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Levofloxacin is authorised in the world under the following brand names: Cravit, Cravit Ophthalmic, Elequine, Floxel, Iquix, Leroxacin, Lesacin, Levaquin, Levokacin, Levox, Levoxacin, Mosardal, Nofaxin, Quixin, Reskuin, Tavanic, Volequin.

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(British Approved Name, US Adopted Name, rINN)

Drug Nomenclature

International Nonproprietary Names (INNs) in main languages (French, Latin, Russian, and Spanish):

Generic Name: Levofloxacin

Under what local brands and in what dosages is generic Levofloxacin sold in pharmacies of Britain, United States, and Canada?

In pharmacies of the United States, Great Britain and Canada the pharmacists offer you to buy Levofloxacin according to your prescription or without a prescription under such brand names and in such strengths and dosage forms:

Adverse Effects and Precautions

As for Ciprofloxacin.

Symptomatic hyperglycaemia and/or hypoglycaemia have been reported, usually in diabetics who are also taking hypoglycaemics or insulin. Such patients should have their blood-glucose concentrations closely monitored and if signs or symptoms of glucose disturbances develop, levofloxacin should be stopped.

Effects on glucose metabolism. See also under Gatifloxacin.

Interactions

As for Ciprofloxacin.

Use of levofloxacin with drugs that alter blood-glucose concentrations increases the risk of blood-glucose disturbances.

Levofloxacin does not appear to interact significantly with theophylline or ciclosporin.

Antimicrobial Action

As for Ciprofloxacin.

Levofloxacin is generally considered to be about twice as active as ofloxacin, the racemic substance. Levofloxacin has a broad spectrum of activity which includes Gram-positive bacteria.

Pharmacokinetics

Levofloxacin is rapidly and almost completely absorbed after oral doses with peak plasma concentrations occurring within 1 to 2 hours. It is widely distributed into body tissues including the bronchial mucosa and lungs, but penetration into CSF is relatively poor. Levofloxacin is about 30 to 40% bound to plasma proteins. Only small amounts are metabolised, to inactive metabolites. The elimination half-life of levofloxacin is 6 to 8 hours, although this may be prolonged in patients with renal impairment. Levofloxacin is excreted largely unchanged, primarily in the urine with less than 5% as metabolites. It is not removed by haemodialysis or peritoneal dialysis.

Uses and Administration

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Levofloxacin is the S-(-)-isomer of the fluoroquinolone antibacterial ofloxacin. It is given orally, or by intravenous infusion as a 5 mg/mL solution over 30 to 90 minutes, to treat susceptible infections including tuberculosis (but see under Uses and Administration of Ciprofloxacin). Levofloxacin is given as the hemihydrate but doses are expressed in terms of the base; levofloxacin hemihydrate 256 mg is equivalent to about 250 mg of levofloxacin. Usual doses range from 250 to 500 mg once or twice daily for 7 to 14 days depending on the severity and nature of the infection. A dose of 250 mg once daily for 3 days may be given for uncomplicated urinary-tract infections. A 28-day course of treatment with a dose of 500 mg once daily should be given for chronic bacterial prostatitis. In the United States of America (USA), doses of 750 mg once daily for 7 to 14 days may be used for complicated skin infections and for hospital-acquired pneumonia; a shorter course of 750 mg once daily for 5 days may be given for community-acquired pneumonia, acute bacterial sinusitis, complicated urinary-tract infections, and acute pyelonephritis. A 60-day course of treatment with a dose of 500 mg once daily is also licensed in the USA for treatment and pos-texposure prophylaxis of inhalation anthrax.

Doses should be reduced in patients with renal impairment (see below).

Levofloxacin is also used topically as the hemihydrate in eye drops. A solution containing the equivalent of 0.5% of levofloxacin is used for the treatment of bacterial conjunctivitis and 1.5% for corneal ulcers caused by susceptible strains of bacteria.

