Tavanic Sanofi solution to treat infections (100ml)
Dosage form Box X 100ml
Specifications Levofloxacin
Ingredient
| Composition information | Content |
| Levofloxacin | 500mg |
Uses
Indications
Tavanic infusion solution indicated treatment in the following cases:
Tavanic is a synthetic antibiotic belonging to the Fluoroquinolon group. The drug works by killing bacterial bacteria in the body.
Mechanism of impact
is an antibacterial drug of fluoroquinolon, levofloxacin inhibits the synthetic DNA of bacteria by acting on the DNA-DNA Gyrase and Topoisomerase IV complex.
Pharmacy and pharmaceutical relationship
The level of bactericidal activity of levofloxacin depends on the ratio of the maximum concentration of the drug in serum (CMAX) or the area under the curve (AUC) with a minimum inhibitory concentration (Mic).
resistance mechanism
resistance to levofloxacin obtained through a step -by -step process by having mutations in the destination position of all types of Topoisomerase TIP II, DNA Gyrase and Topoisomerase TIP IV. Other anti -drug mechanisms such as osmotic barriers (common in Pseudomonas Aeruginosa) and pump mechanisms that can also affect the sensitivity to Levofloxacin. There is a cross -resistance between levofloxacin and other fluoroquinolones. Due to the impact mechanism, usually there is no cross -resistance between levofloxacin and other group antibiotics.
fractures
Eucast suggests mic fractures for levofloxacin, here there is a separation of bacterial sensitivity strains with intermediate sensitive bacteria and intermediate sensitive bacteria strains with resistance strains, presented in the table below to check the mic (Mg/L).
Clinical mic fractures for levofloxacin, according to Eucast (version 2.0, 2012):
streptococcus pneumoniae1 2 Fluoroquinolon resistance is low (mic ciprofloxacin is 0.12-0.5 mg/l) may occur but there is no evidence that this resistance is clinically importance in respiratory infections caused by H Influenzae. 3 strains with mic values on sensitive breaks are very rare or have not been reported. The determination and inspection of the province sensitive to antibiotics for any such isolated strains must be repeated and state the confirmation results, the sample should be sent to the reference lab. Until there is clinical evidence of clinical response to the sagging certified with larger mic than the current fracture, it is necessary to report this antibiotic resistance status. 4 broken points apply for a dose of 500 mg x 1 to 500 mg x 2 times and one | Intravenous dose of 500 mg x 1 to 500 mg x 2 times.
Bacterial species are often sensitive
Gas Gram -positive bacteria:
Anaerobic bacteria:
Other:
Aerobic gram -positive bacteria
Aerobic gram -positive bacteria:
#s. Methicillin Aureus is very resistant to fluoroquinolon, including levofloxacin.
pharmacokinetic
absorption
Stable blood concentration is reached within 48 hours after taking 500 mg of levofloxacin once or twice daily.
distribution
about 30-40% levofloxacin is associated with serum protein. The average distribution of levofloxacin is about 100 liters after a single dose and repeats 500 mg, showing a wide distribution of drugs into the body tissue.
penetrates into tissues and fluids
levofloxacin has been shown to penetrate the bronchial mucosa, epithelium lining, alveolar, lung tissue, skin (fluid in the skin of the skin), prostate tissue and urine. However, Levofloxacin penetrates poorly into the cerebrospinal fluid.
Biological Change
Levofloxacin is very small, metabolic substances are desmethyl-levofloxacin and levofloxacin n-oxide. These metabolites account for
Elimination
After intravenous injection, levofloxacin is relatively slowly eliminated from plasma (t ½ = 6-8 hours). Excretion mainly through the kidney (> 85% dose). The average average clearance of levofloxacin after a single dose of 500 mg is 175 ± 29.2 ml/min. There is no difference in levofloxacin pharmacokinetics after intravenous injection and after drinking, suggesting that intravenous and oral infusion can be replaced,
linear properties
Levofloxacin pharmacokinetics are linearly in the dose range from 50 to 1000 mg.
Special population
Object of renal failure: levofloxacin pharmacokinetics affected by kidney failure. Reducing kidney function, elimination function and reduced clearance level reducing the sale time, shown according to the table below:
Pharmacokinetic pharmacokinetics on the subject of renal failure after a single dose of 500 mg by oral:
There is no significant difference in pharmacokinetics Levofloxacin among young and elderly subjects, unless people have a difference in creatinine clearance.
