Maxitrol eye ointment for short -term treatment of corticosteroids in the eye (3.5g)

Dosage form Tube
Specifications Neomycin, dexamethasone, polymyxin b sulfate

Ingredient

Composition information	Content
Neomycin	3.5mg
Dexamethasone	1mg
Polymyxin b sulfate	6000iu

Uses

indications

Maxitrol drug is indicated in the following cases:

Short -term treatment for corticosteroids in the eye when antibiotic prophylaxis, after eliminating the presence of mushrooms and viruses.

Pharmacology

dexamethason: The exact mechanism of anti -inflammatory effects of dexamethason is not clear. Dexamethason inhibits cytoskins that cause inflammation and cause glucocorticoid and mineral corticosteroid effects.

Polymyxin B Sulfate : Lipopeptid antibiotics penetrate gram -negative cell membranes that stabilize cytoplasmic membrane. This antibiotic has little effect on gram -positive bacteria.

Neomycin: Aminoglycosides antibiotics have the main effect on cell membranes by inhibiting the synthesis of polypeptide and ribosom.

Medicine resistance mechanism: Bacterial resistance with polymyxin B is derived from chromosomes and is not common. The role of the occurrence of changes in phospholipids of cytoplasmic membranes.

Bacterial resistance to Neomycin occurs in several different mechanisms including (1) changes of ribosom subunit in bacterial cells; (2) The obstruction of the transport of Neomycin into bacterial cells and (3) causes inactivity with a fence of adenylation enzymes, chemical phosphorylation and acetylation. Genetic information to produce inactive enzymes can be transmitted through chromosomes or bacterial plasmids.

Determination of sensitivity to each gram of maxitrol eye ointment contains 6000 units of Polymyxin B Sulfate and 3500 Neomycin Sulfate units. Consider the dual activity of the form of preparation combined with polymyxin B and Neomycin, the point to determine the sensitivity to the drug and the in vitro spectrum is given below.

The points that determine the sensitivity of the drug are listed below based on the anti -drug resistance with some specific species found in the eye infections and the proportion of the international activity unit between polymyxin B and neomycin in maxitrol eye ointment: resistance level:> 5: 2.5 to 40:20 depending on bacteria.

pharmacokinetics

absorption:

dexamethason: After checking the drug into the conjunctiva bag, corticosteroids such as dexamethasone are absorbed into the aquatic fluid and may occur in the body's absorption. However, because the local corticosteroid dose is lower than that of the system, there is often no clinical evidence of the absorption of body drugs.

Dexamethason's oral bioavailability in humans and normal patients is in the range of 70-80%.

Neomycin: Rabbit studies suggest that after medicine, Neomycin absorbs slowly into the aesthetics. The absorption increases when the cornea is worn out. Oral absorption of low Neomycin, on average about 2.5%.

Polymyxin B: Polymyxin B is said to not absorb from the conjunctiva bag. Polymyxin B uses non -body sugars that are not distributed into the aquarium of the eye, even when the presence of inflammation. No body absorption is not detected after eye medicine. Polymyxin B does not absorb through oral and usually only absorbed when used on the spot or intravenously.

Distribution:

dexamethason: The volume of distribution in a stable state after using the injection of dexamethasone is 0.58 l/kg. In vitro, there is no change in the ratio linked to plasma protein with dexamethasone concentration from 0.04 to 4 µg/ml, the ratio is associated with the average protein about 77.4%.

Neomycin: The distribution of Neomycin's distribution is 0.25 l/kg with a ratio attached to a low plasma protein of 20%.

Polymyxin B: Polymyxin B has a small distribution (0.07 - 0.21 l/kg) in severe patients. Polymyxin B binds to protein at an average level on normal objects (56%); However, this ratio increased to 90% in severe patients; The ratio of polymyxin b attached to α-glycoprotein can increase to 5 times in serum due to pressure.

Metabolism:

dexamethason: After using intravenously, 60% of the drug is found in the form of 6β-hydroxydexamasone metabolites and 5-10% found in other metabolic forms are 6β-tydroxy-20dihydrodexamethasone.

neomycin: Neomycin metabolizes negligible.

Polymyxin B: unknown.

