Тетрадерм

Uses

Dexpanthenol is used for-

• For prevention and treatment of diaper rash in infants.
• For prevention and treatment of cracked or sore nipples in nursing women.
• For prevention and treatment of chafed, cracked or split skin.
• For treatment of light skin wounds and dry skin

Econazole Cream: All fungal skin infections due to dermatophytes, yeasts, moulds and other fungi. These include Vulvo-vaginal candidiasis, Candidial napkin rash, and other candidial infection, Ringworm (tinea) infections, Athlete's foot, Paronychia, Pityriasis versicolor and Balanitis.

Econazole-G Cream: Vulvo-vaginal candidiasis or any other fungal infection of vagina.

Econazole VT: Vulvo-vaginal candidiasis or any other fungal infection of vagina.

For the treatment of onychomycosis, local therapy with Econazole cream, combined with an oral antimycotic, is recommended.

Mometasone furoate is a corticosteroid used to treat asthma, allergic rhinitis, nasal congestion, nasal polyps, dermatitis, and pruritus.

There are 3 formulations of mometasone furoate with various indications. The inhaler is indicated for prophylaxis of asthma in patients ≥4 years. The nasal spray is indicated for treating nasal symptoms of allergic rhinitis in patients ≥2 years, treating symptoms of nasal congestion from seasonal allergic rhinitis in patients ≥2 years, treating nasal polyps in patients ≥18 years, and prophylaxis of seasonal allergic rhinitis in patients ≥12 years. The ointment is indicated for symptomatic treatment of dermatitis and pruritis in patients ≥2 years.

Тетрадерм is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Bursitis, Canker Sore, Contusions, Dermabrasion, Diaper Rash, Dry Skin, Edema, Hoarseness, Inflammation, Inflammation of Mouth, Insect Bites, Lateral Epicondylitis, Lesions of the Mucous Membranes, Nasal Congestion, Pharyngeal inflammation, Pruritus, Respiratory Tract Infections (RTI), Seasonal Allergic Rhinitis, Sinusitis, Skin Roughness, Sore Throat, Sunburn, Tendinitis, Tooth Extraction Site Healing, Traumatic Injuries caused by Dental Prosthesis, Urticaria, Vitamin Deficiency, Wounds caused by Surgery, Oral of the Tonsils, Dry, cracked skin, Dryness of the nose, Superficial Conjunctival injuries, Superficial Corneal injuries, Superficial Traumatic Injuries of the Nasal Mucosa, Superficial Wounds, Irrigation therapy, Nutritional supplementation, Oropharyngeal antisepsis, Vitamin supplementationAllergy Skin, Balanitis candida, Dermatitis, Fungal infectious disorders of the Beard, Fungal skin infection, Herpes Zoster, Intertrigo, Mycotic Eczema, Pityriasis versicolor, Ringworm, Skin candida, Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea pedis of the interdigital, Vulvovaginal mycotic infection, Cutaneous candidiasis, Cutaneous dermatophyte infectionAllergic Rhinitis (AR), Asthma, Dermatitis, Dermatitis, Eczematous caused by superficial Fungal skin infection, Moderate to Severe Plaque Psoriasis, Polyps, Nasal, Pruritus, Psoriasis, Psoriasis, Moderate to Severe, Seasonal Allergies, Skin Diseases, Eczematous, Skin Infections

How Тетрадерм works

Dexpanthenol is an alcohol derivative of pantothenic acid, a component of the B complex vitamins and an essential component of a normally functioning epithelium. Dexpanthenol is enzymatically cleaved to form pantothenic acid, which is an essential component of Coenzyme A, which acts as a cofactor in many enzymatic reactions that are important for protein metabolism in the epithelium.

Dermatological effects of the topical use of dexpanthenol include increased fibroblast proliferation and accelerated re-epithelialization in wound healing. Furthermore, it acts as a topical protectant, moisturizer, and has demonstrated anti-inflammatory properties .

Econazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Econazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis.

In asthma, mometasone is believed to inhibit mast cells, eosinophils, basophils, and lymphocytes. There is also evidence of inhibition of histamine, leukotrienes, and cytokines.

Corticosteroids diffuse across cell membranes into the cytosol of cells where they bind to glucocorticoid receptors to produce their activity. Mometasone furoate has a particularly high receptor affinity compare to other corticosteroids, 22 times higher than that of dexamethasone. Mometasone furoate binding to a glucocorticoid receptor causes conformational changes in the receptor, separation from chaperones, and the receptor moves to the nucleus. Once at the nucleus, receptors dimerize and bind to a DNA sequence known as the glucocorticoid response element which either increases expression of anti-inflammatory molecules or inhibits expression of pro-inflammatory molecules (such as interleukins 4 and 5). Mometasone furoate also reduces inflammation by blocking transcription factors such as activator-protein-1 and nuclear factor kappa B (NF-kappaB).

Dosage

Тетрадерм dosage

Check with the doctor or pharmacist if you are unsure how to use Dexpanthenol.

The usual dosage is generally:

• Diaper rash: Apply a thin layer on the baby’s bottom at every diaper change.
• Nipples: Apply a thin layer on the nipples after each nursing session. Wash the nipples thoroughly before the next nursing session.
• Dry/cracked skin or light wounds and chafed skin: Apply to the dry areas and/or to the wound up to 3 times a day.

