Oftan - instructions for use, analogs, reviews and release forms (eye drops Katachrom, Dexamethasone, Timolol, Ida, eye gel Timogel) medications for the treatment of cataracts, glaucoma, scleritis in adults, children and pregnancy. Compound
Tradename: Oftan® dexamethasone
International nonproprietary name:
Dexamethasone
Dosage form:
Eye drops
Compound:
1 ml of the drug contains:
Active substance
: Dexamethasone sodium phosphate 1.32 mg (equivalent to dexamethasone 1.0 mg)
Excipients:
Benzalkonium chloride 40.0 mcg, boric acid 15.0 mg, sodium tetraborate 600.0 mcg, disodium edetate 500.0 mcg, water for injection up to 1 ml.
Description: Transparent, colorless solution
Pharmacotherapeutic group:
Glucocorticoid for local application
ATX code S01BAO1
pharmachologic effect
Pharmacodynamics
Synthetic fluorinated glucocorticosteroid. It has a pronounced anti-inflammatory and antiallergic effect.
By interacting with a specific protein receptor in target tissues, it regulates the expression of corticoid-dependent genes and thus affects protein synthesis. Stabilizes lysosomal enzymes of leukocyte membranes; inhibits the synthesis of kinins, mitosis and migration of leukocytes; suppresses antibody synthesis and disrupts antigen recognition. All of these effects are involved in the suppression inflammatory reaction in tissues in response to mechanical, chemical or immune damage. The duration of the anti-inflammatory effect after instillation of 1 drop of solution is from 4 to 8 hours.
Pharmacokinetics
When applied topically, systemic absorption is low. After instillation into the conjunctival sac, it penetrates well into the corneal epithelium and conjunctiva; while in aqueous humor eyes therapeutic concentrations are achieved; with inflammation or damage to the mucous membrane, the penetration rate increases. About 60-70% of dexamethasone entering the systemic blood flow, binds to plasma proteins. Metabolized in the liver under the influence of cytochrome P450 containing enzymes (CYP3A4); metabolites are excreted through the intestines. The plasma half-life (t1/2) averages 3.6 ± 0.9 hours.
Indications for use
Acute and chronic inflammatory processes:
Non-purulent forms of conjunctivitis, keratitis, keratoconjunctivitis without damage to the epithelium and blepharitis;
- scleritis and episcleritis;
- iritis, iridocyclitis and other uveitis of various origins;
- superficial damage to the cornea of various etiologies(chemical, physical or immune mechanisms) after complete epithelization of the cornea;
- inflammation of the posterior segment of the eye (choroiditis, chorioretinitis);
- sympathetic ophthalmia.
Allergic eye diseases:
Allergic conjunctivitis or keratoconjunctivitis.
Prevention and treatment inflammatory phenomena in the postoperative and post-traumatic period.
Contraindications
Keratitis associated with herpes simplex, chicken pox and others viral diseases cornea and conjunctiva;
- eye tuberculosis;
- mycobacterial eye infections;
- fungal diseases eye;
- spicy purulent diseases eye;
- damage to the corneal epithelium (including the condition after removal foreign body cornea);
- corneal epitheliopathy;
- increased intraocular pressure;
- glaucoma;
- childhood up to 18 years of age (due to the lack of data on the effectiveness and safety of the drug in children and adolescents under 18 years of age);
- hypersensitivity to any of the components of the drug.
Pregnancy and lactation
To date, there are no clinical trial data regarding the use of Oftan® Dskxamethasone during pregnancy and lactation. Oftan Dsksamstazon can be used during pregnancy and during breastfeeding only as prescribed by your doctor, unless expected healing effect justifies the potential risk to the fetus and the child.
Duration of therapy: no more than 7-10 days.
Directions for use and doses
At acute conditions: 1-2 drops into the conjunctival sac every 1-2 hours.
After reducing inflammation, Oftan® Dsksamstazon eye drops are instilled 1-2 drops into the conjunctival sac 3-5 times a day.
Duration of treatment eye drops Oftan® Dexamethasone should not exceed 2-3 weeks.
The decision on the duration of treatment is based on objective data, including the effectiveness of the drug, the severity of clinical symptoms And possible risk emergence side effects.
Side effect
After instillation eye drops Oftan® Dexamethasone may cause a quickly passing burning sensation, allergic reactions.
