Voltaren Ofta - instructions for use, dose, side effects, contraindications

Excipients: benzalkonium chloride 0.05 mg, disodium edetate 1 mg, hydroxypropyl-γ-cyclodextrin 20 mg, hydrochloric acid 1 M 2.1 mg, propylene glycol 19 mg, trometamol 1 mg, tyloxapol 1 mg, water for injection up to 1 ml.

Description:Transparent solution from colorless to light yellow color.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:Diclofenac has anti-inflammatory and analgesic effect. The mechanism of action of the drug is due to the indiscriminate inhibition of the activity of cyclooxygenase 1 and 2, which leads to suppression of the synthesis of prostaglandins. When used in the form of a 0.1% solution of eye drops diclofenac reduces the severity of eye inflammation and pain syndrome associated with developing after surgery, defects of the corneal epithelium; reduces miosis during surgical operations for cataracts. The use of diclofenac does not affect the time of wound regeneration.

Pharmacokinetics:In experimental studies, when instilled into the conjunctival cavity, the peak concentration of diclofenac in the cornea and conjunctiva was noted after 30 minutes. The drug was quickly excreted from the body, complete elimination is observed after 6 hours. When Voltaren® Ota is instilled in people, diclofenac penetrates into the anterior chamber of the eye. However, the drug concentration achieved in the blood is well below the detection limit and is not clinically relevant.

Indications:

- Prevent development of miosis during operations for cataracts.

- Prophylaxis of cystic edema of the macula after removal of the lens and implantation of the intraocular lens.

- Treatment of inflammatory processes after surgery for cataracts or other surgical interventions.

- Reducing the severity of pain in ophthalmology and photophobia after eye surgery and allergic conjunctivitis.

- Treatment of post-traumatic inflammatory process with non-penetrating injuries of the eyeball.

Contraindications:Hypersensitivity to diclofenac sodium or to any components of the drug. Attacks of bronchial asthma, urticaria or acute rhinitis in the history, provoked by the intake of acetylsalicylic acid or other NSAIDs. Consider the possibility of cross-sensitivity to acetylsalicylic acid, derivatives of phenylacetic acid and other NSAIDs.

Pregnancy, III trimester.

Eye drops Naklof should not be used in children and adolescents under 18 years of age. There is limited experience in using the drug in children when performing strabismus correction.

Carefully:

Pregnancy and lactation:

In the first and second trimesters of pregnancy and lactation, the administration of the eye drops of Voltaren® Ophta should only be made when the expected benefit to the mother exceeds the potential risk to the fetus or child. Diclofenac, like other inhibitors of prostaglandin synthesis, should not be used in the last 3 months of pregnancy (it is possible to suppress the uterine contractility and premature closure of the arterial duct infetus).

Clinical studies on the use of diclofenac in pregnant women have not been conducted. 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 Voltaren Ophta eye drops of 0.1%, an insignificant trace amount of the drug was found in breast milk that did not have undesirable effects on the baby.

Dosing and Administration:

Adult patients for the prevention of complications during and after surgery:

- before the operation, the drug is instilled in the conjunctival sac 1 drop five times within 3 hours;

- in the first day after the operation, 1 drop 3 times in 4 dots, starting from the second day, 1 drop 3-5 times a day.

Adult patients to reduce the severity of pain and photophobia, to treat post-traumatic inflammatory diseases and non-penetrating injuries of the eyeball - 1 drop within 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 the pain syndrome after surgery on the eyes (after refractive surgery) Voltaren Ophta should be instilled 1 -2 per hour before surgery, 1-2 drops a drop in the first 15 minutes after the operation and 1 drop every 4- 6 hours within 3 days after the operation. Elderly patients do not need a dose adjustment. Do not use Voltaren Ophta eye drops for subconjunctival injections or inject into the anterior chamber of the eye.

Side effects:

Often: temporary light or moderate eye irritation.

