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Manufacturers: Gedeon Richter (Hungary)
Active ingredients
- Mazipredon
- Miconazole
Disease class
- Mycosis of nails
- Mycosis, unspecified
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Anti-inflammatory
- Antifungal
- Antibacterial
Pharmacological group
- Antifungal agents in combinations
- Glucocorticoids in combinations
Ointment for external use Mycosolon (Mycosolon)
Instructions for medical use of the drug
Description of pharmacological action
Miconazole stops the development of dermatophytes, Candida fungi and some, mainly gram-positive, bacteria. Mazipredone has a local anti-inflammatory and antiallergic effect.
Indications for use
Fungal infections of the skin and nails, accompanied by severe inflammation and itching; mycoses combined with superinfection caused by gram-positive bacteria.
Release form
Ointment for external use 1 tube miconazole 0.02 g mazipredone hydrochloride 0.0025 g in tubes of 15 g; 1 tube in a box.
Pharmacodynamics
A combined drug that has anti-inflammatory, desensitizing, antipruritic, antifungal and antibacterial effects. Mazipredone is a water-soluble derivative of prednisolone that has anti-inflammatory, desensitizing and antipruritic effects. Miconazole has an antifungal effect against dermatophytes, candida and an antibacterial effect mainly against gram-positive bacteria.
Pharmacokinetics
When applied topically, the absorption of miconazole is insignificant: almost the entire amount of miconazole is found on the skin unchanged. Less than 0.5% is excreted by the kidneys. Mazipredone is absorbed slowly when applied to the skin.
Use during pregnancy
Data on the safety and effectiveness of the drug during pregnancy and breastfeeding are not provided. Prescription of Mycozolon during these periods is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. When using Mycozolon during lactation, it is necessary to decide on the abolition of breastfeeding.
Contraindications for use
Skin tuberculosis, herpes infection, tumors and precancerous skin diseases, smallpox, chicken pox.
Side effects
Side effects are very rare. With increased sensitivity, the following may occur: local skin irritation, burning sensation, redness of the skin. If you are sensitive to isoconazole, tioconazole, or oxiconazole, cross-allergy may occur. With prolonged use of the drug, skin atrophy and stretch marks are possible. In the case of long-term use on a large surface in children, due to the ratio of skin surface area to body weight, as well as insufficient sensitivity of the epidermis, it is possible to absorb a proportionately larger amount of glucocorticosteroid when applied topically and, accordingly, the manifestation of a systemic effect.
Directions for use and doses
Externally, apply to affected areas of the skin 2 times a day. For nail infections: after removing the affected nail segments, use the drug in the form of an occlusive dressing. Treatment continues without interruption until the nails are completely regenerated. For ear infections: inject turundas soaked in the drug into the external auditory canal 2 times a day. The course is on average 2–5 weeks.
Overdose
To date, no cases of overdose have been reported.
Interactions with other drugs
Not described.
Special instructions for use
It is recommended to cut the affected nails as short as possible before application; Treatment is continued after rejection of the affected nail, until complete recovery (2–3 months).
Storage conditions
At a temperature of 8–15 °C.
Best before date
24 months
ATX classification:
D Dermatotropic drugs
D07 Corticosteroids for the treatment of skin diseases for external use
D07B Corticosteroids in combination with antiseptics
D07BA Low-active corticosteroids in combination with antiseptics
Miconazole vaginal suppositories 100 mg No. 7x1
Name
Miconazole supp vag 100 mg in container pack No. 7x1
Description
Suppositories are cylindrical-conical, white or white with a yellowish tint. The cut is allowed to have an airy and porous core and a funnel-shaped depression.
Main active ingredient
Miconazole
Release form
Suppositories
Dosage
100mg
pharmachologic effect
Antiseptics and antimicrobials for the treatment of gynecological diseases (excluding combinations with corticosteroids). Imidazole derivatives. ATX code: G01AF04.
