LEVONEXT

Each film coated tablets contains:

(Levofloxacin Hemihydrate IP equivalent to Levofloxacin 750 mg)

Tablet for Oral Use

Levofloxacin exerts its antimicrobial activity via the inhibition of two key bacterial enzymes: DNA gyrase and topoisomerase IV. Both targets are type II topoisomerases, but have unique functions within the bacterial cell.  Levofloxacin promotes the breakage of DNA strands by inhibiting DNA-gyrase in susceptible organisms, which inhibits the relaxation of supercoiled DNA. The end result is a blockade of DNA replication, th

Absorption: Levofloxacin is rapidly absorbed and widely distributed in the body. The bioavailability of levofloxacin is 99%; therefore, levofloxacin’s intravenous and oral preparations are used interchangeably. The time to peak plasma concentration (Tmax) is approximately 1.5 hours.

Distribution: The volume of distribution of levofloxacin generally varies from 74 Liters to 112 Liters (single and multiple 500 mg or 750 mg doses), demonstrating extensive distribution in body tissues. Outcomes of the study suggest that levofloxacin is widely distributed in the skin, muscles, liver, kidney, and spleen. Drug concentrations in tissues and fluids are typically higher than in plasma.

Protein Binding: Levofloxacin has plasma protein binding of 24–38 %; it binds primarily to albumin.

Metabolism & Excretion: Levofloxacin undergoes little hepatic metabolism in humans and is eliminated unchanged in the urine. Levofloxacin clearance is primarily via the renal route 87%). 

Half Life: The mean plasma elimination half-life (t) of levofloxacin is approximately 6 to 8 hours following single or multiple doses of levofloxacin.

• Lower  and Upper Respiratory Tract Infections
• Genito Urinary Tract Infections
• Skin & skin structure Infections
• Otitis Media

ADVERSE REACTION:

The primary adverse effects of levofloxacin include: Photosensitivity, Nausea, Diarrhea, Headache, Tendinitis, Tendon rupture, Hyper-hypoglycemia, Seizures, Prolonged QT interval, and peripheral neuropathy

DOSAGE AND ADMINISTRATION: The recommended oral dose regimen is 500 to 750 mg once daily to treat nosocomial pneumonia, complicated skin and skin structure infections (7 to 14 days), community-acquired pneumonia, acute bacterial sinusitis, complicated urinary tract infection (UTI), or acute pyelonephritis (five days).

CONTRAINDICATIONS:

• The concurrent administration of levofloxacin with drugs that prolong the QT interval is contraindicated.
• Hypersensitivity to the drug or excipients, as cases of anaphylaxis have been reported.
• Fluoroquinolones, including levofloxacin, are contraindicated in pregnancy
• It is recommended to avoid Levofloxacin and other fluoroquinolone antibiotics in patients with myasthenia gravis due to an increased risk of exacerbation of existing muscle weakness.

WARNINGS AND PRECAUTIONS:

• Levofloxacin should be administered two hours before or two hours after taking antacids containing magnesium or aluminum
• It is advisable to minimize or avoid exposure to natural or artificial sunlight while taking levofloxacin
• Avoid prescribing Levofloxacin in elderly patients and patients with a history of Marfan syndrome or Ehlers-Danlos syndrome

Pregnancy Category: B

Drug Interaction:

• Concomitant administration of oral hypoglycemic agents such as glimepiride increases the risk of hypoglycemia. 
• Bleeding can occur with concurrent administration of warfarin due to weak inhibiting potential on the CYP2C9 enzyme.
• There is a risk of QTc prolongation when Levofloxacin and Thioridazine are administered. The combination should be avoided.
• Cations in Aluminum Hydroxide, Magnesium Oxide, Ferrous Sulfate, and Calcium Carbonate can chelate and reduce the absorption of Levofloxacin. Consequently, these drugs should be administered at least two hours before or after levofloxacin.