Levofloxacin Hemihydrate Film coated tablet 500 mg, each film coated tablet contains : Levofloxacin hemihydrate equivalent to Levofloxacin 500 mg.
Levofloxacin Hemihydrate contains Levofloxacin hemihydrate (equivalent to Levofloxacin) as active ingredient are available in film coated tablet 500 mg.
Levofloxacin Hemihydrate is indicated for the treatment of adults (≥ 18 years of age) with mild, moderate and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below :
- Acute maxillary sinusitis : Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis.
- Acute bacterial exacerbation of chronic bronchitis : Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae or Moraxella catarrhalis.
- Community acquired pneumonia : Staphylococcus aureus, Streptococcus pneumoniae (including Penicillin-resistant strains), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila or Mycoplasma pneumoniae.
- Complicated skin and skin structure infections : Methicillin-resistant Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes or Proteus mirabilis.
- Uncomplicated skin and skin structure infections (mild to moderate including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections) : Staphylococcus aureus or Streptococcus pyogenes.
- Complicated urinary tract infections (mild to moderate) : Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis or Pseudomonas aeruginosa.
- Acute pyelonephritis (mild to moderate) caused by Escherichia coli.
- Uncomplicated urinary tract infections (mild to moderate) : Escherichia coli, Klebsiella pneumoniae or Staphylococcus saprophyticus.
DOSAGE AND ADMINISRATIONS :
Usual dose in patients with normal renal (i.e., creatinine clearance ≥ 50 ml/minute) :
250 – 750 mg once daily for 3 – 14 days depending on the severity of the disease.
Patients with normal renal function :
|Infection||Levofloxacin once daily|
|Acute maxillary sinusitis||500 mg||10 – 14 days|
|Acute bacterial exacerbation of chronic bronchitis||500 mg||7 days|
|Community acquired pneumonia||500 mg||7 – 14 days|
|Complicated skin & skin structure infections||750 mg||7 – 14 days|
|Uncomplicated skin & skin structure infections||500 mg||7 – 10 days|
|Complicated UTI||250 mg||10 days|
|Uncomplicated UTI||250 mg||3 days|
|Acute pyelonephritis||250 mg||10 days|
Patients with impaired renal function :
|Renal status||Levofloxacin once daily|
|Acute bacterial exacerbation of chronic bronchitis /Community acquired pneumonia/Acute maxillary sinusitis/Uncomplicated skin & skin structure infections||Initial dose||Subsequent dose|
|ClCr from 50 to 80 ml/minute||No dosage adjustment required|
|ClCr from 20 to 49 ml/minute||500 mg||250 mg q 24 h|
|ClCr from 10 to 19 ml/minute||500 mg||250 mg q 48 h|
|Hemodialysis||500 mg||250 mg q 48 h|
|CAPD||500 mg||250 mg q 48 h|
|Complicated skin & skin structure infections|
|ClCr from 50 to 80 ml/minute||No dosage adjustment required|
|ClCr from 20 to 49 ml/minute||750 mg||750 mg q 48 h|
|ClCr from 10 to 19 ml/minute||750 mg||500 mg q 48 h|
|Hemodialysis||750 mg||500 mg q 48 h|
|CAPD||750 mg||500 mg q 48 h|
|Complicated UTI/Acute pyelonephritis|
|ClCr 20 ml/minute||No dosage adjustment required|
|ClCr from 10 to 19 ml/minute||250 mg||250 mg q 48 h|
|Uncomplicated UTI||No dosage adjustment required|
ClCr = Creatinine Clearances
CAPD = Chronic Ambulatory Peritoneal Dialysis
Levofloxacin is contraindicated in patients with a history of hypersensitivity to Levofloxacin, Quinolone antimicrobial agents or any other components of this product.
WARNINGS AND PRECAUTIONS :
Convulsion and toxic psychoses have been reported in patients receiving Quinolones, including Levofloxacin. It may also increased intracranial pressure and CNS stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmare, insomnia and rarely suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving Levofloxacin, this drug should be discontinued.
- Although Levofloxacin is more soluble than other Quinolones, adequate hydration of patients receiving Levofloxacin should be maintained to prevent the formation of a highly concentrated urine.
- Administered Levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of Levofloxacin may be reduced. In patients with impaired renal function (creatinine clearance ≤ 80 ml/minute), adjustment of the dosage regimen is necessary to avoid the accumulation of Levofloxacin due to decreased clearance.
- Moderate to severe phototoxicity reactions have been observed in patients exposed to direct sunlight while receiving drugs in this class. Therapy should be discontinued if phototoxicity (e.g., a skin eruption) occurs.
- As with other Quinolones, Levofloxacin should be used with caution in any patient with a known or suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction).
- Use in pregnancy and lactation : The safety and efficacy of Levofloxacin in pregnant women and nursing mothers have not been established.
- Use in children : The safety and efficacy of Levofloxacin in children and adolescents <18 years have not been established.
- If during the use of Fluoroquinolone patient experiences pain, swelling, tendon and rupture tendon inflammation, then :
- Levofloxacin should be discontinued.
- Patient should contact their healthcare provider regarding changing to a non-Quinolone antimicrobial drug.
- Patient should avoid exercise and using the affected area.
DRUG INTERACTIONS :
- Antacids, Sucralfate, metal cations, multivitamins.
Levofloxacin tablets : While the chelation by divalent cations is less marked than with other Quinolones, concurrent administration of Levofloxacin tablets with Antacids containing magnesium or aluminium, as well as Sucralfate, metal cations such as iron and multivitamin preparations with zinc may interfere with the gastrointestinal absorption of Levofloxacin, resulting in systemic levels considerably lower. Tablets with Antacids containing magnesium, aluminium, as well as Sucralfate, metal cations such as iron and multivitamins preparations with zinc should be taken at least 2 hours before or 2 hours after Levofloxacin administration.
- The concomitant administration of a NSAID with a Quinolone, including Levofloxacin, may increase the risk of CNS stimulation and convulsive seizures.
- Antidiabetic agents may cause disturbances of blood glucose, including hyperglycemia and hypoglycemia. Therefore, careful monitoring of blood glucose is recommended when this agents are concomitant administered.
- Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and therefore, may give false negative results in the bacteriological diagnosis of tuberculosis.
ADVERSE REACTIONS :
- The most frequently reported : Nausea, diarrhea, itching, abdominal pain, headache and constipation.
- Commonly adverse reactions : Insomnia, vomiting, dyspepsia, rash, vaginitis, flatulence, pruritus, chest pain and back pain.
- Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported.
- Hypersensitivity reactions : Skin reactions, e.g., skin eruption, macula erythema and Steven-Johnson syndrome.
Levofloxacin Hemihydrate Film coated tablet 500 mg Box, 10 blisters @ 10 film coated tablets
Reg. No. GKL0402335717B1
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia