Diclofenac-SOLOfarm - instructions for use, dose, side effects, contraindications

Active substance:
Diclofenac sodium	1.0 mg
Excipients:
Benzalkonium chloride	0.05 mg
Hydroxypropyl betadex	20.0 mg
Propylene glycol	15.0 mg
Boric acid	4.8 mg
Sodium tetraborate decahydrate (borax)	0.4 mg
Disodium edetate (Trilon B)	0.1 mg
Water for injections	up to 1 ml

Description:

Transparent, colorless or light yellow liquid.

Pharmacotherapeutic group:NSAIDs

ATX: & nbsp

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 indiscriminate inhibition of cyclooxygenase 1 and 2, which leads to suppression of the synthesis of prostaglandins in the inflammatory focus.

When topical application in the form of eye drops diclofenac reduces inflammation of the eye, resulting from infection, trauma or surgery; reduces miosis during surgical operations, reduces the synthesis of prostaglandins in the moisture of the anterior chamber.

Pharmacokinetics:

The maximum concentration of the substance in the cornea and in the conjunctiva is reached by 30 minutes after instillation. The drug is rapidly excreted from the body, complete elimination is observed after 6 hours.

The drug penetrates into the anterior chamber of the eye; in the systemic circulation in therapeutically significant concentrations is not received.

Indications:

- ANDngibirovanie miosis during cataract surgery (preparation has no mydriatic properties and does not replace the standard drugs that cause mydriasis);

- treatment and prevention of inflammatory processes after surgical interventions on the eyeball;

- prevention of cystic edema of the macula after operations for cataracts;

- treatment of non-infectious conjunctivitis;

- treatment and prevention of post-traumatic inflammatory process with penetrating and non-penetrating injuries of the eyeball (as an addition to local antibiotic therapy).

Contraindications:

Hypersensitivity to the components of the drug, violation of hematopoiesis of unknown origin, erosive and ulcerative processes in the gastrointestinal tract in the acute stage.

Like other non-steroidal anti-inflammatory drugs (NSAIDs), the drug is contraindicated in patients with bouts of bronchial asthma, hives, acute rhinitis associated with the use of acetylsalicylic acid or other drugs that inhibit the activity of prostaglandin synthetase. There is the possibility of cross-sensitivity to acetylsalicylic acid, derivatives of phenylacetic acid and other NSAIDs.

Contraindicated intraocular use of the drug during surgical procedures.

Carefully:

Epithelial herpetic keratitis (including in the anamnesis); diseases, I callbleeding disorders (including hemophilia, prolonged bleeding time, a tendency to bleed); bronchial asthma caused by the intake of acetylsalicylic acid; elderly age.

Pregnancy and lactation:

The drug is contraindicated in pregnancy because of the possible risk of premature closure of the arterial duct and possible suppression of birth pain.

In experimental studies, no negative effect of diclofenac on the course of pregnancy, embryonic and postnatal development.

When diclofenac tablets were taken orally in nursing mothers at a dose equivalent to 50 ml of Diclofenac-SOLOfarm, ocular drops 0.1%, in breast milk an insignificant trace amount of the drug was revealed, not having undesirable effects on the child.

Dosing and Administration:

Locally.

For inhibition of intraoperative miosis the drug is instilled in the conjunctival sac for 2 hours at an interval of 30 minutes (4 times) before the operation.

For the prevention of cystic edema of the macula the drug is instilled in 1 drop 3 times a day for 2-3 weeks after the operation.

For the treatment of post-traumatic inflammatory process with non-penetrating injuries of the eyeball Bury in 1 drop for 4-6 hours.

The duration of treatment is determined by the doctor, depends on the course of the disease and the needs of the patient.

For example, to reduce the severity of pain after surgical intervention in the eyes (after refractive operations), the drug should be instilled in 1-2 drops per hour before surgery, 1-2 drops in the first 15 minutes after the operation and 1 drop every 4-6 hours within 3 days after the operation.

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.

The procedure for working with a tube-dropper (see Fig.):

1. Separate one tube-dropper, rest put back in the package.

2. Open the tube-dropper (making sure that the solution is in the bottom of the tube-dropper, rotate the movements and turn off the valve).

3. Inject the required amount of the drug into the eyes.

4. Close the tube with a dropper valve.

The opened tube-dropper can be stored no more than 24 hours, then the tube-dropper should be discarded.

Side effects:

The adverse events presented below are listed according to the frequency of occurrence. Frequency of occurrence is defined as follows: Often (≥ 1/10), often (≥1 / 100 and <1/10), infrequently (≥ 1/1000 and <1/100), rarely (≥ 1/10000 and <1/1000), rarely (<1/10000, including individual cases).

Often: temporary light or mild eye irritation.

Infrequently: itching in the eyes, congestion hyperemia and blurred vision (immediately after instillation).

Rarely: point keratitis or corneal lesions (after repeated use of the drug).Patients at risk of developing corneal lesions, for example, using glucocorticosteroids or as a result of various diseases (infection, rheumatoid arthritis), with repeated use of the drug in rare cases may develop sight-threatening complications of ulcerative or spot keratitis, corneal epithelial defects, edema and thinning cornea.

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

Allergic reactions

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

Overdose:

Data on drug overdose are absent.

The drug is safe if accidentally swallowed, as a 5 ml solution contains 5 mg of diclofenac (3% of the maximum daily oral doses of diclofenac adult).

Interaction:

Inhalation into the conjunctival cavity of the NSAID, including diclofenacTogether with glucocorticosteroids (GCS) in patients with severe corneal inflammation can lead to the progression of corneal lesions.Care should be taken when using the drug with GCS in patients with severe corneal inflammation.

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

Special instructions:

Anti-inflammatory action of NSAIDs, including diclofenac, can make it difficult to diagnose eye infections. Patients with an eye infection or a potential risk of its development should be prescribed along with appropriate antibiotic therapy.

During the treatment with the drug, it is not recommended to wear soft contact lenses. When using hard lenses, remove them before applying the drug and re-put them 15-20 minutes after instillation.

Pressing the lower lacrimal point or closing the eyes within 3 minutes after instillation into the conjunctival sac reduces the drug's entry into the systemic bloodstream, which contributes to a more effective local action of the drug and a reduction in the incidence of systemic side effects.

Do not touch the tip of the pipette to the eye.

Effect on the ability to drive transp. cf. and fur:

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Eye drops, 0,1%.

Packaging:

For 0,5 ml in a tube-dropper from low-density polyethylene or from polypropylene.

For 5 or 10 tubes in a foil bag or without it, together with instructions for use in a pack of cardboard.

5 ml per bottle with a dropper of low-density polyethylene and a lid with a control of the first opening or a flask-dropper made of high-density polyethylene, complete with a cap screwed and stopper-dropper.

1 bottle with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

After opening the bottle - 1 month.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003803

Date of registration:22.08.2016

Expiration Date:22.08.2021

The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia

Manufacturer: & nbsp

GROTEKS, LLC Russia

Representation: & nbspGROTEKS, LLCGROTEKS, LLC

Information update date: & nbsp10.10.2016

Illustrated instructions

Instructions

Diclofenac-SOLOfarm (Diclofenac-SOLOfarm)