Appamage Plus (Appamide Plus)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTropicamide + PhenylephrineTropicamide + Phenylephrine
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  • Appamage Plus
    drops d / eye 
    Apparel Ocular Device (P) Ltd. (Pharma Division)     India
  • Phenicamid
    drops d / eye 
    GROTEKS, LLC     Russia
    • Dosage form: & nbspeye drops
    Composition:

    In 1 ml contains:

    Active substances: tropicamide - 8 mg, phenylephrine hydrochloride - 50 mg.

    Excipients: chlorobutanol 5 mg, sodium hydrophosphate 0.28 mg, sodium dihydrogen phosphate 0.005 mg, sodium chloride 4.5 mg, disodium edetate 0.5 mg, water up to 1 ml.

    Description:A clear, colorless solution.
    Pharmacotherapeutic group:M-holinoblokator + alpha-adrenomimetic
    ATX: & nbsp

    S.01.F.A.56   Tropicamide in combination with other drugs

    Pharmacodynamics:

    Tropicamide. M-cholinoblocking agent, blocks the receptors of the sphincter of the pupil and ciliary muscle, causing short-term mydriasis and accommodation paralysis. Slightly increases the intraocular pressure. The onset of action is 5 minutes, the optimal time for the examination of eye refraction is 25-40 minutes (for 0.5% solution) and 25-30 minutes after re-instillation (for 1% solution). For 0.8% solution, the time for the effect will be within the specified values. The maximum dilatation of the pupil is maintained for 1 hour (for 0.5% solution) and 2 hours (for 1% solution). The initial width of the pupils is restored after 6 hours.

    Phenylephrine. Has a pronounced stimulating effect on postsynaptic α-adrenoceptors, weakly affects β1-adrenergic receptors of the heart. Has vasoconstrictor effect (vasopressor effect of phenylephrine is weaker than that of norepinephrine, but longer), practically does not have a chrono and inotropic effect. After instillation phenylephrine reduces the pupil dilator and smooth muscles of the arterioles of the conjunctiva, thereby causing pupil dilatation and constriction of the conjunctival vessels, improves the outflow of intraocular fluid. The dilatation of the pupil occurs within 10-60 min after a single instillation and lasts for 4-6 hours.

    Pharmacokinetics:

    Tropicamide. Easily penetrates the tissues of the eye, quickly absorbed into the bloodstream. The lower limit of the determination of tropicamide in plasma is less than 240 pg / ml, the range is 240 pg / ml - 10 ng / ml.

    Phenylephrine. Easily penetrates into the eye tissue, the peak concentration in plasma is observed 10-20 min after topical application. Phenylephrine is excreted by the kidneys in unchanged form (<20%) or in the form of inactive metabolites.

    Indications:

    Dilation of the pupil: 1) with diagnostic ophthalmic procedures; 2) before surgical and laser operations.

    Contraindications:

    Hypersensitivity to the components of the drug, age to 18 years, angle-closure glaucoma, increased intraocular pressure, diseases of the cardiovascular system (including coronary sclerosis, angina pectoris, arrhythmia, hypertensive crisis), thyrotoxicosis, type 1 diabetes mellitus, pregnancy, lactation period , simultaneous administration (and also within 3 weeks after their withdrawal) of monoamine oxidase inhibitors (MAO).

    Carefully:

    Diabetes mellitus type 2, elderly age (risk of ventricular arrhythmia and myocardial infarction in patients with cardiovascular disease).

    Dosing and Administration:

    To dilate the pupil with diagnostic ophthalmologic and surgical interventions in the conjunctival cavity, drop in 1-2 drops for 15-30 minutes before the procedure or operation.

    Side effects:

    Allergic reactions.

    Local Reactions: transitory burning, conjunctival hyperemia, blocking the angle of the anterior chamber (with narrowing of the angle), blurred vision, a feeling of discomfort in the eye, lacrimation, superficial pinpoint keratitis, increased intraocular pressure,photophobia; rarely - reactive cramps the day after the application (repeated instillation of the drug at this time may give less pronounced mydriasis than the day before, the effect is often seen in elderly patients).

