CRYSELLE- norgestrel and ethinyl estradiol kit

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

NORGESTREL (UNII: 3J8Q1747Z2) (NORGESTREL - UNII:3J8Q1747Z2), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Հասանելի է:

RPK Pharmaceuticals, Inc.

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Cryselle is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use. Cryselle is contraindicated in females who are known to have or develop the following conditions: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 Have deep-vein thrombosis or pulmonary embolism, now or in the past Have inherited or acquired coagulopathies Have cerebrovascular disease Have coronary artery disease Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation) Have uncontrolled hypertension Have diabetes mellitus with vascular disease Headaches with focal neurological symptoms or migraine headaches with aura Women over age 35 with any migra

Ապրանքի ամփոփագիր:

Cryselle® (norgestrel and ethinyl estradiol tablets USP), 0.3 mg/0.03 mg are available in packages of 6 blister card dispensers (NDC 0555-9049-58), each containing 28 tablets as follows: 21 active, white, round, film-coated, biconvex tablets debossed with dp on one side and 543 on the other side and 7 inert, round, light-green colored, uncoated tablets debossed dp and 331. Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. G 7/2022

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

CRYSELLE- NORGESTREL AND ETHINYL ESTRADIOL
RPK PHARMACEUTICALS, INC.
----------
CRYSELLE
(NORGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
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 ARE CONTRAINDICATED IN WOMEN
WHO ARE OVER 35 YEARS OF AGE AND SMOKE _[SEE CONTRAINDICATIONS]_.
DESCRIPTION
Cryselle is a combination oral contraceptive containing the
progestational compound
norgestrel, USP and the estrogenic compound ethinyl estradiol, USP.
Norgestrel is
designated as (2)
(±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one
and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5
(10)-trien-20-yne-3,17-
diol). Each white active Cryselle tablet contains 0.3 mg norgestrel,
USP and 0.03 mg
ethinyl estradiol, USP. The inactive ingredients present are
hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol and
pregelatinized corn starch. The light-green inactive tablets also
contain D&C Yellow No.
10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6
Aluminum
Lake.
NORGESTREL, USP
C
H
O MW: 312.45
®
®
21
28
2
ETHINYL ESTRADIOL, USP
C
H
O MW: 296.40
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Combined oral contraceptives (COCs) prevent pregnancy primarily by
suppressing
ovulation.
INDICATIONS AND USAGE
Cryselle is indicated for use by females of reproductive potential to
prevent pregnancy.
In a study of 1,287 women with a total of 11,085 cycles or 852.7
women-years of
usage, the pregnancy rate in women age 15 to 40 years was
approximately 1
pregnancy per 100 women-years of use.
CONTRAINDICATIONS
Cryselle is contraindicated in females who are known to have or
develop the following
conditions:
A high risk of arterial or venous thrombotic diseases. Examples
include women who
are