Akriderm ointment for external use 0.05%, 15g

Composition

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of 100 g of ointment contains:

Active ingredient:  

betamethasone dipropionate in terms of 100% substance – 0.064 g, which is equivalent to 0.05 g of betamethasone;

excipients:  

propyl parahydroxybenzoate-0.05 g,

liquid paraffin (vaseline oil) – 4 g,

isopropyl myristate-1 g,

petrolatum – up to 100 g.

Pharmacological action

Pharmacodynamics

Akriderm® is a glucocorticosteroid for external use. It has anti-inflammatory, anti-allergic, antiexudative, vasoconstrictor, antipruritic and antiproliferative effects. It inhibits the accumulation of white blood cells, the release of lysosomal enzymes and pro-inflammatory mediators in the inflammatory focus, inhibits phagocytosis, reduces vascular-tissue permeability, and prevents the formation of inflammatory edema.

When applied to the surface of the skin, the drug has a rapid and strong effect in the focus of inflammation, reducing the severity of objective symptoms (erythema, edema, lichenification) and subjective sensations (itching, irritation, pain).

Pharmacokinetics

When the drug is applied on the skin in therapeutic doses, the transdermal absorption of the Active ingredient into the blood is very insignificant. The use of occlusive dressings, inflammation and skin diseases increase the transdermal absorption of betamethasone, which may lead to an increased risk of systemic side effects.

Indications

Skin diseases amenable to glucocorticosteroid therapy:

Use during pregnancy and lactation

The safety of external use of glucocorticosteroids in pregnant women has not been established; the use of drugs of this group during pregnancy is justified only if the potential benefit to the mother exceeds the possible risk to the fetus. During pregnancy, drugs of this group should not be used in high doses or for a long time. If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.

Contraindications

Hypersensitivity to betamethasone or other components of the drug. Tuberculosis of the skin, skin manifestations of syphilis, bacterial, fungal, viral (chickenpox, herpes simplex) skin diseases, skin post-vaccination reactions, open wounds, trophic ulcers of the lower leg, rosacea, vulgar utrs, skin cancer, nevus, atheroma, melanoma, hemangioma, xanthoma, sarcoma, lactation and children under 1 year of age. Use with caution for long-term use or application on large surfaces: cataracts, diabetes mellitus, glaucoma, tuberculosis.

Side effects

As a rule, it is weakly expressed. With external use of glucocorticosteroids, the following may occur: itching, burning, irritation, dry skin, folliculitis, hypertrichosis, striae, acne-like rashes (“steroid” acne), hypopigmentation, perioral dermatitis, allergic contact dermatitis. With prolonged use, as well as the use of occlusive dressings -maceration of the skin, secondary infection, skin atrophy, local hirsutism, telangiectasia, sweating, purpura. When applied to large areas of the body, mainly in children, systemic side effects of glucocorticosteroids may occur (hyperglycemia, glucosuria, reversible suppression of the adrenal cortex, manifestation of Itsenko – Cushing syndrome). If you experience side effects that are not described in the instructions, you should consult a doctor.

Interaction

There were no clinically significant interactions with other drugs.

How to take, course of use and dosage

Externally. Akriderm ® ointment is applied in a thin layer to the affected area of the skin 2 times a day-in the morning and in the evening, lightly rubbing. On areas with denser skin (for example, elbows, palms and feet), as well as places from which the drug is easily erased, Akriderm ointment can be applied more often. The duration of treatment depends on the effectiveness and tolerability of the therapy and is usually no more than 4 weeks. Repeated therapy is possible throughout the year. If clinical improvement does not occur, the diagnosis should be clarified. In children and patients with facial skin lesions, the course of treatment should not exceed 5 days.

Overdose

Acute overdose is unlikely, however, with excessive or prolonged use of the drug, a chronic overdose is possible, accompanied by signs of hypercorticism: hyperglycemia, glucosuria, reversible suppression of the adrenal cortex, manifestation of Itsenko-Cushing syndrome. Treatment:  it is recommended to gradually cancel the drug and, if necessary, conduct symptomatic treatment.

Special instructions

If there is no effect from treatment within two weeks, it is recommended to consult your doctor for possible clarification of the diagnosis. If irritation or hypersensitivity reaction is noted during the use of the drug, treatment should be discontinued and consult your doctor. In case of secondary fungal or bacterial infection, appropriate medications should be used. In the absence of a rapid positive effect, the use of Akriderm should be discontinued until all signs of infection are eliminated.

Long-term use of the drug on the skin of the face is not recommended. Do not use Akriderm in the eye area, because in this case, cataracts, glaucoma, fungal infection and exacerbation of herpes infection may develop.

Use in pediatrics

Children may be more susceptible to the use of topical corticosteroids that cause hypothalamic-pituitary-adrenal system (HPA) depression than older patients, due to increased drug absorption associated with a greater ratio of their surface area to body weight. The following side effects were observed in children taking local corticosteroids: suppression of the HPA system function, Cushing’s syndrome, linear growth retardation, lag in weight gain, increased intracranial pressure.

Symptoms of adrenal cortical suppression in children include a decrease in plasma cortisol levels and a lack of response to ACTH stimulation. An increase in intracranial pressure is manifested by a bulging fontanel, headache, and bilateral edema of the optic nerve disc.

Form of production

Ointment for external use

Storage conditions

The drug should be stored out of the reach of children at a temperature of 15 to 25°C.

Shelf

life is 2 years.

Active ingredient

Betamethasone

Dosage form

ointment

Description

Pregnant women as prescribed by a doctor, For adults, Children over 12 years of age

Indications

Neurodermatitis, Dermatitis, Eczema, Allergies, Psoriasis, Dermatosis