Efficacy and safety of Alphagan R in the treatment of patients with primary open-angle glaucoma


Contraindications

Alphagan should not be prescribed to patients with:

  • Concomitant therapy with drugs that inhibit monoamine oxidase;
  • In children (up to 2 years) or in patients with low body weight (less than 20 kg);
  • During lactation;
  • In case of hypersensitivity to any components of the drug.

Caution is required when prescribing Alphagan to patients with orthostatic hypotension, impaired functioning of the heart, cerebral vessels, renal failure (if creatinine clearance is less than 40 ml/min), Raynaud's syndrome, depression, liver failure, thromboangiitis obliterans.

Caution should also be observed when treating children aged 2 to 7 years.

Brimonidine can penetrate the placental bloodstream, but no harmful effect on the fetus has been established. Can be used in pregnant women only if there is a clear benefit that outweighs the potential harm.

Alphagan R, eye drops 0.15%, 5 ml

Manufacturer

Allergan, USA

Compound

1 ml - brimonidine tartrate 1.5 mg
auxiliary components: stabilized oxy-chloro complex (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, water.

pharmachologic effect

Pharmaceutical group: Antiglaucoma drug. Pharmaceutical action: Brimonidine is a selective alpha2-adrenergic agonist that has a stimulating effect on alpha2-adrenergic receptors. When used in the dosage form of eye drops 0.15%, the maximum reduction in intraocular pressure (IOP) is achieved after 2 hours. The hypotensive effect of brimonidine is achieved by reducing the formation and increasing the outflow of intraocular fluid along the uveoscleral pathway.

Indications

  • Open angle glaucoma.
  • Ocular hypertension (in monotherapy or in combination with other drugs that lower IOP).

Use during pregnancy and breastfeeding

Pregnancy

Preclinical studies did not reveal any effect on reproductive function.

However, it has been established that brimonidine penetrates the placental barrier and is found in small amounts in fetal blood plasma. No harmful effect on the fetus has been established.

There have been no controlled studies in pregnant women.

During pregnancy, ALPHAGAN R should be used with extreme caution, only in cases where the expected benefit to the mother significantly outweighs the possible risk to the fetus.

Lactation

Animal studies have shown that brimonidine tartrate passes into breast milk. Breastfeeding should be stopped while using the drug.

Use in children

Contraindicated in children under 2 years of age, with caution in children aged 2 to 7 years.

Contraindications

  • hypersensitivity to brimonidine and other components of the drug;
  • simultaneous therapy with MAO inhibitors;
  • children under 2 years of age, low body weight (up to 20 kg);
  • breastfeeding period.

With caution: orthostatic hypotension, heart failure, cerebrovascular diseases leading to cerebrovascular insufficiency, renal failure (creatinine clearance below 40 ml/min), liver failure, depression, Raynaud's syndrome, thromboangiitis obliterans, children aged 2 to 7 years.

Side effects

The frequency of side effects identified during the studies was assessed as follows: very often (>10%), often (>1% and 0.1% and 0.01% and

Clinical studies of the drug Alphagan R revealed the following side effects:

From the organ of vision: very often - allergic conjunctivitis, conjunctival hyperemia, itching of the mucous membrane of the eyes and skin of the eyelids; often - burning sensation, conjunctival folliculosis or follicular conjunctivitis, local allergic reactions of the eyes (including keratoconjunctivitis), blepharitis, blepharoconjunctivitis, blurred visual perception, cataracts, conjunctival edema, conjunctival hemorrhage, conjunctivitis, retention lacrimation, mucous discharge from the eyes, dryness and irritation of the mucous membrane of the eyes, pain, swelling of the eyelids, redness of the eyelids, sensation of a foreign body in the eyes, keratitis, eyelid lesions, photosensitivity, superficial punctate keratopathy, lacrimation, loss of visual fields, functional disorders of the vitreous, hemorrhages in the vitreous body, floaters in the vitreous body and decreased visual acuity; infrequently - corneal erosion, barley;

From the side of the central nervous system: often - headache, drowsiness, insomnia, dizziness.

From the cardiovascular system: often - increased blood pressure; infrequently - decreased blood pressure.

From the respiratory system: often - bronchitis, cough, shortness of breath; infrequently - dry nasal mucosa, apnea.

From the gastrointestinal tract: often - gastrointestinal disorders - dyspepsia, dryness of the oral mucosa.

From 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 - perversion of taste.

In children, the following were noted: apnea, bradycardia, decreased blood pressure, hypothermia, muscle hypotension.

In the post-marketing period, additional reports of the following side effects have been received:

From the organ of vision: frequency unknown - iritis, sicca keratoconjunctivitis, miosis;

From the central nervous system: depression;

From the cardiovascular system: bradycardia, tachycardia.

From the gastrointestinal tract: nausea.

From the skin and subcutaneous fat: local skin reactions (erythema, itching of the eyelids, swelling of the face, rash and vasodilation of blood vessels in the skin of the eyelids and face).

Interaction

No studies have been conducted to study drug interactions with Alphagan R, 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 from the alpha-agonist group to reduce blood pressure and heart rate, caution should be exercised when using antihypertensive drugs and cardiac glycosides simultaneously.

