KOMPOSISI :
Tiap vial mengandung,
Zefoperazone sodium setara dengan Cefoperazone........... 1 g

Tiap ampul mengandung,
Air steril untuk injeksi............................................................ 5 ml

CARA KERJA OBAT :
LOGAFOX® (Cefoperazone sodium) merupakan antibiotik golongan sefalosporin generasi ketiga yang mempunyai khasiat bakterisidal dan bekerja dengan menghambat sintesis dinding sel bakteri.
Cefoperazone secara invitro dan klinik aktif terhadap :
- Bakteri gram positive aerobs :
Staphylococcus aureus strain penghasil penicillinase & tidak penghasil penicillinase
Staphylococcus pneumoniae (Diplococcus pneumoniae)
Streptococcus pyogenes (Streptococcus B-hemolytic grup A)
Streptococcus agalactiae (Streptococcus B-hemolytic grup B)
Enterococcus (Streptococcus faecalis, S. faeccium & S. durans)
- Gram negative aerobs :
Escherichia coli
Klebsiella sp. (termasuk K. pneumoniae)
Enterobacter sp.
Citrobacter sp.
Haemophilus influenzae
Proteus mirabilis
Proteus vulgaris
Morganella morganii (proteus morganii)
Providencia stuartii
Providencia retgeri (proteus rettgeri)
Serratia marcescens
Pseudomonas aeruginosa
Pseudomonas sp.
Beberapa strain Acinetobacter calcoaceticus
Neisseria gonorrhoeae
- Organisme anaerobs
Cocci gram positive (termasuk Peptococcus & Streptococcus)
Bacteroides fragilis

INDIKASI :
Infeksi parah yang disebabkan oleh bakteri gram negatif dan beberapa mikroorganisme anaerobik yang sensitif terhadap Cefoperazone seperti :
- Infeksi saluran pernafasan (atas dan bawah)
- Infeksi saluran urin (atas dan bawah)
- Peritonitis, cholecystitis, cholangitis dan infeksi intra abdominal lain
- Septicemia
- Meningitis
- Infeksi kulit dan jaringan lunak
- Infeksi tulang & sendi
- Penyakit pelvic inflamatory, endometritis, gonorrhea & infeksi lain saluran genital
- Pencegahan infeksi pada operasi

KONTRA INDIKASI :
Penderita yang hipersensitif terhadap cephalosporin.

EFEK SAMPING :
- Reaksi hipersensitivitas dan hipoprotrombinaemia.
- Hati : kenaikan sementara nilai SGOT, SGPT dan alkaline fosfatase.
- Saluran pencernaan : diare, loose stools, mual, muntah, gejala pseudomembran colitis.
- Test fungsi ginjal : kenaikan sementara BUN dan serum creatinine.
- Reaksi lokal : sakit pada tempat suntikan (im), phlebitis (iv).

PERINGATAN DAN PERHATIAN :
- Hati-hati penggunaan pada penderita yang sensitif terhadap penicillin.
- Hati-hati penggunaan pada penderita dengan penyakit hati, obstruksi empedu dan kegagalan ginjal.
- Hati-hati penggunaan pada penderita yang menerima antikoagulan.
- Pemakaian jangka panjang dapat menyebabkan pertumbuhan yang berlebihan dari organisme yang kurang peka.
Bila terjadi superinfeksi, ganti dengan pengobatan yang tepat.
- Hati-hati pemakaian pada penderita dengan riwayat gastro-intestinal khususnya colitis.
- Dapat terjadi reaksi positif palsu untuk glukosa urine terhadap pereaksi Benedict dan Fehling.
- Seperti antibiotika lain, pemakaian Cefoperazone dapat menyebabkan defisiensi vitamin K.
- Pemakaian pada wanita hamil hanya bila benar-benar diperlukan.
- Hati-hati pemakaian pada wanita menyusui.
- Keamanan & efektivitas pemakaian pada anak-anak belum ditetapkan.

INTERAKSI OBAT :
- Alkohol
- Pemberian bersamaan dengan aminoglycosida atau Cephalosporin lain menaikkan bahan nephrotoxicitas.

ATURAN PAKAI :
Dewasa : 2 - 4 g/hari im atau iv, dalam dosis terbagi 2 x.
Infeksi parah : 6 - 12 g/hari, dalam dosis terbagi 2 - 4 x.
Gonococcal urethritis tanpa komplikasi : 500 mg im sebagai dosis tunggal
Pencegahan infeksi pada operasi : diberikan 1 - 2 g iv 30 - 90 menit sebelum operasi.
Dosis diberikan setiap 12 jam dan diteruskan sampai 72 jam setelah operasi.
Untuk pengobatan infeksi yang disebabkan oleh streptococcus pyogenes lama pengobatan minimum 10 hari.

