Alfagan R, eye drops 0.15% 5 ml

Pharmgroup: Antiglaucoma drug.
Pharmacological action: Brimonidine is a selective alpha2-adrenomimetic with stimulating effect on alpha2-adrenoreceptors. When used in the dosage form of eye drops 0.15% maximum decrease in intraocular pressure (IOP) is achieved in 2 hours. The hypotensive effect of brimonidine is provided by reducing the formation and increasing the outflow of intraocular fluid through the uveoscleral pathway.

Indications

Glaucoma

• Open angle glaucoma.
• Ophthalmohypertension (in monotherapy or in combination with other IOP-lowering drugs).

Active ingredient

Brimonidine

Composition

1 ml – brimonidine tartrate 1.5 mg

Auxiliary components: oxy-chloro complex stabilized (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.

.

How to take, the dosage

Topically.

In the conjunctival sac of the affected eye 1 drop 3 times a day with about 8 hours between injections.

Alphagan R can be used with other ophthalmic medications to reduce IOP. If more than 2 drugs are used, there should be a 5 minute break between instillations.

Interaction

There have been no studies on drug interaction of the drug Alfagan R, but during its concomitant use it is necessary to consider the possibility of enhancing the effect of CNS-depressing drugs (alcohol, barbiturates, opium derivatives, sedatives, general anesthetics). Taking into account the ability of drugs of a group of alpha-adrenomimetics to decrease BP and HRV, hypotensive drugs and cardiac glycosides should be used simultaneously with caution.

Due to the known decreased hypotensive effects of clonidine (alpha 2-adrenomimetics) when used with tricyclic antidepressants, the possible decrease of efficacy of Alfagan P with concomitant treatment with tricyclic antidepressants cannot be excluded.

Precaution should be exercised when using Alfagan P with tricyclic antidepressants as they may affect amine metabolism and distribution in the vascular system.

Special Instructions

Use in liver function disorders

With caution: hepatic failure.

Prevention in renal dysfunction

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

Impact on driving and operating ability

The use of Alphagan R may be accompanied by episodes of weakness and somnolence in some patients. If the patient’s work involves potentially hazardous activities, driving motor vehicles, he must be warned in advance about the possible decrease in concentration and psychomotor reaction rate, and advised to refrain from these activities.

.

Contraindications

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

With caution: orthostatic hypotension, heart failure, cerebrovascular disease leading to cerebrovascular insufficiency, renal insufficiency (CK below 40 ml/min), liver failure, depression, Raynaud’s syndrome, obliterating thrombangitis, children age 2 to 7 years.

.

Side effects

The frequency of side effects found in the studies was estimated as follows: very common (>10%), common (>1% and0.1% and0.01% and

The following side effects were found in the clinical trials of Alphagan R:

Overlooking organ: very frequently, allergic conjunctivitis, conjunctival hyperemia, itching of ocular mucosa and eyelid skin; frequently, burning sensation, conjunctival folliculosis or follicular conjunctivitis, local allergic eye reactions (incl. keratoconjunctivitis, blepharitis, blepharoconjunctivitis, blurred vision, cataracts, conjunctival edema, conjunctival hemorrhage, conjunctivitis, retention lacrimation, mucous discharge from eyes, dry and irritated mucosa, pain, edema, reddened eyelids, sensation of foreign body in eyes, keratitis, eyelid lesions, photosensitization, superficial pitting keratopathy, lacrimation, visual field loss, functional disorders of vitreous body, vitreous hemorrhage, floating opacities in vitreous body and decrease in visual acuity; infrequent – corneal erosion, barley;

CNS disorders: frequent – headache, drowsiness, insomnia, dizziness.

Cardiovascular system: frequently – increase of BP; infrequently – decrease of BP.

Respiratory system: frequently – bronchitis, cough, shortness of breath; infrequently – dry nasal mucosa, apnea.

Gastrointestinal disorders: often – gastrointestinal disorders – dyspepsia, dry mouth.

Skin and subcutaneous fatty tissue: often – rash.

Infectious and parasitic diseases: often – flu-like syndrome, infectious disease (chills and respiratory infection), rhinitis, sinusitis, including infectious.

Laboratory measures: often – hypercholesterolemia.

Other: frequent – general allergic reactions, asthenia, fatigue; infrequent – perversion of taste.

In children: apnea, bradycardia, decreased BP, hypothermia, muscle hypotension have been noted.

The following side effects have additionally been reported in the post-marketing period:

Visually: frequency unknown – iritis, dry keratoconjunctivitis, miosis;

CNS: depression;

Cardiovascular system: bradycardia, tachycardia.

Gastrointestinal disorders: nausea.

Skin and subcutaneous fatty tissue: local skin reactions (erythema, itching of the eyelids, facial edema, rash and vasodilation of the eyelid and facial skin vessels).

.

Overdose

• Symptoms: in case of accidental ingestion of the drug the following is possible – central nervous system depression, drowsiness, depression and fainting, decreased BP, bradycardia, decreased body temperature, cyanosis of the skin, apnea.
• Treatment: if symptoms of overdose are detected, symptomatic therapy is necessary, control of airway patency

.

Pregnancy use

Pregnancy

Preclinical studies have shown no effect on reproductive function.

Brimonidine has, however, been found to penetrate the placental barrier and is present in small amounts in fetal blood plasma. No damaging effect on the fetus has been established.

There have been no controlled studies in pregnant women.

In pregnancy, ALFAGAN R should be used with extreme caution, only when the expected benefits to the mother far exceed the possible risk to the fetus.

Lactation

Brimonidine tartrate has been found to penetrate into breast milk in animal studies. Breast-feeding should be stopped during the use of the drug.

Pediatric use

It is contraindicated in children under 2 years of age, with caution in children aged 2 to 7 years.

.

Similarities

Mirwazo Derm.