Trusopt eye drops 20mg/ml, 5ml

Composition

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1 ml is dorzolamide hydrochloride 22.26 mg, which corresponds to the content of dorzolamide 20 mg

Auxiliary substances:

mannitol-23 mg,

hyethellose-4.75 mg,

sodium citrate-2.94 mg,

benzalkonium chloride-0.075 mg,

sodium hydroxide-for pH correction 5.5-5.8,

water for injection-up to 1 ml

Pharmacological action

Trusopt eye drops have an anti-glaucoma effect.

The composition of the drug Trusopt includes an inhibitor of carbonic anhydrase II-dorzolamide hydrochloride. Inhibition of carbonic anhydrase in the ciliary body of the eyeball reduces the production of intraocular fluid. A decrease in intraocular pressure occurs as a result of slowing down the synthesis of bicarbonate ions with their subsequent reduction to sodium and removal of fluid.

Pharmacokinetics

With prolonged use, dorzolamide selectively accumulates in red blood cells as a result of selective binding to carbonic anhydrase II, while the concentration of free dorzolamide in plasma remains extremely low.

Dorzolamide forms a single metabolite, N-desethyl-dorzolamide, which inhibits the enzyme carbonic anhydrase II and the enzyme carbonic anhydrase I to a lesser extent than dorzolamide. The metabolite accumulates in red blood cells, binding mainly to carbonic anhydrase I.

Dorzolamide is moderately bound to plasma proteins (about 33%).

Dorzolamide and its metabolite are mainly excreted unchanged through the kidneys. After the end of treatment, dorzolamide is washed out of red blood cells unevenly, i. e., very intensively at the beginning, which leads to a rapid and significant decrease in concentration, followed by a slow washout phase with T1/2 for about 4 months.

Indications

Trusopt is prescribed to reduce elevated intraocular pressure associated and unrelated to glaucoma. Trusopt is indicated for patients with:

• intraocular hypertension (increased intraocular pressure);
• primary open-angle glaucoma, including pseudoexfoliative glaucoma;
• and secondary glaucoma (without anterior chamber angle block).

Use during pregnancy and lactation

Trusopt is contraindicated for use during pregnancy and lactation.

Use in children

The drug is used in children older than 1 week.

Contraindications

• chronic renal failure;
• pregnancy;
• lactation (breastfeeding);
• age less than 1 week;
• hypersensitivity to the components of the drug.

With caution

The use of Trusopt has not been studied in patients with severe hepatic insufficiency, and therefore, the drug should be used with caution in this category of patients.

Side effects

In clinical trials, Trusopt was administered to 1,108 patients as monotherapy or as an adjunct to beta-blocker therapy. In approximately 3% of patients, the drug was discontinued due to local adverse reactions from the eye, the most common of which were conjunctivitis and reactions from the eyelids.

Side effects reported in the course of studies and during the post-marketing period are classified by frequency: very frequent (>1/10), frequent (≥1/100, >

From the nervous system: often-headache; rarely-dizziness, paresthesia.

From the side of the visual organ: very often – burning and pain; often-superficial pinpoint keratitis, lacrimation, conjunctivitis, inflammation of the eyelids, itching, irritation of the eyelid, blurred vision; infrequently-iridocyclitis; rarely-redness of the eyes, pain, hyperkeratosis of the eyelids, transient myopia (disappearing after discontinuation of the drug), corneal edema, decreased intraocular pressure, detachment of the choroidal membrane of the eye after surgical interventions to restore the outflow of intraocular fluid.

From the respiratory system: rarely-nosebleeds, pharyngitis.

From the digestive system: often – nausea, bitter taste in the mouth; rarely-dry mouth.

From the skin and mucous membranes: rarely-contact dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis.

From the urinary tract: rarely-urolithiasis.

Allergic reactions: rarely-signs and symptoms of local reactions (from the eyelids) and systemic allergic reactions, including angioedema, urticaria, pruritus, rash, difficulty breathing, less often-bronchospasm.

From the body as a whole: often – asthenia, fatigue.

Children

In a 3-month double-blind multicenter study using the active drug as a control, conducted in 184 children under the age of 6 years, the profile of adverse reactions of Trusopt® was comparable to the profile of adverse reactions in adult patients. The most common adverse reactions associated with the use of Trusopt® in children under 2 years of age were conjunctival injection (5.4%) and eye discharge (3.6%). In children aged 2 to 6 years, the most common adverse reactions were a burning sensation in the eye (12.1%), conjunctival injection (7.6%), eye pain (3%), and eyelid inflammation (3%).

Interaction

Trusopt eye drops are compatible with betaxolol and timolol ophthalmic solutions.

It is allowed to combine the drug with calcium antagonists (verapamil, nifedipine, amlodipine, cinnarizine, etc. ), diuretics, nonsteroidal anti-inflammatory drugs (including aspirin), estrogens, thyroxine, insulin, as well as ACE inhibitors (captopril, enalapril, perindopril, etc. ). When taking large doses of aspirin, toxicity may increase.

How to take, course of use and dosage

The usual dose is 1 drop in the affected eye (or both eyes). 3 times a day (morning, afternoon and evening. )

When using Trusopt concomitantly with other eye drops, they should be instilled at intervals of at least 10 minutes.

If you replace any anti-glaucoma drug with Trusopt, you should start treatment with Trusopt from the next day after the previous drug is discontinued.

Instructions for use:

1. Make sure that the protective strip on the outside of the bottle is not damaged, there is no gap between the cap and the bottle.

2. Remove the protective strip and unscrew the cap in the direction of the pointing arrows shown on it.

3. Tilt your head back, pull the lower eyelid down a little until there is a space between the eye and the eyelid.

4. Turning the bottle upside down, lightly press the place for pressing with your finger indicated on the bottle – one drop will fall into the eye. Never touch the tip of the open bottle on any surface!

5. Repeat for the second eye if necessary.

6. Tighten the cap tightly until it comes into close contact with the bottle.

Overdose

It is manifested by disorders of water and electrolyte metabolism, acidosis, and disorders of the central nervous system.

Overdose is treated symptomatically by monitoring serum electrolytes and blood pH.

Special instructions

The preservative benzalkonium chloride is absorbed by contact lenses, so they must be removed before instillation of the drug and put on no earlier than 15 minutes.

Influence on the ability to drive a car and work with machinery. It is recommended to stop driving vehicles and perform work that requires increased concentration of attention and rapid psychomotor reactions during treatment with Trusopt.

Form of production

Eye drops in the form of a clear, colorless or almost colorless, slightly viscous solution.

Storage conditions

Store at room temperature (15-30°C) in a dark place out of the reach of children.

Shelf

life is 2 years. After the first autopsy – 4 weeks.

Active ingredient

Dorzolamide

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Description

For adults as directed by your doctor

Indications

Glaucoma