Lojaimiess Prescribing Information
LoJaimiess is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (
LoJaimiess is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
LoJaimiessis indicated for use by females of reproductive potential to prevent pregnancy.
| Take the missed tablet as soon as possible. Take the next tablet at the regular time. Continue taking one tablet a day until the pack is finished. A back-up birth control method is not required if the patient has sex. |
If two white to off-white tablets in a row are missed | Take the two missed tablets as soon as possible, and the next two tablets the next day. Continue taking one tablet a day until the pack is finished. Use additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets. |
If three or more white to off-white tablets in a row are missed |
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If any of the seven light peach tablets are missed |
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LoJaimiess consists of 84 white to off-white tablets containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, and 7 light peach tablets containing 0.01 mg ethinyl estradiol. (
LoJaimiess consists of 84 white to off-white tablets containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, and 7 light peach tablets containing 0.01 mg ethinyl estradiol.
LoJaimiess (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is available in Extended-Cycle Tablet Blister Pack, each containing a 13-week supply of tablets: 84 white to off-white tablets, each containing 0.1 mg of levonorgestrel and 0.02 mg ethinyl estradiol, and 7 light peach tablets each containing 0.01 mg of ethinyl estradiol. The white to off-white tablets are round, biconvex tablets with
The pharmacokinetics of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have not been studied in subjects with hepatic impairment. However, COCs may be poorly metabolized in patients with hepatic impairment. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females with acute hepatitis or severe decompensated cirrhosis
A high risk of arterial or venous thrombotic diseases
Undiagnosed abnormal uterine bleeding
Breast cancer
Liver tumors or liver disease, acute viral hepatitis or decompensated cirrhosis
Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir,
LoJaimiess 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 females who are known to:
o Smoke, if over age 35[see Boxed Warningand Warnings and Precautions (5.1)]o Have current or history of deep vein thrombosis or pulmonary embolism[see Warnings and Precautions (5.1)]o Have cerebrovascular disease[see Warnings and Precautions (5.1)]o Have coronary artery disease[see Warnings and Precautions (5.1)]o 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)]o Have inherited or acquired hypercoagulopathies[see Warnings and Precautions (5.1)]o Have uncontrolled hypertension or hypertension with vascular disease[see Warnings and Precautions (5.5)]o Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration[see Warnings and Precautions (5.7)]o Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches[see Warnings and Precautions (5.8)]
Current diagnosis of, or history of, breast cancer, which may be hormone sensitive
[see Warnings and Precautions (5.11)]Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis
[see Warnings and Precautions (5.2)]Undiagnosed abnormal uterine bleeding
[see Warnings and Precautions (5.8)]Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
[see Warnings and Precautions (5.4)].
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females with acute viral hepatitis or severe (decompensated) cirrhosis of the liver
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females with benign or malignant liver tumors
Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. The attributable risk of liver cancers in COC users is less than one case per million users.
A high risk of arterial or venous thrombotic diseases (
)4 CONTRAINDICATIONSA high risk of arterial or venous thrombotic diseases
Undiagnosed abnormal uterine bleeding
Breast cancer
Liver tumors or liver disease, acute viral hepatitis or decompensated cirrhosis
Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir,
LoJaimiess 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 females who are known to:
o Smoke, if over age 35[see Boxed Warningand Warnings and Precautions (5.1)]o Have current or history of deep vein thrombosis or pulmonary embolism[see Warnings and Precautions (5.1)]o Have cerebrovascular disease[see Warnings and Precautions (5.1)]o Have coronary artery disease[see Warnings and Precautions (5.1)]o 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)]o Have inherited or acquired hypercoagulopathies[see Warnings and Precautions (5.1)]o Have uncontrolled hypertension or hypertension with vascular disease[see Warnings and Precautions (5.5)]o Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration[see Warnings and Precautions (5.7)]o Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches[see Warnings and Precautions (5.8)]
Current diagnosis of, or history of, breast cancer, which may be hormone sensitive
[see Warnings and Precautions (5.11)]Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis
[see Warnings and Precautions (5.2)]Undiagnosed abnormal uterine bleeding
[see Warnings and Precautions (5.8)]Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
[see Warnings and Precautions (5.4)].