Due to the known decrease in the severity of the hypotensive effect of clonidine (alpha2-adrenergic agonist) when used together with tricyclic antidepressants, a possible decrease in the effectiveness of the drug Alphagan R cannot be ruled out during concomitant treatment with tricyclic antidepressants.

Alphagan R should be used with caution with tricyclic antidepressants, which may affect the metabolism of amines and their distribution in the vascular bed.

How to take, course of administration and dosage

Locally.

Into the conjunctival sac of the affected eye, 1 drop 3 times a day with an interval between doses of about 8 hours.

Alphagan R can be used with other ophthalmic drugs to reduce IOP. If more than 2 drugs are used, then it is necessary to take a 5-minute break between installations.

Overdose

  • Symptoms: if the drug is accidentally taken orally, the following may occur: depression of the central nervous system, drowsiness, depression and fainting, decreased blood pressure, bradycardia, decreased body temperature, cyanosis of the skin, apnea.
  • Treatment: if symptoms of overdose are detected, symptomatic therapy and monitoring of airway patency are necessary.

Special instructions

Use for liver dysfunction

With caution: liver failure.

Use for renal impairment

With caution: renal failure (creatinine clearance below 40 ml/min).

Impact on the ability to drive vehicles and operate machinery

Taking Alphagan R may be accompanied by episodes of weakness and drowsiness in some patients. If the patient’s work involves potentially hazardous activities, such as driving vehicles, he must be warned in advance about a possible decrease in concentration and speed of psychomotor reactions, and recommended to refrain from these types of activities.

Release form

Eye drops are transparent, yellowish-green in color.

Storage conditions

At a temperature not exceeding 25 °C

Best before date

2 years.

Active substance

Brimonidine

Conditions for dispensing from pharmacies

On prescription

Dosage form

eye drops

Purpose

For children over 2 years old, For adults

Indications

Glaucoma

Barcode and weight

Barcode: 5016007202809 Weight: 0.018 kg

Side effects

When using Alphagan eye drops, local side effects may develop, which include allergic conjunctivitis, redness of the mucous membrane, itching, burning in the eye area, follicular conjunctivitis, dry mucous membrane, swelling of the eyelids, keratitis, photosensitivity, loss of visual fields, keratopathy, clouding of the substance vitreous, decreased visual acuity.

Systemic side effects of Alphagan include headache, increased blood pressure, insomnia, dizziness, cough, bronchitis, shortness of breath, dyspepsia, skin rashes, flu-like syndrome, sinusitis, hypercholesterolemia, fatigue.

When Alphagan is prescribed to children, bradycardia, apnea, muscle hypotension, and hypothermia may develop.

Trusopt

Trusopt eliminates the symptoms of pathological conditions: open-angle and secondary glaucoma, ocular hypertension, pseudoexfoliative glaucoma. The medication can be combined with medications based on betaxolol and timolol, as well as diuretics. Trusopt can be used in combination with hormonal substances such as insulin, thyroxine or estrogen.

It is prohibited to combine the medication with carbonic anhydrase.

The cost of Trusop ranges from 459 to 567 rubles.

Interactions

No special studies have been conducted regarding drug interactions with Alphagan eye drops. With the simultaneous administration of drugs that depress the nervous system, the effect may be potentiated. You should also use drugs with caution that reduce blood pressure and pulse, including cardiac glycosides.

The effectiveness of Alphagan may be slightly reduced with simultaneous use of tricyclic antidepressants.

Arutimol

The active component is timolol hydromaleate. This substance belongs to beta-blockers. The product provokes a decrease in fluid production, which normalizes pressure surges. The action of Arutimol develops 20 minutes after application. The maximum concentration in the blood is observed after 2 hours. The active substance is capable of penetrating into the general bloodstream, so the medication should be prescribed under the strict supervision of the attending physician.

Arutimol does not affect pupil size and accommodation. The therapy does not reduce the clarity of vision. It is possible to prescribe medication for newborns. The cost of Arutimol is 60 rubles.

Okumed

The medication is characterized by antiglaucoma properties and belongs to the group of beta blockers. The drug reduces pressure inside the eye and normalizes the amount of secretion produced. The therapeutic result is observed 20 minutes after the first injection. The effects of Okumed are observed throughout the day.

Medicine is prescribed to stop the development of pathological conditions:

  • increased pressure inside the eye;
  • congenital glaucoma;
  • open-angle glaucoma;

It is used in complex therapy with miotics for angle-closure glaucoma. The drug costs about 60 rubles.

Timolol

The medication is prescribed for the following pathologies: open-angle or closed-angle glaucoma, elimination of eye hypertension, treatment of congenital glaucoma, relief of muscle spasm, with an increase in ophthalmotonus. Timolol is absorbed into the systemic circulation through the cornea. The therapeutic result is observed 40 minutes after application.

The effect of the drug lasts for 22 hours. The cost ranges from 24 to 93 rubles.

Drugs similar in effect to Alphagan are characterized by more pronounced side effects and contraindications. A doctor should prescribe substitutes for the main medication.

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