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Niglys SR 6.4 Capsules (Glyceryl Trinitrate 6.4)Oliza 500 Tablets (Levofloxacin 500mg Film Coated Tablets)

Oliza 250 Tablets (Levofloxacin 250mg Film Coated Tablets)
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Oliza 250 Tablets (Levofloxacin 250mg Film Coated Tablets)

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Warfarin: There have been reports during the post marketing experience in patients that Oliza (Levofloxacin) enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and Oliza (Levofloxacin) use have been associated with, episodes of bleeding. Prothrombin time, international normalized ratio (INR), or other suitable anticoagulation tests should be closely monitored and appropriate dosage adjustments should be made when Oliza (Levofloxacin) is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in sum theophylline levels.
Probenecid or Cimetidine: No dosage adjustment for Oliza (Levofloxacin) when probenecid or cimetidine is necessary Cyclosporine: No dosage adjustment for Levofloxacin or cyclosporin when administered concomitantly.
Non-steroidal anti-inflammatory drugs: The concomitant administration of a non-steoridal anti-inflammatory drug with the quinolones. Including Oliza (Levofloxacin), may increase the risk of CNS stimulation and convulsive seizures.
Antidiabetic agents: Disturbance of blood glucose, including hyperglycemia, have been reported concomitantly with quinolones and an antidiabetic agent Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:

In a life time bioassay in rats, Oliza (Levofloxacin) exhibited no carcinogensis potential following daily dietary administration for 2 years, the highest dose (l00mng/kg/day) was 1.4 times the highest recommended human dose (750mg) based upon relative body surface area. Oliza (Levofloxacin) also caused no impairment of fertility or reproductive performance in rats at oral doses as high as 360mg/kg/day, corresponding to 4.2 times the highest recommended human has dose based upon relative body surface area and intravenous doses as high as l00mg/kg/day, corresponding to 1.2 times the highest recommended human dose based upon relative body surface area.

PREGNANCY, TERATOGENIC EFFECTS. PREGNANCY CATEGORY-C:

Oliza (Levofloxacin) was not teratogenic in rats at oral doses as high 810mg/kg/day which corresponds to 9.4 times the highest recommended human dose based upon relative body surface area. The oral dose of 810mg/kg/day to rats caused decreased fetal body weight increased fetal mortality. No teratogenicity was observed when rabbits were dosed orally as high as 50mg/kg/day which corresponds to 1.1 times the highest recommended human dose based upon relative body surface area. However No adequate and well-controlled studies in pregnancy human. Oliza (Levofloxacin) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

NURSING MOTHERS:

Oliza (Levofloxacin) has not been measured in human milk. Based upon data from ofloxacin. it can be presumed that Oliza (Levofloxacin) will be excreted in human milk because of the potential or serious adverse reactions fromOliza (Levofloxacin) in nursing infants, a decision should be made not wether to discontinue the drug, taking in to account the importance of the drug to the mother.
PEDIATRIC USE: Safety and effectiveness in pediatric patient adolescence below the age of 18 years have not been established. Quinolones, including Levofloxacin, cause angiopathy and osteochondrosis in juvenile animal of several species.

GERlTARlC USE:

In phase 3 clinical trials 1,190 Levofloxacin-treated patients (25%) were 65 years of age. Of these, 675 patients (14%) were between the ages of 65 and 74 and 515 patients (11%) were 75 years older. No overall difference in safety or effective were observed. Between the subjects and younger subjects, and other reported clinical experience has not identified difference is responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The phamacokinetic properties of Oliza (Levofloxacin) in younger adults do not differ significantly when creatinine clearance is taken into consideration. However since the drug is known to be substantially excreted by the kidney, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS:

The incidence of drug-related adverse reactions in patients during phase 3 clinical trails conducted in North America was 6.2%. Among patients receiving Oliza (Levofloxacin) therapy, 4.3% discontinued Oliza (Levofloxacin) therapy due to adverse experience. The overall incidence, type and distribution of adverse event was similar in patients receiving Levofloxacin does of 750mg once daily compared to patients receiving doses from 250mg once daily to 500mg twice daily. In clinical trails, the following events were considered likely to be drug related in patients receiving Levofloxacin nausea 1.2% diarrhea 1.0% vaginitis 0.6% insomnia 0.4% abdominal pain 0.4% flatulence 0.3% pruritus dizziness 0.3% rash 0.3% dyspepsia 0.2% injection side pain 0.2% injection side reaction 0.2% injection site inflammation 0.1% constipation 0.1% fungal infection 0.I% rash erythematous 0.1% urticaria 0.1% tremor 0.1% condition aggravated 0.1% Allergic reaction 0.1% in clinical trails, the following event occurred in> 3% of patients regardless of drug relationship nausea 7.1% headache 6.2% diarrhea 5.5% insomnia 5.1% constipation 3.5%.