Undiagnosed abnormal uterine bleeding (
)4 CONTRAINDICATIONSA high risk of arterial or venous thrombotic diseases
Undiagnosed abnormal uterine bleeding
Breast cancer
Liver tumors or liver disease, acute viral hepatitis or decompensated cirrhosis
Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir,
LoJaimiess 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 females who are known to:
o Smoke, if over age 35[see Boxed Warningand Warnings and Precautions (5.1)]o Have current or history of deep vein thrombosis or pulmonary embolism[see Warnings and Precautions (5.1)]o Have cerebrovascular disease[see Warnings and Precautions (5.1)]o Have coronary artery disease[see Warnings and Precautions (5.1)]o 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)]o Have inherited or acquired hypercoagulopathies[see Warnings and Precautions (5.1)]o Have uncontrolled hypertension or hypertension with vascular disease[see Warnings and Precautions (5.5)]o Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration[see Warnings and Precautions (5.7)]o Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches[see Warnings and Precautions (5.8)]
Current diagnosis of, or history of, breast cancer, which may be hormone sensitive
[see Warnings and Precautions (5.11)]Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis
[see Warnings and Precautions (5.2)]Undiagnosed abnormal uterine bleeding
[see Warnings and Precautions (5.8)]Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
[see Warnings and Precautions (5.4)].
Breast cancer (
)4 CONTRAINDICATIONSA high risk of arterial or venous thrombotic diseases
Undiagnosed abnormal uterine bleeding
Breast cancer
Liver tumors or liver disease, acute viral hepatitis or decompensated cirrhosis
Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir,
LoJaimiess 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 females who are known to:
o Smoke, if over age 35[see Boxed Warningand Warnings and Precautions (5.1)]o Have current or history of deep vein thrombosis or pulmonary embolism[see Warnings and Precautions (5.1)]o Have cerebrovascular disease[see Warnings and Precautions (5.1)]o Have coronary artery disease[see Warnings and Precautions (5.1)]o 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)]o Have inherited or acquired hypercoagulopathies[see Warnings and Precautions (5.1)]o Have uncontrolled hypertension or hypertension with vascular disease[see Warnings and Precautions (5.5)]o Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration[see Warnings and Precautions (5.7)]o Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches[see Warnings and Precautions (5.8)]
Current diagnosis of, or history of, breast cancer, which may be hormone sensitive
[see Warnings and Precautions (5.11)]Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis
[see Warnings and Precautions (5.2)]Undiagnosed abnormal uterine bleeding
[see Warnings and Precautions (5.8)]Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
[see Warnings and Precautions (5.4)].
Liver tumors or liver disease, acute viral hepatitis or decompensated cirrhosis (
)4 CONTRAINDICATIONSA high risk of arterial or venous thrombotic diseases
Undiagnosed abnormal uterine bleeding
Breast cancer
Liver tumors or liver disease, acute viral hepatitis or decompensated cirrhosis
Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir,
LoJaimiess 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 females who are known to:
o Smoke, if over age 35[see Boxed Warningand Warnings and Precautions (5.1)]o Have current or history of deep vein thrombosis or pulmonary embolism[see Warnings and Precautions (5.1)]o Have cerebrovascular disease[see Warnings and Precautions (5.1)]o Have coronary artery disease[see Warnings and Precautions (5.1)]o 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)]o Have inherited or acquired hypercoagulopathies[see Warnings and Precautions (5.1)]o Have uncontrolled hypertension or hypertension with vascular disease[see Warnings and Precautions (5.5)]o Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration[see Warnings and Precautions (5.7)]o Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches[see Warnings and Precautions (5.8)]
Current diagnosis of, or history of, breast cancer, which may be hormone sensitive
[see Warnings and Precautions (5.11)]Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis
[see Warnings and Precautions (5.2)]Undiagnosed abnormal uterine bleeding
[see Warnings and Precautions (5.8)]Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
[see Warnings and Precautions (5.4)].
Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, (
)4 CONTRAINDICATIONSA high risk of arterial or venous thrombotic diseases
Undiagnosed abnormal uterine bleeding
Breast cancer
Liver tumors or liver disease, acute viral hepatitis or decompensated cirrhosis
Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir,
LoJaimiess 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 females who are known to:
o Smoke, if over age 35[see Boxed Warningand Warnings and Precautions (5.1)]o Have current or history of deep vein thrombosis or pulmonary embolism[see Warnings and Precautions (5.1)]o Have cerebrovascular disease[see Warnings and Precautions (5.1)]o Have coronary artery disease[see Warnings and Precautions (5.1)]o 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)]o Have inherited or acquired hypercoagulopathies[see Warnings and Precautions (5.1)]o Have uncontrolled hypertension or hypertension with vascular disease[see Warnings and Precautions (5.5)]o Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration[see Warnings and Precautions (5.7)]o Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches[see Warnings and Precautions (5.8)]
Current diagnosis of, or history of, breast cancer, which may be hormone sensitive
[see Warnings and Precautions (5.11)]Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis
[see Warnings and Precautions (5.2)]Undiagnosed abnormal uterine bleeding
[see Warnings and Precautions (5.8)]Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
[see Warnings and Precautions (5.4)].