Prednitop

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PREDNI TOP®

Composition:

Active substance: prednicarbate;

1 g of cream contains 2.5 mg of prednicarbate;

Excipients:

stearyl alcohol, cetyl alcohol, myristyl alcohol, light mineral oil, polysorbate 60, sorbitan stearate, ethylenediaminetetraacetic acid, octyldodecanol, benzyl alcohol, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: white, opaque, slightly shiny cream.

Pharmacotherapeutic group. Corticosteroids for dermatological use. Simple corticosteroids. Potent corticosteroids (group III). Prednicarbate.

ATC code D07AC18.

Pharmacological Properties.

Pharmacodynamics.

Prednicarbate, an ingredient of the drug Prednitop®, is specifically designed for topical use and is a potent glucocorticoid with pronounced anti-inflammatory, anti-allergic, anti-exudative, anti-proliferative, and anti-pruritic effects.

The anti-proliferative effect of glucocorticoids is explained by reduced turnover of involved cells and decreased intensity of DNA synthesis. It is known that this results in suppression of granulation, wound closure, and fibroblast proliferation.

The anti-allergic effect of glucocorticoids is due to their immunosuppressive action and influence on antibody-mediated and cell-mediated hypersensitivity:

The immunosuppressive action of glucocorticoids is primarily based on reduction in number and activity of lymphocytes (T-lymphocytes, B-lymphocytes).

Their effect on antibody-mediated hypersensitivity also involves suppression of release of vasoactive substances (e.g., histamine), while on cell-mediated hypersensitivity – reduction in lymphokine release.

The anti-inflammatory effect is partly based on influence on arachidonic acid metabolism, resulting in decreased production of inflammatory mediators (e.g., prostaglandins, leukotrienes). On the other hand, excessive cellular signals are reduced to normal levels.

Results of conducted double-blind studies have shown that, from the standpoint of clinical efficacy, prednicarbate—despite being non-halogenated—is equivalent to halogenated corticosteroids such as betamethasone valerate, desoximethasone, or fluorocortisone.

The exceptionally minimal effect of prednicarbate on collagen synthesis and fibroblast growth in human skin reflects the low atrophogenic potential of the active substance. Suppression of endogenous cortisol synthesis after application over large areas of affected skin (e.g., psoriasis, neurodermatitis) has not been observed with prednicarbate.

Pharmacokinetics.

After topical application, prednicarbate is further metabolized in the skin to prednisolone-17-ethylcarbonate, which exhibits 8.3 times greater affinity for glucocorticoid receptors than prednicarbate itself. Prednisolone-17-ethylcarbonate slowly degrades to prednisolone. After application to the skin, neither prednicarbate nor its known metabolites were detected systemically. Minimal systemic availability after dermal application was also confirmed by unchanged levels of endogenous cortisol secretion.

Clinical characteristics.

Indications.

Inflammatory skin conditions requiring treatment with locally applied corticosteroids.

Prednitop®, cream, is indicated for the treatment of acute and/or exudative skin disorders.

Contraindications.

• Hypersensitivity to prednicarbate or to any other component of the product.
• Application in the area around the eyes.
• Presence of skin reactions to vaccination.
• Skin infections (including tuberculosis, syphilis), viral infections (including varicella, herpes simplex lesions).
• Perioral dermatitis, rosacea.

Interaction with other medicinal products and other forms of interaction.

Not known so far.

Concomitant use of Prednitop® cream in the genital or anal area, due to the presence of liquid paraffin as an excipient, may reduce the strength and reliability of latex condoms.

Special precautions for use.

Treatment with Prednitop® in bacterial and fungal skin infections is possible only in combination with antibacterial or antifungal agents.

Do not apply the drug to areas around the eyes. Avoid contact of the drug with eyes or mucous membranes.

Regular entry into the conjunctival sac of even small amounts of topical corticosteroid-containing preparations such as Prednitop®, cream, may over time lead to increased intraocular pressure.

Visual disturbances

Visual disturbances may occur during systemic or topical use of corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, they should be referred to an ophthalmologist to evaluate possible causes; among these, including cataract, glaucoma, or rare conditions such as central serous choroidoretinopathy, which has been reported following systemic or topical administration of corticosteroids.

