Levofloxacin | Levoflox viaL

Levoflox viaL 

Levofloxacin 500 mg

Company Name

Memphis

Therapeutic Group

INJ FLUOROQUINOLONES

Pharmaceutical form

20 ml vial IV infusion

Package

carton box containing brown glass vial of 20 ml with inner insert.

Indications

"Levoflox is indicated for the treatment of the following infections due to levofloxacin susceptible microorganisms:

- Acute sinusitis

- Acute exacerbation of chronic bronchitis.

- Community -acquired pneumonia

- Complicated urinary tract infections including pyelonephritis.

- Skin and soft tissue infections.

- Prostatitis.

Warning & Precautions

"Exacerbation of myasthenia gravis:Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilator support, have been associated with .fluoroquinolone use in persons with myasthenia gravis. Avoid fluoroquinolones in patients with known history of myasthenia gravis .Patients predisposed to seizures should use levoflox with extreme caution- .If pseudo-membraneous colitis is suspected, levoflox must be stopped immediately- tendinitis: rarely observed with quinolones, may occasionally lead to rupture involving Achilles tendon in particular. This undesirable effect may -.occur within 48 hours of starting of treatment and may be bilateral Elderly patients are more initis The risk of tendon rupture may be increased by the co-administeration of corticosteroid, if tendinitis is suspected, treatment with levoflox must be -.stopped immediately and the affected tendons must be put at rest . The dose of levoflox should be adjusted in patients with renal impairment- . It is recommended that patients should not expose themselves unnecessarily to strong sunlight or to artificial UV or to artificial UV rays- Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to hemolytic reactions when treated with -.(quinolone , antibacterial agents (e.g.levoflox .Levoflox may cause dizziness, vertigo and visual disturbances whice may cause risk during driving a car or operating machinery- . The use of levofloxacin, especially if prolonged, may result in overgrowth of non-susceptible organisms-

Product Type

Human

Dosage

"Adults:

- Acute sinusitis: 500 mg once daily for 10 to 14 days by oral route.

- Acute exacerbation of chronic bronchitis: 250 to 500 mg once daily for 7 to 10 days by oral route.

- Community-aquired pneumonia: 500 mg once or twice daily for 7 to 14 days by oral or intravenous route.

- Complicated urinary tract infections including pyelonephritis: 250 mg once daily for 7 to 10 days by oral or intravenous route. In case of severe infection, consideration should be taken to increase the dose.

- Skin and soft tissue infections:250 mg once daily or 500 mg once or twice daily for 7 to 14 days by oral or intravenous route.

-Prostatitis: 500 mg once daily for 28 days by oral or intravenous route.

Dosage in adult patients with impaired renal function (creatinine clearance ≤ 50 ml/min)

-According to the severity of the infection, three treatment regimens are recommended. Creatinine Clerara Dosage regimen

50-20 ml/min first dose: first dose: first dose:

250 mg 500 mg 500 mg

then then then

125 mg/24 h 250 mg/24 h 250 mg/12h


19-10 ml/min first dose: first dose: first dose: 250 mg 500 mg 500 mg

then then then

125 mg/48h 125 mg/24 h 125 mg/12h


<10 ml/min first dose: first dose: first dose:

Including

Hemodialysis

And CAPD* 250 mg 500 mg 500 mg

then then then

125 mg/48 h 125 mg/24 h 125 mg/24h

Continuous ambulatory peritoneal dialysis.*

No additional doses are required after hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

- No dose adjustment is required in patients with impaired liver function, elderly patients. However, special attention to renal function should be paid in elderly patients, and the dosage should be adapted accordingly.

- Levoflox is only intended for slow intravenous infusion administered once or twice daily. The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg.

- Levoflox solution for infusion should be used immediately (within 3 hours) after perforation of the rubber stopper in order to prevent any bacterial contamination."

Adverse Reactions

"Gastrointestinal system:

nausea, diarrhea,anorexia, vomiting, dyspepsia, abdominal pain, rare:bloody diarrhea( pseudomembranous colitis), very rare: hypoglycemia particularly in diabetic patients.

Skin and allergic reactions:

rash, pruritus,Bronchospasm, swelling of the face,tongue,throat at larynx, hypotension, anaphylactic shock, photosensitization, isolated cases of severe bullous eruption, toxic epidermal necrolysis, erythema exudativum multiforme.

Nervous system:

Headache, dizziness, drowsiness, insomnia, depression, anexity, psychotic reactions (hallucinations), paresthesia (numbness, tingling and burning), tremor, agitation, confusion, convulsion, hypoesthesia, visual and auditory disturbances, taste and smell disorders.

Cardiovascular system:

Tachycardia, hypotension, QT interval prolongation.

Muscle and skeleton:

Arthralgia, myalgia, tendon disorders, muscular weakness which may be of special importance in patients with myasthenia gravis(chronic progressive muscle disease); isolated cases of rhabdomyolysis (dissolution of the muscle).

Liver and kidney:

Common: Increase in liver enzymes, uncommon: increase in bilirubin and serum Creatinine,very rare: hepatitis and acute kidney failure.

Blood:

Eosinophilia, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, hemolytic anemia, pancytopenia.

Others:

Asthenia, fungal overgrowth and proliferation of other resistant microorganisms, allergic pneumonitis, fever, extrapyramidal symptoms and vasculitis, attacks of porphyria .

For infusion solution only: common: pain, reddening of the infusion site and phlebitis (inflammation of vein).

Postmarketing Experience: Exacerbation of myasthenia gravis.

Contra Indications

"Levoflox is contraindicated in :

- Patient hypersensitive to levofloxacin and other quinolones or any other component of the drug.

- Patient with epilepsy or history of tendon disorders related to fluoroquinolone administration.

- Children or adolescents. Pregnancy and lactation:

Levoflox is contraindicated during pregnancy and lactation."

Drug Interactions

"It is recommended that preparations containing divalent or trivalent cations such as iron altsor magnesium or aluminium containing antacids should not be taken 2 hours before or after levoflox administration because of a possible reduction in absorptionThe bioavailability of levofloxacin is significantly reduced when administered together with sucralfate, so it is recommended to administer sucralfate 2 hours after the the levoflox administration

- Pronounced lowering of the cerebral seizure threshold may occur when quinolones (e.g. levoflox) are given concurrently with theophylline, fenbufen or similar non steroidal anti-inflammatory drugs or other agents, which lower the seizure threshold

- Caution should be exercised when levoflox is co-administered with drugs that affect the tubular renal secretion such as probenecid and Cimetidine, especially in renally impaired patients

- Increased coagulation tests and/or bleeding, which may be severe, are reported in patients treated with levoflox in combination with a vitamin K antagonist (e.g warfarin)

- Levoflox solution for infusion should not be mixed with heparin or alkaline solutions (e.g. sodium hydrogen carbonate) but is compatible with the following solutions for infusion: 0.9% sodium chloride solution, 5 % dextrose injection, 2.5% dextrose in ringer solution or combination solutions .for parenteral nutrition) amino-acids, carbohydrates electrolytes)

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