Clinical and pharmacological group: & nbsp

Ophthalmic products

Included in the formulation
  • Appamage Plus
    drops d / eye 
  • Phenicamid
    drops d / eye 
    GROTEKS, LLC     Russia
  • АТХ:

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

    Pharmacodynamics:

    Tropicamide. M-holinoblokator. Has a blocking effect on the receptors of the sphincter of the pupil and ciliary muscle, resulting in short-term mydriasis and accommodation paralysis. The onset of action 5-10 min after instillation. The duration of the effect reaches 6 hours.

    Phenylephrine. Stimulates postsynaptic alpha-adrenergic receptors. Has a vasopressor effect, reduces the dilator pupil and smooth muscle arterioles of the conjunctiva, leading to pupil dilating and narrowing of the conjunctival vessels. Increases the outflow of intraocular fluid.

    Pharmacokinetics:

    Tropicamide. After instillation of the drug into the conjunctival sac tropicamide to a small extent is subjected to systemic absorption (especially in children and the elderly).

    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:

    For diagnostic purposes, if necessary, mydriasis and cycloplegia, including in the study of the fundus and the definition of refraction.Hypersensitivity to other drugs that dilate the pupil (atropinescopolamine). In the complex therapy of inflammatory processes and synechia.

    XXI.Z00-Z13.Z01.0   Examination of eyes and eyesight

    Contraindications:

    Hypersensitivity, glaucoma (especially closed-angle), increased intraocular pressure.

    Carefully:

    Increased sensitivity to tropicamide and other such drug substances was detected in infants, small children, blond and blue-eyed children, in adults and children with Down's syndrome in children and adults with brain impairment and spastic paralysis. Pregnancy, breast-feeding, breast age.

    Pregnancy and lactation:Adequate and well-controlled studies in humans and animals have not been conducted. There is no information on the penetration into breast milk.

    Recommendations for FDA - Category C.

    Dosing and Administration:

    Study fundus (fundoscopy) - 1 drop of 0.5% solution of 2 times at intervals of 5 minutes, or three times for 10 minutes.

    Determination of refraction method skiascopy - 1 drop of 1% solution 4-6 times in 5-10 minutes, accommodation spasm occurs within 1 hour.

    Inflammatory processes and adhesions in the chambers of the eye - 1-2 drops to 6 times a day.

    Side effects:

    Local reactions: increased intraocular pressure, acute attack of closed-angle glaucoma, blurred vision, photophobia, irritation (swelling, hyperemia).

    Systemic effects: behavioral disorders or psychotic reactions (unusual behavior, especially in children), clumsiness and instability, headache, confusion, palpitations, reddening of the face, visual and auditory hallucinations, thirst, dry mouth, dry skin, fever, dermal rashes, slurred speech, cramps, bloating, delayed urination, unusual drowsiness, fatigue, weakness.

    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: intravenous injection of physostigmine (children - 0.5 mg, in the absence of the effect of increasing the dose to 2 mg, adults - 2 mg, in the absence of the effect of repeated intravenous injection of 1-2 mg after 20 minutes).
    Interaction:

    Sympathomimetics - strengthening of mydriatic action.

    Tricyclic antidepressants, phenothiazines, antihistamines - strengthening of systemic cholinoblocking action.

    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. Phenylephrine increases the risk of cardiovascular depression while inhaling general anesthesia.

    Special instructions:

    In comparison with other mydriaticians tropicamide causes a minimum of side effects when used in healthy newborns, and in combination with cyclopentolate and phenylephrine is the most effective mydriatic.

    Combination tropicamide 0,5 % + phenylephrine 2.5% provides maximum mydriasis and causes a minimum of side effects. The preliminary instillation of local anesthetics can increase the systemic absorption of phenylephrine and prolong the mydriasis.

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