Universal reference book for medicines
Name of the drug: OPTOFENAZOLE (OPHTHOPHENAZOLE)

Active substance: antazoline, naphazoline

Type: The drug with antiallergic and vasoconstrictive action for topical application in ophthalmology

Manufacturer: Representative office of Warsaw Pharmaceutical Plant Polfa (Russia)
Composition, form of production and packaging
?
Drops of the eye in the form of a transparent, colorless or light yellow liquid.
1 ml

antazolin sulfate 5 mg

naphazoline nitrate 0.25 mg

Excipients: boric acid 15 mg, disodium edetate dihydrate 0.5 mg, benzalkonium chloride 50% 0.2 mg, sodium hydroxide solution 10% to pH 4.0-5.5, water purified to 1 ml.

10 ml - a bottle-droppers polyethylene (1) ll - boxes cardboard.

15 ml - a bottle-droppers polyethylene (1) ll - boxes cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

The drug Oftofenazole is a combined preparation containing in its composition an antihistamine drug - antazolin and? -adrenomimetic drug - naphazoline.

Antazolin is a blocker of H1-histamine receptors of the first generation.
By means of a competitive blockade of H1-histamine receptors, the drug weakens such allergic reactions as the expansion and increase in the permeability of blood vessels, in particular, associated with the release of histamine.
Naphazoline stimulates? -adrenergic receptors of blood vessels;
with topical application narrows the dilated blood vessels of the conjunctiva and eliminates the symptoms of inflammation (reduces swelling, flushing and exudation).
PHARMACOKINETICS

The effect of naphazoline appears only 5 minutes after topical application.
The duration of action is 6-8 hours.
Naphazoline can be absorbed through the mucous membranes, having a systemic effect, although such action in adults after administration of the drug into the conjunctival sac is unlikely.
Systemic reactions mainly appear in elderly patients and in young children. The appearance of systemic action of antazoline is unlikely.
INDICATIONS

- Acute, seasonal or year-round allergic conjunctivitis.

DOSING MODE

The drug is intended only for topical application in the form of installations in the conjunctival sac.

Adults and children over 6 years of age:

1-2 drops in the conjunctival sac, if necessary, the dose can be repeated after 4-6 hours.

After instillation of the drug, gently close the eye, do not blink and do not open for about 2 minutes, so that the drug is absorbed.
After instillation, gently flex the finger on the inner corner of the lower eyelid for 1-2 minutes. This can prevent drops from entering the nasolacrimal canal into the nasal cavity and the occurrence of side effects of a systemic nature. Then wash your hands to remove the remnants of the drug and close the vial.
The drug is not recommended for use for longer than 3-5 days without a doctor's recommendation.

The need to change the dose or duration of treatment is determined by the doctor individually in each case.

Carefully:

- for patients with chronic conjunctivitis, the drug should be used for a short time and only in case of exacerbation of symptoms;

- should be observed the recommended time of application of the drug and not exceed the prescribed dose due to the danger of secondary strengthening of the edema of the conjunctiva and increase the discharge, as well as the development of persistent changes in the epithelium.

SIDE EFFECT

Usually there are temporary symptoms from the conjunctiva: burning, itching in the eye, visual disturbance, redness of the conjunctiva.

Systemic reactions: drowsiness, lethargy, increased blood pressure, headaches and dizziness, nausea, tenderness of the eyes.

Preservation of symptoms or increased local changes is an indication for the withdrawal of the drug.

CONTRAINDICATIONS

hypersensitivity to the components of the drug;

- an angle-closure glaucoma;

- with increased sensitivity to adrenomimic drugs;

- reception of monoamine oxidase inhibitors (MAO);

- Children under 6 years.

PREGNANCY AND LACTATION

During pregnancy, the use of the drug is contraindicated.
If you need to use the drug during lactation, breastfeeding should be discontinued.
APPLICATION FOR CHILDREN

Contraindicated in children under 6 years.
Applied in children older than 6 years.
SPECIAL INSTRUCTIONS

The drug Oftofenazole ® contains benzalkonium chloride as a preservative, patients who wear contact lenses should remove them before installing eye drops and wait at least 15 minutes before installing them again.
Benzalkonium chloride can cause eye irritation and change the color of contact lenses.
When using the drug, avoid touching the tip of the dropper with any surface to avoid microbial contamination.

Impact on the ability to drive vehicles and service moving machinery

Patients who, after applying the drug, temporarily lose their clear vision, do not drive vehicles and work with moving mechanisms immediately after instillation of eye drops.

OVERDOSE

There are no data on the acute overdose of drops administered topically into the conjunctival sac.

Prolonged or too frequent administration of the drug to children, or occasional ingestion may lead to depression of the central nervous system, drowsiness, hypothermia, and even coma.
There may be a decrease in blood pressure and tachycardia. Symptomatic treatment should be prescribed.
DRUG INTERACTION

Do not use the drug simultaneously with monoamine oxidase (MAO) inhibitors and tricyclic antidepressants.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Keep the drug out of reach of children at a temperature of no higher than 25 ° C.
Do not freeze.
Shelf life - 3 years.
Shelf life after autopsy - 4 weeks. Do not use after the expiry date printed on the package.
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