Olotedin Eye Drops Samchundang Pharm Eye Drops Samchundant Patriarchal Periodic Period (5ml)

Dosage form Bottle x 5ml
Specifications Olopatadine

Ingredient

Composition information	Content
Olopatadine	1.11mg/ml

Uses

Indications

Olotedin Eye Drops drugs are indicated in the following cases: Treatment of signs and symptoms of seasonal conjunctivitis.

Pharmacokology

olopatadine is a histamine release inhibitor from large cells and is a relatively selective antagonist H1, inhibitors of type 1 in vivo and in vitro allergies including histamine -effect inhibitors on conjunctive epitheliums. Olopatadine eliminates effects on alpha-adrenergic, dopamine, and Muscarin receptor 1 and 2.

Dynamic pharmacokinetics

After small eyes, olopatadine is absorbed in the body very little. Two studies conducted on healthy volunteers (a total of 24 patients) using 0.15% olopatadine eye solution every 12 hours in 2 weeks shows that the concentration of olopatadine in serum is generally lower than the quantitative limit (

Some cases can quantify oloratadine after 2 -hour drug and the concentration is between 0.5 to 1.3ng/ml. Serum half -life is approximately 3 hours and the drug is excreted mainly through the kidneys. About 60 - 70% of the absorbing drugs are excreted in urine in the form of unchanged. The two main metabolites are Mono - Desmethyl and N - Oxyd metabolites eliminated in the urine with low concentrations.

Before taking Olotedin Eye Drops Samchundang Pharm Eye Drops Samchundant Patriarchal Periodic Period (5ml)

How to use

eye drops.

Dosage

1-2 drops into each eye 2 times daily.

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 using overdose? Olopatadine has low toxicity for experimental animals. Inadvertently drinking 1 bottle of 5ml small olopatadine eye solution 1 mg/ml can lead to the maximum body absorption of 5mg olopatadine. With the assumption of 100%absorbed drug, drinking 1 bottle of 5ml olopatadine 1 mg/ml is equivalent to a dose of 0.5mg/kg for a child weighing 10kg.

extends the QT segment in dogs that have been recorded at a higher dose than the maximum dosage for humans. The dose of 5mg oloratadine is used twice a day for 2.5 days for 102 men and women who volunteered healthy including the elderly and young people showing no significant extension of the QT segment in the drug group compared to the placebo.

About the peak concentration of the blood in the Hang Dinh state (from 35 to 127ng/ml) measured in this study is at least 70 times the safety limit for Olopatadine external use for the effect on the heart. In case of overdose, it is necessary to apply appropriate treatments. If you use too much olopatadine to drop your eyes, need to wash your eyes with warm water. Do not add more medication until the next dose next. If you swallow olopatadine eye drops, you need to drink more water to increase the elimination of the drug and consult a doctor.

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 Olotedin Eye Drops, you may experience unwanted effects (ADR).

Unwanted effects related to the eye include: blurred vision, burning or itchy eye, dry eyes, strange feeling, congestion, sensitivity, corneal inflammation, itchy eyelids can occur.

Headache is reported at 7%. The following unwanted effects are reported in some patients: depression, symptoms, sensitivity, nausea, sore throat, rhinitis, sinusitis, change of taste, dizziness, dry nose, dry mouth, red rash, abdominal pain, liver dysfunction, jaundice, hypertension, leukopenia, lymphocytes, creatinine and bun in serum, difficulty urinating.

After circulating in the host country: The results of after -sales research in the host country in 848 patients, the unwanted incidence of the unwanted effect is 1.46% (n: 12/822, a total of 13 cases), whether or not is not related to the cause: eye irritation, congestion, corneal inflammation, dry eye and eye pain.

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug

Warnings

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

Contraindicated

Olotedin Eye Drops drugs are contraindicated in the following cases: Patients with hypersensitivity to olopatadine hydrochloride or any ingredients of the drug.

Precautions when using

Use drugs for children: Safety and effectiveness when using this drug for children under 3 years of age has not been determined.

Use the drug for the elderly: It is recommended to start taking the drug in low doses due to the decline in physiological function in the elderly.

Be cautious when using:

Be cautious when driving or operating machinery and medicine can cause drowsiness.

If the patient is taking long -term steroids that want to reduce the dose of steroids by taking this medication, the steroid dose is slowly reduced and monitor patients with patients

When taking this drug, treating conjunctivitis seasonal allergies, it is necessary to take the drug from the beginning of the season to the end of the season.

If symptoms do not improve after taking the drug, do not take the medication for a long time.

This drug is only used for small eyes, not injected or taken. Patients wear soft contact lenses need to remove contact lenses before the Olotedin Eye Drops eye drops and wait at least 10 minutes after the eye will wear contact lenses.

To prevent contamination of drug solutions and small heads, avoid touching the tip of the drug into the eyelids or around the eyes when the drug is small. Tighten the lid of the vial after use.

Other caution:

The ability to cause mutant cancer, affecting fertility: Long -term studies are conducted in mice and rats, showing no evidence to prove the ability to cause cancer when using oral clopatadine with a dose of up to 500mg/kg/day/kg/day, equivalent to 31,250 times the maximum dose is recommended for humans. Not observing the likelihood of causing mutations in a leaking test of the recovery bacterial gene (AMES) on in vitro, a wrong test of mammal chromosomes on in vitro or mouse cell multiplication test on Vivo. There are no human tests on the influence of olopatadine on fertility. In reproductive studies on experimental animals, olopatadine does not affect the fertility of male mice and female mice when used orally at the equivalent dose of 7,800 times the maximum dose recommended for human eyes. However, it has been observed the reduction of reproductive index, the number of emperors and the rate of embryo culture when taking oral dose equivalent to 7,800 times the maximum eye -catching eye recommended for humans.

This medication inhibits the skin's allergic reactions and affects the determination of allergens. Therefore, this medication should therefore be used before testing allergens in the skin.

The ability to drive and operate machinery

Patients need to be cautious when driving or operating machinery and drugs can cause blurring and drowsiness.

Pregnancy

olopatadine does not cause teratogen when used for rats and rabbits. However, when used for mice at a dose of 600mg/kg/day, equivalent to 93,750 times the maximum dose recommended for humans and when used for rabbits at a dose of 400mg/kg/day corresponding to 62,500 times the maximum dose recommended for humans during the formation of the fetal organs shows a reduction in the survival rate of the fetus. However, there are no adequate and controlled studies on pregnant women. Because animal studies do not always respond to the same person, it is only used for pregnant women when they have considered the benefits of treatment and possible risks.

Breastfeeding period

olopatadine has been determined in mother mouse milk after oral use. It is unknown whether or not to use medication in the eye, the amount of body absorption is enough to cause the concentration of the drug in breast milk at the detected concentration or not. However, be careful when taking Olotedin Eye Drops eye drops for breastfeeding women.

Drug interaction

When used simultaneously with other eye drops, it should be used at least 5 minutes apart.

Storage

In closed packaging, avoid light, at temperatures below 30 ° C.

Other drugs

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