Interactions between Bupropion and Junel 1.5/30

The norethindrone in Junel 1.5/30 has a major potential interaction with Abnormal Uterine Bleeding.

The use of contraceptives is contraindicated when there is an undiagnosed abnormal genital bleeding. Adequate diagnostic measures should be undertaken to rule out the presence of any malignancy.

The ethinyl estradiol in Junel 1.5/30 has a major potential interaction with Abnormal Uterine Bleeding.

The use of estrogens is contraindicated in patients with undiagnosed, abnormal vaginal bleeding. Prolonged (greater than 1 year), unopposed estrogen use (i.e. estrogen without concomitant progestin therapy) has been associated with a significant, dose-related risk of endometrial carcinoma. The risk may be offset substantially by the addition of a progestin but may not be completely abolished. Prior to initiating estrogen therapy, appropriate diagnostic tests should be performed in patients with abnormal vaginal bleeding to rule out endometrial malignancy. The same applies if recurrent or persistent bleeding develops during estrogen therapy.

buPROPion has a major potential interaction with Alcoholism.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

The ethinyl estradiol in Junel 1.5/30 has a moderate potential interaction with Angioedema.

The use of exogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with hereditary angioedema. Consider the risk versus benefits of estrogen therapy. Close monitoring is recommended when prescribing these agents to patients predisposed to angioedema.

buPROPion has a major potential interaction with Anorexia Nervosa.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

The ethinyl estradiol and norethindrone in Junel 1.5/30 both have a moderate potential interaction with Asthma.

Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.

buPROPion has a major potential interaction with Bipolar Disorder.

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials; these trials did not show increased risk in patients older than 24 years and risk was reduced in patients 65 years and older. Adult and pediatric patients with major depressive disorder may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressants; this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders; such disorders are the strongest predictors of suicide. Patients of all ages treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of drug therapy, and at times of dose changes. Family members/caregivers should be advised to monitor for changes in behavior and to notify the health care provider. Changing the therapeutic regimen (including discontinuing the medication) should be considered in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

buPROPion has a moderate potential interaction with Bipolar Disorder.

Bupropion is not approved for the treatment of bipolar depression. Antidepressant therapy can trigger a manic, mixed, or hypomanic episode; the risk appears increased in patients with bipolar disorder or with risk factors for bipolar disorder. Before starting bupropion, patients should be screened for history of bipolar disorder and risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). Depressed patients treated with bupropion have had various neuropsychiatric signs/symptoms, including delusions, hallucinations, psychosis, concentration disturbance, confusion, and paranoia; some of these patients had a diagnosis of bipolar disorder. In some cases, these symptoms abated with dose reduction and/or discontinuation of therapy. Bupropion should be discontinued if such reactions occur.

buPROPion has a major potential interaction with Brain Tumor.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

The norethindrone in Junel 1.5/30 has a major potential interaction with Breast Cancer.

The use of progestogens is considered by manufacturers to be contraindicated in patients with existing or suspected malignancy of the breast. Some supportive data are available for medroxyprogesterone. Specifically, medroxyprogesterone treatment may be associated with breast cancer, primarily when the drug is administered intramuscularly. A pooled analysis of two case-control studies, one from the World Health Organization and the other from New Zealand, revealed a small overall relative risk of breast cancer in women who have ever used intramuscular medroxyprogesterone acetate. The relative risk was higher in the subgroup of women who had initiated therapy within the previous 5 years. Thus, an increased risk (approximately 2-fold) is associated with intramuscular medroxyprogesterone use in the first 5 years. A more recent U.S. study also found a statistically significant increase in breast cancer risk among recent users (defined as last use within the past five years) who used depo-medroxyprogesterone acetate for 12 months or longer.

The ethinyl estradiol in Junel 1.5/30 has a major potential interaction with Breast Cancer.

