What happens if I overdose Ciprofloxacin 0.3% Thephaco?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Ciprofloxacin 0.3% Thephaco:
Ciprofloxacin 0.3% Thephaco is usually handled and stored by a health care provider. If you are using Ciprofloxacin 0.3% Thephaco at home, store Ciprofloxacin 0.3% Thephaco as directed by your pharmacist or health care provider. Keep Ciprofloxacin 0.3% Thephaco out of the reach of children and away from pets.
Overdose of Ciprofloxacin 0.3% Thephaco in details
In the event of acute overdosage, the patient should be carefully observed and given supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria. Adequate hydration must be maintained. Only a small amount of Ciprofloxacin 0.3% Thephaco (<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 0.3% Thephaco between 125 and 300 mg/kg.
What should I avoid while taking Ciprofloxacin 0.3% Thephaco?
Avoid caffeine while you are using Ciprofloxacin 0.3% Thephaco, because the medicine can make the effects of caffeine stronger.
Avoid exposure to sunlight or tanning beds. Ciprofloxacin 0.3% Thephaco 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.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using Ciprofloxacin 0.3% Thephaco and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Ciprofloxacin 0.3% Thephaco may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Ciprofloxacin 0.3% Thephaco warnings
Care should be taken for therapy withCiprofloxacin to pregnant women, nursing women and children below 18 years of age.
Ciprofloxacin 0.3% Thephaco may cause convulsions, toxic psychosis, C.N.S events including dizziness, confusion, tremors, hallucination and depression. The drug is discontinued and appropriate therapy instituted.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia which is the cause of antibiotic associated colitis.
Ciprofloxacin 0.3% Thephaco has not been shown to be effective in the treatment of syphilis.
Ciprofloxacin 0.3% Thephaco may cause rarely crystaluria because human urine is acidic, but it is more frequent in animals because it is alkaline and therefore alkalinity of the patients urine receiving Ciprofloxacin 0.3% Thephaco is avoided and patients should be highly hydrated to avoid concentration of the urine
Phototoxicty represented by sun burn is observed in patients receiving quinolone therapy while they are exposed to direct sun light.
Ciprofloxacin 0.3% Thephaco should not be taken concurrently with milk while dietary calcium will affect absorption of Ciprofloxacin 0.3% Thephaco.
What should I discuss with my healthcare provider before taking Ciprofloxacin 0.3% Thephaco?
Some medical conditions may interact with Ciprofloxacin 0.3% Thephaco. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you wear contact lenses
Some MEDICINES MAY INTERACT with Ciprofloxacin 0.3% Thephaco. Because little, if any, of Ciprofloxacin 0.3% Thephaco is absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Ciprofloxacin 0.3% Thephaco may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Ciprofloxacin 0.3% Thephaco precautions
Crystals of Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco has been reported only rarely in humans because human urine is usually acidic. Alkalinity of the urine should be avoided in patients receiving Ciprofloxacin 0.3% Thephaco. Patients should be well hydrated to prevent the formation of highly concentrated urine.
Central Nervous System
Quinolones, including Ciprofloxacin 0.3% Thephaco, 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 0.3% Thephaco 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.
Information for Patients
Patients should be advised:
- To contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Ciprofloxacin 0.3% Thephaco treatment. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
- That fluoroquinolones like Ciprofloxacin 0.3% Thephaco may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Patients should call their healthcare provider right away if they have any worsening muscle weakness or breathing problems.
- That antibacterial drugs including Ciprofloxacin 0.3% Thephaco for oral suspension should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When Ciprofloxacin 0.3% Thephaco for oral suspension 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 0.3% Thephaco for oral suspension or other antibacterial drugs in the future.
- That Ciprofloxacin 0.3% Thephaco may be taken with or without meals and to drink fluids liberally. As with other quinolones, concurrent administration of Ciprofloxacin 0.3% Thephaco with magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder, other highly buffered drugs, or with other products containing calcium, iron or zinc should be avoided. Ciprofloxacin 0.3% Thephaco may be taken two hours before or six hours after taking these products. Ciprofloxacin 0.3% Thephaco should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since absorption of Ciprofloxacin 0.3% Thephaco may be significantly reduced; however, Ciprofloxacin 0.3% Thephaco may be taken with a meal that contains these products.
- That Ciprofloxacin 0.3% Thephaco may be associated with hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash or other allergic reaction.
- That photosensitivity/phototoxicity has been reported in patients receiving quinolones. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, patients should contact their physician.
- That peripheral neuropathies have been associated with Ciprofloxacin 0.3% Thephaco use, that symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, patients should immediately discontinue Ciprofloxacin 0.3% Thephaco for oral suspension and contact their physician.
- That Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco increases the effects of tizanidine (Zanaflex®). Patients should not use Ciprofloxacin 0.3% Thephaco if they are already taking tizanidine.
- That Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco, and to notify their physician before taking this drug if there is a history of this condition.
- That Ciprofloxacin 0.3% Thephaco has been associated with an increased rate of adverse events involving joints and surrounding tissue structures (like tendons) in pediatric patients (less than 18 years of age). Parents should inform their child's physician if the child has a history of joint-related problems before taking this drug. Parents of pediatric patients should also notify their child's physician of any joint-related problems that occur during or following Ciprofloxacin 0.3% Thephaco therapy..
