Hydrocortisonum Aflofarm – composition, action, application, precautions

Proven content

Hydrocortisonum Aflofarm is a medicinal product in the form of a cream or ointment, the active substance of which is acetate hydrocortisone. This preparation is used in dermatology, venereology and allergology as a drug with a weak local anti-inflammatory, antipruritic and antiallergic effect. Hydrocortisonum is freely available and does not require a prescription issued by a doctor. What does Hydrocortisonum Aflofarm contain and how does it work? What are the indications and contraindications for its use? What side effects can the use of this cream have? What precautions should be taken when using it?

Hydrocortisonum Aflofarm – cream characteristics

Hydrocortisonum Aflofarm is a medicinal product that belongs to a group of medicines called corticosteroids. The active substance is hydrocortisone acetate, which has anti-inflammatory, antipruritic and vasoconstrictive properties. The drug Hydrocortisonum is also recommended for patients as a continuation of treatment after completing treatment with potent glucocorticosteroids.

This product is a white cream that should be applied topically. It is sold in an aluminum tube containing 15 g of cream, placed in a cardboard box. This cream is available without a prescription and its price is non-refundable and amounts to approximately PLN 7.

Keep the drug out of the sight and reach of children, at a temperature below 25 degrees Celsius. The cream should not be frozen and should not be used after the expiry date which is stated on the tube and on the box.

The entity responsible for the production and distribution of Hydrocortisonum cream is the Polish company Aflofarm Farmacja Polska sp. Z oo, which was established on January 19, 1989.

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Composition and action of Hydrocortisonum Aflofarm cream

The active substance of Hydrocortisonum Aflofarm cream is acetate hydrocortisone (Hydrocortisoni acetas). It is a low-potency synthetic glucocorticoid that can be applied topically to the skin.

1 g of Hydrocortisonum Aflofarm cream contains 5 mg of hydrocortisone acetate. The cream excipients include: cetyl alcohol, stearyl alcohol, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, macrogol, cetostearyl ether, liquid paraffin, sorbitan stearate, white petroleum jelly and purified water.

Hydrocortisone acetate, when applied to the skin, easily penetrates into the stratum corneum, acting as an anti-inflammatory, antipruritic and vasoconstrictor. This substance is only slightly able to penetrate into the circulatory system and then it may have a general effect.

After absorption, cortisone is mainly metabolised in the liver. Increased absorption of hydrocortisone acetate occurs when an occlusive dressing is used, after applying the product to delicate skin, e.g. face and diseased areas, e.g. burns, inflammations, and long-term use.

After applying the cream to the skin, hydrocortisone acetate is distributed in the skin around the application site, and most of the absorbed hydrocortisone is bound to blood proteins. Metabolites and unchanged hydrocortisone are excreted in the urine (this applies to hydrocortisone in the systemic circulation). The biological half-life is 8-12 hours.

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Indications for use of the drug Hydrocortisonum Aflofarm

Hydrocortisonum Aflofarm is indicated for topical use in the treatment of:

1. atopic dermatitis AD (allergic eczema, urticaria);
2. erythema multiforme;
3. lichen planus with severe itching;
4. lupus erythematosus;
5. seborrheic dermatitis;
6. various forms of eczema, especially lichen eczema;
7. burns I. and II. degree (including solar);
8. soothing reactions after insect bites;
9. scalp psoriasis, long-term psoriasis;
10. scabies.

The drug Hydrocortisonum is also indicated as a continuation of treatment after the completion of treatment with potent glucocorticosteroids.

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Contraindications to the use of the drug Hydrocortisonum Aflofarm

The Hydrocortisonum Aflofarm medicinal product, despite the indications for its use, cannot always be included in the treatment. If in doubt, consult a physician who will individually assess the risk that treatment with this preparation may cause in a patient.

Primary a contraindication to the use of Hydrocortisonum is allergic (hypersensitive) to hydrocortisone acetate or any of the ingredients. In addition, this drug is contraindicated for use in cases of:

1. acne vulgaris or rosacea;
2. dermatitis around the mouth;
3. bacterial, viral, fungal, or systemic mycosis;
4. in the atrophy of the skin;
5. skin cancer or skin precancerous condition;
6. perioral dermatitis;
7. skin lesions associated with tuberculosis;
8. open wounds, damaged skin;
9. children up to 12 years of age without consulting a doctor.

Particular caution should be exercised in the case of patients with certain diseases or other circumstances that may constitute a contraindication to use or an indication for a change in the use of Hydrocortisonum.

There are also situations in which, before using this preparation, it is necessary to conduct a thorough medical history, and even carry out certain control tests.

The cream must not be used on healthy skin. The inclusion of Hydrocortisonum in treatment requires consultation with a doctor in the case of applying the cream to a large area of ​​the skin, in high doses, and also in the case of long-term treatment. Also, pregnant women, planning to become pregnant or breastfeeding, should consult a doctor before using the cream.

Corticosteroids are absorbed through the skin, therefore, when using the preparation, there is a risk of systemic side effects of hydrocortisone acetate, characteristic of corticosteroids, including suppression of the function of the adrenal cortex.

People suffering from psoriasis should be especially careful in the use of Hydrocortisonum, as it may cause relapse caused by the development of tolerance and the risk of generalized pustular psoriasis and general toxic effects caused by the disturbance of the skin’s continuity.

This cream is not recommended for long-term use by people suffering from diabetes, and people suffering from glaucoma or cataracts should avoid using the preparation on the eyelids and the skin around the eyes, as the symptoms of the disease may worsen.

