FERZOPE-300 SR – Faropenem 300 mg Sustained Release Tablets

FERZOPE-300 SR by Amcare Pharmaceuticals contains Faropenem Sodium Hydrate JP equivalent to Faropenem 300 mg in a film-coated sustained-release tablet. It is an oral penem antibacterial formulation intended for the treatment of selected bacterial infections.

The provided product pack specifies Faropenem Sodium Hydrate JP equivalent to Faropenem 300 mg, with excipients q.s. and titanium dioxide as the colour. The pack shown contains 10 × 1 × 6 tablets.

Faropenem is an orally active penem antibiotic. In India, CDSCO records extended-release Faropenem strengths including 225/300/450 mg for respiratory tract, urinary tract, skin/skin-structure and gynaecological infections.

Composition of FERZOPE-300 SR

Each film-coated sustained-release tablet contains:

• Faropenem Sodium Hydrate JP
• Equivalent to Faropenem 300 mg
• Excipients – q.s.
• Colour: Titanium Dioxide IP

Product Details

Uses of FERZOPE-300 SR

Faropenem is used for selected bacterial infections. The Indian CDSCO database lists extended-release Faropenem for:

• Respiratory tract infections
• Urinary tract infections
• Skin and skin-structure infections
• Gynaecological infections

The exact use should depend on the suspected or confirmed organism, infection site, susceptibility and physician assessment.

Clinical studies have also evaluated oral faropenem in conditions such as acute bacterial sinusitis, although indication and prescribing recommendations depend on the applicable regulatory information.

Important Antibiotic Stewardship Note

Faropenem is a broad-spectrum oral penem antibiotic. Its use should be restricted to appropriate bacterial infections because unnecessary use of broad-spectrum antibiotics can contribute to antimicrobial resistance. Published literature has specifically raised concerns about inappropriate or excessive use of oral faropenem and potential cross-resistance with carbapenems.

How FERZOPE-300 SR Works

Faropenem

Faropenem is a beta-lactam penem antibacterial. It acts by interfering with bacterial cell-wall synthesis through binding to penicillin-binding proteins (PBPs). This disrupts bacterial cell-wall formation and can result in bacterial cell death.

Faropenem has demonstrated antibacterial activity against a range of Gram-positive and Gram-negative organisms as well as some anaerobic bacteria.

Sustained-Release Formulation

FERZOPE-300 SR is formulated as a sustained-release tablet, designed to modify the release of the active ingredient over time. The tablet should therefore be taken according to the prescribing instructions and should not be crushed or chewed unless the product-specific prescribing information explicitly permits it.

Dosage and Administration

The dosage and duration of FERZOPE-300 SR should be decided by the treating physician based on:

• Type and severity of infection
• Patient’s age
• Kidney function
• Suspected or confirmed causative organism
• Previous antibiotic exposure
• Clinical response

Do not self-medicate with Faropenem or alter the prescribed duration.

Some published Indian prescribing references list adult oral Faropenem regimens of 300 mg twice daily for certain indications, but the appropriate regimen for a sustained-release formulation should follow the specific product’s approved prescribing information rather than being inferred from another Faropenem formulation.

FERZOPE-300 SR tablets should be swallowed as directed by the physician.

Possible Side Effects

Possible adverse effects associated with Faropenem may include:

• Nausea
• Vomiting
• Diarrhea
• Abdominal discomfort or abdominal pain
• Skin rash
• Headache or other gastrointestinal symptoms

Published drug references identify diarrhea, nausea, vomiting and abdominal pain among reported adverse reactions.

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

Precautions and Warnings

Allergic Reactions

Patients with a history of hypersensitivity to Faropenem, other penems or beta-lactam antibiotics should inform their physician before treatment. Hypersensitivity reactions can occasionally be serious.

Kidney Function

Patients with impaired renal function should inform their doctor because kidney function can influence the handling of antibacterial medicines and may affect dosing decisions.

Antibiotic-Associated Diarrhea

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

Antimicrobial Resistance

FERZOPE-300 SR should be used only for appropriate bacterial infections and according to the prescribed course. Avoid using leftover antibiotics or sharing antibiotics with others.

Drug Interactions

Before starting FERZOPE-300 SR, inform the physician about all medicines and supplements being taken.

Particular attention may be required for:

• Other antibiotics
• Medicines affecting kidney function
• Anticoagulants or other medicines requiring monitoring
• Medicines prescribed for chronic medical conditions

The treating physician or pharmacist should assess the complete medication list for clinically relevant interactions.

Storage

Store FERZOPE-300 SR according to the storage conditions printed on the product packaging.

General pharmaceutical storage precautions include:

• Keep in a dry place.
• Protect from excessive heat and moisture.
• Keep the strip/carton properly closed until use.
• Keep out of reach of children.

Why Choose FERZOPE-300 SR by Amcare Pharmaceuticals?

FERZOPE-300 SR offers:

• Faropenem 300 mg strength
• Sustained-release tablet formulation
• Oral penem antibacterial formulation
• Clearly specified Faropenem Sodium Hydrate composition
• Convenient tablet dosage form
• Pharmaceutical product from Amcare Pharmaceuticals