Hydrocortisone-pos®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HYDROCORTISON-POS® (HYDROCORTISON-POS®)

Composition:

Active substance: hydrocortisone acetate;

1 g of ointment contains 10 mg or 25 mg of hydrocortisone acetate;

Excipients: white soft paraffin, mineral oil, lanolin.

Pharmaceutical form. Eye ointment.

Main physicochemical properties: a homogeneous yellowish-white ointment of soft consistency (in the form of a suspension), free from lumps and streaks.

Pharmacotherapeutic group. Medicinal products used in ophthalmology. Anti-inflammatory agents. Corticosteroids. ATC code S01B A02.

Pharmacological properties.

Pharmacodynamics

The mechanism of action of corticosteroids has not yet been fully elucidated. It is likely that corticosteroids interact with protein receptors in the cytoplasm of sensitive cells, forming a steroid-receptor complex. After appropriate conformational changes, the steroid-receptor complex enters the nucleus, where it affects the cell's genetic apparatus in such a way as to inhibit the synthesis of certain proteins responsible for chemotaxis and immune responses. In addition, inflammatory and allergic reactions are suppressed due to functional changes in leukocytes and macrophages. The anti-inflammatory efficacy of hydrocortisone is due to inhibition of phospholipase A2—an enzyme required for the synthesis of arachidonic acid, which is a precursor of pro-inflammatory substances such as prostaglandins and leukotrienes. Thus, corticosteroids are effective in inflammatory processes in mesenchymal tissues caused by infections, allergens, and trauma.

Pharmacokinetics

The extent of penetration of hydrocortisone acetate, which largely depends on the condition of the cornea, significantly increases during inflammation or damage to ocular mucous membranes.

Hydrocortisone is absorbed by aqueous humor, cornea, iris, choroid, ciliary body, and retina. Systemic absorption occurs, but it is likely to have clinical significance only with high-dose administration or prolonged treatment in children.

The plasma half-life of hydrocortisone is approximately 90 minutes. Inactivation occurs primarily in the liver. Over 90% of hydrocortisone is excreted by the kidneys as glucuronide. Only about 0.5% of the dose can be found in urine as free cortisol. Approximately 90% of hydrocortisone is bound to plasma proteins, of which about 75% bind to specific transport proteins.

Clinical characteristics.

Indications.

Hormonal treatment of allergic, non-infectious inflammatory diseases of the conjunctiva, cornea, anterior segment of the eye, as well as eyelids (e.g., blepharitis).

Contraindications.

• Hypersensitivity to the active substance or to any of the excipients of the medicinal product;
• epithelial herpetic keratitis or other viral eye diseases;
• bacterial eye infections;
• corneal wounds and ulcerative lesions;
• open-angle and closed-angle glaucoma;
• ocular tuberculosis or fungal eye infections.

Interaction with other medicinal products and other forms of interaction.

Specific studies on drug interactions of the medicinal product have not been conducted.

Concomitant use with other agents that may increase intraocular pressure (e.g., atropine or other anticholinergic agents) may lead to additional elevation of intraocular pressure in patients predisposed to such effects.

When using the medicinal product together with other topical ophthalmic agents, a 15-minute interval should be maintained between administrations, and hydrocortisone acetate ointment should be applied last.

Special precautions for use

Contact lenses must not be worn during treatment with this medicinal product.

Intraocular pressure should be monitored regularly during treatment. Since the use of this product in existing bacterial, viral, or fungal eye infections may worsen the course of such infections, the cornea and lens of the patient should be closely observed when this product is used under such conditions.

Lanolin, an ingredient of this product, may cause local irritation (e.g., contact dermatitis).

Infants born to mothers who used hydrocortisone acetate ophthalmic ointment during pregnancy should be carefully evaluated for adrenal insufficiency (hypoadrenalism).

Visual disturbances may occur during treatment with systemic or topical corticosteroids. If a patient experiences symptoms such as blurred vision or other visual disturbances, they should be referred to an ophthalmologist to determine possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSC), which has been reported following the use of systemic or topical corticosteroid preparations.

