INTROVALE- levonorgestrel and ethinyl estradiol kit

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Xiromed, LLC.

INN (Nome Internazionale):

LEVONORGESTREL

Composizione:

LEVONORGESTREL 0.15 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Introvale®  (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Introvale 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 d

Dettagli prodotto:

Introvale tablets (levonorgestrel and ethinyl estradiol, USP) are available in extended-cycle blister cards (NDC 70700-117-87 ) , 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. 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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

INTROVALE- LEVONORGESTREL AND ETHINYL ESTRADIOL
XIROMED, LLC.
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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, USP
0.15 MG/0.03 MG
FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INTROVALE (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS) IS
CONTRAINDICATED IN WOMEN
OVER 35 YEARS OLD WHO SMOKE. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Warnings and Precautions, Malignant Neoplasms (5.11) 04/2022
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
•
•
•
•
•
•
ADVERSE REACTIONS
®
Take one tablet daily by mouth at the same time every day for 91 days.
(2.1)
Take tablets in the order directed on the Extended-Cycle Blister
Cards. (2.2)
_THROMBOTIC DISORDERS AND OTHER VASCULAR PROBLEMS:_ Stop
levonorgestrel and ethinyl estradiol 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 del