Reduced pressure, high intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Monotherapy in patients with contraindication to beta-blockers, for local use.

In combination with other treatments that decrease the intraocular pressure in the case where monotherapy does not achieve the IOP target (see section Pharmacodynamics).
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Recommended Dose in Adult (Including Elderly Patient)

The recommended dosage is one drop of BRIMONIDINE MYLAN twice daily in the affected eye or eyes, with the two instillations to be spaced about 12 hours apart. The use of eye drops in elderly patients does not require any dosage adjustment.

As with all eye drops, in order to reduce possible systemic absorption, it is recommended to compress the lachrymal sac at the inner canthus (occlusion point) for one minute. This must be done immediately after the instillation of each drop.

In the case of the use of several ophthalmic products for local use, the instillations of the different products must be spaced from 5 to 15 minutes.
Use in patients with impaired hepatic or renal function

Brimonidine has not been studied in patients with renal or hepatic impairment (see Warnings, Special and Precautions for Use). Code>
Use in children and newborns

No clinical studies have been carried out in adolescents (12 to 17 years of age).
Brimonidine is not recommended for use in children under 12 years of age and is contraindicated in newborns and infants (less than two years) (see section 4.4). Precautions, use and overdose). Severe adverse effects have been reported in newborns. In children, the safety and efficacy of brimonidine have not been established.

Pharmacotherapeutic group: Sympathomimetics in the treatment of glaucoma

ATC code: S01EA05

Brimonidine is an alpha-2 adrenergic receptor agonist 1000 times more selective for alpha-2 receptors than adrenergic alpha-1 receptors.
Because of this selectivity, no mydriasis or microvessel vasoconstriction is associated with human retinal xenografts.
Local administration of brimonidine tartrate reduces intraocular pressure (IOP) in humans and affects only minimally the cardiovascular or pulmonary parameters.

Restricted data on patients with bronchial asthma have not demonstrated any adverse effect.

Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action. It is believed that brimonidine reduces IOP by reducing the formation of aqueous humor and increasing the flow of the aqueous mucus through the uveoscleral pathway.
Clinical studies show that brimonidine is effective in combination with beta-blockers for local use. Shrimonidine has an additional, clinically significant effect on the decrease in IOP in combination with travoprost (6 weeks) and latanoprost (3 months).

Brimonidine has a minor or moderate influence on the ability to drive and use machines

Brimonidine is likely to cause fatigue and / or drowsiness which may impair the ability to drive or use machines. Brimonidine is likely to cause blurred or abnormal vision which may impair the ability to drive or use machines, especially at night or in the event of a reduction in brightness.

Hypersensitivity to the active substance or to any of the excipients.
Newborns and infants (see section Undesirable effects).

Patients receiving treatment with a monoamine oxidase inhibitor (MAO) or an antidepressant affecting transmission, noradrenergic (eg antidepressant, tricyclic and mianserin).

Children aged 2 to 7 years and / or weighing less than 20 kg should be treated with caution and closely monitored because of the high risk of drowsiness See section Effects, undesirable).

Particular attention is needed in patients with a severe or unstable and uncontrolled cardiovascular disease

In clinical trials, a few patients (12.7%) had an ocular allergy reaction with brimonidine (see side effects). In the event of an allergic reaction, treatment with brimonidine should be discontinued.

Brimonidine should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, hypotension, orthostatic or thromboangitis obliterans. >

Brimonidine has not been studied in patients with renal or hepatic impairment, special attention is required when treating these patients

Benzalkonium chloride, a preservative present in BRIMONIDINE MYLAN, may cause ocular irritation. Contact with soft contact lenses should be avoided. Remove the contact lenses before using the eye drops and wait for them to settle for at least 15 minutes. This product is known to yellow contact soft contact lenses.

Although there is no specific study of drug interactions with brimonidine, the possibility of an additive or potentiating effect when taking central nervous system depressants (alcohol, barbiturates, opiates, Sedative or anesthetic) should be taken into account.
No information is available regarding the level of circulating catecholamines after administration of brimonidine. As a result, vigilance should be exercised with patients taking specialties that may affect the metabolism and binding of circulating amines (eg chlorpromazine, methylphenidate, reserpine). >

After instillation of brimonidine, in some patients, decreases in blood pressure were not clinically significant. Caution should be exercised in the case of concomitant use of brimonidine and antihypertensives and / or cardiac glycosides.

Particular attention is directed to the initiation (or modification of the dosage) of a concomitant systemic treatment (regardless of the pharmaceutical form) likely to interact with α-adrenergic agonists or Interfering with their activity, such as agonists or antagonists of the adrenergic receptors (eg isoprenaline, prazosin).

Not applicable.

Overdose, ophthalmic

There is no information available in the adult regarding the unlikely event of an ophthalmic overdose.

However, symptoms of overdosage with brimonidine such as loss of consciousness, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnea have been reported in some neonates and infants who had received brimonidine as part of Of the medical treatment of congenital glaucoma

Systemic overdose resulting from accidental ingestion

Two notifications of adverse effects were received as a result of the inadvertent ingestion of 9 or 10 drops of brimonidine by adults. These subjects presented an episode of hypotension, followed in a case of hypertension rebounding about 8 hours after ingestion. Complete recovery in 24 hours, however, was reported in both subjects. No adverse effect was observed in a third subject who had ingested an unknown quantity of brimonidine.
Reported cases of oral overdosage with other alpha-2-stimulants have included symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, myosis, apnea, hypotonia, hypothermia, depression; Convulsion.

The safety of use in women during pregnancy has not been established.

In animal studies, brimonidine tartrate did not cause a teratogenic effect.

BRIMONIDINE MYLAN should be used only when the potential benefits for the mother exceed the potential risks incurred by the fetus

It has not been established whether brimonidine is excreted in the woman's milk. The product is excreted in the milk of lactating rats. BRIMONIDINE MYLAN should not be used during breastfeeding

The most commonly reported undesirable events are dry mouth, ocular hyperaemia, burning sensations, tingling sensation, occurring in 22-25% of patients. They are usually transient and rarely severe enough to require cessation of treatment.

In clinical studies, symptoms of allergic reactions appeared in 12.7% of patients (resulting in discontinuation of treatment, in 11.5% of patients) and occurred within 3 to 9 months of treatment in The majority of patients.

In each frequency group, undesirable effects are presented by decreasing order of severity. The frequency of adverse reactions is indicated as follows

Very common (≥1 / 10)

Common (≥1 / 100 to; 20 kg (25%) (see section 4.4 Special warnings and precautions, Job search).
Reduced pressure, high intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, monotherapy in patients, contraindications to beta-blockers, local use. , Treatments decreasing the intraocular pressure in the case where monotherapy does not reach the target IOP (see section Properties, pharmacodynamics).