Plot 8, Block ‘M’, Abimbola Street, Isolo, P.O.Box, 3344, Mushin, Lagos State.
Lek Pharm. & Chemical Co. d. d., Verovskova 57, Ljubljana, Slovenia.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: 04-1836): Each tablet contains 400 mg of Pefloxacin in the form of methanesulfonate
Pack size: Boxes of 10 and 50.
Injection (NRN: 04-1837): Each ampoule (5 mL) contains 400 mg of Pefloxacin in the form of methanesulfonate.
Pack size: Ampoules in boxes of 5 and 10.
Pefloxacin is a synthetic antimicrobial substance which belongs to the quinolones. Its bactericidal acivity results from the inhibition of bacterial DNA replication. Pefloxacin also acts on RNA and bacterial protein synthesis.
After oral administration, pefloxacin is rapidly absorbed and maximum serum levels occur in 90 minutes. The half-life of pefloxacin is approximately 8 hours. Pefloxacin penetrates well into tissues (including heart, bronchial mucosa, central nervous system and bones). It is excreted unchanged and partially metabolized as demethyl pefloxacin, pefloxacin-N-oxide and pefloxacin glucuronide.
Pefloxacin has a broad spectrum of activity. Susceptible microorganisms to Pefloxacin are: Eschericia coli, Klebsiella spp., Enterobacter spp., Serratia spp., Salmonella spp., Shigella spp., Haemophilus spp., Proteus mirabilis, indole-positive Proteus, Citrobacter spp., C. jejuni, Providencia stuartii, Yersinia enterocolitica, Aeromonas spp., Staphylococcus spp. (including methicillin-resistant species), Neisseria gonorrheae and Legionella spp.
Moderately susceptible are Streptococcus spp., Pneumococcus spp., Pseudomonas spp., Acinetobacter spp., Clostridium perfringes, Mycoplasma and Chlamydia trachomatis. Generally resistant are: gram-negative anaerobes, Spirochaetes and Mycobacterium tuberculosis.
Infections caused by pefloxacin susceptible microorganisms:
- Urinary tract infections (including prostatitis);
- Respiratory tract infections (acute exacerbations of chronic bronchitis, excerbation in cystic fibrosis, nosocomial pneumonia);
- ENT infections (chronic sinusitis, malignant otitis externa);
- Gynaecological infections;
- Abdominal and hepatobiliary infections, serious bacterial gastrointestinal infections, carrier state of Salmonella;
- Bone and joint infections (osteomyelitis caused by gram-negative microorganisms);
- Skin and soft tissue infections caused by Staphylococci resistant to antistaphylococal penicillin;
- Septicemia and endocarditis;
- Meningitis (if the causative organism is susceptible to pefloxacin only);
Known hypersensitivity to quinolones, children under 15 years of age, pregnant and nursing women, in G-6-PD deficiency, in patients with CNS diseases (epilepsy and cerebral atherosclerosis).
Avoid exposure to ultraviolet light during Abaktal therapy because of the risk of photosensitivity reactions. Dosage adjustment is required in severe hepatic insufficiency.
Antacids or sucralfate combined with Quinolones may decrease the absoption quinolones to 50% therefore they should be given at least 2 hours apart.
Quinolones decrease Theophylline clearance in plasma and increase its serum concentration.
With concurrent use of Theophylline retard formulation and a systemic quinolone, monitoring of theophylline plasma levels is recommended although clinically insignificant interaction with pefloxacin has been observed and adjustment of Abaktal dose is not needed.
Mild GI disturbances, loss of appetite, change in taste and vomiting have been reported. When diarrhea and abdominal pain occur, the patient should report to the physician to rule out the risk of pseudomembranous colitis.
Muscle and/or joint pains, photosensitivity, allergic reactions, neurological disturbances (headache, convulsions, insomnia), thrombocytopenia (at doses of 1600 mg/day) have been observed.
Side effects are reversible and disappear after stopping the therapy.
Dosage & Administration
The usual dosage for adults and children over 15 years of age is 800 mg.
One tablet twice daily (morning and evening); in urinary tract infections, one tablet is administered every 24 hours because of high pefloxacin concentration in urine and long elimination half-life. The drug should be given with food to avoid gastrointestinal disturbances.
Abaktal should be administered as a slow 1-hour intravenous infusion administered twice daily, in the morning and evening. The contents of one ampoule (400 mg) are diluted in 250 mL of 5% Glucose.
Do not dilute Abaktal with Sodium chloride solution or any other solution containing chloride ions.
To achieve immediate effective blood concentrations, a loading dose of 800 mg may be administered on starting treatment.
Dosage in hepatic insufficiency is 8 mg/kg of body weight administered as 1-hour intravenous infusion: once daily (jaundice) every 36 hours (ascites) every 48 hours (jaundice and ascites).
Tablets: Protected from light and humidity below 25oC.
Ampoules: protected from light below 25oC.