Zaditen - instructions for use, doses, side effects, contraindications

Excipients: benzalkonium chloride 0.1 mg, glycerol (glycerol) 21.25 mg, 1 M sodium hydroxide solution 0.75 ml (to pH 5.3), water for injection up to 1 ml.

Description:Transparent, colorless or slightly yellowish solution, odorless.

Pharmacotherapeutic group:Antiallergic agent for topical application

ATX: & nbsp

S.01.G.X.08 Ketotifen

R.06.A.X.17 Ketotifen

Pharmacodynamics:

In vivo and in vitro ketotifen inhibits the release of mediators (histamine, leukotrienes, prostaglandins and platelet activating factor) from cells involved in Type I allergic reactions (mast cells, eosinophils, basophils and neutrophils). Ketotifen suppresses chemotaxis, activation and degranulation of eosinophils and stabilizes cell membranes by inhibiting phosphodiesterase and decreasing the level of cyclo-AMP.

Ketotifen also blocks H₁-gistaminovye receptors.

Pharmacokinetics:

The concentration of ketotifen in the blood after instillation into the conjunctival cavity for 14 days in most cases was below the quantification limit (20 pg / ml).

At systemic application 50% of ketotifenum is metabolized at "the first passage" through a liver. The maximum concentration in blood plasma is reached within 2-4 hours. Binding to plasma proteins is 75%. It is biphasic. The early half-life is 3-5 hours, the final elimination is 21 hours. It is excreted by the kidneys, 60-70% in the form of metabolites in the form of glucuronides, 1% in unchanged form.

Indications:Prevention and treatment of seasonal allergic conjunctivitis.

Contraindications:

Increased individual sensitivity to ketotifen or any other components of the drug.

Because the effectiveness and safety of treatment with eye drops Zaditen® in children younger than 3 years, as well as during pregnancy and lactation are not established, the drug should not be used in this category of patients.

Dosing and Administration:

Adults, patients over the age of 65, children older than 3 years: 1 drop in the conjunctival sac 2 times a day.

Patients over the age of 65 do not need a dosage adjustment.

Patients with renal and hepatic pathology do not require correction of the dosing regimen.

The maximum duration of treatment with the drug should not exceed 6 weeks.

Side effects:

Undesirable reactions are listed using the following frequency designations: very often (≥1/10), often (from ≥1/100 to <1/10), infrequently (from ≥1/1000 to <1/100), rarely (from ≥1/10000 to <1/1000), very rarely (<1/10000). Within the same frequency category, unwanted reactions are given in order of severity.

Immune system disorders: infrequently - hypersensitivity.

Disturbances from the nervous system: infrequently - headache, drowsiness.

Disturbances on the part of the organ of sight: often - dotted keratitis, corneal erosion, irritation and pain in the eyes; infrequent - visual acuity reduction (with instillation of the drug), dry eye syndrome, eyelid disorders, conjunctivitis, photophobia, conjunctival hemorrhages.

Disorders from the gastrointestinal tract: infrequent - dry mouth.

Disturbances from the skin and subcutaneous tissues: infrequently - skin rash, eczema, urticaria.

Adverse reactions, the frequency of which is not established (post-marketing experience):

Local Reactions: allergic reactions / hypersensitivity, including contact dermatitis, eye swelling, pruritus and edema of the eyelids.

Systemic reactions: Systemic hypersensitivity reactions including but not limited to swelling / puffiness of the face (in some cases associated with contact dermatitis) and exacerbation of previous allergic conditions such as asthma and eczema. Cases of vertigo are also described.

Overdose:

Data on drug overdose are absent.

Eye drops Zaditen® are safe for inadvertent ingestion, since in 5 ml of the solution contains 1.25 mg of ketotifen, which is 60% of the maximum oral dose for children over 3 years old.

When oral administration of ketotifen in a dose of up to 20 mg, no serious symptoms developed.

Interaction:

Data on the interaction of eye drops Zaditen® with other medicines are absent.

Special instructions:

ZADITEN®, eye drops, contains as a preservative benzalkonium chloride, which can cause eye irritation and is able to penetrate into the material of soft contact lenses. The drug is used only after removal of contact lenses. Wear contact lenses 15 minutes after instillation. All eye drops, which include benzalkonium chloride, can change the color of soft contact lenses.

When the original package is opened, the sterility of the dropper bottle is impaired. To prevent contamination of the drug solution during instillation, patients should not touch the tip of the dropper bottle to any surface.

To avoid damage, do not touch the eyes.

If it is necessary to instill several drugs into the conjunctival cavity, the preparations should be applied separately with an interval of at least 5 minutes.

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

With the development of blurred vision, drowsiness in the background of treatment Zaditenom® patients should abandon the management of vehicles or work with mechanisms.

Form release / dosage:

Eye drops 0.25 mg / ml.

Packaging:

5 ml in a polyethylene bottle-dropper of white color.

1 bottle with instructions for use in a cardboard box.

Storage conditions:

Store at temperatures up to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Shelf life after bottle opening 1 month.

The drug should not be used after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014207 / 01

Date of registration:18.05.2009 / 26.12.2012

Expiration Date:Unlimited

Date of cancellation:2018-03-22

The owner of the registration certificate:ALKON PHARMACEUTICS, LLC ALKON PHARMACEUTICS, LLC Russia

Manufacturer: & nbsp

EXCELVISION France

Representation: & nbspALKON PHARMACEUTICS LLCALKON PHARMACEUTICS LLCRussia

Information update date: & nbsp22.03.2018

Illustrated instructions

Instructions

Zaditen® (Zaditen® )