Oftan Dexamethasone: instructions for use and reviews
Latin name: Oftan Dexamethason
ATX Code: S01BA01
Active ingredient: Dexamethasone (Dexamethasone)
Manufacturer: Santen, Finland
Actualization of the description and photo: 07/25/2018
Prices in pharmacies: from 193 rubles.
Oftan Dexamethasone is a local drug for use in ophthalmology with anti-allergic, anti-inflammatory action.
Release form and composition
Dosage form of release - eye drops: transparent, colorless (in plastic bottles, droppers, 5 ml, 1 bottle, dropper in a cardboard box).
The composition of 1 ml of solution includes:
- Active ingredient: dexamethasone - 1 mg (in the form of dexamethasone sodium phosphate - 1.32 mg),
- Auxiliary components: benzalkonium chloride, boric acid, sodium tetraborate, edetate disodium, water for injection.
Pharmacodynamics and pharmacokinetics
The drug has a pronounced anti-inflammatory and anti-allergic effect.
When interacting with a specific protein receptor in target tissues, the agent regulates the expression of corticoid-dependent genes and affects protein synthesis.
Also, the drug has the following effects on the body:
- stabilization of lysosomal enzymes of leukocyte membranes,
- suppression of the synthesis of antibodies and kinins,
- antigen recognition disorder,
- suppression of mitosis and migration of leukocytes.
All of the described effects are involved in the suppression of a local inflammatory response in the tissues in response to immune, chemical or mechanical damage.
The duration of the anti-inflammatory effect after instilling 1 drop is 4–8 hours.
Systemic absorption when applied topically is low. When instilled into the conjunctival sac, the drug penetrates well into the corneal epithelium and conjunctiva, which leads to therapeutic concentrations in the aqueous humor of the eye. In case of damage or inflammation of the mucous membrane, an increase in the rate of penetration is observed.
Approximately 60–70% of the dexamethasone entering the systemic circulation binds to plasma proteins. Metabolism of the drug occurs in the liver under the action of CYP3A4 enzymes, the excretion of metabolites is carried out through the intestines. Plasma half-life is about 3.6 ± 0.9 hours.
Indications for use
According to the instructions, Oftan Dexamethasone is used to treat inflammatory processes in the acute and chronic course, as well as allergic eye diseases:
- Episcleritis, scleritis,
- Conjunctivitis, keratitis, keratoconjunctivitis, blepharitis in non-purulent forms,
- Superficial corneal damage of various origins (immune, physical, chemical) after complete epithelization of the cornea,
- Iridocyclitis, iritis and other uveitis with different etiologies,
- Inflammation, swelling (including in the period after the operation),
- Inflammation of the posterior segment of the eye (chorioretinitis, choroiditis),
- Keratoconjunctivitis or conjunctivitis of an allergic etiology,
- Sympathetic ophthalmia.
Also, the drug is shown for therapeutic and prophylactic purposes with inflammatory events in the period after injuries and surgical interventions.
- Increased intraocular pressure
- Keratitis, which is associated with chickenpox, herpes simplex and other viral diseases of the conjunctiva and cornea,
- Mycobacterial infections of the eye,
- Eye tuberculosis,
- Fungal and acute purulent eye diseases,
- Damage to the corneal epithelium (including the state after removal of a foreign body from the cornea),
- Corneal epitheliopathy,
- Up to 18 years of age (due to the lack of necessary data on the efficacy and safety of using Oftan dexamethasone in this age group of patients),
- Hypersensitivity to the drug.
During pregnancy and lactation, eye drops of Oftan Dexamethasone are prescribed for a course of no longer than 7-10 days only after the doctor assesses the ratio of the estimated benefits to the possible risk to the health of the woman and the child.
During the application of eye drops Oftan Dexamethasone may be observed violations of the organ of vision: a short burning sensation after instillation, allergic reactions. As an auxiliary component of the preparation includes a preservative - benzalkonium chloride, which can lead to eye irritation.
With a long course of therapy, the development of steroid cataracts and secondary glaucoma, as well as clouding, ulceration, perforation and / or thinning of the cornea, in rare cases - the spread of herpes or bacterial infections can be observed.
With proper use of the drug overdose is unlikely. In extremely rare cases, eye irritation may occur.
In case of an overdose, the eyes should be washed with running water. There is no specific antidote, symptomatic therapy is recommended. If you repeat the symptoms of the drug should be discontinued.
Benzalkonium chloride (one of the auxiliary components) can be absorbed by soft contact lenses, leading to a change in their color, and adversely affect the eye tissue. In this regard, before the procedure, the lens must be removed, you can install them 15 minutes after instillation.
