DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL kit

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Naari Pte. Limited

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP is 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 a Method (1) Typical Use b (2) Perfect Use c (3) (4) Chance d 85 85 Spermicides e 26 6 40 Periodic Abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal f 2 Post-Ovulation 1 Withdrawal 19 4 Cap g Parous Wome

leaflet_short:

Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP are available in 28 days regimen of blister pack (NDC 79929-020-05) as follows: 21 White to off white, round, biconvex, film coated tablets, debossed with FT1 on one side and plain on other side containing 0.15 mg desogestrel and 0.02 mg ethinyl estradiol, 2 light-green coloured, round, biconvex, film coated tablets debossed with FT3 on one side and plain on other side containing inert ingredients and 5 Yellow coloured, round, biconvex, film coated tablets, debossed with FT2 on one side and plain on other side containing 0.01 mg ethinyl estradiol. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

authorization_status:

Abbreviated New Drug Application

SPC

DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL-
DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
NAARI PTE. LIMITED
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DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS
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, USP and Ethinyl
Estradiol Tablets,
USP, 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 lactose monohydrate,
pregelatinized starch
(Maize starch), povidone K-30, vitamin E, stearic acid, colloidal
anhydrous silica, purified
talc, magnesium stearate, Hypromellose, Polyethylene glycol and
followed by 2 inert
light-green round tablets with the following inactive ingredients
/lactose monohydrate,
pregelatinized starch (Starch 1500), colloidal anhydrous silica, talc,
magnesium stearate,
hypromellose, triacetin, titanium dioxide, FD&C blue no. 1 aluminium
lake, D&C yellow no.
10 aluminium lake, FD&C yellow no. 6 aluminium lake. Desogestrel and
Ethinyl Estradiol
Tablets, USP and Ethinyl Estradiol Tablets, USP also contains 5 yellow
coloured 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 lactose
monohydrate, pregelatinized
starch (Maize starch), povidone K-30, vitamin E, stearic acid,
colloidal anhydro