FERZOPE-100 DS – Faropenem 100 mg/5 mL Oral Suspension

FERZOPE-100 DS by Amcare Pharmaceuticals is a Faropenem Sodium for Oral Suspension formulation containing Faropenem 100 mg per 5 mL after reconstitution. The product image specifies Faropenem Sodium Hydrate JP equivalent to Faropenem 100 mg, supplied as a dry syrup with sterile water.

Faropenem is an orally active penem/beta-lactam antibacterial that works by inhibiting bacterial cell-wall synthesis through interaction with penicillin-binding proteins.

Composition of FERZOPE-100 DS

Each 5 mL of reconstituted oral suspension contains:

• Faropenem Sodium Hydrate JP
• Equivalent to Faropenem 100 mg
• Excipients – q.s.
• Flavoured Base – q.s.

Pack: 6.6 g/30 mL
Dosage form: Dry Syrup for Oral Suspension
Reconstitution: With sterile water

Product Details

Uses of FERZOPE-100 DS

Faropenem oral suspension has been studied and used for selected bacterial infections, particularly in paediatric patients. Published paediatric data have evaluated faropenem in infections including:

• Upper respiratory tract bacterial infections
• Pharyngitis and tonsillitis
• Acute bronchitis
• Otitis media
• Urinary tract infections

The appropriate indication depends on the patient’s age, clinical condition, suspected/confirmed organism and local prescribing guidance.

Faropenem formulations have also been associated with treatment of selected respiratory, urinary, skin/skin-structure and gynaecological bacterial infections in broader clinical use.

Important Antibiotic Stewardship Information

FERZOPE-100 DS should be used only when prescribed for an appropriate bacterial infection. Unnecessary use of broad-spectrum antibiotics can contribute to antimicrobial resistance. Published literature has specifically highlighted concerns about inappropriate or excessive use of oral Faropenem and possible cross-resistance with other carbapenems.

How FERZOPE-100 DS Works

Faropenem

Faropenem is an orally active penem beta-lactam antibacterial.

It inhibits bacterial cell-wall synthesis by binding to penicillin-binding proteins (PBPs). This interferes with the formation of the bacterial cell wall and can lead to bacterial cell death.

Faropenem has activity against a range of Gram-positive and Gram-negative bacteria and some anaerobic organisms, although susceptibility varies between organisms and regions.

Dosage and Administration

The dosage of FERZOPE-100 DS should be determined by the treating physician based on:

• Child’s age
• Body weight
• Type and severity of infection
• Suspected or confirmed bacterial organism
• Kidney function
• Clinical response

Published paediatric research has evaluated Faropenem at approximately 15–30 mg/kg/day divided into three doses for certain mild-to-moderate bacterial infections. This should not be treated as a universal dosing instruction for FERZOPE-100 DS; the prescribed regimen should follow the applicable product information and physician’s instructions.

Reconstitution

FERZOPE-100 DS is supplied as a dry syrup with sterile water.

1. Use the sterile water supplied with the pack.
2. Reconstitute according to the instructions provided with the product.
3. Ensure the suspension is properly mixed before administration.
4. Measure each dose using an appropriate measuring device.
5. Follow the product-specific instructions for storage and duration of use after reconstitution.

Do not use household measuring spoons for accurate dosing.

Possible Side Effects

Possible adverse effects associated with Faropenem may include:

• Diarrhea
• Nausea
• Vomiting
• Abdominal discomfort
• Skin rash
• Other gastrointestinal symptoms

Published paediatric research reported diarrhea as the principal adverse event observed in one study, with no serious adverse drug reactions reported in that study population.

If severe diarrhea, significant rash, breathing difficulty, facial swelling or other serious symptoms occur, seek medical attention promptly.

Precautions and Warnings

Beta-Lactam Allergy

Tell the doctor if the child has previously experienced an allergic reaction to:

• Faropenem
• Penicillins
• Cephalosporins
• Carbapenems
• Other beta-lactam antibiotics

A history of serious beta-lactam hypersensitivity requires particular medical consideration.

Kidney Function

Inform the physician if the child has kidney disease or impaired renal function, as renal function can affect the handling of antibacterial medicines.

Antibiotic-Associated Diarrhea

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

Antimicrobial Resistance

Complete the prescribed course unless the treating physician advises otherwise. Do not use leftover antibiotics or share the medicine with another person.

Drug Interactions

Inform the doctor about all medicines, vitamins and supplements the child is taking.

The physician/pharmacist should evaluate potential interactions, particularly where other antibiotics or medicines affecting renal function are being used.

Storage

Before Reconstitution

Store the dry syrup according to the conditions stated on the product packaging.

After Reconstitution

Follow the specific storage instructions supplied with FERZOPE-100 DS, including the recommended period for use after reconstitution.

Keep the bottle tightly closed and keep the medicine out of reach of children.

Why Choose FERZOPE-100 DS by Amcare Pharmaceuticals?

FERZOPE-100 DS provides:

• Faropenem 100 mg/5 mL strength
• Oral suspension dosage form
• Convenient liquid formulation for paediatric administration
• Faropenem Sodium Hydrate JP as the active ingredient
• Sterile water supplied with the product
• Pharmaceutical product from Amcare Pharmaceuticals