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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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Buy Levofloxacin [Levaquin 250mg, 500mg, 750mg]

Levofloxacin (Johnson & Johnson’s Levaquin, Sanofi-Aventis’ Tavanic, Daiichi’s Cravit) (Figure 12) is a widely successful fluoroquinolone approved for the treatment of community-acquired pneumonia and several other bacterial infections (e.g., bronchitis, urinary tract infection, skin infections). In the United States, the agent is a leading antibiotic for community-acquired pneumonia owing to its high bioavailability, broad-spectrum activity, tolerability, and once-daily dosing. Levofloxacin was first launched in Japan in 1993 and has been widely available since 1998. Most recently, a new, high-dose formulation (750 mg) has been approved that provides patients an abbreviated five-day treatment course for community-acquired pneumonia. The agent is expected to lose patent protection in the United States and Japan in 2010 and in Europe in 2011. The drug is available in oral and IV formulations.

Levofloxacin is the levo enantiomer of ofloxacin. The agent’s mechanism of action involves inhibition of bacterial topoisomerase IV and DNA gyrase, which are enzymes required for DNA replication, transcription, repair, and recombination. Levofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms.

Levofloxacin’s efficacy in adult inpatients and outpatients with community-acquired pneumonia was evaluated in two pivotal Phase III clinical studies. In the first study, 590 patients were treated with levofloxacin (500 mg) once daily orally or intravenously for 7 to 14 days or with the cephalosporin ceftriaxone (1-2 grams), administered intravenously once or twice daily, followed by the cephalosporin cefuroxime axetil (500 mg) administered orally twice daily for a total of 7 to 14 days (Ortho-McNeil, 2004). Patients assigned to treatment with the cephalosporins were allowed to receive erythromycin (or doxycycline if intolerant of erythromycin) if an infection due to atypical pathogens was suspected or proven. Clinical success (defined as the percentage of patients cured or improved at 5 to 7 days post-therapy) with levofloxacin was superior (95%) to success in the control group (83%). In a second, noncomparative study, 264 patients were treated with 500 mg levofloxacin orally or intravenously once daily for 7 to 14 days; the clinical success rate of evaluable patients in this study was 93%.

(British Approved Name, US Adopted Name, rINN)

Drug Nomenclature

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

Synonyms: S-(-)-Ofloxacin; DR-3355; HR-355; Levofloksasiini; Levofloxacin; Levofloxacino; Levofloxacinum; RWJ-25213
BAN: Levofloxacin
USAN: Levofloxacin
INN: Levofloxacin [rINN (en)]
INN: Levofloxacino [rINN (es)]
INN: Lévofloxacine [rINN (fr)]
INN: Levofloxacinum [rINN (la)]
INN: Левофлоксацин [rINN (ru)]
Chemical name: (-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid
Molecular formula: C18H20FN3O4 =361.4
CAS: 100986-85-4 (levofloxacin); 138199-71-0 (levofloxacin hemihydrate)
ATC code: J01MA12; S01AX19
Read code: y0C5m

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:

UK US Canada
Evoxil 250mg film-coated tablets Evoxil 500mg film-coated tablets Evoxil 5mg/ml solution for infusion Levofloxacin 250mg Tablets Levofloxacin 500mg Tablets Levofloxacin 5mg/ml Solution for Infusion Tavanic I.V. 5 mg/ml Tavanic 250 mg Tablets Tavanic 500 mg Tablets Levaquin 250 mg Tablets Levaquin 500 mg Tablets Levaquin 750 mg Tablets Levaquin Solution 250mg/10ml Levaquin Injectable 500mg/20ml Levaquin Injectable 750mg/30ml Levofloxacin 250 mg Tablets Levofloxacin 500 mg Tablets Levofloxacin 750 mg Tablets Levaquin 250 mg Tablets Levaquin 500 mg Tablets Levaquin 750 mg Tablets Novo-Levofloxacin 250 mg Tablets Mylan-Levofloxacin 500 mg Tablets Apo-Levofloxacin 750 mg Tablets Levofloxacin Solution 250mg/10ml Levofloxacin Injectable 500mg/20ml Levofloxacin Injectable 750mg/30ml

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

India: Levoflox Oz Kit

Levaquin

Levofloxacin: Side Effects

Levofloxacin, the levorotatory (S)-enantiomer of the racemate ofloxacin, is an oral and parenteral fluoroquinolone that has bactericidal activity against a wide spectrum of Gram-negative and Gram-positive bacilli (including Streptococcus pneumoniae), as well as atypical respiratory pathogens.