Era:

dexamethason: After intravenous injection, the whole body clearance is 0.125 l/h/kg. The sale time is reported for 3-4 hours but it lasts a bit longer in men. This difference does not change the body clearance but leads to the difference in the distribution and body weight. After using systemic sugar, 2.6% of the drug is found in urine in non -metabolic form.

neomycin: Neomycin absorbed the whole body is excreted in the form of constant feces (97%) and urine (1%).

Polymyxin B: Polymyxin B has a clearance of 0.27 - 0.81 ml/min/kg in patients with serious illness (e.g. infections), with

Before taking Maxitrol eye ointment for short -term treatment of corticosteroids in the eye (3.5g)

How to use

If you are taking more than one eye medication, the drugs must be used at least 5 minutes apart. Eye ointment needs to be used final.

Dosage

Adults:

Look up the amount of drugs in conjunctiva bags, maybe up to 3 or 4 times a day.

Do not let the tip of the drug touch the eye.

Children:

Not yet established the safety and effectiveness of maxitrol eye ointment in children.

Elderly:

The dose is like in adults.

Patients with liver failure, kidney failure:

Maxitrol eye ointment has not been studied on these subjects. However, due to the whole body absorption of active ingredients in the preparation after low eye examination, it is not necessary to adjust the dose.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when overdose? In case of an acidic ointment of maxitrol overdose, should be washed with warm water.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Maxitrol, you may experience unwanted effects (ADR).

Common, ADR> 1/100

immune system disorders: Hypersensitivity

Nervous system disorders: headaches

Eye disorders: corneal ulcer, blurred vision, fear of light, dilated pupils, eyelids, eye pain, swelling of the eye, feeling of exterior in the eyes, congestor of the eyes, increasing tears.

Uncommon, 1/1000

Eye disorders: corneal inflammation, internal pressure increased, itchy eye, discomfort in the eyes, eye irritation.

Rare, ADR

Skin and tissue disorders: Stevens-Johnson syndrome.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Maxitrol drug is contraindicated in the following cases:

Hypersensitivity to active ingredients (dexamethasone, polymyxin B, neomycin) or any ingredients of the drug.

Malaritis due to Herpes Simplex .

Beef, chickenpox and other virus infections in the cornea or conjunctiva.

Fungal diseases of eye structure or eye diseases due to untreated parasites.

TB infections in the eye.

Be cautious when using

only used for eye examination. Do not be injected or swallowed. After opening the lid, if the ring is guaranteed to be removed, remove before use.

As well as all antibiotics, prolonged use can lead to excessive growth of non -sensitive bacterial strains or fungi. In case of superinfection, it is recommended to start appropriate treatment.

Some patients may occur sensitive to Aminoglycosides used on the spot, like Neomycin. It is necessary to stop treating if hypersensitivity appears during the use of the drug. The severity of allergic reactions can be from local reactions to the whole body reaction such as erythema, itching, urticaria, skin rash, anaphylactic shock, anaphylactic reaction or water ball reaction.

If there is a sign of a serious or hypersensitivity reaction, the maxitrol eye medication is stopped.

Patients who use eye -catching eye -containing eye -containing eye -containing eye -containing eye -containing eye -containing medications should see a doctor if the eye pain, redness, swelling or irritation worse or prolonged.

There have been serious adverse reactions including nerve toxicity, hearing and kidney toxicity on patients treated with Neomycin system system or when used on the spot to treat open wounds or skin damage.

The toxicity reaction on the kidneys and nerves also occurs with the body polymyxin. Although these effects have not been reported after this medication, should be cautious when used simultaneously with aminoglycosides or polymyxin B system.

Using long -term corticosteroids can lead to glaucoma and/ or glaucoma, with optic nerve damage, vision reduction and market defects and causing cataracts under the following bags. Should monitor the glaucoma periodically and regularly for patients to treat corticosteroids in the eye. This is especially important for children, because the risk of glaucoma due to the use of corticosteroids in children may be higher and occur earlier than in adults.

Maxitrol eye ointment is not approved for use in children.

The risk of glaucoma due to the use of corticosteroids and/ or opaque glass increases in infected patients (for example: diabetes).

