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A new antibiotic on the Bulgarian market

Since January 2021 G. ZENTIVA Bulgaria puts on sale, your new product:

  • PENLAC (PENLAK) 875 mg/ 125 mg powder for oral suspension insachet (powder for oral suspension insachet) x 12. Each sachet contains amoxicillin trihydrate (amoxicillin trihydrate) equivalent to 875 mg amoxicillin (amoxicillin) and potassium clavulanate (potassium clavulanate) equivalent to 125 mg clavulanic acid (clavulanic acid).

Amoxicillin / clavulanic acid is the first choice for empirical therapy in the recommendations for the treatment of lower respiratory tract infections1 , especially pneumonia, acquired in society, as well as first choice for empirical antibiotic therapy for ENT infections in outpatient care1 , in particular, in rhinosinusitis.

Amoxicillin / clavulanic acid is indicated for the treatment of the following infections in adults and children: acute bacterial sinusitis (adequately diagnosed), acute otitis media, acute exacerbations of chronic bronchitis (adequately diagnosed), community-acquired pneumonia, cystitis, pyelonephritis, skin and soft tissue infections (in particular cellulite), animal bites, severe tooth abscess with spreading cellulite, bone and joint infections, in particular osteomyelitis.

PENLAC 875 mg/ 125 mg in sachet is an innovative formula suitable for patients with problems in swallowing the tablet form. It is recommended to be taken during meals, to minimize possible gastrointestinal intolerance and to improve the absorption of amoxicillin / clavulanic acid.

Recommended doses in adults and children ≥ 40 kg :

  • Standard dose (for all indications) 875 mg / 125 mg twice daily;
  • Higher dose - (for infections such as otitis media, synuite, lower respiratory tract infections and urinary tract infections) 875 mg / 125 mg three times daily.

Recommended doses in children < 40 kg. Children can be treated with amoxicillin / clavulanic acid, suspensions or pediatric sachets:

  • 25 mg / 3.6 mg / kg / day to 45 mg / 6.4 mg / kg / day, divided into two separate doses:
  • To 70 mg / 10 mg / kg / day, divided into two separate doses may be considered for use in some infections (for example in otitis media, sinusitis and lower respiratory tract infections).

Prescription drug. Before prescribing, please read the full text of the SPC:

  • KHPPENLAC sachet 875 mg/ 125 mg: 20200114 / 25.09.2020

Please, report side effects, arising from the use of PENLAC by the Pharmacovigilance Department of Zentiva Bulgaria, e-mail: PV-Bulgaria@zentiva.com or the Executive Agency for Medicines by e-mail: bda@bda.bg

References:

  1. A guide to empirical antimicrobial therapy for infections in outpatient care - https://www.bam-bg.net/index.php/bg/ Access on 10.11.2020
  2. https://portal.ncpr.bg/registers/pages/register/list-medicament.xhtml

Alvogen Pharma Bulgaria EOOD (Zentiva Bulgaria) Sofia 1680, it is. Bulgaria № 86А, fl. 2, Monastery meadows - West

Tel: +359 2 441 71 36; e-mail: zentivabgcommunication@zentiva.com; web: www.zentiva.bg

Bg 233/ Approved 01/2021 IAL-0344/05.01.2021