CEFIXIME & OFLOXACIN TABLETS

Advance Information*

Cefixime & Ofloxacin Tablets - Comprehensive Product Description

Cefixime & Ofloxacin Tablets, marketed under ISSKOCEF-PLUS by ALISKOSS WELLNESS PVT. LTD, combine the therapeutic action of two potent antibacterial agents: Cefixime and Ofloxacin. This combination formulation is widely used for its efficacy in treating a broad spectrum of bacterial infections. This detailed product description encompasses every aspect of Cefixime & Ofloxacin Tablets to inform healthcare providers and patients about its usage, efficacy, and safety profile.

Composition

Each Cefixime & Ofloxacin Tablet contains a precise and balanced combination of: - Cefixime (as trihydrate): 200 mg - Ofloxacin (as hemihydrate): 200 mg

This formulation allows for a synergistic action against bacterial pathogens, enhancing therapeutic outcomes.

Therapeutic Indications

Cefixime & Ofloxacin Tablets are indicated for the treatment of various bacterial infections, including but not limited to: - Respiratory tract infections (e.g., bronchitis, pharyngitis, and tonsillitis) - Urinary tract infections (e.g., cystitis, pyelonephritis) - Gastrointestinal infections (e.g., infectious diarrhea) - Skin and soft tissue infections - Typhoid fever - Sexually transmitted infections, including gonorrhea

The combination targets both gram-positive and gram-negative bacteria, making it a versatile option for multiple infectious conditions.

Mechanism of Action

Cefixime:

Cefixime is a third-generation cephalosporin antibiotic that works by inhibiting bacterial cell wall synthesis. This bactericidal activity stems from its ability to bind to penicillin-binding proteins (PBPs), which are crucial for cell wall construction. By disrupting the cell wall, Cefixime leads to osmotically unstable bacterial cells that ultimately undergo lysis.

Ofloxacin:

Ofloxacin is a fluoroquinolone antibiotic that exhibits its antibacterial action by inhibiting DNA gyrase and Topoisomerase IV, both of which are essential enzymes for DNA replication, transcription, repair, and recombination. By interfering with these vital processes, Ofloxacin induces cell death in susceptible bacteria.

By combining these two mechanisms, Cefixime & Ofloxacin Tablets exert a dual attack on bacterial pathogens, enhancing efficacy, and reducing the likelihood of resistance development.

Dosage and Administration

The dosage of Cefixime & Ofloxacin Tablets should be individualized according to the severity of the infection, the susceptibility of the causative organism, and the patient’s renal function.

Typical Dosage Regimen:

• Adults: One tablet, containing a combination of cefixime 200 mg and ofloxacin 200 mg, taken orally twice daily.

Special Considerations:

• Pediatric Patients: The dosage should be determined based on the child’s weight and severity of the infection.
• Renal Impairment: Dosage adjustments are necessary for patients with renal dysfunction to avoid accumulation and potential toxicity. Consultation with a healthcare provider is essential.
• Duration of Therapy: The length of treatment typically ranges from 7 to 14 days, depending on the infection type and severity, as well as the patient’s clinical response.

Always follow the healthcare provider's instructions for the best therapeutic outcome. Avoid self-medication and ensure complete adherence to the prescribed regimen.

Pharmacokinetics

Cefixime:

• Absorption: Cefixime is well-absorbed from the gastrointestinal tract, with oral bioavailability around 40% to 50%.
• Distribution: It is widely distributed in body tissues and fluids. Plasma protein binding is approximately 65%.
• Metabolism: Cefixime is minimally metabolized in the liver.
• Excretion: The drug is primarily excreted unchanged in the urine, around 50% within 24 hours. The elimination half-life is approximately 3 to 4 hours.

Ofloxacin:

• Absorption: Ofloxacin exhibits rapid and almost complete absorption from the gastrointestinal tract, with a bioavailability of nearly 98%.
• Distribution: It has a large volume of distribution and penetrates well into various tissues and body fluids. Plasma protein binding is about 25%.
• Metabolism: Ofloxacin undergoes limited metabolism in the liver.
• Excretion: It is excreted predominantly via the urine, with about 65% to 80% of the drug eliminated unchanged within 24 to 48 hours. The elimination half-life is approximately 5 to 7 hours.

Drug Interactions

Cefixime & Ofloxacin Tablets may interact with other medications, affecting their efficacy or increasing the risk of adverse effects. Notable interactions include: - Antacids containing magnesium or aluminum: These can reduce the absorption of Ofloxacin, leading to decreased therapeutic effectiveness. - Iron supplements and multivitamins: May also