Long-term use (more than 3 weeks) of dexamethasone can cause secondary glaucoma and steroid cataracts, as well as possible ulceration, opacification, thinning or perforation of the cornea; V in rare cases Dexamethasone can contribute to the spread of herpes and bacterial infections.
Oftan® Dexamethasone contains the preservative benzalkonium chloride, which can cause eye irritation.
If side effects occur, you should contact your doctor as soon as possible.
Overdose
Overdose with topical use of Oftan® Dexamethasone eye drops is unlikely.
Symptoms: local irritation possible.
There is no specific antidote. The drug should be discontinued and symptomatic therapy prescribed.
Interaction with other drugs
Interaction with other drugs is mainly due to the participation of cytochrome P450 containing enzymes (CYP3A4) in the elimination of dexamethasone. It induces the enzyme CYP3A4, thus reducing the effectiveness of blockers calcium channels, quinidine and erythromycin. With the usual regimen of topical administration, the dose of the drug is insufficient to cause induction or saturation of liver enzymes.
At long-term use with iodoxuridine, it is possible to intensify destructive processes in the corneal epithelium.
special instructions
Oftan® Dexamethasone contains the preservative benzalkyl chloride, which can be absorbed by soft contact lenses and cause discoloration and adverse effects on eye tissue. If necessary use contact lenses during treatment with Oftan® Dexamethasone, they should be removed before using the drug and, if necessary, put on no earlier than 15 minutes after instillation.
During treatment with the drug for more than 2 weeks, it is necessary to regularly monitor intraocular pressure and the condition of the cornea.
Corticosteroid therapy may mask an ongoing bacterial or fungal infection. If infection is present, the use of drops should be combined with appropriate antimicrobial therapy.
Due to possible lacrimation after instillation, the drug is not recommended for use immediately before administration. vehicles or operating mechanical equipment.
Release form
Eye drops 1 mg/ml
5 ml in a polyethylene dropper bottle, sealed with a plastic stopper with a screw cap. The dropper bottle along with instructions for use is placed in a cardboard box.
Best before date
2 years.
After opening the bottle - 1 month.
Do not use after the expiration date stated on the package.
Storage conditions
List B. Store at a temperature of 2 to B ° C, out of the reach of children.
Vacation conditions
On prescription
Manufacturer
Santen AO, Niittyhaankatu 20, 33720 Tampere, Finland
Representative office of JSC Santen in Moscow
(for sending consumer complaints)
119049 Moscow, st. Mytnaya, 1, office 13
Latin name: Oftan Dexamethason
ATX code: S01BA01
Active substance: Dexamethasone
Manufacturer: Santen, Finland
Dispensing from the pharmacy: Over the counter
Storage conditions: t up to 25 C
Best before date: 2 years
Oftan Dexamethasone drops - drugs for local use, allow you to quickly get rid of signs of the inflammatory process, and exhibit an antihistamine effect.
Oftan Dexamethasone eye drops are prescribed for therapeutic therapy for inflammatory ophthalmological pathologies corneas and conjunctiva (including those resulting from an allergic reaction or in the postoperative period).
Composition and release forms
1 ml of ophthalmic drops contains the only active ingredient– dexamethasone sodium phosphate, its amount in the drug is 1.32 mg. Also present in eye drops:
- Boric acid
- Sodium tetraborate
- Benzalkonium chloride
- Edetate disodium
- Prepared water.
A transparent and absolutely colorless solution without a distinct odor is poured into 5 ml dropper bottles.
Medicinal properties
The drug contains a corticosteroid, which is characterized by anti-inflammatory activity, namely, it inhibits the adhesion of molecules inside vascular endothelial cells, while reducing the influence of cyclooxygenase I and II with the subsequent release of cytokines. Thanks to this action, the rate of formation of inflammatory mediators is reduced, the adhesion of leukocyte cells directly to vascular endothelium, which helps prevent their entry into inflamed tissues. Dexamethasone exhibits anti-inflammatory effects, while a slight mineralocorticoid effect is observed in comparison with other drugs. steroid drugs. It is one of the potent anti-inflammatory substances.
During the use of Oftan Dexamethasone in the dosages prescribed by the doctor, no systemic effects were observed.
The highest level of dexamethasone in the composition intraocular fluid was 30 ng/ml, this value is reached within 2 hours after installation. Subsequently, the concentration of the active substance gradually decreased. The half-life lasts no more than 3 hours.
