Neladex drops 5 ml eye/ear

  • $14.80
Sku: c044ff3982a7

the Trade name
of Neladex

the International unlicensed name
Is not present

the Dosage form
of the Drop eye/ear, 5 ml

1 ml of drug contains
active agents: dexamethasone of 1.0 mg,
Neomycinum (in the form of sulfate) 3.5 mg,
polymyxin B of sulfate 6000 ME,
excipients: a hydroksipropilmetiltsellyuloza, a benzalkoniya chloride, dinatrium edetat, sodium chloride, polysorbate 80, sodium hydroxide or acid chlorohydrogen, water for injections.

Fine suspension of white color, flavourless.

Pharmacotherapeutic group
Drugs for treatment of ophthalmologic and otological diseases. Glucocorticosteroids in a combination with antimicrobial drugs. Dexamethasone in a combination with antimicrobial drugs.
The ATX S03CA01 code

the Pharmacological

Pharmacokinetics Due to properties in system a blood stream researches of pharmacokinetics were not conducted by low extent of absorption of drug. Except cases of perforation of a tympanic membrane.
The pharmacodynamics
of Neladex represents the combined drug for topical administration possessing anti-inflammatory, antiallergic and antibacterial action.
Damages a membrane of microbic cells, breaks a stream of metabolites in a cell with the subsequent her death.
The Protivospalitelny effect of drug is caused by the dexamethasone which is its part – a synthetic glucocorticosteroid, to metilirovanny derivatives of a ftorprednizolon, and is reached by means of release oppression by eosinophils of mediators of inflammation, induction of formation of lipokortin and reduction of quantity of the mast cells producing hyaluronic acid, reduction of permeability of capillaries, stabilization of cellular membranes and membranes of organellas (especially lizosomalny). Dexamethasone possesses also antiallergic and anti-exudative action that is caused by decrease in quantity of the circulating eosinophils, leading to decrease in discharge of mediators of an immediate allergy, decrease in influence of mediators of an allergy to effector cells. Dexamethasone has no mineralokortikoidny activity.
The combination of antibiotics of Neomycinum and polymyxin B provides a wide range of antibacterial effect of drug on the majority of gram-negative and gram-positive microorganisms. Neomycinum – an antibiotic from group of aminoglycosides, has bactericidal effect due to disturbance of synthesis of protein in a microbic cell, is active in the relation: Staphylococcus aureus, E.coli, Haemophilus influenzae, Klebsiella pneumoniae.
Polymyxin B – an antibiotic of polypeptide structure contacts phospholipids of cell membranes of activators, leads to their destruction, is active in the relation: E.coli, Klebsiella pneumoniae, Haemophilus influenzae, Pseudomonas aeruginosa. Streptococcus spp are resistant to action of these antibiotics. (including, Streptococcus pneumoniae) and anaerobic bacteria.

For short-term therapy of inflammatory diseases of the eyes which are followed by a superficial bacterial infection or with risk of a bacterial infection, responding to treatment by corticosteroids after an exception of a fungal and viral infection:
- inflammatory conditions of a conjunctiva, a century or an eyeball
- inflammation of a cornea and front segment of an eye
- a chronic uveitis of a front segment of an eye
- defeat of a cornea chemicals, radiation, thermal burns or a foreign body
- external otitis without injury of a tympanic membrane

the Route of administration and doses
Before prescribing of drug is recommended to define sensitivity of the microflora which caused a disease to the antibiotics which are a part of drug.
Just before use it is recommended to warm a bottle, having taken it in a hand, in order to avoid unpleasant cold feelings and slightly to stir up bottle contents.
Use in ophthalmology:
Neladex dig in in a conjunctival sac of the affected eye 1-2 drops each 4-6 hours. It is necessary to reduce gradually use frequency in process of improvement of clinical signs. It is not recommended premature to stop treatment.
The course of treatment is defined by the attending physician.
Technology of instillation in eyes. To carefully wash up hands before drug use. To slightly incline the head back and to delay a lower eyelid down so that the pocket turned out and to dig in in it 1-2 drops of drug. To close eyes and to rotate eyeballs within 1-2 minutes. To repeat actions with other eye if it is offered the doctor. To wash up hands.
For prevention of microbic pollution of contents of a bottle – a dropper it is necessary to avoid contact of its tip with any surfaces, including eyes. Between use the bottle needs to be held densely closed.
It is necessary to observe 5-10 minute interval between burying and other ophthalmologic solutions.
Use in otolaryngology:
Neladex appoint 2-3 drops 3-4 times a day. After instillation drug in one ear it is recommended to incline the head in the protivopozhny party for several minutes, and then if it is necessary, to dig in other ear.
Course of treatment of 5-6 days.