Gender difference:
separate analysis for male and female subjects shows a small difference in margin for levofloxacin pharmacokinetics. There is no evidence that these gender differences are clinically related.
Before taking Tavanic Sanofi solution to treat infections (100ml)
How to use
Tavanic infusion solution is only used for slow intravenous infusion; The drug is used once or twice daily. Injecting time must be at least 30 minutes for 250 mg of levofloxacin (50 ml of infusion solution) or at least 60 minutes for 500 mg of levofloxacin (100 ml of infusion solution). After a few days, it is possible to switch from in the beginning to oral intravenously to the same dose, depending on the condition of the patient.
Skin protection avoids sunlight
It is necessary to avoid direct sunlight during Tavanic. The skin of the patient will be more sensitive to the sun and may suffer from burns, burning or blistering without applying the following precautions
Use sunscreen with high index.
Always wear hats and wear long sleeves and pants.
Avoid sunbathing.
Dosage
Tavanic is used once or twice daily. Dosage depends on the type and severity of infection and the sensitivity of the hypothetical pathogen.
Treatment time
Duration of treatment varies depending on the type of disease (see below). Like antibiotic treatment in general, it is advisable to continue using Tavanic for at least 48 to 72 hours after the fever is gone or there is evidence of bacterial deduction.
If you stop using Tavanic
Do not stop using Tavanic yourself just because the patient feels better. It is important to complete the Tavanic course that the doctor has prescribed.
If you stop taking Tavanic too early, infection will recur, the condition of the patient may be worse or the bacteria will become resistant.
Dosage in patients with normal renal function (clearing creatinine> 50 ml/minute):
Caution for patients with renal failure
Because levofloxacin is mainly excreted in water, reduces the dose in patients with renal failure. Related information is presented in the following table:
No dose adjustment, because levofloxacin is not metabolized in the liver at any level.
Elderly patients
No need to adjust the dose in the elderly, in addition to considering the possibility of renal function decline (see warning and caution when taking the drug).
Children's patients
Contraindicated to use Tavanic for children and teenagers is growing.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? Qt.
Affects the central nervous system including confusion, convulsions, hallucinations, and shaking tremors after being circulated in the market.
If an overdose occurs, patients should be closely monitored, including ECG testing and symptom treatment should be conducted. Dialysis, including peritoneal and peritoneal fertilizer, is constantly working, not effective to eliminate levofloxacin from the body. There is currently no specific antidote.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
The following information is based on data from clinical studies in 8300 patients and based on the experience used after the drug is widely circulated.
The frequency in this table is defined according to the following convention: Very common (≥1/10), common (≥1/100,
In each frequency group, unwanted effects are presented in the order of severity. Against disease Nonflower tank Platelet reduction Neutral leukemia Reduce all blood cells grain leukemia Hematalate anemia Hypersensitivity (see caution when taking the drug) Anaphylaxis* Anaphylaxis shock* (see caution when taking the drug) Metabolic and nutrition disorders Sugar sexual coma (see caution when taking the drug) Stress Mental reactions (for example, hallucinations, paranoia) Depression excitement Unusual dreams nightmares dizzy drowsy Run Disorders of taste Convulsions (see contraindications and caution when taking drugs) Perpetual Peripheral sensory neuropathy (see caution when used) Modified neuropathy-enlightenment (see caution when taking drugs) Smaric disorders include loss of smell Movement disorder Periodic disorders Lost taste fainting benign intracranial turbocharger eye disorders Dizziness due to loss of balance hearing loss cardiovascular disorders ventricular and twisted arrhythmia (reports mainly in patients with risk factors for extending the QT), extending the QT distance on the electrocardiogram (see caution when taking the drug and overdose) Bronchospasm Allergic pneumonia vomit Nausea abdominal pain indigestion Astonious bloating Constipation Pancreatitis bile liver disorders jaundice and severe liver damage, including patients with acute liver failure, most patients with patients with drugs should be seriously ill when used) Hepatitis itch urticaria Increase sweating muscle pain Stevens Johnson syndrome Diverse roses Increase light sensitivity White blood vessels in the skin stomatitis muscle weakness can be especially important in patients with myasthenia gravis (see caution when taking the drug) Demonstration tendon rupture (for example: Achilles) (see contraindicated and cautious when taking the drug) ligament rupture muscle break arthritis kidney and urinary disorders The response to the infusion (pain, redness) Pain (including back pain, chest, and limbs)
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Tavanic infusion solution is contraindicated in the following cases:
Precautions when using
to be out of reach of children. Please read the instructions carefully before use. Immediately notify the doctor or pharmacist the harmful reactions encountered when using the drug
Warning
Serious reactions are likely to not recover and cause disabilities, including tendonitis, tendon, peripheral neuropathy, and adverse effects on the central bodies.
