Oftofenazole - instructions for use, dose, side effects, contraindications

Active substanceAntazolin + NaphazolineAntazolin + Naphazoline

Similar drugsTo uncover

Oftofenazole®

drops d / eye

Representative Office of Warsaw Pharmaceutical Factory Polfa Russia

Sanorin-analgesin

drops nazal.

Teva Pharmaceutical Enterprises Co., Ltd. Israel

Dosage form: & nbspeye drops

Composition:

Composition per ml:

Active substances: antazolin sulfate 5.00 mg, nafazoline nitrate 0.25 mg.

Excipients: boric acid 15.00 mg, disodium edetate dihydrate 0.50 mg, benzalkonium chloride solution 50% 0.20 mg, sodium hydroxide solution 10 % (to pH 4.0-5.5), water purified to 1 ml.

Description:

Transparent colorless or light yellow liquid.

Pharmacotherapeutic group:Antiallergic combination drug (H1-histamine receptor blocker + alpha-adrenomimetic)

ATX: & nbsp

S.01.G.A.51 Naphazoline in combination with other drugs

Pharmacodynamics:

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

Antazolin is a blocker of H1-histamine receptors of the first generation. Through 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 a-adrenergic receptors in 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:

The drug is used for acute, seasonal or year-round allergic conjunctivitis.

Contraindications:

- Hypersensitivity to the components of the drug;

- angle-closure glaucoma;

- with increased sensitivity to adrenomimic drugs;

- inhibition of monoamine oxidase (MAO);

- children's age till 6 years.

Carefully:

- Patients with chronic conjunctivitis should be used for a short time and only if the symptoms worsen;

- should comply with 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.

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.

Dosing and Administration:

The drug is intended only for topical application in the form of instillations 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.

Side effects:

Usually there are temporary symptoms from the conjunctiva; burning, itching in the eye, a vision disorder, 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.

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 can 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.

Interaction:

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

Special instructions:

The drug Oftofenazole® contains as a preservative benzalkonium chloride, patients who wear contact lenses should remove them before instilling eye drops and wait at least 15 minutes before installing them again. Benzalkonium chloride may 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.

Effect on the ability to drive transp. cf. and fur:

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.

Form release / dosage:

Eye drops.

Packaging:5 ml are packed in a polyethylene bottle with a dropper, closed with a cover with a warranty ring. 2 bottles along with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years. Shelf life after autopsy - 4 weeks.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001578

Date of registration:11.03.2012

Expiration Date:11.03.2017

The owner of the registration certificate:Representative Office of Warsaw Pharmaceutical Factory Polfa Representative Office of Warsaw Pharmaceutical Factory Polfa Russia

Manufacturer: & nbsp

Representative Office of Warsaw Pharmaceutical Factory Polfa Russia

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp20.06.2017

Illustrated instructions

Instructions

Oftofenazole® (Ophthophenazole®)