Vigamox alcon eye drops treat conjunctivitis (5ml)
Dosage form Bottle x 5ml
Specifications Moxifloxacin
Ingredient
| Composition information | Content |
| Moxifloxacin | 0.5% |
Uses
Indications
Vigamox drugs are indicated in the following cases:
Vigamox eye small solution is indicated in the treatment of conjunctivitis caused by bacteria caused by sensitive bacteria strains of the following microorganisms:
Aerobic gram -positive microorganisms:
Aerobic gram -negative microorganisms:
Other microorganisms:
*Effective on this microorganism is studied in less than 10 infections.
In addition, Vigamox eye small solution is used in the following cases:ATC code: S01AE07.
Mechanism of action
Moxifloxacin is a 4th -generation fluoroquinolon, which inhibits DNA Gyrase and Topoisomerase IV enzymes that are necessary to participate in the process of copying, editing and regenerating DNA of bacteria.
Medicine resistance mechanism
Bacterial resistance to fluoroquinolon, including moxifloxacin, often occurs due to chromosomal mutations in the enzyme encoding genes of Gyrase and Topoisomerase IV. In Gram -negative bacteria, moxifloxacin can be caused by mutations in the Mar gene systems (antibiotic resistance) and QNR (Quinolon resistance). The cross resistance between moxifloxacin and beta-lactam antibiotics, macrolid and aminoglycosides is difficult to occur due to the difference in the mechanism of action of these antibiotics.
threshold value
Minimum inhibiting concentration (mic) (mg/l) is established by the European Commission on antibiotic sensitivity test of bacteria (EUCAST) as follows:
Sensitivity
Antibiotic resistance ratio may vary depending on the geographical location, along with the time of sampling and information about local drug resistance is essential, especially in the case of treatment of severe infections. When necessary, experts should be consulted in the event of an inexpliceness of local drug resistance before using moxifloxacin to treat some infections.
Common sensitive species
Aerobic gram -positive microorganisms:
Aerobic gram -negative microorganisms:
Other microorganisms:
Aerobic gram -positive microorganisms:
Aerobic gram -negative microorganisms:
Other microorganisms: None.
microorganisms that resistance to drugs have been known in advance
Aerobic gram -negative microorganisms:
Other microorganisms: None.
pharmacokinetic
absorption
After using Moxifloxacin eye solution, 0.5% at a dose of 3 times/day for both eyes in 5 days (1 dose at the 5th day), the maximum concentration of drug (cmax) in plasma and area under the curve (AUC 0 - ∞) of moxifloxacin is 2.7 ng/mL and 42 ng.
This maximum (cmax) value of this concentration is 1667 times lower than the drug concentration in a stable state is reported and the area value below the curve (AUC 0 - ∞) is 917 times lower than the AUC value after taking the AVELOX 400mg tablet. Moxifloxacin's systematic half -life after small eyes is about 13 hours.
Distribution
After small eye moxifloxacin solution, the drug is distributed into the patient's tear film. After 3 days of taking the drug at a dose of 3 times/day for 2 eyes, the peak concentration of moxifloxacin in tears is 55.2 ng/ml and the bottom concentration after 1 day of using the drug at a dose of 3 times/day for 2 eyes is 4.2 µg/ml. These are also minimum inhibitors for many bacteria that often cause conjunctivitis.
In rabbits, moxifloxacin is widely distributed into the endocardic tissue with the highest concentration achieved in the cornea after 0.5 hours. Moxifloxacin is attached to melanin, so there is a long half -life in iris - eyelashes (rabbits/colored hairs) after small eyes.
moxifloxacin is less attached to plasma proteins, the non -linked ratio has been reported in men is 55%, and does not depend on concentrations over a wide range (0.1 - 10 ng/mL).
Metabolism
In humans, moxifloxacin is metabolized by both roads: sulfatization (main) and glucuronide. The sulfate process occurs in the secondary amino of moxifloxacin while the glucuronide process occurs in carboxylic acid to form acyl glucuronid. After drinking, N-Sulfonate and Acyl Glucuronid accounts for approximately 1/3 and 1/10 of the maximum concentration of the original drug. The significant ratio of acyl glucuronid formed after oral use is the result of the first metabolism in stage II. Both N-Sulfonate and Acyl Glucuronid metabolites seem to have no pharmacological activity.
Research on drug-drug interaction has not been conducted with Vigamox eye drops. In-Vitro studies show that moxifloxacin or n-sulfonate form of moxifloxacin do not inhibit the same forms of the P-450; CYP3A, CYP2D6, CYP2C9, CYP2C19 or CYP1A2. Based on the observed concentration of moxifloxacin in human plasma after small eyes, the interaction of the drug is unlikely.
Elimination
After using moxifloxacin system, over 95% of the dose detected in urine and feces. Elimination through the foundation is the main excretion path. In stool, both original drugs (accounting for 25% of the dose) and N-sulfonate metabolites (accounting for 35% of the dose) accounted for 60% of the total dose used. No acyl glucuronid detection in the feces after using the whole body. Elimination through urine accounts for 35% of the total doses of use with 20% in the form of original drug, 15% in the form of nsulfonate metabolites and 5% in the form of acyl-glucuronid metabolites.
