Alfagan P drops 0.15% 5ml

Alfagan P user manual

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Contraindications

- hypersensitivity to brimonidine and other components of Alfagan P;
- simultaneous therapy with MAO inhibitors;
- Children under 2 years old, low body weight (up to 20 kg);
- the period of breastfeeding.
With caution: orthostatic hypotension, heart failure, cerebrovascular diseases leading to cerebral circulatory insufficiency, renal failure (CC below 40 ml / min), liver failure, depression, Raynaud's syndrome, thromboangiitis obliterans, children ages 2 to 7 years.

Dosing and Administration (Instruction)

Alfagan P is applied topically, in the conjunctival sac of the affected eye 1 drop 3 times a day with an interval between administrations of about 8 hours.
To reduce the systemic exposure of the drug immediately after instillation, it is recommended to press the lacrimal sac at the inner corner of the eye (closing the lacrimal point) within 1 minute.
Alfagan P can be used with other ophthalmic drugs to reduce IOP. When using two or more drugs, it is necessary to make a five-minute break between instillations.
The use of Alfagan P has not been studied in patients with impaired hepatic or renal function; Care should be taken when treating such patients.

Pharmachologic effect of Alfagan P

Brimonidine - selective alpha2-adrenomimetic, which has a stimulating effect on alpha2-adrenergic receptors. When applied in the form of a drop of ophthalmic 0.15%, the maximum decrease in intraocular pressure is achieved after 2 hours. The hypotensive effect of Alfagan P is provided by reducing the formation and increasing the outflow of intraocular fluid along the uveoscleral pathway.

Side effects

The most common undesirable reactions from the side of the organ of vision are allergic conjunctivitis, conjunctival hyperemia, itching of the eye mucosa and eyelid skin. The majority of undesirable reactions were of a rapid-passing nature and mild severity (not requiring discontinuation of treatment).
According to clinical studies, symptoms of allergic reactions from the eyes were observed in 12.7% of cases (being the reason for discontinuation of treatment in 11.5% of cases), while in most patients they were manifested in 3-6 months of the drug (according to the current information about the experience of using Alfagan P in a concentration of 0.2%).
The incidence of adverse events observed during the study was evaluated as follows: very often (> 10%), often (> 1% and <10%); infrequently (> 0.1% and <1%), rarely (> 0.01% and <0.1%).
In clinical studies of Alfagan P, the following side effects were 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, blurring of vision; often a burning sensation, conjunctival follicles or follicular conjunctivitis, local allergic reactions from the eyes (including keratoconjunctivitis), visual impairment, blepharitis, blepharoconjunctivitis, cataracts, conjunctival edema, conjunctival hemorrhage, conjunctivitis, retinal lacrimation, epiphore, mucous discharge from the eyes , dryness and irritation of the mucous membrane of the eyes, pain in the eye, eyelid edema, redness of the eyelids, sensation of foreign body in the eyes, keratitis, eyelid lesions, photosensitivity, stitching in the eye, dermal punctate keratopathy, lachrymation, loss of visual fields, vitreous body detachment, vitreous hemorrhage, floating opacities in the vitreous and decreased visual acuity; infrequently - the erosion of the cornea, barley.
From the side of the central nervous system: often - headache, drowsiness, insomnia,
dizziness.
From the cardiovascular system: often - increase or decrease in blood pressure.
On the part of the respiratory system: often - bronchitis, pharyngitis, cough, shortness of breath; infrequently - dryness of the nasal mucosa; apnea.
From the gastrointestinal tract: often - gastrointestinal disorders - dyspepsia, dryness of the oral mucosa.
From the skin and subcutaneous fat: often - a rash.
Infectious and parasitic diseases: often - an influenza-like syndrome,
infectious disease (chills and respiratory infection), rhinitis, sinusitis, including infectious.
Laboratory indicators: often - hypercholesterolemia.
Others: often - general allergic reactions, asthenia, fatigue, taste disorder; infrequently a perversion of taste.
In children (including newborns and infants): apnea, bradycardia, lowering blood pressure (BP), hypothermia, muscle hypotension, pallor, drowsiness, decreased attention.
Certain serious adverse reactions, such as coma, lethargy and respiratory depression in a newborn and an infant, that is, at an age where the use of the drug is not approved, were noted when the drug was used at a concentration of 0.2% exceeding the concentration of the drug.
In the postmarketing period, additional reports of the following side effects were received:
From the side of the organ of vision: the frequency is unknown - iritis, dry keratoconjunctivitis, miosis;
From the central nervous system: depression, syncope;
From the cardiovascular system: bradycardia, tachycardia;
From the gastrointestinal tract: nausea;
From the skin and subcutaneous fat: local skin reactions (erythema, itchy eyelids, face swelling, rash and vasodilation of the skin of the eyelids and face), hypersensitivity.)

