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Дактарин

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Дактарин

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Treatment option: Pregnancy, Infection, Candidiasis,Vaginal

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Дактарин

Property Description
Active ingredient Miconazole Nitrate
Form Cream, Powder, Lotion, Gel, Tincture, Suppository
Pharmacological class Azole Antifungal (Imidazole derivative)
Common use Fungal infections and Yeast infections
Origin Synthetic

What is Дактарин and What is its Active Ingredient?

Дактарин is an Antifungal medication whose pharmacological identity is defined by its single Active ingredient, Miconazole Nitrate. The substance is chemically classified as an Azole Antifungal and specifically an Imidazole derivative. Miconazole is a synthetic compound, manufactured to specifically target microbial structures. The medication has been clinically recognized for its role in treating superficial mycotic conditions.

What Type of Drug is Miconazole Nitrate?

Miconazole Nitrate functions as a broad-spectrum antimycotic agent with efficacy against various fungi and yeasts. The active ingredient's versatility is reflected in the multiple Pharmaceutical Preparations available under the Дактарин name, including a Cream, Powder, Lotion, Gel, Tincture, and Suppository forms, facilitating its primary Route of administration via the Topical route. For instance, the powder form is often positioned for use in intertriginous areas, a differentiating feature that makes it suitable for moist skin folds.

What is the General Therapeutic Purpose of Daktarin?

The general purpose of Дактарин is to address the source of Fungal infections and related Yeast infections. The therapeutic goal is the elimination of the causative organisms. Miconazole Nitrate achieves this Physiological action by interfering with the synthesis of ergosterol, a molecule essential for the stability and formation of the fungal cell membrane. This mechanism prevents the fungi from sustaining growth, which is the primary way the drug clears the surface infection, such as in the typical use scenario of treating athlete's foot.

Regulatory References

  1. NIH Antifungal Ergosterol Synthesis Inhibitors

What side effects are possible with Дактарин?

Possible Side Effects and Safety Information

The officially documented adverse effects for Miconazole Nitrate formulations, such as Дактарин, are primarily localized to the site of application, consistent with its topical and intravaginal route. These effects are classified by regulatory authorities based on the affected system and reported frequency.

Adverse Reactions by System Organ Class

Adverse drug reactions are most often reported under the Skin and Subcutaneous Tissue Disorders and General Disorders and Administration Site Conditions classifications. Local reactions frequently documented include Application site irritation, Application site burning, and Application site pruritus (itching). Specific skin reactions listed are Skin burning sensation, Contact dermatitis, Rash, and Erythema.

Within the Immune System Disorders class, serious adverse reactions such as Hypersensitivity, Anaphylactic reaction, and Angioedema (swelling) are documented, typically with a frequency of Not Known based on post-marketing surveillance.

Safety Considerations and Limitations

The safety profile includes specific limitations and potential interaction patterns. Hypersensitivity to Miconazole or other imidazole derivatives is a contraindication. The regulatory text also specifies that if irritation or signs of hypersensitivity occur, treatment should be discontinued.

While systemic absorption is limited, a potential drug interaction exists with oral anticoagulants such as Warfarin. Miconazole may enhance the anticoagulant effect, which can lead to an increased risk of bleeding. Regarding specific patient groups, no different side effects are typically expected in older adults or pediatrics, though caution is advised for use during Pregnancy and Lactation.

Overdose and Emergency Response

The official regulatory documents on Miconazole Nitrate (Дактарин) define overdose based on specific exposure scenarios and drug interactions, rather than a singular systemic toxicity.

A critical risk documented with the oral gel formulation is the potential for over-anticoagulation when used simultaneously with oral anticoagulants, such as Warfarin. This interaction can lead to severe bleeding events, including those with fatal outcomes. For these symptoms—including unexplained bruising or bleeding—patients are required by regulatory authorities to seek immediate medical attention and to stop treatment without delay.

Other documented overdose presentations are linked to exposure route. Accidental massive inhalation of the talc-containing powder formulation may cause impaction blockage of airways and minor respiratory arrest, necessitating intensive supportive therapy and oxygen. For excessive topical application, the primary manifestation is localized skin irritation, which is managed by discontinuation of therapy. Accidental ingestion of large quantities of topical formulations may cause stomach irritation and requires appropriate supportive care; gastric lavage is an officially described procedure for certain liquid forms. No specific antidote is known for Miconazole toxicity.

Therapeutic Uses of Дактарин

Quick Facts

  • Addresses: Fungal infections of the skin and mucous membranes.
  • Manages: Specific conditions like vulvovaginal candidiasis and oral thrush (oropharyngeal candidiasis).
  • Supports: The treatment of certain skin mycoses, including tinea (e.g., ringworm, athlete's foot) and cutaneous candidiasis.

