Ganfort, eye drops 0.3mg+5mg/ml, 3ml

Composition

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1 ml of a solution of eye drops contains:

Active ingredient

• Bimatoprost 0.3 mg.
• Timolol maleate 6,8 mg.
  • In terms of timolol 5.0 mg.

Auxiliary substances

Benzalkonium chloride,

citric acid monohydrate,

sodium hydrophosphate heptahydrate,

sodium chloride,

hydrochloric acid,

sodium hydroxide,

water.

Pharmacological action

Ganfort is a combined drug, and its components bimatoprost and timolol reduce intraocular pressure (IOP) due to the combined interaction, leading to a significantly more pronounced antihypertensive effect compared to the effect of each of the components separately.

Bimatoprost belongs to synthetic prostamides, similar in chemical structure to prostaglandin F2a (PGF2a). Bimatoprost has no effect on any of the known types of prostaglandin receptors. The hypotensive effect of bimatoprost is achieved by increasing the outflow of intraocular fluid through the trabecula and along the uveoscleral pathway of the eye.

Timolol is a non-selective beta-blocker, does not have internal sympathomimetic and membrane-stabilizing activity.

Timolol reduces IOP by reducing the formation of intraocular fluid. The exact mechanism of action has not been established; it may be associated with inhibition of cyclic adenosine monophosphate (c-AMP) synthesis and is caused by endogenous stimulation of beta-adrenergic receptors.

Indications

Reduction of intraocular pressure (IOP)in patients with open-angle glaucoma and intraocular hypertension with insufficient effectiveness of topical use of beta-blockers and prostaglandin analogues.

Use during pregnancy and lactation

Ganfort is contraindicated in children under 18 years of age, pregnant women and during lactation.

Contraindications

• hypersensitivity to the components of the drug;
• syndrome of increased airway reactivity, including acute bronchial asthma and a history of episodes, severe chronic obstructive pulmonary disease (COPD);
• sinus bradycardia, atrioventricular block II and III degrees, clinically expressed heart failure, cardiogenic shock.

With caution: impaired liver and kidney function (the drug has not been sufficiently studied in this category of patients). In patients with risk factors for macular edema (for example, with aphakia, pseudophakia, lens rupture).

In patients with diabetes mellitus (unstable course) and impaired glucose tolerance, since the beta-blocker timolol included in the Ganfort preparation can mask the signs of hypoglycemia. In patients with inflammatory eye changes, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma (no data on efficacy and safety studies).

Side effects

The frequency of side effects identified in the studies was estimated as follows: very common (>1/10), common (>1/100,1/1000, >>

The following side effects have been identified in clinical trials of Ganfort:

From the central nervous system: infrequently-headache;

From the side of the visual organ: very often – conjunctival hyperemia, eyelash growth; often — superficial keratitis, corneal erosion, burning sensation, itching, burning pain in the eyes, foreign body sensation, dryness of the eye mucosa, redness of the eyelids, eye pain, photophobia, eye discharge, visual impairment, itching of the eyelid skin; infrequently – iridocyclitis, irritation of the eye mucosa, conjunctival edema, blepharitis, epiphora, swelling of the eyelids, eyelid soreness, decreased visual acuity, asthenopia, trichiasis; frequency unknown: cystic macular edema.

From the respiratory system: infrequently-rhinitis;

From the skin and subcutaneous fat: often – pigmentation of the skin of the eyelids; infrequently-hirsutism.

Other side effects that were observed with the use of one of the components of the drug and potentially possible during treatment with Ganfort:

Bimatoprost

From the cardiovascular system: increased blood pressure.

General disorders and changes at the injection site: asthenia, peripheral edema.

From the side of the visual organ: allergic conjunctivitis, cataracts, darkening of the eyelashes, increased pigmentation of the iris, blepharospasm, eyelid retraction, retinal hemorrhage, uveitis.

Laboratory parameters: changes in the activity of liver enzymes.

Timolol

Mental disorders: insomnia, nightmares, decreased libido.

From the central nervous system: myasthenia gravis, paresthesia, cerebral ischemia.

From the side of the visual organ: decreased corneal sensitivity, diplopia, ptosis, retinal detachment (after surgical treatment), refractive changes (due to the withdrawal of therapy with myotic agents in some cases), keratitis.

From the side of the organ of hearing and vestibular apparatus: tinnitus.

From the cardiovascular system: heart block, cardiac arrest, cardiac arrhythmias, loss of consciousness, bradycardia, heart failure, congestive heart failure; low blood pressure, chest pain, impaired cerebral circulation, intermittent claudication, Raynaud’s syndrome, cold extremities, palpitations.

