How do you administer this medicine?
What are the possible side effects of Levofloxacin-Winthrope?
Get emergency medical help if you have signs of an allergic reaction to Levofloxacin-Winthrope: hives, or the first sign of a skin rash; rapid heart rate, difficult breathing; swelling of your face, lips, tongue, or throat.
Levofloxacin-Winthrope may cause swelling or tearing of (rupture) a tendon. Levofloxacin-Winthrope can also have serious effects on your nerves, and may cause permanent nerve damage.
Stop taking Levofloxacin-Winthrope 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 Levofloxacin-Winthrope 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 Levofloxacin-Winthrope in details
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:
- Tendon Effects
- Exacerbation of Myasthenia Gravis
- Hypersensitivity Reactions
- 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
- Photosensitivity/Phototoxicity [see
- Development of Drug Resistant Bacteria
Hypotension has been associated with rapid or bolus intravenous infusion of Levofloxacin-Winthrope. Levofloxacin-Winthrope should be infused slowly over 60 to 90 minutes, depending on dosage.
Crystalluria and cylindruria have been reported with quinolones, including Levofloxacin-Winthrope. Therefore, adequate hydration of patients receiving Levofloxacin-Winthrope 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 Levofloxacin-Winthrope 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 Levofloxacin-Winthrope for a wide variety of infectious diseases. Patients received Levofloxacin-Winthrope 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 Levofloxacin-Winthrope doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of Levofloxacin-Winthrope 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 Levofloxacin-Winthrope-treated patients and less common adverse reactions, occurring in 0.1 to <1% of Levofloxacin-Winthrope-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 Levofloxacin-Winthrope. 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 Levofloxacin-Winthrope. 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 Levofloxacin-Winthrope?
- Levofloxacin-Winthrope tablets may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Levofloxacin-Winthrope 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 Levofloxacin-Winthrope tablets. These nerve problems can happen soon after Levofloxacin-Winthrope 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).
- Levofloxacin-Winthrope tablets only works against bacteria; it does not treat viral infections (eg, the common cold).
- Be sure to use Levofloxacin-Winthrope 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 Levofloxacin-Winthrope 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.
- Levofloxacin-Winthrope 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 Levofloxacin-Winthrope tablets. Talk with your doctor before you receive any vaccine.
- Diabetes patients - Levofloxacin-Winthrope tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Levofloxacin-Winthrope tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Levofloxacin-Winthrope tablets.
- Lab tests, including liver and kidney function and complete blood cell counts, may be performed while you use Levofloxacin-Winthrope 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 Levofloxacin-Winthrope tablets with caution in the ELDERLY; they may be more sensitive to its effects especially tendon problems, irregular heartbeat, and liver problems.
- Levofloxacin-Winthrope 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 Levofloxacin-Winthrope tablets while you are pregnant. Levofloxacin-Winthrope tablets is found in breast milk. Do not breast-feed while using Levofloxacin-Winthrope tablets.
Patients hypersensitive to Levofloxacin-Winthrope or any other quinolones or any excipients of Levofloxacin-Winthrope. Patients with epilepsy and those with history of tendon disorder related to fluoroquinolone administration.
Use in pregnancy: Levofloxacin-Winthrope 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, Levofloxacin-Winthrope 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, Levofloxacin-Winthrope 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 Levofloxacin-Winthrope, cause arthropathy and osteochondrosis in juvenile animals of several species.
Elderly: The pharmacokinetic properties of Levofloxacin-Winthrope in younger adults and elderly do not differ significantly when creatinine clearance is taken into consideration. However, since Levofloxacin-Winthrope is known to be substantially excreted by the kidney, the risk of toxic reactions to Levofloxacin-Winthrope 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).
ReviewsThe results of a survey conducted on ndrugs.com for Levofloxacin-Winthrope 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 Levofloxacin-Winthrope. 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.
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Information checked by Dr. Sachin Kumar, MD Pharmacology