About 60% of the dose used is excreted directly in the urine in the form of a metabolite - 6-β-hydroxydexamethasone. The connection with plasma proteins is recorded at the level of 77-84%.
Oftan Dexamethasone: complete instructions
Price: from 169 to 299 rubles.
Subconjunctival use of drugs is indicated.
Before opening the bottle, you must shake it thoroughly.
The dosage regimen and duration of therapy are determined strictly individually.
Standard application for acute course diseases - instillation of 1-2 drops. medications, the interval between uses is 30 minutes - 1 hour. After relief of the main signs of the disease, 1-2 drops are added. with a time interval of 2-4 hours. It is possible to reduce the dose to 1 drop; in this case, instillation procedures are carried out three or four times a day.
If no significant improvement is observed during the first days of therapy, it is necessary to consult with ophthalmologists and reconsider the prescribed treatment.
Intraocular pressure should be monitored regularly.
There is no need to adjust the dose of drops in persons with pathologies of the liver and renal system.
The use of the medicine during pregnancy and lactation is possible after consultation with an ophthalmologist and obstetrician-gynecologist.
Contraindications
A drug based on dexamethasone is not prescribed for:
- Availability fungal infection mucous membranes of the eyes
- Tuberculous eye damage
- Development of keratitis, which is associated with herepevirus or varicella zoster virus; presence of signs viral infection cornea and conjunctiva
- Diagnosing glaucoma
- Occurrence infectious diseases eyes caused by mycobacteria
- Recurrent corneal erosion
- Ophthalmotonus
- Development of purulent eye diseases
- Injury to corneal tissue (including conditions after removal of a foreign body).
The ophthalmic drug is not used in pediatrics, since there is no information about the safety of its use in children under 18 years of age. Treatment should not be carried out if you are hypersensitive to the components of the drops.
Precautionary measures
Unlike other ophthalmic agents, Oftan Dexamethasone contains benzalkonium chloride (a preservative); while wearing contact lenses, a change in the shade of the eyes and irritation of the mucous membranes may be observed. In this regard, burying ophthalmic solution should take place after removing contact lenses, their subsequent installation is possible after 15 minutes. from the moment of installation.
If the duration of treatment exceeds 2 weeks, it is necessary to regularly monitor intraocular pressure, as well as monitor the condition of the corneal tissue.
Corticosteroid therapy may reduce the severity of bacterial or fungal infection of the mucous membranes of the eyes. Once an infection is identified, it is necessary to apply antibacterial drugs local action.
After installation, lacrimation is possible; during this period it is not recommended to drive vehicles or engage in potential dangerous species activities before full recovery visual function.
Cross drug interactions
Possible drug interactions associated with the process of dexamethasone elimination of the CYP3A4 isoenzyme. Since the main component of the drops induces the CYP3A4 isoenzyme, the effect of calcium channel blockers, erythromycin, and quinidine is significantly reduced. When using standard dosages, saturation of liver enzymes is not observed.
Long-term therapy with iodoxuridine can provoke an increase in the severity of destructive processes that occur in the cornea.
Side effects
After installation, there may be a slight burning sensation, various allergic manifestations. With prolonged therapy, the possibility of developing secondary glaucoma, lens opacification, the occurrence of steroid cataracts, disruption of the integrity of the cornea or its ulceration cannot be excluded. Very rarely - infection of the mucous membranes (herpes virus, bacteria).
Overdose
Low probability of overdose.
Local irritation may develop; symptomatic therapy is prescribed.
Analogues
Alcon-Couvreur, Belgium
Price from 228 to 356 rub.
The drug is complete analogue Oftan Dexamethasone, yes ophthalmic agents contain the same glucocorticosteroid. The drug is characterized by anti-inflammatory and antihistamine properties, which helps to quickly eliminate the feeling of discomfort. Can be used for prophylaxis after elective ophthalmic surgery. Dosage forms: drops and ointment.
Pros:
- The anti-inflammatory effect appears quickly
- Effective for conjunctivitis and keratoconjunctivitis
- You can combine drops with ointment.
Minuses:
- Not prescribed for dendritic keratitis
- Available with prescription
- With prolonged use, adverse reactions may develop.
3D images
Composition and release form
in plastic dropper bottles of 5 ml; 1 bottle in a cardboard pack.
