LEVOFLOXACIN TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

Disponível em:

PRO DOC LIMITEE

Código ATC:

J01MA12

DCI (Denominação Comum Internacional):

LEVOFLOXACIN

Dosagem:

500MG

Forma farmacêutica:

TABLET

Composição:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 500MG

Via de administração:

ORAL

Unidades em pacote:

50/100

Tipo de prescrição:

Prescription

Área terapêutica:

QUINOLONES

Resumo do produto:

Active ingredient group (AIG) number: 0131663004; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2016-10-03

Características técnicas

pseudomonal β
(≥65 yearsofage):
§
§
§
§
§
≤
(≥65 yearsofage)
therapy) occurringin ≥1%of
≥
≤
≥20 mL/min
otherclasses ofantimicrobial agents,suchasβ
maybe susceptibletofluoroquinolones.Forexample,β
∞ reported,unless otherwise specified;
≤
·
·
65% predicted,with ≥4 exacerbationsinthepreceding
12monthsand/orthepresence ofsignificantco
once daily for≥24hours
8hfor ≥3days
ThemITTpopulationincluded patientswhohad
aclinicaldiagnosisofAPorcUTIandwho had apositive(≥10
(≥ 10
≥600mg/kg,
≥200mg/kg,
≥6mg/kg,
≥30mg/kg,
≥6mg/kg,
respirationdepth;≤10 mg/kg,
pressure;≥
≥200mg/kg,
≥200mg/kg,
≥10x10
withimpairedrenal function(creatinineclearance≤80 mL/min).
Dosageadjustmentmaybe
≤0.008
≤0.008
≤0.008
≤ 0.008
≤0.008
(MIC ≤0.06
≤0.004
≥2.0
≤0.004
(MIC≤0.25
(MIC ≥1.0
(MIC ≥1.0
≤2
≥8
≤2
≤2
≥8
≥17
≤13
≥17
≥17
≤13
↓
↓
↓
↓
↑
↑
↓
↓
↓
↓
↑
↓
↓
↓
♀
♂
andhypothermiaat800mg/kg. Transient↓fcintreated ♂
↓bw gainduring week 1in ♂
↑ WBCdue to↑in
lymphocytesat800mg/kg.PMNs↓ in
♀
♂ ↓K
,andureaand ↑ P and ALT (primaril
↓relativeheartweightsat800 mg/kgand ↑ cecal
♀
♂
Salivation,↑ largefecal
haircoatmainlyat 320mg/kg. ↑ fc at80 and320mg/kg,
↑
♀
↓ PMNsin alltreated
rats, ↑ glucose(treated ♂ ), ↓triglycerides (320 mg/kg♀ ↓ß
(treatedrats),↓α
♀),↓Cl
♀
↓total protein(
♂), and↑ urinarypHat 80and 320mg/kg.
related ↑cecal weight, elongatedand/ordistendedceca and
♀
♂
↓bw at400and800mg/kg.
↓
(≥200
♂
only).↑ALPat800mg/kg(♀
↓absoluteliverweight≥400 ♂
↑ cecalweightandcecal distension(≥100).Noarthropathy.
♂
♂
↑cecalweightand ↓ (mild)ASTand ALT at 160 mg/kg. Noarthropathy.
♀
♂
Transient↓
♂), ↓
↓
activity, urinary protein,andRBC. ↑ WBC,retic, andfibrinogenat
↓
braindue to↓
↑cecalweightat60 and 180mg/kg. Arthropathy at60
♀
♂
Slight↓fc
♂
Mild ↓
♂
↓ fc. Mild↑ A/Gandalbumin at30and 90 mg/kg(♂
♂
♀
↑