NORGESTIMATE AND ETHINYL ESTRADIOL- norgestimate and ethinyl estradiol kit

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Beschikbaar vanaf:

Lupin Pharmaceuticals, Inc.

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Norgestimate and ethinyl estradiol tablets USP are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)]. Norgestimate and ethinyl estradiol tablets USP is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and ethinyl estradiol tablets USP should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see CLINICAL STUDIES (14)]. Norgestimate and ethinyl estradiol tablets are 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:           o  Smoke, if over age 35 [see BOXED WARNING AND WARNINGS AND PRECAUTIONS (5.1)]           o   Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS (5.1)]           o   Have inherited or acquired hyper coagulopathies [see WARNINGS AND PRECAUTIONS (5.1)]           o   Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS (5.1)]           o   Have coronary artery disease [see WARNINGS AND PRECAUTIONS (5.1)]           o   Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS (5.1)]           o   Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS (5.4)]           o   Have diabetes mellitus with vascular disease [see WARNINGS AND PRECAUTIONS (5.6)]           o   Have headaches with focal neurological symptoms or migraine headaches with aura [see WARNINGS AND PRECAUTIONS (5.7)]                ■   Women over age 35 with any migraine headaches [see WARNINGS AND PRECAUTIONS (5.7)]     •    Liver tumors, benign or malignant, or liver disease [see WARNINGS AND PRECAUTIONS (5.2)]     •    Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS (5.8)]     •    Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see WARNINGS AND PRECAUTIONS (5.10)]     •    Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see WARNINGS AND PRECAUTIONS (5.3)] Risk Summary There is no use for contraception in pregnancy, therefore, norgestimate and ethinyl estradiol tablets USP should be discontinued during  pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. Risk Summary Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other forms of contraception until she discontinues breast-feeding. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for norgestimate and ethinyl estradiol tablets USP and any potential adverse effects on the breast-fed child from norgestimate and ethinyl estradiol tablets USP or from the underlying maternal condition. Safety and efficacy of norgestimate and ethinyl estradiol tablets have been established in women of reproductive age. Efficacy is expected to be the same for post  pubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated. There was no significant difference between norgestimate and ethinyl estradiol tablets and placebo in mean change in total lumbar spine (L1 to L4) and total hip bone mineral density between baseline and Cycle 13 in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the Intent To Treat (ITT) population. Norgestimate and ethinyl estradiol tablets have not been studied in postmenopausal women and are not indicated in this population. The pharmacokinetics of norgestimate and ethinyl estradiol tablets has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. [see CONTRAINDICATIONS (4) AND WARNINGS AND PRECAUTIONS (5.2).] The pharmacokinetics of norgestimate and ethinyl estradiol tablets has not been studied in women with renal impairment.

Product samenvatting:

Norgestimate and ethinyl estradiol tablets USP are available in a blister pack (NDC 68180-838-71) containing 28 tablets packed in a pouch (NDC 68180-838-71). Such three pouches are packaged in a carton (NDC 68180-838-73). Each blister (28 tablets) contains in the following order:     •    7 white, round, film coated tablets, debossed with "E25" on one side and "LU" on the other side of the tablet contains 0.18 mg norgestimate and 0.035 mg ethinyl estradiol     •    7 light blue, round, film coated tablets, debossed with "E26" on one side and "LU" on the other side of the tablet contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol     •    7 blue round, film coated tablets, debossed with on "E27" one side and "LU" on the other side of the tablet contains 0.25 mg norgestimate and 0.035 mg ethinyl estradiol     •    7 green, round, biconvex, film coated tablets (non-hormonal placebo) debossed with 'LU' on one side and "E24" on the other side contains inert ingredients     •    Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP controlled room temperature].     •    Protect from light.     •    Keep out of the reach of children.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

NORGESTIMATE AND ETHINYL ESTRADIOL - NORGESTIMATE AND ETHINYL
ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORGESTIMATE AND
ETHINYL ESTRADIOL TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP. NORGESTIMATE AND
ETHINYL
ESTRADIOL TABLETS USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• NORGESTIMATE AND ETHINYL ESTRADIOL TABLET IS CONTRAINDICATED IN
WOMEN OVER 35
YEARS OLD WHO SMOKE. (4)
• CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR
EVENTS FROM
COMBINATION ORAL CONTRACEPTIVES (COC) USE. (4)
RECENT MAJOR CHANGES
Contraindications, Pregnancy (4) Removed 06/2023
INDICATIONS AND USAGE
Norgestimate and ethinyl estradiol tablets USP are combinations of
norgestimate, a progestin, and ethinyl
estradiol, an estrogen, indicated for use by females of reproductive
potential to prevent pregnancy. (1.1)
Norgestimate and ethinyl estradiol tablets USP is indicated for the
treatment of moderate acne vulgaris in
females at least 15 years of age, who have no known contraindications
to oral contraceptive therapy and
have achieved menarche.
Norgestimate and ethinyl estradiol tablets USP should be used for the
treatment of acne only if the
patient desires an oral contraceptive for birth control. (1.2)
DOSAGE AND ADMINISTRATION
• Take one tablet daily by mouth at the same time every day. (2.1)
• Take tablets in the order directed on the blister pack. (2.1)
• Do not skip or delay tablet intake. (2.1)
DOSAGE FORMS AND STRENGTHS
Norgestimate and ethinyl estradiol tablets consist of 28 round,
biconvex, coated tablets in the following
order (3):
• 7 white tablets each containing 0.18 mg norgestimate and 0.035 mg
ethinyl estradiol
• 7 light blue tablets each containing 0.215 mg norgestimate and
0.035 mg ethinyl estra