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 combination 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
- 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:
- Thromboembolic Disorders and Other Vascular Problems
-
Estimates of Mortality from Contraceptive Use
-
Carcinoma of the Reproductive Organs and Breasts
-
Hepatic Neoplasia
-
Use in women receiving Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential
for ALT elevations
-
Ocular Lesions
-
Oral Contraceptive Use Before or During Early Pregnancy
-
Gallbladder Disease
-
Carbohydrate and Lipid Metabolic Effects
-
Elevated Blood Pressure
-
Headache
-
Bleeding Irregularities
- 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.
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:
- Thromboembolic Disorders and Other Vascular Problems
- Estimates of Mortality from Contraceptive Use
- Carcinoma of the Reproductive Organs and Breasts
- Hepatic Neoplasia
- Use in women receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir,
with or without dasabuvir, due to the potential for ALT elevations
- Ocular Lesions
- Oral Contraceptive Use Before or During Early Pregnancy
- Gallbladder Disease
- Carbohydrate and Lipid Metabolic Effects
- Elevated Blood Pressure
- Headache
- Bleeding Irregularities
- 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.