LIFBACT-500 – Levofloxacin 500 mg Tablets

LIFBACT-500 by Amcare Pharmaceuticals contains Levofloxacin Hemihydrate IP equivalent to Levofloxacin 500 mg in a film-coated tablet. Levofloxacin is a fluoroquinolone antibacterial used for selected infections caused by susceptible bacteria.

The product image specifies Levofloxacin Hemihydrate IP equivalent to Levofloxacin 500 mg, with excipients q.s. and Red Oxide of Iron + Titanium Dioxide IP as colours.

Composition of LIFBACT-500

Each film-coated tablet contains:

• Levofloxacin Hemihydrate IP
• Equivalent to Levofloxacin 500 mg
• Excipients – q.s.
• Colour: Red Oxide of Iron and Titanium Dioxide IP

Product Details

Uses of LIFBACT-500

Levofloxacin may be prescribed for selected bacterial infections caused by susceptible organisms. Approved uses for levofloxacin tablets include conditions such as:

• Community-acquired pneumonia
• Hospital-acquired/nosocomial pneumonia
• Complicated skin and skin-structure infections
• Selected urinary tract infections
• Acute pyelonephritis
• Chronic bacterial prostatitis
• Certain bacterial respiratory infections
• Acute bacterial sinusitis
• Acute bacterial exacerbation of chronic bronchitis

The exact indication depends on the causative organism, susceptibility, infection severity and patient-specific factors.

Important Antibiotic Stewardship Information

Levofloxacin should be used only for infections that are proven or strongly suspected to be caused by susceptible bacteria. Because fluoroquinolones can cause serious adverse reactions, prescribing information recommends reserving them for certain uncomplicated infections when alternative treatment options are unavailable.

How LIFBACT-500 Works

Levofloxacin

Levofloxacin is a fluoroquinolone antibacterial that inhibits bacterial enzymes required for DNA replication and repair, primarily DNA gyrase and topoisomerase IV.

By interfering with these essential bacterial enzymes, levofloxacin disrupts bacterial DNA processes and produces an antibacterial effect.

Dosage and Administration

The dosage and duration of LIFBACT-500 should be determined by the treating physician based on:

• Type and severity of infection
• Suspected or confirmed bacterial organism
• Patient’s age
• Kidney function
• Other medical conditions
• Other medicines being taken

The 500 mg strength is used for specific indications and dosing schedules; it should not be assumed to be appropriate for every infection.

Patients should take the medicine exactly as prescribed and should not stop or extend treatment without medical advice.

Administration Instructions

LIFBACT-500 may generally be taken with or without food.

Oral levofloxacin should be separated from products containing magnesium, aluminium, iron or zinc, because these can reduce absorption. Such products are generally taken at least 2 hours before or 2 hours after levofloxacin.

Possible Side Effects

Commonly reported adverse effects of levofloxacin include:

• Nausea
• Headache
• Diarrhea
• Dizziness
• Constipation
• Insomnia

Levofloxacin also has important fluoroquinolone-class safety warnings involving tendons, nerves and the central nervous system.

If serious or persistent symptoms occur, medical attention should be sought.

Precautions and Warnings

Tendinitis and Tendon Rupture

Levofloxacin and other fluoroquinolones have been associated with tendinitis and tendon rupture. Risk may be higher in older adults, people taking corticosteroids and certain transplant recipients.

Patients should promptly report tendon pain, swelling or inflammation.

Peripheral Neuropathy

Levofloxacin can cause peripheral neuropathy, potentially involving symptoms such as:

• Pain
• Burning
• Tingling
• Numbness
• Weakness

Serious symptoms require prompt medical evaluation.

Central Nervous System Effects

Fluoroquinolones may cause central nervous system effects such as dizziness, insomnia, anxiety, confusion and other neurological symptoms.

Myasthenia Gravis

Levofloxacin may worsen muscle weakness in patients with myasthenia gravis and should be avoided in patients with a known history of this condition.

QT Interval Prolongation

Levofloxacin can prolong the QT interval and may increase the risk of certain cardiac rhythm disturbances in susceptible patients. Particular caution is required with known QT prolongation, low potassium levels or concomitant QT-prolonging medicines.

Hypersensitivity

Serious allergic reactions, including anaphylaxis, can occur and may occur after the first dose. Levofloxacin is contraindicated in patients with known hypersensitivity to levofloxacin or other quinolones.

Antibiotic-Associated Diarrhea

Persistent or severe diarrhea during or after treatment should be medically evaluated because Clostridioides difficile-associated diarrhea can occur with antibacterial therapy.

Drug Interactions

Inform the healthcare professional about all medicines, vitamins and supplements being taken.

Important interactions may involve:

• Aluminium/magnesium-containing antacids
• Iron supplements
• Zinc-containing multivitamins
• Sucralfate
• Warfarin
• Certain antidiabetic medicines
• Medicines that prolong the QT interval
• Certain corticosteroids

Antacids, iron and zinc-containing preparations can reduce levofloxacin absorption and should generally be separated from the antibiotic.

Storage

Store LIFBACT-500 according to the storage conditions printed on the product packaging.

General precautions:

• Store in a cool, dry place.
• Protect from excessive heat and moisture.
• Keep tablets in the original blister until use.
• Keep out of reach of children.

Why Choose LIFBACT-500 by Amcare Pharmaceuticals?

LIFBACT-500 provides:

• Levofloxacin 500 mg strength
• Levofloxacin Hemihydrate IP as the active ingredient
• Film-coated tablet formulation
• Convenient oral dosage form
• Clearly specified pharmaceutical composition
• Product from Amcare Pharmaceuticals