Nevanac Alcon eye drops treat inflammation, pain after cataract surgery (5ml)

Dosage form Bottle x 5ml
Specifications Nepafenac

Ingredient

Thành phần cho 1ml

Composition information	Content
Nepafenac	1mg

Uses

Indications

Nevanac medicine is indicated in the following cases:

Preventive and treat inflammation, pain after cataract surgery.

Nepafenac makes an anti -inflammatory and non -steroid analgesic. After small eyes, Nepafenac seepes through the cornea, and is then metabolized by hydrolase at the eye tissue into AMFENAC, which is a nonsteroidal anti -inflammatory drug. Amfenac inhibits the effect of prostaglandin h synthase (cyclo - oxygenase), which is an enzyme necessary for the production of prostaglandin.

Pharmacological effect

Most of the metabolism of drugs occurs in the retina/membrane, then in the iris/lashes and cornea in accordance with the perfusion level of the tissue.

The results from clinical studies show that Nevanac eye drops do not have a significant effect on internal pressure.

pharmacokinetic

absorption

After small eyes, Nevanac eyes are three times/day in both eyes, there has been discovered Nepafenac and Amphenac in plasma in small amounts, but enough to be able to quantify in most patients from 2 to 3 hours after the corresponding small medicine. Maximum maximum concentration of CMAX in a stable state after the eye drops of Nepafenac and Amfenac corresponding to 0.310 ± 0.104ng/ml and 0.422 ± 0.121ng/ml.

Distribution

Amfenac has high affinity with serum albumin proteins. On the In Vitro test, the percentage of AMFENAC associated with mouse albumin, human albumin and serum human corresponding to 98.4%, 95.4%and 99.1%.

Mouse studies show that when using the drug marked 14C Nepafenac, single or multi -dose oral doses, related substances are widely distributed in the body.

Metabolism

Nepafenac undergo a rapid transmission of biological conversion to amfenac thanks to the inner hydrolase. After that, AMFENAC experienced strong metabolism into higher polarity metabolites, including aromatic hydroxylation hydroxylation to form glucoronid complex.

Radioactive chromatography analysis before and after hydrolysis by beta - glucuronidase shows all metabolites are in the form of glucuronid complex, except for Amfenac. AMFENAC is the main metabolite in plasma, with about 13% of the total radioactive activity of plasma. The second largest metabolite in plasma is determined as 5 - Hydroxy Nepafenac, with about 9% of total radioactive activity at CMAX.

Interaction with other drugs: Both Nepafenac and AMFENAC do not inhibit any metabolic activity in vito cytochrom P450 of the person (CYP1A2, 2C9, 2C19, 2D6, 2E1 and 3A4), with a concentration of up to 300ng/ml. Therefore, there is almost no possibility of interacting with other drugs to use simultaneously, if these interactions through metabolism have CYP participating. Drug interactions through the mechanism of association with protein are also unlikely to occur.

Elimination

After taking the 14C radioactive marker - Nepafenac oral for healthy volunteers, excreted through the urine has been determined as the main excretion pathway through radioactive determination, accounting for about 85% while the excretion through the fertilizer accounts for only about 6% of the doses. Nepafenac and AMFENAC do not quantify in urine.

After taking a single dose of Nevanac eye small, 5ml eye for 25 patients with cataract surgery, the concentration of drugs in aquatic fluid is measured at 15, 30, 45 and 60 minutes after taking the drug. The average drug concentration in the aquatic fluid is determined at 1 hour after taking the drug (Nepafenac 177ng/ml, AMFENAC 44.8ng/ml). These results show that the drug penetrates the cornea quickly.

Before taking Nevanac Alcon eye drops treat inflammation, pain after cataract surgery (5ml)

How to use

Medicine only small eyes.

Need to guide patients to shake the vials before use. If using more than one eye medication, the drugs must be used at least 5 minutes apart.

To prevent the infection of the drug solution and the tip of the vial, it is necessary to be careful not to let the tip of the vial touch the eyelids, or the areas around the eyes or other positions of the body - need to carefully instruct the patient to cover the bottle carefully when not in use.

Dosage

for adults, including the elderly

To prevent and treat inflammation and pain, the dose is a drop of Nevanac eye in the conjunctiva bag of the eye damaged, 3 times a day, starting from 1 day before the cataract surgery, followed by the surgery day and lasts for the first 2 weeks after surgery.

The treatment process may last up to the first 3 weeks after surgery if the doctor is indicated. Can use an additional drop in a period of 30 to 120 minutes before surgery.

To reduce the risk of an edema after a cataract surgery in diabetics, the dose is a drop of NEVANAC eye shift 5ml into the conjunctiva bag of the damaged eye, three times a day, starting from a day before cataract surgery, followed by surgery day and lasts up to 60 days after surgery if any doctor's prescription. Can use an additional drop in a period of 30 to 120 minutes before surgery.

For children

Safety and effectiveness of Nevanac eye small epidemic in children has not been set. No data available. It is not recommended to use small nevanac eye fluid for children.

Used in patients with liver and kidney failure

Nevanac eye small epidemic has not been studied in patients with liver or kidney failure. Nepafenac is mainly excreted through biological metabolism, and the body exposure is very low after eye drops. No need to adjust the dose for these patients.