Elimination through the kidneys is the result of the filtration process in the glomerular, positive excretion (Acyl glucuronid metabolites) and the renal tubular reabsorption process. There is no significant difference in moxifloxacin concentration in plasma between healthy subjects and patients with mild or moderate liver impairment patients. This may be the result of excretion by kidney and no kidneys and do not need to adjust the dose in these patients.
Before taking Vigamox alcon eye drops treat conjunctivitis (5ml)
How to use
Only use to drop the eyes. Do not be injected. Do not inject Vigamox small eye solutions in the conjunctiva nor do not put the drug directly into the room's room.
To avoid the infection at the top of the small bottle, do not let the head of the drug come into contact with the eyelids, the area around the eyes or any surface.
After removing the lid, if the attachment is loose, it is necessary to remove before use.
Instructions for use, processing and cancellation
unused drugs or waste should be canceled in accordance with local regulations.
Dosage
used in adults, including the elderly
1 drop in the eyes is inflamed 3 times/day, taking the drug for 7 days.
Inflammation is usually improved after 5 days, it is necessary to continue treating in 2-3 days. If inflammation does not improve after 5 days of treatment, it is advisable to reconsider the diagnosis or treatment.
Use in children
No dose adjustment.
Used in people with liver failure and kidney failure
No dose adjustment.
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?
There is no case of overdose of any vigamox eye solution. When the eyes are overdose, Vigamox can wash the eyes immediately with warm water to eliminate medicine.
In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not use double the prescribed dose.
Side Effects
When using vigamox drugs , you may experience unwanted effects (ADR).
The following adverse reactions have been reported in clinical trials with vigamox eye solutions and classified according to the following conventions: very common (> 1/10), common (> 1/100 to 1/1,000 to 1/10,000 to Common
Less
Rare
Eye disorders: corneal epithelium, corneal disorders, conjunctivitis , eyelid inflammation, eye swelling, conjunctival edema, blurred vision, vision loss, eye strain, eyelid red rash.
Other adverse reactions are determined from the supervisors after circulation listed below.
cannot estimate the frequency from the available data. The adverse reactions in each organ system are arranged in the order of severity.
Skin and subcutaneous tissue disorders: Red rash, itching, rash, urticaria.
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
Vigamox drug contraindicated in the following cases:
Caution when using
In patients with body quinolon, including moxifloxacin, a report occasionally occurred the serious (hypersensitivity) reactions that are serious causing death, some cases occur at the initial dose of treatment. Stop taking the medication immediately and notify the doctor as soon as the first sign of the rash or allergic reaction. Some of the attached reactions such as cardiovascular collapse, unconsciousness, aneurysm (including laryngeal edema, pharynx or face), obstruction of the respiratory tract, shortness of breath, urticaria and itching.
If an allergic reaction to moxifloxacin occurs, it is necessary to stop taking the drug. With serious hypersensitivity reactions, it is necessary to conduct immediate emergency treatment. Airways should be conducted and provided oxygen depending on clinical indications.
Like other anti -infections, taking prolonged drugs can lead to over -proliferation of non -sensitive microorganisms, including mushrooms. If the infection occurs, the medication should be stopped and applied alternative treatments.
It is necessary to recommend that patients should not wear contact lenses if there are signs and symptoms of bacterial conjunctivitis.
Inflammation and ligament breakage may occur when using fluoroquinolon systems, including moxifloxacin, especially in elderly patients and those who are treating simultaneously with corticosteroids. Therefore, it is necessary to stop treating with small Vigamox eye solution as soon as there is the first sign of ligament inflammation.
The ability to drive and operate machinery
is like any other eye drops, temporary blurred vision and other visual disorders that can affect the ability to drive or operate machinery. If there is a phenomenon of blurred vision, the patient must wait until it is clear to drive or operate machinery.
Pregnancy
There are very few or no data on the use of vigamox eye small eye solutions in pregnant women. However, it is expected that the drug does not affect pregnant women because the absorption of moxifloxacin from small -eye preparations is negligible.
Because there are no control and adequate studies in pregnant women, Vigamox eye small solution should only be used during pregnancy when the benefits used for mothers are higher than the risk that may occur for the fetus.
Breastfeeding period
It is unknown whether moxifloxacin will be excreted in breast milk. Animal studies show that after taking moxifloxacin, the drug is excreted with low concentrations in breast milk. However, it is expected that at the level of treatment of small vigamox eye solution does not affect breastfeeding.
Be cautious when using vigamox eye solution during breastfeeding.
Drug interaction
Research on drug-drug interaction has not been conducted with vigamox eye small solution. In vitro studies show that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19 or CYP1A2, so the drug is less likely to affect the pharmacokinetics of metabolic drugs by this ISOENZE CYTOCHROM P450.
Because after this eye drops, the body concentration of moxifloxacin is low, the drug interaction is almost no occurrence.
Storage
Store at a temperature not exceeding 30 ° C.
Expiry date: 24 months from the date of manufacture.
Do not use after opening the lid for the first time 28 days.
Do not use overdue drugs indicated on the packaging.
Manufacturer: Alcon Research, Ltd.
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