Pharmacodynamics
Miconazole is a synthetic antifungal agent, an imidazole derivative. Has antifungal and antibacterial effects. The most sensitive to miconazole are dermatomycetes and yeast. Active against the causative agent of pityriasis versicolor (Malassezia furfur), causative agents of some dermatomycosis (Candida albicans, Trichophyton, Epidermophyton floccosum, Microsporum). Shows activity against Dimorphons fungi, Cryptococcus neoformans, Aspergillus spp., Pityrosporum, Torulopsis glabrata, Pseudallescheria boydii; some gram-positive microorganisms, including staphylococci and streptococci. The fungicidal and fungistatic effect of miconazole nitrate is due to inhibition of ergosterol biosynthesis, changes in lipid composition and cell wall permeability, which causes fungal cell death.
Pharmacokinetics
When administered intravaginally, miconazole nitrate is absorbed slightly and is not detected in plasma.
Indications for use
vulvovaginal candidiasis; superinfection caused by gram-positive microorganisms. If you need more information about your condition, ask your doctor for advice.
Directions for use and doses
The use of this medicine is possible only after consultation with a doctor! Do not stop taking MICONAZOLE without first consulting your doctor! If you have any doubts or questions, contact your healthcare provider. For vaginal use. 1 suppository (100 mg) once a day, in the evening before bedtime for 7-14 days, or one suppository in the morning and evening for 7 days. The suppository is released from the contour packaging, having previously cut the film along the contour of the suppository using scissors, and inserted as deep as possible into the vagina, in a lying position.
Use during pregnancy and lactation
If you are pregnant or breastfeeding, think you may be pregnant, or think you might be pregnant, tell your doctor. The drug is contraindicated for use in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the drug can be used only in cases where the expected benefit to the woman outweighs the potential risk to the fetus. Caution should be exercised when using the drug during lactation.
Precautionary measures
Prescribe with caution for diabetes mellitus and microcirculation disorders. The use of suppositories may reduce the reliability of mechanical contraception (condoms, vaginal diaphragms) due to the interaction of the suppository base with latex or rubber. If a sexual partner has an infection, appropriate treatment should be prescribed. The appearance of allergic reactions or lack of clinical improvement within 7 days requires discontinuation of treatment and additional examination. If necessary, the drug can be removed by rinsing the vagina with boiled water. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with other miconazole products. If hypersensitivity reactions or irritation occur during treatment, treatment should be discontinued. Use of the drug in children It is not recommended for use in children and adolescents under 18 years of age due to the lack of data on effectiveness and safety. Use in persons with impaired renal function: no particularities. Use in geriatric practice: no particularities.
Interaction with other drugs
If you are currently or have recently taken other medications, tell your doctor. Miconazole increases the effectiveness of indirect anticoagulants for oral administration, hypoglycemic agents, sulfonylurea derivatives, and phenytoin. Rifampicin weakens the therapeutic effect of miconazole, and their combined use should be avoided. When used simultaneously with carbamazepine, the risk of side effects increases. When used simultaneously with astemizole, cisapride, terfenadine, the risk of developing arrhythmias increases. Due to the limited systemic availability of miconazole after vaginal administration, clinically significant interactions occur very rarely. Therapeutic effects and adverse reactions of drugs metabolized by CYP2C9 (for example, oral hypoglycemic drugs and phenytoin), as well as CYP3A4 (for example, HMG-CoA reductases, such as simvastatin and lovastatin, and calcium channel blockers, such as dihydropyridines and verapamil), with co-administration with miconazole may be enhanced, so caution should be exercised.
Contraindications
Hypersensitivity to miconazole and other imidazole derivatives; severe liver dysfunction; first trimester of pregnancy; age up to 18 years, use for virgins.
Compound
1 suppository contains: active substance: miconazole nitrate 100 mg; excipients: solid fat.
Overdose
Due to the low absorption of the drug, an overdose with intravaginal use is unlikely. In case of accidental ingestion, no problems are expected. If a large amount of the drug is swallowed, gastric lavage is performed if necessary.
Adverse reactions
If side effects occur, tell your doctor. This applies to all possible side effects, including those not described in this leaflet. MedDRA frequency convention Very common (?1/10); frequent (?1/100,
Storage conditions
Store in a dry place, protected from light, at a temperature not exceeding 25 °C. Do not freeze.
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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Mycozolon, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Mikozolon is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!
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Miconazole cream 20mg/g 15g No.1
Name
Miconazole cream dnar.approx. 20 mg in tubes 15 g in pack No. 1
Description
The cream is white in color and has a uniform consistency.
