Instructions Hydrocortisone eye ointment 5 mg/g tube 3 g
Composition
active ingredient: hydrocortisone;
1 g of ointment contains hydrocortisone acetate 5 mg;
excipients: methylparaben (E 218), white soft paraffin.
Dosage form
Eye ointment.
Main physicochemical properties: white or almost white translucent oily soft mass. The ointment should be homogeneous.
Pharmacotherapeutic group
Drugs used in ophthalmology. Anti-inflammatory drugs. Corticosteroids, simple.
ATX code S01B A02.
Pharmacological properties
Pharmacodynamics
The mechanism of action of corticosteroids is still not fully understood. It is likely that 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 the synthesis of certain proteins responsible for chemotaxis and immunological reactions is inhibited. In addition, due to functional changes in leukocytes and macrophages, inflammatory and allergic reactions are inhibited. 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.
Indication
- Allergic conjunctivitis;
- acute and chronic iritis, iridocyclitis, uveitis, chorioretinitis;
- sympathetic ophthalmia, postoperative irritations;
- restoration of corneal transparency after keratitis, (chemical) burn;
- inhibition of neovascularization.
Contraindication
- Hypersensitivity to the active substance or to any of the 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
During the period of treatment with Hydrocortisone, vaccination against smallpox, as well as other forms of immunization, are not recommended due to the lack of an immune response. Increased resorption of hydrocortisone into the bloodstream may reduce the activity of insulin, as well as oral hypoglycemic and hypertensive drugs; anticoagulants and drugs that reduce the level of salicylates in the blood, if used incorrectly or for too long. The risk of adverse reactions is higher in cases of concomitant use of oral contraceptives, anabolic steroids, neurolytic drugs, cholinergic receptor inhibitors, antihistamines, tricyclic antidepressants, nitrates, cardiac glycosides. Due to bilateral inactivation, the drug cannot be used together with drugs containing lead and silver.
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 predisposed patients.
When using the drug simultaneously with other topical ophthalmic drugs, a 15-minute interval should be maintained between applications, and hydrocortisone acetate ointment should be applied last.
Application features
It is not recommended to extend the treatment period. Since prolonged treatment (duration more than 2 weeks) with ophthalmic corticosteroids may cause reversible increase in intraocular pressure or irreversible cataract formation, when using the drug for more than 2 consecutive weeks, intraocular pressure and the condition of the cornea and lens should be regularly checked.
In the case of diseases that cause thinning of the cornea, the use of the drug may lead to its perforation.
When using the drug, the risk of developing fungal or viral (keratitis caused by herpes simplex) eye diseases may increase.
Topical corticosteroids should not be prescribed for undiagnosed pink eye, as improper use of the medication can cause blindness.
Contact lenses should not be worn during treatment with hydrocortisone acetate eye ointment. Prolonged use may also lead to skin sensitivity and the development of resistance. Prolonged use may lead to a risk of adrenal suppression in infants. Corticosteroid treatment should not be repeated or prolonged without regular review to rule out the possibility of increased intraocular pressure, cataract formation, or unexpected infections.
Use during pregnancy or breastfeeding
The potential risks of using the drug in pregnant women are unknown. The drug should be prescribed to pregnant women with caution after careful assessment of the benefits and risks of such use.
It is not known whether topical application of the drug leads to systemic absorption and penetration of significant amounts of hydrocortisone into breast milk. Therefore, for safety reasons, the drug should be used during breastfeeding only if the expected effect of treatment for the mother outweighs the possible risks to the child.
Ability to influence reaction speed when driving vehicles or other mechanisms
After using Hydrocortisone eye ointment, vision may temporarily deteriorate due to the formation of a film on the cornea, which leads to a decrease in the speed of reaction when driving a car and working with mechanisms. Therefore, such patients are recommended to apply the ointment only in the evening before bedtime.
Method of administration and doses
Unless otherwise prescribed by the doctor, a strip of ointment approximately 1 cm long should be placed in the conjunctival sac several times a day. Usually the duration of treatment should not exceed 2 weeks. The exact duration of treatment is determined by the doctor based on a comparison of data on the effectiveness of treatment, possible side effects and the clinical picture of the disease.
When applying eye ointment, avoid contact of the tip of the tube with the eye or skin.
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.
Adverse reactions
From the side of the organs of vision: in case of corneal injury, the epithelium may lead to inhibition of the therapeutic effect with the risk of corneal perforation. Slows down the healing of the damaged cornea. Long-term treatment may lead to the development of post-steroid glaucoma. After several cycles of treatment, glaucoma may develop again.
In diseases that cause thinning of the cornea, its perforation is possible.
Long-term treatment with ophthalmic preparations containing glucocorticosteroids may cause irreversible cataract formation and a temporary increase in intraocular pressure in some patients.
Infections: the spread of secondary infectious processes, especially of viral origin, is possible.
On the part of the immune system: development of hypersensitivity reactions, including itching, burning, short-term blurred vision; contact dermatitis, dermatoconjunctivitis and eyelid eczema.
Contains methylparaben. May cause allergic reactions (delayed action).
Expiration date
2 years.
The shelf life after first opening the tube is 4 weeks.
Storage conditions
Store at a temperature not exceeding 25 °C.
Packaging
3 g of eye ointment in a tube; 1 tube in a cardboard box.
Vacation category
According to the recipe.
Producer
Pharmaceutical factory Elfa A.T.
Location of the manufacturer and its business address
58-500 m. Jelenia Góra, 21 Vincentiego Pola Street, Poland.
