Alphabrim® (Alfabrim)

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBrimonidineBrimonidine
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    drops d / eye 
    Micro Labs Limited     India
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    • Dosage form: & nbspeye drops
    Composition:

    Each ml of the preparation contains:

    active substance: Brimonidine tartrate -1.5 mg;

    Excipients: carmellose sodium -1.69 mg, boric acid -2.0 mg, sodium tetraborate 0.25 mg, potassium chloride -1.4 mg, sodium chloride 6.0 mg, calcium chloride dihydrate 0.2 mg, magnesium chloride hexahydrate - 0.06 mg, stabilized oxychlorocomplex (sodium chlorite, sodium chlorate, chlorine dioxide) in terms of sodium chloride - 0.05 mg, sodium hydroxide - q.s. up to pH 6.0, water for injection - up to 1 ml.

    Description:

    A clear, colorless or light yellow solution

    Pharmacotherapeutic group:Antiglaucoma means - alpha2-adrenomimetic selective
    ATX: & nbsp

    S.01.E.A   Sympathomimetics for the treatment of glaucoma

    S.01.E.A.05   Brimonidine

    Pharmacodynamics:

    Brimonidine - selective α2-adrenomimetic. The maximum decrease in intraocular pressure (IOP) is achieved after 2 hours. The hypotensive action of brimonidine is provided by reducing the formation of watery moisture and increasing outflow along the uveoscleral pathway.

    Pharmacokinetics:

    When instillation of eye drops, the maximum concentration of brimonidine in plasma is reached after 0.5-2.5 h, the systemic half-life (T1/2) is about 2 hours.

    Brimonidine intensively metabolized in the liver.

    Excreted mainly by the kidneys in the form of unchanged brimonidine and its metabolites. About 87% of radiolabeled brimonidine is excreted within 120 hours, 74% of the radioactive label is found in the urine.

    Indications:

    Decreased elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

    Contraindications:
    • Hypersensitivity to brimonidine and other components of the drug.
    • Simultaneous therapy with monoamine oxidase inhibitors (MAO).
    • Children under 2 years.
    • The period of breastfeeding.
    Carefully:

    Orthostatic hypotension, heart failure, cerebrovascular diseases, resulting in cerebral circulatory insufficiency, renal failure, liver failure, depression, Raynaud's syndrome, thromboangiitis obliterans, children 2-7 years of age.

    Pregnancy and lactation:

    Pre-clinical studies showed no teratogenic effects on the fetus. However, it has been established that brimonidine penetrates the placental barrier, and in a small amount is contained in the fetal blood plasma. Controlled studies in pregnant women; women were not conducted. During pregnancy brimonidine It should be used only in cases where the expected benefit to the mother exceeds the possible risk to the fetus.

    In animal studies, it has been established that brimonidine penetrates into breast milk. For the duration of the drug, breast-feeding should be discontinued.

    Dosing and Administration:

    Locally.

    In the conjunctival sac of the affected eye, 1 drop 3 times a day with an interval between administrations of about 8 hours.

    Brimonidine can be used with other ophthalmic drugs to reduce IOP. If 2 or more drugs are used, then a 5-minute break between instillations is necessary.

    Changes in the dosing regimen in the elderly are not required.

    Data on the use of brimonidine in patients with renal or hepatic insufficiency are absent.

    Side effects:

    In clinical trials, the following side effects were identified:

    With a frequency of 10-20%: allergic conjunctivitis, conjunctival hyperemia, itching in the eye.

    With a frequency of 5-9%: burning in the eye, conjunctival follicles, increased blood pressure, allergic reactions from the sight, dryness of the oral mucosa, impaired vision.

    With a frequency of 1-4%: violation of taste perception, allergic reactions, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, edema of the conjunctiva, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, epiphary, discharge from the eye, dry eye, irritation eyes, pain in the eye, edema of the eyelid, redness of the eyelid, weakness, flu-like syndrome, follicular conjunctivitis, foreign body sensation in the eye, lesions of the gastrointestinal tract, headache, hypercholesterolemia, reduced (mainly colds and respiratory system), sleep disorders, keratitis, age-related damage, pharyngitis, photophobia, rash, rhinitis, sinusitis, drowsiness, tingling sensation in the eye, superficial punctate keratopathy, increased lachrymation, prolapse fields of view,vitreous body detachment, vitreous damage, "floating" opacities of the vitreous body, decreased visual acuity.

    With a frequency of <1%: corneal erosion, barley, dry nasal mucosa, taste distortion.

    In children 2-6 years, the most frequent undesirable drug reactions were drowsiness (50-83%) and decreased activity. In children older than 7 years (body weight> 20 kg), somnolence occurred in 25% of cases. About 16% of children stopped using the drug due to the occurrence of drowsiness.

    In the postmarketing period, the following adverse reactions were reported, regardless of the causal relationship: bradycardia, depression, hypersensitivity, iritis, dry keratoconjunctivitis, miosis, nausea, skin reactions (including erythema, pruritus, rash and vasodilation), syncope and tachycardia . Children were diagnosed with apnea, bradycardia, coma, lowering of blood pressure, hypothermia, muscle hypotension, lethargy, pallor, respiratory depression and drowsiness.

    Overdose:

    At casual reception of a preparation in adults the unique symptom is registered: depression of arterial pressure.In children, cases of overdose during instillation and accidental ingestion have been reported.

    When identifying symptoms of overdose, it is necessary to carry out symptomatic therapy, ensuring airway patency. Data on the excretion of brimonidine by hemodialysis are absent.

    Interaction:

    In view of the possible hypotensive effect of brimonidine, its simultaneous use with antihypertensive agents and cardiac glycosides requires caution.

    Brimonidine can exacerbate the CNS depression that oppresses the central nervous system (including alcohol, barbiturates, narcotic analgesics, sedatives and anesthetics).

    Tricyclic antidepressants can enhance the hypotensive effect of clonidine. The effect of simultaneous use of tricyclic antidepressants and brimonidine has not been studied. Care must be taken with their simultaneous use, since tricyclic antidepressants are able to disrupt the metabolism of circulating amines.

    MAO inhibitors can aggravate systemic adverse drug reactions of brimonidine, for example, lowering blood pressure.

    Special instructions:

    Brimonidine can aggravate the course of syndromes accompanied by vascular insufficiency. Brimonidine should be used with caution in patients with depression, cerebral or coronary circulation, Reynaud's syndrome, orthostatic hypotension or obliterating thromboangiitis.

    Despite the fact that according to the results of clinical studies there was no significant effect of brimonidine on blood pressure, in patients with cardiovascular diseases the drug should be used with caution.

    Cases of bacterial keratitis after application of the drug in vials for multiple instillations are described. These cases resulted from unintentional contamination of the vial by patients who, in most cases, had concomitant diseases of the cornea or damage to the epithelium of the surface of the eyeball.

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

    The use of brimonidine can be accompanied by episodes of weakness and drowsiness in some patients. In the event that the patient's work is associated with potentially hazardous activities, driving,it must be warned in advance about the possible decrease in concentration of attention and speed of psychomotor reactions, and recommend refraining from these activities.

    Form release / dosage:

    Eye drops 0.15% m / vol.

    Packaging:For 5 ml of the drug into the bottles of IVP bottles sealed with a screw cap of white color from PVP with a point for piercing a dropper. 1 bottle with instructions for use 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:

    36 months.

    Shelf life of the drug after the first opening of the bottle-dropper is 28 days.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002123
    Date of registration:04.07.2013 / 29.07.2016
    Expiration Date:04.07.2018
    Date of cancellation:2018-01-17
    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: & nbsp17.01.2018
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