Description of the drug MAXIDEX

Pharmacodynamics and pharmacokinetics

Dexamethasone by its nature is a glucocorticosteroid (GCS) that does not have mineralocorticoid activity, but can have a pronounced anti-inflammatory and antiallergic effect, prevent or weaken allergic reactions (desensitizing effect). Active suppression of inflammatory processes occurs due to inhibition of the release of inflammatory mediators by eosinophils, as well as the migration of mast cells, which reduces capillary permeability.

Side effects

Long-term use of steroid drugs can cause an increase in intraocular pressure (IOP) , as well as the future development of glaucoma . As a result, it is possible to develop characteristic lesions of the optic nerve, the development of posterior subcapsular cataracts , and changes in visual fields. Therefore, it is recommended to regularly measure IOP when using the drug for more than 10 days. In addition, diseases leading to thinning of the cornea and sclera, perforation of the fibrous membrane as a side effect, cause a slowdown in the wound healing process.

Fungal infections of the cornea may occur, especially with long-term use of steroid drugs. If non-healing ulcers appear on the cornea after a long course of treatment with steroids, this may be evidence of the development of fungal invasion .

Description of the drug MAXIDEX

Caution should be used in case of parasitic and infectious diseases of a viral, fungal or bacterial nature (currently or recently suffered, including recent contact with a patient) - herpes simplex, herpes zoster (viremic phase), chicken pox, measles, amoebiasis, strongyloidiasis (established or suspected), systemic mycosis; active and latent tuberculosis. Use for severe infectious diseases is permissible only against the background of specific therapy.

It should be used with caution within 8 weeks before and 2 weeks after vaccination, with lymphadenitis after BCG vaccination, with immunodeficiency conditions (including AIDS or HIV infection).

The following should be used with caution for gastrointestinal diseases:

• peptic ulcer of the stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, recently created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscess formation, diverticulitis.

Should be used with caution for diseases of the cardiovascular system, incl. after a recent myocardial infarction (in patients with acute and subacute myocardial infarction, the necrotic focus may spread, slowing down the formation of scar tissue and, as a result, rupture of the heart muscle), with decompensated chronic heart failure, arterial hypertension, hyperlipidemia), with endocrine diseases - diabetes mellitus ( including impaired 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 gravis, acute psychosis , obesity (III-IV degree), with poliomyelitis (with the exception of the form of bulbar encephalitis), open- and closed-angle glaucoma.

If intra-articular administration is necessary, it should be used with caution in patients with a general severe condition, ineffectiveness (or short duration) of the action of 2 previous administrations (taking into account the individual properties of the GCS used).

Before and during GCS therapy, it is necessary to monitor a general blood count, glycemic levels and plasma electrolyte levels.

For intercurrent infections, septic conditions and tuberculosis, simultaneous antibiotic therapy is necessary.

Relative adrenal insufficiency caused by dexamethasone may persist for several months after its discontinuation. Taking this into account, in stressful situations that arise during this period, hormonal therapy is resumed with the simultaneous administration of salts and/or mineralocorticoids.

When using dexamethasone in patients with corneal herpes, the possibility of corneal perforation should be kept in mind. During treatment, it is necessary to monitor intraocular pressure and the condition of the cornea.

With the sudden withdrawal of dexamethasone, especially in the case of previous use in high doses, a so-called withdrawal syndrome occurs (not caused by hypocortisolism), manifested by anorexia, nausea, lethargy, generalized musculoskeletal pain, and general weakness. After discontinuation of dexamethasone, relative adrenal insufficiency may persist for several months. If stressful situations arise during this period, GCS is prescribed (according to indications), if necessary in combination with mineralocorticoids.

During the treatment period, monitoring of blood pressure, water and electrolyte balance, peripheral blood picture and glycemic level, as well as observation by an ophthalmologist is required.

In children, during long-term treatment, careful monitoring of the dynamics of growth and development is necessary. Children who during the treatment period were in contact with patients with measles or chickenpox are prescribed specific immunoglobulins prophylactically.

Instructions for use of Maxidex (Method and dosage)

Instructions for Maxidex eye drops: instill 1-2 drops into the conjunctival sac every 3-6 hours or as prescribed by your doctor.

For eye ointment: place a 1–1.5 cm strip of ointment behind the lower eyelid, repeat up to 3 times a day. It is correct to combine ointment and eye drops, using the ointment before bedtime and the eye drops several times during the day.

Do not use the drug for injection. To avoid introducing bacteria into the vial when using drops, do not touch the dropper to any surfaces. It is not recommended to wear contact lenses during treatment with Maxidex. Shake the bottle before each use.

Maxidex 0.1% 3.5 g eye ointment.

