LFX 500 Levofloxacin Hemihydrate Tablets

LFX’ – 500
Levofloxacin Tablets 500 mg.

 

Only for the use of Registered Medical Practitioner or Medical or laboratory

 

Composition

Each film coated tablets contains:

Levofloxacin Hemihydrate

Equivalent to Levofloxacin 500mg

Excipients Q.S.

Colour: Yellow Oxide of Iron and Titanium Dioxide B.P.

 

Pharmacological Action

Levofloxacin is a fluoroquinolone class which has a broad spectrum of antibacterial activity against both Gram-positive and Gram negative bacteria. Levofloxacin exerts its effect by inhibiting the bacterial DNA gyrase, which is responsible for coiling the genetic material as a prerequisite for bacterial multiplication.

 

Pharmacokinetics

Levofloxacin is rapidly and completely absorbed after oral administration. Peak plasma concentration is attained 1 – 2 hrs after oral dosing. The bioavailability is 99%. The peak plasma concentration of levofloxacin is up to 11.5 mcg/ml after 500mg dose given orally. Levofloxacin is 24 to 38 % bound to plasma protein. It has limited metabolism in humans, approx 87 % of an unchanged drug is excreted in urine within 48 hours, whereas less than 4% of the dose is recovered in feces in 72 hours. The elimination half-life of levofloxacin range from 6.3 to 7.5 hours.

 

Indications

Levofloxacin tablets are indicated for the treatment of typhoid. Levofloxacin tablets are indicated for the treatment of enteric Infection.

Levofloxacin Tablets are indicated for the treatment of the following bacterial infections.

Nosocomial Pneumonia and Community-Acquired Pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae.

Acute Bacterial Sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.

Acute Bacterial Exacerbation of Chronic Bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumonia, Haemophilus infleunzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Complicated and uncomplicated Skin and Skin Structure Infections methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.

Chronic Bacterial Prostatitis due to Escherichia coli, Enterococcus faecalis or methicillin-susceptible Staphylococcus epidermidis.

Complicated and uncomplicated Urinary Tract Infections due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Proteus mirabilis, or Pseudomonas aeruginosa.

Acute Pyelonephritis due to Escherichia coli.

 

Contraindications

Levofloxacin Tablets is contraindicated in persons with a history of hypersensitivity associated with the use of levofloxacin or any member of the quinolone group of antimicrobial agents.

 

Warnings and Precautions

Fluoroquinolones including levofloxacin are associated with an increased risk of tendinitis and tendon rupture in all ages. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones. Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients. It has been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Convulsions and toxic psychoses have been reported in patients receiving Levofloxacin. Fluoroquinolones may also 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. Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions. Levofloxacin can cause changes in blood sugar in people with diabetes.

 

Interactions

Solution with antacids containing magnesium, or aluminum, 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 than desired. There have been reports during the postmarketing experience in patients that Levofloxacin enhances the effects of warfarin. Disturbances of blood glucose, Including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered.

The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including Levofloxacin, may increase the risk of CNS stimulation and convulsive seizures. Theophylline levels should be closely monitored and appropriate dosage adjustments made when Levofloxacin is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels.

 

Pregnancy and Lactation

There are, however, no adequate and well-controlled studies in pregnant women. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. For lactation safety has not been established.

 

Dosage and Directions for Use

The usual dose of Levofloxacin Tablets 250 mg, 500 mg or 750 mg administered orally every 24 hours, as indicated by infection.

Infection Dose Duration (days)
Community Acquired Pneumonia 500mg 7-14
Community Acquired Pneumonia 750 mg 5
Nosocomial Pneumonia 750 mg 7-14
Acute Bacteril Exacerbation of Chronic Bronchitis 500 mg 7
Complicated SSSI 750 mg 7-14
Uncomplicated SSSI 500 mg 7-10
Complicated urinary tract 250 mg 10
Uncomplicated urinary tract 250 mg 3

 

Side-Effects and Special Precautions

Nausea, stomach upset, loss of appetite, diarrhea, drowsiness, dizziness, headache, or trouble sleeping may occur. Chest pain, change in the amount of urine, dark urine, easy bruising/bleeding, fainting, fast/irregular heartbeat, mental/mood changes, persistent nausea/vomiting, persistent sore throat or fever, seizures, unusual fatigue, yellowing eyes and skin may occur. Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. This medication may rarely cause severe intestinal condition due to resistant bacteria. There are chance of abdominal or stomach pain/cramping, blood/mucus in your stool, persistent diarrhea. Symptoms of a serious allergic reaction include: rash, hives, itching, swelling severe dizziness trouble breathing.

 

Symptoms of Overdoes and Particulars of Its Treatments

In the event of an acute overdose, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.

 

Presentation

Alu-Alu Blister packages are supplied as 1 x 10 tablets.

 

Storage instructions

Store in a cool, dry place below 25°C and protect from light.

 

KEEP ALL MEDICINES AWAY FROM THE REACH OF CHILDREN.

 

NAFDAC Reg. No.: A4-4114

 

Marketed by

FECCOX PHARMA LTD.

No. 1 A, Airport Road,

Kano Nigeria.

 

Manufactured by

SWISS PHARMA PVT. LTD.

3709, G.I.D.C., Phase 4, Vatva,

Ahmedabad-382445, Gujarat, India.

 

Manufactured for

SWISS PARENTERALS PVT. LTD.

INDIA.

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