INSTRUCTION
for medical use of the medicinal product
LEVOMEKOL
(LAEVOMECOLUM)
Storage:
active substances: chloramphenicol (levomycetin), methyluracil;
1 g of ointment contains chloramphenicol (levomycetin) 7.5 mg, methyluracil 40 mg;
auxiliary substances: polyethylene glycol 400, polyethylene glycol 1500.
Medicinal form. Ointment.
Main physicochemical properties: white or white ointment with a yellowish tint.
Pharmacotherapeutic group.
Drugs that promote healing (scarring) of wounds. ATX code D03A X.
Pharmacological properties.
Pharmacodynamics.
Combined drug for local use with antimicrobial, reparative and anti-inflammatory effects. Chloramphenicol (levomycetin), which is part of the medicinal product, has an antimicrobial effect, the mechanism of which is related to the violation of the synthesis of proteins of microorganisms. Acts bacteriostatically, active against gram-positive and gram-negative microorganisms (staphylococcus, streptococcus, Pseudomonas aeruginosa and Escherichia coli). Methyluracil accelerates cell regeneration processes, promotes scarring of wounds and has an anti-inflammatory effect.
Pharmacokinetics.
Polyethylene oxide base adsorbs wound exudate, potentiates the activity of medicinal substances. The drug easily penetrates tissues without damaging biological membranes, but the extent of systemic absorption after application of the drug to skin, wounds, and mucous membranes is unknown.
Clinical characteristics.
Indication.
Treatment of purulent wounds (infected with mixed microbial flora) in the first phase of the wound process, trophic ulcers, bedsores, infected burns, boils, carbuncles.
Contraindication.
Increased sensitivity to the components of the drug; psoriasis, eczema, fungal skin lesions.
Interaction with other medicinal products and other types of interactions.
It is undesirable to use simultaneously with drugs that inhibit hematopoiesis: sulfonamides, cytostatics, pyrazoline derivatives; with diphenyl, barbiturates, ethanol.
Simultaneous use of the drug with erythromycin, oleandomycin, nystatin and levorin increases the antibacterial activity of the ointment, and with benzylpenicillin salts, it decreases it.
Features of application.
The use of antibacterial agents for external use can lead to sensitization of the skin, which is accompanied by the development of hypersensitivity reactions during further use of this drug externally or in the form of a medicinal form of systemic action.
In the presence of pus or necrotic masses, the antibacterial effect of the drug is preserved. Do not allow the ointment to get on the mucous membrane of the eyes.
With long-term (longer than 1 month) use of the drug, it is necessary to monitor the condition of the peripheral blood picture.
You should not violate the rules of use of the medicinal product.
Use during pregnancy or breastfeeding.
The use of the drug during pregnancy or breastfeeding is justified only if the expected benefit to the mother exceeds the potential risk to the fetus or child.
The ability to influence the speed of reaction when driving vehicles or other mechanisms.
Does not affect.
Method of application and dosage.
Levomekol is intended for external use by adults and children over 3 years of age. Ointment is impregnated with sterile gauze napkins, which should be used to fill the wound. It is possible to introduce ointment into purulent cavities through a catheter (drainage tube) using a syringe. In such cases, Levomekol is preheated to 35-36 °С. Dressings should be performed daily until the wounds are completely cleaned of purulent-necrotic masses and before their granulation begins. With a large area of wound surfaces, the daily dose of ointment in terms of chloramphenicol (levomycetin) should not exceed 3 g.
The ointment should be used from the first day of injury for 4 days. Levomekol hyperosmolar ointment is not recommended to be used for a long time, because it can cause osmotic shock in intact cells. On the 5th-7th day of treatment, it is recommended to change the ointment to drugs that restore the integrity of the damaged tissue.
Children.
The drug should be used by children over 3 years of age.
Overdose.
Long-term (more than 5-7 days) external use often leads to contact sensitization, which is accompanied by the development of hypersensitivity reactions at the next application of the drug externally or in the form of dosage forms for systemic use. The therapy is symptomatic.
Adverse reactions.
Allergic reactions are possible, including skin rashes, dermatitis, burning sensation, itching, local swelling, hyperemia, angioedema, urticaria; general weakness is possible. In such cases, it is necessary to stop using the ointment and consult a doctor.
Expiration date. 2 years.
Storage conditions.
Store in the original packaging at a temperature not higher than 25 °C, do not allow freezing. Keep out of the reach of children.
Packaging.
25 g in containers. 20 g or 30 g or 40 g in aluminum or laminate tubes in a pack or without a pack.
Leave category. Without a prescription.
Producer. PrJSC Pharmaceutical factory "Viola".
The location of the manufacturer and its address of the place of business.
Ukraine, 69063, Zaporizhzhia, str. Akademika Amosova, 75.
The applicant PrJSC Pharmaceutical factory "Viola".
Location of the applicant.
Ukraine, 69063, Zaporizhzhia, str. Akademika Amosova, 75.