Cetyl and stearyl alcohol may cause limited local skin irritation (e.g., contact dermatitis).

Use during pregnancy or breastfeeding.

Pregnancy

There are currently insufficient data on the use of Prednitop®, cream, in pregnant women. Due to the embryotoxic and teratogenic effects of glucocorticoids confirmed in animal studies following systemic administration, prednicarbate should be used during pregnancy only if clearly necessary and after careful assessment of benefit versus risk. Do not apply prednicarbate to skin areas exceeding 20% of body surface.

Breastfeeding period

There are no data on whether prednicarbate is excreted in human milk. Other glucocorticoids are known to be excreted in breast milk. Therefore, during breastfeeding, prednicarbate should not be applied over large skin areas. Avoid contact of the infant with treated skin areas. Do not apply Prednitop® to the area of the mammary glands.

Ability to influence reaction speed while driving or operating machinery.

No data available.

Method of administration and dosage.

Apply the medication once daily as a thin layer to affected skin areas and, if possible, gently rub in. If necessary, the frequency of application may be increased to twice daily.

The physician determines the time of day (morning or evening) when Prednitop® should be applied.

There is experience with treatment for up to 2 weeks. Treatment for longer periods should only be carried out after careful assessment of benefit versus risk. Prior to initiating repeated treatment, consult a physician.

Children.

Prednitop®, cream, may be used in children under 1 year of age only when urgently indicated, as the risk of systemic effects due to absorption of glucocorticoids (e.g., growth suppression) is increased. If treatment with Prednitop®, cream, cannot be avoided, its use should be limited to the smallest amount necessary to achieve therapeutic success.

Overdose.

No adverse effects have been observed following short-term use of higher-than-recommended doses (very large quantity, very large application area, or very frequent application).

With prolonged use of higher-than-recommended doses or exceeding the recommended treatment duration, local adverse effects may occur (e.g., skin striae, skin atrophy). In addition, typical systemic corticosteroid effects should not be ruled out.

Adverse Reactions

During treatment with Prednitop® cream, a sensation of skin burning may occasionally occur.

When using the medication, pruritus, folliculitis, or allergic skin reactions (e.g., redness, weeping, pustules, and burning sensation) may rarely occur.

During treatment with Prednitop®, theoretically possible adverse effects typical of topical glucocorticoids may occur. These include: skin atrophy with partial, prolonged (irreversible), clinically visible thinning of the skin; prolonged dilation of small superficial skin vessels (telangiectasia); visible skin redness (erythema); and skin striae (Striae distensae); rosacea-like or perioral dermatitis with or without skin atrophy. Sudden discontinuation of therapy may lead to recurrent exacerbation of prolonged symptoms (rebound phenomenon), impaired wound healing, and, when applied around the eyes, increased risk of developing glaucoma and/or cataract (lens opacification). Due to the immunosuppressive action of glucocorticoids, a masked or exacerbated development of existing skin infections may occur, such as fungal, bacterial, or viral infections (e.g., herpes simplex), skin depigmentation (hypopigmentation), and localized or generalized excessive hair growth (hypertrichosis).

The risk of local adverse effects increases with prolonged duration of treatment and/or with use under an occlusive dressing, as well as in areas of increased sensitivity, such as the face.

After prolonged and/or excessive use or application to large skin areas, especially under occlusive dressings, suppression of the hypothalamic–anterior pituitary–adrenal cortex regulatory system due to skin absorption should not be ruled out.

In case of hypersensitivity to cetyl and stearyl alcohol, skin irritation (contact dermatitis) may occur.

Eye Disorders

Frequency unknown: central serous chorioretinopathy (class effect), blurred vision (see also section "Special precautions for use").

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions during the post-marketing period is very important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions.

Shelf life.

3 years. After opening the tube – 6 months.

Storage conditions.

Store out of reach of children at a temperature not exceeding 25 °C.

Packaging.

Tubes of 10 g, 30 g, or 50 g, in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

mibe GmbH Arzneimittel.

Manufacturer's address and location of operations.

Muenchenstrasse 15, Breuna, Saxony-Anhalt, 06796, Germany.