Aubra®

Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg

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Aubra® is an AB-Rated generic oral contraceptive

Reference Drug: Lutera®

Compares to: Aviane®, Orsythia®, Sronyx® and Falmina ®
  • Launched on October 9, 2013
  • A progestin-estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
    • 21 white to off-white tablets of levonorgestrel and ethinyl estradiol
    • 7 brown non-hormone containing tablets to help ease administration
    • Combined in a 28-day tablet blister pack
Product Gallery
ndc # package size pi order numbers
50102-120-03 Carton Containing
3 Packages

ORDER Aubra®

AmerisourceBergen

1-610-727-7000
www.amerisourcebergen.com
10181189

ANDA

1-800-331-2632 (Ext. 74591)
www.andanet.com
327267

Cardinal

1-800-326-6457
www.cardinal.com
5397765

R&S Northeast

1-800-262-7770
www.rsnortheast.com
0120030

Seacoast Medical LLC

1-877-410-0811
www.seacoastmedical.com/afaxys
500037

Smith Medical Partners LLC

1-800-292-9653
340B 1-877-445-7970 www.smpspecialty.com
5679659

IMPORTANT SAFETY INFORMATION

Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

INDICATIONS AND USAGE

Combination oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

SELECTED SAFETY INFORMATION
WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

CONTRAINDICATIONS

Combination oral contraceptives should not be used in women with any of the following conditions:


  • Thrombophlebitis or thromboembolic disorders
  • A history of deep-vein thrombophlebitis or thromboembolic disorders
  • Cerebrovascular or coronary artery disease (current or past history)
  • Valvular heart disease with thrombogenic complications
  • rombogenic rhythm disorders
  • Hereditary or acquired thrombophilias
  • Major surgery with prolonged immobilization
  • Diabetes with vascular involvement
  • Headaches with focal neurological symptoms
  • Uncontrolled hypertension
  • Known or suspected carcinoma of the breast or personal history of breast cancer
  • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Cholestatic jaundice of pregnancy or jaundice with prior pill use
  • Hepatic adenomas or carcinomas, or active liver disease
  • Known or suspected pregnancy
  • Hypersensitivity to any of the components of levonorgestrel and ethinyl estradiol tablets
  • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
RISKS

The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis. Practitioners prescribing oral contraceptives should be familiar with information relating to these risks.

Risk information described in the full Prescribing Information includes:

  1. Thromboembolic Disorders and Other Vascular Problems
  2. Estimates of Mortality from Contraceptive Use
  3. Carcinoma of the Reproductive Organs and Breasts
  4. Hepatic Neoplasia
  5. Use in women receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
  6. Ocular Lesions
  7. Oral Contraceptive Use Before or During Early Pregnancy
  8. Gallbladder Disease
  9. Carbohydrate and Lipid Metabolic Effects
  10. Elevated Blood Pressure
  11. Headache
  12. Bleeding Irregularities
  13. Ectopic Pregnancy

ADVERSE REACTIONS

The most serious reactions are discussed in detail in the full product labeling and include serious cardiovascular events and smoking, vascular events and liver disease. Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness and headache.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, Aubra (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours.

Reference: Aubra® prescribing information, Charleston SC USA August 2017

Please see full Prescribing Information here.

To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.