Instructions for Inflarax ointment tube 50 g
Composition
active ingredients: amikacin, nimesulide, benzalkonium, lidocaine;
1 g of ointment contains amikacin sulfate equivalent to amikacin 5 mg, nimesulide 10 mg, benzalkonium chloride 5 mg, lidocaine hydrochloride 40 mg;
excipients: polyethylene glycol 1500 and polyethylene glycol 400 in a ratio of 1:4.
Dosage form
Ointment.
Main physicochemical properties: yellowish-greenish ointment of uniform consistency.
Pharmacotherapeutic group
Dermatological agents. Antibiotics and chemotherapeutic agents, combinations. ATX code D06C.
Pharmacological properties
Pharmacodynamics
The ointment has anti-inflammatory, analgesic, and antimicrobial effects.
Amikacin is a semi-synthetic antibiotic of the aminoglycoside group with a broad spectrum of action. It has a bactericidal effect. Actively penetrating the cell membrane of bacteria, it irreversibly binds to the 30S subunit of bacterial ribosomes, which inhibits the synthesis of the pathogen's protein.
Highly active against aerobic gram-negative bacteria: Pseudomonas aeruginosa, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp., Enterobacter spp., Serratia spp., Providencia stuartii.
It is also active against some gram-positive bacteria: Staphylococcus spp. (including strains resistant to penicillin, methicillin, some cephalosporins), some strains of Streptococcus spp.
Inactive against anaerobic bacteria.
Benzalkonium chloride has a broad spectrum of antimicrobial activity against gram-positive and gram-negative microorganisms, including staphylococci, Pseudomonas aeruginosa and Escherichia coli. The mechanism of action is due to the fact that it binds to ribosomes, which leads to irreversible inhibition of protein synthesis, and is fixed on the cytoplasmic membranes of bacteria, disrupting their permeability, as a result of which the cell loses potassium ions, amino acids, nucleotides.
Nimesulide has an anti-inflammatory (suppresses the inflammatory phase due to a decrease in the activity of inflammatory mediators, which helps reduce the permeability of the vascular wall) and analgesic effect (reduction of tissue edema is accompanied by a decrease in pain).
Lidocaine inhibits sensitive nerve endings of the skin and mucous membranes, i.e. causes reversible inhibition of the conductivity of tissue elements of nerve cells (neuron, axon, synapses). Lidocaine inhibits the stimulus-activated transient increase in the permeability of sodium ions and, to a lesser extent, reduces the passive permeability of potassium and sodium ions, thereby stabilizing neuronal membranes. Lidocaine reduces the degree of depolarization that occurs in response to a physiological stimulus, as well as the amplitude of the action potential and inhibits nerve conduction. Lidocaine absorbed after topical application can cause excitation or depression of the central nervous system (CNS). Its effect on the cardiovascular system can manifest itself in the form of conduction disturbances and peripheral vasodilation.
The water-soluble base of the ointment – polyethylene oxide – enhances and prolongs its antibacterial and anti-inflammatory effect, exhibits a pronounced and long-lasting osmotic effect. Thus, when using the ointment, perifocal edema is eliminated and the wound is cleansed of purulent-necrotic contents. Therapeutic activity persists for 20–24 hours.
Pharmacokinetics
Not studied.
There are no data on the topical use of amikacin. In the case of absorption after topical application, it can be expected that amikacin is evenly distributed in extracellular fluid (abscess contents, pleural effusion, ascitic, pericardial, synovial, lymphatic and peritoneal fluids); in high concentrations it is found in urine; in low concentrations - in bile, breast milk, aqueous humor, bronchial secretion, sputum and cerebrospinal fluid. It easily penetrates all tissues of the body, where it accumulates intracellularly. High concentrations are found in organs with intensive blood supply: lungs, liver, myocardium, spleen and especially in the renal cortex; lower concentrations - in muscles, adipose tissue and bones. In adults, when used in average therapeutic doses (normal), amikacin does not penetrate the blood-brain barrier. Amikacin crosses the placental barrier: found in fetal blood and amniotic fluid. Not metabolized. Excreted by the kidneys by glomerular filtration (65–94%) mainly unchanged. Excreted by hemodialysis and peritoneal dialysis.
After topical application, lidocaine penetrates into the tissues and has a local anesthetic effect. Lidocaine is rapidly absorbed when applied to mucous membranes and damaged skin, but is poorly absorbed when applied to healthy skin. The rate of absorption and the amount of active substance that enters the bloodstream depend on the dose, type, size and condition of the surface to which the drug is applied (skin or mucous membrane), as well as the duration of exposure. Metabolized in the liver. It is first dealkylated and then hydrolyzed. Both the unchanged substance and metabolites are excreted mainly by the kidneys.
