DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

ETHINYL ESTRADIOL

Composition:

ETHINYL ESTRADIOL 0.02 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Desogestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II 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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year * (4) Method (1) Typical Use † (2) Perfect Use ‡ (3) Chance§ 85 85 Spermicides¶ 26 6 40 Periodic abstinence 25 63      Calendar 9      Ovulation Method 3      Sympto-Thermal# 2      Post-Ovulation 1 Withdrawal 19 4 CapÞ      Parous Women 40 26 42      Nulliparous Women 20 9 56 Sponge      Parous Women 40 20 42      Nulliparous Women 20

Product summary:

Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP, 0.15 mg/0.02 mg and 0.01 mg contain 21 round white to off-white tablets, 2 round green tablets and 5 round light peach tablets in a blister pack. Each round white to off-white tablet (debossed with “232” on one side and other side plain) contains 0.15 mg desogestrel and 0.02 mg ethinyl estradiol. Each round green tablet (debossed with “294” on one side and other side plain) contains inert ingredients. Each round light peach tablet (debossed with “233” on one side and other side plain) contains 0.01 mg ethinyl estradiol. Cartons of 3 NDC 0378-7296-53 Cartons of 6 NDC 0378-7296-56 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL-
DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
MYLAN PHARMACEUTICALS INC.
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DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, USP AND ETHINYL ESTRADIOL
TABLETS,
USP
RX ONLY
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS
Cigarette smoking increases the risk of serious cardiovascular events
from
combination oral contraceptive (COC) use. This risk increases with
age, particularly
in women over 35 years of age, and with the number of cigarettes
smoked. For
this reason, COCs, including desogestrel and ethinyl estradiol tablets
and ethinyl
estradiol tablets, are contraindicated in women who are over 35 years
of age and
smoke (see CONTRAINDICATIONS and WARNINGS).
DESCRIPTION
Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol
Tablets, USP provide
an oral contraceptive regimen of 21 white to off-white round tablets
each containing
0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17
alpha-pregn- 4-en- 20-yn-
17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5
(10)-trien-20-yne-3,17-
diol), and inactive ingredients which include anhydrous lactose,
colloidal silicon dioxide,
polyvinyl pyrrolidone, potato starch, stearic acid, and vitamin E,
followed by 2 inert green
round tablets with the following inactive ingredients: FD&C Blue No. 1
Aluminum Lake,
ferric oxide yellow, lactose monohydrate, magnesium stearate and
polacrilin potassium.
Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol
Tablets, USP, 0.15
mg/0.02 mg and 0.01 mg also contain 5 light peach round tablets
containing 0.01 mg
ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-
yne-3,17-diol) and inactive
ingredients which include anhydrous lactose, _dl_-alpha-tocopherol,
FD&C _Y_ellow No. 6
Aluminum Lake, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polacrilin potassium and povidone K-25. The molecular weights for
desogestrel and
ethinyl estradiol are 310.48 and 296.40 respectively. The structura