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Brimonidine is a selective alpha2-adrenergic agonist, which has a stimulating effect on alpha2-adrenergic receptors. When used in a dosage form of 0.15% eye drops, the maximum decrease in intraocular pressure (IOP) is achieved after 2 hours. The hypotensive effect of brimonidine is provided by reducing the formation and increasing the outflow of intraocular fluid along the uveoscleral pathway.
When instilling eye drops, the maximum concentration of the drug in the blood plasma is reached after 0.5-2.5 hours, the half-life (T1 / 2) is about 2 hours. Systemic absorption of brimonidine is slow. The drug is metabolized mainly in the liver. Brimonidine and its metabolites are excreted by the kidneys.
Indications for use
- Open-angle glaucoma.
- Ophthalmic hypertension (in monotherapy or in combination with other drugs that lower IOP).
Dosage and administration
Into the conjunctival sac of the affected eye, 1 drop 3 times a day with an interval between injections of about 8 hours.
ALFAGAN® can be used with other ophthalmic drugs in order to reduce IOP. If more than 2 drugs are used, then it is necessary to take a 5 minute break between instillations.
Hypersensitivity to brimonidine and other components of the drug;
Concomitant therapy with monoamine oxidase (MAO) inhibitors;
Children under 2 years of age, low body weight (up to 20 kg);
Orthostatic hypotension, heart failure, cerebrovascular diseases leading to cerebrovascular insufficiency, renal failure (creatinine clearance below 40 ml / min), hepatic failure, depression, Raynaud's syndrome, thromboangiitis obliterans, children's age from 2 to 7 years.
Application during pregnancy and lactation
In preclinical studies, no effect on reproductive function was found. However, it was found that brimonidine crosses the placental barrier, and is contained in a small amount in the fetal blood plasma. The damaging effect on the fetus has not been established. There have been no controlled studies in pregnant women. During pregnancy, ALFAGAN® should be used with extreme caution, only in cases where the expected benefit to the mother significantly outweighs the possible risk to the fetus.
In animal studies, it was found that brimonidine tartrate passes into breast milk. During the use of the drug, breastfeeding should be discontinued.
There are no reports of drug overdose.
If the drug is accidentally taken inside, the following symptoms are possible: depression of the central nervous system, drowsiness, depression and loss of consciousness, decreased blood pressure, bradycardia, decreased body temperature, cyanosis of the skin, apnea.
If symptoms of an overdose are detected, it is necessary to carry out symptomatic therapy, control the patency of the airways.
Interaction with other medicinal products
Studies on the study of drug interactions of the drug ALFAGAN® have not been carried out, however, with its simultaneous use, the possibility of enhancing the effect of drugs that depress the central nervous system (alcohol, barbiturates, opium derivatives, sedatives, general anesthetics) should be taken into account. Given the ability of drugs of the alpha-adrenergic agonist group to reduce blood pressure and heart rate (HR), antihypertensive drugs and cardiac glycosides should be used with caution.
Due to the known decrease in the severity of the hypotensive effect of clonidine (alpha2-adrenergic agonist) when used together with tricyclic antidepressants, it is impossible to exclude a possible decrease in the effectiveness of ALFAGAN® with concomitant treatment with tricyclic antidepressants.
Caretaken should be to use the drug ALFAGAN® with tricyclic antidepressants, which can affect the metabolism of amines and their distribution in the vascular bed.
Taking ALFAGAN® may 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 vehicles, it is necessary to warn him in advance about a possible decrease in concentration of attention and speed of psychomotor reactions, and recommend to refrain from these activities.
The shelf life of the drug after the first opening of the dropper bottle is 28 days.
The frequency of side effects identified in the course of studies was assessed as follows: very often (> 10%), often (> 1% and <10%); infrequently (> 0.1% and <1%), rarely (> 0.01% and <0.1%).
In clinical studies of the drug ALFAGAN® P, the following side effects have been identified:
From the side of the organ of vision: very often - allergic conjunctivitis, conjunctival hyperemia, itching of the mucous membrane of the eyes and eyelid skin; often - a burning sensation, follicular conjunctiva or follicular conjunctivitis, local allergic reactions from the eyes (including keratoconjunctivitis), blepharitis, blepharoconjunctivitis, blurred vision, cataract, conjunctival edema, conjunctival lacrimation, hemorrhagic conjunctivitis discharge from the eyes, dryness and irritation of the mucous membrane of the eyes, pain, edema of the eyelids, redness of the eyelids, sensation of a foreign body in the eyes, keratitis, lesions of the eyelids, photosensitivity, superficial punctate keratopathy, lacrimation, loss of visual fields, functional disorders of the vitreous humor, hemorrhage in the vitreous body, floating opacities in the vitreous and decreased visual acuity; infrequently - corneal erosion, barley;
From the side of the central nervous system: often - headache, drowsiness, insomnia, dizziness;
From the side of the cardiovascular system: often - an increase in blood pressure, infrequently - a decrease in blood pressure;
On the part of the respiratory system: often - bronchitis, cough, shortness of breath; infrequently - dryness of the nasal mucosa; apnea;
From the gastrointestinal tract: often - gastrointestinal disorders - dyspepsia, dryness of the oral mucosa;
On the part of the skin and subcutaneous fat: often - rash; Infectious and parasitic diseases: often - flu-like syndrome, infectious disease (chills and respiratory infection), rhinitis, sinusitis, incl. infectious;
Laboratory indicators: often - hypercholesterolemia;
Others: often - general allergic reactions, asthenia, fatigue, infrequently - taste perversion.
In children, it was noted: apnea, bradycardia, lowering blood pressure (BP), hypothermia, muscle hypotension.
In the post-marketing period, additional reports were received about the following side effects:
From the side of the organ of vision: the frequency is unknown - iritis, keratoconjunctivitis dry, miosis;
From the central nervous system: depression;
On the part of the cardiovascular system: bradycardia, tachycardia;
From the gastrointestinal tract: nausea;
On the part of the skin and subcutaneous fat: local skin reactions (erythema, itching of the eyelids, edema of the face, rash and vasodilation of the vessels of the skin of the eyelids and face).