Pharmacological authorities
Pharmacodynamics.
The drug replaces diclofenac sodium, a non-steroidal anti-inflammatory drug with analgesic powers. The mechanism of diclofenac sodium binding to the inhibition of prostaglandin synthesis.
It has been clinically proven that diclofenac inhibits myosis during cataract surgery and changes the inflammatory process, pain in the eye, caused by deteriorating corneal epithelium after various types of surgery. a warm hand-over.
Every day we recommend infusing diclofenac on wounds.
Pharmacokinetics.
When instilled, diclofenac is absorbed into the systemic bloodstream. When instilled into the conjunctiva, the maximum concentration of diclofenac in the cornea and conjunctiva was 30 minutes. The drug is quickly eliminated from the body; further elimination occurs after 6 years.
However, the concentration of the active substance that reaches the blood is significantly lower than that observed and does not have clinical significance.
Drug interactions
- Methotrexate, diflunisal, sulfonylureas, other NSAIDs, including acetylsalicylic acid in high doses (3 g or more per day): there is a risk of bleeding from the gastrointestinal tract;
- Lithium preparations, indirect anticoagulants, digitoxin: their effect is enhanced.
If necessary, other drugs for local use in ophthalmology (including glucocorticosteroids) can be prescribed simultaneously, but at least 5-minute intervals should be observed between instillations.
Showing
- Inhibition of the development of intraoperative miosis during cataract surgery. (Diclo-F does not have the characteristic middramatic powers and does not replace the standard medicinal methods that cause expanded areas).
- Treatment of the postoperative ignition process after cataract removal and other surgical procedures.
- Control of the severity of pain and discomfort in ophthalmology associated with damage to the corneal epithelium after excimer photorefractive therapy (PRT) or minor non-penetrating trauma.
- Control of the development of the ignition process after argon laser trabeculoplasty (ALT).
- Changes in the signs and symptoms of seasonal allergic conjunctivitis (SAH) in ophthalmology.
- Treatment of the ignition process and discomfort after surgical treatment of the oblique bone.
- Treatment of pain and discomfort in ophthalmology after radial keratotomy.
Contraindicated
Hypersensitivity to real speech or to any other speech.
Internal administration of the drug during the hour of the surgical procedure.
Like other non-steroidal anti-inflammatory drugs (NSAIDs), the drug is contraindicated in patients with attacks of bronchial asthma, urticaria, acute rhinitis associated with stagnation of acetylsalicylic acid or other drugs iv, which suppresses the synthesis of prostaglandins. The development of cross-sensitivity to acetylsalicylic acid, similar phenyloctic acid and other non-steroidal anti-inflammatory drugs is particularly likely. Therefore, caution should be exercised when prescribing the drug to patients who are sensitive to these drugs.
Interactions with other medicinal drugs and other types of interactions
If more than one type of eye drops is assigned, they should be buried at intervals of at least 5 drops.
Immediate administration of NSAIDs for local inflammation, such as diclofenac, and steroids for local inflammation in patients with existing inflammation of the cornea may increase the risk of development of folding on the side of the horn. vki, as well as to increase the suppression of the cornea, the drug must be frozen with care.
Immediate use of medications to prevent bleeding may increase the risk of hemorrhage.
Eye drops, which act as a substitute for 0.1% diclofenac, have been successfully tested in clinical studies with a combination of antibiotics and beta blockers for local inflammation.
Composition and release form
Eye drops, appearance – a transparent, colorless or light yellow solution. Available in bottles with a dropper of 5 milliliters, the material is plastic. There is also another form of packaging - glass bottles complete with a dropper, the content volume is the same - 5 milliliters. Packaging: cardboard boxes.
The composition of 1 milliliter of the drug includes the active substance – diclofenac sodium – 1 milligram.
Auxiliary components: benzalkonium chloride, tromethamine, disodium edetate, boric acid, polyoxyl 35 castor oil, distilled water.
Features of good stagnation
The anti-inflammatory action of ophthalmic non-steroidal anti-inflammatory agents can mask the beginning and/or progression of eye infections. If an infection is evident or there is a potential risk of developing an infection, a similar therapy (for example, antibiotic therapy) should be prescribed immediately with the drug.
