Subject: In-Practice Usage and Performance (IPUP) Study of Faroright 200 mg tablets;
Study code: IPUP/Faroright 200 mg /Maxxim / April’23

Carbapenem antibiotics such as meropenem, imipenem, ertapenem, and faropenem are atypical b-lactam antibiotics with the broadest antibacterial spectrum and strong antibacterial activity. They have become one of the most important antibacterial drugs to treat serious bacterial infections. While meropenem, imipenem, and ertapenem are strictly injectable antibiotics, which is very inconvenient for use in outpatients, faropenem is an orally available b-lactam antibiotic.

Faropenem belong to penem class of antibiotics. Faropenem is resistant to hydrolysis by nearly all b-lactamases and demonstrates broad-spectrum in vitro antimicrobial activity against many Gram-positive and Gram-negative bacteria and many anerobes. Faropenem is structurally similar to the other carbapenems, but it is distinguished by a sulfur atom at position 1 to make it resistant against b-lactamases. Faropenem displays broad tissue specificity and is able to diffuse into sputum, tooth extraction wounds, skin, tonsils, maxillary sinus mucosa, female genitalia, subcutaneous spaces and prosthetic tissues.¹ Faropenem is approved for treatment of respiratory tract infections (both upper and lower), skin and soft tissue infections, urinary tract infections (both uncomplicated and complicated) and gynecological infections.²

Faroright tablets 200 mg are marketed by the ‘Maxxim ’ team of Sun Pharmaceutical Industries Ltd.

Although every product is marketed only after regulatory approval, it is important to know how it performs in day-to-day practice of individual medical practitioners. This retrospective study will help to assess the real-life performance of Faroright in patients with respiratory tract infections (both upper and lower), skin and soft tissue infections, urinary tract infections (both uncomplicated and complicated) and gynecological infections.

We invite you to participate in this study. All you need to do is to report on a standard form your experience with Faroright when you prescribe this product in the normal course of your practice. Thus, this is not an experimental/interventional study because the product will be prescribed and purchased as you and your patients normally do.

If you agree to participate, you will need to copy the relevant information from the suggested number of patient’s case papers, and investigational reports, if any (which we call source documents), on to the standard case report forms (which we call CRF).

A monitor will assist you in verifying the CRF with the source documents to ensure that the CRF signed by you are free from errors or omissions. Let us assure you that the CRF will not contain the patients’ names, so as to ensure confidentiality.

If any serious adverse events (AE) occur during ‘Faroright’ therapy, you will be expected to report them to the monitor or to me immediately on the AE reporting form.

As you will be spending some extra time to keep, copy and verify these patients records, we offer to pay you by cheque a professional fee of Rs. {{$contractAmount}} /-, and accordingly on receiving the completed CRFs.