OFTALMODEK

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT OFTALMODEK

Composition:

Active substance: decamethoxine;

1 ml of solution contains 0.2 mg of decamethoxine calculated as 100% substance;

Excipients: sodium chloride, purified water.

Pharmaceutical form. Eye drops.

Main physicochemical properties: colorless clear liquid.

Pharmacotherapeutic group.

Antimicrobial agents used in ophthalmology. ATC code S01A X.

Pharmacological properties.

Pharmacodynamics.

The drug exerts an antiseptic effect and has a broad spectrum of antimicrobial activity against Gram-positive cocci (staphylococci, pneumococci, streptococci) and Gram-negative cocci (gonococci, meningococci), Corynebacterium species, Gram-negative bacteria (Enterobacteriaceae, Pseudomonas), protozoa, dermatophytes, yeast-like fungi of the genus Candida, chlamydia, and viruses. Resistant microbial variants develop slowly during the use of Oftalmodek. The drug potentiates the action of conventional antimicrobial agents in combined therapy.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Acute and chronic conjunctivitis, blepharoconjunctivitis, gonoblenorrhea, chlamydial infection of ocular mucosa; for prophylaxis of blennorrhea in newborns, administered in preoperative period and after ophthalmic surgeries for prevention of purulent-inflammatory complications. For disinfection of contact lenses.

Contraindications.

Hypersensitivity to decamethoxin or to other components of the drug.

Interaction with other medicinal products and other forms of interactions.
Not studied.

Special precautions for use.

The drug should not be used in case of individual hypersensitivity.

Use during pregnancy or breastfeeding.

The use of the drug during pregnancy or breastfeeding is possible only when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence the speed of reactions while driving or operating machinery.

Patients who experience blurred vision after instillation of the drug should refrain from driving or operating machinery.

Administration and Dosage.

For the treatment of acute and chronic conjunctivitis, blepharoconjunctivitis, gonococcal ophthalmia, and chlamydial conjunctival infection, instill 2–3 drops of Oftalmodek into the conjunctival sac 4–6 times daily until full recovery.

For the prevention of ophthalmia neonatorum in newborns, instill 2 drops into each eye immediately after birth and again 2 hours after delivery.

For prophylactic use, administer Oftalmodek 2–3 drops 4–6 times daily, starting 1 day before surgical intervention and continuing for 3–5 days after surgery.

To disinfect contact lenses, immerse them in the drug solution for 10–15 minutes, then rinse in sterile 0.9% sodium chloride solution.

Children. The drug may be used in newborns for the prevention of ophthalmia neonatorum.

Overdose. No cases of overdose have been reported.

Side effects.

Allergic reactions and local eye irritation are possible in cases of increased individual sensitivity to decamethoxine.

Shelf life. 3 years.

The shelf life of the solution after opening the bottle is 14 days.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging.

5 ml or 10 ml in a bottle with a dropper cap in a carton.

Prescription status. Prescription only.

Manufacturer.

Limited Liability Company "Experimental Plant 'GNCLS'".

Limited Liability Company "FARMEKS GROUP".

Manufacturer's address and place of business.

8 Vorobiova Street, Kharkiv, Kharkiv Region, Ukraine.

(Limited Liability Company "Experimental Plant 'GNCLS'")

100 Shevchenka Street, Boryspil, Kyiv Region, 08301, Ukraine.

(Limited Liability Company "FARMEKS GROUP")