Afloderm - instructions for use, dose, side effects, contraindications

Active substanceAlclomethasoneAlclomethasone

Similar drugsTo uncover

Afloderm®

ointment externally

Beluga, medicines and cosmetics. Croatia

Afloderm®

cream externally

Beluga, medicines and cosmetics. Croatia

Dosage form: & nbspointment for external use

Composition:

1 g of ointment contains:

active substance: alclomethasone dipropionate 0.500 mg;

auxiliary substances: paraffin soft white - 799,500 mg, beeswax white - 60,00 mg, propylene glycol monopalmitostearate - 20,00 mg, hexylene glycol -120,00 mg.

Description:

Homogeneous ointment from colorless to light yellow color without mechanical inclusions.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

D.07.A.B Corticosteroids are moderately active (group II)

D.07.A.B.10 Alclomethasone

Pharmacodynamics:

Glucocorticosteroid for external use from mild to moderate activity. Has anti-inflammatory, antipruritic and vasoconstrictive effect. The mechanism of anti-inflammatory action is completely unclear. It is believed that alclomethasone induces the synthesis of inhibitors of phospholipase A2 (lipocortins). As a result, the release of arachidonic acid from phospholipid membranes is reduced. This leads to inhibition of the synthesis of prostaglandins and leukotrienes (inflammatory mediators) from arachidonic acid.

Pharmacokinetics:

Absorption through the skin depends on a number of factors (including the form of the dosage form and the integrity of the skin). Inflammatory and other skin diseases can increase absorption. In healthy volunteers, within 3 hours, 3% of the alklomethasone is absorbed.

Indications:

Dermatoses and inflammatory skin diseases that react to topical therapy with glucocorticosteroid drugs (including eczema, atopic dermatitis, allergic and contact dermatitis, including phytodermatitis, psoriasis, photodermatitis and sunburn, allergic reactions to insect bites).

Afloderm® ointment is intended for the treatment of chronic and subacute dermatoses, especially with dry and flaky lesions, with infiltration, or in cases where the occlusive effect of the ointment is necessary.

Contraindications:

Hypersensitivity to alclomethasone or to any of the auxiliary components of the drug; skin tuberculosis, cutaneous manifestations of syphilis, chickenpox, viral skin infections, skin post-vaccination reactions, open wounds, trophic ulcers, rosacea, acne vulgaris; children's age (up to 6 months).

Pregnancy and lactation:

Pregnancy

The use of the drug Afloderm® ointment in pregnant women is allowed. In these cases, The application should be under the supervision of a doctor, be short and limited to small areas of the skin. Data on the teratogenic effect are absent.

Breast-feeding

It is possible to use the drug Afloderm® ointment in nursing mothers. It is necessary to observe precautions when using the drug in nursing mothers, in particular, the drug should not be applied to the skin of the breast before feeding.

Dosing and Administration:

For external use only.

Afloderm® ointment is applied evenly on the affected skin 2-3 times a day. At children and in the period of aftercare it is possible to use the drug once a day. To prevent relapse in the treatment of chronic diseases, therapy should continue for some time after the disappearance of all symptoms.

The drug Afloderm® can be used in children from the sixth month of life. It should be borne in mind that in young children, skin folds and synthetic diapers can have an effect similar to the effect of an occlusive dressing and increase the resorption of the active substance of the drug.In addition, children can have a greater degree of systemic resorption due to the relationship between skin surface and body weight, and also due to insufficient maturation of the skin. It is not recommended to apply under occlusive dressings, in places of contact of diapers and diapers with a skin. The maximum duration of treatment in children is 3 weeks. Longer use of the drug should be done only under the supervision of a doctor.

If there is no effect within 2 weeks, the diagnosis should be clarified.

With common dermatoses, along with the use of Afloderm® ointment, for the therapy of dermatoses localized in delicate and sensitive areas of skin (on the face, neck, chest, genital area), it is advisable to switch to the use preparation of Afloderm® in the form of a cream. In addition, the cream Afloderm® has cosmetic advantages - it is easily absorbed and does not leave a greasy shine.

Side effects:

Usually the drug is well tolerated. Side effects with external application of alclometasone develop rarely and are reversible.

From the skin: with a frequency of 1% - itching, burning, erythema; infrequently - folliculitis, acneiform rash, hypopigmentation, perioral dermatitis, dermatitis, secondary infection, skin atrophy, striae, sweating.

In case of development of hypersensitivity reactions or side effects, therapy should be canceled and consult a doctor!

Overdose:

Symptoms: development of systemic side effects of GCS.

Treatment: symptomatic.

Interaction:

Interactions with other drugs are unknown.

Special instructions:

Avoid contact with the eye (due to the possible development of glaucoma and cataracts), as well as open wound surfaces. If the course of the disease is complicated by the development of a secondary bacterial or fungal infection, an antibacterial or antifungal agent must be added to therapy with the drug Afloderm®.

Effect on the ability to drive transp. cf. and fur:

Data on the impact of Afloderm® on the ability to drive vehicles and mechanisms are not available.

Form release / dosage:

Ointment for external use 0,05%.

Packaging:

For 20 g and 40 g of ointment in aluminum tubes. The tube opening is protected by a membrane. The tube is closed with a polyethylene cap with a perforator for the membrane. Each tube is placed in a cardboard box together with instructions for use.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N012153 / 01

Date of registration:18.08.2010 / 20.04.2012

Expiration Date:Unlimited

The owner of the registration certificate:Beluga, medicines and cosmetics.Beluga, medicines and cosmetics. Croatia

Manufacturer: & nbsp

BELUPO, Pharmaceuticals & Cosmetics, d.d. Croatia

Representation: & nbspBeluga, medicines and cosmetics. Beluga, medicines and cosmetics. Croatia

Information update date: & nbsp20.09.2017

Illustrated instructions

Instructions

Afloderm® (Afloderm®)