Active substanceKetotifenKetotifen
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  • Dosage form: & nbspeye drops
    Composition:

    In 1 ml contains:

    active substance: ketotifen fumarate in terms of ketotifen 0.5 mg;

    Excipients: disodium edetate dihydrate 1.0 mg, polyvinyl alcohol 14.0 mg, benzalkonium chloride 50% solution 0.2 mg (in terms of benzalkonium chloride) 0.1 mg, sodium chloride 5.61 mg, sodium hydroxide q.s. to pH 4.6-5.4, hydrochloric acid q.s. up to pH 4.6-5.4, water for injection up to 1 ml.

    Description:A clear, colorless or almost colorless solution.
    Pharmacotherapeutic group:Antiallergic agent - stabilizer of membranes of mast cells
    ATX: & nbsp

    S.01.G.X.08   Ketotifen

    R.06.A.X.17   Ketotifen

    Pharmacodynamics:

    Ketotifen is a blocker H1-gistaminovyh receptors. It also inhibits the release of inflammatory mediators (including histamine, leukotrienes, prostaglandins, platelet activating factor) from cells involved in the realization of immediate-type hypersensitivity reactions (mast cells, eosinophils, basophils and neutrophils). Ketotifen reduces chemotaxis, activation and degranulation of eosinophils; stabilizes cell membranes due to the inhibition of phosphodiesterase increase in intracellular cAMP content.

    Pharmacokinetics:

    After instillation into the conjunctival cavity for 14 days, 18 healthy volunteers, the concentration of ketotifen in the blood in most cases did not reach the lower limit of quantification (<20 pg / ml).

    At systemic application 50% of ketotifenum is metabolized at "the first passage" through a liver. The maximum concentration in the blood is reached within 2-4 hours.The connection with plasma proteins is 75%. It is biphasic. Initial half-life (T1/2) - 3-5 hours, terminal T1/2 - 21 hours 60-70% is excreted by the kidneys in the form of glucuronides, 1% in unchanged form.

    Indications:Prevention and treatment of seasonal allergic conjunctivitis.
    Contraindications:

    Hypersensitivity to ketotifen or other components of the drug. Pregnancy, breast-feeding.

    Age to 3 years.
    Pregnancy and lactation:

    In studies of reproductive toxicity in animals no risk to the fetus has been identified, no controlled studies have been performed in pregnant women. There is no information on the penetration of ketotifen into breast milk. The use of the drug during pregnancy and lactation is contraindicated.

    Dosing and Administration:

    Adults and children older than 3 years: 2 times a day, 1 drop in a conjunctival bag of both eyes.

    Duration of treatment should not exceed 6 weeks.

    Side effects:

    The undesirable effects listed below are given in accordance with the following gradations of their occurrence frequency: very often (≥ 10%), often (≥ 1%, <10%, infrequently (≥ 0.1%, <1%), rarely (≥ 0.01%, <0.1%), very rarely (< 0.01%), including individual messages, the frequency is unknown - according to available data to establish the frequency of occurrence is not possible.

    Undesirable drug reactions are presented in descending order of severity.

    From the side of the organ of vision: often - irritation and pain in the eyes, pinpoint keratitis, corneal erosion; infrequent - blurred vision (after instillation of eye drops), dry eye mucosa, eyelid irritation, conjunctivitis, photophobia, hemorrhages in the conjunctiva.

    From the immune system: infrequently - hypersensitivity.

    From the nervous system: infrequently - headache, drowsiness.

    From the digestive system: infrequent - dryness of the oral mucosa.

    Diseases of the skin and subcutaneous tissue: infrequently - skin rash, eczema, hives, allergic reactions.

    Results of post-registration experience of observation

    From the side of the organ of vision: frequency unknown - allergic reactions / hypersensitivity, including contact dermatitis, eye swelling, pruritus and edema of the eyelids.

    From the immune system: frequency unknown - systemic hypersensitivity reactions, including but not limited to swelling / swelling of the face (in some cases caused by contact dermatitis) and exacerbation of previous allergic conditions,such as bronchial asthma and eczema.

    Overdose:

    There is no information about drug overdose.

    In 5 ml of the drug contains 2.5 mg of ketotifen, which is 120% of the recommended daily dose for people over 3 years. When oral administration of ketotifen in a dose of up to 20 mg, serious toxic reactions were not observed.

    Interaction:

    With the simultaneous use of several ophthalmic drugs, the interval between their use should be at least 5 minutes.

    After oral administration ketotifen can enhance the effect of drugs that depress the central nervous system (sedatives, H1-histamine receptor blockers, alcohol, etc.). Despite this, when using eye drops containing ketotifen, such reactions were not noted, but the possibility of their development is not excluded.

    Special instructions:

    As a preservative, the preparation contains benzalkonium chloride, which is absorbed by soft contact lenses and has a toxic effect on the cornea, therefore it is recommended to remove the lenses before instillation of Daltiphen preparation® and wear them no earlier than 15 minutes after instillation.

    Do not use Daltiphen®, if the cause of irritation are contact lenses.

    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 infection with the coccyx bottle, do not touch the eyes.

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

    With a decrease in visual acuity, the occurrence of drowsiness and other undesirable drug reactions that can affect visual acuity or concentration, during the period of treatment with Daltiphen® it is necessary to refrain from potentially dangerous activities requiring an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Eye drops, 0.05%.

    Packaging:

    To 5 ml of the drug in the bottles-droppers from PNP, sealed with a screw cap of PVP with a point for piercing the dropper.

    One bottle together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    The drug should not be used after the expiration date.

    After opening the bottle, eye drops should be used within one month.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002663
    Date of registration:20.10.2014 / 02.04.2015
    Expiration Date:20.10.2019
    Date of cancellation:2018-05-11
    The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India
    Manufacturer: & nbsp
    Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India
    Information update date: & nbsp11.05.2018
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