When conducting a course longer than 14 days, it is necessary to regularly monitor intraocular pressure and the state of the cornea.
Eye drops Oftan Dexamethasone may mask a current fungal or bacterial infection. When confirming the presence of infection, the use of the drug should be combined with the appropriate antimicrobial therapy.
After instillation, due to the likelihood of tearing, driving is not recommended.
With the combined use of dexamethasone with some drugs, the following effects may occur:
- Iodoxuridine (with long-term therapy): increased destructive processes in the corneal epithelium,
- Calcium channel blockers, quinidine, erythromycin: reducing their effectiveness.
Analogs of Oftan dexamethasone are: Dexamethasone, Dexmethasone Phosphate, Dexamethasonlong, Dexamethasone Bufus, Dexapos, Medexol, Dexazone, Maxidex, Oftan dexa chlora, Farmadex, Dexmethasone VFZ, Ozurdex, Hydrocortisone.
The main therapeutic effects of the drug:
Dexamethasone is a hormonal component of the glucocorticosteroid group. Its pronounced anti-inflammatory effect is due to the inhibitory effect on cyclooxygenase, the suppression of cytokine production (substances involved in the development of the inflammatory process). The basis of the anti-allergic effect of dexamethasone is stabilization of the membranes of mast cells.
The active ingredient quickly penetrates into inflamed eye tissue. The therapeutic effect of the drug reaches a maximum after 2 hours after instillation, lasts from 4 to 8 hours.
Mode of application
The way of application (frequency of instillation, dose) should be selected by the doctor taking into account the type of the disease, the severity of inflammation. According to the instructions, the solution is instilled in 1-2 drops:
- every 30 minutes or an hour - for acute inflammation,
- every 2–4 hours - when the intensity of the symptoms decreases,
- 3-4 times a day - after relief of acute inflammation.
If on the fifth day after the start of therapy the condition does not improve, you need to consult a doctor to clarify the diagnosis or replace the drug.
The duration of treatment should not exceed 2-3 weeks. Longer treatment with dexamethasone, like other corticosteroids, can provoke glaucoma with damage to the optic nerve, a significant deterioration in acuity and visual field disturbances.
If the drops are applied for more than 10 days, you need to control the intraocular pressure, the state of the cornea.
Release form Oftan dexamethasone, product packaging and composition.
Eye drops 0.1% in the form of a clear, colorless solution.
5 ml - plastic dropper bottle (1) - cardboard packs.
DESCRIPTION OF ACTIVE SUBSTANCE.
All the above information is presented only for familiarization with the drug, the possibility of the use should be consulted with the doctor.
Pharmacokinetics of the drug.
Plasma protein binding is 60-70%. Penetrates histohematogenous barriers. In small quantities excreted in breast milk.
Metabolized in the liver.
T1 / 2 is 2-3 hours. It is excreted by the kidneys.
When applied topically in ophthalmology is absorbed through the cornea with intact epithelium in the moisture of the anterior chamber of the eye. When inflammation of the eye tissue or damage to the mucous membrane and cornea, the rate of absorption of dexamethasone increases significantly.
Dosage and method of use of the drug.
Individual. Inside in case of serious diseases, at the beginning of treatment, up to 10-15 mg / day is prescribed, the maintenance dose can be 2-4.5 mg or more per day. The daily dose is divided into 2-3 doses. In small doses, take 1 time per day in the morning.
For parenteral administration, it is introduced into / in a slow jet or drip (for acute and emergency conditions), in / m, periarticular and intra articular administration is also possible. During the day, you can enter from 4 to 20 mg of dexamethasone 3-4 times. The duration of parenteral administration is usually 3-4 days, then switch to maintenance therapy with the oral form. In the acute period, with various diseases and at the beginning of treatment, dexamethasone is used in higher doses. When the effect is achieved, the dose is reduced at intervals of several days until the maintenance dose is reached or until treatment is discontinued.
When used in ophthalmology in acute conditions, instilled into the conjunctival sac 1-2 drops every 1-2 hours, then, with a decrease in inflammation, every 4-6 hours. Duration of treatment from 1-2 days to several weeks depending on the clinical course diseases.
Side Effects Of Oftan Dexamethasone:
From endocrine system: reduction of glucose tolerance, steroid diabetes or a manifestation of latent diabetes mellitus, adrenal suppression, Cushing's syndrome (moon face, obesity, pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae), delay sexual development in children.