Side effects
it is frequent
- increase in intraocular pressure
- irritation of an eye
- discomfort in an eye (burning manifestation, acute prickings, an itching)
- damage of an optic nerve
- a keratitis
- a subkapsulyarny cataract
- an ulcer keratitis, thinning of a cornea, a photophobia, illegibility of sight, a mydriasis, eye pain, an itching of an eye, eye hypostasis, a ptosis, feeling of a foreign body in an eye, increase in dacryagogue, dysfunction of eyes
is frequent
- hypersensitivity (system or local)
- at disturbance of integrity of a tympanic membrane – risk of toxic impact on a hearing and vestibular mechanism

the Contraindication headache
- hypersensitivity to any component of drug
- a vaccinia, chicken pox and other viral infections of a cornea and conjunctiva (except for the keratitis caused by herpes zoster
- the epithelial keratitis caused by Herpes simplex (treelike keratitis) - mikobakterialny infections of eyes - fungus diseases of eyes
- viral and fungal infections of ears
- infectious or traumatic injuries of a tympanic membrane
- the started purulent infections - drug do not appoint after uncomplicated removal of a foreign body from a cornea
- infectious or traumatic damages of a membrane (risk of ototoxicity)

Medicinal interactions
Medicinal interaction of the drug Neladex with other medicines is not established.
Combined and/or consecutive use of aminoglycoside (Neomycinum) and others system, peroral or topical administration of the medicines having neurotoxic, ototoksichesky or nephrotoxic effects can result in additive toxicity and, whenever possible, has to be excluded.

Special instructions
Only for local use. Not intended for injections or intake.
As well as in a case with other antibacterial drugs long use can lead to the overgrowth of insensitive bacterial strains or mushrooms. In case of development of superinfection it is necessary to begin the corresponding treatment.
During use of drug the hypersensitivity to aminoglycosides of topical administration and also cross sensitivity to other aminoglycosides can be observed. In case of serious reactions of hypersensitivity it is necessary to stop drug use.
It is necessary to see a doctor in case of steady manifestation or strengthening of pain in an eye, redness, puffiness, irritation during use of the drugs containing Neomycinum sulfate.
It is necessary to consider a possibility of cumulative toxicity when using Neladex medicine together with system aminoglycosides or polymyxin B.
Long use or increase in frequency rate of use of drug can lead to increase in intraocular pressure and/or development of glaucoma with the subsequent injury of an optic nerve, to decrease in visual acuity, disturbance of a field of vision and also formation of a back subkapsulyarny cataract. At patients inclined to listed sostoyany, increase in intraocular pressure can be observed even after the short period of use of drug.
At patients, it is long primenenyayushchy corticosteroids locally in eyes, it is recommended to control intraocular pressure constantly.
Corticosteroids can reduce resistance to a bacterial, viral or fungal infection and also contribute to their development, can mask clinical signs of infection, complicating timely detection of inefficiency of an antibiotic or to suppress reactions of hypersensitivity to drug components. At patients with the steady keratohelcosis accepting or accepting corticosteroids the probability of presence of a fungal infection is not excluded. In case of confirmation of a fungal infection the treatment by corticosteroids has to be stopped.
At topical administration of corticosteroids in the diseases causing thinning of a cornea or sclera their perforation is possible.
The corticosteroids applied locally in eyes can slow down healing of corneal wounds.
To avoid risk of development of herpetic defeat of a cornea it is necessary to carry out often the patient's assessment by means of biomicroscopy with a slit lamp.
Carrying contact lenses is not recommended during treatment of inflammations or an infection of eyes.
The drug Neladex contains preservative a benzalkoniya chloride which can cause irritation of eyes or decolour soft contact lenses. It is necessary to avoid contact with soft contact lenses. Before use of drug it is necessary to remove contact lenses from eyes and to wait 15 minutes after drug use before entering lenses again.
Use for patients with a renal and liver failure
of the Drop eye/ear not was are investigated at this category of patients. However, owing to low system absorption of active components at topical administration, correction of a dosage it is not required.
Use in pediatrics
is not recommended use for children.
Pregnancy and the period of a lactation
Safety and efficiency of use of this drug during pregnancy is not established.
Drug is not recommended to be used during pregnancy.
There are no reliable data about whether active components of drug after topical administration get into breast milk.
As system corticosteroids and aminoglycosides get into breast milk, the risk for the baby cannot be excluded.
It is necessary to make the weighed decision on interruption of breastfeeding or the termination (abstention from drug treatment, considering advantage/risk of breastfeeding for the child and advantage of treatment for the woman).
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
After use of drug the temporary illegibility of sight or other visual concerns is possible that it can negatively affect ability to drive the car or other potentially dangerous mechanisms. In this case it is necessary to wait some time before recovery of sight before driving the car or to use potentially dangerous mechanisms.

Now about cases of overdose of drug it was not reported.

A form of release and packing
On 5 ml of drug in a plastic bottle with a stopper dropper and the screwing-up protective cover supplied with a safety ring.
On 1 bottle together with the instruction for medical use in the state and Russian languages put in a cardboard box.

To Store storage conditions at a temperature from 150 With up to 250 C.
Not to freeze!
To store out of children's reach!
The use period after opening of a bottle within 1 month.

2 years
not to apply a period of storage after an expiration date.

Prescription status
According to the prescription

Producer E.I.P.I. To., Egypt
to Develop
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