LIFBACT-250 – Levofloxacin 250 mg Tablets

LIFBACT-250 by Amcare Pharmaceuticals contains Levofloxacin Hemihydrate IP equivalent to Levofloxacin 250 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 250 mg, with excipients q.s. and Red Oxide of Iron + Titanium Dioxide IP as colours.

Composition of LIFBACT-250

Each film-coated tablet contains:

• Levofloxacin Hemihydrate IP
• Equivalent to Levofloxacin 250 mg
• Excipients – q.s.
• Colour: Red Oxide of Iron and Titanium Dioxide IP

Product Details

Uses of LIFBACT-250

Levofloxacin may be prescribed for selected bacterial infections caused by susceptible organisms. Depending on the applicable prescribing information, levofloxacin is used for conditions such as:

• Certain community-acquired bacterial respiratory infections
• Selected urinary tract infections
• Certain skin and skin-structure infections
• Acute bacterial sinusitis in appropriate patients
• Selected bacterial infections where susceptibility supports its use
• Certain other infections for which a fluoroquinolone is an appropriate treatment option

The 250 mg strength is not automatically appropriate for every infection. The dose and duration depend on the infection, patient characteristics and kidney function.

Antibiotic Stewardship

Levofloxacin should be reserved for appropriate bacterial infections because fluoroquinolones can cause serious adverse reactions and unnecessary antibiotic exposure contributes to antimicrobial resistance.

How LIFBACT-250 Works

Levofloxacin

Levofloxacin is a fluoroquinolone antibacterial. It inhibits bacterial enzymes involved in DNA replication and repair, principally DNA gyrase and topoisomerase IV.

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

Dosage and Administration

The dosage of LIFBACT-250 should be determined by the treating physician according to:

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

Do not self-medicate with levofloxacin or change the prescribed dose.

Levofloxacin tablets may generally be taken with or without food. Adequate fluid intake is recommended during treatment.

Important Administration Instructions

Levofloxacin absorption can be reduced when taken close to products containing magnesium, aluminium, iron, zinc or other polyvalent cations. Antacids containing magnesium/aluminium, iron preparations and zinc-containing multivitamins should generally be separated from oral levofloxacin by at least 2 hours before or 2 hours after administration.

Possible Side Effects

Commonly reported adverse effects of levofloxacin include:

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

Levofloxacin also carries important class-specific warnings. Fluoroquinolones have been associated with tendinitis and tendon rupture, peripheral neuropathy and central nervous system effects, some of which may be serious or potentially irreversible.

Precautions and Warnings

Tendinitis and Tendon Rupture

Fluoroquinolones including levofloxacin have been associated with tendinitis and tendon rupture. The risk may be increased in certain patients, including older adults and those receiving corticosteroids.

Patients should promptly report tendon pain, swelling or inflammation.

Peripheral Neuropathy

Levofloxacin can cause peripheral neuropathy. Symptoms may include pain, burning, tingling, numbness or weakness.

QT Interval Prolongation

Levofloxacin can prolong the QT interval in susceptible patients. Particular caution is required in patients with known QT prolongation, electrolyte abnormalities or concomitant medicines that also prolong the QT interval.

Central Nervous System Effects

Fluoroquinolones can produce central nervous system effects including dizziness, confusion, anxiety, insomnia and other neurological symptoms.

Blood Glucose Disturbances

Levofloxacin can cause disturbances in blood glucose, particularly in patients receiving insulin or oral antidiabetic medicines. Appropriate monitoring may be required.

Antibiotic-Associated Diarrhea

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

Drug Interactions

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

Important interactions include:

• Magnesium/aluminium-containing antacids
• Iron supplements
• Zinc-containing multivitamins
• Sucralfate
• Warfarin
• Certain medicines affecting blood glucose
• Other medicines that can prolong the QT interval

Antacids, iron and zinc-containing products should generally be separated from levofloxacin by at least 2 hours before or after administration. Levofloxacin may also increase the effect of warfarin in some patients, requiring appropriate monitoring.

Storage

Store LIFBACT-250 according to the storage conditions printed on the product packaging.

General storage precautions:

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

Why Choose LIFBACT-250 by Amcare Pharmaceuticals?

LIFBACT-250 provides:

• Levofloxacin 250 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