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? The toxic effect is not likely to appear in the case of small eyes overdose or even taking the wrong drug into the gastrointestinal tract.

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. Note that it should not be used double the prescribed dose.

Side Effects

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

The following unwanted effects have been reported in clinical trials with small nevanac eye fluids and are classified as follows: Very popular (≥ 1/10), popular (≥ 1/100 to In each frequency group, unwanted effects are presented in the order of severity. System system group Unwanted effects Head . Increasing tears, conjunctival conjunctiva
unknown: The healing process (cornea) is affected, disabled/free cornea sea disorders, opaque cornea, corneal scars, vision loss, irritant eyes, eye swelling DA

less common: Skin flabby

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

Nevanac contraindicated in the following cases:

Hypersensitivity to active ingredients, any excipients of the drug, or other nonsteroidal anti -inflammatory drugs (NSAIDs).

Like other nonsteroidal anti -inflammatory drugs, Nevanac eye is contraindicated for patients with asthma attacks, urticaria or acute rhinitis due to the promotion of acetylsalicylic acid or other nonsteroidal anti -inflammatory drugs.

Be cautious when using

not to be injected. Instruct patients not to drink small nevanac eye.

Instructions for patients on the need to avoid sunlight during treatment with Nevanac eye small.

The use of small nsaids eye can cause keratitis. In some sensitive patients, the prolonged use of nonsteroidal anti -inflammatory drugs (NSAIDs) on the spot can cause weakening epithelium, thin cornea, corneal slip, corneal ulcer and corneal perforation. These incidents can threaten vision. For patients with evidence of a corneal impairment, the use of Nevanac eye is immediately stopped and should be closely monitored on the cornea.

NSAIDs drugs used on the spot, can slow or hinder the healing process. Similarly, topical corticosteroid drugs also show slow or hinder the healing process. The simultaneous use of local NSAIDs with local steroids will increase the severity of the problems during the healing process.

Experiences in after -sales monitoring of NSAIDs used on the spot show that patients with eye surgery are repeated or complex, cutting cornea nerves, defects in the cornea epithelium, diabetes, disease in the surface of the eyeball, dry eye or rheumatoid arthritis, the risk of unwanted effects in the cornea increases, can threaten vision.

Need to use carefully nsaids in the spot in these patients. The use of local NSAIDs can increase risks, increasing the severity of unwanted effects in the cornea.

There have been reports on nsAIDS drugs that increase hemorrhage in eyeball tissue (including prevention bleeding) when used in eye surgery. Be cautious when using Nevanac eye shrines in patients tends to easily bleed or patients who are taking other drugs that prolong bleeding time.

There are little data on simultaneous use similar to prostaglandin and Nevanac eye small. When considering their acting mechanism, simultaneous use of these drugs is not recommended.

Nevanac eye -catching small eye contains benzalkonium chloride that can cause eye irritation and change soft contact lenses. On the other hand, during the time after cataract surgery, patients wearing contact lenses. Therefore, patients need to be warned not to wear contact lenses while treating with Nevanac eye small. Benzalkonium chloride is a preservative commonly used in eye medications, which has been reported to cause corneal or corneal ulcer due to toxicity. Need to closely monitor patients when using Nevanac eye small or long -lasting chaos.

Acute eye infections can be covered when taking local anti -inflammatory drugs. NSAIDs do not have antibacterial effects. When there is an eye infection, it is necessary to be cautious when taking this drug with antibacterial drugs.

Cross -sensitive hypersensitivity: Ability to appear cross -sensitive between Nepafenac and acetylsalicylic acid, derivatives of phenylacitic acid and other NSAIDs.

The ability to drive and operate machinery

Nevanac does not have or affect the ability to drive and operate machinery.

temporary blurring vision or other visual disorders may affect the ability to drive or operate machinery. If blurred vision appears after small eyes, patients have to wait until they can see or operate machinery.

Pregnancy

Not enough data on the use of Nepafenac for pregnant women. Experimental animal studies have shown that the drug is toxic in reproduction. This potential risk in humans is unknown. Because the systemic exposure in non -pregnant women is negligible after treating with Nevanac eye shrines, the risk caused by drugs in pregnancy can be low.

However, the synthesis of prostaglandin may have adversely affected pregnancy or embryo/fetal development or childbirth or baby's development after birth. It is not recommended to use Nevanac eye small chaos during pregnancy and women are likely to be pregnant without using contraception.

Breastfeeding period

It is unknown whether Nepafenac will be secreted into breast milk or not. Animal studies show that Nepafenac is excreted in mouse milk. However, it is expected that the drug does not affect the breastfeeding due to the mother's body exposure to Nepafenac is negligible.

Can be used with small nevanac eye fluid when breastfeeding.

Drug interaction

In vitro studies have shown that this drug is very little interactive with other drugs or interacting with linked proteins.

Simultaneous use of NSAIDs and local sterors may increase the risk of wound healing. Simultaneously using Nevanac eye shrimp with drugs that prolong bleeding can increase the risk of bleeding.

Storage

Store at a temperature not exceeding 30 ° C.

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