Leosil exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.
Leosil Tablet is used for Acute maxillary sinusitis , Acute bacterial exacerbation of chronic bronchitis , Nosocomial pneumonia Community acquired pneumonia, Uncomplicated urinary tract infections Complicated urinary tract infections, Acute pyelonephritis, Uncomplicated & complicated skin and skin structure infections, Chronic bacterial prostatitis
Leosil Injection is used to treat Acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, community acquired pneumonia, uncomplicated urinary tract infections, complicated urinary tract infections, acute pyelonephritis, uncomplicated & complicated skin and skin structure infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, chronic bacterial prostatitis and typhoid fever.
Leosil Injection has
- Proven clinical success in hospital infections
- Reaches high concentrations in lung, urine, skin and prostate
- Ensures excellent gram-positive and gram-negative bacterial coverage, Offers better option for switch therapy
Leosil Eye drops is used for the treatment of corneal ulcer caused by susceptible strains of the following bacteria:
- Gram-positive Bacteria: Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Viridans group streptococci
- Gram-negative Bacteria: Pseudomonas aeruginosa, Serratia marcescens.
Leosil is also used to associated treatment for these conditions: Abscesses caused by susceptible bacteria, Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible bacteria, Acute Pyelonephritis caused by Infection Due to Escherichia Coli, Bacterial Conjunctivitis caused by susceptible bacteria, Cellulitis caused by susceptible bacteria, Community Acquired Pneumonia (CAP) caused by susceptible bacteria, Furuncle caused by susceptible bacteria, Impetigo caused by susceptible bacteria, Nosocomial Pneumonia caused by Pseudomonas Infections, Nosocomial Pneumonia caused by susceptible bacteria, Plague caused by Yersinia pestis, Pyoderma caused by susceptible bacteria, Wound Infections caused by susceptible bacteria, Acute bacterial sinusitis caused by susceptible bacteria, Chronic Bacterial prostatitis caused by susceptible bacteria, Chronic Pseudomonas Infections, Complicated Urinary Tract Infection caused by susceptible bacteria, Complicated skin and skin-structure infections caused by susceptible bacteria, Inhaled anthrax caused by Bacillus anthracis, Uncomplicated Urinary Tract Infection caused by susceptible bacteria, Uncomplicated skin and skin-structure infections caused by susceptible bacteria
|Levofloxacin Other Names||(S)-Ofloxacin, L-Ofloxacin, Levofloxacin, Levofloxacine, Levofloxacino, Levofloxacinum|
Levofloxacin is 24-38% protein-bound in plasma, primarily to albumin. The extent of protein-binding is independent of its plasma concentration.
|Therapeutic Class||4-Quinolone preparations|
|Manufacturer||Silco Pharmaceutical Ltd|
|Last Updated:||June 23, 2021 at 11:22 am|
Acute sinusitis: 500 mg once daily for 10-14 days or 750 mg once daily for 5 days
Exacerbation of chronic bronchitis: 500 mg once daily for 7 days
Community acquired pneumonia: 500 mg once daily for 7-14 days or 750 mg once daily for 5 days
Nosocomial pneumonia: 750 mg once daily for 7-14 days
Uncomplicated urinary tract infections: 250 mg once daily for 3 days
Complicated urinary tract infections and acute pyelonephritis: 250 mg once daily for 10 days
Complicated urinary tract infections and acute pyelonephritis: 750 mg once daily for 5 days
Uncomplicated skin and skin structure infections: 500 mg once daily for 7-10 daysComplicated skin and skin structure infections: 750 mg once daily for 7-14 days
Chronic bacterial prostatitis: 500 mg once daily for 28 days
Leosil solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the causative pathogen. The duration of treatment varies according to the severity of the disease. Adult:
- Community-acquired pneumonia: 500 mg once or twice daily,
- Complicated urinary tract infections (including pyelonephritis): 250 mg once daily,
- Chronic bacterial prostatitis: 500 mg once daily,
- Skin and soft tissue infections: 500 mg twice daily
- Enteric fever: 500 mg once daily.
Leosil can be used in children aged as low as 6 months. The usual dose for children in community acquired pneumonia is:
- Children aged 6 months to less than 5 years: 10 mg/kg b.i.d. (up to 500 mg per day) for 10 days,
- Children aged 5 years to 16 years: 10 mg/kg q.d. (up to 500 mg per day) for 10 days.
The usual dose for children in recurrent or persistent Acute Otitis Media is:
- Children aged 6 months to less than 5 years: 10 mg/kg per day (maximum dose: 500 mg/day) given twice daily for 10 days.
Paediatric Use: Leosil is not recommended for children less than 6 (six) months of age.
Leosil ophthalmic solution:
- Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring.
- Day 4 through treatment completion: Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake.
0.5% ophthalmic solution:
- Days 1 and 2: Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.
- Days 3 through 7: Instill one to two drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.
Administration of Leosil (solution for infusion) should be continued for a minimum of 48 to 72 hours after the patient has become febrile or evidence of bacterial eradication has been obtained. Leosil 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 Leosil solution for infusion. It is possible to switch from an initial intravenous application to the oral route at the same dosage after a few days.
The most frequently reported adverse events were headache and a taste disturbance following instillation. Other adverse events included decreased/blurred vision, diarrhea, dyspepsia, fever, infection, instillation site irritation/discomfort, ocular infection, nausea, ocular pain/discomfort, and throat irritation.
The following measures should be taken during administration of Leosil: While taking Leosil adequate amount of water should be drunk to avoid risk of crystalluria. Dose adjustment should be exercised during Leosil ingestion in presence of renal insufficiency & hepatic insufficiency.