On the part of metabolism: increased excretion of calcium ions, hypocalcemia, increased body weight, negative nitrogen balance (increased protein breakdown), increased sweating, hypernatremia, hypokalemia.
CNS: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, cerebellar pseudo-tumor, headache, convulsions.
Since the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest), development (in susceptible patients) or increased severity of chronic heart failure, ECG changes characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle, with intracranial administration - epistaxis.
On the part of the digestive system: nausea, vomiting, pancreatitis, steroid gastric ulcer and duodenal ulcer, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups, rarely - increased activity of hepatic transaminases and alkaline fluorosis.
On the part of the senses: posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, a tendency to develop secondary bacterial, fungal or viral infections of the eye, trophic changes of the cornea, exophthalmos.
On the part of the musculoskeletal system: slower growth and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the head of the humerus and femur), muscle tendon rupture, steroid myopathy, muscle mass reduction (atrophy).
Dermatological reactions: delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, steroid acne, stretch marks, tendency to the development of pyoderma and candidiasis.
Allergic reactions: generalized (skin rash, itchy skin, anaphylactic shock) and when applied topically.
Effects associated with immunosuppressive effects: the development or exacerbation of infections (the joint use of immunosuppressants and vaccination contribute to the occurrence of this side effect).
Local reactions: with parenteral administration - tissue necrosis.
When applied topically: rarely - itching, hyperemia, burning, dryness, folliculitis, acne, hypopigmentation, perioral dermatitis, allergic dermatitis, skin maceration, secondary infection, skin atrophy, stria, streak. With prolonged use or application to large areas of the skin may develop systemic side effects characteristic of GCS.
Use during pregnancy and lactation.
During pregnancy (especially in the first trimester), as well as during lactation, dexamethasone is used taking into account the expected therapeutic effect and the negative effect on the fetus. With prolonged therapy during pregnancy does not exclude the possibility of fetal growth disorders. In the case of use at the end of pregnancy there is a risk of atrophy of the adrenal cortex in the fetus, which may require replacement therapy in the newborn.
Special instructions on the use of Oftan dexamethasone.
Use with caution in parasitic and infectious diseases of a viral, fungal or bacterial nature (currently or recently transferred, including recent contact with a patient) - herpes simplex, herpes zoster (viraemic phase), chicken pox, measles, amebiasis, strongyloidosis (established or suspect), systemic mycosis, active and latent tuberculosis. Use in severe infectious diseases is permissible only against the background of specific therapy.
Use with caution for 8 weeks before and 2 weeks after vaccination, for lymphadenitis after BCG vaccination, for immunodeficiency states (including AIDS or HIV infection).
Use with caution in diseases of the gastrointestinal tract: gastric ulcer and duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, a newly created intestinal anastomosis, ulcerative colitis with a threat of perforation or abscess formation, and diverticulitis.
Use with caution in diseases of the cardiovascular system, incl. after a recent myocardial infarction (patients with acute and subacute myocardial infarction may spread necrosis, slow the formation of scar tissue and, consequently, rupture of the heart muscle), with decompensated chronic heart failure, hypertension, hyperlipidemia), with endocrine diseases - diabetes including violation of tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease, with severe chronic renal and / or liver failure , nephrourolithiasis, with hypoalbuminemia and conditions predisposing to its occurrence, with systemic osteoporosis, myasthenia, acute psychosis, obesity (III-IV degree), with poliomyelitis (except for the form of bulbar encephalitis), open-and-close-angle glaucoma.
If necessary, intra-articular administration should be used with caution in patients with a general serious condition, inefficiency (or short duration) of the effect of 2 previous injections (taking into account the individual properties of the used GCS).
Before and during the treatment of corticosteroids, it is necessary to monitor the complete blood count, glycemia level and plasma electrolyte content.
For intercurrent infections, septic conditions and tuberculosis, simultaneous antibiotic therapy is necessary.
The relative adrenal insufficiency caused by dexamethasone may persist for several months after its cancellation. Given this, when stressful situations occur during this period, hormone therapy is resumed with the simultaneous appointment of salts and / or mineralocorticoids.
When applying dexamethasone in patients with herpes of the cornea should be borne in mind the possibility of its perforation. During treatment, it is necessary to control the intraocular pressure and the state of the cornea.
With the sudden cancellation of dexamethasone, especially in the case of previous use in high doses, there is a so-called withdrawal syndrome (not caused by hypocorticism), manifested by anorexia, nausea, inhibition, generalized musculoskeletal pain, and general weakness. After dexamethasone is canceled for a few months, the relative insufficiency of the adrenal cortex may persist. If during this period there are stressful situations, appoint (according to indications) for the period of GCS, if necessary in combination with mineralocorticoids.
During treatment, control of blood pressure, water and electrolyte balance, pictures of peripheral blood and blood glucose levels, as well as observation of an ophthalmologist are required.
In children during prolonged treatment, careful monitoring of the dynamics of growth and development is necessary. Children who were in contact with measles or chicken pox during the treatment period are prescribed specific immunoglobulins prophylactically.
Interaction Oftan dexamethasone with other drugs.
With simultaneous use with antipsychotics, bukarbanom, azathioprine, there is a risk of developing cataracts, with agents that have anticholinergic action - the risk of developing glaucoma.
With simultaneous use with dexamethasone, the effectiveness of insulin and oral hypoglycemic drugs is reduced.
When used simultaneously with hormonal contraceptives, androgens, estrogens, anabolic steroids, hirsutism and acne are possible.
With simultaneous use with diuretics may increase potassium excretion, with NSAIDs (including acetylsalicylic acid) - increases the incidence of erosive-ulcerative lesions and bleeding from the gastrointestinal tract.
With simultaneous use with oral anticoagulants may weaken the anticoagulant effect.
When used simultaneously with cardiac glycosides, the tolerance of cardiac glycosides may deteriorate due to potassium deficiency.
With simultaneous use with aminoglutetimid may reduce or inhibit the effects of dexamethasone, with carbamazepine - may decrease the action of dexamethasone, with ephedrine - increase the excretion of dexamethasone from the body, with imatinib - may decrease the concentration of imatinib in the blood plasma due to induction of its metabolism and increase excretion from the body.
With simultaneous use with itraconazole, the effects of dexamethasone are enhanced, with methotrexate - increased hepatotoxicity is possible, with praziquantel - reduction of praziquantel in the blood is possible.
With simultaneous use with rifampicin, phenytoin, barbiturates, the effects of dexamethasone may be reduced by increasing its elimination from the body.
Benzalkonium chloride may irritate the eyes and appear allergen.
Immediately after instillation, a burning sensation or an allergic reaction may occur.
- secondary development glaucoma or cataracts (caused by reception steroids),
- the appearance of ulcers, clouding or thinning of the cornea,
- appearance in the eye (or spread) herpes or bacterial infection.
Instructions for use (method and dosage)
The medicine is taken subconjunctival.
Shake well before use.
Dosage and duration of treatment should be determined by the attending physician.
According to the instructions for Oftan Dexamethasone, during the acute period, 1-2 drops are prescribed to the affected eye (s), every half hour or hour, then the agent is taken in 1-2 drops every 2-4 hours. The dosage can be reduced to 1 drop, 3-4 times a day.
If there is no improvement within 3-4 days, the diagnosis should be revised or the drug should be replaced.
During treatment should be monitored intraocular pressure.
Adjusting the daily dosage for patients with liver or kidney disease due to low systemic absorption means is not required.
During pregnancy and lactation
The use of drops in pregnant and lactating women is not recommended.
Reviews of eye drops Oftan Dexamethasone is small, but of those that are available, most are good. The medicine is often used to relieve inflammation when wearing contact lenses, while conjunctivitis. The drug is quite effective and is inexpensive.
Dosage of the drug OFTAN DEXAMETHONE
With acute conditions appoint 1-2 drops in the conjunctival sac every 1-2 hours.
After reducing inflammation, the drug is instilled 1-2 drops into the conjunctival sac 3-5 times / day.
The duration of treatment should not exceed 2-3 weeks.
The decision on the duration of treatment is based on objective data, including the effectiveness of the drug, the severity of clinical symptoms and the possible risk of side effects.
The use of OFTAN DEXAMETHONE for pregnancy
To date, clinical trials data regarding the use of the drug Oftan Dexamethasone during pregnancy and lactation are not available. Oftan Dexamethasone can be used during pregnancy and during breastfeeding only as prescribed by the attending physician, if the expected therapeutic effect justifies the potential risk to the fetus and the baby. The duration of therapy is no more than 7-10 days.
OFTAN DEXAMETHONE - side effects
On the part of the organ of vision: after instillation, a transient burning sensation, allergic reactions are possible. With prolonged use may develop secondary glaucoma and steroid cataracts, as well as ulceration, turbidity, thinning and / or perforation of the cornea, rarely - the spread of bacterial or herpes infections. The drug contains in its composition the preservative benzalkonium chloride, which can cause eye irritation.
