HYDROCORTISONE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HYDROCORTISONE (HYDROCORTISONE)

Composition:

Active substance: hydrocortisone;

1 g of ointment contains hydrocortisone acetate 5 mg;

Excipients: methylparaben (E 218), white soft paraffin.

Pharmaceutical form. Ophthalmic ointment.

Main physicochemical properties: a white or almost white, semi-transparent, greasy, soft mass. The ointment should be homogeneous.

Pharmacotherapeutic group. Agents used in ophthalmology. Anti-inflammatory agents. Simple corticosteroids.

ATC Code: S01BA02.

Pharmacological properties.

Pharmacodynamics.

The mechanism of action of corticosteroids has not yet been fully elucidated. It is believed 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, resulting in inhibition of the synthesis of certain proteins responsible for chemotaxis and immune responses. In addition, due to functional changes in leukocytes and macrophages, inflammatory and allergic reactions are suppressed. The anti-inflammatory efficacy of hydrocortisone is due to inhibition of phospholipase A2—an enzyme essential for the synthesis of arachidonic acid, which is a precursor of pro-inflammatory mediators such as prostaglandins and leukotrienes. Thus, corticosteroids are effective in inflammatory processes affecting 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, increases significantly during inflammation or damage to the ocular mucous membranes.

Clinical characteristics.

Indications.

• Allergic conjunctivitis;
• acute and chronic iritis, iridocyclitis, uveitis, choroidoretinitis;
• sympathetic ophthalmia, postoperative irritations;
• restoration of corneal transparency after keratitis, (chemical) burns;
• suppression of neovascularization.

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.

Vaccination against smallpox and other forms of immunization are not recommended during treatment with hydrocortisone due to lack of immune response. Increased systemic absorption of hydrocortisone may reduce the activity of insulin, as well as oral hypoglycemic and antihypertensive agents; anticoagulants and drugs that decrease salicylate levels in the blood, particularly in cases of incorrect or prolonged use. The risk of adverse reactions is higher when used concomitantly with oral contraceptives, anabolic steroids, neuroleptic drugs, cholinergic receptor inhibitors, antihistamines, tricyclic antidepressants, nitrates, and cardiac glycosides. Due to mutual inactivation, the drug must not be used in combination with medicinal products containing lead or silver.

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 predisposed patients.

Concomitant use with CYP3A inhibitors, including medicinal products containing cobicistat, increases the risk of systemic adverse effects.

Such combinations should be avoided unless the expected benefit outweighs the risk of systemic adverse effects from corticosteroid use; in such cases, patients must be monitored for the development of systemic corticosteroid-related adverse reactions.

When using this product concomitantly 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.

Prolonged treatment is not recommended. Since prolonged use (longer than 2 weeks) of ophthalmic corticosteroid preparations may cause reversible elevation of intraocular pressure or irreversible cataract formation, intraocular pressure and the condition of the cornea and lens should be regularly monitored when the drug is used continuously for more than 2 weeks.

In diseases causing corneal thinning, use of the drug may lead to corneal perforation.

Use of the drug may increase the risk of developing fungal or viral (e.g. herpes simplex-induced keratitis) eye infections.

Corticosteroids for topical use should not be prescribed in cases of undiagnosed red eye, as inappropriate use of the medicinal product may lead to blindness.

Visual disturbances, including blurred vision, may occur during treatment with systemic and topical corticosteroids.

If symptoms such as blurred vision or other visual disturbances occur, patients should consult an ophthalmologist to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported with use of both systemic and topical corticosteroids.

Contact lenses should not be worn during treatment with hydrocortisone acetate ophthalmic ointment. Prolonged use may also lead to skin sensitivity and development of organism resistance. Long-term use may pose a risk of adrenal suppression in infants. Corticosteroid treatment should not be repeated or prolonged without regular examinations to exclude possible elevation of intraocular pressure, cataract formation, or unexpected infections.

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

Hypertrophic cardiomyopathy has been reported after hydrocortisone use in premature neonates; therefore, diagnostic evaluation and monitoring of cardiac function and structure are advisable.

Use during pregnancy or breastfeeding.

Pregnancy. Since significant amounts of the active substance may be absorbed into the systemic circulation after application of hydrocortisone acetate ophthalmic ointment, use of the drug during pregnancy should be avoided. If use of hydrocortisone acetate ophthalmic ointment is absolutely necessary during pregnancy, treatment should be carried out for the shortest possible duration and with the lowest possible 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, there is ongoing discussion about a potential link between metabolic and cardiovascular diseases in adulthood and intrauterine exposure to corticosteroids. When corticosteroids are used late in pregnancy, adrenal atrophy may develop in the fetus, which may require replacement therapy with gradual dose reduction.

Breastfeeding. Corticosteroids may pass into breast milk. Adverse effects in infants are currently unknown. However, the drug should be used during breastfeeding only if clearly needed. Breastfeeding should be discontinued if higher doses of the drug are required for treatment.

Fertility. Currently, there is no information available on adverse effects of the drug on fertility.

Ability to affect reaction speed when driving vehicles or operating machinery.

After application of hydrocortisone ophthalmic ointment, vision may be temporarily impaired due to formation of a film on the cornea, resulting in reduced reaction speed when driving a vehicle or operating machinery. Therefore, such patients are advised to apply the ointment only in the evening before bedtime.

Method of Administration and Dosage

Unless otherwise prescribed by a physician, apply a strip of ointment approximately 1 cm in length into the conjunctival sac several times a day. The usual duration of treatment should not exceed 2 weeks. The exact duration of therapy is determined by the physician based on assessment of treatment efficacy, potential adverse effects, and the clinical presentation of the disease.

When applying the ophthalmic ointment, avoid contact between the tube tip and the eye or skin.

Children

There is no experience with the use of this medicinal product in children.

Overdose

With proper use of the medicinal product, 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 lacking.

Adverse reactions.

Ocular disorders: In case of corneal epithelial injury, the drug may inhibit the healing process, with a risk of corneal perforation. It may delay healing of the damaged cornea. Prolonged treatment may lead to the development of post-steroidal glaucoma. After several treatment cycles, glaucoma may recur.

Blurred vision may occur.

Corneal perforation may occur in diseases causing corneal thinning.

Prolonged treatment with ophthalmic preparations containing glucocorticosteroids may cause irreversible cataract formation and transient increase in intraocular pressure in some patients.

Cardiovascular system disorders: Hypertrophic cardiomyopathy in preterm infants (frequency unknown).

Metabolism and nutrition disorders: Weight gain (frequency unknown).

Infections: Possible spread of secondary infections, especially of viral origin.

Immune system disorders: Development of hypersensitivity reactions, including itching, burning sensation, transient blurred vision; contact dermatitis, dermatokeratoconjunctivitis, and eyelid eczema.

The medicinal product contains methylparaben, which may cause allergic reactions (delayed-type).

Shelf life. 2 years.

Shelf life after first opening of the tube – 4 weeks.

Storage conditions. Store at a temperature not exceeding 25 °C.

Packaging. 3 g of ophthalmic ointment in a tube; 1 tube per cardboard box.

Prescription status. Prescription only.

Manufacturer. Jelfa Pharmaceutical Plant A.T.

Manufacturer's address and place of business.
58-500 Jelenia Góra, ul. Władysława Pola 21, Poland.