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

In rare cases, using Voltaren® Ophta (usually after repeated use), there was spot keratitis or corneal lesions.

In patients with a risk of developing corneal lesions, for example, when using glucocorticosteroids or as a result of various diseases (infection, rheumatoid arthritis), with repeated application of Voltaren Ophta, in rare cases development of vision-threatening complications: ulcerative or point keratitis, epithelial defects of the cornea, edema and thinning of the cornea.

In isolated cases with Voltaren Ophta, patients experienced shortness of breath and a worsening of the course of bronchial asthma.

With the use of the drug, the development of conjunctival hyperemia, allergic conjunctivitis, redness, itching and edema of the eyelids, urticaria, rash, eczema, erythema, pruritus, hypersensitivity, cough and rhinitis was rarely noted.

Overdose:Data on drug overdose are absent. Eye drops Voltaren® Ota are safe for inadvertent ingestion, since 5 ml of the solution contains 5 mg of diclofenac (3% of the maximum oral daily dose of diclofenac for adults).

Interaction:

Burial in the conjunctival cavity of NSAIDs, including diclofenacTogether with glucocorticosteroids (GCS) in patients with severe corneal inflammation can lead to the progression of corneal lesions. Caution should be exercised when using Voltaren® Ophta together with GCS in patients with severe corneal inflammation.

If necessary, the drug can be used simultaneously with other eye drops: antibiotics and β-blockers. In this case, the break between applications should be at least 5 minutes to prevent the leaching of active substances with subsequent doses.

Data on the reduction in blood clotting in patients on the background of treatment with Voltaren® Ophta are absent. However, theoretically, with the application of Voltaren® Opht together with drugs that reduce blood coagulability, or in patients with reduced coagulability, bleeding time may increase.

Special instructions:

Anti-inflammatory effect 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.

The drug is used only after removal of contact lenses. Wear contact lenses no earlier than 15 minutes after instillation.

Eye drops Voltaren® Ophta contains as a preservative benzalkonium chloride, which can cause eye irritation and change the color of soft contact lenses.

The composition of eye drops Voltaren Ofta includes cyclodextrin (CD) and hydroxypropyl-γ-cyclodextrin (GP-γ-CD). CD increases the solubility in water of some lipophilic water-insoluble drugs.It is assumed that CD plays the role of a carrier that holds molecules of hydrophobic drugs in a dissolved state and delivers them to biological membranes.

When the original packaging is opened, the sterility of the dropper is impaired. To prevent contamination of the drug solution during instillation, patients should avoid contact with the tip of the dropper with the eye and skin.

Pressing the lower lacrimal point or closing the eyes within 3 minutes after instillation into the conjunctival sac reduces the ingestion of Voltaren® Otor 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.

Effect on the ability to drive transp. cf. and fur:In patients during Voltaren® Ophta therapy, blurred vision may be adversely affecting the ability to drive and work with machinery. If such symptoms appear, the patient should refuse to drive the car or work with the mechanisms until the visual impairment disappears completely.

Form release / dosage:Eye drops 0.1%.

Packaging:5 ml in a polypropylene bottle equipped with a dropper.One bottle, equipped with a dropper, along with instructions for use in a cardboard bundle.

Storage conditions:At a temperature of no higher than 30 ° C. Keep out of the reach of children.

Shelf life:

2 years. After opening the bottle the drug should be used within a month. The drug should not be used after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013506 / 01

Date of registration:16.01.2008 / 24.12.2012

Expiration Date:Unlimited

The owner of the registration certificate:ALKON PHARMACEUTICS, LLC ALKON PHARMACEUTICS, LLC Russia

Manufacturer: & nbsp

EXCELVISION France

Representation: & nbspALKON PHARMACEUTICS LLCALKON PHARMACEUTICS LLCRussia

Information update date: & nbsp06.03.2017

Illustrated instructions

Instructions

Voltaren® Ophta (Voltaren® Ophtha)