Expiration date: 07/2025
Release form: Eye drops
Composition
1 ml. contains brimonidine tartrate 1.5 mg,
auxiliary components: the oxy-chloro complex is stable (sodium chloride, sodium chlorate, chlorine dioxide), sodium carmellose, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, boric acid, sodium tetraborate decahydrate, hydrochloric acid or sodium hydroxide, purified water.
Packaging
5 ml vial.
Pharmacological action
The brimonidine — selective ?2-agonists that have a stimulating effect on ?2-adrenergic receptors. When used in the form of eye drops, 1.5 mg/ml the maximum effect of lowering intraocular pressure (IOP) achieved in 2 hours Hypotensive effect brimonidine is provided by reducing the formation and increase of intraocular fluid outflow via the uveoscleral tract.
Testimony
Open-angle glaucoma. Increased pressure in the eye (as monotherapy and in combination with other drugs that lower IOP).
Contraindications
Hypersensitivity to brimonidine tartrate and other components of Alphagan R. Simultaneous treatment with MAO inhibitors. Pregnancy and breast-feeding. Children up to age 2 years, low body weight (20 kg), since safety and efficacy of the drug in these patient populations has not been studied.
Method of application and doses
Alphagan R applied locally. Instilled into the conjunctival SAC of affected eye 1 drop 3 times a day with an interval between doses 8 hours Alphagan R can be used with other ophthalmic drugs to lower IOP. If the patient is simultaneously use other eye drops should adhere to the interval of at least 5 min between drops.
Side effects
The incidence of adverse effects identified in the studies evaluated in this manner: very often (&,>,10%), often (&,>,1%&, 0,1% and 0,01%&, In clinical studies of the drug Alphagan P identified the following side effects:
From the side of organs of vision: often — conjunctivitis allergic, conjunctival hyperemia eyes, itching of the mucous membrane of the eyes and the eyelid skin, often burning sensation, follicules eye conjunctiva, and a follicular conjunctivitis include allergic reactions of the mucous membrane of the eye (including keratoconjunctivitis sicca), blepharitis, blepharoconjunctivitis, violation of clarity of vision, cataracts, swelling of the conjunctiva, bleeding in the conjunctiva, conjunctivitis, watery eyes, mucous discharge from the eyes, dryness and irritation of the mucous membranes of the eyes, pain, swelling of the eyelids, redness of the eyelids, foreign body sensation in eyes, keratitis, eyelid, photosensitivity, surface spotted keratopathy, tearing, falling out of sight, functional damage of the vitreous body, bleeding in the vitreous body, floating opacities in the vitreous and decreased visual acuity, rarely, erosion of the cornea, barley.
CNS: frequently — headache, drowsiness, insomnia, dizziness.
Of the cardiovascular system: often- increased blood pressure, rarely — decreased blood pressure.
From the side of respiratory system: often — bronchitis, cough, shortness of breath, rarely, dryness of the mucous membrane of the nose, apnea.
By the blood: often — gastrointestinal disorders, dyspepsia, dry mucous membranes of the mouth.
The skin and subcutaneous fat: often — rash, infectious disease (fever and respiratory infection), rhinitis, sinusitis, including an infection.
The laboratory parameters: often — hypercholesterolemia.
Other: often — General allergic reaction, asthenia, fatigue, rarely — change in taste.
The children observed: apnea, bradycardia, decreased blood pressure, hypothermia, muscular hypotonia.
Additionally, the data obtained about the following effects:
From the side of organs of vision: frequency unknown — iritis, keratoconjunctivitis sicca, miosis.
CNS: depression.
From the side of cardiovascular system: bradycardia, tachycardia.
Gastrointestinal: nausea.
The skin and subcutaneous fat: local skin reactions (erythema, pruritus, swelling face, rash, and vasodilation of blood vessels of the eyelid skin).
Special instructions
Despite evidence of a slight impact on the overall brimonidine tartrate HELL, you need to apply caution in patients with the following diseases: orthostatic hypotension, severe cardiovascular diseases, which are accompanied by heart failure, cerebrovascular disease, resulting in cerebral insufficiency, renal failure (creatinine clearance &Must rigorously monitor the condition of patients with the above conditions, when the deterioration of the patient must stop taking the drug.
Patients who wear soft contact lenses before instillation of drug should take them off. Contact lenses can again be worn after 15 min.
Drug interactions
If more than one local ophthalmic means the drugs are used with an interval of 5 min.
Despite the lack of special studies of the interaction of the drug should consider the possibility of strengthening effect of drugs which depress the Central nervous system (alcohol, barbiturates, derivatives of opium, sedatives, General anesthetics). Given the ability of alpha-agonists lower BP and HR, hypotensive drugs and cardiac glycosides should be used with caution.
In connection with the known reduction in the magnitude of the hypotensive effect of clonidine (alpha-agonists) when used in combination with tricyclic antidepressants, we cannot exclude the possibility of reducing the effectiveness of the drug Alphagan R with concomitant treatment with tricyclic antidepressants.
With caution should designate product in Alphagan P with tricyclic antidepressants which can affect the metabolism of amines and their distribution in the bloodstream.
Overdose
Reported cases of drug overdose not. If you accidentally taking the drug inside the following symptoms: CNS depression, drowsiness, loss of consciousness, decreased blood pressure, bradycardia, decreased body temperature, cyanosis of the skin, apnea. The detection of symptoms of overdose it is necessary symptomatic therapy, control of the airway.
Storage conditions
Keep at temperature not exceeding 25 °C.
Shelf life
2 years.