OVER DOSAGE:

Oliza (Levofloxacin) exhibits a low potential of acute toxicity. Rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of Oliza (Levofloxacin) ataxia, decreased locomotor activity, dysponea, prostration, tremors, and convulsions. Doses in excess of 1500mg/kg orally and 250mg/kg i v produced significant mortality in rodents. In the event of an acute over dosage, the stomach should be emptied. The patient should be observed and appropriate hydration should be maintained Oliza (Levofloxacin) is not efficiently removed by hemodialysis or peritoneal dialysis.

DOSAGE AND ADMINISTRATION:

The usual dose of Oliza (Levofloxacin) tablets is 250mg or 500mg administered orally every 24 hours or 750mg administered orally, as indicated by infection and described in the following dosing chart. These recommendation apply to patients with normal renal functioin (i.e., creatinine clearance>80 ml/min). Oral doses should be administered at least 2 hours before or 2 hours after antacids containing magnesium, aluminium, as well as sucralfate, metal cations such as iron and multivitamins preparations with zinc of didanosine, chewable/duffered tablets or the pediatric powder for oral solution.

Patient with Normal Renal Function Infection Unit Dose Duration Daily Dose

  • Community Acquired Pneumonia 500mg 7-14days 500mg
  • Nosocanial Pneumonia 750mg 7-14days 750mg
  • Complicated SSSI 750mg 7-14 days 750mg
  • AECB 500mg 7days 500mg
  • Acute Maxillary Sinusltis 500mg I0-14days 500mg
  • Uncomplicated SSSI 500mg 7-10days 500mg
  • Chronic Bacterial Prostatitis 500mg 28days 500mg
  • Acute Pyelonephritis 250mg 10 days 250mg
  • Uncomplicated UTI 250mg 3days 250mg
  • Typhoid Fever 250mg 7-10days 250mg
  • Complicated UTI 250mg 10 days 250mg

PRESENTATION:

  • OLIZA 250 (Levofloxacin 250mg-as hemihydrate) Each Pack Contains Blister strip of 1x10's Film Coated Tablets
  • OLIZA 500 (Levofloxacin 500mg-as hemihydrate) Each Pack Contains Blister strip of 1x10's Film Coated Tablets
  • OLIZA 750 (Levofloxacin 750mg-as hemihydrate) Each Pack Contains Blister strip of 1x10's Film Coated Tablets
  • Oliza (Levofloxacin) is a synthetic broad spectrum antibacterial, Chemically it is the pure (-) (s) enantiomer of the racemic drug substance ofloxacin

CLINICAL PHARMACOLOGY:

Pharmacokinetics: Oliza (Levofloxacin) is rapidly and essentially completely absorbed after oral administration Peak plasma concentrations are usually attained in 1 to 2 hours after oral dosing. Oliza (Levofloxacin) tablets can be administered without regard to food. The main volume of distribution of Levofloxacin generally ranges from 74 to 112 hours after single and multiple 500mg or 750mg doses indicating wide spread distribution into body tissues Levofloxacin reaches its peak levels in skin tissues and in body fluid of healthy subjects at approximately 3 hours after dosing. Metabolism of Oliza (Levofloxacin) is stereo- chemically stable in plasma and urine and does not invert metabolically to its enantiomer, D-ofloxacin undergoes limited metabolism in humans and is primarily excreted as unchanged in the urine. Oliza (Levofloxacin) is excreted largely as unchanged drug in the urine. The mean terminal plasma elimination half life of Oliza (Levofloxacin) ranges from approximately 6 to 8 hours following single or multiple doses of Oliza (Levofloxacin) given orally. The mean apparent total body clearance and renal clearance range from approximately 144 to 226 ml./min and 96 to 142 ml./min respectively.