Fluoroquinolon antibiotics are associated with serious harmful reactions that can cause disabilities and non -recovery on different organs of the body. These reactions may appear simultaneously on the same patient. Harmful reactions are often recorded with tendonitis, tendon, joint pain, muscle pain, peripheral neuropathy, and adverse effects on the central nervous system, anxiety, depression, insomnia, severe headaches and confusion). These reactions may occur within hours to a few weeks after using the drug. Patients of any age or no risk factors that exist before may have these harmful reactions.
Stop using the drug as soon as there are signs or first symptoms of any serious harmful reactions. In addition, avoid using Fluoroquinolon antibiotics for patients who have had serious reactions related to fluoroquinolon.
Precautions when taking drugs
Levofloxacin resistance bacteria
Staphylococcus aureus bacteria resistant to methicillin (MRSA) are more likely to resist resistance of fluoroquinolones including levofloxacin. Therefore, it is not recommended to use levofloxacin to treat mRSA infections that have been known or suspected unless there is a microbiological test result to confirm the sensitivity of pathogens with levofloxacin.
Escherichia coli bacteria resistant to fluoroquinolon - the most common pathogens in urinary tract infections, distributed varies by region. The treatment doctor is recommended to pay attention to the ratio of Fluoroquinolon of E.coli in the locality.
Variasis time
The recommended intravenous time is at least 30 minutes with a bottle of 50 ml of Tavanic 250 mg or 60 minutes with a bottle of 100 ml of Tavanic 500 mg infusion solution to be followed. There have been cases of increased heart rate and hypotension during the infusion ofloxacin. In some rare cases, as a result of a loss of blood pressure, cardiovascular collapse may occur. While levofloxacin fluid is the transmission co-distribution of Ofloxacin- if there is a significant reduction in blood pressure, it is necessary to stop transmission immediately.
Sodium content
This drug contains 7.8 mmol (181 mg) sodium in a dose of 50 ml and 15.8 mmol (363 mg) in a 100 ml dose. Pay attention to patients who are following sodium control diet.
muscle tendonitis and tendons
muscle tendonitis rarely occurs. The most common is the heeled tendon (Achilles tendon) and can lead to tendons that can occur within 48 hours after starting treatment with levofloxacin, occasionally being recorded by both sides and has been recorded until several months after stopping treatment. The risk of muscle tendon and tendons increases in patients over 60 years old, in patients inpatient treatment with daily data of 1000 mg and in patients who are taking corticosteroids. Moreover, because patients with organ transplantation increase the risk of muscle tendonitis, caution should be used when using fluoroquinolon in this group of patients. The daily dose must be adjusted in elderly patients based on creatinine clearance. Therefore, it is necessary to monitor these patients closely if treated levofloxacin. All patients must advise their treatment doctor if they have experienced symptoms of muscle tendonitis. If there is a suspected tendonitis, levofloxacin must be discontinued immediately, and the scales start appropriate treatment (e.g. holding immobile) for the affected muscle tendon.
Clostridium difficile disease
diarrhea, especially when severe, persistent or without blood, during or after treatment with levofloxacin (including a few weeks after treatment), may be symptoms of disease caused by Clostridium difficile (CDAD). CDAD can change from mild to severe that can be life -threatening, the most severe body of this disease is fake colitis. Therefore, it is necessary to consider the diagnosis for patients with serious diarrhea occurring during or after treatment with levofloxacin.
