Levofloxacin hemihydrate.
Each mL contains: Levofloxacin hemihydrate equivalent to Levofloxacin base 5.0 mg.
Pharmacology: Levofloxacin has a wide-spectrum antibacterial effect. Levofloxacin is active against gram-positive and gram-negative bacteria including anaerobes. Moreover, Levofloxacin has shown antibacterial activity against Chlamydia pneumoniae and Mycoplasma pneumoniae.
The main mechanism of action of Levofloxacin is through the inhibition of DNA gyrase (a type II topoisomerase), resulting in inhibition of bacterial DNA synthesis.
1. Respiratory tract infections (mild to moderate): Acute maxillary sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis; Acute bacterial exacerbation of chronic bronchitis or community acquired pneumonia caused by Staphylococcus aureus, Streptococcus pneumoniae, or Haemophilus pneumoniae.
2. Skin infections, such as abscesses, cellulitis, impetigo or wound infections, etc. caused by Staphylococcus aureus, Streptococcus pyogenes.
3. Urinary tract infections (mild to moderate) caused by E. coli or K. pneumoniae.
4. Acute pyelonephritis (mild to moderate) caused by E. coli.
Levores is an intravenous injection drug which should be infused slowly. The doses of 250 or 500 mg should be administered over a period of 60 minutes. The doses of 750 mg should be administered over a period of 90 minutes.
Patients with normal renal function: 250-750 mg once daily for 7-14 days depending on the severity of the disease.
Patients with impaired renal function: Dosage of Levofloxacin should be modified for patients with creatinine clearance less than 50 mL / minute.
It is unnecessary to adjust levofloxacin dosage in patients with hepatic impairment because most of the drug is excreted unchanged in urine.
Patients with hypersensitivity to levofloxacin, quinolone antimicrobial agents or any components of levofloxacin.
Levofloxacin or any other quinolones is contraindicated in patients who have known hypersensitivity.
Avoid using Levofloxacin in pregnancy and lactation.
If there are any symptoms of rash, muscle pains, hand or Achilles tendonitis, Levofloxacin should be discontinued and consult a physician.
Levofloxacin may be harmful to a kidney or a liver.
Avoid using levofloxacin in patients who have CNS disorders that predispose to seizures. The events are considered to be drug related.
Levofloxacin may prolong QT interval. Use with cautions in such patients who have risk factors such as older ages, existing heart problems, arrhythmic, hypertension or low blood potassium, etc.
Avoid using Levofloxacin with any drugs that prolong QT interval, such as antiarrhythmic class IA (quinidine, procainamide), class III (amiodarone), Cisapride, Erythromycin, Antipsychotics, Tricyclic antidepressants, etc.
Levofloxacin may cause phototoxicity reaction which may be serious, like Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, Erythema Multiforme, etc.
Levofloxacin may alter blood glucose level. Use with cautions in such patients.
Levofloxacin may increase the pharmacological action of Warfarin.
Ruptures of the shoulder, hand and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones. If there is such a symptom, the drug should be withdrawn. Patients should be advised to rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded.
Convulsions and toxic psychoses have been reported in patients receiving quinolones, including levofloxacin. Quinolones may also cause increased intracranial pressure and central confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely, suicidal thoughts or acts.
Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones. These reactions often occur following the 1st dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat or facial edema/swelling), airway obstruction including broncho-spasm, shortness of breath, and acute respiratory distress, dyspnoea, urticaria, itching and other serious skin reactions. Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis".
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Most cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Use in Pregnancy & Lactation: The safety and efficacy of levofloxacin in pregnant and nursing women have not been established.
Use in Children: The safety and efficacy of levofloxacin in children, and adolescent (< 18 years) have not been established.
The drug should not be used in pregnancy and lactation.
The symptoms that may occur include the gastrointestinal symptom such as nausea, diarrhea, constipation. Additional adverse events include insomnia, headache and injection site reactions.
Levofloxacin has potential to form stable compounds with many metal ions. Antacids containing aluminium or magnesium and drugs containing iron decrease absorption of Levofloxacin. The administration of these drugs are recommended at least 2 hrs before or after Levofloxacin administration.
The concomitant administration of NSAID with a quinolone including Levofloxacin, may increase the risk of CNS stimulation and convulsive seizures.
Antidiabetic agents: Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with quinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered.
Store below 30°C and protect from light.
Keep container in the outer carton for protection from light before use.
Levores could be used within 7 days after removal from the outer carton if stored under indoor light condition and at below 30°C.
Levores could be used within 12 hours after perforation of the rubber stopper.
No protection from light is required during infusion.
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Levores infusion 5 mg/mL
100 mL x 1's
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