LEVONORGESTREL AND ETHINYL ESTRADIOL kit

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Tersedia dari:

Mylan Pharmaceuticals Inc.

INN (Nama Internasional):

ETHINYL ESTRADIOL

Komposisi:

ETHINYL ESTRADIOL 0.03 mg

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Levonorgestrel and ethinyl estradiol tablets, 0.15 mg/30 mcg are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have the following conditions:

Ringkasan produk:

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/30 mcg are available in a carton of 3 pouches and a carton of 6 pouches, each pouch contains 28 tablets: 21 Active Tablets: White to off-white, round, unscored tablets debossed with 209 on one side and plain on the other side. 7 Inert Tablets: Green, round, unscored tablets debossed with 274 on one side and plain on the other side. NDC 0378-6550-53, cartons of 3 pouches, each pouch containing 28 tablets NDC 0378-6550-56, cartons of 6 pouches, each pouch containing 28 tablets Store at 20° to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

LEVONORGESTREL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL
ESTRADIOL
MYLAN PHARMACEUTICALS INC.
----------
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.15 MG/30 MCG
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 levonorgestrel and ethinyl estradiol
tablets, are
contraindicated in women who are over 35 years of age and smoke [see
CONTRAINDICATIONS and WARNINGS (1)].
DESCRIPTION
Levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/30 mcg are a
combination oral
contraceptives (COC) consisting of 21 white to off-white active
tablets, each containing
0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl
estradiol, an
estrogen, and 7 green inert tablets (without hormones).
The structural formulas for the active components are:
LEVONORGESTREL
C
H O MW: 312.45
Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one,
13-ethyl-17-hydroxy-
,(17α)-(-)-.
21
28
2
ETHINYL ESTRADIOL
C
H O MW: 296.40
Ethinyl Estradiol is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,
17-diol.
Each white to off-white active tablet contains the following inactive
ingredients: lactose
monohydrate, magnesium stearate, and polacrilin potassium.
Each green inert tablet contains the following inactive ingredients:
FD&C Blue No. 1
aluminum lake, lactose monohydrate, magnesium stearate, polacrilin
potassium, and
yellow oxide of iron.
CLINICAL PHARMACOLOGY
Combination oral contraceptives prevent pregnancy primarily by
suppressing ovulation.
INDICATIONS AND USAGE
Levonorgestrel and ethinyl estradiol tablets, 0.15 mg/30 mcg are
indicated for use by
females of reproductive potential to prevent pregnancy.
CONTRAINDICATIONS
Levonorgestrel and ethinyl estradiol tablets are contraindicated in
females who are
known to have the following cond