INGREDIENT FORMULA OF DRUGS
– Active ingredient: Levofloxacin 500mg
– Excipients: Microcrystalline cellulose, Anhydrous colloidal silica, yellow iron oxide, red iron oxide, …
POINT:
Infections caused by bacteria sensitive to levofloxacin, such as:
• Acute sinusitis.
• Exacerbation of chronic bronchitis.
• Community pneumonia.
• Prostatitis.
• Complicated or not.
• Complications in the skin and in the skin under the skin.
• Prevention after exposure and thorough treatment for anthrax
DOSAGE AND ADMINISTRATION:
– Respiratory tract infections:
+ Exacerbation of chronic bronchitis: 500mg, 1 time / day for 7 days.
+ Acquired pneumonia in the community: 500mg, 1 -2 times / day for 7-14 days
+ Acute maxillary sinusitis: 500mg once daily for 10-14 days
– Infections of the skin and organization under the skin:
+ Complications: 750mg, 1 time / day for 7-14 days
+ No complications: 500mg, 1 time / day for 7-10 days
– Urinary tract infections:
+ Complications: 250mg, 1 time / day for 10 days.
+ No complications: 250mg, 1 time / day for 3 days.
– Acute pyelonephritis: 250 mg once daily for 10 days.
Oral administration:
• The time of levofloxacin intake does not depend on the meal (may be taken inside or away from the meal).
• Do not use aluminum and magnesium antacids, heavy metal preparations such as iron and zinc, sucralfate, didanosin (dosage forms containing antacids) within 2 hours before and after taking levofloxacin.

CONTRAINDICATIONS:
• People with a history of hypersensitivity to levofloxacin, to other quinolones, or to any component of the drug.
• Seizures, G6PD deficiency, a history of tendon disease due to a fluoroquinolon. Children younger than 18 years old.

WARNING CAUTION:
• Tendonitis, especially the tendon heel (Achile), can lead to a tendon rupture. This complication may appear at the first 48 hours, after starting the medication and may be on both sides. Tendonitis occurs primarily in at-risk subjects: people over 65, taking corticosteroids (including inhalation spray). These two factors increase the risk of tendonitis. As a precaution, daily dosage of the drug should be adjusted in elderly patients according to glomerular filtration rate.
• Effects on musculoskeletal system: levofloxacin, as with most quinolones, can cause degenerative articular cartilage degeneration in many young animals, so levofloxacin should not be used for children under 18 years.

• My weakness: Be cautious in patients with myasthenia gravis because the symptoms may worsen.
• Central nervous system effects: There have been reports of adverse reactions such as psychosis, increased intracranial pressure, central nervous stimulation leading to convulsions, tremors, restlessness, and headache. , insomnia, depression, confusion, hallucinations, nightmares, suicidal intent or action (rarely) when using quinolone antibiotics, even when used at the first dose. If these adverse reactions occur while using levofloxacin, the drug should be stopped and appropriate measures to manage symptoms. Be careful when using for patients with central nervous system diseases such as epilepsy, cerebral vascular sclerosis … because may increase the risk of seizures.
• Hypersensitivity reactions: hypersensitivity reactions with various clinical manifestations, even anaphylactic shock when using quinolones, including levofloxacin, have been reported. The drug should be discontinued as soon as the first signs of hypersensitivity reactions and appropriate management measures are taken.

• Clostridium difficile pseudomembranous colitis: this adverse reaction has been reported with a range of antibiotics, including levofloxacin, which can occur from mild to life-threatening. Attention should be paid to accurately diagnosing diarrhea cases that occurred while patients were using antibiotics for appropriate management measures.
• Moderate to severe light sensitivity has been reported with many fluoroquinolones, including levofloxacin (although so far, the incidence of this adverse reaction when using levofloxacin has been very low <0) ,first%). Patients should avoid direct exposure to light during treatment and 48 hours after treatment.

• Pregnancy: Do not use levofloxacin in pregnant women. Effects on metabolism: As with other quinolones, levofloxacin can cause metabolic disorders, including hyperglycemia and hypoglycemia, which often occur in diabetics who are taking levofloxacin concurrently with an oral medication. hypoglycemia or with insulin; Therefore, it is necessary to monitor blood sugar in this patient. If hypoglycemia occurs, levofloxacin should be discontinued and appropriate management measures taken.
• prolongation of the QT interval on the electrocardiogram: use of quinolones can cause prolongation of the QT interval on the electrocardiogram in some patients and rare arrhythmias, so use in patients with existing conditions should be avoided. prolonged QT interval, patients with hypokalemia, patients taking antiarrhythmic drugs of group IA (quinidine, procainamide …) or group III (amiodarone, sotalol …); Levofloxacin should be used with caution in patients who are currently in the pancreas

• Lactation: levofloxacin concentration in breast milk has not been measured, but based on the distribution of ofloxacin in breast milk, it can be predicted that levofloxacin is also distributed into breast milk. Because the drug has a high risk of cartilage damage in young children, do not breastfeed while taking levofloxacin.
DRUG INTERACTIONS:
• Antacid, sucralfate, metal ion, multivitamin: When used concurrently can reduce the absorption of levofloxacin, it is necessary to take these drugs away from levofloxacin at least 2 hours.
• Theophylin: A number of studies in healthy volunteers have shown no interaction. However, because plasma concentrations and AUC of theophylin are often increased when used simultaneously with other quinolones, still need to closely monitor theophylin concentration and adjust the dose if necessary when used simultaneously with levofloxacin.
• Warfarin: Because it has been reported that warfarin increases its effects when used with levofloxacin, it is important to monitor coagulation parameters when using these two drugs simultaneously.
• Cyclosporin, digoxin: The interaction has no clinical significance, so there is no need to adjust the dose of these drugs when used concurrently with levofloxacin.
• Nonsteroidal anti-inflammatory drugs: May increase the risk of CNS excitation and seizures when used concurrently with levofloxacin.
• Hypoglycemic agents: Concomitant administration with levofloxacin may increase the risk of dysglycemia, requiring close monitoring.

UNWANTED EFFECTS:
• Common: ADR> 1/100:
o Gastrointestinal: Nausea, diarrhea.
o Liver: Increased liver enzymes.
o Neurological: Insomnia, headache.
o Skin: Irritating the injection site
• Less common 1/100> ADR> 1/1000:
o Neurological: Dizziness, nervousness, agitation, anxiety
o Gastrointestinal: Abdominal pain, flatulence, indigestion, vomiting, constipation.
o Liver: Increased bilirubin in blood.
o Urology, genital: Vaginitis, genital candidiasis infection.
o Skin: Itching, rash
• Rarely, ADR <1/1000:
o Cardiovascular: Increasing or lowering blood pressure, arrhythmia
o Gastrointestinal: Pseudomembranous colitis, dry mouth, gastritis, edema of the tongue
o Musculoskeletal: Arthralgia, muscular weakness, myalgia, osteomyelitis, Achille tendonitis.
o Neurological: Convulsions, abnormal dreams, depression, mental disorders
o Allergies: Quinck’s edema, anaphylaxis, Stevens-Johnson syndrome and Lyelle.
STORAGE CONDITIONS: Store at temperatures not exceeding 30 ° C, in the original packaging.
HAN USE: 36 months from date of manufacture.
MANUFACTURED BY: DELORBIS PHARMACEUTICALS LTD – Cyrup