Drugs AMLEVO 750 have composition Levofloxacine 750mg. Levofloxacin is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed in Dosage and administration section
Hapenxin 500 is indicated for the treatment of the infections Respiratory tract, Skin, soft tissue
COMPOSITION
Each film-coated tablet contains:
– Levofloxacine 750 mg (as Levofloxacine hemihydrate)
– Excipients: Copovidone, L-HPC, Microcrystalline cellulose 101, Croscarmellose sodium, Magnesium stearate. Talc, Colloidal anhydrous silica, Opadry It white. Purified water q.s one tablet.
PROPERTIES
Pharmacodynamics:
AMLEVO 750 ( Levoftoxacin ) is a synthetic antibacterial agent of the fluoroquinolone class. Levofloxacin has activity against a wide range of Gram-negative and Grampositive microorganisms.
Microbiology: Levofloxacin has activity against the following microorganisms:
– Aerobic Gram-positive microorganisms: Enterococcus faecalis, Staphylococcus aureus (methicifiin-susceptible strains), Staphylococcus epidermidis. Staphylococcus saprophyticus, Streptococcus pneumoniae (including multi-drug resistant strains). Streptococcus pyogenes.
– Aerobic Gram-negative microorganisms: Enterobacterctoacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens.
– Anaerobic Gram-positive microorganisms: Clostridium perfringens
– Other microorganisms: Chlamydophila pneumoniae, Mycoplasma pneumoniae..
Pharmacokinetics
AMLEVO 750 ( Levofloxacin ) is rapidly and essentially completely absorbed after oral administration. Peak plasma concentrations are usually attained one or two hours after oral dosing. Steady-state conditions are reached within 48 hours following a 500 mg or 750 mg once-daily dosage regimen.
The mean volume of distribution of levofloxacin generally ranges from 74 to 112 L after single and multiple 500 mg or 750 mg doses, indicating widespread distribution into body tissues. Levofloxacin also penetrates well into lung tissues. Lung tissue concentrations were generally 2- to 5- fold higher than plasma concentrations.
Levofloxacin undergoes limited metabolism in humans and is primarily excreted as unchanged drug in the urine. Following oral administration, approximately 87% of an administered dose was recovered as unchanged drug in urine within 48 hours, whereas less than 4% of the dose was recovered in feces in 72 hours.
INDICATIONS
Levofloxacin is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed in Dosage and administration section.
DOSAGE AND ADMINISTRATION
The dose of Levofloxacin is as described in table below. The dose of Levofloxacin is administered orally every 24 hours; levofloxacin can be administered without regard to food.
| Dosage in adult patients with normal ranal function (CrCI > 50 ml/min) | ||
| Type of infection | Dosed every 24 hours | Duration |
| Noeocomial Pneumonia | 750 mg | 7-14 days |
| Community aoquired Pneumonia | 500-750 mg | 7-14 days |
| Acute bacterial sinusitis | 500 mg | 10-14 days |
| Acute bacterial exacerbation of Chronic Bronchitis | 500 mg | 7 days |
| Complicated skin and skin structure Infections | 750 mg | 7-14 days |
| Uncomplicated skin and skin structure infections | 500 mg | 7-14 days |
| Chronic bacterial prostatitis | 500 mg | 28 days |
| Uncomplicated urinary tract Infection | 250 mg | 3 days |
| Complicited urinary tract Infection | 250 mg | 10 days |
| Inhalational anthrax | 500 mg | 60 days |
Renal Impairment: Dosage adjustment based on Creatinine clearance
| CrCI > 50 ml/min | CrCI 20 – 49 ml/min | CrCl 10 – 19 mL/ min | Hemodialysis or Chronic ambulatory peritoneal dlalyels |
| 750 mg/ 24 hours | 750 mg/ 48 hours | 750 mg initial dose, then 500 mg/ 48 hours | 750 mg initial dose. then 500 mg/ 48 hours |
| 500 mg/ 24 hours | 500 mg initial dose, then 250 mg/ 24 hours | 500 mg initial dose. I then 250 mg/ 48 hours | 500 mg Initial dose, then 250 mg/48 hours |
| 250 mg/ 24 hours | No dosage adjustment required | 250 mg/ 48 hours If treating uncomplicated urinary tract infection.
then no dosage adjustment is required |
No information on dosing adjustment is available |
CONTRAINDICATIONS
– Hypersensitivity to any of the ingredients of drug.
– Use of Levofloxacin is contraindicated in children under 18 years of age.
ADVERSE REACTIONS
The most common adverse reactions were nausea, headache, diarrhea, insomnia, constipation, abdominal pain, tinnitus, vomiting- leading to discontinuation in some cases. Crystalluria has also been reported with quinolones.
INFORM YOUR DOCTOR IN CASE OF ANY ADVERSE REACTION RELATED TO DRUG USE
DRUG INTERACTIONS
– Antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, zinc may interfere with the gastrointestinal absorption of levofloxacin. These agents should be taken at least two hours before or two hours after oral Levofloxacin administration.
– The concomitant administration of a non-steroidal anti-inflammatory drug with a quinolone, including Levofloxacin, may increase the risk of CNS stimulation and convulsive seizures.
– Disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported with Levofloxacin, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent In these patients, careful monitoring of blood glucose is recommended.
– AMLEVO 750 may produce false-positive urine screening results for opiates.
PRECAUTIONS
– Administration of Levofloxacin resulted in increased osteochondrosis in animal; therefore Levofloxacin should not be used in children under 18 years of age.
– AMLEVO 750 should be used with extreme caution in patients with a known or suspected central nervous system disorder or in the presence of other risk factors that may predispose them to seizures.
– Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones. Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity.
OVERDOSE
In the event of an acute overdosage, the stomach should be emptied. AMLEVO 750 is not efficiently removed by hemodialysis or peritoneal dialysis.
STORAGE: Store at temperature below 30°C. Avoid direct sunlight and moisture.
PRESENTATION: 5 film-coated tablets/ Btister/catch cover. Box of 2 or 4 blisters.
SPECIFICATIONS: Manufacturer’s
EXPIRY DATE: 36 months from manufacturing date.
Keep out of reach of children Read the package insert carefully before use Ask your doctor for further information Use upon doctor’s prescription only