Description of the dosage form
Colorless transparent solution.
pharmachologic effect
pharmachologic effect- antiallergic, anti-inflammatory.Indications of the drug Oftan ® Dexamethasone
Acute and chronic inflammatory processes: non-purulent forms conjunctivitis, keratitis, keratoconjunctivitis and blepharitis, scleritis and episcleritis, iritis, iridocyclitis and other uveitis of various origins, superficial injuries of the cornea of various etiologies (chemical, physical or immune mechanisms) after complete epithelization of the cornea, inflammation of the posterior segment of the eye (choroiditis, chorioretinitis), sympathetic ophthalmia.
Allergic conjunctivitis or keratoconjunctivitis.
Prevention and treatment of inflammatory phenomena in the postoperative and post-traumatic period.
Contraindications
Keratitis caused by Herpes simplex, chicken pox and other viral diseases of the cornea and conjunctiva, mycobacterial eye infections, fungal eye diseases, acute purulent eye diseases with damage to the corneal epithelium, corneal epitheliopathy, increased intraocular pressure, increased sensitivity to any of the components of the drug.
Use during pregnancy and breastfeeding
Possibly, if the expected effect of therapy exceeds the potential risk to the fetus (to date, there are no clinical trial data regarding the use of the drug during pregnancy, lactation, or in children)
Side effects
A quickly passing burning sensation.
With long-term use, secondary glaucoma and steroid cataracts may occur, therefore, when using the drug for more than 2 weeks, and in patients with a history of glaucoma, it is recommended to regularly monitor intraocular pressure.
Interaction
May enhance the effect of phenytoin, barbiturates and warfarin. Reduces the effectiveness of CCB, quinidine and erythromycin (induces the CYP3A4 isoenzyme). With the usual regimen of topical administration, the dose is insufficient to cause induction or saturation of liver enzymes.
Directions for use and doses
Conjunctivally. 1-2 drops into the conjunctival sac 3-5 times a day.
The course is no more than 2-3 weeks.
Overdose
When applied topically, an overdose is unlikely.
Precautionary measures
Use for 2 weeks or more should be carried out under the control of intraocular pressure.
If a bacterial or fungal infection is present, treatment should be carried out in combination with appropriate antimicrobial therapy.
Before instillation, contact lenses should be removed and reinserted 15 minutes after using the drug (to avoid precipitation of the preservative benzalkonium chloride on them).
Due to possible lacrimation after instillation, it is not recommended to use the drug immediately before driving a vehicle or servicing mechanical equipment.
special instructions
Eye drops in an opened bottle should be used within 1 month.
Storage conditions for the drug Oftan ® Dexamethasone
At a temperature of 2-8 °C.Keep out of the reach of children.
Shelf life of Oftan ® Dexamethasone
2 years. After opening the bottle - 1 month.Do not use after the expiration date stated on the package.
Synonyms of nosological groups
Category ICD-10 | Synonyms of diseases according to ICD-10 |
---|---|
H10.1 Acute atopic conjunctivitis | Allergic eye diseases |
Allergic conjunctivitis | |
Allergic conjunctivitis | |
Allergic conjunctivitis caused by chemical and physical factors | |
Allergic rhinoconjunctivitis | |
Allergic eye inflammation | |
Spring Qatar | |
Spring keratitis | |
Spring conjunctivitis | |
Allergic conjunctivitis | |
Year-round allergic conjunctivitis | |
Exacerbation of hay fever in the form of rhinoconjunctival syndrome | |
Acute allergic conjunctivitis | |
Superficial bacterial infection eye | |
Rhinoconjunctivitis | |
Seasonal allergic conjunctivitis | |
Seasonal conjunctivitis | |
Sennoz | |
H10.4 Chronic conjunctivitis | Papillary conjunctivitis |
Chronic allergic conjunctivitis | |
Chronic inflammation of the conjunctiva | |
H10.9 Conjunctivitis, unspecified | Secondarily infected conjunctivitis |
Hyperpapillary conjunctivitis | |
Catarrhal conjunctivitis | |
Year-round conjunctivitis | |
Non-purulent conjunctivitis | |
Non-purulent forms of conjunctivitis | |
Non-purulent conjunctivitis | |
Non-infectious conjunctivitis | |
