- Available:In stock716
- Availability date:2020-07-30
- Dosage form:Drops (Bottle)
- In stock:716 Items
active ingredients: dexamethasone, neomycin sulfate, polymyxin B sulfate;
1 ml of suspension contains:
dexamethasone 1 mg, neomycin sulfate 3,500 IU, polymyxin B sulfate 6,000 IU;
excipients: sodium chloride, polysorbate 20, benzalkonium chloride, 50% solution, hypromellose, hydrochloric acid / sodium hydroxide (for pH regulation), purified water.
Dosage form. Eye drops, suspension.
Basic physical and chemical properties: white or almost white suspension.
Pharmacotherapeutic group. Products used in ophthalmology. Corticosteroids in combination with antimicrobials.
ATX code S01C A01.
Combined drug with antibacterial and anti-inflammatory effects.
Neomycin is a broad-spectrum antibiotic from the aminoglycoside group. It has a bactericidal effect, disrupting protein synthesis in the microbial cell. Active against Gram-positive and Gram-negative microorganisms, including Staphylococcus aureus, Streptococcus pneumopiae, Escherichia coli, Proteus spp., Shigella spp. It is inactive against Pseudomonas aegidyposa and streptococci.
Inactive against pathogenic fungi, viruses, and anaerobic flora. Resistance of microorganisms to neomycin develops slowly and to a small extent.
Polymyxin B is a polypeptide-like antibiotic. The mechanism of action is due to the ability to bind to phospholipids of microbial cell membranes, which leads to their destruction. Active against Gram-negative microorganisms, including Eschegichia coli, Shigella spp., Enterobacter spp., Klebsiella spp., Haemophilus influenzae, Salmonella spp., Bordetella pertussis. Highly active against Pseudomonas aegidyposa. Does not work on Proteus spp., Neisseria spp., obligate anaerobes and Gram-positive bacteria.
Vibrio cholerae (with the exception of the eltor subtype), as well as Coccidioides and mmmitis are sensitive to polymyxin B, but in general fungi show resistance to this antibiotic.
Dexamethasone is a glucocorticoid (HCV) drug. It has no mineralocorticoid activity. It has a pronounced anti-inflammatory, anti-allergic and desensitizing effect. Dexamethasone actively inhibits inflammatory processes and the release of inflammatory mediators by eosinophils, mast cell migration, and reduces capillary permeability.
When applied topically, systemic absorption is low.
Inflammation of the eye tissues in which corticosteroids are indicated and there is a superficial bacterial infection or risks of its development (inflammation of the bulbar conjunctiva and conjunctiva of the eyelids, cornea and anterior segment of the eyeball, chronic uveitis of the anterior segment and corneal lesions caused by chemical, radiation or heat burns or ingestion of foreign bodies).
- Hypersensitivity to any component of the drug.
- Keratitis caused by herpes simplex (the causative agent of herpes simplex).
- Viral diseases of the cornea and conjunctiva (including cow and chickenpox).
- Mycobacterial eye infections.
- Fungal eye diseases.
Interactions with other drugs and other types of interactions.
Concomitant administration of topical steroids and topical nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of complications in corneal wound healing.
CYP3A4 inhibitors (including ritonavir and cobicistat) may reduce dexamethasone clearance and enhance the effect of adrenal suppression/Cushing's syndrome. Such combinations should be avoided unless the benefits outweigh the risk of increased systemic side effects of corticosteroids, in which case the systemic effects of corticosteroids should be carefully monitored.
In the case of concomitant therapy with other topical ophthalmic drugs, an interval of 10-15 minutes between their instillation should be observed. Eye ointments should be used last.
The drug is intended for topical use only.
Instill in the eyes as prescribed by a doctor.
The bottle with the drug should be shaken before use.
Avoid contact of the tip of the dropper with any surfaces to prevent microbial contamination of the drug.
Some patients may develop sensitivity to aminoglycosides, namely neomycin, applied topically. In case of hypersensitivity when using this drug, its use should be discontinued.
In addition, neomycin for topical application in the eye can lead to skin sensitivity.