If suspected or confirmed to have a CDAD, levofloxacin must be stopped and started appropriate treatment without delay. Treatment with intestinal peristaltic drugs is contraindicated in this clinical situation.
Patients who are susceptible to diseases
Quinolon can reduce the threshold of the disease and can stimulate diseases.
Levofloxacin contraindicated in patients with a history of epilepsy and, as well as other quinolons, must be very careful when using drugs in patients who are susceptible to diseases or are being treated at the same time with active ingredients that may reduce the threshold of brain disease, such as theophylin. In cases where there are diseases with jerks, to stop treating with levofloxacin.
Patients with glucose-6-phosphate dehydrogenase
Potential or actually missing patients with glucose-6-phosphate dehydrogenase may have hemolytic reactions when treated with quinolon. Therefore, if you have to use levofloxacin in these patients, you must monitor the possibility of hemolysis.
Patients with renal failure
Because levofloxacin is out of the kidney, Tavanic's dose must be adjusted according to the degree of kidney failure.
Hypersensitivity reactions
levofloxacin can cause serious hypersensitivity reactions, potentially fatal (for example, a circuit up to anaphylactic shock), or sometimes follow a starting dose. Patients must stop treating immediately and consult with a doctor or an emergency doctor, so that this person will start appropriate emergency treatment measures.
Severe blister reactions
Cases of severe blistering skin reactions like Stevens Johnson's syndrome or poisoned necrosis. If the reactions occur in the skin and/or in the mucosa, the patient is advised to see a doctor immediately before continuing this medication.
Blood sugar disorders
Like other quinolones, blood sugar disorders include both hypoglycemia and hyperemms that have been reported, usually in diabetics used at the same time as an oral hypoglycemic drug (for example, glibenclamide) or with insulin. Cases of coma due to hypoglycemia have been reported. In diabetics, it is recommended to carefully monitor blood sugar.
Prevention of increased light sensitivity
Increased light sensitivity has been reported to levofloxacin. It is recommended that these patients do not dry themselves unnecessarily with strong sunlight or artificial ultraviolet rays (for example, sunlight, sunbathing room), during treatment and during 48 hours after stopping to prevent increased sun -sensitive sun.
Patients treated with anti -vitamin K drugs
Due to the ability to increase blood clotting tests (prothrombin/INR) and either bleeding in patients treated with levofloxacin at the same time with a vitamin K resistant (e.
Mental reactions
Psychiatric reactions have been reported in patients with quinolon treatment, including levofloxacin. Very rare cases of progress to the thoughts of suicide and self -dangerous behavior sometimes after just one dose of levofloxacin. In the case of patients with these reactions, levofloxacin should be discontinued and properly handled measures. Be careful if using levofloxacin in mental patients or in patients with a history of mental illness.
extends the range of qt
Be cautious when using fluoroquinolon, including levofloxacin, in patients with risk factors for extending QT about known as:
Elderly patients and women may be more sensitive to the known drugs that cause QT around. Therefore, it is necessary to be cautious when using fluoroquinolon, including levofloxacin, in these patient groups.
Peripheral neuropathy
Peripheral sensory neuropathy and peripheral sensory neuropathy have been reported in patients using fluoroquinolon, including levofloxacin, which can quickly onset. Levofloxacin should be stopped if the patient has symptoms of peripheral neuropathy to prevent progress to the loss of recovery.
Liver disorders
Cases of liver necrosis or fatal liver failure have been reported when taking levofloxacin, mainly in patients with diseases should be serious, for example: blood infections. The patient should stop treatment and contact the doctor if there are signs and symptoms of progressive liver disease such as anorexia, jaundice, dark urine, itching or abdominal pain when pressing.
To worsen myasthenia gravis
fluoroquinolon, including levofloxacin, is capable of choosing a nervous place and can weaken muscles in myasthenia patient. The serious adverse reactions after circulation of the drug, including death and need for respiratory help, occur with the use of fluoroquinolon in patients with myasthenia gravis. It is recommended not to use levofloxacin in patients with a history of myriadia.
vision disorders
If the vision is impaired or appears any impact on the eyes, the patient must advise with an eye expert immediately.
superinfection
The use of levofloxacin, especially if prolonged, can lead to excessive growth of non -sensitive organisms. If superinfection occurs during treatment, it is necessary to take appropriate evaluation measures.