Subacute conjunctivitis | |
Trachomal conjunctivitis | |
H16 Keratitis | Adenoviral keratitis |
Bacterial keratitis | |
Spring keratitis | |
Deep keratitis without epithelial damage | |
Deep keratitis without damage to the epithelium | |
Discoid keratitis | |
Arborescent keratitis | |
Keratitis rosacea | |
Keratitis with corneal destruction | |
Superficial keratitis | |
Superficial punctate keratitis | |
Punctate keratitis | |
Traumatic keratitis | |
H16.2 Keratoconjunctivitis | Bacterial keratoconjunctivitis |
Vernal keratoconjunctivitis | |
Deep forms of adenoviral keratoconjunctivitis | |
Infectious conjunctivitis and keratoconjunctivitis caused by Chlamydia trachomatis | |
Acute allergic keratoconjunctivitis | |
Phlyctenular keratoconjunctivitis | |
Chronic allergic keratoconjunctivitis | |
H20 Iridocyclitis | Sluggish posterior uveitis |
Indolent posterior uveitis | |
Posterior uveitis | |
Iridocyclitis of the posterior segment of the eye | |
Iridocyclitis and other uveitis | |
Iritis | |
Keratoiridocyclitis | |
Acute iridocyclitis | |
Acute iritis | |
Acute non-infectious uveitis | |
Recurrent iritis | |
Sympathetic iridocyclitis | |
Uveitis | |
Cyclit | |
S05 Injury to the eye and orbit | Non-penetrating wound eyeball |
Superficial corneal injury | |
Post-traumatic keratopathy | |
Post-traumatic central retinal dystrophy | |
Penetrating corneal injury | |
Penetrating corneal injuries | |
Penetrating eye injuries | |
Condition after eye injuries | |
Condition after eyeball injuries | |
Condition after eyeball injury | |
Injuries anterior section eyes | |
Corneal injuries | |
Injuries to eye tissue | |
Injuries to eye tissue |
In this article you can find instructions for use medicinal product Oftan. Feedback from site visitors - consumers - is presented of this medicine, as well as the opinions of specialist doctors on the use of Oftan in their practice. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Oftan, if available structural analogues. Use for the treatment of cataracts, glaucoma, scleritis and iridocyclitis in adults, children, as well as during pregnancy and lactation. Composition of the drug.
Oftan - combination drug, which improves the energy metabolism of the lens (Oftan Katahrom).
Cytochrome C plays important role in biochemical redox processes in the tissues of the eyeball and is an antioxidant.
Adenosine is a precursor of ATP and takes part in the metabolic processes of the lens.
Nicotinamide stimulates the synthesis of nicotinamide dinucleotide, a cofactor for dehydrogenases.
Oftan Dexamethasone
Synthetic fluorinated glucocorticosteroid (GCS) for local use in ophthalmology. The drug has a pronounced anti-inflammatory and antiallergic effect.
Dexamethasone interacts with specific protein receptors in target tissues, thus regulating the expression of corticosteroid-dependent genes and further influencing protein synthesis. Stabilizes lysosomal enzymes of leukocyte membranes and inhibits the release of enzymes. Inhibits the synthesis of kinins, mitosis and migration of leukocytes. Inhibits antibody synthesis and impairs antigen recognition. All of these mechanisms are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical or immune damage.
The duration of the anti-inflammatory effect after instillation of 1 drop of the drug is 4-8 hours.
Oftan Timogel
Antiglaucoma drug, non-selective beta-blocker. Reduces increased intraocular pressure by reducing the production of aqueous humor. Like other beta-blockers, timolol has little effect on the aqueous outflow system. It has a weak anesthetic effect and does not affect the size of the pupil and accommodation.
Oftan Timolol
Antiglaucoma drug, non-selective beta-blocker. It does not have internal sympathomimetic and membrane-stabilizing activity. When applied topically as eye drops, timolol reduces both normal and elevated intraocular pressure by reducing the formation of intraocular fluid. Does not affect pupil size and accommodation.
Compound
Cytochrome C + Adenosine + Nicotinamide + Excipients(Oftan Katahrom).
Dexamethasone sodium phosphate + excipients (Oftan Dexamethasone).
Timolol maleate + excipients (Oftan Timolol and Oftan Timogel).
Idoxuridine + excipients (Oftan Idu).