In patients with meningitis, levofloxacin penetration in cerebrospinal fluid and the liquor-to-plasma ratio was assessed at 2 hours after dosing in five patients with spontaneous acute bacterial meningitis. Cerebrospinal fluid levofloxacin concentration at 2 hours after dosing was 2.0 µg/ml, and the liquor-to-plasma ratio at 2 hours after dosing was 0.35.

Observational studies

In 10 patients who took levofloxacin 500 mg/day and rifampicin 600 mg/day for 2-6 months, there were no adverse reactions in 46% of patients, occasional digestive symptoms in 40%, and mild diarrhea in 13%; these patients also took unspecified anti-inflammatory drugs. There was sleeplessness in 6% but neither tendinitis nor changes in liver function.

In a prospective, multicenter open trial, 313 patients with clinical signs and symptoms of bacterial infections of the respiratory tract, skin, or urinary tract were treated with levofloxacin. Of these, 134 patients had a pathogen recovered from the primary infection site and had an MIC of the pathogen to levofloxacin determined. Levofloxacin generated clinical and microbiological response rates of about 95%. These response rates included pathogens such as Streptococcus pneumoniae and Staphylococcus aureus. In a logistic regression analysis, the clinical outcome was predicted by the ratio of peak plasma concentration to MIC and site of infection. Microbiological eradication was predicted by the peak concentration/MIC ratio. Both clinical and microbiological outcomes were most likely to be favorable if the peak concentration/MIC ratio was at least 12.

Of 17 individuals with suspected latent multidrug-resistant tuberculosis treated with pyrazinamide and levofloxacin, 11 developed musculoskeletal adverse effects related to therapy, 5 had nervous system effects, and 15 had raised liver enzymes, uric acid, or creatinine kinase.

Comparative studies

In comparative trials involving commonly used regimens, levofloxacin had equivalent if not greater activity in the treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, acute pyelonephritis, and complicated urinary tract infection.

General adverse effects

The adverse effects rates of levofloxacin are 1.3% for nausea, 0.1% for anxiety, 0.3% for insomnia, and 0.1% for headache. No levofloxacin-related adverse events were reported at a rate higher than 1.3%, and most were less common. High-dose levofloxacin (750 mg) was also well tolerated. Surveillance data reported low adverse event rates: nausea 0.8%, rash 0.5%, abdominal pain 0.4%, and diarrhea, dizziness, and vomiting 0.3%. The adverse drug reactions rate for levofloxacin is still one of the lowest of any fluoroquinolone, at 2% compared with 2-10% for other fluoroquinolones.

Levofloxacin: Organs and Systems

Drug-Drug Interactions

Chinese medicines

Chinese medicines did not influence the systemic availability or renal excretion of levofloxacin.

Efavirenz

Levofloxacin pharmacokinetics in HIV-positive patients were not altered by steady-state treatment with efavirenz

HIV protease inhibitors

Levofloxacin pharmacokinetics in HIV-positive patients were not altered by steady-state treatment with nelfinavir.

Lithium

Co-administration with levofloxacin can cause severe lithium toxicity; the authors did not discuss the mechanism.

Theophylline

Theophylline clearance was reduced by levofloxacin plus clarithromycin in a 59-year-old Japanese man, who had stimulation, insomnia, and tachycardia due to theophylline toxicity.

The mechanism was probably inhibition of theophylline metabolism by CYP1A2 and CYP3A4.

Warfarin

Enhanced hypoprothrombinemia has been reported when levofloxacin was given with warfarin.

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