Main active ingredient
Miconazole
Release form
cream for external use
Dosage
2% 15 g
pharmachologic effect
Pharmacodynamics
Miconazole is an antifungal agent from the group of imidazole derivatives, active against most pathogenic fungi and yeasts. The mechanism of action is associated with a change in the permeability of cell membranes due to the suppression of ergosterol biosynthesis, changes in the lipid composition of membranes, and an inhibitory effect on the activity of oxidases and peroxidases. The accumulation of ergosterol precursors and toxic peroxides leads to the death of the fungal cell. The clinical effectiveness of miconazole has been demonstrated against the following species: Dermatophytes, Candida spp., Dimorphic fungi, Aspergillus spp., Cryptococcus neoformans, Pityrosporum spp., Torulopsis glabrata. Miconazole also has antibacterial activity against some gram-positive bacteria.
Pharmacokinetics
After topical application, miconazole is almost not subject to systemic absorption. The small amount that is absorbed (less than 1%) binds to plasma proteins (88.2%) and red blood cells (10.6%). It is excreted from the body mainly through the intestines unchanged and in the form of metabolites.
Indications for use
Fungal infections of the skin and nails caused by dermatophytes or yeasts sensitive to miconazole. Superinfections caused by gram-positive bacteria.
Directions for use and doses
The cream is lightly rubbed into the affected areas of the skin 2 times a day, morning and evening. Depending on the location and severity of the process, the duration of treatment varies from 2 to 6 weeks. In order to prevent relapses, the use of the drug must be continued for at least 1 week after the disappearance of clinical symptoms of the disease. During therapy, mycological control is carried out, the results of which determine the duration of treatment. When treating onychomycosis, after preliminary detachment of the affected nail plate, the cream is applied to the nail bed 1-2 times a day. Treatment is carried out continuously and continues for at least 10 days after the disappearance of clinical symptoms. With caution: For children under 3 years of age, the cream is prescribed under the supervision of a doctor.
Use during pregnancy and lactation
Pregnancy In animals, miconazole nitrate does not exhibit teratogenic effects, but is fetotoxic when taken orally in high doses. Only a small amount of miconazole nitrate is absorbed when applied topically. However, like other imidazoles, miconazole nitrate should be used with caution during pregnancy. Lactation When administered topically, miconazole is minimally absorbed into the systemic circulation, and it is unknown whether miconazole passes into breast milk. Caution should be exercised when using topical miconazole during lactation. The medicine should not be applied to the mammary glands during breastfeeding.
Precautionary measures
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with topical miconazole. If hypersensitivity reactions occur during treatment, the drug must be discontinued. Do not allow the cream to get into your eyes. The cream should not be applied to open wounds. If your nails are affected, you should trim them as short as possible. If the feet are affected, carefully treat the spaces between the toes. The drug contains propylene glycol and cetostearyl alcohol, and therefore may cause skin irritation and local skin reactions (for example, contact dermatitis).
Interaction with other drugs
Miconazole is an inhibitor of cytochrome CYP3A4/2C9. Due to limited systemic availability when administered topically, clinically significant interactions are unlikely. However, in patients receiving oral anticoagulants (eg, warfarin), caution should be exercised and the anticoagulant effect monitored. When used simultaneously with miconazole, oral hypoglycemic agents and phenytoin may increase the effects, including undesirable ones. It is not recommended to use simultaneously with other ointments or creams.
Contraindications
Hypersensitivity to miconazole or to any of the auxiliary components of the drug.
Compound
Each tube (15 g) contains: active ingredient: miconazole nitrate – 0.3 g; excipients: propylene glycol, macrogol 400, cetostearyl alcohol, emuxol 268 grade A, macrogol cetostearyl ether.
Overdose
Excessive topical application of the cream may cause skin irritation, which usually disappears after discontinuation of use. The cream is intended for external use. If a large amount of cream is accidentally ingested, an appropriate gastric emptying method may be used if necessary.
Side effect
The following adverse reactions may develop: From the immune system: hypersensitivity reactions, including anaphylactic reactions, angioedema. From the skin and subcutaneous tissue: rash, itching, erythema, urticaria, skin inflammation, contact dermatitis, skin hypopigmentation, reactions at the application site, including skin irritation, hyperemia, burning.
Storage conditions
At a temperature not higher than 25 °C. Keep out of the reach of children.
