Sunday, September 23, 2012

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FORM.

Eye drops are pale yellow-green color.

Indications Combigan (brimonidine and timolol ophthalmic).

Reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who do not respond sufficiently urgent action of beta-blockers for outdoor use.

Dosage and method of administration.

The recommended dose for adults (including the elderly) is one drop of Combigan (brimonidine and timolol ophthalmic) twice daily, approximately 12 hours, it is possible in the morning and evening.
If you need to use more than one drop of ophthalmic drugs, the next dose should be separated by at least 5 minutes. Like all eye drops to reduce possible systemic absorption, it is recommended to compress the lacrimal sac medial (blocked tear points) for one minute. This should be done immediately after each instillation of eye drops.
Combigan (brimonidine and timolol ophthalmic) has not been studied in patients with hepatic or renal insufficiency. These patients should be cautious in the treatment. Use in children and adolescents: Combigan (brimonidine and timolol ophthalmic) should not be used in infants (see: "Contraindications", "Overdose"). Safety and effectiveness of Combigan (brimonidine and timolol ophthalmic) in children and adolescents has not been established, so the use of the drug in these patients is not recommended. To avoid contamination of the eye in the application, the tip of the pipette should not come into contact with any other surfaces.

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Contraindications.

Respiratory diseases, including bronchial asthma or in the past, chronic obstructive pulmonary disease bradycardia, atrioventricular block second or third degree controlled pacemaker, heart failure, cardiogenic shock, use in neonates, patients taking antidepressants, with monoamine oxidase (MAO) with the action of the noradrenergic transmission (eg, hypersensitivity to the active substance or to any of the excipients. tricyclic antidepressant, mianserin)

Special warnings and precautions for use.

As with other topical ophthalmic tools, Combigan (brimonidine and timolol ophthalmic) may be taken systematically. In clinical trials, only some patients have reported allergic reactions to the conjunctiva of the eyes (allergic and allergic blepharitis) following use Combigan (brimonidine and timolol ophthalmic). Conjunctival allergy was reported in 5.2% of patients. Allergic blepharitis was (<1%).
In case of allergic reaction should discontinue using Combigan (brimonidine and timolol ophthalmic). Given the presence of timolol ophthalmic, beta-adrenergic active elements, proceed with caution in patients with severe cardiovascular or pulmonary disease. Before therapy in heart failure is necessary to adequately control. Combigan (brimonidine and timolol ophthalmic) should be used with caution in patients with metabolic acidosis. Substances that cause beta-adrenergic blockade should be used with caution in patients with the spontaneous hypoglycemia in diabetic patients not controlled (especially labile diabetes).
Contact lenses should be removed prior to instillation and may be re-applied after 15 minutes. It is known that brimonidin can discolour soft contact lenses.

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Interaction.

Must take into account the possibility of additive or enhance the effects of the introduction of Combigan (brimonidine and timolol ophthalmic) in combination with agents, CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics). The combined use of a drop of Combigan (brimonidine and timolol ophthalmic) containing timolol and calcium channel blockers, guanitidina, beta-blockers, cardiac arrhythmias, digitalis glycosides, sympathomimetic or additive effects may lead to hypotension or marked bradycardia.
Advised to be cautious when taking medications that may alter metabolism, such as chlorpromazine, methylphenidate, reserpine. In addition, it is recommended to be careful when you start or change the dosage of concomitant treatment with drugs sistemnymyh (regardless of dosage form) that can interact with the alpha-adrenergic agonists or interfere with their activities, such as isoprenaline, prazosin.

Pregnancy and breast-feeding.

Pregnancy, there is no adequate data on the use of Combigan (brimonidine and timolol ophthalmic) in pregnant women.
Studies in animal reproductive toxicity at high doses have shown (see "Preclinical safety data"). The use of timolol ophthalmic, epidemiological studies have shown no effects of defects, but showed the downside risks to growth in the use of beta-blockers. In addition, newborns were signs and symptoms of beta-receptor blockade, such as bradycardia, hypotension, respiratory distress and hypoglycaemia), the introduction of beta-blockers in the mother before birth. In the case of Combigan (brimonidine and timolol ophthalmic) to the birth, the child should be monitored closely during the first days of life.
Combigan (brimonidine and timolol ophthalmic) should not be used during pregnancy unless there is a clear need at. Lactation. timolol ophthalmic is excreted in breast milk. Not known or brimonidin allocated in human milk, but is excreted in breast milk of rats.
Combigan (brimonidine and timolol ophthalmic) should not be used by women, breast-feeding children.

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