MILI- 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:

Aurobindo Pharma Limited

INN (International Name):

NORGESTIMATE

Composition:

NORGESTIMATE 0.250 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mili tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Mili is 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: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] Have cerebrovascular disease [see Warnings and Precautions (5.1)] Have coronary artery disease [see  Warnings and Precautions (5.1)] 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)] Have uncontrolled hypertension [see Warnings and Precautions (5.4)] Have diabetes mel

Product summary:

Mili ( norgestimate and ethinyl estradiol tablets USP 0.250 mg/0.035 mg) are available in a blister pack. Each blister pack (28 tablets) contains in the following order: The blister packs are available in the following packages:                 Carton of 1 Blister Pack                                                         NDC 65862-776-28                 Carton of 3 Blister Packs packaged in mono cartons           NDC 65862-776-85                 Carton of 6 Blister Packs packaged in mono cartons           NDC 65862-776-86                 Carton of 1 Pouch                                                                   NDC 65862-776-87                 Carton of 3 Pouches                                                               NDC 65862-776-88                 Carton of 6 Pouches                                                               NDC 65862-776-92  

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MILI- NORGESTIMATE AND ETHINYL ESTRADIOL
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MILI
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MILI.
MILI (NORGESTIMATE AND 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._
MILI 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
Warnings and Precautions (5.11) 11/2021
INDICATIONS AND USAGE
Mili is estrogen/progestin COCs, indicated for use by women to prevent
pregnancy. (1.1)
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
Mili consists of 28 round, biconvex tablets in the following order
(3):
21 dark blue, coated tablets each containing 0.250 mg norgestimate and
0.035 mg ethinyl estradiol
7 green, uncoated tablets (inert)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Current diagnosis of, or history of, breast cancer, which may be
hormone-sensitive (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Thromboembolic Disorders and Other Vascular Problems: Stop Mili if a
thrombotic event occurs. Stop
at least 4 weeks before and through 2 weeks after major surgery. Start
no earlier than 4 weeks after
delivery, in women who are not breastfeeding. (5.1)
Liver disease: Discontinue Mili if jaundice occurs. (5.2)
High blood pressure: If used in women with well-controlled
hypertension, moni