每瞳令-普益點眼液

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

下载 资料单张 (PIL)
06-07-2020
下载 公众评估报告 (PAR)
14-04-2020

有效成分:

TROPICAMIDE;;PHENYLEPHRINE HCL

可用日期:

台灣參天製藥股份有限公司 台北市中山區松江路126號9樓之1 (86383884)

ATC代码:

S01FA56

药物剂型:

點眼液劑

组成:

PHENYLEPHRINE HCL (1212002310) 5MG; TROPICAMIDE (5224000400) 5MG

每包单位数:

瓶裝

类:

製 劑

处方类型:

限由醫師使用

厂商:

SANTEN PHARMACEUTICAL CO., LTD. SHIGA PLANT 348-3, AZA-SUWA, OAZA-SHIDE, TAGACHO INUKAMIGUN, SHIGA, JAPAN JP

治疗领域:

tropicamide, combinations

疗效迹象:

散瞳和睫狀肌麻痹

產品總結:

有效日期: 2028/09/04; 英文品名: MYDRIN-P

授权日期:

1978-06-06

资料单张

                                1
Dilating eye drops used for examination
Mydrin
®
-P Ophthalmic Solution
MYDRIN
®
-P
Tropicamide and Phenylephrine Ophthalmic Solution
DOH Import No. 005728
CONTRAINDICATIONS (THIS PRODUCT IS CONTRAINDICATED IN THE FOLLOWING
PATIENTS.)
1) Patients with glaucoma or those predisposed to ocular hypertension
as evidenced by a narrow angle or shallow anterior
chamber. [Acute angle-closure glaucoma may occur.]
2) Patients with a history of hypersensitivity to any ingredients of
this product
COMPOSITION, CHARACTERISTICS
Product Name
Mydrin
®
-P Ophthalmic Solution
Active Ingredients
tropicamide
phenylephrine hydrochloride
Content (per 1 mL)
5mg
5 mg
Additives
e-aminocaproic acid, benzalkonium chloride,
chlorobutanol, boric acid, hydrochloric acid, purified
water
pH
4.5~5.8
Ratio of osmotic
pressure
0.9~1.1
Characteristics
Colorless to light yellow, clear, sterile water-based
ophthalmic solution
INDICATION
Mydriasis and cycloplegia
CATEGORY
This drug must be prescribed by a physician
ADMINISTRATION AND DOSAGE
For pupil dilation, usually 1-2 drops per time, or 1 drop each time at
an interval of 3 to 5 minutes and 2 attempts in total. For
cycloplegia, usually 1 drop each time at an interval of 3 to 5 minutes
and 2 to 3 attempts in total. The dosage may be increased
or decreased as appropriate depending on the symptoms.
PRECAUTIONS
1. Careful administration (This product should be administered with
care in the following patients)
1) Children [See “6. Pediatric Use” section]
2) Patients with hypertension [Symptoms may be aggravated due to
hypertensive effect of phenylephrine]
3) Patients with atherosclerosis [Symptoms may be aggravated due to
the hypertensive effect of phenylephrine]
4) Patients with heart disease, including coronary artery disease or
heart failure [Symptoms may be aggravated due to the
β
1
agonistic effect of phenylephrine]
5) Patients with diabetes [Symptoms may be aggravated due to
gluconeogenesis promoting effect of phenylephrine]
6) Patients with hyperthyroidism [Since hyperthyroidism may be
ac
                                
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