AMETHIA LO- levonorgestrel/ethinyl estradiol and ethinyl estradiol kit

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:

Mayne Pharma Inc.

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.1 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AMETHIATM Lo (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. Do not prescribe AMETHIA Lo 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 o

Product summary:

AMETHIA Lo (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 2 Extended-Cycle Tablet Dispensers NDC 51862-045-91 Storage Store at 20 to 25°C (68 to77°F) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

AMETHIA LO- LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
MAYNE PHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMETHIA LO TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR AMETHIA LO.
AMETHIA LO (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 AMETHIA LO.
(4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE.
RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions (5.4 ) 08/2017
INDICATIONS AND USAGE
AMETHIA Lo 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
AMETHIA Lo 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)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with or without
dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop AMETHIA Lo if a thrombotic event occurs. Stop
AMETHIA Lo at least 4 weeks before and through
2 weeks after major surgery. Start AMETHIA Lo no earlier than 4 weeks
after delivery, in women who are not
breastfeeding. (5.1)
Liver disease: Discontinue AMETHIA Lo if jaundice occurs. (5.3)
High blood pressure: Do not prescribe AMETHIA Lo for women with
uncontrolled hypertension or hypertension with
vascular disease. (5.5)
Carbohydrate and lipid metabo