Aifagan Eye Drops 0.1% 5ml×5 Aiphagan Brimonidine Tartrate Eye Drops 0.1%

Aifergen Eye Drops 0.1% is an ophthalmic drug used to treat glaucoma and ocular hypertension. Its active ingredient is bimatoprost, which is a prostaglandin analog. It effectively reduces intraocular pressure (IOP) by increasing aqueous humor outflow, thereby slowing down optic nerve damage and preventing vision deterioration. Clinical studies have shown that once-daily drops can significantly reduce intraocular pressure, and the effect is long-lasting and stable. In addition, bimatoprost also has the effect of promoting eyelash growth. The drug is generally well tolerated, and common side effects include mild eye irritation, conjunctival congestion, or eyelash lengthening and thickening, and serious adverse reactions are rare.

1. Basic information of the drug

1. Common name : Brimonidine Tartrate
2. Product name : アイファガン eye drops 0.1%
3. Dosage form : slightly yellow-green to yellow-green clear sterile water-based eye drops
4. Indications : Cataract, ocular hypertension (when other cataract treatment drugs are not effective or cannot be used)
5. Element :
• Active ingredients : 1 mL contains 1 mg of ブリモニジンtartaric acid
• Additives : ラマグネシウム, ホウ acid, ホウ sand, カルメロースナトリウム, amoxic acid ナトリウム, isotonic chemical, pH adjusting agent
6. Properties :
• pH ： 6.7~7.5
• Penetration pressure ratio: Physiological liquid pressure ratio 0.9~1.1
7. Storage method and validity period :
• Storage method: Store at room temperature
• Validity period: 3 years
8. Accreditation number : 22400AMX00040
9. Year of sale : May 2012

2. Usage and Dosage

• Usual dosage : 1 drop per time, apply in eyes twice a day.

3. Taboo

1. Patients with a history of allergy to the ingredients of this drug.
2. Low birth weight, newborn, infant or infant under 2 years old.

IV. Precautions

1. Special Populations

• Pregnant women : Use only when the benefits of treatment outweigh the risks.
• Lactating women : The benefits of treatment need to be weighed against the benefits of breastfeeding. Animal experiments have shown that drugs can enter breast milk.
• Children : It is forbidden for children under 2 years old; Children aged 2 to 7 years may experience high frequency of trance ( 25~83% ) when using 0.2% preparation.

2. Medication Instructions

• When applying eye drops, avoid contact between the tip of the container and the eye to prevent contamination of the drug solution.
• When used with other eye drops, there should be a gap of at least 5 minutes.
• After applying the drug to the eye, press the lacrimal sac for 1 to 5 minutes to reduce systemic absorption.

3. Other notes

• It may cause side effects related to systemic absorption (such as drowsiness, sleepiness, slow pulse, low blood pressure, etc.), so please be careful.
• If you experience symptoms such as corneal opacity, congestion, or decreased vision, you should seek medical attention immediately.

5. Drug Interactions

Xie Ming, etc.	Clinical symptoms and treatment methods	Machine sequence and risk factors
reduce pressure	The pressure-reducing effect may be enhanced	Additive effect leads to enhanced pressure reduction effect
CNS inhibitory agent・アルコール	Possible increased sedative effect	Additive effect leads to enhanced sedative effect
モノアミンAcidifying Enzyme Inhibitor	May affect blood pressure changes	Influences the metabolism and reabsorption of ノルアドレナリン

VI. Adverse Reactions

1.Significant side effects (unknown frequency)

• Corneal opacity, allergic conjunctivitis, blepharitis, dyspnea, etc.

2. Other side effects

• Eyes : punctate keratitis, itchy eyes, conjunctival congestion, eye fat, foggy vision, and decreased vision.
• Systemic : drowsiness, headache, dizziness, hypotension, bradycardia, dry mouth.

7. Pharmacological Action

1. Mechanism of action : It inhibits the production of aqueous humor by stimulating adrenalin α2 receptors and promotes the drainage of aqueous humor through the uveoscleral outflow pathway, thereby reducing intraocular pressure.
2. Inhibition of aqueous humor production : Animal experiments show that the inhibition rate of aqueous humor production can reach up to 43.9% one hour after eye drops of 0.3% solution.

8. Pharmacokinetics

1. Blood concentration : After healthy adults used 0.15% or 0.2% preparation for eye drops, the peak blood concentrations were 38.57±11.22pg/mL and 44.25±14.94pg/mL , respectively, and were below the quantitative limit after 24 hours.
2. Distribution : The highest concentration in eye tissues is distributed in the iris, conjunctiva, cornea, etc. After repeated eye drops, the concentration in the iris is 5 to 17 times that of a single application.

IX. Clinical Research

1. Domestic third comparative trial : Compared with 0.5%チモロール eye drops, the non-inferiority of this agent in reducing intraocular pressure was not confirmed, but it showed superiority when used in combination with PG drugs.
2. Long-term administration trial : When used alone or in combination, it continued to show a stable intraocular pressure-lowering effect for 52 weeks.

10. Packaging specifications

• プラスチック eye drops container: 5ml×5 , 5ml×10

11. Production Information

Manufacturing and selling products : Senju Sesame Co., Ltd.