    Systemic side effects: Pallor, dry mouth, nausea, vomiting, headache, contact dermatitis, disorders of the central nervous system and muscle rigidity, palpitation, tachycardia, arrhythmia, hypertension, reflex bradycardia, occlusion of the coronary arteries, pulmonary embolism; In rare cases (in elderly patients with diseases of the cardiovascular system) - ventricular arrhythmia, myocardial infarction.

    Overdose:

    Data on overdose of tropicamide and phenylephrine in local application are absent.

    Symptoms (in case of excessive intake of the drug inside): Dry skin and mucous membranes, hyperthermia, tachycardia, mydriasis, agitation, convulsions, coma, respiratory paralysis.

    Treatment: gastric lavage, reception of activated charcoal; as antidote - fizostigmii (0.03 mg / kg by slow intravenous injection), benzodiazepines; to eliminate hyperthermia - cold compresses.To stop the systemic action of phenylephrine - α-adrenoblockers (5-10 mg of phentolamine intravenously, if necessary, repeat the injection).

    Interaction:

    Adrenomimetics strengthen, m-holinomimetiki - weaken the effect of tropicamide. Tricyclic antidepressants, phenothiazines, amantadine, quinidine, antihistamines increase the likelihood of systemic side effects of tropicamide.

    Atropine enhances mydriatic effect of phenylephrine. Simultaneous application with MAO inhibitors, and also within 21 days after discontinuation of their intake increases the risk of systemic adrenergic effects. The vasopressor effect of α-adrenomimetics can also be enhanced when combined with tricyclic antidepressants, propranolol, guanethidine, methyldopa, and m-cholinoblockers, β-adrenoblockers increase the risk of a sharp increase in blood pressure. Phenylephrine increases the risk of suppression of cardiovascular activity with inhalation of general anesthesia.

    Special instructions:

    Preservatives contained in the preparation can be adsorbed by soft contact lenses.The drug can be irritating to the eye when wearing contact lenses, so any contact lenses should be removed before instillation and put on not earlier than 15 minutes after it.

    Drops should be instilled in the lower conjunctival sac. To reduce the risk of developing a systemic side effect, it is recommended to lightly press a finger on the area of ​​the projection of lacrimal sacs at the inner corner of the eye within 1-2 minutes after instillation.

    Due to a significant reduction in the pupil dilator, after 30-45 minutes after instillation in the moisture of the anterior chamber of the eye, pigment particles from the iris pigment sheet can be detected. The suspension in the chamber moisture must be differentiated with the manifestations of anterior uveitis or with the ingress of the formed elements of blood into the moisture of the anterior chamber. The preliminary instillation of local anesthetics can increase the systemic absorption of phenylephrine and prolong the mydriasis.

    Effect on the ability to drive transp. cf. and fur:During the period of treatment, it is not recommended to drive vehicles and engage in other hazardous activities that require an increased concentration of attention and speed of psychomotor reactions, since due to changes in accommodation and the width of the pupil, visual acuity can be reduced.
    Form release / dosage:Eye drops.
    Packaging:5 ml of the drug in an opaque bottle-dropper made of polyethylene low density with white cover from high-density polyethylene. Vial with instructions for usein a pack of cardboard.
    Storage conditions:

    In the dark place at a temperature of 15 ° C to 25 ° C. Keep out of the reach of children.

    Shelf life:

    2 years. 4 weeks from the time the vial is opened (under the same storage conditions). Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000480
    Date of registration:01.03.2011 / 04.07.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Apparel Ocular Device (P) Ltd. (Pharma Division)Apparel Ocular Device (P) Ltd. (Pharma Division) India
    Manufacturer: & nbsp
    Representation: & nbspPharmInform Ltd.PharmInform Ltd.Russia
    Information update date: & nbsp10.09.2017
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