Olopatadine Hydrochloride Eye Drops
It is used to treat the signs and symptoms of allergic conjunctivitis.
Key words:
Olopatadine Hydrochloride Eye Drops
Classification:
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Graphic Details
Date of approval:2019Year04Month03Day
First revision date:2019Year06Month12Day
Second revision date: October 19, 2020
Olopatadine Hydrochloride Eye Drops Instructions
Please read the instructions carefully and use them under the guidance of a physician.
[Name of Drug]]
Common Name: Olopatadine Hydrochloride Eye Drops
English Name:Olopatadine Hydrochloride Eye Drops
Chinese Pinyin:Yansean Aoluotading Diyanye
[ingredients]]
The main ingredient of this product is olopatadine hydrochloride.
Chemical Name:11-[(Z)-3-(dimethylamino)Acrylic]-6,11-dihydrodiphenyl[B,e]oxa-2-Acetic acid hydrochloride.
Chemical structural formula:
Molecular formula:C21H23NO3·HCl
Molecular weight:373.87
Bacteriostatic:0.01%Benzalkonium chloride
Inactive IngredientsDisodium hydrogen phosphate, sodium chloride, dilute hydrochloric acid or sodium hydroxide (adjustedpHvalue), water for injection.
character]
This product is a colorless to slightly yellow clear liquid.
indications]
It is used to treat the signs and symptoms of allergic conjunctivitis.
[specification]]
0.1%(5ml:5mg,C21H23NO3)
Usage and dosage]
recommend dose for the affected eye each time1-2Drops, Daily2times, intervals6-8More than an hour.
adverse reaction]
It has been reported that the incidence of headache after medication is7%.
The following adverse reactions have been reported, and the incidence rate is less5%Fatigue, blurred vision, burning or tingling sensation, cold syndrome, dry eye, foreign body sensation, hyperemia, allergies, keratitis, eyelid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis, and inverted taste. A considerable part of the adverse reactions and the symptoms of the disease itself are similar.
taboo]
Prohibited if you are allergic to any ingredient in this product.
[Note]]
1. Only eye local drops, can not be injected. For patients wearing contact lenses, please do not wear contact lenses when using this product.
2. At the time of purchase, if the seal is found to be damaged or broken, do not use it.
3. In order to avoid contamination of the bottle mouth liquid, do not make the bottle mouth contact with the eyelid or eye skin.
4. Please tighten the bottle mouth when not in use.
5. Keep this product out of the reach of children.
6. This product should not be used after opening the cover for four weeks.
Medication for pregnant and lactating women]
Pregnancy: Pregnancy categoryCNo teratogenic effect of olopatadine was found in rats and rabbits. However, during the organogenesis period in rats600 mg/kg/day, or the maximum amount of human eye recommend93,750Times; for rabbits400 mg/kg/day, or the maximum amount of human eye recommend62,500Times, fetal survival rate decreased. There are no appropriate controlled studies in pregnant women. Because animal studies are not always the same as human reactions, pregnant women can use this medicine when the benefits of this product to the mother outweigh the possible risks to the embryo or fetus.
lactating women: Olopatadine was found in the milk of lactating rats that took this drug orally. It is not known whether there will be sufficient systemic absorption after topical ocular instillation to make the drug detectable in breast milk. In any case, nursing mothers should be cautious when using this product.
children medication]
Not yet determined3The safety and effectiveness of this product in children under the age.
elderly medication]
This experiment was not performed and there are no reliable references.
drug interaction]
This experiment was not performed and there are no reliable references.
drug overdose]
This experiment was not performed and there are no reliable references.
pharmacology and toxicology]
Pharmacological effects:
Olopatadine is a mast cell stabilizer and relatively selective histamineH1-Receptor antagonists. inhibition in both in vivo and in vitroIAnaphylaxis. Olopatadine onα-Adrenergic receptors, dopamine receptors, muscarinicIType andIItype receptor and5-Serotonin receptors have no effect.
Toxicology studies:
Carcinogenesis, mutagenicity and impairment of fertility:
to500 mg/kg/Day and200 mg/kg/Oral administration of olopatadine to mice and rats at daily doses did not cause carcinogenesis. By each drop40 ulThese doses are larger than the maximum amount of human eye recommend.78,125and31,250Times. The possibility of inducing mutations was not observed in the bacterial reverse mutation test in vitro, the mammalian chromosome aberration test in vitro, or the mouse micronucleus test in vivo, etc. Male and female rats were orally given the maximum recommended amount for human eyes.62,500After a double dose of olopatadine, the fertility index decreased slightly and the pregnancy rate decreased. The maximum amount of human eye recommend7,800Times were not found to affect reproductive function.
pharmacokinetics]
Only a very small amount of olopatadine enters the systemic circulation after topical eye drops in humans. In two sessions about healthy volunteers (total24People) in the study, the eyes drop.0.15%of olopatadine eye drops, each12Once every hour for two weeks, the plasma concentration is generally lower than the detectable value (<0.5ng/ml). Only after medication2Olopatadine can be detected in some plasma samples within hours at a concentration0.5To1.3ng/ml. The plasma half-life is approximately3hours, mainly excreted by the kidneys approx.60-70%The original medicine. Two metabolites were found in the urine, single norectol andN-Oxide, very low concentration.
storage]
4~30 DEG C to save.
[packaging]]
Low density polyethylene medicinal eye drops bottle,1Bottle/Box.
[validity period]]36Months
executive standard]YBH00792019
[Approval No.]]Chinese medicine standard wordH20193095
Drug Marketing Authorization Holder]
Name: Zhejiang Jianfeng Pharmaceutical Co., Ltd.
Registered Address:Second Floor, Office Quality Inspection Building, X02, No.58 Gaofan Section, Baitang Downline, Wucheng District, Jinhua City, Zhejiang Province
production enterprise]
Company: Zhejiang Jianfeng Pharmaceutical Co., Ltd.
Production address: 368 Jinqu Road, Jinhua Industrial Park, Zhejiang Province
Postal Code:321016
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