Wanting to know about such side effects every day, it is theoretically possible that in patients who are stagnant with other medications, they may suffer from bleeding, or in patients nts with diagnosed disorders of the throat of the blood when the drug is ingested, aggravated illness can be avoided.
It is clear that the oil refinery works for local stagnation or to stop the stagnation. Corticosteroids for local congestion can also relieve congestion of the cornea. Therefore, it is necessary to be careful with one-hour stagnation of NPZD for local stagnation, such as diclofenac, and steroid drugs for patients with inflammation of the cornea (section “Interactions with other medicinal agents and our forms of mutuality").
Eye drops are not approved for injection. It cannot be administered subconjunctivally or in the anterior chamber of the eye. During the hour of bathing with eye drops, in order to eliminate microbial contamination, do not touch the eye drops, adjacent areas or other surfaces.
It is important to immediately institute medication for patients who have symptoms of impaired corneal integrity.
It is clear that patients who have undergone complex operations on the eyes/eyes, denervation of the cornea, or who may have defects in the corneal epithelium, blood diabetes, non-bacterial diseases of the eyes (for example, dry eye syndrome), rheumatoid arthritis, or those who have undergone repeated ocular/ocular surgery Over the course of a short period of time, there is a looming risk of developing an unpleasant influx of diclofenac onto the cornea, which can pose a threat to vision.
Suspension of NPZD for 24 years before surgery or up to 14 days after surgery may increase the patient's risk/severity of side effects on the side of the cornea.
It appears that diclofenac sodium, drops in the eyes, should not cause a real surge in the eye pressure. However, it is necessary to use diclofenac sodium drops with care after surgery for cataracts, the fragments of which may cause dislocation of the internal eye pressure.
It is advisable to remove benzalkonium chloride from the preservative, which can cause irritation of the eyes, as well as remove deposits on the surface of soft contact lenses. Therefore, the drug should not be frozen when wearing soft contact lenses: before drying the drug, the lenses must be removed and reinserted no earlier than 15 days after instillation. It is recommended to avoid wearing contact lenses when treating sore eyes.
After instillation of eye drops, occlusion (pressing with a finger) of the nasolacrimal ducts or closing the eyes for 3 strands will ensure a decrease in systemic absorption.
This, in turn, reduces the risk of systemic side effects and promotes the local effect of the drug.
Suspension during pregnancy or breastfeeding.
Vaginism
Data on the use of the drug Diklo-F during pregnancy are daily.
Studies on animals with diclofenac have shown reproductive toxicity.
1st and 2nd trimester: studies on animals have not yet shown any harm to the fetus, and there are no other controlled studies in pregnant women.
Third trimester: diclofenac should not be used due to the possible risk of premature closure of the ductus arteriosus and possible suppression of the birth canal.
Anniversary breastfeeding
Diclofenac is excreted in breast milk. However, infusion of the drug in therapeutic doses to a child during infancy does not last. The use of diclofenac in ophthalmology is not recommended during the breastfeeding period, as long as the bark is cleared from the use of the drug, there is a possible risk.
This is due to the fluidity of the reaction during treatment with vehicles or other mechanisms.
If the drug is used, it can immediately reduce the clarity of the vision and cause other damage to the vision, fogging, which can be caused by vehicles or other mechanisms. Those patients who are afraid of adverse reactions should avoid treatment with transport methods and robots with mechanisms.