While taking Leosil adequate amount of water should be drunk to avoid risk of crystalluria. Dose adjustment should be exercised during Leosil ingestion in presence of renal insufficiency & hepatic insufficiency.
Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles or after expiry date.
If an allergic reaction to levofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.
Prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of corneal ulcer. Avoid contaminating the applicator tip with material from the eye, fingers or other source.
Specific drug interaction studies have not been conducted with this drug. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.
- Take with or without food. Food slightly alters kinetics but not to any clinically significant extent.
Volume of Distribution
Leosil is widely distributed in the body, with an average volume of distribution following oral administration between 1.09-1.26 L/kg (~89-112 L). Concentrations in many tissues and fluids may exceed those observed in plasma. Leosil is known to penetrate well into skin tissue, fluids (e.g. blisters), lung tissue, and prostatic tissue, amongst others.
The average terminal elimination half-life of levofloxacin is 6-8 hours.
The average apparent total body clearance of levofloxacin ranges from 8.64-13.56 L/h, and its renal clearance ranges from 5.76-8.52 L/h. The relative similarity of these ranges indicates a small degree of non-renal clearance.
Pregnancy & Breastfeeding use
Leosil is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.
Leosil is contraindicated in patients with a history of hypersensitivity to Leosil, quinolone antimicrobial agents, or any other components of this product.
Use in Children: From clinical studies, it is evident that Leosil can be used in children aged as low as 6 months.The usual dose for children in community acquired pneumonia (CAP) is-
- Children aged 6 months to less than 5 years: 10 mg/kg b.i.d. (up to 500 mg per day) for 10 days.
- Children aged 5 years to 16 years: 10 mg/kg q.d. (up to 500 mg per day) for 10 days.
The usual dose for children in recurrent or persistent Acute Otitis Media (AOM) is Children aged 6 months to less than 5 years: 10 mg/kg per day (maximum dose: 500 mg/day) given twice daily for 10 days.
Leosil exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.
Store in a cool & dry place, protected from light. Keep out of the reach of children.
What is Leosil used for?
Leosil is used to treat certain infections such as pneumonia, and kidney, prostate , and skin infections.
How safe is Leosil?
Leosil generally safe.It can cause serious side effects, including tendon problems, side effects on your nerves , serious mood or behavior changes, or low blood sugar (which can lead to coma).
How does Leosil work?
Leosil works by stopping the growth of bacteria.Leosil treats only bacterial infections.
What are the common side effects of Leosil?
Common side effects of Leosil may include:
- nausea, constipation, diarrhea;
- headache, dizziness; or.
- trouble sleeping.
Is Leosil safe during pregnancy?
Leosil should be used during pregnancy only if the benefit outweighs the risk to the fetus.According to some authorities, use is contraindicated.
Is Leosil safe during breastfeeding?
Use of Leosil is acceptable in nursing mothers with monitoring of the infant for possible effects on the gastrointestinal flora, such as diarrhea or candidiasis.Avoiding breastfeeding for 4 to 6 hours after a dose should decrease the exposure of the infant to levofloxacin in breastmilk.
Can I drink alcohol with Leosil?
It is safe to drink alcohol in moderation while taking Leosil.
Can I drive after taking Leosil?
Do not drive or operate machinery if levofloxacin makes you feel dizzy or tired. Avoid alcohol.
When should be taken of Leosil?
You can take Leosil before or after meals. If you are taking one dose a day, it is preferable to take it in the morning. If you are taking more than one dose a day, try to space out your doses so ideally, take a tablet every 12 hours.
Should I take Leosil at night?
Leosil is best to take the doses at evenly spaced times, day and night.
Can Leosil be taken on an empty stomach?
You may take Leosil tablets with or without food. Take Leosil oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal.
How long does it take for Leosil to work?
Leosil will begin working within a matter of hours, but it can be two to three days before symptoms begin to improve. Take the full course of antibiotics as prescribed by a healthcare provider, even if you feel better after a few days.
How long does Leosil stay in my system?
If the patient generally has good health, the body can eliminate Leosil in about 30 to 40 hours, or about a day and a half to two days, but some side effects of the drug can show up as long as two months or longer after taking Leosil.
What happens if I take too much Leosil?
Liver damage can happen in people who take Leosil. Call your doctor right away if you have unexplained symptoms such as: nausea or vomiting. stomach pain.
Is Leosil bad for kidneys?
Case reports have indicated acute kidney injury with use, and prescription labels carry a warning of kidney failure.
Who should not use Leosil?
Should only be used by adults. Not suitable for people with myasthenia gravis, certain heart rhythm disturbances, or pediatric patients.
Is Leosil safe for heart patients?
In general, clinicians should be aware that azithromycin and Leosil are relatively safe for patients without complications or additional risk factors of QT prolongation, and decision regarding the initiation of medication therapy should be made on a case by case basis.
Can Leosil cause heart palpitations?
If you have low blood potassium or an abnormally slow heartbeat,Leosil may increase your risk of having a fast, slow, or irregular heartbeat, loss of consciousness, or fainting spells. If these symptoms occur, tell your doctor right away.
What happens if I stop taking Leosil?
If you experience any of the following symptoms, stop taking Leosil and call your doctor immediately: numbness, tingling, pain, burning, or weakness in the arms or legs; or a change in your ability to feel light touch, vibrations, pain, heat, or cold.
What happens if I miss a dose of Leosil?
If you miss a dose of your Leosil, take it as soon as you remember. If you remember relatively close to the time you take your next dose then you should skip the missed dose. You should then take your next dose and continue on with your normal dosing schedule. Do not double up on doses if you have missed one to avoid an overdose.