SPRINTEC- norgestimate and ethinyl estradiol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

NORGESTIMATE

Composition:

NORGESTIMATE 0.25 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies(14)]. Do not prescribe Sprintec 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-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion. Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur

Product summary:

Sprintec® (norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of six blister cards. Each card contains 21 blue tablets and 7 white tablets containing inert ingredients. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol which are round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 987 on the other side. Each white tablet contains inert ingredients and are round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 143 on the other side. NDC: 63187-911-28 Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SPRINTEC- 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
SPRINTEC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SPRINTEC.
SPRINTEC (NORGESTIMATE/ETHINYL ESTRADIOL) TABLETS, 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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INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Sprintec (norgestimate and ethinyl estradiol tablets USP) consists of
28 round, flat-faced, beveled-edge,
unscored tablets in the following order (3):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions reported during clinical trials
(≥2%) were: headache/migraine,
abdominal/gastrointestinal pain, vaginal infection, genital discharge,
breast issues (including breast pain,
discharge, and enlargement), mood disorders (including depression and
mood altered), flatulence,
®
SPRINTEC 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)
Sprintec
(norgestimate and ethinyl estradiol tablets) is an estrogen/progestin
COC, indicated for use
by women to prevent pregnancy. (1.1)
®
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 blue tablets each containing 0.250 mg norgestimate and 0.035 mg
ethinyl estradiol
7 white tablets (inert)
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Breast cancer or other estrogen-or progestin-sensitive cancer (4)
Thromboembolic Disorders and Other Vascular Problems: Stop Sprintec if
a throm