Pataday eye drops 0.2% Alcon prevention and treatment of allergic conjunctivitis (2.5ml)

Dosage form Bottle x 2.5ml
Specifications Olopatadine hydrochloride

Ingredient

Composition information	Content
Olopatadine hydrochloride	0.2%

Uses

Indications

Pataday eye drops are indicated for prevention and treatment of symptoms and eyes in the allergic conjunctivitis.

Pharmacokological

olopatadin is a powerful and selective anti -hype and antihistamine, promoting effect through many separate mechanisms of action. Olopatadine antagonistic histamine (the main intermediate of allergens in humans) and prevent cytamine from producing cytokin causing inflammation from human conjunctiva cells. Data from In vitro studies show that the drug can be acting on mast cells in the conjunctiva of the human to inhibit the release of inflammatory intermediate substances. In patients with smooth, small nasal tubes with small pataday eye solution, the reduction of nasal signs and symptoms often accompanied by seasonal allergic conjunctivitis. Olopatadin does not cause clinical changes in the diameter of the pupil.

pharmacokinetic

absorption

olopatadin is absorbed into the eyes and reaches the maximum concentration (CMAX) within 30 minutes to 2 hours (TMAX) in the eye tissue after small men on the sides of New Zealand white rabbit eyes (NZW), each eye 1 drop of olopatadine with increasing dose content (0.15%; 0.2%and 0.7%). Low plasma olopatadine concentrations (cmax Distribution

Rabbit studies show that eye tissues related to drug use such as conjunctiva and cornea, with the highest olopatadin concentration after the small white rabbit eyes New Zealand (NZW), each eye 1 drop of olopatadine with increasing dose content (0.15%; 0.2%and 0.7%). Olopatadine concentration in aquaculture, darkness, iris (ICB) and lens increases with the increasing concentration of olopatadin. Studies conducted in Dutch rabbits are marked by dyeing, which shows low levels of cohesion on melanin pigment tissues.

Biological/transformation transformation

The studies have not been conducted to survey the metabolism of olopatadin in the eye tissue due to the studies of toxicity and clinical, which has shown that olopatadine is safe and effective. The main metabolites of olopatadin after drinking in humans are N-Desmethyl olopatadin (M1) and olopatadin N-OXID (M3). N-Desmethyl olopatadin (M1) is almost unique to Demethyl turned by the IZYM 3A4 of Cytochrome P450 (CYP3A4). Olopatadin is not an inhibitor of cytochrom P450 and therefore there is no drug -drug interaction due to metabolic interaction.

In humans, after the eye, the metabolic n-Desmethyl of olopatadin (M1) is not quantified (≤ 0.050 ng/ml) the sum of plasma samples of all objects.

Excretion/excretion

In humans, the excretion of drugs in the form of unchanged urine is the main excretion sugar.

In humans, the half -life of systemic plasma is lower than 3 hours.

Linear/non -linear

In a single dose study, olopatadin shows that the dose increases proportional to the exposure (shown via CMAX and AUC) in the eye tissue after small eyes.

Before taking Pataday eye drops 0.2% Alcon prevention and treatment of allergic conjunctivitis (2.5ml)

How to use

Only use to drop the eyes. Do not use for injection or drinking.

After opening the lid, if the attachment is guaranteed in the neck of the bottle, remove it before taking the drug.

To avoid the infection at the small tip of the drug and the solution, be cautious, not to put the drug's head to touch the eyelids, the area around the eyes or any surface.

Close the lid of the vial when not in use.

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

advise patients not to wear contact lenses if their eyes are red.

Do not use small pataday eye solution to treat eye irritation related to contact lenses.

Dosage

Adults

Put one drop on each eye, 1 time/day.

Elderly

Unnecessary dose adjustment in elderly patients.

Group of children's patients

Safety and efficiency have been established in children of children 2 years of age or older.

Special patient groups

Pataday eye solution has not been studied in patients with kidney disease or liver disease. However, no adjustments are expected to be necessary in the case of liver failure or kidney failure.

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? On low -level olopatadin animals. When unfortunately drinking 1 bottle of small pataday® solution, the maximum body exposure is 5 mg of olopatadin. Suppose the drug is 100% absorbed, this exposure is so gradually the last dose in a 10 kg child is 0.5 mg/kg.

In case of overdose, it is necessary to check and take care of proper patients.

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 pataday , you may experience unwanted effects (ADR).

The following unwanted effects have been reported in clinical studies with 0.1% and 0.2% Pataday eye solution. In each frequency group, unwanted effects are presented in the order of severity.

Not popular, 1/1000 ADR

Nervous system disorders: headache, taste disorder.

Eye disorders : keratitis, keratitis, eye pain, dry eye, cool eyelids, itchy eyes, eye rust, eye congestion, eyelid scales, eye discomfort.

Respiratory disorders, chest and mediastinum: dry nose.

Systemic disorders and medication on the spot: fatigue.

Rare, 1/10,000

Nervous disorders: dizziness.

Eye disorders: Fear of light, blurred vision, eyelid red.

Gastrointestinal disorders : dry mouth.

Skin and tissue disorders: contact dermatitis.

The following unwanted effects are also reported:

encountered in 7 to 11% of patients: colds and pharyngitis syndrome. Some of these manifestations are similar to the symptoms of the study.

The following adverse effects occur in In the eyes: conjunctivitis, hypersensitivity.

The following other unwanted effects are determined from after -sales monitoring. It is impossible to estimate the frequency from existing data. In each group of organs, unwanted effects are presented in the order of severity.

immune system disorders: Hypersensitivity reaction.

Eye disorders: tearing.

Gastrointestinal disorders: Nausea.

Instructions on how to handle ADR

Notify the doctor or pharmacist of 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

Pataday drugs are contraindicated in cases of hypersensitivity to active ingredients or any excipients of the drug.

Caution when using

Pataday eye solution containing benzalkonium chloride can cause eye irritation and have knew how to change soft contact lenses. Avoid contact with soft contact lenses.

Patients must be instructed to remove contact lenses before using Ppataday® eye solution and wait at least 15 minutes before wearing glasses again.

Pataday eye solution is an anti -allergic/antihistamine drug and although the eye is used, the drug is still absorbed by the whole body.

It is necessary to stop using the drug when there are signs of serious reactions or hypersensitivity reactions.

benzalkonium chloride has been reported to cause keratitis and/or corneal ulcer caused by toxins.

It is necessary to control strictly when using the drug regularly or prolonged on patients with dry eyes or when the cornea is damaged.

The ability to drive and operate machinery

olopatadin is a non -thin antihistamine. Temporarily blurred vision after small eyes or other vision disorders may affect the ability to drive or operate machinery. If the blurred vision appears after the drug, the patient must wait until he can see it clearly to drive or operate machinery.

Pregnancy

without or very little data from using small olopatadin eyes for pregnant women.

It is not recommended to use olopatadin for pregnant women and women who are likely to be pregnant when not using contraception.

Breastfeeding period

Data available on animals showed that olopatadin was excreted into breast milk after eyeed eyes. The risk for infants/young children cannot exclude. Pataday® should not be used for women who are breastfeeding.

Drug interactions

No clinical interactions have been described.

Storage

Store at 2 ° C to 25 ° C (36 ° F to 77 ° F).

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