Indication
In surgical practice, the drug is used to treat purulent wounds in the first (purulent-necrotic) phase of the wound process, to prevent suppuration of superficial and deep wounds, and in postoperative complications (postoperative suppuration of wounds, phlegmon, fistula, abscess); in combustiology - for the prevention and treatment of suppuration of burn wounds; in dermatology - for the treatment of purulent-inflammatory skin diseases (pyoderma).
Contraindication
Hypersensitivity to any of the components of the drug/local anesthetics of the amide type, psoriasis, eczema, fungal skin lesions. Do not use in patients in whom acetylsalicylic acid or other drugs that inhibit prostaglandin synthesis cause allergic reactions such as rhinitis, urticaria or bronchospasm.
Interaction with other medicinal products and other types of interactions
When used topically, the drug has no known interactions with other drugs. It should be noted that when used in combination, amikacin may increase (mutually) the effects of carbenicillin, benzylpenicillin, and cephalosporins; nimesulide may increase the effects of sulfonamides and anticoagulants; lidocaine may increase the effects of novocaine and bupivacaine.
With caution, prescribe the drug simultaneously with anticoagulants, digoxin, phenytoin, lithium preparations, diuretics, antihypertensive drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclosporine, methotrexate, oral hypoglycemic agents, antiarrhythmic drugs. With simultaneous topical use of several NSAIDs, local irritation in the form of urticaria, skin redness, peeling may develop.
Glucocorticoids and antirheumatic drugs (gold preparations, aminoquinolones) enhance the anti-inflammatory effect of nimesulide.
Benzalkonium chloride is chemically incompatible with soaps and other anionic surfactants (surfactants), as well as with iodine preparations. Nonionic surfactants reduce or eliminate the antimicrobial effect of benzalkonium chloride.
Application features
The drug should be applied only to damaged areas of the skin, preventing the ointment from getting on intact areas of the skin, in the eyes and on the mucous membranes.
Should not be used in patients with known hypersensitivity to NSAIDs. If hypersensitivity reactions develop, treatment should be discontinued.
During treatment with the drug, photosensitivity reactions may develop.
Use the drug with caution and under the supervision of a physician in elderly patients with impaired renal or hepatic function, congestive heart failure, impaired hematopoiesis, gastroduodenal bleeding, ulcers in the acute stage, or severe blood clotting disorders.
Ability to influence reaction speed when driving vehicles or other mechanisms
Unknown.
Use during pregnancy or breastfeeding
The safety of the drug during pregnancy or breastfeeding has not been established.
Method of administration and doses
Apply the ointment in a thin layer to the affected areas 1-2 times a day or soak sterile gauze napkins with the ointment and apply to the wound. The required amount of the drug is determined by the area of the wound surface and the degree of purulent exudation. The ointment should cover the entire affected area.
When treating purulent wounds and purulent-inflammatory skin diseases, the ointment should be used daily.
When treating burns – daily or 2–3 times a week, depending on the amount of purulent discharge.
The duration of the course of treatment is determined individually, depending on the effectiveness of the therapy and the size of the lesion. Dressings with ointment should be done until the wound is completely cleansed of the purulent-necrotic process.
Children
The safety and effectiveness of the drug in children have not been established.
Overdose
Due to the insignificant penetration of the drug through the mucous membranes and skin, overdose is unlikely, but when applying the ointment to large areas of damage, when exceeding the recommended doses and with prolonged use of the ointment, systemic side effects characteristic of amikacin, nimesulide, lidocaine are possible (see the section "Adverse reactions").
In case of overdose, the drug should be discontinued. Treatment is symptomatic.
Adverse reactions
Allergic and local irritation phenomena (including skin rashes, itching, peeling, swelling, burning, erythema), photosensitivity reactions; rarely, in sensitive patients, anaphylactic reactions may occur, such as Quincke's edema, vasomotor rhinitis, shortness of breath, bronchospasm.
If the drug is used according to the instructions, the incidence of systemic effects is extremely low, since the amount of active substance that can reach the bloodstream is very small. When using high doses and in the case of rapid absorption of lidocaine or in case of hypersensitivity, idiosyncrasy or reduced tolerance, adverse reactions characteristic of local anesthetics of the amide type may develop when used systemically.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
50 g in a tube in a box.
According to the recipe.
Producer
Limited Liability Company "Pharmaceutical Company "Zdorovya".
Location of the manufacturer and its business address
Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenko street, building 22.