- That diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
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 0.3% Thephaco (500 mg BID for 3 days). The hypotensive and sedative effects of tizanidine were also potentiated. Concomitant administration of tizanidine and Ciprofloxacin 0.3% Thephaco is contraindicated.
As with some other quinolones, concurrent administration of Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco, 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 0.3% Thephaco 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 0.3% Thephaco, 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 0.3% Thephaco.
Concomitant administration of a single tablet dose of 500 mg Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco
Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant Ciprofloxacin 0.3% Thephaco. To avoid the loss of seizure control associated with decreased phenytoin levels, and to prevent phenytoin overdose-related undesirable effects when Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco with phenytoin.
Oral Antidiabetic Agents
Hypoglycemia has been reported when Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco with glyburide has, on rare occasions, resulted in severe hypoglycemia. Fatalities have been reported.
The serum concentrations of Ciprofloxacin 0.3% Thephaco and metronidazole were not altered when these two drugs were given concomitantly.
Some quinolones, including Ciprofloxacin 0.3% Thephaco, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
Simultaneous administration of Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco with an oral anticoagulant (for example, warfarin).
Probenecid interferes with renal tubular secretion of Ciprofloxacin 0.3% Thephaco and produces an increase in the level of Ciprofloxacin 0.3% Thephaco in the serum. This should be considered if patients are receiving both drugs concomitantly.
Renal tubular transport of methotrexate may be inhibited by concomitant administration of Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco therapy is indicated.
Metoclopramide significantly accelerates the absorption of oral Ciprofloxacin 0.3% Thephaco resulting in shorter time to reach maximum plasma concentrations. No significant effect was observed on the bioavailability of Ciprofloxacin 0.3% Thephaco.
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 0.3% Thephaco, similar effects can be expected upon concomitant administration.
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.
In a study conducted in 12 patients with Parkinson's disease who were administered 6 mg ropinirole once daily with 500 mg Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco.
In a study conducted in 9 healthy volunteers, concomitant use of 1.5 mg/kg IV lidocaine with 500 mg Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco and an increase in side effects related to lidocaine may occur upon concomitant administration.
Following concomitant administration of 250 mg Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco are advised..
Following concomitant administration of a single oral dose of 50 mg sildenafil with 500 mg Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco.
Drugs Known To Prolong QT Interval
Precaution should be taken when using Ciprofloxacin 0.3% Thephaco concomitantly with drugs known to prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) as Ciprofloxacin 0.3% Thephaco may have an additive effect on the QT interval.
CARCINOGENESIS, MUTAGENESIS & IMPAIRMENT OF FERTILITY
Eight in vitro mutagenicity tests have been conducted with Ciprofloxacin 0.3% Thephaco, 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 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco. The time to development of the first skin tumors was 50 weeks in mice treated concomitantly with UVA and Ciprofloxacin 0.3% Thephaco (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 0.3% Thephaco 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 0.3% Thephaco up to 100 mg/kg (approximately 0.7-times the highest recommended therapeutic dose based upon mg/m2) revealed no evidence of impairment.
Teratogenic Effects. Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco exposed children.
Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures).11 There were 70 Ciprofloxacin 0.3% Thephaco exposures, all within the first trimester. The malformation rates among live-born babies exposed to Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco.
No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco. In rabbits, oral Ciprofloxacin 0.3% Thephaco 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.
Ciprofloxacin 0.3% Thephaco is excreted in human milk. The amount of Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco, 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.
Ciprofloxacin 0.3% Thephaco, like other quinolones, causes arthropathy and histological changes in weight-bearing joints of juvenile animals resulting in lameness.
Inhalational Anthrax (Post-Exposure)
Ciprofloxacin 0.3% Thephaco is indicated in pediatric patients for inhalational anthrax (post-exposure). The risk-benefit assessment indicates that administration of Ciprofloxacin 0.3% Thephaco to pediatric patients is appropriate. For information regarding pediatric dosing in inhalational anthrax (post-exposure), see and.
Complicated Urinary Tract Infection and Pyelonephritis
Ciprofloxacin 0.3% Thephaco is indicated for the treatment of complicated urinary tract infections and pyelonephritis due to Escherichia coli. Although effective in clinical trials, Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco arm compared to 31% (109/349) in the control arm.
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 0.3% Thephaco IV 10 mg/kg/dose q8h for one week followed by Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco.
Musculoskeletal adverse events in patients with cystic fibrosis were reported in 22% of the patients in the Ciprofloxacin 0.3% Thephaco group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the Ciprofloxacin 0.3% Thephaco group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco. 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 0.3% Thephaco can not be definitively determined, particularly since patients with cystic fibrosis may develop arthralgias/arthritis as part of their underlying disease process.
Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Ciprofloxacin 0.3% Thephaco. 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 0.3% Thephaco to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco encompassing over 3500 Ciprofloxacin 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco 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 0.3% Thephaco?
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.
- DailyMed. "CIPROFLOXACIN; DEXAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "ciprofloxacin". http://www.drugbank.ca/drugs/DB00537 (accessed September 17, 2018).
- MeSH. "Topoisomerase II Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- FDA Medication Guides. "Cipro: FDA Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. ". https://www.accessdata.fda.gov/drugs... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology