Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
Norgestimate (UNII: C291HFX4DY) (Norgestimate - UNII:C291HFX4DY), Ethinyl Estradiol (UNII: 423D2T571U) (Ethinyl Estradiol - UNII:423D2T571U)
Akorn
Norgestimate
Norgestimate 0.25 mg
ORAL
PRESCRIPTION DRUG
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: - 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 and Precautions (5.1)] Have deep vein thrombosis or
Norgestimate and Ethinyl Estradiol Tablets USP, (0.25 mg/0.035 mg) Norgestimate and Ethinyl Estradiol Tablets USP, (0.25 mg/0.035 mg) are available in a blister card: (NDC 17478-260-28). Each blister card (28 tablets) contains in the following order: Norgestimate and Ethinyl Estradiol Tablets USP, (0.25 mg/0.035 mg) are packaged in a carton (NDC 17478-260-06) containing 6 blister cards. 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 17478-261-28). 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 17478-261-06).
Abbreviated New Drug Application
NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL ESTRADIOL AKORN ---------- 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 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) 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 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) 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): 21 dark blue tablets each containing 0.25 mg norgestimate and 0.035 mg ethinyl estradiol 7 white tablets (inert) 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 o সম্পূর্ণ নথি পড়ুন