Prednitop

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PREDNI TOP®

Composition:

Active substance: prednicarbate;

1 g of ointment contains 2.5 mg of prednicarbate;

Excipients:

glycerol monooleate, octyldodecanol, white soft paraffin (stabilized with alpha-tocopherol).

Pharmaceutical form. Ointment.

Main physicochemical properties: soft, white, transparent, slightly shiny ointment.

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

ATC code D07AC18.

Pharmacological Properties

Pharmacodynamics

Prednicarbate, the active ingredient in Prednitop®, is specifically designed for topical use and is a potent glucocorticoid with pronounced anti-inflammatory, anti-allergic, anti-exudative, antiproliferative, and antipruritic effects.

The antiproliferative effect of glucocorticoids is attributed to reduced turnover rate of involved cells and decreased intensity of DNA synthesis. This results in inhibition of granulation, wound closure, and fibroblast proliferation.

The anti-allergic effect of glucocorticoids is due to their immunosuppressive action and influence on antibody- and cell-mediated hypersensitivity. The immunosuppressive effect 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 their effect on cell-mediated hypersensitivity involves decreased release of lymphokines.

The anti-inflammatory effect is partly due to interference with arachidonic acid metabolism, resulting in reduced production of inflammatory mediators (e.g., prostaglandins, leukotrienes). In addition, excessive cellular signaling is reduced to normal levels.

Results from double-blind clinical 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 fluorocortolone.

The extremely low impact of prednicarbate on collagen synthesis and fibroblast growth in human skin reflects the minimal 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 have been detected systemically. Minimal systemic availability after topical application has also been confirmed by unchanged cortisol secretion profiles.

Clinical characteristics.

Indications.

Inflammatory skin disorders requiring treatment with locally applied corticosteroids.

Prednitop®, ointment, is used for the treatment of chronic or dry skin disorders.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Not known.

Concomitant use of Prednitop®, ointment, in the genital or anal area, due to the presence of the excipient white petroleum jelly, may reduce the strength and reliability of latex condoms.

Special precautions for use

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

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

Repeated entry of small amounts of topical preparations containing corticosteroids, such as Prednitop®, ointment, into the conjunctival sac over time may 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, the patient should be referred to an ophthalmologist to determine possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported following systemic or topical use of corticosteroids.

Use during pregnancy or breastfeeding

Pregnancy

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

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 between the infant and treated skin areas. Do not apply Prednitop® to the area of the mammary glands.

Ability to influence reaction speed when driving or operating machinery

No data available.

Dosage and Administration

Apply the medication once daily as a thin layer to the 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 a longer duration should only be carried out after careful assessment of benefit versus risk. Prior to initiating repeated treatment, consult a physician.

Children

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

Overdose

No adverse effects have been observed with short-term use of elevated doses (very large amount, 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., development of skin striae, skin atrophy). In addition, typical systemic corticosteroid effects should not be ruled out.

Adverse Reactions.

During treatment with the medicinal product Prednitop®, oily ointment, a sensation of skin burning may sometimes occur.

Rarely, pruritus, folliculitis, or allergic skin reactions (e.g., redness, weeping, pustules, and burning sensation) may occur during use of the product.

During treatment with Prednitop®, undesirable adverse effects theoretically may occur that are typical of topical glucocorticoids. These include: skin atrophy with partial, prolonged (irreversible), clinically visible thinning of the skin; prolonged dilation of small superficial blood vessels of the skin (telangiectasia); visible redness of the skin (erythema); and striae on the skin (Striae distensae); rosacea-like or perioral dermatitis with or without skin atrophy. Upon abrupt discontinuation of therapy, a rebound exacerbation of prolonged symptoms (return to the previous pathological condition) is possible, impaired wound healing, and when applied around the eyes – increased risk of developing glaucoma and/or cataract (lens opacity). Due to the immunosuppressive effect of glucocorticoids, a masked or enhanced development of existing skin infections may occur, e.g., fungal, bacterial, or viral infections (e.g., herpes simplex), skin depigmentation, localized or generalized excessive hair growth (hypertrichosis).

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

After prolonged and/or very frequent use or application over large skin areas, especially under occlusive dressings, impairment of the hypothalamus–anterior pituitary–adrenal cortex regulatory system due to skin absorption should not be excluded.

Eye Disorders

Frequency unknown: central serous choroidoretinopathy (class effect), blurred vision (see also section "Special Warnings and Precautions for Use").

Reporting of suspected adverse reactions

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

Shelf life.

3 years. After opening the tube – 6 months.

Storage conditions.

Store out of the 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 & Co. KG.

Manufacturer's address and location of business activity.

Muenchener Strasse 15, Brehna, Saxony-Anhalt, 06796, Germany.