Дактарин (Miconazole) is a medication that is used in the management of certain fungal infections of the skin and mucous membranes. It is an agent intended to control the presence of various fungi, including Candida species and dermatophytes.

Therapeutic applications of this medicine include providing relief from symptoms associated with vulvovaginal candidiasis (yeast infection) and oral candidiasis (oral thrush) in adults. It assists in improving the condition of common skin infections, such as ringworm (tinea corporis), athlete's foot (tinea pedis), and jock itch (tinea cruris). The medicine is formulated to help resolve these types of infections by addressing the underlying fungal presence. It is frequently used as part of a regimen for dermatophytosis and cutaneous candidiasis, helping to maintain a healthy skin environment.

This treatment is a step in the overall recovery process for patients with these specific mycoses, and it may contribute to the reduction of fungal overgrowth.

Regulatory References

  1. NIH MedlinePlus guidance on Miconazole

Eligibility and Restrictions for Use

Eligibility and Contraindications for Daktarin (Miconazole Nitrate)

The official population eligibility for Daktarin is governed by absolute exclusions and specific restrictions based on age, product formulation, and the patient's co-existing medical status.

Absolute Contraindications

Use is contraindicated in any patient with a known hypersensitivity to the active ingredient, miconazole nitrate, other imidazole derivatives, or any inactive excipients in the product.

Crucially, the oral gel formulation carries strict regulatory exclusions:

  • It must not be used in infants less than four months of age or in those with an insufficiently developed swallowing reflex, due to a documented risk of choking.
  • It is contraindicated for patients concurrently taking the anticoagulant warfarin or similar oral anticoagulants, as this may lead to serious bleeding complications.
  • It is contraindicated in patients with liver dysfunction.

Age-Related and Conditional Use

Population Group Regulatory Status
Infants (< 4 Weeks) Not recommended for certain topical uses; safety and efficacy are unestablished by regulators.
Children & Adults Generally eligible for use unless specific contraindications are present.
Pregnancy Status Conditional use only; a formal risk-benefit assessment must justify the potential risk to the fetus.
Lactation Status Use requires caution, as it is unknown if the drug is excreted in human breast milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Дактарин (Miconazole Oral Gel) may interact with a variety of other medicinal products due to its ability to inhibit the CYP3A4 and CYP2C9 enzyme systems in the liver. This inhibition can significantly raise the blood concentration of co-administered drugs that are metabolized by these enzymes, potentially leading to increased effects and adverse reactions.

Contraindicated Combinations (Do not use concomitantly):

  • Warfarin and other oral anticoagulants: Concurrent use is generally contraindicated due to the high risk of enhancing the anticoagulant effect, leading to serious bleeding. Close monitoring and dose adjustment by a healthcare professional is mandatory if co-administration is unavoidable.
  • Certain HMG-CoA Reductase Inhibitors (Statins): Specifically simvastatin and lovastatin are contraindicated due to the risk of muscle toxicity (rhabdomyolysis).
  • Drugs that prolong the QT-interval: Such as terfenadine, astemizole, cisapride, and pimozide, due to the increased risk of severe cardiac arrhythmias.
  • Oral Triazolam and Midazolam (when taken orally) and Ergot Alkaloids.

Combinations Requiring Caution and Monitoring:

  • Oral Hypoglycaemics (e.g., sulfonylureas): The risk of hypoglycaemia is increased, requiring dose reduction of the antidiabetic drug.
  • Immunosuppressive agents (e.g., cyclosporine, tacrolimus, sirolimus): Increased blood levels of these drugs may occur, requiring dosage reduction and concentration monitoring.
  • Phenytoin: Miconazole can increase phenytoin levels, necessitating monitoring of both drug levels.

Mechanism of Action

Disruption of Fungal Cell Structure

The mechanism of miconazole focuses on targeting the fungus's enzyme system responsible for constructing its cell membrane. The drug directly acts as an inhibitor of the enzyme Cytochrome P450 14alpha-lanosterol demethylase (CYP51). This inhibition blocks the synthesis of ergosterol, the primary structural component of the fungal cell barrier. The resulting buildup of toxic, abnormal intermediate sterols causes the cell membrane to lose stability and become excessively permeable, initiating cellular dysfunction.

Chemical Attack via Oxidative Stress

The drug employs a secondary mechanistic effect by inhibiting the fungus's natural defense enzymes, peroxidase and catalase. This prevents the fungal cell from detoxifying its own highly toxic metabolic byproducts, known as Reactive Oxygen Species (ROS). The massive, uncontrolled accumulation of these internal toxins triggers widespread damage to the cell's lipids, proteins, and DNA, leading to internal poisoning.