Econazole Cream is applied to the affected skin areas once or twice daily, in the morning and/or in the evening and gently rubbed in with the clean finger.

For mycoses of the hands, application is recommended following each washing of the hands. For the treatment of onychomycosis, occlusive dressings are recommended.

Econazole-G Cream is applied with the applicator par vaginally once or twice daily.

Econazole VT is applied with the applicator par vaginally one tablet once or twice daily.

In order to prevent relapse, treatment should be continued for 2 weeks after clinical cure.

Side Effects

As with any medicine, use of Dexpanthenol may cause side effects in some users. Do not be alarmed by the list of side effects. You may not suffer from any of them. Discontinue use and refer to a doctor immediately in the event of: Allergic reaction and/or allergic skin reaction such as: atopic dermatitis, allergic dermatitis, pruritus, redness, rash, eczema, urticaria, local irritation or blistering. If a side effect occurs, worsens, or if you suffer from a side effect not mentioned in this leaflet, consult with the doctor.

Rarely, transient local mild irritation, itching & redness may occur immediately after application. Econazole has minimal allergic effect. It is well tolerated, even by delicate skin. Local irritations are not likely to occur, except in rare cases, e.g., in eczematous skin areas. In such cases, anti-eczematous treatment is recommended for several days before therapy with Econazole is initiated.

Toxicity

Mouse LD50 : 9gm/kg (Intraperitoneal) Mouse: LD50 7gm/kg (Intravenous) Mouse: LD50 15gm/kg (Oral) Rabbit LD50 4gm/kg (Oral)

Overdosage of econazole in humans has not been reported to date. In mice, rats guinea pigs and dogs, the oral LD 50 values were found to be 462, 668, 272, and > 160 mg/kg, respectively.

Overdose with a mometasone furoate inhaler may occur with chronic overuse. Symptoms of chronic overuse may present as hypercorticism and adrenal suppression, and patients may not require any more treatment than monitoring.

In animal studies of pregnancy, some fetal toxic effects were seen at or above the maximum recommended human dose, though rodents are more sensitive to these effects than humans. The benefits and risks of use should be considered in pregnant patients

It is unknown if mometasone furoate is excreted in breast milk but other corticosteroids are and therefore caution should be exercised when administering to nursing mothers.

Safety and effectiveness in pediatric populations has been established through clinical trials, though there may be a reduction in expected growth of about 1cm per year depending on the dose and duration of treatment. Pediatric patients should be titrated to the lowest effective dose for mometasone furoate inhalers.

A trial of geriatric patients showed no difference in safety or efficacy compared to younger patients, however patients of an even greater age may still be more sensitive to mometasone furoate.

The use of a mometasone furoate inhaler in moderate or severe hepatic impairment rarely leads to detectable plasma concentrations though caution may be prudent with increasing degrees of severity.

The effects of mometasone furoate in renal impairment, and across gender and race have not been studied.

Precaution

Hypersensitivity has rarely been recorded. If something like this occur, administration of the product should be discontinued. The infected area should be kept clean and dry during treatment.

Interaction

Although not studied, based on the chemical similarity of enconazole with other imidazole compounds, a theoretical potential for competitive interaction with compounds metabolized by CYP3A4/2C9 exists. Due to the limited systemic availability after vaginal application (see Pharmacokinetics under Actions), clinically relevant interactions are unlikely to occur, in patients on oral anticoagulants eg, warfarin and acenocoumarol, caution should be exercised and monitoring of the anticoagulant effect should be considered.

Volume of Distribution

Dexpanthenol is readily converted to pantothenic acid which is widely distributed into body tissues, mainly as coenzyme A. Highest concentrations are found in the liver, adrenal glands, heart, and kidneys.

Steady state volume of distribution of 152L.

Elimination Route

Dexpanthenol is soluble in water and alcohol, although insoluble in fats and oil based substances. With the appropriate vehicle, Dexpanthenol is easily penetrated into the skin. Rate of penetration and absorption is reduced when Dexpanthenol is administered as an oil/water formula.

After topical application to the skin of normal subjects, systemic absorption of econazole nitrate is extremely low. Although most of the applied drug remains on the skin surface, drug concentrations were found in the stratum corneum which, by far, exceeded the minimum inhibitory concentration for dermatophytes.

Half Life

Half life have not been reported

The terminal half life of an inhaled dose is approximately 5 hours though it has been reported as 5.8 hours by other sources.

Clearance

The clearance rate of mometasone furoate is not readily available, though it may be close to 90L/h.

Elimination Route

Milk of nursing mothers receiving a normal diet contains about 2 ug of pantothenic acid per mL. About 70% of an oral dose of pantothenic acid is excreted unchanged in urine and about 30% in feces.

For an inhaled dose, approximately 74% is excreted in the feces and 8% is excreted in the urine.

Pregnancy & Breastfeeding use

During pregnancy: There is no information of any abnormality or adverse event in neonates while Econazole Cream / VT had been used during pregnancy.

During lactation: As the systemic absorption of Econazole Nitrate cream is extremely low after topical/vaginal use, excretion in breast milk is likely to be negligible. So, it can be used topically/vaginally during lactation if needed.

Contraindication

Hypersensitivity to any component of Econazole.

Acute Overdose

Econazole Cream / VT is intended for topical and vaginal use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered desirable.

Storage Condition

Do not store above 30 degree Celsius. Keep away from light and out of the reach of children.

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