Administration in children. Since fluoroquinolones can cause degenerative changes in weight-bearing joints of young animals they should only be used in children and adolescents where their use may be justified if the benefits outweigh the risks. Although levofloxacin is not licensed for use in this age group in either the UK or United States of America (USA), a pharmacokinetic study has suggested that the following doses would be needed:

• children 5 years of age and older, 10 mg/kg daily

• infants and children from 6 months to less than 5 years of age, 10 mg/kg every 12 hours

Administration in renal impairment. Although initial doses (see above) remain unchanged in patients with renal impairment, subsequent doses of levofloxacin should be adjusted according to creatinine clearance (CC). In the UK, the following doses are recommended:

• CC 20 to 50 mL/minute: subsequent doses are halved

• CC 10 to 19 mL/minute: subsequent doses are reduced to one-quarter of the usual dose; a regimen of 250 mg daily should be reduced to 125 mg every 48 hours

• CC less than 10 mL/minute (including haemodialysis and continuous peritoneal dialysis patients): usual doses of 250 mg or 500 mg daily are reduced to 125 mg every 48 or 24 hours respectively; a regimen of 500 mg twice daily is reduced to 125 mg every 24 hours

In the United States of America (USA), the following dose modifications are recommended:

After an initial dose of 750 mg daily,

• CC 20 to 49 mL/minute: subsequent doses are 750 mg every 48 hours

• CC up to 19 mL/minute (including haemodialysis and continuous peritoneal dialysis patients): subsequent doses are 500 mg every 48 hours

After an initial dose of 500 mg daily,

• CC 20 to 49 mL/minute: subsequent doses are 250 mg every 24 hours

• CC up to 19 mL/minute (including haemodialysis and continuous peritoneal dialysis patients): subsequent doses are 250 mg every 48 hours

After an initial dose of 250 mg daily,

• CC 10 to 19 mL/minute: subsequent doses are 250 mg every 48 hours

A pharmacokinetic study in 10 critically ill patients undergoing continuous renal replacement therapy with either venovenous haemofiltration or haemodiafiltration suggested that a dose of either levofloxacin 250 mg every 24 hours or 500 mg every 48 hours would be suitable in such situations.

Peptic ulcer disease. For mention of the potential use of levofloxacin in eradication regimens for Helicobacter pylori.

Preparations

Proprietary Preparations

Argentina: Floxlevo; Grepiflox; Leflumax; Levaquin; Septibiotic; Tavanic; Teraquin; Ultraquin; Uniflox; Valiflox;

Austria; Tavanic;

Belgium: Tavanic;

Brazil: Levaquin; Levotac; Levoxin; Tamiram; Tavanic;

Canada: Levaquin;

Chile: Auxxil; Medibiox; Novacilina; Quinobiot; Recamicina; Tavanic;

Czech Republic: Oftaquix; Tavanic;

Denmark: Oftaquix;

Finland: Oftaquix; Tavanic;

France: Tavanic;

Germany; Oftaquix; Tavanic;

Greece: Tavanic;

Hong Kong; Cravit;

Hungary: Leflokin; Oftaquix; Tavanic;

India: Glevo †; Leeflox; Levocide; Levof †; Levoflox; Lufi; Tavanic;

Indonesia: Armolev; Cravit; Cravox; Difloxin; Farlev; Lefos; Levocin; Levores; Levovid; Levoxal; Lexa; Lovequin; Mosardal; Nislev; Nufalev; Prolecin; Prolevox; Reskuin; Rinvox; Tevox; Volequin; Voxin;

Ireland: Tavanic;

Israel: Levo; Tavanic;

Italy: Levoxacin; Oftaquix; Prixar; Tavanic;

Japan: Cravit;

Malaysia: Cravit; Glevo; Loxo †;

Mexico: Elequine; Ran-Levo; Tavanic;

The Netherlands: Oftaquix; Prixar; Tavanic;

Philippines: Floxel; Levox; Oftaquix;

Poland: Oftaquix;

Portugal: Oftaquix; Tavanic;

Russia: Lefoxin; Tavanic:

South Africa; Tavanic;

Singapore: Cravit;

Spain: Tavanic;

Sweden: Oftaquix; Tavanic;

Switzerland: Tavanic;

Thailand: Cravit; Lefloxin;

Turkey: Cravit; Tavanic;

UAE: Jenoquine;

United Kingdom (UK): Oftaquix; Tavanic;

United States of America (US and USA): Iquix; Levaquin; Quixin;

Venezuela: Levaquin; Proxime; Tavanic.

Multi-ingredient

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