Levofloxacin Hemihydrate IP 500 mg Tablet

If you are allergic to Levofloxacin or any other Excipients of tablet

If you are using corticosteroids, sometimes called steroids

If you have ever had a fit (seizure)

If you have kidney problems

If you have something known as ‚glucose-6-phosphate dehydrogenase deficiency‚. You are more likely to have serious problems with your blood when taking this medicine

If you have ever had mental health problems.

If you are diabetic.

If you have ever had liver problems

Contraindicated in patients with known hypersensitivity to levofloxacin or other quinolone drugs and caution should be exercised in prescribing to patients with liver disease.

Levofloxacin is also considered to be contraindicated in patients with epilepsy or other seizure disorders, and in patients who have a history of quinolone-associated tendon rupture.

Diarrhea

Abdominal or stomach cramps or pain (severe)

Agitation

Blisters

Confusion

Diarrhea (watery and severe) which may also be bloody

Feeling that others can hear your thoughts or control your behavior

Fever

Pain, inflammation, or swelling in the calves of the legs, shoulders, or hands

Redness and swelling of the skin

Seeing, hearing, or feeling things that are not there

Sensation of burning on the skin

Severe mood or mental changes

Skin rash, itching, or redness

Trembling

Unusual behavior

This is Preferred Dosage:
• One tablet of Levofloxacin 500 mg, once each day or as directed by physician.
• This medicine must not be given to children or teenagers.

Disclaimer:To be taken only after consulting with the doctor.

Pharmacodynamics

Pharmacotherapeutic group: Quinolone antibacterials - Fluoroquinolones
ATC code: J01MA12
Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class and is the S(-) enatiomer of the racemic drug substance ofloxacin.

Mechanism of Action

Levofloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria. Like all quinolones, it functions by inhibiting the two type II topoisomerase enzymes, namely DNA gyrase and topoisomerase IV. Topoisomerase IV is necessary to separate DNA that has been replicated (doubled) prior to bacterial cell division. With the DNA not being separated, the process is stopped, and the bacterium cannot divide. DNA gyrase, on the other hand, is responsible for supercoiling the DNA, so that it will fit in the newly formed cells. Both mechanisms amount to killing the bacterium, that is, levofloxacin acts as a bactericide.

Pharmacokinetics

Absorption:
•Orally administered Levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations being obtained within 1- 2 h. The absolute bioavailability is 99- 100 %.
• Food has little effect on the absorption of Levofloxacin.
•Steady state conditions are reached within 48 hours following a 500 mg once or twice daily dosage regimen. Distribution: Widely distributed in bronchial mucosa, lungs; CSF (relatively poor).
Protein-Binding: 30-40%.
Metabolism: Levofloxacin is stereochemically stable in plasma and urine and does not invert metabolically to its enantiomer, D-ofloxacin. Levofloxacin undergoes limited metabolism in humans and is primarily excreted as unchanged drug in the urine. Following oral administration, approximately 87% of an administered dose was recovered as unchanged drug in urine within 48 hours, whereas less than 4% of the dose was recovered in feces in 72 hours. Less than 5% of an administered dose was recovered in the urine as the desmethyl and N-oxide metabolites, the only metabolites identified in humans. These metabolites have little relevant pharmacological activity.
Excretion: Mainly via urine (largely as unchanged drug); 6-8 hours (elimination half-life).

•Corticosteroids, sometimes called steroids – used for inflammation. You may be more likely to have inflammation and/or rupture of your tendons.
• Warfarin - used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.
• Theophylline - used for breathing problems. You are more likely to have a fit (seizure) if taken with Levofloxacin tablets.
• Non-steroidal anti-inflammatory drugs (NSAIDS) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. You are more likely to have a fit (seizure) if taken with Levofloxacin tablets.
• Ciclosporin - used after organ transplants. You may be more likely to get the side effects of ciclosporin.
•Medicines known to affect the way your heart beats. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine,), for psychiatric disorders (antipsychotics), and for bacterial infections (‚macrolide‚ antibiotics such as erythromycin, azithromycin and clarithromycin).
• Probenecid – used for gout and cimetidine – used for ulcers and heartburn. Special care should be taken when taking either of these medicines with Levofloxacin tablets. If you have kidney problems, your doctor may want to give you a lower dose.

what should i know before taking the medicine:
Do not take this medicine and tell your doctor if:
•You are allergic to levofloxacin, any other quinolone antibiotics such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of this medicine.
• Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You have ever had epilepsy - You have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‚quinolone antibiotic‚. A tendon is the cord that joins your muscle to your skeleton.
• You are pregnant, might become pregnant or think you may be pregnant.
• You are breast-feeding.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Levofloxacin tablets.

How to take it:
Before you start taking the tablets, read the manufacturer‚s printed information leaflet from inside the pack. The manufacturer‚s leaflet will give you more information about levofloxacin and a full list of the side-effects which you may experience from taking it.
• Take levofloxacin exactly as your doctor tells you to. The usual dose is 500 mg daily, although for some types of infection a dose of 250 mg daily is sufficient, and for others, 500 mg twice daily is needed. Read the label carefully to make sure you know what dose is right for you.
• You can take levofloxacin 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.

how is the disease caused. How medicine helps to eradicate it.
Levofloxacin belongs to a group of medicines called antibiotics. Levofloxacin is a ‚quinolone‚ antibiotic. It works by killing the bacteria that cause infections in your body. Levofloxacin tablets can be used to treat infections of the:
•Sinuses - Lungs, in people with long-term breathing problems or pneumonia.
• Urinary tract, including your kidneys or bladder - Prostate gland, where you have a long lasting infection.
• Skin and underneath the skin, including muscles. This is sometimes called ‚soft tissue‚.

(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid

Chemical data