KEMASAN :
Dus, 1 vial @ 1 g dan 1 ampul @ 5 ml air steril untuk injeksi.
No. Reg. : DKL 9915614844 A1

Simpan dalam wadah tertutup rapat

HARUS DENGAN RESEP DOKTER

ENGLISH VERSION

COMPOSITION:
- LOGAFOX injection, each vial contains:
Cefoperazone sodium equal to Cefoperazone 1 gram

PHARMACOLOGY:
Logafox is the third generation cephalosporin antibiotic. It has the bactericidal action from the inhibition of bacterial cell wall synthesis. Logafox is active in vitro against a wide variety of clinically significant organisms, and is resistant to degradation by many ?-lactamases.
Susceptible organisms include:
Gram-Positive Organisms: Staphylococcus aureus, penicillinase and nonpenicillinase-producing strains, Staphylococcus epidermidis, Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes (Group A ?-haemolytic Streptococci), Streptococcus agalactiae (Group B ?-hemolytic Streptococci), many strains of Streptococcus faecalis (enterococcus), most other strains of ?-hemolytic Streptococci.
Gram-Negative Organisms: Escherichia coli, Klebsiella, Enterobacter and Citrobacter sp., Haemophilus influenzae (?-lactamase-positive and negative strains), Proteus mirabilis, Proteus vulgaris, Morganella morganii (formerly Proteus morganii), Providencia rettgeri (formerly Proteus rettgeri), Providencia and Serratia sp., Pseudomonas, some strains of Acinerobacter calcoaceticus, Neisseria meningitides, Bordetella pertusis, Yersinia enterocolitica.
Anaerobic Organisms: Gram-positive and gram-negative cocci (including Peptococcus, Peptostreptococcus and Veillonella sp.)
Gram-positive bacilli (including Clostridium, Eubacterium and Lactobacillus sp.)

INDICATIONS:
Treatment of severe infections particularly those caused by gram-negative organisms:
- Respiratory Tract Infections (upper and lower)
- Urinary Tract Infections (upper and lower)
- Peritonitis, cholecystitis, cholangitis and other intra-abdominal infections
- Septicaemia, meningitis,
- Skin and soft tissue infections
- Infections of bones and joints
- Pelvic inflammatory disease, endometritis, gonorrhoea and other infections of the genital tract
- Prophylaxis: Cefoperazone may be indicated in the prophylaxis of postoperative infection in patients undergoing abdominal and gynaecological surgery, cardiovascular and orthopaedic surgery, for patients at risk of infections.

CONTRA-INDICATIONS:
Patients with known allergy to the cephalosporin class of antibiotic.

ADVERSE REACTIONS:
- Hypersensitivity and hypoprothrombinemia.
- Liver: transient elevation of SGOT, SGPT and alkaline phosphatase evels have been noted.
- Gastrointestinal Tract: altered bowel habits (loose stools or diarrhoea) have been reported.
- Renal Function Test: transient elevation BUN and serum creatinine.
- Local Reactions: Cefoperazone is well tolerated following IM administration. Occasionally, transient pain may follow administration by this route. Some patients develop phlebitis at the infusion site (following IV administration).

PRECAUTIONS AND WARNINGS:
- Careful inquiry should be made to determine whether the patients has had previous hypersensitivity reactions to cephalosporins and penicillins, patients with hepatic diseases, biliary obstruction, renal impairment and patients with anticoagulant treatment.
- As with other antibiotics, overgrowth of nonsusceptible organisms may occur during prolonged use of cefoperazone.
- As with other antibiotics, vitamin K deficiency has occurred in a few patients treated with cefoperazone.
- Logafox should be used during pregnancy only if clearly needed.
- Caution should be made when Logafox is administered to a nursing mother.
- Safety and effectiveness in children have not been established.

DRUG INTERACTIONS:
- Alcohol
- Concomitant use with aminoglycoside or other cephalosporins can increased the nephrotoxicity risk.

DOSAGE:
Adult: 2-4 g daily, administered in equally divided doses every 12 hours.
In severe infections, the dosage may be increased to 6-12 g daily, in 2-4 divided doses.
Usage of up to 16 g daily in divided doses has been reported without complications.
Uncomplicated Gonococcal Urethritis: 500 mg IM as a single dose.
For the antibiotic prophylaxis of surgical procedures: 1-2 g should be administered IV 30-90 minutes prior to the start of surgery. The dose may be repeated every 12 hours, the prophylactic administration of Logafox may be continued for 72 hours following the completion of surgery.

ADMINISTRATION:
IV administration: Logafox 1 gram reconstituted with 5 mL sterile water for injection or other compatible solutions.
For intermittent IV infusion: 1-2 g vial Logafox should be dissolved in 20-100 mL of a compatible sterile IV solution and infused over a period of 15 minutes to 1 hour. If sterile water for injection is the preferred diluents, no more than 20 mL should be added to the vial.
For continuous IV infusion: 1 g Logafox should be dissolved in either 5 mL of sterile water for injection and the solution added to an appropriate IV diluent.
For direct IV injection: the maximum dose of Logafox should be 2 g/administration for adults. The drug should be dissolved in an appropriate diluent to give a final concentration of 100 mg/mL and administered over a period of no less than 3-5 minutes.

IM administration: Sterile water for injection or Bacteriostatic water for injection may be used to prepare Logafox for IM injection. When concentrations of >250 mg/mL are to be administered, a lidocaine solution should be used. These solutions should be prepared using a combination of sterile water for injection and 2% lidocaine HCl injection that approximates a 0.5% lidocaine HCl solution.
See table for recommended dilution:
LOGAFOX Final concentration of Logafox injection (mg/mL) Step 1,
Volume of sterile water to be added (mL) Step 2,
Volume of 2% lidocain (mL) Total Volume (mL)
1 g 250 2.6 0.9 4.0
1 g 333 1.8 0.6 3.0

PRESENTATIONS:
LOGAFOX injection: Box of 1 vial @ 1 g Cefoperazone & 1 ampoule @ 5 mL sterile water for injection.