Combined Fungicidal Action

The simultaneous structural failure and intracellular chemical poisoning create a dual-action mechanism. This concerted assault facilitates the destruction of the fungal organisms. This comprehensive physiological outcome is essential for the physiological effect of reducing the fungal population and shaping the drug's overall pharmacological effect.

Dosage and Administration Information

How to use Дактарин (Miconazole) Oral Gel: Administration Guidelines

Дактарин oral gel is administered by the oral route for local application within the mouth and upper gastrointestinal tract. The medicine is intended to be held in the mouth for as long as possible before swallowing to achieve maximum effect.

Age Group Dose (Four times daily) Special Instructions
Adults and Children ge 2 years 2.5 mL (Half spoon) Keep the gel in the mouth as long as possible before swallowing.
Infants (4 to 24 months) 1.25 mL (Quarter spoon) Apply the dose in smaller portions to the front of the mouth using a clean finger. Do not apply to the back of the throat.

Procedural Steps

  1. Timing: The gel must be applied after meals.
  2. Application: Measure the correct dose using the provided spoon. For all users, the gel must be kept in the mouth for an extended period before being swallowed.
  3. Infants: For infants aged 4 months to 2 years, the measured dose must be divided into smaller portions and applied with a clean finger to the affected areas in the front of the mouth. This prevents the risk of the gel obstructing the throat.
  4. Dentures: If dentures are worn, they should be removed at night and brushed with the gel.
  5. Duration: Treatment should be continued for at least one week after the visible signs of the infection have fully disappeared.

Missed Dose: If a dose is missed, it should be taken as soon as remembered. If it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular schedule resumed. Do not take a double dose to compensate for a missed dose.

Recent Clinical Evidence

Miconazole: Recent Clinical Evidence

Daktarin contains miconazole nitrate, a broad-spectrum imidazole antifungal agent primarily used for the topical treatment of superficial fungal infections, including athlete's foot (tinea pedis), ringworm (tinea corporis, tinea cruris), and various candidiasis (yeast) infections of the skin and nails.

Clinical Trial Findings

Research has explored miconazole's efficacy in managing dermatophyte and yeast infections. Early and recent double-blind clinical trials comparing topical miconazole to other established antifungal agents, such as clotrimazole, have often indicated comparable outcomes for resolving symptoms of common superficial fungal infections.

  • Duration and Success: Studies on cutaneous candidiasis and dermatophyte infections typically involve treatment periods ranging from two to six weeks. The observed success in clearing the infection is often documented by continuing treatment for at least one week after all visual signs have resolved.
  • Safety Profile: Adverse event reporting across multiple clinical trials (e.g., in a summary of 21 double-blind trials involving over 800 patients) documented the most common local reactions as skin burning sensation, irritation, or redness. These events are generally reported as uncommon and tend to be mild.

Mechanism and Future Research

While sharing a mechanism with other azoles (inhibiting ergosterol synthesis), miconazole is noted in research for also having a fungicidal action potentially linked to increased intracellular reactive oxygen species (ROS) in certain fungal organisms.

Research is ongoing into new formulations and delivery systems for miconazole, such as transethosomal gels, which are being explored for potential benefits in terms of targeted delivery and skin penetration.

Key Studies & References

  1. Novel Transethosomal Gel Containing Miconazole Nitrate; Development, Characterization, and Enhanced Antifungal Activity (Research on new formulations)

Frequently Asked Questions (FAQ)

Common questions about Дактарин (FAQ)

Q: What is Дактарин (Daktarin) used for?

Дактарин (miconazole) is an antifungal medication indicated for the treatment of various fungal skin infections, including athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). It may also be used for certain yeast infections.

Q: How does Дактарин treat fungal infections?

Miconazole works by inhibiting the synthesis of ergosterol, an essential component of the fungal cell membrane. This action disrupts the structure of the fungal cell, leading to the inhibition of growth and eventual cell death.

Q: What are the known side effects of Дактарин?

Common side effects reported for topical application include mild irritation, burning sensation, or redness at the application site. Should severe symptoms occur, discontinuation of use and consultation with a healthcare provider is recommended.

How should Дактарин be stored and disposed of?

Storage and Disposal Requirements

Official regulatory guidelines mandate specific conditions to ensure the stability and safety of Daktarin (Miconazole).

Storage Condition Requirement
Temperature Store at Controlled Room Temperature (20 C to 25 C); Do not freeze and keep away from excessive heat.
Container & Protection Keep in the original container and ensure it is tightly closed. The product must be protected from moisture and direct light.
Child Safety Keep out of the sight and reach of children as specified in the official labeling.
Disposal Do not use past the expiration date. Dispose of unused or expired medicine through an official drug take-back program. If unavailable, secure disposal involves mixing the product with an undesirable substance and discarding it in household trash, avoiding wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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