Instructions Hydrocortisone-POS eye ointment 10 mg/g tube 2.5 g
Composition
active ingredient: hydrocortisone acetate;
1 g of ointment contains 10 mg or 25 mg of hydrocortisone acetate;
excipients: white soft paraffin, mineral oil, lanolin.
Dosage form
Eye ointment.
Main physicochemical properties: homogeneous yellowish-white ointment of soft consistency (in the form of a suspension), free from lumps and streaks.
Pharmacotherapeutic group
Drugs used in ophthalmology. Anti-inflammatory drugs. Corticosteroids. ATX code S01B A02.
Pharmacological properties
Pharmacodynamics
The mechanism of action of corticosteroids is still not fully understood. Presumably, corticosteroids interact with protein receptors in the cytoplasm of sensitive cells to form a steroid-receptor complex. After appropriate conformational changes, the steroid-receptor complex enters the nucleus, where it affects the genetic apparatus of cells in such a way that it inhibits the synthesis of certain proteins responsible for chemotaxis and immunological reactions. In addition, due to functional changes in leukocytes and macrophages, inhibition of inflammatory and allergic reactions occurs. The anti-inflammatory efficacy of hydrocortisone is due to the inhibition of phospholipase A2, an enzyme necessary for the synthesis of arachidonic acid, which is a precursor of phlogogenic substances - prostaglandins and leukotrienes. Thus, corticosteroids are effective in inflammatory processes in mesenchymal tissues caused by infections, allergens and injuries.
Pharmacokinetics
The degree of permeability of hydrocortisone acetate, which largely depends on the condition of the cornea, increases significantly when the mucous membranes of the eye are inflamed or damaged.
Hydrocortisone is absorbed by the aqueous humor, cornea, iris, choroid, ciliary body, and retina. Systemic absorption occurs, but is likely to be of clinical significance only at high doses or in long-term treatment in children.
The plasma half-life of hydrocortisone is approximately 90 minutes. Its inactivation occurs mainly in the liver. More than 90% of hydrocortisone is excreted by the kidneys as a glucuronide. Only about 0.5% of the dose can be found in the urine as free cortisol. Approximately 90% of hydrocortisone is bound to blood proteins, of which about 75% is bound to specific transport proteins.
Indication
Hormonal treatment of allergic, non-infectious, inflammatory diseases of the conjunctiva, cornea and anterior segment of the eyes, as well as eyelids (e.g. blepharitis).
Contraindication
Hypersensitivity to the active substance or to any excipients of the drug;
epithelial herpetic keratitis or other viral eye diseases;
bacterial eye infections;
wounds and ulcerative lesions of the cornea;
open- and closed-angle glaucoma;
ocular tuberculosis or fungal infections of the eye.
Interaction with other medicinal products and other types of interactions
No specific drug interaction studies have been conducted.
Concomitant use with other drugs that can increase intraocular pressure (e.g. atropine or other anticholinergics) may lead to an additional increase in intraocular pressure in patients predisposed to such manifestations.
When using the drug simultaneously with other topical ophthalmic agents, a 15-minute interval should be maintained between applications, and hydrocortisone acetate ointment should be applied last.
Application features
Contact lenses should not be worn during treatment with the drug.
During treatment with the drug, intraocular pressure should be regularly checked. Since the use of the drug in case of existing bacterial, viral or fungal eye infections may worsen their course, the condition of the patient's cornea and lens should be monitored during such use.
Lanolin, which is part of the preparation, may cause local irritation (e.g. contact dermatitis).
Children of mothers who used hydrocortisone acetate eye ointment during pregnancy should be carefully examined for adrenal hypofunction (hypoadrenalism).
Cases of visual disturbances may occur with systemic or topical corticosteroids. If a patient experiences symptoms such as blurred vision or other visual disturbances, they should consult an ophthalmologist to determine possible causes, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy (CSR), which has been reported with systemic or topical corticosteroids.
Use during pregnancy or breastfeeding
Pregnancy
Prolonged use of corticosteroids during pregnancy may cause intrauterine growth retardation. In animal studies, corticosteroids have been shown to cause congenital cleft palate. In humans, the increased incidence of congenital cleft palate in children resulting from maternal corticosteroid treatment during the first trimester of pregnancy is still being investigated. Based on epidemiological and animal studies, there is debate about the association of metabolic and cardiovascular diseases that develop in adulthood with intrauterine exposure to corticosteroids. When corticosteroids are used late in pregnancy, the fetus may develop adrenal atrophy, which may require replacement therapy with a gradual reduction in dosage.
Breast-feeding
Corticosteroids can pass into breast milk. Side effects observed in infants are not yet known. However, during breastfeeding, the drug can be used only if there are serious indications. Breastfeeding should be discontinued if higher doses of the drug are required for treatment.
Fertility
To date, there is no information about the undesirable effects of the drug on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
After using hydrocortisone acetate eye ointment, vision may temporarily deteriorate due to the formation of a film of ointment on the cornea, which leads to a decrease in reaction time when driving a car or operating other mechanisms.
Method of administration and doses
A strip of ointment approximately 1 cm long is placed in the conjunctival sac of the affected eye or applied to the affected eyelid 2-3 times a day. Once the desired effect is achieved, 1-2 applications per day are sufficient.
Usually the duration of treatment should not exceed 2 weeks. Depending on the clinical picture, the effectiveness of the treatment, intraocular pressure and corneal condition should be periodically monitored in order to determine the feasibility of prolonging or changing therapy.
When applying eye ointment, avoid contact of the tip of the tube with the eye or skin.
Contact lenses should be removed before applying the drug and should not be worn during the course of treatment.
Children.
There is no experience with the use of the drug in the treatment of children.
Overdose
When used properly, overdose or intoxication is not expected. No cases of overdose with hydrocortisone-containing drugs have been reported. Therefore, there is no information on specific symptoms of overdose and its treatment.
Side effects
The following terminology is used to estimate 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), frequency unknown (frequency cannot be estimated from the available data).
On the part of the immune system
Rare: allergic reactions including contact dermatitis, dermatoconjunctivitis and eyelid eczema.
From the organ of vision
Uncommon: In some patients sensitive to corticosteroids, prolonged treatment with ophthalmic corticosteroids without regular monitoring of intraocular pressure may cause increased intraocular pressure with optic nerve damage, decreased visual acuity, or narrowing of the visual field.
Rare: exophthalmos, cataract, development of additional eye infections (e.g. viral, fungal or bacterial infections), tingling, burning, weeping blisters after surgical removal of cataracts, trophic damage to the cornea.
Frequency unknown: Cases of perforation may occur with topical corticosteroids in diseases that lead to thinning of the cornea or sclera. There is information about delayed wound healing, ptosis, mydriasis, blurred vision (see section "Special instructions").
In certain viral infections (Herpes simplex), corticosteroid treatment requires close medical supervision with frequent slit-lamp examination. Concomitant use of hydrocortisone acetate ophthalmic ointment may mask acute bacterial, viral, and fungal corneal infections. Since fungal corneal infections often develop during prolonged corticosteroid therapy, the possibility of developing such infections should be considered in pre-existing corneal defects and after completion of therapy.
Expiration date
3 years.
Do not use after the expiry date stated on the packaging.
Use no more than 4 weeks after first opening the tube.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
2.5 g of eye ointment in an aluminum tube with a polyethylene tip and cap.
1 tube in a cardboard box.
Vacation category
According to the recipe.
Producer
URSAPHARM Arzneimittel GmbH/URSAPHARM Arzneimittel GmbH.
Location of the manufacturer and address of its place of business.
Industriestrasse 35, 66129 Saarbrucken, Germany.
