Bionam

Imipenem, cilastatin.

Each vial contains: Imipenem 500 mg, Cilastatin 500 mg.

Pharmacology: Pharmacodynamics: The bacterial activity of BIONAM results from inhibition of bacterial cell wall synthesis. BIONAM is active in vitro against a wide range of bacteria infections including: Gram-positive aerobes: Bacillus spp., Enterococcus faecalis, Erysipelothrix rhusiopathiae, Listeria monocytogenes, Nocardia spp., Pediococcus spp., Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis (including penicillinase-producing strains), Staphylococcus saprophyticus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus Group C, Streptococcus Group G, Viridans group streptococci (including alpha and gamma hemolytic strains).
Gram-negative aerobes: Achromobacter spp., Acinetobacter spp. (formerly Mina-Herellea), Aeromonas hydrophila, Alcaligens spp., Bordetella bronchicanis, Bordetella bronchiseptica, Bordetella pertussis, Brucella melitensis, Campylobacter spp., Capocytophaga spp., Citrobacter spp., Citrobacter diversus, Citrobacter freundii, Eikenella corrodens, Enterobacter spp., Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, (including β-lactamase-producing strains), Haemophilus parainfluenzae, Hafnia alvei, Klebsiella spp., Klebsiella ozaenae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella spp., Morganella morganii (formerly Proteus morganii), Neisseria gonorrhea (including penicillinase-producing strains), Neisseria meningitides, Pasteurella spp., Pasteurella multocida, Plesiomonas shigelloides, Proteus spp., Proteus mirabilis, Proteus vulgaris, Providencia spp., Providencia rettgeri (formerly Proteus rettgen), Providencia stuartii, Providencia alcalifaciens, Pseudomonas spp., Pseudomonas aeruginosa, Pseudomonas putida, Pseudomonas fluorescens, Pseudomonas stutzeri, Pseudomonas pseudomallei, Salmonella spp.,Salmonella typhi, Serratia marcescens, Shigella spp., Yersinia enterocolitica/Yersinia pseudotuberculosis.
Anaerobic Bacteria: Bacteroides spp., Bacteroides distasonis, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatusi, Bilophila wadsworthia, Fusobacterium spp., Fusobacterium necrophorum, Fusobacterium nucleatum, Porphyromonas asaccharolyticas (formerly Bacteroides asaccharolyticus, Prevotella bivia (formerly Bacteroides bivius), Prevotella disiens (formerly Bacteroides disiens), Prevotella intermedia (formerly Bacteroides intermedius), Prevotella melaninogenica (formerly Bacteroide melaninogenicus), Veillonella spp. Actinomyces spp., Bifidobacterium spp., Clostridium spp., Clostridium perfringens, Eubacterium spp., Lactobacillus spp., Mobiluncus spp., Microaerophilic streptococcus, Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp. (including P. acnes).
Other: Mycobacterium fortuitum.
Mycobacterium smegnatis.
In vitro test show imipenem act synergistically with aminoglycoside antibiotics against some isolate of Pseudomonas aeruginosa.

BIONAM is indicated for the treatment of the following infections due to susceptible organisms: Intra-abdominal infections, Skin and soft tissue infections, Infective endocarditis, Genitourinary tract infections, Gynecological infections, Septicaemia, Lower respiratory tract infections, Bone and joint infections.

Intravenous injection.
Duration of treatment should be based on the type or severity of infection. Treatment should be continuous until recovery and/or treat for at least 2 days further after the symptom of infection disappear. However, the effectiveness/safety of treatment more than 14 days have not been established.
Adults: Treatment: Dosage schedule for patients with normal renal function should be based on severity of infections. The maximum daily dosage should not exceed 50 mg/kg. (See Table 1.)

Click on icon to see table/diagram/image

Treatment: Dosage schedule for patients with impaired renal function should be reduced appropriate. Using the table as follows, find the appropriate reduced dosing schedule. (See Table 2.)

Click on icon to see table/diagram/image

Use in children: BIONAM is not recommended for Intravenous injection in the therapy of meningitis because it may cause seizures. Clinical data are insufficient to recommend dosing for children under 30 kg weight, or pediatric patients with impaired renal function.
3 months or older (Non-CNS infections): 15 mg/kg every 6 hours. The total daily dose should not exceed 2 g. In children over 40 kg weight, adult dosage should be used.

No specific information is available on the treatment of overdosage with imipenem/cilastatin.
Imipenem/cilastatin is hemodialyzable.

BIONAM is contraindicated in patients who have hypersensitivity to this drug and meningitis.

Do not reconstitute BIONAM with solution that have benzyl alcohol before given in children because it may cause toxicity from benzyl alcohol.
BIONAM can cause rapid resistant especially in some strain of Pseudomonas aeruginosa.
Prolonged use may occasionally result in overgrowth of nonsusceptible organisms. Pseudomembranous colitis has been reported and may range in severity from mild to life-threatening. It is important, therefore, to consider this diagnosis in patients who present with diarrhea subsequent to the administration of BIONAM, should be discontinued. If have severe Pseudomembranous colitis, the appropriate antibiotic should be used for treatment Clostridium difficile that cause colitis.
Before therapy with BIONAM is instituted, careful inquiry should be made concerning previous hypersensitivity reaction to either penicillins, cephalosporins or other beta-lactam antibiotics. If an allergic reaction occurs, the drug should be discontinued.
Patients with creatinine clearance of <5 mL/min/1.73m² should not receive BIONAM.
Children with meningitis should not receive BIONAM by intravenous injection because it may cause seizures.

Pregnancy: Category C.
There are no adequate and well controlled studies in pregnant women. BIONAM should be used with caution when the potential benefit outweighs the potential risk.
Imipenem has been detected in human milk patient should stop nursing.

Local Reactions: pains, thrombophlebitis at the site of injection.
Dermatologic reactions: urticaria, rash, pruritus, erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson Syndrome.
Gastrointestinal: nausea (2%), vomiting, diarrhea (1.8%), Pseudomembranous colitis, hepatitis, jaundice.
Haematology: increase eosinophils, agranulocytosis, thrombocytopenia, thrombocytosis positive direct Coombs' test.
Hepatic: increased transaminases, alkaline phosphatase and bilirubin.
Central Nervous System: seizures.
Electrolyte: decreased blood sodium level, increased blood potassium level and blood chloride level.

Ganciclovir: Generalized seizures have been reported in patients who received ganciclovir and imipenem/cilastatin.

Store below 30°C.

Other Beta-Lactams

J01DH51 - imipenem and cilastatin ; Belongs to the class of carbapenems. Used in the systemic treatment of infections.

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