If you are in doubt about the possibility of using the drug, consult your doctor or pharmacist and inform about any diseases, conditions and other important issues that may affect the way the drug works.

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Side effects after using Hydrocortisonum Aflofarm cream

Like any other Hydrocortisonum Aflofarm medicinal product, it may cause side effects that may not be experienced by every person using this medicine. After authorization of the medicinal product, it is important to report any suspected adverse reactions so that the benefit / risk balance of the medicinal product can be monitored.

The general classification of the frequency of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare ( ≥100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

The use of Hydrocortisonum cream for a period longer than 14 days, on large areas of the skin or under a dressing, and in children, may cause side effects such as:

1. skin and subcutaneous tissue disorders: atrophic dermatitis, folliculitis, contact allergy, periocular inflammation, dermatitis around the mouth, hirsutism, delayed wound and ulcer healing, petechiae (small red or purple spots on the skin), stretch marks, posteroid purpura (skin discoloration and discoloration), steroid acne, dermatitis perioralis, burning sensation, redness, excessive dryness;
2. infections and parasitic infections: bacterial, fungal and viral infections, recurrence of infection;
3. vascular disorders: superficial vasodilation, ecchymosis;
4. eye disorders: glaucoma or cataract.

Moreover, hydrocortisone acetate, which is the active ingredient of Hydrocortisonum Aflofarm, may cause systemic side effects characteristic of glucocorticosteroids. They occur, as with other side effects, when the medicinal product is used for a long time, when it is applied to a large area of ​​the skin, under an occlusive dressing, or when used in children.

These include, but are not limited to, inhibition of the hypothalamic-pituitary-adrenal axis, Cushing’s syndrome, inhibition of growth and development in children, hyperglycaemia and glucosuria.

If any of the above-mentioned symptoms occur, stop taking the drug and contact your doctor. However, if you experience any side effects not listed above, please tell your doctor or pharmacist.

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Dosage and application of Hydrocortisonum Aflofarm cream

Hydrocortisonum Aflofarm cream should always be used according to the directions provided in the package leaflet or according to the doctor’s or pharmacist’s instructions.

This drug is intended for topical use. A thin layer of cream should be applied to the affected skin, 2 or 3 times a day.

Avoid using the cream on healthy skin and large areas of the body. However, in the case of the treatment of skin lesions on the face, it cannot be used for more than 3 days.

The drug should not be used in children under 12 years of age without consulting a doctor. The patient should not use the medicinal product without consulting a doctor for more than 14 days. If the symptoms worsen or there is no improvement after 7 days of using the drug, you should contact your doctor.

The recommended doses should not be exceeded, because it does not increase the effectiveness of the drug, and may be harmful to health and life.

If you use more Hydrocortisonum Aflofarm than you should, it may disturb the growth and development of children, and suppress the hypothalamic-pituitary-adrenal axis (this is the name of the hormone-producing interdependent endocrine gland system).

Symptoms of an overdose include: increased blood sugar (hyperglycaemia), sugar in the urine (glucosuria), Cushing’s syndrome (characteristic silhouette: moon face, rounded torso and lean limbs).

If a dose is missed, treatment should be continued without increasing the next dose. Any doubts related to the use of Hydrocortisonum, should be consulted with a doctor or pharmacist.

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Warnings and precautions in the use of Hydrocortisonum Aflofarm

Despite the fact that Hydrocortisonum Aflofarm is an open-access pharmaceutical product sold without a prescription, before starting to use the drug, you should discuss with your doctor or pharmacist if:

1. you have diabetes – the drug should not be used for a long time;
2. you have glaucoma or cataracts, as the drug applied to the eyelids or the skin around the eyelids may aggravate the symptoms of your disease;
3. you have psoriasis, as topical use of corticosteroids may cause the disease to come back;
4. the patient is pregnant, suspects that she may be pregnant or is planning to have a child (the drug may be used in short-term pregnancy and in small areas only if absolutely necessary, when the benefit for the mother outweighs the potential risk to the fetus, special caution is recommended. in the first 3 months of pregnancy);
5. the patient is breastfeeding (the drug should be used with caution, short-term and on a small area of ​​the skin, there is no information whether topical corticosteroids pass into breast milk);
6. children under 12 years of age (because of a higher body surface area to body weight ratio than in adults, suppression of the hypothalamic-pituitary-adrenal axis and the occurrence of side effects characteristic of corticosteroids, including growth and development disorders) may occur more easily than in adults ).

In addition, when using Hydrocortisonum Aflofarm, the following warnings should be followed:

1. do not use large doses of the drug, on a large area of ​​the skin and for a long time;
2. if you develop a skin infection at the site of application, contact your doctor;
3. avoid contact of the drug with the eyes and mucous membranes;
4. the drug can be used on the skin of the face and the skin of the armpits and groin only when absolutely necessary, because the drug is absorbed faster in these places and there is a risk of intensification of side effects;
5. after applying the drug to the skin, do not cover the area with any dressing (especially foil or oilcloth), as this increases the absorption of the drug;
6. if there is no improvement after 7 days of using the product, contact your doctor;
7. do not use on healthy skin;
8. the medicine should not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of that month;
9. this medicine should not be disposed of via wastewater or household waste. It’s best to ask your pharmacist how to dispose of medicines you no longer use.

You should also remember about special warnings related to the presence of auxiliary substances in the composition of Hydrocortisonum cream. The first substance, propylene glycol, can cause skin irritation. Cetyl alcohol and stearyl alcohol may cause a local skin reaction (e.g. contact dermatitis). In contrast, methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible delayed reactions).

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