Vigadexa Alcon eye drops treat eye infections (5ml)

Dosage form Bottle x 5ml
Specifications Moxifloxacin, dexamethasone phosphate

Ingredient

Thành phần cho 1ml

Composition information	Content
Moxifloxacin	5mg
Dexamethasone phosphate	1mg

Uses

Indications

Vigadexa medicine are indicated in the following cases:

Treatment of eye infections, caused by sensitive bacteria and to prevent inflammation and infections that may occur after eye surgery. and DNA Gyrase. These enzymes are needed for regeneration, copy, repair and combination of bacteria DNA, in Gram -negative bacteria, fluoroquinolon acting mainly on DNA Gyrase rather than Topoisomerase IV, and in Gram -positive bacteria is the opposite.

moxifloxacin works with most strains of bacteria after both in vitro and in clinical infections.

Aerobic gram -positive bacteria: Corynebacterium*: Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphococcus warneri* Pneumonia, Streptococcus Viridans.

Aerobic gramy bacteria: Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*.

* Effective on these strains of bacteria is studied in less than 10 patients.

dexamethasone has anti -inflammatory effects through reducing arachidonic acid release, inhibiting molecular adhesion of endothelial cellular cells, reducing the effects of cyclooxygenase and cytokine. This effect leads to the release of chemical intermediate substances that cause inflammation and reduce the adhesion of leukocytes circulating into the endothelial blood vessel tissue, preventing their movement on inflammatory organizations in the eye. Moreover, Cycloxygenase inhibits will reduce inflammation prostaglandin, a substance known to damage blood barriers - aquariums and cause plasma proteins to penetrate the eye tissue.

Clinical effectiveness

In two random, double, conceptual clinical studies, multicolored, patients have eye small eyes 3 times a day in 4 days of moxifloxacin solution 0.5%, 66 - 69% of patients with bacterial conjunctivitis from the disease on the 5th - 6th day. It should be noted that killing bacteria does not always correspond to the effect of clinical treatment.

In 2 random, double clinical studies, the patient has a small Vigadexa eye solution 4 times daily, starting a day before eye surgery and lasts for 15 days after surgery, no patient has eye infections.

pharmacokinetics

Moxifloxacin plasma concentrations have been measured in adults, both men and women, small eye moxifloxacin solution 0.5% 3 times daily. The average CMAX peak value in equilibrium (2.7ng/ml) and daily absorption level is expected to AUC (45 ng.He/ml) lower than 1600 and 1000 times cmax and AUC obtained after oral moxifloxacin with a dose of 400mg treatment.

Moxifloxacin's plasma sale time is estimated at 13 hours. Dexamethasone phosphate is quickly converted to dexamethasone in humans. After finishing the eye a single drop of 0.1% dexamethasone eye solution in patients with cataract surgery, the concentration of dexamethasone obtained in the aquatic fluid at 90 minutes to 120 minutes after the average drug is about 31 ± 3.9ng/ml.

Before taking Vigadexa Alcon eye drops treat eye infections (5ml)

How to use

The drug is used for eye drops.

After opening the lid, if the attachment is removed, it is necessary to remove it before taking the drug.

To avoid the infection at the small tip of the drug and the solution, avoid the small medicine of the vial in contact with any object. Close the lid of the vial after use.

Should press the turbulent tube or close your eyes slightly after small eyes. This can reduce the body absorption of the drug through the eye and help reduce the unwanted effect.

If you are taking more than one eye drops, the drugs must be used at least 5 minutes apart. Eye ointments need to be used final.

Dosage

To prevent inflammation and postoperative infection in the eye, 1 drop of solution, 4 times a day on the surgical eye, start a day before surgery and last 15 days after surgery. For patients with cataract surgery, small medicine immediately after surgery. For patients with lasik refractive surgery, small drugs within 15 minutes after surgery. For patients with eye infections due to sensitive bacteria, small drugs 4 times/day, 1 drop each time, for 7 days or as directed by the doctor.

Elderly

No need to adjust the dose when used for the elderly.

Children

Efficiency and safety of drugs in children has not been established.

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 to do when overdose?

If too much small eye is in the eye, it is necessary to wash with plenty of warm water. There is no small amount of drugs to the eye until the next dose.

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 vigadexa medicine , you may experience unwanted effects (ADR).

