rates of these events in pediatric patients with complicated urinary tract infection and pyelonephritis within six weeks of follow-up were 9.3% (31/335) versus 6% (21/349) for control agents. The rates of these events occurring at any time up to the one year follow-up were 13.7% (46/335) and 9.5% (33/349), respectively. The rate of all adverse events regardless of drug relationship at six weeks was 41% (138/335) in the ciprofloxacin arm compared to 31% (109/349) in the control arm.
Cystic Fibrosis
Short-term safety data from a single trial in pediatric cystic fibrosis patients are available. In a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5-17 years), 67 patients received ciprofloxacin IV 10 mg/kg/dose q8h for one week followed by ciprofloxacin tablets 20 mg/kg/dose q12h to complete 10-21 days treatment and 62 patients received the combination of ceftazidime IV 50 mg/kg/dose q8h and tobramycin IV 3 mg/kg/dose q8h for a total of 10-21 days. Patients less than 5 years of age were not studied. Safety monitoring in the study included periodic range of motion examinations and gait assessments by treatment-blinded examiners. Patients were followed for an average of 23 days after completing treatment (range 0-93 days). This study was not designed to determine long term effects and the safety of repeated exposure to ciprofloxacin.
Musculoskeletal adverse events in patients with cystic fibrosis were reported in 22% of the patients in the ciprofloxacin group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the ciprofloxacin group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the ciprofloxacin group and 11% in the comparison group. Other adverse events were similar in nature and frequency between treatment arms. One of sixty-seven patients developed arthritis of the knee nine days after a ten day course of treatment with ciprofloxacin. Clinical symptoms resolved, but an MRI showed knee effusion without other abnormalities eight months after treatment. However, the relationship of this event to the patient's course of ciprofloxacin can not be definitively determined, particularly since patients with cystic fibrosis may develop arthralgias/arthritis as part of their underlying disease process.
Geriatric Use
Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as ciprofloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing ciprofloxacin to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue ciprofloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur.
In a retrospective analysis of 23 multiple-dose controlled clinical trials of ciprofloxacin encompassing over 3500 ciprofloxacin treated patients, 25% of patients were greater than or equal to 65 years of age and 10% were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. Ciprofloxacin is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. No alteration of dosage is necessary for patients greater than 65 years of age with normal renal function. However, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients.
In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia)..
What happens if I miss a dose of Ciprofloxacin?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.
References
- DrugBank. "ciprofloxacin". http://www.drugbank.ca/drugs/DB00537 (accessed September 18, 2017).
- MeSH. "Topoisomerase II Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/680590... (accessed September 18, 2017).
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Information checked by Dr. Sachin Kumar, MD Pharmacology