PHARMACODYNAMICS: Oliza (Levofloxacin) is the L-isomer of the racemate, Ofloxacin. The antibacterial activity of ofloxacin, resides primarily in the L-isomer. The mechanism of action of Oliza (Levofloxacin) and other fluoroquinolone antimicrobial, involves inhibition of bacterial topoisomerase IV and DNA gyrase (both of which are type II topoisomerase) enzymes required for DNA replication, transcription, repair and recombination. Oliza (Levofloxacin) has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. Oliza (Levofloxacin) is often bactericidal at concentration equal to or slightly greater than inhibitory concentration, fluoroquinolones, including Levofloxacin, differ in chemical structure and mode of action from aminoglycosides, macrolides and B-lactam antibiotics including penicillins. Flouroquinolones may therefore be active against bacteria resistant to these antimicrobials.

INDICATIONS AND DOSAGE: Acute maxillary sinusitis due to Streptococcus Pneumoniae haemophilus Parainfluenzae or Moraxella Catarrhalis Nosocomial Pneumonia due to methicillin susceptible staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Eschechia coli, Klebsiella pneumoniae, Haemophillis influenzae or streptococcus pneumoniae adjunctive therapy should be used as clinically indicated. Where pseudomonas aeruginosa is a documented or presumative pathogen, combination therapy with an anti-pseudomonal B-lactam is recommended.
Community-acquired pneumonia due to staphylococcus aureus, streptococcus pneumoniae (including penicillin-resistant strains, MIC value for Penicillin =2ug/ml) haemophilus influenzae, Haemophilus Parainfluenzae, Pseudomonas Aerueginosa, Klebsiella Pneumonia, Chlamydia pneumoniae, Ligionella Pneumoniae or Mycoplasma pneumoniae.
Complicated skin and skin structure infections due to methiciliin susceptible staphylococcus aureus, Enterococcus faecalis. Streptococcus Pyogenes , or proteus mirabilis Uncomplicated skin and skin structure infections (mild to moderate) including abscesses, celluitis, furuncles, impetigo, pyoderma wound infections, due to staphylococcus aureus or streptococcus pyogens.
Chronic bacterial prostatitis due to Escherichia coli, Entercoccus faecalis
Complicated urinary tract injections (mild to moderate) due to enterococcus faecalis, Entrobacter cloacae, Escheroichia coli Klebsiella pneumoniae, proteus mirabilis or pseudomonas aerueginosa
Acute pyelonephirits (mild to moderate) caused by Escherichia coli
Uncomplicated urinary tract infection (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or staphylococcus saprophyticus. Appropiate culture and susceptibility test should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to Oliza (Levofloxacin). Therapy with Oliza (Levofloxacin) may be initiated before results of these test are known, once results become available, appropriate therapy should be selected. As with other drugs in this class, Some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Oliza (Levofloxacin). Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.

CONTRAINDICATIONS: Levofloxacin is contraindicated in person with history of hypersensitivity to Oliza (Levofloxacin), quinolone antimicrobial agents, or any other components of this product.

WARNINGS: In immature rats and dogs, the oral and intravenous administration of Oliza (Levofloxacin) increased the incidence and severity of osteocnondosis. Other fluoroquinolones also produce similar erosions in the weight bearing joints an other signs of authropathy in immature animals of various species. Convulsions and toxic psychosis have been reported in patients receiving quinolones, including Oliza (Levofloxacin) or these may cause increased intracranial pressure and central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving Oliza (Levofloxacin), the drug should be discontinued and appropriate measures instituted. As with other quinolones. Oliza (Levofloxacin) should be used with caution in patients with a known or suspected CNS disorder that may predispose to seizures or lower the seizur threshold (e.g .. Severe cerebral arteriosclerosis. epilepsy) or in the presence of other risk factors that may predispose to seizure or lower the seizure threshold (e.g., Certain drug therapy, renal dysfunction).

PRECAUTIONS:

General: Prescribing Oliza in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increase the risk of the development of drug-resistant bacteria. Although Oliza (Levofloxacin) is more soluble than other quinolomes, adequate hydration of patients receivingOliza (Levofloxacin) should be maintained to prevent of a highly concentrated urine AdministerOliza (Levofloxacin) with caution in the presence of renal insufficiency. In patients with impaired renal function (creatinine clearancc