From the respiratory system: bronchospasm (mainly in people with a history of episodes of bronchospasm), shortness of breath, cough.

From the gastrointestinal tract: nausea, diarrhea, dyspepsia, dryness of the oral mucosa.

From the skin and subcutaneous fat: alopecia, psoriasis-like rashes, exacerbation of psoriasis.

Musculoskeletal and connective tissue disorders: systemic lupus erythematosus.

From the urinary system: Peyronie’s disease.

Others: swelling, chest pain, fatigue.

How to take, course of use and dosage

Recommended doses in adults (including elderly patients): 1 drop is instilled into the conjunctival sac of the affected eye 1 time a day in the morning.

If the drug is missed once, the drug is administered the next day. It is not recommended to exceed the dose of 1 injection 1 time per day. If more than 2 medications are used, it is necessary to take a 5-minute break between each instillation.

Overdose

No cases of overdose of Ganfort have been reported; when administered as eye drops, overdose is unlikely.

Bimatoprost

In case of unintentional oral use of Ganfort, the following information may be useful: there were no symptoms of toxic effects of bimatoprost in doses up to 100 mg / kg / day. during 2-week oral use in an experiment on rats and mice. The dose used in the study, expressed in mg / m, exceeds by 70 times the possible dose of bimatoprost in case of accidental ingestion of the contents of a bottle of Ganfort by a child with a body weight of 10 kg.

Timolol

An overdose of timolol may cause the following symptoms: bradycardia, decreased blood pressure, bronchospasm, headache, dizziness, shortness of breath, and cardiac arrest. Studies have shown that timolol is not completely eliminated by hemodialysis. If an overdose occurs, it is necessary to conduct symptomatic therapy.

Special instructions

Just like other ophthalmic medications, Ganfort can enter the systemic circulation.

Symptoms of heart failure should be compensated before starting the use of Ganfort. It is necessary to regularly monitor the condition of patients with severe heart failure, determine the heart rate. Side effects from the cardiovascular and respiratory system have been reported with timolol, including deaths due to bronchospasm in patients with bronchial asthma, and less often from heart failure.

Beta-blockers can mask the symptoms of hypoglycemia, hyperthyroidism and cause worsening of Prinzmetal angina, severe peripheral and central vascular disorders, as well as arterial hypotension. In patients with a history of atopic manifestations and severe anaphylactic reactions to various allergens, doses of epinephrine (epinephrine), which are usually used to stop anaphylactic reactions, may not be effective against the background of beta-blockers. In patients with mild liver disease or initially elevated liver enzymes alanine aminotransferase (ALT), aspartate aminotransferase (ACT), and/or total bilirubin, bimatoprost had no effect on liver function during the study period of 4 hours lasting more than 24 months.

Before starting treatment, patients should be informed about the possible growth of eyelashes, increased pigmentation of the skin of the eyelids and pigmentation of the iris of the eyes, since these side effects have been established during studies of bimatoprost and Ganfort. Some changes may be permanent, and may be accompanied by differences between the eyes, if the drug was installed only in one eye. After discontinuation of Ganfort, the pigmentation of the iris may remain constant. After 12 months of treatment with Ganfort, the frequency of iris pigmentation was observed in 0.2% of patients. And after 12 months of treatment with only bimatoprost in the form of eye drops of 1.5%, a further increase in the frequency of this effect was not observed during therapy lasting 3 years. Increased pigmentation of the iris is due to increased production of melanocytes, and not just an increase in their number.

The excipient benzalkonium chloride, which is part of the preparation Ganfort, can cause irritation of the mucous membrane of the eyes and discoloration of soft contact lenses. Contact lenses must be removed before the drug is administered, and they can be put on 15 minutes after instillation. Benzalkonium chloride can cause acute keratitis and / or toxic corneal ulcers. In this regard, it is necessary to monitor the patient’s condition during frequent or prolonged treatment with Ganfort in people with dry eye syndrome and corneal changes.

After opening the bottle, it is impossible to exclude the possibility of microbial contamination of its contents, which can lead to inflammatory lesions of the eyes. The shelf life of the drug after the first opening of the bottle is 28 days. After the specified time has elapsed, the bottle should be discarded, even if the solution is not fully used.

It is recommended to write down the date of opening the bottle on the cardboard pack of the drug.

Influence on the ability to drive vehicles and mechanisms

There may be a temporary deterioration in vision after use of the drug, so the patient should wait until full vision is restored before starting to drive a car or operate mechanisms.

Form of production

Eye drops

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Bimatoprost, Timolol

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Purpose

For adults as directed by your doctor

Indications

Glaucoma