Overdose

Symptoms of overdose with topical application are presented previously noted undesirable reactions.
Overdose with accidental ingestion: reports of cases of drug overdose in adults are quite small. To date, one unwanted reaction has been reported, associated with a decrease in blood pressure (BP). With the development of arterial hypotension, ricochetial hypertension was subsequently observed.
In case of accidental ingestion of Alfagan P, the following symptoms are possible inside: depression of the central nervous system, drowsiness, depression and loss of consciousness, lowering of blood pressure, bradycardia, lowering of body temperature, cyanosis of the skin, apnea, asthenia, vomiting, convulsions, arrhythmia, miosis.
When identifying symptoms of overdose, it is necessary to carry out symptomatic therapy, control of airway patency.
Overdose in children: Symptoms of an overdose of brimonidine were observed in the treatment of congenital glaucoma or accidental ingestion in young children. If an overdose develops,
supporting and symptomatic therapy, and intensive therapy with intubation may be necessary. Complete relief of symptoms of an overdose of brimonidine in all reported cases occurred within 6-24 hours.

Special instructions

Careful monitoring and monitoring of the condition of patients aged 2 to 7 years (especially with a body weight of up to 20 kg) is necessary because of the high incidence and severity of drowsiness.
When developing allergic reactions to Alfagan P, you must stop treatment and consult a doctor.
It is possible to increase intraocular pressure in the case of delayed hypersensitivity reactions.
Bacterial keratitis cases have been reported with the use of multi-dose vials of topical ophthalmic agents infected with patients who, in most cases, have concomitant corneal disease or concomitant epithelial damage to the cornea and conjunctiva. If improperly handled, or if the tip of the dropper bottle comes into contact with the eye or surrounding structures, ophthalmic preparations may become infected with bacteria that cause eye infections. Using an infected solution can lead to serious damage to the eye with subsequent loss of vision.
Do not use the solution after the expiry date indicated on the vial.
If an ophthalmic operation has been postponed or if a concomitant ocular disease has occurred (for example, trauma or infection), you should immediately consult with your doctor regarding the continued use of this multi-dose vial.
Shelf life of the drug after the first opening of the bottle-dropper is 28 days.
The intake of Alfagan P may be accompanied by episodes of weakness and drowsiness in some patients. In the event that the patient's work is associated with potentially dangerous activities, driving vehicles, he must be warned in advance about the possible decrease in concentration and speed of psychomotor reactions, and recommend refraining from these activities.

Interaction

When using more than one local ophthalmologic agent, the drugs are applied with an interval of 5 minutes.
Despite the absence of special studies of drug interaction, the possibility of enhancing the effect of drugs that suppress the central nervous system (alcohol, barbiturates, opium derivatives, sedatives, general anesthetics) should be considered.
Given the ability of alpha-adrenomimetics to reduce blood pressure and heart rate, antihypertensive drugs and cardiac glycosides should be administered with caution.
In connection with the known decrease in the severity of the antihypertensive effect of clonidine (alpha-adrenomimetic) when combined with tricyclic antidepressants, one can not exclude the possibility of a decrease in the effectiveness of Alfagan P with concomitant treatment with tricyclic antidepressants.
Caution should be given to the drug with tricyclic antidepressants, which can affect the metabolism of amines and their distribution in the vascular bed.

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