For thinning diseases of the cornea or fracture, there is a puncture of those parts after taking local corticosteroids.

corticosteroids can reduce resistance and facilitate infection of non -sensitive bacteria, parasitic fungal infections.

The risk of glaucoma due to the use of corticosteroids and/or opaque glass increases in infected patients (for example: diabetes).

For thinning diseases of the cornea or fracture, there is a puncture of those parts after taking local corticosteroids.

corticosteroids can reduce resistance and facilitate infection of non -sensitive bacteria, fungal infections, parasites or viruses and cover the clinical signs of the disease or may reduce the hypersensitivity reactions to the active ingredient in the drug. It is necessary to consider the possibility of fungal infections in patients with prolonged corneal ulcer. Corticosteroid treatment should be stopped immediately when infected with fungal infection.

To avoid the risk of enhancing herpes corneal diseases, regular light slot is required.

corticosteroids in place in the eye can slow down the restoration of corneal wounds. It is known that the use of non -steroid anti -inflammatory drugs (NSAIDs) also slows down or delayed the recovery of wounds. Simultaneous use of nonsteroidal anti -inflammatory drugs and topical steroids may increase the risk of wound recovery.

Do not wear contact lenses when treating inflammatory conditions in the eye. Therefore, patients should not wear contact lenses when treated with Maxitrol.

In addition, Neomycin used on the spot can lead to skin sensitivity.

may occur cross -sensitive with other aminoglycosides, which should consider the possibility of patients who become sensitive to local -spot neomycin that can also be sensitive to local and/ or other body aminogensides.

Cushing syndrome and/ or adrenal suppression inhibit the body absorption when used at the eye 1/ dexamethason may occur after intensive or continuous treatment in patients with risk factors, including children and patients treated with ritonavir. In these cases, treatment should not stop suddenly but should gradually reduce the dose.

As well as other antibiotics, long -term use of antibiotics such as Neomycin and polymyxin can lead to excessive growth of unsure microorganisms, including fungi in people who have or are taking medication and stop corticosteroids if fungal infections occur. If the infection occurs, it is advisable to stop using and start the replacement therapy.

This drug contains methylparhydroxybenzoate and propylparhydroxybenzoate that can cause an allergic reaction (may occur late).

This drug contains lanolin that can cause local skin reactions (for example, contact dermatitis).

The ability to drive and operate machinery

temporary blurred vision or other vision disorders may affect the ability to drive or operate machinery. If you are blurred when looking at your eyes, the patient must wait until it is clearly visible and operate machinery.

Pregnancy

Aminoglycosid antibiotics such as neomycin do not pass the placenta after intravenous injection in pregnant women. Pre -clinical and clinical studies have shown toxicity on the ear and kidneys of aminoglycosides.

In low doses used on the spot, Neomycin is said to not cause above toxicity and kidneys when the drug is exposed to the uterus. Using prolonged and repeated corticosteroids during pregnancy is associated with high risk of uterine growth. Babies with mothers use corticosteroids during pregnancy should carefully observe the signs of adrenal functional impairment.

Animal studies have shown the reproductive toxicity of dexamethasone after body and eye use. There is no data on the safety of polymyxin B in pregnant animals. It is not recommended to use maxitrol eye ointment during pregnancy.

The period of breastfeeding

It is unknown whether dexamethasone, neomycin or polymyxin B will excrete in breast milk or not. Aminoglycosides are excreted in breast milk after using systemic drugs. There is no data on dexamethasone and polymyxin B into breast milk.

However, it does not seem to detect the amount of dexamethasone, neomycin and polymyxin B in breast milk and are not able to cause clinical effects in babies when mothers use topical drugs. No risk for breastfeeding.

It is necessary to consider the benefits of breastfeeding with the baby and the benefits of the treatment for mothers to decide to stop breastfeeding or stop/avoid the use of maxitrol eye ointment.

Drug interactions

Tocidal use in place with topical nonsteroidal anti -inflammatory drugs may increase the risk of corneal deficit recovery.

In patients treated with ritonavir , there is an increase in dexamethasone concentration in plasma.

Storage

Store drugs at temperatures from 2-80C.

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