Active ingredients: Neomycin (neomycin sulfate), Bacitracin
BIMIXIN 25.000 I.U. + 2,500 I.U. tablets
BIMIXIN 150.000 I.U. + 15,000 I.U. syrup
Why is Bimixin used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Intestinal antibacterial
THERAPEUTIC INDICATIONS
Infections of the intestinal tract caused by germs sensitive to neomycin and bacitracin.
Contraindications When Bimixin should not be used
Hypersensitivity to neomycin and bacitracin or other components of the product; kidney failure; myasthenic syndromes; malabsorption.
The antibiotic should not be administered simultaneously with potentially nephrotoxic agents (kanamycin, streptomycin, gentamicin, polymyxin, viomycin, colistin, cephalosporins, etc.)
Products containing neomycin for oral use are contraindicated in children under two years of age. Even partial intestinal obstruction.
Precautions for use What you need to know before taking Bimixin
Following repeated or prolonged administration, the development of non-sensitive microorganisms may occur; there is in particular the possibility of staphylococcal enterocolitis. In such cases, the patient must be kept under control by instituting suitable therapy.It is advisable during treatment to carry out periodic checks of renal function and audiometric tests to promptly reveal signs of nephros and ototoxicity. Antiemetic or anti-kinetotic drugs should not be given concurrently as these may prevent early recognition of early signs of ototoxicity. Particular caution is required in the treatment of patients with hepatic lesions, even of modest severity, since it is possible to accumulate small doses of antibiotics which can sometimes be absorbed, especially at the level of intestinal lesions.
Interactions Which drugs or foods can modify the effect of Bimixin
The antibiotic should not be administered simultaneously with potentially nephrotoxic agents (kanamycin, streptomycin, gentamicin, polymyxin, viomycin, colistin, cephalosporins, etc.).
Warnings It is important to know that:
In women during pregnancy, during lactation and in infancy, the product should be used in case of real need and under direct medical supervision. Neomycin should be used with caution in patients taking potentially ototoxic drugs, anticoagulants and neuromuscular blocking agents. The simultaneous use of very active diuretics should be avoided because of the possible enhancement of the negative effects on the kidneys and the acoustic nerve.
The syrup formulation contains sucrose. This must be taken into account in diabetic patients and in those subjected to a low-calorie diet.
It is advisable to suspend the therapy once the symptoms linked to the infection have ceased (the treatment, however, should not be prolonged beyond 3-5 days).
Keep this medicine out of the reach of children.
Dose, Method and Time of Administration How to use Bimixin: Posology
1-2 tablets or 2 dessert spoons every 6-8 hours, as needed.
In children over two years, 1 dessert spoon (10 ml) or one tablet every 6-8 hours. To prepare the syrup, carefully read the instructions below.
The treatment should not be extended beyond 3-5 days.
Overdose What to do if you have taken too much Bimixin
With very high doses of neomycin, manifestations of nephrotoxicity and ototoxicity that require adequate treatment (peritoneal dialysis or hemodialysis) are possible.
Side Effects What are the side effects of Bimixin
The most frequently reported are nausea, vomiting and constipation. During prolonged or repeated therapies, a malabsorption syndrome with diarrhea and steatorrhea may occur, probably linked to inhibition of lipases, phenomena of nephrotoxicity (oliguria, albuminuria, cylindruria, hematuria, hyperazotemia) and ototoxicity (dizziness, buzzing, hypoacusis).
Rarely hypersensitivity reactions with skin rashes of different types and locations.
If undesirable effects not described above occur, the patient should notify his doctor or pharmacist.
Expiry and Retention
Store at a temperature not exceeding 25 ° C.
After preparation, it is advisable to use BIMIXIN SYRUP within four days, preferably keeping the package in a cool place.
Attention: see the expiry date printed on the package. Do not use the medicine after this date.
Composition and pharmaceutical form
BIMIXIN tablets
One tablet contains:
Active principles:
neomycin sulfate F.U. 25,000 I.U., Bacitracin F.U. 2,500 I.U.
Excipients:
lactose, corn starch, potato starch, precipitated silica, talc, stearic acid.
BIMIXIN syrup
- The reservoir vial contains:
Active principles:
neomycin sulfate F.U. 150,000 I.U., Bacitracin F.U. 15,000 I.U.
Excipient
sucrose.
- The bottle of 60 ml of syrup contains: sucrose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium citrate, orange flavor, sodium edetate, saccharin, purified water.
PHARMACEUTICAL FORM AND CONTENT
- Bottle of 16 tablets for oral use.
- Bottle of 60 ml of syrup + reservoir vial containing antibiotics, for oral use.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BIMIXIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets:
Each tablet contains:
Active principles
neomycin sulfate F.U. 25,000 I.U.
bacitracin F.U. 2,500 I.U.
Syrup:
Each reservoir vial contains:
Active principles
neomycin sulfate F.U. 150,000 I.U.
bacitracin F.U. 15,000 I.U.
03.0 PHARMACEUTICAL FORM
Divisible tablets, for oral administration
Syrup, for oral administration.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Infections of the intestinal tract sustained by germs sensitive to neomycin and bacitracin.
04.2 Posology and method of administration
1-2 tablets or 2 dessert spoons every 6-8 hours, according to the needs of the case. In children over two years, 1 dessert spoon (10 ml) or 1 tablet every 6-8 hours. However, the treatment should not be extended beyond 3-5 days.