Pharmacokinetics
When applied topically, cytochrome C is not absorbed into the systemic circulation. Adenosine penetrates well through the cornea. Cytochrome C is completely metabolized in the body in the same ways as amino acids, and heme is broken down into bilirubin, which is excreted in bile. Adenosine is metabolized in virtually all tissues to form inosine, xanthine and urate, which are excreted in the urine. Ribose, which is part of the adenosine molecule, is metabolized to glyceraldehyde-3-phosphate and then to pyruvate, and is finally broken down in the Krebs cycle. Nicotinamide is partially metabolized to nicotinic acid. Both compounds are methylated to form N-methylnicotinamide, which is further broken down in the liver. Unchanged nicotinamide and metabolites are excreted in the urine.
About 60-70% of dexamethasone entering the systemic circulation is bound to plasma proteins. Metabolites are excreted through the intestines.
When applied topically, timolol maleate quickly penetrates the cornea. After instillation of eye drops, the maximum concentration of timolol in the aqueous humor of the eye is reached after 1-2 hours. 80% of timolol, used in the form of eye drops, enters the systemic circulation through absorption through the vessels of the conjunctiva, nasal mucosa and lacrimal tract. Excretion of timolol metabolites is carried out primarily by the kidneys.
Indications
Oftan Katahrom
- cataracts of various origins.
Oftan Dexamethasone
- non-purulent forms of conjunctivitis, keratitis, keratoconjunctivitis and blepharitis;
- scleritis and episcleritis;
- iritis, iridocyclitis and other uveitis of various origins;
- superficial damage to the cornea of various etiologies (chemical, physical or immune mechanisms) after complete epithelization of the cornea;
- inflammation of the posterior segment of the eye (choroiditis, chorioretinitis);
- swelling, inflammation (including in the postoperative period);
- sympathetic ophthalmia;
- allergic conjunctivitis or keratoconjunctivitis.
Oftan Timolol
- increased intraocular pressure (ophthalmohypertension);
- open-angle glaucoma;
- glaucoma on the aphakic eye and other types of secondary glaucoma;
- as additional means to reduce intraocular pressure in closed-angle glaucoma (in combination with miotics);
- congenital glaucoma (if other means are ineffective).
Oftan I'm coming
- keratitis and keratoconjunctivitis caused by the Herpes simplex virus (superficial form of herpes).
Release forms
Eye drops (Oftan Katahrom, Dexamethasone, Timolol, Idu).
Eye gel (Oftan Timogel).
Instructions for use and method of use
Drops Katachrom
Prescribe 1-2 drops into the conjunctival sac 3 times a day.
When using the bottle for the first time, turn the bottle cap while pressing down and then open the bottle.
Dexamethasone drops
In acute conditions, 1-2 drops are prescribed into the conjunctival sac every 1-2 hours.
After reducing inflammation, the drug is instilled 1-2 drops into the conjunctival sac 3-5 times a day.
The duration of treatment should not exceed 2-3 weeks.
The decision on the duration of treatment is based on objective data, including the effectiveness of the drug, the severity of clinical symptoms and the possible risk of side effects.
Timolol drops
At the beginning of treatment, 1-2 drops are prescribed into the affected eye in the form of eye drops 0.25% or eye drops 0.5% 2 times a day.
If intraocular pressure normalizes with regular use, the dose should be reduced to 1 drop once a day in the morning.
Treatment with Oftan Timolol is usually carried out over a long period of time. A break in treatment or a change in the dosage of the drug is carried out only as prescribed by the attending physician.
Drops I'm Coming
Conjunctivally. 1 drop into the conjunctival cavity every hour during the day and every 2 hours at night; after sustained improvement - every 2 hours during the day and every 4 hours at night. Treatment is continued for 3-5 days after complete healing, confirmed by the absence of fluorescein staining of the cornea.
The course of treatment is no more than 21 days.
Side effect
- short-term burning and tingling sensation in the eyes;
- allergic reactions;
- blurred vision;
- irritation and hyperemia of the conjunctiva;
- contact dermatitis;
- nausea;
- arterial hypotension;
- dizziness;
- dyspnea;
- sensation of heat and pulsation in the temples;
- fainting (due to the vasodilating effect of nicotinic acid);
- development of secondary glaucoma and steroid cataract (Oftan Dexamethasone).
Contraindications
- bronchial asthma or other severe chronic obstructive airway diseases;
- sinus bradycardia;
- 2nd and 3rd degree AV block;
- decompensated heart failure;
- dystrophic processes in the cornea;
- children and adolescents under 18 years of age (due to the lack of data on the effectiveness and safety of the drug in children and adolescents);
- hypersensitivity to the components of the drug;
- increased intraocular pressure (Dexamethasone);
- glaucoma (Dexamethasone);
- pregnancy;
- lactation.
