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

Active substanceDiphenhydramine + NaphazolineDiphenhydramine + Naphazoline

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Ditadrine®

drops d / eye

Warsaw Pharmaceutical Plant Polfa, JSC Poland

SIGIDA duo

drops d / eye

GROTEKS, LLC Russia

Dosage form: & nbspEye Drops

Composition:

Active substances:

Diphenhydramine hydrochloride 1 mg

Naphazoline Nitrate 0.33 mg

Excipients:

boric acid 19.0 mg, disodium edetate 0.5 mg; benzalkonium chloride, a solution of 0.2 mg; sodium hydroxide 10% to pH 4.4-5.6; water purified to 1.0 ml.

Description:Colorless transparent liquid.

Pharmacotherapeutic group:Anti-allergic drug combined (H1-histamine receptor blocker + alpha-adrenomimetic).

ATX: & nbsp

Naphazoline in combination with other drugs

Pharmacodynamics:

Ditadrine® is a combined drug, has antihistamine (diphenhydramine) and vasoconstrictive (naphazoline) action.

Diphenhydramine is an antagonist of H1 receptors. By competitive blockade of histamine H1 receptors, it reduces allergic symptoms, especially those associated with the release of histamine, such as increased permeability and vasodilatation.

Naphazoline stimulates the alpha-adrenergic receptors of the vessels, and its topical application leads to narrowing of the dilated vessels and a reduction in the symptoms of the inflammatory condition.

Pharmacokinetics:

The full local effect of naphazoline is detected after only 5 minutes from the time of application. The action lasts 6 - 8 hours.

Naphazoline can be absorbed from the mucous membranes, causing systemic effects, although such action in adults after administration of the drug into the conjunctival sac is unlikely. Systemic reactions occur mainly in elderly patients and in young children.

The appearance of systemic action of diphenhydramine is unlikely.

Indications:

Exacerbation of seasonal or year-round allergic conjunctivitis;

Inflammatory conditions associated with irritation of the conjunctiva as a result of the use of contact lenses, exposure to sunlight, cigarette smoke, contact with water in a swimming pool, etc.

Contraindications:

Hypersensitivity to any component of the drug (including to sympathomimetic amines);
Pregnancy;
Breast-feeding;
Closed-angle glaucoma;
Children's age (up to 2 years).

Carefully:

Do not use drops in case of prolonged conjunctivitis, they can be used for a short time in case of exacerbation of a chronic disease.

The systemic effect of the components of the drug after administration to the conjunctival sac is unlikely, but it should be used with caution in patients with hypertension, arrhythmia, atherosclerosis, chronic rhinitis, bronchial asthma with hypersensitivity to sympathomimetic amines, in hyperthyroidism, as well as prostatic hypertrophy and in old age . These patients should be warned that in the event of any systemic reactions indicating the absorption of naphazoline, it is necessary to stop using the drug.

It is not recommended to use the drug in newborns and in children under 6 years due to the possible emergence of potentially dangerous side effects.

The patient should be warned that the persistence of symptoms of irritation or pain in the eyes for more than 72 hours is an indication for the withdrawal of the drug. Contraindicated use of the drug for more than 5 days or with an interval of less than 3 hours because of the risk of developing a syndrome leading to a secondary increase in edema and hypersecretion, as well as the possibility of developing persistent changes in the epithelium.

Pregnancy and lactation:During pregnancy, the use of the drug is not recommended.If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.

Dosing and Administration:Locally, in the conjunctival sac.

Adults and children over 6 years of age:

1-2 drops in the conjunctival sac, if necessary every 6-8 hours.

The drug should not be used for more than 3-5 days.

Side effects:

Burning, itching, irritation of the conjunctiva, pain in the eyes, visual impairment, dryness of the nasal mucosa, mydriasis, increased intraocular pressure.

A single case of corneal opacity (when applied for 7 days at least 10 times a day), which disappeared after discontinuation of treatment, is described.

Long-term use can lead to local epithelial changes associated with hypoxia (worsening prognosis).

Overdose:

Prolonged or too frequent administration of the drug in children under 6 years of age can lead to inhibition of the central nervous system, hypothermia (lowering of body temperature), prolonged mydriasis, increased blood pressure, tachycardia, coma.

Treatment: symptomatic.

Interaction:The use of drugs containing naphazoline, simultaneously with the use of tricyclic antidepressants,can potentiate the vasoconstrictive effect of naphazoline.

The simultaneous use of nafazoline with MAO inhibitors can lead to the development of hypertensive crisis.

Special instructions:The drug is intended for topical use only: instillation into the conjunctival sac.

Taking into account the content of benzalkonium chloride in the preparation, you should remove soft contact lenses before instillation and install them not earlier than 15 minutes after instillation.

Benzalkonium chloride can cause eye irritation and change the color of contact lenses.

Effect on the ability to drive transp. cf. and fur:Due to a possible visual impairment, the drug should be used with caution in persons managing vehicles and servicing mechanisms.

Form release / dosage:Eye drops.

Packaging:For 5 ml polyethylene bottle with a dropper, closed with a screw cap with a warranty ring. 1 or a set of 2 vials. 2 x 5 ml (10 ml) is placed in a cardboard box with instructions for use.

Storage conditions:

In the dark place at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Shelf life after opening the bottle is 4 weeks.

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

Terms of leave from pharmacies:On prescription

Registration number:P N 014982/01

Date of registration:01.07.2008 / 19.03.2012

The owner of the registration certificate:Warsaw Pharmaceutical Plant Polfa, JSCWarsaw Pharmaceutical Plant Polfa, JSC Poland

Manufacturer: & nbsp

Warsaw Pharmaceutical Factory Polfa A.O. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp05.01.2016

Illustrated instructions

Instructions

Ditadrine® (Ditadrin®)