04.3 Contraindications
Hypersensitivity to neomycin and bacitracin or other components of the product; kidney failure; myasthenic syndromes; malabsorption. Products containing neomycin for oral use are contraindicated in children under two years of age. Furthermore, the antibiotic should not be administered simultaneously with potentially nephrotoxic agents (kanamycin, streptomycin, gentamicin, polymyxin, viomycin, colistin, cephalosporins, etc.). Even partial intestinal obstruction.
04.4 Special warnings and appropriate precautions for use
Following repeated or prolonged administration, the development of non-sensitive microorganisms may occur; there is in particular the possibility of staphylococcal enterocolitis. In such cases, the patient must be kept under control by instituting suitable therapy. It is advisable during treatment to carry out periodic checks of renal function and audiometric tests to promptly reveal signs of nephros and ototoxicity. Antiemetic or anti-kinetotic drugs should not be given concurrently as these may prevent early recognition of early signs of ototoxicity. It is advisable to suspend the therapy once the symptoms linked to the infection have ceased (the treatment, however, should not be prolonged beyond 3-5 days).
Particular caution is required in the treatment of patients with hepatic lesions, even of modest severity, as it is possible to accumulate small doses of antibiotic which can sometimes be absorbed, especially at the level of intestinal lesions.
The syrup formulation contains sucrose. This must be taken into account in diabetic patients and in those subjected to a low-calorie diet.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
Neomycin should be used with caution in patients taking potentially ototoxic drugs, anticoagulants and neuromuscular blocking agents. Furthermore, the antibiotic should not be administered simultaneously with potentially nephrotoxic agents (kanamycin, streptomycin, gentamicin, polymyxin, viomycin, colistin, cephalosporins, etc.). The simultaneous use of very active diuretics should be avoided due to the possible enhancement of the negative effects on the kidneys and the auditory nerve.
04.6 Pregnancy and lactation
In women during pregnancy, during lactation and in infancy, the product should be used in cases of real need and under direct medical supervision.
04.7 Effects on ability to drive and use machines
There are no restrictions.
04.8 Undesirable effects
The most frequently reported are nausea, vomiting and constipation. During prolonged or repeated therapies, a malabsorption syndrome with diarrhea and steatorrhea may occur, probably linked to inhibition of lipases, phenomena of nephrotoxicity (oliguria, albuminuria, cylindruria, hematuria, hyperazotemia) and ototoxicity (dizziness, buzzing, hypoacusis). Rarely hypersensitivity reactions with skin rashes of different types and locations.
04.9 Overdose
With very high doses of neomycin, manifestations of nephrotoxicity and ototoxicity that require adequate treatment (peritoneal dialysis or hemodialysis) are possible.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ATC code: A07AA51
Bimixin is a "combination of neomycin and bacitracin indicated for the treatment of bacterial infections of the intestinal tract sensitive to the two antibiotics.
Bacitracin: polypeptide with a complex structure formed by different components, produced by a sporogenic, Gram-positive strain of Bacillus subtilis. Bacitracin is bactericidal against numerous Gram-positive bacteria, some Gram-negative bacilli and microorganisms of the clostridial group, it also inhibits Endamoeba histolytica and Treponema pallidum. Mechanism of action similar to penicillins: inhibition of the synthesis of bacterial wall.
Neomycin: polybasic compound with a complex structure produced by the metabolism of Streptomyces fradiae. Neomycin has a broad spectrum of action including numerous Gram-positive and Gram-negative microorganisms, mycobacteria and Endamoeba histolytica. It has cross-resistance with paromomycin and kanamycin. Mechanism of action: inhibition of endocellular protein synthesis.
Bacitracin + neomycin: the different mechanism of action and the bactericidal activity are the theoretical presupposition of the positive synergistic or additive interaction between the two antibiotics, demonstrated in "vitro" by various authors. On 36 pathogenic strains the increase in the antibacterial activity of the association compared to the single components was found in 94.5% of the tested strains.
05.2 Pharmacokinetic properties
Neomycin after oral administration shows a poor absorption of the order of 3% of the total dose, while the remainder is eliminated unchanged in the faeces. Bacitracin does not show appreciable absorption after oral administration.
05.3 Preclinical safety data
The toxicity of neomycin after administration of oral therapeutic doses is negligible; high injecting nephro and ototoxicity.
Absence of toxicity after oral administration of bacitracin, while parenteral high nephrotoxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Tablets:
lactose, corn starch, potato starch, precipitated silica, talc, stearic acid.
Reservoir vial:
sucrose.
Syrup bottle:
sucrose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium citrate, orange flavor, sodium edetate, saccharin, purified water.
06.2 Incompatibility
None known so far.
06.3 Period of validity
18 months.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C.
After preparation, it is advisable to use the Bimixin syrup within 4 days, preferably keeping the package in a cool place.
06.5 Nature of the immediate packaging and contents of the package
Tablets: cardboard box containing a glass bottle with 16 tablets;
Syrup: cardboard box containing a 60 ml glass bottle of syrup + 1 reservoir bottle containing antibiotics.
06.6 Instructions for use and handling
After opening the bottle, pour the powder contained in the reservoir bottle into the syrup; close, shake and use according to the recommended dosage.
After preparation, it is advisable to use the Bimixin syrup within 4 days, preferably keeping the package in a cool place.
07.0 MARKETING AUTHORIZATION HOLDER
sanofi-aventis S.p.A. - Viale L. Bodio, 37 / B - Milan
08.0 MARKETING AUTHORIZATION NUMBER
Tablets: A.I.C. n. 008477061
Syrup: A.I.C. n. 008477073
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: 01.06.2005
10.0 DATE OF REVISION OF THE TEXT
01/10/2007
