KURVELO- levonorgestrel and ethinyl estradiol kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Lupin Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

ETHINYL ESTRADIOL

Composição:

ETHINYL ESTRADIOL 0.03 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Kurvelo is indicated for use by females of reproductive potential to prevent pregnancy. Kurvelo is contraindicated in females who are known to have the following conditions: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see BOXED WARNING and WARNINGS (1)]. Have current or history of deep vein thrombosis or pulmonary embolism [see WARNINGS (1)]. Have cerebrovascular disease [see WARNINGS (1)]. Have coronary artery disease [see WARNINGS (1)]. Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS (1)]. Have inherited or acquired hypercoagulopathies [see (1)]. Have uncontrolled hypertension or hypertension with vascular disease [see WARNINGS (3)]. Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years

Resumo do produto:

Kurvelo Tablets (levonorgestrel and ethinyl estradiol tablets USP) (3 x 28) are available in packages of 3 wallets, each containing 28 tablets as follows: Each blister strip contains 21 light orange tablets, each containing of 0.15 mg levonorgestrel and 30 mcg ethinyl estradiol, debossed with "LU" on one side and "U31" on the other side. 7 inert pink, round, biconvex tablets, debossed with "LU" on one side and "U32" on the other side. They are supplied as follows: Kurvelo tablets are available in a wallet (NDC 68180-844-11) containing 28 tablets, such 3 wallets are packed in a carton (NDC 68180-844-13). Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].   Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States   Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA Revised: June 2019                                                                                         ID#: 258169

Status de autorização:

Abbreviated New Drug Application

Características técnicas

KURVELO - LEVONORGESTREL AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
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KURVELO™
(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 Kurvelo, are
contraindicated in women who are over 35 years of age and smoke [see
CONTRAINDICATIONS
and WARNINGS (1)].
DESCRIPTION
Kurvelo™ (levonorgestrel and ethinyl estradiol tablets USP) is a
combination oral contraceptive (COC)
consisting of 21 light-orange active tablets, each containing 0.15 mg
of levonorgestrel, a synthetic
progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 pink
inert tablets (without hormones).
The structural formulas for the active components are:
LEVONORGESTREL C H O MW: 312.4
Levonorgestrel is chemically (d(-)-13
beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one).
21
28
2
ETHINYL ESTRADIOL C
H O MW: 296.4
Ethinyl Estradiol is (19-nor-17α-pregna-1,3,5
(10)-trien-20-yne-3,17-diol).
Each light-orange active tablet contains the following inactive
ingredients: croscarmellose sodium,
FD&C Yellow #6, lactose monohydrate, magnesium stearate,
microcrystalline cellulose and povidone.
Each pink inert tablet contains the following inactive ingredients:
croscarmellose sodium, D & C Red
#30, lactose monohydrate, magnesium stearate and microcrystalline
cellulose.
CLINICAL PHARMACOLOGY
Combination oral contraceptives prevent pregnancy primarily by
suppressing ovulation.
INDICATIONS AND USAGE
Kurvelo is indicated for use by females of reproductive potential to
prevent pregnancy.
CONTRAINDICATIONS
Kurvelo is contraindicated in females who are known to have the
following conditions:
A high risk of arterial or venous thrombotic diseases. Examples
include women who are known to:
Smoke, if over