Voltaren Oftan
Active material: Diclofenac
When ATH: S01BC03
CCF: Valium for local application in ophthalmology
ICD-10 codes (testimony): H10.1, H16, H16.2, S05, Z29.8, Z51.4
When CSF: 05.01.03.03
Manufacturer: NOVARTIS PHARMA AG (Switzerland)
Pharmaceutical form, composition and packaging
Eye drops 0.1% in the form of a clear solution of light yellow color.
| 1 ml | |
| diclofenac sodium | 1 mg |
Excipients: benzalkonium chloride, disodium эdetat, gidroksipropil cyclodextrin-γ-, 1M hydrochloric acid, propylene glycol, trometamol, tyloxapol, water d / and.
5 ml – vials made of polypropylene (1) with dropper – packs cardboard.
Pharmacological action
Valium for local application in ophthalmology.
Diclofenac has anti-inflammatory and analgesic effect. The mechanism of action is due to non-selective inhibition of COX-1 and COX-2, that leads to the suppression of prostaglandin synthesis.
When used in the form of 0.1% eye drops, diclofenac reduces inflammation and eye pain, associated with developing post-surgical corneal epithelial defects; reduces cramps during surgery for cataract.
Diclofenac has no effect on the regeneration of wounds.
Pharmacokinetics
IN experimental studies with instillation into conjunctival cavity Tmax diclofenac in the cornea and conjunctiva was 30 m. The drug is rapidly eliminated from the body, complete elimination is observed in 6 no.
With instillation of the drug Voltaren® Oftan people there is penetration of diclofenac into the anterior chamber. However, the concentration of drug, achieved in the blood, well below the limit of detection and has no clinical significance.
Testimony
- Prevention of miosis during cataract surgery;
- Prevention of cystoid macular edema after lens removal and implantation of intraocular lens;
- Treatment of inflammation after cataract surgery or other surgery on the eyeball;
- Reduction in the severity of pain and photophobia after ophthalmic surgery on the eyeball and allergic conjunctivitis;
- Treatment of post-traumatic inflammation in the non-penetrating injuries of the eyeball.
Dosage regimen
Adults
The duration of treatment depends on the course of the disease, the needs of the patient and determined by the physician.
To prevention of complications during and after surgery: preoperatively Bury drug in the conjunctival sac of 1 drop 5 times during 3 no. On the first day after surgery – by 1 drop 3 times / day. Starting from the second day – by 1 drop 3-5 time / day.
To reduce the severity of pain and photophobia, treatment of post-traumatic inflammation in the non-penetrating injuries of the eyeball the drug should be instilled at 1 dropwise over 4-6 no.
To reduce the severity of pain after surgery on the eyeball (after refractive surgery) Voltaren® Oftan Bury on 1-2 drop / h before surgery, by 1-2 drop in the first 15 minutes after the operation and 1 every drop 4-6 h for 3 day after surgery.
Elderly patients does not require correction dose.
Do not use eye drops Voltaren® Oftan for subconjunctival injection or administered into the anterior chamber.
Side effect
On the part of the organ of vision: often – Temporary mild to moderate eye irritation; sometimes – itchy eyes, conjunctival hyperemia, blurred vision (immediately after instillation of the drug).
In rare cases, when using the drug Voltaren® Ofta (usually after repeated use) marked punctate keratitis or corneal lesions.
Patients at risk of developing corneal lesions (incl. the application of the SCS, as a result of various diseases / infection, rheumatoid arthritis/), with repeated use of the drug Voltaren® Oftan in rare cases may develop sight-threatening complications: ulcerative keratitis or spot, corneal epithelial defects, edema and corneal thinning.
Allergic reactions: rarely – conjunctival hyperemia, allergic conjunctivitis, hyperemia, itching and swelling of the eyelids, hives, rash, eczema, itch, hypersensitivity reactions, cough, rhinitis; in a few cases – breathlessness, worsening asthma.
Contraindications
- Bronchial asthma, hives, coryza history, provoked reception using aspirin or other NSAIDs;
- III trimester of pregnancy;
- Hypersensitivity to diclofenac sodium or other ingredients.
The drug should not be used in children and adolescents under the age of 18 years. There is limited experience with the drug in children for operations to correct strabismus.
Pregnancy and lactation
Use of the drug Voltaren® Oftan in I and II trimesters of pregnancy and lactation is possible only in the case, when the intended benefits to the mother outweighs the potential risk to the fetus or child.
Diclofenac should not be used in the III trimester of pregnancy due to possible suppression of uterine contractility, and premature closure of the ductus arteriosus in the fetus.
IN experimental studies diclofenac negative impact on pregnancy, postanatalnoe embryonic development and has not been established. Clinical studies on the use of diclofenac in pregnant patients have not been conducted.
In applying the nursing mother tablets of diclofenac oral dose, equivalent 50 ml 0.1% eyedrops Voltaren® Ofta, breast milk allocated a small trace amount of the drug, no adverse effect on the child.
Cautions
Anti-inflammatory effects of NSAIDs, including diclofenac, can complicate diagnosis of ocular infectious processes. Patients with eye infections or potential risk of its development should be prescribed along with appropriate antibiotic therapy.
The drug is used only after removal of contact lenses. Establish contact lenses should not earlier, than 15 minutes after instillation.
Eye drops Voltaren® Oftan contain a preservative benzakloniya chloride, which can cause eye irritation and discolour soft contact lenses.
The composition of eyedrops Voltaren® Ofta vhodit cyclodextrin (CD) and gidroksipropil cyclodextrin-γ- (GP-γ-CD). CD increases the solubility in water of some lipophilic water-insoluble drugs. Expected, CD that plays the role of carrier, holding the molecule hydrophobic drugs in solution and delivering them to the biological membranes.
When opening the original packaging is broken sterile dropper. To prevent contamination of the drug solution with instillation patients should avoid contact with the dropper tip of the eye and skin.
Pressing the lower lacrimal point or closing of the eyes for 3 min after instillation in the conjunctival sac reduces penetration of diclofenac into the systemic circulation, which promotes more effective local action of the drug and reduce the incidence of systemic side effects.
Effects on ability to drive vehicles and management mechanisms
In patients during therapy with Voltaren® Oftan possibly blurred vision, have a negative impact on the ability to drive vehicles and use machines. When these symptoms the patient should give up driving or using machinery until the complete disappearance of visual impairment.
Overdose
Data on drug overdose Voltaren® Oftan missing.
Eye drops Voltaren® Oftan Accidental ingestion, since 5 ml solution contains 5 mg diclofenac (3% the maximum daily oral dose for adults diclofenac).
Drug Interactions
Caution should be exercised when using the drug Voltaren® Oftan with corticosteroids in patients with severe corneal inflammation, as instillation into conjunctival cavity NSAIDs, including diclofenac, together with corticosteroids in patients with severe corneal inflammation can lead to the progression of corneal lesions.
If necessary, the preparation can be used concurrently with other eyedrops: antibiotics and beta-blockers. At the same time interval between applications should be at least 5 min to prevent leaching of the active ingredients by subsequent doses.
Data on reducing blood clotting in patients on background treatment with Voltaren® No Oftan. Theoretically, however, when using the drug Voltaren® Oftan with drugs, reduce blood clotting, or in patients with reduced blood clotting time, bleeding may increase.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children at a temperature up to 30 ° C. Shelf life – 2 year.
After opening the bottle the drug should be used within 1 Months.
