Miramistin-Darnitsa - instructions for use, doses, side effects, contraindications

Active substanceBenzyldimethyl [3- (myristoylamino) propyl] ammonium chloride monohydrateBenzyldimethyl [3- (myristoylamino) propyl] ammonium chloride monohydrate

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ointment locally externally

DARNITSA PHARMACEUTICAL FIRM, CJSC Ukraine

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Dosage form: & nbspointment for topical and topical application

Composition:

Active substance: 1 g of ointment contains Benzyldimethyl [3- (myristoylamino) propyl] ammonium chloride, monohydrate (Miramistin) - 5 mg;

Excipients: disodium edetate dihydrate, macrogol 400, macrogol 1500, macrogol 6000, poloxamer 268 (proxanol 268), propylene glycol, purified water.

Description:Homogeneous ointment of white color.

Pharmacotherapeutic group:Antiseptic

ATX: & nbsp

D.08.A.J Quaternary ammonium compounds

S.01.A.X Other antimicrobials

Pharmacodynamics:

Ointment Miramistin®-Darnitsa contains a cationic antiseptic miramistin, which has an antimicrobial effect on gram-positive and gram-negative, aerobic and anaerobic, spore-forming and asporogenous microflora in the form of monocultures and microbial associations, including hospital strains with multidrug resistance to antibiotics.The drug is more effective against gram-positive bacteria (staphylococcus, streptococcus, etc.). Has an antifungal effect on Ascomycetes of the genus Aspergillus and Penicillium, yeasts (Rhodotorula rubra, Torulopsis gabrata etc.) and yeast-like (Candida albicans, Candida tropicalis, Candida krusei etc.) mushrooms, on dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton schoenleini, Trychophyton violaceum, Epidermophyton, Kaufinan-Wolf, Epidermophyton floccosum, Microsporum gypseum, Microsporum canis etc.), as well as other pathogenic fungi (for example, Pityrosporum orbiculare (Malassezia furfur)) in the form of monocultures and microbial associations, including a fungal microflora with resistance to chemotherapeutic drugs.

The drug reduces the resistance of bacteria and fungi to antibiotics. Due to the wide spectrum of antimicrobial action, miramistin effectively prevents infection of wounds and burns, activating regeneration processes. The drug has a pronounced hyperosmolar activity, due to which it stops wound and perifocal inflammation, absorbs purulent exudate and selectively dehydrates necrotic tissues, contributing to the formation of a dry scab. In this case, the ointment does not damage granulation and viable skin cells, does not inhibit marginal epithelization.

Pharmacokinetics:

Due to the physico-chemical properties of the ointment base, Miramistin®-Darnitsa acts not only on the superficial wound microflora, but also on pathogens located in the tissues surrounding the wound, because of which it is possible that a small part of myramistine can enter the systemic circulation.

Indications:

In surgery - in the 1st phase of the wound process for the treatment of infected wounds of various localization and genesis (wounds after surgical treatment of purulent foci, bedsores, trophic ulcers, suppuration of postoperative wounds, fistulas); in the 2 nd phase of the wound process - to prevent reinfection of granulating wounds.

In kombustiologii - for the treatment of superficial and deep burns II-IIIA degree and frostbite, for the preparation of burn wounds for autodermoplasty.

In dermatology - for the treatment of strepto- and staphyloderma, candidiasis of skin and mucous membranes, foot mycoses and large skin folds, including dishydrotic forms and forms complicated by pyoderma, smooth skin dermatomycosis.

To prevent complications of wound infection - with non-extensive industrial and domestic injuries.

Contraindications:

Individual sensitivity to the components of the drug;

There is no sufficient experience of using ointment to treat children, pregnant women and breastfeeding women.

Dosing and Administration:

Ointment Miramistin®-Darnitsa is applied topically and externally. After standard treatment of wounds and burns in adults, the drug is applied directly to the affected surface, then a sterile gauze dressing is applied or an ointment is applied to the dressing and then to the wound. Tampons impregnated with the drug loosely fill the cavities of purulent wounds after their surgical treatment, gauze turuns with ointment are injected into the fistulous passages.

In the treatment of purulent wounds and burns in the first phase of the wound process, the drug is used 1 once a day, in the 2 nd phase - 1 time from one to three days, depending on the state of the wound. 2-4 g of ointment (strip - 1-2 cm) is applied in a thin layer on gauze napkins, applying the latter on the wounds with a 2-3 cm call on undamaged areas in the circumference of the wound with a daily change of dressings. The duration of treatment is determined by the dynamics of cleansing and healing of wounds. With deep localization of infection in soft tissues, it is possible to use the drug together with antibiotics of systemic action,while the duration of treatment will be determined by the duration of the course of antibiotic intake.

In the treatment of dermatological diseases in adults, the drug is applied a thin layer on the damaged skin several times a day, or impregnated with a gauze dressing, followed by its application to the lesion site 1-2 times a day until negative results of microbiological control are obtained. In case of common dermatomycosis, in particular rubromycosis, ointment can be used for 5-6 weeks in complex therapy with griseofulvin or antifungal agents of systemic action.

Side effects:

In some cases, in the treatment of burns and trophic ulcers, the preparation may cause a slight burning sensation, which passes by itself and does not require the use of analgesics and the cessation of the use of the ointment.

Overdose:

An overdose of the drug has not been observed to date. However, when the drug is applied on a large wound surface in large quantities, it can penetrate into the systemic bloodstream, the effect of which will manifest itself as the action of a cationic detergent and may prolong the time of bleeding.

Treatment. Reduction of the dose or discontinuation of the use of the drug, appoint oral calcium preparations, menadione sodium bisulfite (vicasol).

Interaction:

Means containing anionic surfactants (soap solutions) inactivate the drug. With the combined division of the wound, when the local application of the Miramistin ®-Darnitsa ointment is combined with the systemic administration of antibiotics, the dose on the course of the latter can be reduced.

Special instructions:

Due to a wide spectrum of antimicrobial action, the ointment can be used for mixed bacterial and fungal infections, especially in the initial period of treatment, up to the identification of pathogens. The effectiveness of Miramistin®-Darnitsa ointment increases if it is applied on wound surface, previously washed with aseptic solution. The presence of purulent-necrotic masses in the wound requires an additional expenditure of the ointment.

Form release / dosage:Ointment for topical and topical application 0,5%.

Packaging:

In tubes of aluminum for 15 g, 30 g. Each tube together with the instruction for use is placed in a cardboard box. For hospitals: 1000 g in cans of dark glass or 500 grams, 1000 g in cans of polymeric.

Storage conditions:List B.Store in a dry place, at a temperature of 8 ° C to 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use the product after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N013144 / 01

Date of registration:24.06.2010

Expiration Date:Unlimited

The owner of the registration certificate:DARNITSA PHARMACEUTICAL FIRM, CJSCDARNITSA PHARMACEUTICAL FIRM, CJSC Ukraine

Manufacturer: & nbsp

DARNITSA PHARMACEUTICAL FIRM, PAO Ukraine

Information update date: & nbsp09.06.2018

Illustrated instructions

Instructions

Miramistin®-Darnitsa (Myramistin®-Darnitsa)