Use during pregnancy or breastfeeding

Pregnancy

Since significant amounts of the active substance may be absorbed into the systemic circulation following application of hydrocortisone acetate ophthalmic ointment, use of this product during pregnancy should be avoided. If use of hydrocortisone acetate ophthalmic ointment is absolutely necessary during pregnancy, treatment should be conducted for the shortest possible duration and with the lowest effective doses.

Prolonged use of corticosteroids during pregnancy may result in intrauterine growth retardation. Animal studies have shown that corticosteroids can cause congenital cleft palate. Whether maternal corticosteroid treatment during the first trimester increases the risk of cleft palate in humans is still under investigation. Based on epidemiological and animal studies, a possible association between intrauterine exposure to corticosteroids and the later development of metabolic and cardiovascular disorders in adulthood is being discussed. Administration of corticosteroids near the end of pregnancy may lead to adrenal atrophy in the fetus, which may require replacement therapy with gradual dose tapering.

Breastfeeding

Corticosteroids may pass into breast milk. Adverse effects in infants have not been reported to date. Nevertheless, this product should be used during breastfeeding only if clearly needed. Breastfeeding should be discontinued if higher doses of the product are required for treatment.

Fertility

There is currently no information indicating adverse effects of this product on fertility.

Ability to affect performance of skills such as driving vehicles or operating machinery

Following application of hydrocortisone acetate ophthalmic ointment, vision may be temporarily impaired due to the formation of an ointment film on the cornea, resulting in reduced reaction speed when driving a vehicle or operating machinery.

Method of Administration and Dosage.

A strip of ointment approximately 1 cm in length should be instilled into the conjunctival sac of the affected eye or applied to the affected eyelid 2–3 times daily. After achieving the desired effect, 1–2 applications per day are sufficient.

The usual duration of treatment should not exceed 2 weeks. Depending on the clinical picture, the efficacy of treatment, intraocular pressure, and corneal condition should be monitored periodically to determine the need for extending or modifying therapy.

When applying the ophthalmic ointment, care should be taken to avoid contact between the tube tip and the eye or skin.

Contact lenses should be removed before applying the medication, and should not be worn during the course of treatment.

Children.

Experience with the use of the drug for treatment in children is lacking.

Overdose.

When used appropriately, overdose or intoxication is not expected. No cases of overdose with hydrocortisone-containing preparations have been reported to date. Therefore, information regarding specific symptoms of overdose and its treatment is unavailable.

Adverse Reactions

The following terminology is used to classify the frequency of adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).

Immune system disorders

Rare: Allergic reactions, including contact dermatitis, dermatoconjunctivitis, and eyelid eczema.

Eye disorders

Uncommon: In some patients sensitive to corticosteroids, prolonged treatment with ophthalmic corticosteroid preparations without regular monitoring of intraocular pressure may lead to increased intraocular pressure, resulting in optic nerve damage, decreased visual acuity, or visual field constriction.

Rare: Exophthalmos, cataract, development of additional ocular infections (e.g., viral, fungal, or bacterial infections), stinging, burning, oozing blisters after surgical cataract removal, corneal trophic lesions.

Frequency not known: With topical application of corticosteroids in conditions leading to thinning of the cornea or sclera, cases of perforation may occur. There is evidence of delayed wound healing, ptosis, mydriasis, and blurred vision (see section "Special precautions for use").

In certain viral infections (Herpes simplex), corticosteroid treatment requires strict medical supervision with frequent slit-lamp examinations. Concomitant use of hydrocortisone acetate ophthalmic ointment may mask acute bacterial, viral, and fungal infections of the cornea. Since fungal corneal infections often develop during prolonged corticosteroid therapy, particularly in the presence of pre-existing corneal defects and after completion of therapy, the possibility of such infections should be considered.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Use no more than 4 weeks after first opening of the tube.

Storage conditions.

Store at a temperature not exceeding 25°C.

Keep out of the reach of children.

Packaging.

2.5 g of ophthalmic ointment in an aluminum tube with a polyethylene tip and cap.

One tube per cardboard box.

Prescription status. Prescription only.

Manufacturer. URSAPHARM Arzneimittel GmbH / URSAPHARM Arzneimittel GmbH.

Manufacturer's address and place of business.

Industriestrasse 35, 66129 Saarbrucken, Germany.