Use during pregnancy and breastfeeding
There is not enough experience with the use of the drug Oftan Katahrom during pregnancy and lactation (breastfeeding).
It is possible to use the drug Oftan Katahrom during pregnancy and lactation as prescribed by a doctor and in cases where the expected benefit of therapy for the mother outweighs the potential risk for the fetus or infant.
Due to potential carcinogenicity, teratogenicity and mutagenicity, Oftan Ida should not be used during pregnancy and breastfeeding.
Use in children
Contraindicated in children and adolescence up to 18 years of age (due to the lack of data on the effectiveness and safety of the drug in children and adolescents).
special instructions
During treatment with Oftan Katahrom, you should not wear soft contact lenses, because the preservative may be deposited in them and have an adverse effect on the eye tissue. Before using Oftan Katachroma, contact lenses should be removed and reinserted 15 minutes after instillation of the drug.
Oftan Dexamethasone contains the preservative benzalkonium chloride, which can be absorbed by soft contact lenses and cause discoloration and adverse effects on eye tissue. If it is necessary to use contact lenses during treatment with Oftan Dexamethasone, they should be removed before using the drug and, if necessary, installed no earlier than 15 minutes after instillation.
If treatment with Oftan Dexamethasone continues for more than 2 weeks, it is necessary to regularly monitor intraocular pressure and the condition of the cornea.
Impact on the ability to drive vehicles and operate machinery
Patients who experience short-term eye irritation after instillation of the drug should avoid driving vehicles, working with machinery, machines or any other equipment that requires good visual acuity, immediately after using eye drops.
Drug interactions
No clinically significant interactions of Oftan Katahrom with other drugs have been identified.
The combined use of Oftan Timolol with eye drops containing adrenaline may cause pupil dilation.
With the simultaneous use of eye drops containing epinephrine and pilocarpine, Oftan Timolol may increase the reduction in intraocular pressure.
Arterial hypotension and bradycardia may increase with simultaneous use Oftan Timolol with calcium antagonists, reserpine and systemic beta-blockers.
Interaction with other drugs is mainly due to the participation of the CYP3A4 isoenzyme in the elimination of dexamethasone. Dexamethasone induces the CYP3A4 isoenzyme, thereby reducing the effectiveness of calcium channel blockers, quinidine and erythromycin. With the usual regimen of topical administration, the dose of the drug is insufficient to cause induction or saturation of liver enzymes.
Analogues of the drug Oftan
Structural analogues according to active substance The medicine Oftan does not have.
Analogs for therapeutic effect (medicines for the treatment of senile cataracts):
- Vita Iodurol;
- Vitafacol;
- Indocide;
- Quinax;
- Multimax;
- Naklof;
- Oftan Katahrom;
- Polivit Geriatric;
- Strix forte;
- Taufon;
- Focus.
If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.
Eye drops in the form of a clear, colorless solution.
1 ml - dexamethasone sodium phosphate 1.32 mg,
which corresponds to the content of dexamethasone 1 mg
Excipients: benzalkonium chloride, boric acid, sodium tetraborate, disodium edetate, water d/i.
5 ml - polyethylene dropper bottle (1) - cardboard packs.
pharmachologic effect
Synthetic fluorinated corticosteroids for topical use in ophthalmology. The drug has a pronounced anti-inflammatory and antiallergic effect.
Dexamethasone interacts with specific protein receptors in target tissues, thus regulating the expression of corticosteroid-dependent genes and further influencing protein synthesis. Stabilizes lysosomal enzymes of leukocyte membranes and inhibits the release of enzymes. Inhibits the synthesis of kinins, mitosis and migration of leukocytes. Inhibits antibody synthesis and impairs antigen recognition. All of these mechanisms are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical or immune damage.
The duration of the anti-inflammatory effect after instillation of 1 drop of the drug is 4-8 hours.
Pharmacokinetics
Suction
When applied topically, systemic absorption is low. After instillation into the conjunctival sac, it penetrates well into the corneal epithelium and conjunctiva. At the same time, therapeutic concentrations are achieved in the aqueous humor of the eye; with inflammation or damage to the mucous membrane, the penetration rate increases.
Distribution and metabolism
About 60-70% of dexamethasone entering the systemic circulation is bound to plasma proteins. Metabolized in the liver under the influence of the CYP3A4 isoenzyme.
