Diclofenac-Solofarm eye drops 0.1%, 5ml

Composition

>1 ml of the drug contains: Active ingredient: Diclofenac Sodium-1.0 mgsupport substances: Benzalkonium chloride-0.05 Mghydroxypropyl Betadex-20.0 Mgpropylene glycol-15.0 mgBorric acid-4.8 mg Sodium tetraborate decahydrate (borax) – 0.4 mg Disodium edetate (trilon B) – 0.1 mg Water for injection-up to 1 Mldescription Transparent colorless or light yellow liquid.

Pharmacological action

Pharmacotherapy group: NSAIDs: S. 01. B. C. 03 Diclofenac M. 01. A. B. 05 Diclofenac Pharmacodynamics : Diclofenac-a derivative of phenylacetic acid, has an anti-inflammatory and analgesic effect. The mechanism of action is due to the indiscriminate inhibition of cyclooxygenase 1 and 2 activity, which leads to suppression of prostaglandin synthesis in the inflammatory focus. When applied topically in the form of eye drops, diclofenac reduces eye inflammation resulting from infection, trauma or surgery; reduces miosis during surgery, reduces the synthesis of prostaglandins in the moisture of the anterior chamber. Pharmacokinetics: The maximum concentration of the substance in the cornea and conjunctiva is reached by 30 minutes after instillation. The drug is rapidly eliminated from the body, complete elimination is observed after 6 hours. The drug penetrates the anterior chamber of the eye; it does not enter the systemic circulation in therapeutically significant concentrations.

Indications

-Inhibition of miosis during cataract surgery (the drug does not have mydriatic properties and does not replace standard drugs that cause pupil dilation);- treatment and prevention of inflammatory processes after surgical interventions on the eyeball; – prevention of cystic macular edema after cataract operations; – treatment of non-infectious conjunctivitis; – treatment and prevention of post-traumatic inflammatory process in penetrating and non-penetrating wounds of the eyeball (as an addition to local antibacterial therapy).

Contraindications

Hypersensitivity to the components of the drug, hematopoiesis disorders of unknown origin, erosive and ulcerative processes in the gastrointestinal tract in the acute stage. Like other nonsteroidal anti-inflammatory drugs (NSAIDs), the drug is contraindicated in patients with asthma attacks, urticaria, acute rhinitis associated with the use of acetylsalicylic acid or other drugs that inhibit prostaglandin synthetase activity. There is a possibility of cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives and other NSAIDs. Intraocular use of the drug during surgical procedures is contraindicated. With caution: Epithelial herpetic keratitis (including in the anamnesis); diseases that cause blood clotting disorders (including hemophilia, prolongation of bleeding time, tendency to bleed); bronchial asthma caused by taking acetylsalicylic acid; elderly age.

Side effects

The adverse events listed below are listed according to the frequency of occurrence. The frequency of occurrence is defined as follows: very common (≥ 1/10), common (≥1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10000 and < 1/1000), very rare (

Common: temporary mild to moderate eye irritation.

Infrequently: itchy eyes, conjunctival hyperemia and blurred vision (immediately after instillation).

Rarely: pinpoint keratitis or corneal lesions (after repeated use of the drug). In patients at risk of developing corneal lesions, for example, when using glucocorticosteroids or as a result of various diseases (infections, rheumatoid arthritis), repeated use of the drug in rare cases may develop vision-threatening complications: ulcerative or pinpoint keratitis, corneal epithelial defects, corneal edema and thinning.

Very rare: shortness of breath and worsening of the course of bronchial asthma, pain in the eyes.

Allergic reactions

Rare: conjunctival hyperemia, allergic conjunctivitis, redness, itching and swelling of the eyelids, urticaria, rash, eczema, erythema, pruritus, hypersensitivity, cough and rhinitis.

Interaction

Instillation into the conjunctival cavity of NSAIDs, including diclofenac, together with glucocorticosteroids (corticosteroids) in patients with severe corneal inflammation may lead to the progression of corneal damage. Caution should be exercised when using the drug together with corticosteroids in patients with severe corneal inflammation.

If necessary, it can be used simultaneously with other eye drops, including those containing corticosteroids. At the same time, the interval between instillations should be at least 5 minutes to prevent leaching of active substances by subsequent doses.

How to take, course of use and dosage

Locally. To inhibit intraoperative miosis, the drug is instilled into the conjunctival sac for 2 hours with an interval of 30 minutes (4 times) before surgery. To prevent cystic edema of the macula, the drug is instilled 1 drop 3 times a day for 2-3 weeks after surgery. For the treatment of post-traumatic inflammatory process with non-penetrating injuries of the eyeball,1 drop is instilled for 4-6 hours. The duration of treatment is determined by the doctor, depending on the course of the disease and the patient’s needs. For example, to reduce the severity of pain after eye surgery (after refractive surgery), the drug should be instilled 1-2 drops per hour before surgery,1-2 drops in the first 15 minutes after surgery, and 1 drop every 4-6 hours for 3 days after surgery. Other indications: 1 drop 3-4 times a day, depending on the severity of the condition. The course of treatment can last from 1 to 2 weeks. How to work with a dropper tube: 1. Separate one dropper tube, put the rest back in the package. 2. Open the dropper tube (after making sure that the solution is located at the bottom of the dropper tube, turn the valve with rotating movements and separate it).3. Drop the required amount of the drug into the eyes. 4. Close the dropper tube with the valve. The opened dropper tube can be stored for no more than 24 hours, then the dropper tube should be discarded.

Overdose

There are no data on overdose of the drug. The drug is safe for accidental ingestion, since 5 ml of the solution contains 5 mg of diclofenac (3% of the maximum oral daily dose of diclofenac for adults).

Special instructions

The anti-inflammatory effect of NSAIDs, including diclofenac, may make it difficult to diagnose eye infections. Patients with an eye infection or at potential risk of developing it should be given the drug together with appropriate antibacterial therapy. During treatment with the drug, it is not recommended to wear soft contact lenses. When using hard lenses, remove them before applying the drug and put them back on 15-20 minutes after instillation. Pressing the lower lacrimal point or closing the eyes for 3 minutes after instillation in the conjunctival sac reduces the drug’s entry into the systemic bloodstream, which contributes to a more effective local action of the drug and reduces the frequency of systemic side effects. Do not touch the tip of the pipette to the eye. Influence on the ability to drive vehicles and mechanisms: During the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Eye drops,0.1%.0.5 ml per dropper tube made of low-density polyethylene or polypropylene. 5 or 10 dropper tubes in a foil bag or without it, together with the instructions for use in a cardboard pack. 5 ml each in a bottle with a low-density polyethylene dropper and a lid with control of the first opening, or in a high-pressure polyethylene dropper bottle complete with a screw-on lid and a dropper plug. 1 bottle together with the instructions for use in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 2 years. After opening the bottle – 1 month. Do not use after the expiration date.

Active ingredient

Diclofenac

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Cataracts, Inflammatory Eye Diseases, Corneal Injuries, Conjunctivitis