LEVOXAN
LEVOXAN
Levofloxacin Tablets 500mg
LEVOXAN is a synthetic fluoroquinolone antibacterial a wide sectre containing levofloxacin is the Senantiomer (-) (levorotatory form) of racemic ofloxacin for oral and intravenous administration. Levofloxacin acts on the DNA GYRASE complex by inhibiting DNA GYRASE (bacterial topoisomerase Il), an enzyme required for the replication, transcription, repair and recombination of DNA and topoisomerase IV. LEVOXAN is bactericidal in vitro. Its broad antibacterial spectrum covers many gram-positive and gram negative bacteria.
INDICATIONS
For the above-mentioned infections LEVOXAN should be used only when it is considered in appropriate to use anitibacterial agents that are commonly recommended for the initial treatment of these infections.
Pharmacokinetics Properties:
The food has little effect on the absorption of LEVOXAN and tablets can be taken with or between meals. The absorption is significantly reduced LEVOXAN once administered with iron salt, antacids and sucralfate.
Absorption:
LEVOXAN after oral administration is rapidly and almost completely absorbed with peak plasma concentration achieved with a period of one hour. The absolute bioavailability is approximately 100%. LEVOXAN obeys the linear pharmacokinetics over a range of 50to 600mg.
Distribution:
Approximately 30 to 40% of LEVOXAN is bound to plasma proteins. Multiple dose of 500 mg once a day LEVOXAN showed a negligible accumulation. it is a modest but predictable accumulation LEVOXAN after doses of 500 mg twice daily. The equilibria is reached in three days.
Diffusion in fluids and tissues:
LEVOXAN diffuse well into bone tissue in the bronchial mucosa in liquid epithelial wall fuild and lung tissue pad in three days.
Metabolism and elimination:
LEVOXAN is poorly metabolized, the metabolites being dimethyl levofloxacin and levofloxacin N-oxide.
The elimination of LEVOXAN IS primarily renal path way. The elimination half-life (t 1/2) is an average of 6 to 8 hours in patients receiving oral and intravenous treatment.
Dosage form: Film coated Tablets.
The LEVOXAN Should be swallow whole, without being crushed and with sufficient amount of water. These tablets can be compressed with two breaks in the groove to adjust the dosa.
It can be taken on an empty stomach or with a meal. The tablet should be taken two hours before the iron salt, antiacids and sucralfate as they reduc the absorption; there are limits that allow dose adjustment in patients with renal dysfunction.
Reserve for the use in adults (18years)
LEVOXAN is administered once or twice per day. Dosage depends on the type and severity of infection and susceptibility of pathogenic microorganism presumed. The duration of therapy varies depending on the evolution of the disease.
Treatment with LEVOXAN should continue until at least 48 to 72 hours after the patient becomes asymptomatic or obvious until the eradication of bacterial is obtained.
Contra-Indications:
LEVOXAN must not be used:
INDICATIONS
- Nosocomial Pneumonia
- Community-Acquired Pneumonia
- Skin and Skin Structure Infections Complicated and Uncomplicated
- Chronic bacterial prostatitis
- Acute Bacterial Exacerbation of Chronic Bronchitis
- Acute Bacterial Sinusitis
- Inhalational Anthrax, Post-Exposure in adult and pediatric patients
- Plague in adult and pediatric patients
- Urinary Tract Infections (UTI)
- Acute Pyelonephritis
- Bacterial conjunctivitis (Ophthalmic formulation)
For the above-mentioned infections LEVOXAN should be used only when it is considered in appropriate to use anitibacterial agents that are commonly recommended for the initial treatment of these infections.
Pharmacokinetics Properties:
The food has little effect on the absorption of LEVOXAN and tablets can be taken with or between meals. The absorption is significantly reduced LEVOXAN once administered with iron salt, antacids and sucralfate.
Absorption:
LEVOXAN after oral administration is rapidly and almost completely absorbed with peak plasma concentration achieved with a period of one hour. The absolute bioavailability is approximately 100%. LEVOXAN obeys the linear pharmacokinetics over a range of 50to 600mg.
Distribution:
Approximately 30 to 40% of LEVOXAN is bound to plasma proteins. Multiple dose of 500 mg once a day LEVOXAN showed a negligible accumulation. it is a modest but predictable accumulation LEVOXAN after doses of 500 mg twice daily. The equilibria is reached in three days.
Diffusion in fluids and tissues:
LEVOXAN diffuse well into bone tissue in the bronchial mucosa in liquid epithelial wall fuild and lung tissue pad in three days.
Metabolism and elimination:
LEVOXAN is poorly metabolized, the metabolites being dimethyl levofloxacin and levofloxacin N-oxide.
The elimination of LEVOXAN IS primarily renal path way. The elimination half-life (t 1/2) is an average of 6 to 8 hours in patients receiving oral and intravenous treatment.
Dosage form: Film coated Tablets.
The LEVOXAN Should be swallow whole, without being crushed and with sufficient amount of water. These tablets can be compressed with two breaks in the groove to adjust the dosa.
It can be taken on an empty stomach or with a meal. The tablet should be taken two hours before the iron salt, antiacids and sucralfate as they reduc the absorption; there are limits that allow dose adjustment in patients with renal dysfunction.
Reserve for the use in adults (18years)
LEVOXAN is administered once or twice per day. Dosage depends on the type and severity of infection and susceptibility of pathogenic microorganism presumed. The duration of therapy varies depending on the evolution of the disease.
Treatment with LEVOXAN should continue until at least 48 to 72 hours after the patient becomes asymptomatic or obvious until the eradication of bacterial is obtained.
Contra-Indications:
LEVOXAN must not be used:
- in patients hypersensitive to leyofiosacin or other guinolones.
- in patients with epilepsy.
- in patients with history of tendon disorders related toiluoroquinoloneadministation.
- in children or growing adolescents.
- during pregnancy.
- in breast-feeding women.
