Name:
Gentamicin ointment 0.1% (RB)
Description:
Ointment from white to yellow. One tube is composed of: active substance – gentamicin (in the form of gentamicin sulfate) – 25 mg; excipients – solid paraffin 52-54, liquid paraffin, soft paraffin, white. Pharmacotherapeutic group Antibiotics for external use. ATC code: D06AX07. Pharmacological action Gentamicin is characterized by a wide spectrum of antimicrobial activity. Active against most gram-negative and gram-positive microorganisms: Pseudomonas aeruginosa, Escherichia coli, Proteus spp., Klebsiella spp., Serratia spp., Salmonella spp., Shigella spp., Staphylococcus spp., including against multi-resistant strains. The drug does not affect anaerobic bacteria, fungi, viruses. It has a bactericidal effect. Actively penetrating through the cell membrane of bacteria, it binds to the 30S subunit of bacterial ribosomes and inhibits protein synthesis of the pathogen. Indications for use Primary skin infections: impetigo, superficial folliculitis, furunculosis, infected acne. Secondary skin infections: infectious eczematoid dermatitis, infected seborrheic dermatitis, infected abrasions and bacterial superinfections in fungal and viral skin lesions (see Precautions section), In surgery: treatment of infected skin cysts and skin abscesses after opening and draining. Infected varicose ulcers, infected superficial (II-IIA degree) burns. Small wounds and cuts. Dosage and administration Gentamycin ointment is applied externally to dry skin. The drug is applied to the affected area of the skin after removal of pus and necrotic masses, in a thin layer 2-3 times a day, for burns – 2-3 times a week. With extensive burn lesions, the daily dose of the ointment should not exceed 200 g (200 mg of antibiotic). The duration of treatment depends on the form and severity of the disease and is 1-14 days. In the treatment of dermatological diseases, the drug is applied in a thin layer to the affected area 2-3 times a day, or applied to a gauze bandage, followed by application to the affected area of the skin. The duration of treatment is 7-14 days. In the presence of exudate, wounds and erosion are pre-washed with solutions of furacilin (1: 5000), hydrogen peroxide (3%). Side effects When using gentamicin ointment, local irritant effects (redness, itching, burning sensation), allergic reactions (skin rash, itching, urticaria, fever, angioedema, eosinophilia) are possible. If allergic reactions occur, the drug is canceled and desensitizing therapy is carried out. With external use of gentamicin for a long time on large surfaces of the skin, it is necessary to take into account the possibility of a resorptive effect, especially in patients with chronic renal failure. After topical application of gentamicin ointment, especially with prolonged use of the ointment on a large wound surface, ototoxic, vestibular and nephrotic effects are possible. In the event of the above adverse reactions or adverse reactions not listed in these instructions for medical use of the drug, you should consult a doctor. Contraindications Hypersensitivity to gentamicin or any of the excipients. Concomitant systemic administration of aminoglycosides (see section “Precautions”). Renal failure (see Precautions section). Children under 3 years of age, pregnancy (1 trimester). Gentamicin ointment is not intended for application to mucous membranes, including the mucous membrane of the eye. If necessary, application to large surfaces of the skin with caution, the drug is used for neuritis of the auditory nerve. Overdose With prolonged use of the drug in doses exceeding those recommended, with extensive skin lesions, nephrotoxic (proteinuria, azotemia, etc.) and ototoxic (vestibular disorders, rarely hearing loss) effects, hyperbilirubinemia, increased activity of hepatic transaminases, changes in the cellular composition of peripheral blood are possible. Precautions Gentamicin sulfate is a bactericidal agent that is not effective for viral or fungal skin diseases. Treatment is carried out under the control of the antibiogram of the drug, since topical use of antibiotics, including gentamicin, can lead to the growth of non-susceptible pathogens, including fungi. In this case, as well as in the event of skin irritation, allergic reaction or superinfection, treatment with gentamicin should be interrupted and appropriate therapy should be carried out. If there is no therapeutic effect within 1 week, you should consult your doctor. Gentamicin ointment is not recommended for use with concomitant systemic administration of aminoglycosides, as well as in patients with renal insufficiency, as the risk of toxic effects of aminoglycosides increases. Local use of gentamicin in the treatment of skin infections is accompanied by the risk of allergic reactions, the frequency of which increases with increasing duration of use. Group sensitization has been observed with gentamicin and other aminoglycosides such as neomycin and kanamycin. When treating large areas of the skin, especially for a long period or in the presence of skin lesions, the systemic absorption of gentamicin may be increased. In these conditions, especially in children, care must be taken, as the risk of systemic side effects of gentamicin is increased. Due to the presence of systemic neuromuscular blocking effects in aminoglycosides, caution should be exercised in patients with myasthenia gravis, Parkinson’s disease and other diseases accompanied by muscle weakness, as well as while using other drugs with a neuromuscular blocking effect. Due to the presence of white soft paraffin and liquid paraffin in the composition, gentamicin ointment can lead to a decrease in the tensile strength of latex condoms, thereby reducing the safety of their use. This must be taken into account when using gentamicin ointment in the genital or anal area. Use in elderly patients requires caution and timely assessment of the state of renal function. Application during pregnancy and lactation Gentamicin penetrates the hematoplacental barrier and reaches the tissues of the fetus. Animal studies have demonstrated the reproductive toxicity of gentamicin. Gentamicin ointment should not be used in the first trimester of pregnancy. In the II-III trimesters, the use of gentamicin ointment is possible when the intended benefit to the mother outweighs the potential risk to the fetus. Gentamicin is excreted in small amounts in breast milk. Due to the lack of absorption of the drug from the gastrointestinal tract, the occurrence of side effects during breastfeeding is unlikely. Influence on the ability to drive vehicles and other potentially dangerous mechanisms In connection with the possibility of developing adverse reactions when using the drug, care must be taken when driving vehicles and when engaging in activities that require increased concentration. Interaction with other drugs Should not be administered simultaneously with other antibiotics that have oto- and nephrotoxic effects (streptomycin, kanamycin, florimycin, monomycin, ristamycin), with furosemide. The activity of gentamicin decreases in the presence of Na + , K + , Ca ++ , Mg ++ ions, as well as a number of anions (sulfates, phosphates, nitrates, etc.). There is evidence of synergism in combinations of gentamicin with dioxidine. Possible combined use with corticosteroids. In vitro, aminoglycosides are inactivated by penicillins and cephalosporins due to interaction with the β-lactam ring. Gentamicin is incompatible with heparin, solutions with alkaline pH and with drugs unstable at acidic pH. Storage conditionsAt temperature not higher than 25°C. Keep out of the reach of children. Shelf life 3 years. Do not use after the expiration date. Packing In aluminum tubes of 25 g. Each aluminum tube in use is placed in a pack. Release from pharmacies by prescription. Buy Gentamicin ointment 1mg/g 25g №1
INN | GENTAMICIN |
---|---|
The code | 2 479 |
Barcode | 4 810 133 006 826 |
Dosage | 1mg/g 25g |
Active substance | Gentamicin |
Manufacturer | Belmedpreparaty RUE, Belarus |
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