雪蘭芬錠

Land: Taiwan

Språk: kinesiska

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

Aktiva substanser:

CLOMIPHENE CITRATE

Tillgänglig från:

台灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)

ATC-kod:

G03GB02

Läkemedelsform:

錠劑

Sammansättning:

CLOMIPHENE CITRATE (6816000110) MG

Enheter i paketet:

鋁箔盒裝

Klass:

製　劑

Receptbelagda typ:

須由醫師處方使用

Tillverkad av:

TEVA PHARMACEUTICAL INDUSTRIES LTD. 18, ELI HURVITZ STREET, KFAR SABA 44102, ISRAEL IL

Terapiområde:

clomifene

Terapeutiska indikationer:

不排卵婦女之不孕症

Produktsammanfattning:

註銷日期: 2018/03/13; 註銷理由: 未展延而逾期者; 有效日期: 2016/10/29; 英文品名: SEROPHENE

Bemyndigande status:

已註銷

Tillstånd datum:

1996-10-29

Bipacksedel

SEROPHENE®
Clomiphene Citrate Tablets (U.S.P./B.P.)
DESCRIPTION
Each scored white tablet contains:
Clomiphene Citrate USP 50 mg
Clomiphene citrate is designated chemically as
2‐[p‐(2‐chloro‐1,2‐
diphenylvinyl) phenoxy] triethylamine dihydrogen citrate and is
represented structurally as
As shown, one molecule of citric acid is chemically bound with one
molecule
of the organic base, clomiphene.
Clomiphene citrate is a chemical analogue of other triarylethylene
compounds such as chlorotrianisene and the cholesterol inhibitor,
triparanol.
Excipient
：
Microcrystalline Cellulose, Colloidal Silicon Dioxide, Magnesium
Stearate, Sodium Starch Glycolate, Lactose Monohydrate, Starch
ACTIONS
Clomiphene citrate, an orally‐administered, non‐steroidal agent,
may induce ovulation
in selected anovulatory women. It is a drug
of considerable pharmacologic potency. Careful evaluation and
selection of the patient and close attention to the timing of the
dose is mandatory prior to treatment with clomiphene citrate.
Conservative selection and management of the patient contribute
to successful therapy of anovulation. Clomiphene citrate
induces
ovulation
in
most
selected
anovulatory
patients.
The
various
criteria
for
ovulation
include:
an
ovulation
peak
of
estrogen
excretion followed by a biphasic basal body temperature curve;
urinary excretion of pregnanediol at postovulatory levels and,
endometrial histologic findings characteristic of the luteal phase.
A review of eleven publications appearing between
1964 and 1978
showed that pregnancy occurred in 35% of 5154 patients with
ovulatory dysfunction who received clomiphene citrate.
PREGNANCIES FOLLOWING CLOMIPHENE CITRATE
A
Number of Patients
= 5154 (Range)
Percent of Patients Ovulating
b
= 75 (50‐94)%
Percent of Ovulatory Cycles = 53 (33‐69)%
Percent of Patients Pregnant = 35
(11‐52)%
Percent Patients Pregnant
Percent Patients Ovulating = 46
(22‐61)%
Percent Live Birth = 86 (74‐99.8)%
Percent Abortions = 14 (0.2‐26)%
Percent of Single Births = 90 (67‐100)%