Diclofenac
Producer: Federal State Unitary Enterprise Moscow Endocrine Plant Russia
Code of automatic telephone exchange: S01BC03, M01AB05
Release form: Liquid dosage forms. Drops are eye.
General characteristics. Structure:
Active ingredient: 1 mg of diclofenac of sodium in 1 ml of solution.
Excipients: sorbic acid, dinatrium of an edetat a dihydrate, (disodium salt ethylene diamine of tetraacetic acid a dihydrate) hydrophosphate sodium, dodecahydrate solution of sodium of hydroxide of 1 M - to рН 6,5-7,5, sodium chloride, methyl cellulose water-soluble, the water purified.
Pharmacological properties:
Pharmacodynamics. Non-steroidal anti-inflammatory drug, derivative phenylacetic acid, possesses the antiinflammatory and anesthetizing action. Not selectively oppressing cyclooxygenase 1 and cyclooxygenase 2, breaks metabolism of arachidonic acid, reduces amount of prostaglandins in the inflammation center. At topical administration reduces hypostasis and pain at inflammatory processes of a noninfectious etiology.
Pharmacokinetics. Time of achievement of the greatest concentration in moisture of an anterior chamber - 30 minutes after installation, gets into an anterior chamber of an eye; in therapeutic significant concentration does not get into system blood circulation.
Indications to use:
Miosis inhibition during operations for a cataract; prevention and treatment of a cystous maculopathia after surgical removal of a cataract; inflammatory process of the noninfectious nature, conjunctivitis, keratoconjunctivitis, postoperative and posttraumatic uveitis, keratitis, cornea erosion.
Route of administration and doses:
Dig in in a conjunctival sac before operation on 1 drop of 5 times within 3 hours, right after operation - on 1 drop 3 times, further - on 1 drop of 3-5 times a day during time, necessary for treatment; other indications - on 1 drop of 4-5 times a day.
Features of use:
Pregnancy and lactation. There are no data on use of drug during pregnancy and a lactation. When using non-steroidal anti-inflammatory drugs in the III trimester of pregnancy increase in risk of emergence of disturbances of blood circulation of a fruit is possible. Use for pregnant women and nursing mothers is possible only to destination the attending physician if the expected medical effect exceeds risk of development of possible side effects.
Drug is not intended for subconjunctival introduction or to an anterior chamber of an eye. After removal of contact lenses the instillation is made in 5 minutes.
In the presence of an infection or threat of its development at the same time appoint topical antibacterial treatment.
Break between use of various drops - 5 minutes.
During treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
Side effects:
The keratitis, increase in intraocular pressure, adjournment of deposits in a cornea, swelled corneas, burning, an illegibility of visual perception (right after an instillation); opacification of a cornea (cataract), iritis; allergic reactions: an itch in eyes, a hyperemia, a Quincke's disease of the person, fever, a fever, a photosensitization, skin rash (preferential erythematic, a small tortoiseshell), a multiformny exudative erythema; nausea, vomiting.
Interaction with other medicines:
If necessary it is possible to apply along with other eye drops including containing glucocorticosteroids. At the same time the break between applications has to be not less than 5 minutes for prevention of washing away of active ingredients the subsequent doses.
Contraindications:
Hypersensitivity to drug components, acetylsalicylic acid.
With care: erosive and ulcer processes of digestive tract in an aggravation stage; the diseases causing blood coagulation disturbances (including hemophilia, lengthening of a bleeding time, tendency to bleedings); an epithelial herpetic keratitis (including in the anamnesis); children's and advanced age; bronchial asthma.
Storage conditions:
In the place protected from light at a temperature not above 15 °C. To protect from freezing. To store in the places unavailable to children. A period of validity - 2 years. A drug period of validity after opening - 1 month. Not to use after the expiry date specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Drops eye 0,1%. Packaging: 1,5 ml, 2 ml or 5 ml in a tube dropper polymeric. 1, 2, 4, 5 or 10 tube droppers with the application instruction of drug in a pack from a cardboard with partitions or without partitions. 5 ml or 10 ml in a bottle dropper polymeric. The 1 or 2 bottle dropper with the application instruction of drug in a pack from a cardboard. 5 ml in bottles glass. 1 bottle complete with a cover dropper in sterile execution and the application instruction of drug in a pack from a cardboard.