Composition, form of production and packaging
Powder for the preparation of eye drops , upon dissolution of which in an applied solvent, 5 ml of a colorless or light yellow transparent solution is formed.
1 ml of finished r-ra
chloramphenicol 4 mg
colistimethate sodium 180 thousand MIU
roletetracycline 5 mg
Excipients: sodium sulfite.
The composition of the solvent: distilled sterile water, benzalkonium chloride, sodium tetraborate, boric acid, sodium edetate, polysorbate 80.
Vials of dark glass (1) with a lid-reservoir and a lid-dropper - aluminum foil - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2005.
Combined antibacterial preparation for topical application in ophthalmology.
Chloramphenicol - a broad-spectrum antibiotic, inhibits the synthesis of proteins of sensitive microorganisms; is active against Gram-positive and Gram-negative bacteria, Mycoplasma spp., Rickettsia spp., Chlamydia spp .; is not active against Pseudomonas aeruginosa, fungi.
Roilititracycline, a broad-spectrum antibiotic, inhibiting bacterial protein synthesis at the RNA level, has a bacteriostatic effect. It is active against gram-negative bacteria, Chlamydia spp., Mycoplasma spp., Rickettsia spp., Entamoeba histolytica. Stability of microorganisms develops slowly.
Sodium colistimethate is an antibiotic that is isolated from Bacillus polymixa, var. colistinus. It has a bactericidal effect on most gram-negative bacteria (including Pseudomonas spp., Haemophilus spp.); is active against fungi. There is no cross-resistance with broad-spectrum antibiotics with which sodium colistimethate exhibits synergism.
- conjunctivitis (catarrhal, purulent, trahmic);
- bacterial keratitis;
- septic ulcer of the cornea;
The drug is prescribed 1-2 drops 3-4 times / day.
Rules for the preparation and use of eye drops
Remove the lid from the vial and adjust the reservoir to it. Press the red tank cover into the vial, then vigorously shake the vial to dissolve the powder in it. Remove completely the reservoir and put the dropper (pipette) on the vial. Remove the cap from the dropper (pipette) and, turning the bottle, squeeze a drop.
Local reactions: short-term conjunctival hyperemia, burning sensation.
Allergic reactions: angioedema, hives, bullous and spotted-papular dermatitis; predisposed patients may develop attacks of bronchial asthma and other severe allergic reactions (due to the sodium sulfite contained in the eye drops).
- impaired liver function;
- impaired renal function;
- lactation period (breastfeeding);
- Children's age till 8 years;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy and lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in renal dysfunction
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in the violation of liver function.
APPLICATION FOR CHILDREN
The drug is contraindicated for children under 8 years.
In the absence of significant clinical improvement over a relatively short period of time or when allergic reactions occur, Colbiocin should be discontinued and appropriate anti-allergic therapy should be performed.
Because rare cases of bone marrow hypoplasia due to prolonged topical application of chloramphenicol have been reported, Colbiocin should be used for short periods of time and under the supervision of an ophthalmologist.
No cases of an overdose of Colbiocin have been reported.
Drug interaction of the drug Colbiocin with other drugs for topical application is not described.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored at a temperature of no higher than 25 В° C. After opening the vial, the drug should be stored in the refrigerator at a temperature of 2 В° to 8 В° C and used for 15 days. Shelf life - 2 years.
Conditions of leave from pharmacies
The drug is released by prescription.