NORGESTIMATE AND ETHINYL ESTRADIOL kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

A-S Medication Solutions

INN (International Name):

NORGESTIMATE

Sammensetning:

NORGESTIMATE 0.25 mg

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg and Norgestimate and Ethinyl Estradiol Tablets, 0.25 mg/0.035 mg are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)]. Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are 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, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg 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: Risk Summary There is no use for contraception in pregnancy, therefore, norgestimate and ethinyl estradiol tablets 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 breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for norgestimate and ethinyl estradiol tablets and any potential adverse effects on the breastfed child from norgestimate and ethinyl estradiol tablets 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, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, and placebo in mean change in total lumbar spine (L1-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 have 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 have not been studied in women with renal impairment.

Produkt oppsummering:

Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg are available in blister packs containing 28 tablets, as follows: NDC 68462-309-29 1 carton containing 3 blister cards of 28 tablets Norgestimate and Ethinyl Estradiol Tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are available in blister packs containing 28 tablets, as follows: NDC 68462-565-29 1 carton containing 3 blister cards of 28 tablets

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL
ESTRADIOL
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORGESTIMATE AND
ETHINYL ESTRADIOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS.
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS, 0.25 MG/0.035 MG, FOR ORAL
USE
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS, 0.18 MG/0.035 MG, 0.215
MG/0.035 MG,
0.25 MG/0.035 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Contraindications, Pregnancy (4) Removed 06/2023
INDICATIONS AND USAGE
Norgestimate and ethinyl estradiol tablets 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 0.18 mg/0.035 mg, 0.215
mg/0.035 mg, 0.25 mg/0.035 mg are
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 0.18 mg/0.035 mg, 0.215
mg/0.035 mg, 0.25 mg/0.035 mg
should be used for the treatment of acne only if the patient desires
an oral contraceptive for birth control.
(1.2)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg,
consist of 28 round, flat faced beveled
edged, uncoated tablets in the following order (3):
•
•
Norgestimate and Ethinyl Estradiol Tablets, USP 0.18 mg/0.035 mg,
0.215 mg/0.035 mg, 0.25 mg/0.035
mg, consist of 28 round, flat faced beveled edged, uncoated tablets in
the following order (3):
•
•
•
•
CONTRAINDICATIONS
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS ARE CONTRAINDICATED IN
WOMEN OVER 35
YE