Axa-Levo

Axa-Levo

levofloxacin

Manufacturer:

AXA Parenterals

Distributor:

Ambica
Full Prescribing Info
Contents
Levofloxacin.
Description
Each 100 mL contains: Levofloxacin Hemihydrate eq. to Levofloxacin 500 mg, Glucose Anhydrous BP 5.0% w/v, Water for Injection BP qs.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: The mechanism of action of Levofloxacin and other fluoroquinolone antimicrobial involves inhibition of bacterial topoisomerase I.V. and DNA gyrase (both of which are type II topoisomerases) enzymes required in DNA replication transcription repair and recombination.
Pharmacokinetics: Absorption: Levofloxacin pharmacokinetics are linear and predictable after single and multiple I.V. dosing regimens. Steady state conditions are reached within 48 hours following a 500 mg or 750 mg once daily dosage regimen.
Distribution: The mean volume of distribution of Levofloxacin generally ranges from 74 to 112 L after single and multiple 500 mg or 750 mg doses, indicating widespread distribution into body tissues. Levofloxacin reaches its peak levels in skin tissues and in blister fluid of healthy subject at approximately 3 hours after dosing.
Metabolism: Levofloxacin is stereochemically stable in plasma and urine and does not invert metabolically to its enantiomer. D-Ofloxacin, Levofloxacin ranges from approximately 6 to 8 hours following single or multiple doses of Levofloxacin is given intravenously.
Indications/Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Levofloxacin and other antibacterial drugs. Levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Levofloxacin is indicated in the following conditions: Nosocomial pneumonia, acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, complicated skin and skin structure infections, uncomplicated skin and skin structure infections, chronic bacterial prostatitis, complicated urinary tract, uncomplicated urinary tract infections, acute pyelonephritis, inhalational anthrax (Post-Exposure).
Dosage/Direction for Use
Levofloxacin solution is administered by slow intravenous infusion once or twice daily. The dosage depends in the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with Levofloxacin after the initial use of the intravenous preparation may be completed with an appropriate oral Levofloxacin presentation.
Posology: The following dose recommendations can be given for Levofloxacin: See Table 1.

Click on icon to see table/diagram/image

Special populations: Impaired renal function (creatinine clearance ≤ 50 mL/min): See Table 2.

Click on icon to see table/diagram/image

Impaired liver function: No adjustment of dose is required since Levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.
Elderly population: No adjustment of dose is required in the elderly, other than that imposed by consideration of renal function.
Paediatric population: Levofloxacin is contraindicated in children and growing adolescents.
Method of administration: Levofloxacin solution for infusion is only intended for slow intravenous infusion; it is administered once or twice daily. The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg Levofloxacin.
Overdosage
In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and approximate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.
Contraindications
Levofloxacin is contraindicated in persons with known hypersensitivity to Levofloxacin or any member of the quinolone antibacterial.
Warnings
Fluoroquinolones (e.g. Levofloxacin) use have shown increased risk of tendinitis and tendon rupture and exacerbation of muscle weakness in person with myasthenia gravis.
Special Precautions
Rapid or bolus intravenous infusion of Levofloxacin has been associated with hypotension and must be avoided. Levofloxacin should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Adverse Reactions
The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience.
Frequencies below are defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10000 to <1/1000), Very rare: (< 1/10000), Not known (Cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infection and Infestation: Uncommon: Fungal infection (and proliferation of other resistant microorganism).
Blood and lymphatic system disorders: Uncommon: Leukopenia, Eosinophilia. Rare: Thrombocytopenia, Neutropenia. Very rare: Agranulocytosis. Not known: Pancytopenia, Agranulocytosis, Haemolytic anaemia.
Immune system disorders: Very rare: Anaphylactic shock: Anaphylactic and anaphylactoid reactions may sometimes occur even after the first dose. Not known: Hypersensitivity.
Metabolism and nutrition disorders: Uncommon: Anorexia. Very rare: Hypoglycemia, particularly in diabetic patients.
Psychiatric disorders: Uncommon: Insomnia, nervousness. Rare: Psychotic disorder, depression, confusional state, agitation, anxiety. Very rare: Psychotic reactions with self-endangering behaviour including suicidal ideation or acts, hallucination period.
Nervous system disorders: Uncommon: Dizziness, headache, somnolence. Rare: Convulsion, tremor, paraesthesia. Very rare: sensory or sensorimotor peripheral neuropathy, dysgeusia including ageusia, parosmia including anosmia.
Eye disorders: Very rare: Visual disturbance.
Ear and Labyrinth disorders: Uncommon: Vertigo. Very rare: Hearing impaired. Not known: Tinnitus.
Cardiac disorders: Rare: Tachycardia. Not Known: ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged.
Vascular disorders: Common: Phlebitis. Rare: Hypotension.
Respiratory, thoracic and mediastinal disorders: Rare: Bronchospasm, dyspnoea. Very rare: Pneumonitis allergic.
Gastrointestinal disorders: Common: Diarrhoea, nausea. Uncommon: Vomiting, abdominal pain, dyspepsia, flatulence, constipation. Rare: Diarrhoea - haemorrhagic which in very rare cases may be indicative of enterocolitis, including pseudomembranous colitis.
Hepatobiliary disorders: Common: Hepatic enzyme increased (ALT/AST, alkaline phosphatase, GGT). Uncommon: Blood bilirubin increased. Very rare: Hepatitis. Not known: Jaundice and severe liver injury, including cases with acute liver failure, have been reported with levofloxacin, primarily in patients with severe underlying diseases.
Skin and subcutaneous tissue disorders: Uncommon: Rash, pruritus. Rare: Urticaria. Very rare: Angioneurotic oedema, photosensitivity reaction. Not Known: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, hyperhidrosis Mucocutaneous reactions may sometimes occur even after the first dose.
Musculoskeletal and Connective tissue disorders: Rare: Tendon disorder, including tendinitis (e.g. Achilles tendon), arthralgia, myalgia. Very rare: Tendon rupture. This undesirable effect may occur within 48 hours of starting treatment and may be bilateral, muscular weakness which may be of special importance in patients with myasthenia gravis. Not Known: Rhabdomyolysis.
Renal and urinary disorders: Uncommon: Blood creatinine increased. Very rare: Renal failure acute (e.g. due to nephritis interstitial).
General disorders and administration site conditions: Common: Infusion site reaction. Uncommon: Asthenia. Very rare: Pyrexia. Not known: Pain (including pain in back, chest, and extremities).
Other undesirable effects which have been associated with fluoroquinolone administration include: extrapyramidal symptoms and other disorders of muscular coordination, hypersensitivity vasculitis, attacks of porphyria in patients with porphyria.
Drug Interactions
There are no data concerning the interaction of intravenous fluoroquinolone with oral antacids, sucralfate, multivitamins, didanosine or metal cations. However, fluoroquinolone should be co-administered with any solution containing multivalent cations, E.G. magnesium, through the same intravenous line.
Storage
Store at temperatures not exceeding 30°C. Do not freeze.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Soln for infusion 5 mg/mL x 100 mL x 1's.
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