Instructions for medical use of the drug MAXIDEX® Trade name Maxidex® International nonproprietary name Dexamethasone Dosage form Ophthalmic ointment 3.5 g Composition 1 g contains the active substance - dexamethasone 1 mg, excipients: methylparaben 0.05%, propylparaben 0.01%, anhydrous liquid lanolin , white Vaseline. Description Fatty, homogeneous ointment from white to yellowish color without lumps. Pharmacotherapeutic group Preparations for the treatment of eye diseases. Anti-inflammatory drugs, corticosteroids. ATC code S01BA01 Pharmacological properties Pharmacokinetics Dexamethasone is absorbed into the aqueous humor, cornea, iris, choroid, ciliary body and retina. Systemic absorption may only occur with high doses or with prolonged treatment. The maximum concentration of dexamethasone in the aqueous humor of the eye, approximately 30 ng/ml, is achieved within two hours, subsequently decreasing within half an hour to 3 hours. Dexamethasone is excreted in the urine. Approximately 60% of the dose is found in urine as 6-β-hydroxydexamethasone. The half-life from blood plasma is 3-4 hours. Dexamethasone is approximately 77-84% bound to serum albumin. The clearance range is from 0.111 to 0.225 l/hour/kg and the volume of distribution is from 0.576 to 1.15 l/kg. Pharmacodynamics Maxidex® is a glucorticosteroid and does not have mineralocorticoid activity. It has a pronounced anti-inflammatory, antiallergic and desensitizing effect. Maxidex® actively suppresses inflammatory processes, inhibiting the release of inflammatory mediators by eosinophils, the migration of mast cells and reducing capillary permeability. Indications for use - allergic blepharitis - acute and chronic iritis, iridocyclitis - conjunctivitis, keratoconjunctivitis without purulent compartments - prevention and treatment of postoperative inflammation of the anterior part of the eyes; - thermal and chemical burns (after complete epithelization of corneal defects). Method of administration and dose A strip of ointment 1-1.5 cm long is placed behind the lower eyelid of the affected eye 2-3 times a day or in addition to drops before bedtime. Caution should be exercised when stopping therapy prematurely. Do not touch the tip of the tube to your eyes or any other surface to avoid contaminating the contents of the tube. When using several topical ophthalmic drugs, it is necessary to maintain an interval between drugs of 10 to 15 minutes. The ointment is applied last. Side effects - mydriasis - blurred vision, transient discomfort - sensation of a foreign body in the eye - swelling of the eyelid or conjunctiva With long-term use in rare cases, the following may be observed: - increased intraocular pressure with the subsequent development of glaucoma, damage to the optic nerve and visual field, formation of posterior subcapsular cataract - slowing down the wound healing process (in diseases that cause thinning of the cornea or sclera, perforation of the fibrous membrane is possible with local use of steroid drugs) - development of a secondary infection, fungal infection of the cornea with long-term use of steroids. Contraindications - hypersensitivity to any component of the drug - keratitis caused by the herpes pathogen Herpes simplex - viral keratitis: cowpox, chickenpox - fungal eye diseases - acute purulent eye diseases Drug interactions When using several ophthalmic drugs topically, it is necessary to observe the interval between their use from 10 to 15 minutes. Special instructions When using steroids for 10 days or more, intraocular pressure should be regularly monitored and checked in children and in patients not visiting a physician. In the case of glaucoma, intraocular pressure should be checked weekly. Long-term use may suppress the patient's immune response and thus increase the risk of developing secondary eye infections. Pregnancy Maxidex® should be prescribed only in cases where the effectiveness of treatment justifies the possible risk to the fetus. Lactation During breastfeeding, treatment with Maxidex® ophthalmic ointment should be interrupted. Contact lenses During treatment with Maxidex®, an ophthalmic ointment, you should refrain from wearing soft (hydrophilic) contact lenses, or remove them while applying the ointment. Lenses can be worn between uses of the drug and inserted no earlier than 15 minutes after applying the ointment. Maxidex® should not be used over contact lenses. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery After applying the ointment, temporary blurred vision or other visual disturbances may occur, which may negatively affect the ability to drive a car or other potentially dangerous machinery. In this case, you need to wait some time until your vision is restored. Overdose There are no known cases of overdose of this drug. In case of overdose, treatment should be symptomatic and supportive; rinse the eye(s) with copious amounts of water at room temperature. Release form and packaging 3.5 g aluminum tube, coated with epoxy-phenolic coating with a polyethylene tip and a polyethylene cap. Each tube, along with instructions for use, is packed in a cardboard box. Storage conditions Store at temperatures from +80 to +300C. Keep out of the reach of children! Shelf life: 4 years Do not use after expiration date. Shelf life after first opening is 4 weeks at temperatures from +80 to +300C. Conditions for dispensing from pharmacies By prescription Manufacturer Alcon-Couvreur Rijksweg 14, B-2870 Puurs, Belgium

Reviews

Patients who have used Maxidex eye drops say that it is a very powerful remedy that effectively relieves almost any inflammation of the eye, however, daily use is undesirable due to the development of adverse reactions as a result of long-term treatment.

Among the positive reviews are the following:

• “... Helps, the eyes become clean, removes swelling and puffiness”;
• “... Can be used for allergies, relieves tearing.”

In general, the drug is praised and recommended.

Maxidex price, where to buy

The average price of Maxidex eye drops 0.1% (5 ml bottle) is 350 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Maxidex eye drops 0.1% 5mlS.A.
  Alcon-Couvreur nv RUR 317 order

Pharmacy Dialogue

• Maxidex (vial 0.1% 5ml)Alcon

  RUB 308 order

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Pharmacy24

• Maxidex 5 ml drops Alkon-Cuvrior, Belgium
  93 UAH. order

PaniPharmacy

• Maxidex liquid Maxidex h/c 0.1% 5ml Belgium, Alcon-Couvreur

  95 UAH order

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Composition and release form

in dropper bottles (with a Drop Tainer™ dosing device) of 5 ml.

in tubes of 3.5 g; 1 tube in a box.