Indications for use of OFTAN DEXAMETHONE
Acute and chronic inflammatory processes:
- non-purulent forms of conjunctivitis, keratitis, keratoconjunctivitis and blepharitis,
- scleritis and episcleritis,
- iritis, iridocyclitis and other uveitis of various genesis,
- superficial corneal damage of various etiologies (chemical, physical or immune mechanisms) after complete corneal epithelization,
- inflammation of the posterior segment of the eye (choroiditis, chorioretinitis),
- swelling, inflammation (including in the postoperative period),
Allergic eye diseases:
- allergic conjunctivitis or keratoconjunctivitis.
Prevention and treatment of inflammation in the postoperative and post-traumatic period.
- Interacts with protein receptors and affects protein synthesis.
- And also does not allow the membranes of leukocytes to collapse, stabilizing their lysing enzymes.
- Slows down the synthesis of kininov.
- Reduces the division of leukocytes and their migration.
- Contributes to the violation of the recognition of antigens.
Duration of action is 4–8 hours.
Interaction with other drugs
Dexamethasone reduces the effectiveness of:
- Calcium channel blockers,
With long-term intake with iodoxuridine, there is a possibility of an increase in destructive processes in the corneal epithelium.
Composition and features of the release from pharmacies
- The active substance - Dexamethasone - 1 mg (in the form of dexamethasone sodium phosphate - 1.32 mg).
- Benzalkonium chloride.
- Boric acid.
- Sodium tetraborate.
- From the dynasty.
- Water for injections.
Drops contained in dropper bottles of 5 ml. Each bottle is packed in a cardboard box with instructions.
Dispensed from the pharmacy by prescription.
Terms and conditions of storage
Expiration date of the closed bottle 2 years from the date of manufacture.
The opened bottle should be stored no more than 1 month. at a temperature of 5-8 degrees (in a refrigerator).
Storing drops should be out of the reach of children.
Drugs with similar pharmacological properties
Indications for use: allergic conjunctivitis, iritis, uveitis, sympathetic ophthalmia, postoperative conditions, to restore the transparency of the cornea.
- Dexamethasone phosphate.
It is used for conjunctivitis, blepharitis, keratitis, iritis, iridocyclitis, scleritis, inflammation after injuries and operations.
Indications: spring conjunctivitis, iritis, iridocyclitis, uveitis, postoperative inflammatory processes.
Applied with inflammatory processes of the mucous membranes of the eyelids or eyeball, keratitis for herpes, for iritis, cyclites.
Also used as a prophylaxis of postoperative inflammation.
They are treated with non-infectious inflammatory processes and allergies occurring on the conjunctiva and cornea.
Like all glucocorticosteroid drops, Maxidex is used after eye surgery to prevent the development of inflammation.
The drug is effective: nonsuppurative inflammation of the eye (conjunctivitis, keratitis, blepharitis, scleritis, iritis, uveitis), optic neuritis, choroid, chorioretinitis, dermatitis eyelids, corneal injury, allergic conjunctivitis, while otitis, after operations on the eyes and ears.
It is used in inflammatory and allergic diseases of the eye, as well as after injuries and operations.
Used for non-infectious inflammation of the conjunctiva, eyelids, corneas.
There are several Additional tips and warnings on using Oftan Dexamethasone Drops:
- When wearing contact lenses, the preservative, which is part of the medicine, is absorbed into them, changing color and adversely affecting the eyes.
therefore before applying the drops, the lenses are removed and dress no earlier than 20 minutes after instillation.
- Long-term use of the drug (more than 2 weeks) increases intraocular pressure and can injure the cornea.
Consequently, the drug should be used under the supervision of a doctor.
- Corticosteroid therapy masks infections.
In the presence of infectious and fungal diseases a drug used with a combination of antibacterial or antifungal agents.
- Instilling can cause tearfulness of the eyes.
Because of this, drops are not applied immediately before driving vehicles or using mechanical equipment.
Elena writes: «A very long time using contact lenses. Eyes often inflamed. Treating the doctor prescribed a drop of Oftan Dexamethasone.
Immediately after I dig in the product, the eyes may pinch lightly, but inflammation goes away quickly and well.
I apply the drops for redness of the eyes, but since this phenomenon happens quite often, I have to use the remedy not every time. ”
Anastasia writes: "I have was laser vision correction, and ophthalmologist prescribed drops Oftan Dexamethasone. The cost of the drug was about 200 rubles.
As with all other drops for the eyes, the shelf life of the open drug is a month and must be stored in the refrigerator.
Means at application does not cause discomfort and does not burn. Oftan Denkametazon quickly helped me recover from surgery».