Popular (≥ 1/100 to

Eye disorders: itchy eye, eye irritation.

Not common (≥ 1/1000 to

Nervous system disorders: taste disorders.

Eye disorders: blurred vision, eyelid pain.

Respiratory, chest and medical disorders: mouth pain - servants.

Rare (≥ 1/10000 to

Mental disorders: Insomnia.

Other unwanted effects are determined from the supervisors after circulation listed below. It is not estimated that the frequency from the available data.

Unknown

Eye disorders: eye congestion.

Instructions on how to handle ADR

Notify your doctor or pharmacist with unwanted effects when using the drug. Including unwanted effects that have not been listed in this manual.

Warnings

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

Contraindicated

Vigadexa drug contraindicated in the following cases:

Too hypersensitivity to moxifloxacin, dexamethasone, any excipients of the drug or other quinolons.

Herpes Simplex due to herpes Simplex .

Vaccinia, chickenpox (Varicella), and other virus infections in the cornea or conjunctiva.

Fungal diseases of the eye structure.

TB infections in the eye.

Patients with glaucoma or diseases that can cause thin cornea or epidural eye.

Precautions when using

only use to eye eye.

Do not be injected with small vigadexa eye solution under the conjunctiva or put directly into the eye room.

In patients with systemic quinolon, severe hypersensitivity reactions and sometimes fatal (anaphylaxis) have been reported, some cases immediately after the first dose. Some reactions are accompanied by cardiovascular collapse, unconsciousness, angioedema (pharyngeal edema, larynx or face edema), obstructing airway, shortness of breath, urticaria and itching. If an allergic reaction occurs with moxifloxacin, it is necessary to stop taking the drug immediately. Serious hypersensitivity reactions should be rescued promptly. For oxygen breathing and airway control depending on clinical condition.

The prolonged use of prolonged corticosteroids can lead to glaucoma or glaucoma accompanied by optic nerve damage, vision loss, market reduction and causing cataracts below. Patients with prolonged corticosteroid eye drops need periodic and regular glaucoma. This is especially important for children because the risk of glaucoma due to using corticosteroids in children may be higher and occur earlier than in adults. Vigadexa eye small solution is not approved to use for children. The risk of glaucoma due to the use of corticosteroids or cataracts increases in infected patients (for example, patients with diabetes ).

When treated with fluoroquinolon, systemic sugar can appear inflammation and tendon. Therefore, it is necessary to stop treating with Vigadexa eye drops as soon as the first signs of tendonitis appear.

corticosteroids may reduce resistance and facilitate infections, fungal infections or viruses and cover the clinical signs of the disease.

It is necessary to consider the possibility of fungal infection in patients with prolonged corneal ulcer.

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 (see drug interaction).

For thinning or thinning diseases, there is a puncture of those parts after using local corticosteroids.

For a long time, antibiotics can lead to excessive growth of non -sensitive microorganisms, including mushrooms. If the infection occurs, it is necessary to stop taking the drug and conduct an alternative treatment.

The ability to drive and operate machinery

temporary blurring vision or vision disorders can affect the ability to drive or operate machinery. If you look blurred when the eyes are small, the patient needs to wait until it is clearly visible and then allowed to continue driving or operating machinery.

Pregnancy

data on the use of vigadexa eye small solution in pregnant women has not yet or limited. Animal studies with moxifloxacin do not indicate a direct hazardous effect on reproductive toxicity. Animal studies with dexamethasone show that the drug has reproductive toxicity.

Due to the lack of adequate and controlled research on pregnant women, do not use small Vigadexa eye solution for pregnant women, unless considering the benefits that are superior to the risk for the fetus.

Breastfeeding period

whether Vigadexa's small eye solution is excreted in human milk or not. It is not known whether moxifloxacin will excrete in human milk. Animal studies have shown that the drug has a small amount of milk in milk after the dose of moxifloxacin. The systemic corticosteroids are present in human milk. The risk for breastfeeding is not excluded.

Because a lot of drugs can be excreted on breast milk, it is necessary to be cautious when using Vigadexa eye solution for nursing women.

Drug interaction

Steroid use simultaneously locally used steroids with nonsteroidal anti -inflammatory drugs (NSAIDs) on -site may increase the risk of corneal wound recovery.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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