Sinaflan (fluocinolone acetonide) ointment 0.025% 10 g. tube

Description

Sinaflan (fluocinolone acetonide) ointment 0.025% 10 g. tube

Composition

active ingredient: fluocinoloni acetonidum;

1 g of ointment contains: fluocinolone acetonide 0.25 mg;

excipients: benzyl alcohol, propylene glycol, white soft paraffin, lanolin, ceresin.

Dosage form

Ointment.

Basic physical and chemical properties: ointment from light yellow to yellow. The ointment must be homogeneous.

Pharmacological group

Corticosteroids for dermatology.
Code ATX D07A С04.

Pharmacological properties

This pharmaceutical product belongs to the group of corticosteroids used in dermatological practice.
The main active ingredient is fluocinolone. Designed for local external use.
Fluocinolone acetonide is a highly effective synthetic glucocorticosteroid.
If the drug is used in the form of an ointment, it produces a powerful anti-inflammatory, antiallergic, and vasoconstrictor effect.
Possesses lipophilic properties, quickly penetrating through the dermis and absorbed underneath.
Already after applying 2 g of ointment, it can reduce the production of adrenocorticotropic hormone (ACTH) in the pituitary gland, since the drug helps to suppress the functions of the adrenal glands, which are controlled by hormones produced by the pituitary gland.
At the same time, despite the significant accumulation under the skin, the drug does not have the property of being metabolized in the skin.

Indications

This drug Sinaflan ointment is used for the short-term treatment of acute or severe non-infectious inflammatory skin diseases that are not accompanied by abundant fluid secretion (exudation), but are accompanied by itching or hyperkeratosis.
In particular, it is applied when:

• seborrheic dermatitis;
• atopic dermatitis;
• nodular or papular urticaria;
• allergic contact dermatitis;
• erythema multiforme;
• tuberculous lupus;
• psoriasis, lichen planus.

Contraindications

The drug Sinaflan ointment in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components.
It is not used for skin infections, both viral and bacterial diseases caused by various pathogens, including:

• syphilis, skin tuberculosis, pyoderma, herpes, chickenpox;
• actinomycosis, blastomycosis, sporotrichosis, diaper dermatitis;
• anogenital itching, nevus;
• atheroma, hemangioma, xanthoma, skin neoplasms, wounds and ulcerative skin lesions;
• acne.

Application during pregnancy and lactation

This drug is contraindicated for use in the treatment of pregnant women, since no experiments and studies have been carried out that could confirm the safety of this drug for this type of patient.
If it is necessary to administer the drug during breastfeeding, then during treatment, lactation should be suspended.

Method of administration and dosage

This drug Sinaflan ointment is recommended for topical use.
The ointment is applied in a thin layer to the affected skin 1 to 2 times a day. Do not cover with an occlusive dressing, except for psoriasis. In the latter case, the dressing should be changed daily.
The duration of treatment should not exceed 2 weeks.
Treatment should not be carried out continuously for longer than 2 weeks (on the face – 1 week).
For seven days, you should not apply more than 15 grams over the entire period.
If necessary, it can be used in the treatment of children from 2 years of age. In this case, the ointment is applied in the thinnest possible layer and no more than 1 time per day.
The drug is not applied to children’s skin.
The drug is canceled by gradually reducing the amount of ointment applied.
Elderly patients, as well as patients with liver and kidney disease, do not need dosage adjustment.

Overdose

Overdose cases are extremely rare and can occur only with prolonged ingestion in excessive quantities.
In this case, symptoms such as:

• burning of the skin at the site of application of the drug, itching;
• glucosuria, edema;
• arterial hypertension;
• decrease in the body’s resistance to infections;
• hyperglycemia, Itsenko-Cushing’s syndrome.

In case of overdose, symptomatic treatment with supportive therapy should be undertaken. Cancellation of the drug should be gradual.

Side effects

The drug rarely causes side effects and is well tolerated.
The following side effects are possible, such as:

• acne on the skin, purpura, inhibition of epidermal growth;
• burning sensation on the skin, rash, atrophy of the subcutaneous tissue / skin, dry skin;
• increased body hair growth, alopecia;
• skin dipigmentation / hyperpigmentation;
• violation of the integrity of the skin, allergic dermatitis;
• cataracts, glaucoma (when applied to the skin of the eyelids);
• edema, arterial hypertension, decreased resistance to infections (can develop when applying an occlusive dressing);
• secondary immunodeficiency, gastritis, stomach ulcer;
• hyperglycemia, glucosuria;
• adrenal insufficiency, growth inhibition in children;
• Cushing’s syndrome.