Removal
Metabolites are excreted through the intestines. T1/2 averages 3.6±0.9 hours.
Indications for use of the drug OFTAN® DEXAMETHASONE
Acute and chronic inflammatory processes:
- non-purulent forms of conjunctivitis, keratitis, keratoconjunctivitis and blepharitis;
- scleritis and episcleritis;
- iritis, iridocyclitis and other uveitis of various origins;
- superficial damage to the cornea of various etiologies (chemical, physical or immune mechanisms) after complete epithelization of the cornea;
- inflammation of the posterior segment of the eye (choroiditis, chorioretinitis);
- swelling, inflammation (including in the postoperative period);
- sympathetic ophthalmia.
Allergic eye diseases:
- allergic conjunctivitis or keratoconjunctivitis.
Prevention and treatment of inflammatory phenomena in the postoperative and post-traumatic period.
Dosage regimen
In acute conditions, 1-2 drops are prescribed into the conjunctival sac every 1-2 hours.
After reducing inflammation, the drug is instilled 1-2 drops into the conjunctival sac 3-5 times.
The duration of treatment should not exceed 2-3 weeks.
The decision on the duration of treatment is based on objective data, including the effectiveness of the drug, the severity of clinical symptoms and the possible risk of side effects.
Side effect
On the part of the organ of vision: after instillation, a quickly passing burning sensation and allergic reactions are possible. With long-term use, it is possible to develop secondary glaucoma and steroid cataracts, as well as ulceration, opacification, thinning and/or perforation of the cornea; rarely - spread of bacterial or herpetic infections. The drug contains the preservative benzalkonium chloride, which may cause eye irritation.
Contraindications to the use of the drug OFTAN® DEXAMETHASONE
- keratitis associated with herpes simplex, chickenpox and other viral diseases of the cornea and conjunctiva;
- eye tuberculosis;
- mycobacterial eye infections;
- fungal eye diseases;
- acute purulent eye diseases;
- damage to the corneal epithelium (including the condition after removal of a corneal foreign body);
- corneal epitheliopathy;
- increased intraocular pressure;
- glaucoma;
- age under 18 years (due to the lack of data on the effectiveness and safety of the drug in children and adolescents under 18 years of age);
- hypersensitivity to the components of the drug.
special instructions
Oftan® Dexamethasone contains the preservative benzalkonium chloride, which can be absorbed by soft contact lenses and cause discoloration and adverse effects on eye tissue. If it is necessary to use contact lenses during treatment with Oftan® Dexamethasone, they should be removed before using the drug and, if necessary, installed no earlier than 15 minutes after instillation.
If treatment with the drug continues for more than 2 weeks, it is necessary to regularly monitor intraocular pressure and the condition of the cornea.
Corticosteroid therapy may mask ongoing bacterial or fungal infection. If infection is present, the use of drops should be combined with appropriate antimicrobial therapy.
Impact on the ability to drive vehicles and operate machinery
Due to possible lacrimation after instillation, the drug is not recommended for use immediately before driving vehicles or operating mechanical equipment.
Use of the drug OFTAN® DEXAMETHASONE during pregnancy and breastfeeding
To date, there are no clinical trial data regarding the use of Oftan® Dexamethasone during pregnancy and lactation. Oftan® Dexamethasone can be used during pregnancy and breastfeeding only as prescribed by the attending physician, if the expected therapeutic effect justifies the potential risk to the fetus and child. Duration of therapy is no more than 7-10 days.
Overdose
Overdose with topical use of Oftan® Dexamethasone eye drops is unlikely.
Symptoms: local irritation possible.
Treatment: there is no specific antidote. The drug should be discontinued and symptomatic therapy prescribed.
Drug interactions
Interaction with other drugs is mainly due to the participation of the CYP3A4 isoenzyme in the elimination of dexamethasone. Dexamethasone induces the CYP3A4 isoenzyme, thereby reducing the effectiveness of calcium channel blockers, quinidine and erythromycin. With the usual regimen of topical administration, the dose of the drug is insufficient to cause induction or saturation of liver enzymes.
Long-term use with iodoxuridine may increase destructive processes in the corneal epithelium.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Storage conditions and periods
List B. The drug should be stored out of the reach of children at a temperature of 2° to 8°C. Shelf life – 2 years.
After opening the dropper bottle, the shelf life is 1 month.