Method of congestion and dosage
Rozchin Diklo-F, ophthalmic drops, the purpose of instillation of the eye drops in the conjunctival sac. It should never be injected subconjunctivally, nor should it be injected directly into the anterior chamber of the eye.
mature
| Prevention of intraoperative miosis | 1 drop 4 times for 2 years before surgery. |
| Control of the development of the ignition process in the postoperative period | 1 drop 4 times per dose for up to 28 days. |
| Control of the severity of pain and discomfort during the period after PRK | 1 drop 2 times per year before surgery, 1 drop 2 times for 5 weeks immediately after PRK, and then in the postoperative period, 1 drop per skin for 2-5 years during the period of non-sleeping for 24 years. |
| Control of the severity of pain syndrome in ophthalmology associated with abrasion of the corneal epithelium after minor non-penetrating trauma | 1 drop 4 times per dose for 2 days. |
| Monitoring the development of the ignition process after performing ALT | 1 drop 4 times for 2 years before ALT, and then 1 drop 4 times per day for 7 days. |
| Changes in the signs and symptoms of seasonal allergic conjunctivitis in ophthalmology | 1 drop 4 times per serving, as long as necessary. |
| Treatment of the initial process and discomfort after surgical treatment of a club bone | 1 drop 4 times per dose using the 1st pull, 3 times per drop using the 2nd pull, 2 times per drop using the 3rd pull and, if necessary, using the 4th pull. |
| Treatment of pain and discomfort in ophthalmology after radial keratotomy | In the preoperative period – 1 drop before surgery, in the postoperative period – 1 drop once after surgery, and then 1 drop 4 times a day for up to 2 days. |
Children.
The drug should not be given to children. Evidence of the use of diclofenac, drops in the eyes of this age-old group, is based on the data of many published clinical studies obtained during surgical treatment of the oblique bone.
Indications for use
- Suppression of miosis during cataract surgery;
- Treatment of non-infectious conjunctivitis;
- Treatment and prevention of inflammatory processes after eye surgery;
- Treatment and prevention of post-traumatic inflammation in non-penetrating and penetrating wounds of the eyeball (in combination with local antibacterial drugs);
- Prevention of cystoid macular edema after cataract surgery.
Side effects
Adverse reactions, which were monitored during clinical trials, can be divided according to frequency: very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥1/1000 , <1/ 100), rare (≥1/10000, <1/1000), even rare (<1/10000), frequency unknown - cannot be estimated based on obvious data.
From the side of the organs
Common: speckled keratitis, pain in the eyes, mucous membrane irritation, itching, conjunctival hyperemia.
Uncommon: keratitis, swelling of the internal eye, swelling of the cornea, swelling of the conjunctiva, abrasion on the cornea, conjunctival follicles, discomfort in the eyes, vision from the eyes, formation of crusts on the edges of the eyelids, swelling of the tear Ellen, teased cheeks, red eyes.
Frequency unknown: corneal perforation, virulent keratitis, corneal epithelial defects, cloudy cornea, thinning of the cornea, allergic conjunctivitis and other allergic ocular diseases, erythema of the eyes Hook, scratching and itching of the eyes, blurred vision.
On the side of the immune system
Uncommon: hypersensitivity reactions.
Underworld disorders and changes at the place of introduction
Uncommon: destroyed pen.
Infections
Frequency unknown: rhinitis.
On the side of the thoracic system, thoracic cavity and mediastinal organs
Frequency unknown: exacerbation of bronchial asthma, shortness of breath, cough.
On the side of the skin and under the skin
Frequency unknown: kropivyanka, vysypannya, eczema, erythema, itching.
Information about suspected adverse reactions. We kindly ask you to inform medical professionals, patients, and pharmacists about any suspicion of adverse reactions or the presence of a therapeutic effect. Representative office of Sentiss Pharma Pvt. Ltd. in Ukraine or Contact a person with pharmacological data from SENTISS PHARMA PVT. LTD. in Ukraine.
Contraindications
Absolute:
- Exacerbation of the erosive-ulcerative process in the gastrointestinal tract;
- Hematopoietic disorder of unknown origin;
- Hypersensitivity to the components of the drug, acetylsalicylic acid or other NSAIDs.
Relative (diseases/conditions for which eye drops should be used with caution due to the likelihood of complications):
- Epithelial herpetic keratitis, including a history;
- Diseases that cause blood clotting disorders (including bleeding tendency, prolonged bleeding time, hemophilia);
- Elderly age.
There is no data on the safety of using the drug in childhood, during pregnancy and lactation, so drops can be prescribed only in cases where the expected benefits outweigh the possible risks.
