INTROVALE- levonorgestrel and ethinyl estradiol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Available from:

Sandoz Inc

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.15 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

IntrovaleTM (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Do not prescribe IntrovaleTM (levonorgestrel and ethinyl estradiol tablets) 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 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 rythym diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)] Have

Product summary:

Introvale TM tablets (levonorgestrel and ethinyl estradiol, USP) are available in extended-cycle blister cards (NDC 0781-5584-36) , each containing a 13-week supply of tablets: 84 peach active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 white inert tablets packaged in a unit carton. 3 such unit cartons will be packaged in a Tri-Pack carton (NDC 0781-5584-36 ). The active tablets are peach, round, film-coated, debossed “SZ ”on one side and “J4 ”on the other side. The inert tablets are white, round, film-coated, debossed with “SZ ” on one side and “J1 ” on the other side.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

INTROVALE- LEVONORGESTREL AND ETHINYL ESTRADIOL
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INTROVALE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR INTROVALE
.
INTROVALE (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS) FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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•
INDICATIONS AND USAGE
Introvale
is an estrogen/progestin COC indicated for use by women to prevent
pregnancy. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Introvale
(levonorgestrel and ethinyl estradiol tablets, USP) consists of 84
round, peach tablets containing 0.15 mg of
levonorgestrel and 0.03 mg of ethinyl estradiol, and 7 round, white
inert tablets. (3)
CONTRAINDICATIONS
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)
Use of Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to
the
potential for ALT elevations (4)
WARNINGS AND PRECAUTIONS
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•
•
•
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ADVERSE REACTIONS
THE MOST COMMON ADVERSE REACTIONS (≥2%) REPORTED DURING CLINICAL
TRIALS WERE HEADACHE, MENORRHAGIA,
NAUSEA, DYSMENORRHEA, ACNE, MIGRAINE, BREAST TENDERNESS, WEIGHT
INCREASED, AND DEPRESSION. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC., AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Drugs or herbal products that induce certain enzymes (for example
CYP3A4) may decrease the effectiveness of COCs or
TM
TM
TM
INTRO VALE
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS) IS CONTRAINDICATED IN
WOMEN OVER 35 YEARS
OLD WHO SMOKE. (4)
T M
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE. (4)
TM
Take on