Get emergency medical help if you have signs of an allergic reaction to Floxabact: hives, or the first sign of a skin rash; rapid heart rate, difficult breathing; swelling of your face, lips, tongue, or throat.
Floxabact may cause swelling or tearing of (rupture) a tendon. Floxabact can also have serious effects on your nerves, and may cause permanent nerve damage.
Stop taking Floxabact and call your doctor at once if you have:
severe stomach pain, diarrhea that is watery or bloody;
headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
sudden weakness or ill feeling, fever, chills, sore throat, swollen glands, mouth sores, easy bruising or bleeding;
muscle weakness or trouble breathing;
liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
signs of tendon rupture - sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions);
nerve symptoms - numbness, tingling, burning pain, or being more sensitive to temperature, light touch, or the sense of your body position;
changes in mood or behavior - depression, confusion, hallucinations, paranoia, tremors, feeling restless or anxious, unusual thoughts or behavior, insomnia, nightmares;
increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
severe skin reaction - skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common Floxabact side effects may include:
nausea, constipation, diarrhea;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Floxabact in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
Serious and Otherwise Important Adverse Reactions
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
Exacerbation of Myasthenia Gravis
Other Serious and Sometimes Fatal Reactions
Central Nervous System Effects
Clostridium difficile-Associated Diarrhea
Peripheral Neuropathy that may be irreversible
Prolongation of the QT Interval
Musculoskeletal Disorders in Pediatric Patients
Blood Glucose Disturbances
Development of Drug Resistant Bacteria
Hypotension has been associated with rapid or bolus intravenous infusion of Floxabact. Floxabact should be infused slowly over 60 to 90 minutes, depending on dosage.
Crystalluria and cylindruria have been reported with quinolones, including Floxabact. Therefore, adequate hydration of patients receiving Floxabact should be maintained to prevent the formation of a highly concentrated urine.
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Floxabact in 7537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black. Patients were treated with Floxabact for a wide variety of infectious diseases. Patients received Floxabact doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3 to 14 days, and the mean number of days on therapy was 10 days.
The overall incidence, type and distribution of adverse reactions was similar in patients receiving Floxabact doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of Floxabact due to adverse drug reactions occurred in 4.3% of patients overall, 3.8% of patients treated with the 250 mg and 500 mg doses and 5.4% of patients treated with the 750 mg dose. The most common adverse drug reactions leading to discontinuation with the 250 and 500 mg doses were gastrointestinal (1.4%), primarily nausea (0.6%); vomiting (0.4%); dizziness (0.3%); and headache (0.2%). The most common adverse drug reactions leading to discontinuation with the 750 mg dose were gastrointestinal (1.2%), primarily nausea (0.6%), vomiting (0.5%); dizziness (0.3%); and headache (0.3%).
Adverse reactions occurring in ≥1% of Floxabact-treated patients and less common adverse reactions, occurring in 0.1 to <1% of Floxabact-treated patients, are shown in Table 6 and Table 7, respectively. The most common adverse drug reactions (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness.
In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including Floxabact. The relationship of the drugs to these events is not presently established.
Table 8 lists adverse reactions that have been identified during post-approval use of Floxabact. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.
What is the most important information I should know about Floxabact?
Floxabact tablets may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Floxabact tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
Nerve problems in the arms, hands, legs, or feet can happen in people taking Floxabact tablets. These nerve problems can happen soon after Floxabact tablets is started and may be permanent. Call your doctor right away if you have symptoms or nerve problems (eg, not able to handle heat or cold; decreased sensation of touch; unusual burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet).
Floxabact tablets only works against bacteria; it does not treat viral infections (eg, the common cold).
Be sure to use Floxabact tablets for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
Long-term or repeated use of Floxabact tablets may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
Tell your doctor right away if you experience pain or swelling of a tendon or weakness or loss of use of a joint area. Rest the area and avoid exercise until further instruction from your doctor.
Floxabact tablets may cause you to become sunburned more easily. Avoid sunlamps, tanning booths, and try to limit your time in the sun. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Do not receive a live vaccine (eg, typhoid) while you are taking Floxabact tablets. Talk with your doctor before you receive any vaccine.
Diabetes patients - Floxabact tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Floxabact tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Floxabact tablets.
Lab tests, including liver and kidney function and complete blood cell counts, may be performed while you use Floxabact tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Floxabact tablets with caution in the ELDERLY; they may be more sensitive to its effects especially tendon problems, irregular heartbeat, and liver problems.
Floxabact tablets should be used with extreme caution in CHILDREN younger than 18 years old; they may be more sensitive to its effects, especially joint and tendon problems.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Floxabact tablets while you are pregnant. Floxabact tablets is found in breast milk. Do not breast-feed while using Floxabact tablets.
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
Patients hypersensitive to Floxabact or any other quinolones or any excipients of Floxabact. Patients with epilepsy and those with history of tendon disorder related to fluoroquinolone administration.
Use in pregnancy: Floxabact caused no impairment of fertility or reproductive performance in rats at oral doses as high as 360 mg/kg/day. It was not teratogenic in rats at oral doses as high as 810 mg/kg/day or at IV dose up to 160 mg/kg/day. No teratogenicity was observed when rabbits were dosed orally as high as 50 mg/kg/day.
In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, Floxabact must not be used in pregnant women or women suspected of being pregnant.
Use in lactation: In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, Floxabact must not be used in breastfeeding women.
Use in children: Safety and effectiveness in pediatric patients and adolescents <16 years have not been established. Quinolones, including Floxabact, cause arthropathy and osteochondrosis in juvenile animals of several species.
Elderly: The pharmacokinetic properties of Floxabact in younger adults and elderly do not differ significantly when creatinine clearance is taken into consideration. However, since Floxabact is known to be substantially excreted by the kidney, the risk of toxic reactions to Floxabact may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
DailyMed. "LEVOFLOXACIN: 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).
DTP/NCI. "LEVOFLOXACIN: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "(-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Floxabact are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Floxabact. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported side effects
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