Change tests
In patients treated with levofloxacin, the determination of opium in the urine can give a fake positive result. The scale uses more specific screening methods to confirm that the opium test is a real positive.
levofloxacin can inhibit the growth of mycobacterium tuberculosis and therefore can give fake negative results in microbiological diagnosis for tuberculosis.
Using drugs for women during pregnancy and lactation
Pregnant women
There are very little data on the use of levofloxacin in pregnant women. Animal studies do not show direct or indirect effects on reproductive toxicity.
However, due to lack of human data, and due to experimental data shows that fluoroquinolon increases the risk of damage to the weight -resistant cartilage tissue of developing organisms, it is not allowed to use levofloxacin for pregnant women.
breastfeeding women
Tavanic is not only used in women who are breastfeeding. There is not enough information about the excretion of levofloxacin through breast milk; However, other fluoroquinolones are excreted through breast milk. Because of lack of data on humans and due to that empirical data, Fluoroquinolon increases the risk of damage to the cartilage tissue with the weight of developing creatures, so it is not allowed to use levofloxacin in breastfeeding women.
fertility
levofloxacin does not reduce fertility or reproduction in mice.
The effect of the drug on the ability to drive and operate machinery
Patients may experience side effects after using Tavanic, including the feeling of dizziness, drowsiness, dizziness, or visual disorders.
Some of these side effects can reduce the ability to focus and react speed of the patient, and therefore can create risks in some important important situations.
Drug interaction
Tavanic can affect the impact of some other drugs. In contrast, some other drugs may affect the mechanism of Tavanic's action.
The effect of other drugs on Tavanic
Theophylin, fenbufen or non -steroid anti -inflammatory drugs are similar
Notes without pharmacokinetic interaction between levofloxacin and theophylin in a clinical study. However, there is a significant reduction in the threshold of brain disease when using Quinolon at the same time with theophylin, non -steroid anti -inflammatory drugs, or other agents that reduce the threshold of the disease. Levofloxacin concentration will be about 13% higher when used with fenbufen compared to when only used individually.
probenecid and cimetidine
Probenecid and cimetidine have a significant impact on the elimination of levofloxacin. Levofloxacin's kidney clearance levels decreased by cimetidine (24%) and probenecid (34%). This is because both of these drugs have the ability to prevent levofloxacin excretion through the renal tubules. However, in these research doses in this study, the difference in pharmacokinetics has an uncertain statistical statistical significance clinically related.
Be cautious when taking levofloxacin with drugs that affect renal excretion such as Probenecid and cimetidine, especially in patients with impaired renal function.
Other related information
Clinical pharmacological research has shown that levofloxacin pharmacokinetics are not affected by any clinical related level, when levofloxacin is used with the following drugs: Calcium carbonate, digoxin, glibenclamid, ranitidine.
Tavanic's influence on other drugs
cyclosporin
The half -life of cyclosporin increased by 33% when used with levofloxacin.
Vitamin K anti -vitamin drugs
There has been an increase in blood clotting tests (PT/INR) and/or bleeding, which may be severe, in patients treated with levofloxacin at the same time with vitamin K anti -vitamin (e.g. warfarin). Therefore, blood clotting tests must be monitored in patients who are being treated with vitamin K anti -vitamin drugs.
Known drugs cause extended QT
levofloxacin, like other fluoroquinolon, should be used cautiously in patients who are taking the drug that has caused a long -term extension of QT (for example: IA and III anti -arrhythmic drugs, three -round antidepressants, macrolid, anti -psychotic drugs).
Other related information
In a pharmacokinetic interaction study, Levofloxacin does not affect the pharmacokinetics of theophylin (which is a substrate for CYP1A2 exploration), indicating that levofloxacin is not a CYP1A2 inhibitor.
Cavalry or compatibility
Tavanic infusion solution is not mixed with heparin or alkaline solutions (for example, sodium hydrogen carbonate).
Tavanic infusion solution can be compatible with the following infusion solution: 0.9%sodium chloride solution; 5%Dextrose solution; Dextrose solution 2.5% in the ringer, solutions to nourish venous lines (amino acids, carbohydrates, electrolytes).
Storage
In a dry place, the temperature does not exceed 30 ° C, avoiding light.
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