APRI- desogestrel and ethinyl estradiol kit

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

DESOGESTREL (UNII: 81K9V7M3A3) (DESOGESTREL - UNII:81K9V7M3A3), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Доступна з:

Physicians Total Care, Inc.

ІПН (Міжнародна Ім'я):

DESOGESTREL

Склад:

DESOGESTREL 0.15 mg

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Apri (desogestrel and ethinyl estradiol) Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. Method Typical Use  Perfect Use  In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Oral contraceptives like Apri (desogestrel and ethinyl estradiol) tablets should not be used in women who currently h

Огляд продуктів:

Apri® (desogestrel and ethinyl estradiol) Tablet 28 Day Regimen blister cards contain 21 round, unscored, rose-colored tablets and 7 round, unscored white tablets. Each rose-colored tablet (debossed with “dp” on one side and “575” on the other side) contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each white tablet (debossed with “dp” on one side and “570” on the other side) contains inert ingredients. Cartons of 6 blister cards NDC 54868-4754-0.  Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

APRI - DESOGESTREL AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, INC.
----------
APRI
(DESOGESTREL AND ETHINYL ESTRADIOL) TABLETS
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
Rx only
Revised JANUARY 2009
11001429
DESCRIPTION
Apri 28 Day Regimen blister cards for desogestrel and ethinyl
estradiol tablets provide an oral
contraceptive regimen of 21 round rose-colored tablets. Each
rose-colored “active” desogestrel and
ethinyl estradiol tablet for oral administration contains 0.15 mg
desogestrel (13-ethyl-11- methylene-
18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl
estradiol (19-nor-17 alpha-pregna-
1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include
colloidal silicon dioxide, FD&C Blue
No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl
methylcellulose, lactose
monohydrate, polyethylene glycol, polysorbate 80, povidone,
pregelatinized starch, stearic acid,
titanium dioxide, and vitamin E.
Apri 28 Day Regimen blister cards also contain 7 white “inactive”
tablets for oral administration,
containing the following inactive ingredients: lactose anhydrous,
magnesium stearate, microcrystalline
cellulose and pregelatinized starch.
DESOGESTREL C
H O M.W.: 310.4 8
ETHINYL ESTRADIOL C
H
O M.W.: 296.4 1
The 21 rose-colored tablets meet USP Dissolution Test 2.
®
22
30
20
24
2
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Combination oral contraceptives act by suppression of gonadotropins.
Although the primary mechanism
of this action is inhibition of ovulation, other alterations include
changes in the cervical mucus, which
increase the difficulty of sperm entry into the uterus, and changes in
the endometrium which reduce the
likelihood of implantation.
Receptor binding studies, as well as studies in animals, have shown
that 3-keto-desogestrel, the
biologically active metabolite of desogestrel, combines high
progestational activity with minimal
intrinsic androgenicity (91,92). The relevance of