NORGESTIMATE AND ETHINYL ESTRADIOL kit

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Norgestimate (UNII: C291HFX4DY) (Norgestimate - UNII:C291HFX4DY), Ethinyl Estradiol (UNII: 423D2T571U) (Ethinyl Estradiol - UNII:423D2T571U)

Dostupno od:

Proficient Rx LP

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 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 USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 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)]. Do not prescribe Norgestimate and Ethinyl Estradiol Tablets USP to women who are known to have the following conditions: There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-g

Proizvod sažetak:

Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) are available in a blister card (NDC 71205-170-28). Each blister card (28 tablets) contains in the following order: Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) are packaged in a carton containing 6 blister cards: (NDC 71205-170-28).

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL ESTRADIOL
PROFICIENT RX LP
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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._
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RECENT MAJOR CHANGES
Contraindications (4)
09/2017
Warnings and Precautions (5.3)
09/2017
INDICATIONS AND USAGE
Norgestimate and Ethinyl Estradiol Tablets USP are estrogen/progestin
COCs, indicated for use by women to prevent
pregnancy. (1.1)
Norgestimate and Ethinyl Estradiol Tablets USP are also 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
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DOSAGE FORMS AND STRENGTHS
Norgestimate and Ethinyl Estradiol Tablets USP (0.25 mg/0.035 mg)
consist of 28 round tablets in the following order (3):
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Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035 mg,
0.215 mg/0.035 mg and 0.25 mg/0.035 mg) consist of
28 round tablets in the following order (3):
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CONTRAINDICATIONS
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NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP ARE 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)
Take one tablet daily by mouth at the same time every day. (2.2)
Take tablets in the order directed on the blister pack. (2.2)
Do not skip or delay tablet intake. (2.2)
21 dark bl