Cross-hypersensitivity to other aminoglycosides may occur; and it should also be taken into account that patients who become sensitive to neomycin applied topically to the eye may also become sensitive to other local and/or systemic aminoglycosides.
Serious adverse reactions, including neurotoxicity, ototoxicity, and nephrotoxicity, have occurred in patients treated with systemic neomycin therapy or neomycin was used topically to treat open wounds or affected skin, and nephrotoxic and neurotoxic reactions have been observed with systemic polymyxin B.
Prolonged use of corticosteroids topically in the eye can lead to ocular hypertension and/or glaucoma, followed by damage to the optic nerve, deterioration of visual acuity, the appearance of visual field defects, and the formation of posterior subcapsular cataracts. In patients with prolonged use of corticosteroids topically in the eye, intraocular pressure should be monitored regularly and frequently. This is especially important for children, as the risk of increased intraocular pressure caused by corticosteroid use may be higher in children and appear earlier than in adults. The risk of increased intraocular pressure caused by corticosteroids and/or the risk of cataract formation due to the use of corticosteroids increases in patients who have provoking factors (for example, in patients with diabetes mellitus).
Corticosteroids can reduce resistance to insensitive bacterial, fungal, or viral infections and prevent detection of such infections and mask the clinical signs of infection.
If corneal ulcers persist, the possibility of fungal infection in patients should be considered. If a fungal infection occurs, corticosteroid treatment should be discontinued.
As with other antibiotics, prolonged use of neomycin and polymyxin can lead to overgrowth of insensitive microorganisms, including fungi. If a superinfection occurs, treatment should be discontinued and alternative therapy should be prescribed.
It is known that in the presence of diseases that lead to thinning of the cornea or sclera, topical use of corticosteroids can cause perforation. Corticosteroids applied topically to the eye can slow the healing of corneal wounds. Topical use of NSAIDS is also known to slow or delay wound healing. Concomitant topical use of NSAIDs and steroids may increase the risk of wound healing problems (see "interactions with other medications and other types of interactions").
Given the possibility of systemic absorption of dexamethasone, Cushing's syndrome and/or adrenal suppression may occur, especially after prolonged continuous use of dexamethasone eye drops in predisposed patients, including children and patients using CYP3A4 inhibitors (including ritonavir and cobicistat). In these cases treatment should be gradually discontinued
Visual disturbances may occur due to systemic and topical corticosteroid use. If blurred vision or other visual disturbances occur, an ophthalmologist should be consulted to determine possible causes, which may include cataracts, glaucoma, or other rare diseases such as central serous chorioretinopathy that has been reported after systemic corticosteroid use.
Do not wear contact lenses when treating eye inflammation or infections.
Topical corticosteroids are ineffective for keratitis caused by mustard gas or Sjogren's keratoconjunctivitis.
Dexapol eye drops contain benzalkonium chloride, which can cause irritation and discolor soft contact lenses. Avoid contact with soft contact lenses (remove them before use and re-install them 15 minutes after use).
Use during pregnancy or lactation.
Animal studies indicate reproductive toxicity. It is not recommended to use during pregnancy.
Consideration should be given to temporarily discontinuing breast-feeding while Dexapol is being used.
Ability to influence the reaction rate when driving vehicles or other mechanisms.
May cause temporary blurred vision after instillation. Patients should be warned not to drive a car or work with complex mechanisms until their vision returns to normal.
Dosage and administration.
In mild forms of the disease, 1-2 drops are instilled into the conjunctival sac
4-6 times a day. In severe forms of infections, drops can be used every hour, but not more than 2 days. The number of receptions should be gradually reduced as the patient's condition improves. The duration of treatment is determined by the doctor individually in each individual case. Do not stop therapy prematurely.
After instillation, tight eyelid closure or nasolacrimal occlusion is recommended. This reduces the systemic absorption of drugs applied to the eye, which reduces the likelihood of systemic side effects.
The duration of treatment and repeated courses depend on the nature of the disease and the effectiveness of treatment. The course usually lasts 6-10 days.
The safety and efficacy of the drug in children under 18 years of age have not been established, so the drug is not used in children.