Oftan Dexamethasone eye drops 1 mg / ml, 5 ml

$16.00
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Product Description

Composition

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.

pharmachologic effect

Pharmacotherapeutic group:
 
Topical glucocorticosteroid
ATX code S01BAO1
 
pharmachologic effect
 
Pharmacodynamics
 
Synthetic fluorinated glucocorticosteroid. It has a pronounced anti-inflammatory and anti-allergic 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 kinin synthesis, mitosis and leukocyte migration; inhibits the synthesis of antibodies and disrupts antigen recognition. All of these effects are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical, or immune damage. The duration of the anti-inflammatory action after the instillation of 1 drop of the 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 the aqueous humor of the eye, therapeutic concentrations are achieved; with inflammation or damage to the mucous membrane, the penetration rate increases.
 
About 60-70% of dexamethasone entering the systemic circulation binds to plasma proteins. Metabolized in the liver by cytochrome P450-containing enzymes (CYP3A4); metabolites are excreted through the intestines. The half-life in plasma (t1 / 2) averages 3.6 ± 0.9 hours.

Indications

Acute and chronic inflammatory processes:
- non-suppurative 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 epithelialization 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 of inflammatory phenomena in the postoperative and post-traumatic period.

Application during pregnancy and lactation

To date, there are no data from clinical trials regarding the use of Oftan Dexamethasone during pregnancy and lactation.
 
Oftan Dexamethasone can be used during pregnancy and lactation only as directed by the attending physician if the expected therapeutic effect justifies the potential risk to the fetus and baby.
 
The duration of therapy is no more than 7-10 days.

Contraindications

  • Keratitis associated with herpes simplex, chickenpox and other viral diseases of the cornea and conjunctiva.
  • Tuberculosis of the eyes.
  • Mycobacterial eye infections.
  • Fungal eye infections.
  • Acute purulent eye diseases.
  • Damage to the corneal epithelium (including the state after removal of the corneal foreign body).
  • Corneal epitheliopathy.
  • Increased intraocular pressure.
  • Glaucoma.
  • Age up to 18 years (due to the lack of data on the efficacy and safety of the drug in children and adolescents under 18 years of age).
  • Hypersensitivity to drug components.

Side effects

After instillation, a rapidly passing burning sensation, allergic reactions are possible.

With prolonged use it is possible

  • the development of secondary glaucoma and steroid cataracts, as well as ulceration, opacity, thinning and / or perforation of the cornea;
  • rarely - the spread of bacterial or herpes infections.

The preparation contains a preservative benzalkonium chloride, which may irritate the eyes.

Interaction

Interaction with other drugs is mainly due to participation in the elimination of dexamethasone isoenzyme CYP3A4. Dexamethasone induces the CYP3A4 isoenzyme, thus reducing the effectiveness of calcium channel blockers, quinidine and erythromycin. With the usual topical application, the dose of the drug is insufficient to induce the induction or saturation of liver enzymes.

With prolonged use with iodoxuridine, it is possible to enhance destructive processes in the corneal epithelium.

How to take, course of administration and dosage

In acute conditions

  • 1-2 drops into the conjunctival sac every 1-2 hours.

After reducing inflammation

  • 1-2 drops into the conjunctival sac 3-5 times / 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.

Overdose

Overdose with topical application of Oftan Dexamethasone eye drops is unlikely.

  • Symptoms: Local irritation possible.
  • Treatment: no specific antidote. The drug should be discontinued and symptomatic therapy should be prescribed.

Special instructions

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 installation, because 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 the treatment is more than 2 weeks, it is necessary to regularly monitor the intraocular pressure and the condition of the cornea.

Corticosteroid therapy can mask an ongoing bacterial or fungal infection. In the presence of infection, the use of drops should be combined with appropriate antimicrobial therapy.

Influence on the ability to drive vehicles and use mechanisms

In view of the possible lacrimation after instillation, the drug is not recommended to be used immediately before driving or operating mechanical equipment.

Release form

Eye drops in the form of a clear, colorless solution.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 2 ° to 8 ° C.

Shelf life

2 years

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