LOSEASONIQUE- levonorgestrel/ethinyl estradiol and ethinyl estradiol kit

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Physicians Total Care, Inc.

INN (nume internaţional):

LEVONORGESTREL

Compoziție:

LEVONORGESTREL 0.1 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

LoSeasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. Do not prescribe LoSeasonique 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 Have deep vein thrombosis or pulmonary embolism, now or in the past Have cerebrovascular disease Have coronary artery disease Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) Have hypercoagulopathies Have uncontrolled hypertension Have diabetes with vascular disease Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 - Smoke, if over age 35 - Have deep vein thrombosis or pulmonary embolism, now or in the past - Have cerebrovascular disease - Have coronary artery disease - Have thrombogenic valvular

Rezumat produs:

Lo Seasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) are available in an Extended-Cycle Tablet Dispenser that contains 84 round, orange tablets and 7 round, yellow tablets. Each orange tablet (debossed stylized b on one side and 28 on the other side) contains 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol. Each yellow tablet (debossed stylized b on one side and 556 on the other side) contains 0.01 mg ethinyl estradiol. The tablets should not be removed from the protective blister packaging and outer plastic dispenser to avoid damage to the product. The plastic dispenser should be kept in the foil pouch until dispensed to the patient. Box of 1 Extended-Cycle Tablet Dispensers NDC 54868-6275-0 Storage Store at 20 to 25°C (68 to77°F) [See USP Controlled Room Temperature].

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

LOSEASONIQUE - LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOSEASONIQUE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LOSEASONIQUE.
LOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL TABLETS 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_
WOMEN WHO ARE OVER 35 YEARS OLD AND SMOKE SHOULD NOT USE LOSEASONIQUE.
(4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE.
INDICATIONS AND USAGE
LoSeasonique is an estrogen/progestin COC indicated for use by women
to prevent pregnancy. ( 1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day for 91 days.
(2)
DOSAGE FORMS AND STRENGTHS
LoSeasonique consists of 84 orange tablets containing 0.1 mg
levonorgestrel and 0.02 mg ethinyl estradiol, and 7 yellow
tablets containing 0.01 mg ethinyl estradiol. (3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Liver tumors or liver disease (4)
Pregnancy (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop LoSeasonique if a thrombotic event occurs. Stop
LoSeasonique at least 4 weeks before and
through 2 weeks after major surgery. Start LoSeasonique no earlier
than 4 weeks after delivery, in women who are not
breastfeeding. (5.1)
Liver disease: Discontinue LoSeasonique if jaundice occurs. (5.3)
High blood pressure: Do not prescribe LoSeasonique for women with
uncontrolled hypertension or hypertension with
vascular disease. (5.4)
Carbohydrate and lipid metabolic effects: Monitor prediabetic and
diabetic women taking LoSeasonique. Consider an
alternate contraceptive method for women with uncontrolled
dyslipidemias. (5.6)
Headache: Evaluate s