When treated with an estrogen, patients with breast cancer and bone metastases may develop severe hypercalcemia, in which case the drug should be stopped and measures be taken to reduce serum calcium levels.

buPROPion has a major potential interaction with Bulimia.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

The norethindrone in Junel 1.5/30 has a major potential interaction with Cerebral Vascular Disorder.

The use of progestogens, in general, is considered by manufacturers to be contraindicated in patients with active thrombophlebitis, cerebrovascular disease, or a current or past history of thromboembolic disorders. While the role of progestogens in the development of thromboembolic events associated with hormonal therapy is often unclear and thought to be secondary to that of estrogens, it may not be insignificant. Medroxyprogesterone, a common progestational agent, has been shown to produce a hypercoagulable state in high dosages. Whether or not this effect contributes to the development of thrombotic events is unknown. However, thrombophlebitis and pulmonary embolism have been reported with megestrol, an antineoplastic and progestational agent. In addition, an increased risk of nonfatal venous thrombosis has been associated with oral contraceptive combinations containing desogestrel or gestodene relative to those that contain other progestins (e.g., levonorgestrel, norethindrone), suggesting some degree of hemostatic effect by progestogens.

The ethinyl estradiol in Junel 1.5/30 has a major potential interaction with Cerebral Vascular Disorder.

The use of estrogens is considered by manufacturers and some authorities to be contraindicated in patients with active thrombotic, thromboembolic, or thrombophilic disorders. The use of estrogen-containing oral contraceptives is additionally deemed contraindicated in patients with a history of such disorders and/or current cerebrovascular or coronary artery disease. Females with a history of migraines with aura are at an increased risk for stroke and this stroke risk may be further increased in females who have migraines with aura with use of combination oral contraceptives. Hypercoagulability and changes in various clotting factors and blood components have been observed in women receiving estrogen therapy. Known preexisting risk factors for increased thromboembolic or cardiovascular events include smoking, especially over age of 35; hypertension; hyperlipidemia; obesity; diabetes; age over 40; and lupus. Therapy with estrogens should be administered cautiously in the lowest effective dosage and only after careful consideration of risks and benefits. Estrogens should be avoided in patients with a history of thrombotic and thromboembolic disorders associated with estrogen use, except when used in the treatment of metastatic breast or prostatic malignancy.

buPROPion has a major potential interaction with CNS Infection.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

buPROPion has a major potential interaction with Depression.

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials; these trials did not show increased risk in patients older than 24 years and risk was reduced in patients 65 years and older. Adult and pediatric patients with major depressive disorder may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressants; this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders; such disorders are the strongest predictors of suicide. Patients of all ages treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of drug therapy, and at times of dose changes. Family members/caregivers should be advised to monitor for changes in behavior and to notify the health care provider. Changing the therapeutic regimen (including discontinuing the medication) should be considered in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

The ethinyl estradiol and norethindrone in Junel 1.5/30 both have a moderate potential interaction with Depression.

The use of oral contraceptives has been associated with an increased incidence of depression. It is uncertain whether this effect is related to the estrogenic or the progestogenic component of the contraceptive, although excess progesterone activity is associated with depression. Patients with a history of depression receiving estrogen and/or progestogen therapy should be followed closely. The manufacturer of medroxyprogesterone recommends monitoring patients who have a history of depression and to not re- administer medroxyprogesterone if depression recurs.

buPROPion has a major potential interaction with Diabetes Mellitus.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

The ethinyl estradiol and norethindrone in Junel 1.5/30 both have a moderate potential interaction with Diabetes Mellitus.

Impaired glucose tolerance has been observed in some patients administered oral contraceptives and appears to be related primarily to the estrogen dose. However, progestogens can increase insulin secretion and produce insulin resistance to varying degrees, depending on the agent. Caution and close monitoring are recommended in patients with diabetes mellitus during therapy with estrogens and/or progestogens, and adjustments made accordingly in their antidiabetic regimen.

buPROPion has a major potential interaction with Drug Dependence.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

The ethinyl estradiol and norethindrone in Junel 1.5/30 both have a moderate potential interaction with Fluid Retention.

Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.

The ethinyl estradiol in Junel 1.5/30 has a moderate potential interaction with Gallbladder Disease.

A two- to four-fold increase in risk of gallbladder disease has been noted in women receiving postmenopausal estrogen therapy. The risk for gallbladder disease may be less for premenopausal women using oral contraceptives containing low-dose estrogens and/or progestins. Therapy with estrogens should be administered cautiously in patients with preexisting gallbladder disease or a history of pregnancy-related cholestasis.

buPROPion has a moderate potential interaction with Glaucoma, Narrow Angle.

The pupillary dilation that occurs after use of many antidepressant drugs (including bupropion) can induce increased intraocular pressure and result in angle-closure (narrow-angle) glaucoma in a patient with anatomically narrow angles who does not have a patent iridectomy. Patients may want to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible. The use of antidepressants (including bupropion-dextromethorphan) should be avoided in patients with untreated anatomically narrow angles.

buPROPion has a major potential interaction with Head Injury.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

The ethinyl estradiol and norethindrone in Junel 1.5/30 both have a moderate potential interaction with Heart Failure.

Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.

The ethinyl estradiol and norethindrone in Junel 1.5/30 both have a major potential interaction with Hepatic Tumor.

The use of oral contraceptives is contraindicated in patients with liver tumors. An increased risk of benign hepatic adenomas and hepatocellular carcinomas has been associated with long-term, oral estrogen- progestin contraceptive use of at least 4 years and 8 years, respectively. Although these tumors are rare and have not been reported with other types of estrogen or progestogen therapies, any preparation containing estrogens and/or progestogens should probably be avoided in patients with existing tumors of the liver. Hepatic hemangiomas and nodular hyperplasia of the liver have been reported with isolated estrogen therapy.

The ethinyl estradiol in Junel 1.5/30 has a major potential interaction with High Blood Pressure.

The risk of myocardial infarction and strokes, including those associated with oral contraceptive use and some estrogen use, is increased in patients with hypertension. Moreover, estrogens (and progestogens) may elevate blood pressure and worsen the hypertension, thus compounding the risk. Clinically significant blood pressure increases have been reported during estrogen therapy, particularly in patients receiving high dosages or treated with oral contraceptive combinations having high progestational activity. These effects also increase with duration of therapy and patient age. Therapy with estrogens should be administered cautiously in patients with preexisting hypertension. Some estrogen-based therapies, such as combined hormonal contraceptives, may be contraindicated in patients with uncontrolled hypertension or hypertension with vascular disease. Patients should be monitored for changes in cardiovascular status, and their antihypertensive regimen adjusted or estrogen therapy withdrawn as necessary. In patients requiring contraception, alternative methods should be considered for those who are hypertensive, over age 35, and smoke.

The norethindrone in Junel 1.5/30 has a moderate potential interaction with High Blood Pressure.

Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.

The ethinyl estradiol in Junel 1.5/30 has a moderate potential interaction with High Cholesterol.

Estrogens may cause adverse lipid changes. Use of estrogens has been associated with elevations in triglyceride levels, particularly in women with pre-existing hypertriglyceridemia. Discontinue therapy if elevated triglycerides lead to pancreatitis. Manage hypercholesterolemia appropriately as indicated.

The norethindrone in Junel 1.5/30 has a moderate potential interaction with High Cholesterol.

Some progestogenic agents may elevate plasma LDL levels and/or lower HDL levels, although data have been inconsistent. Patients with preexisting hyperlipidemia may require closer monitoring during progestogen therapy, and adjustments made accordingly in their lipid-lowering regimen.

The ethinyl estradiol in Junel 1.5/30 has a major potential interaction with History, Thrombotic/Thromboembolic Disorder.

The use of estrogens is considered by manufacturers and some authorities to be contraindicated in patients with active thrombotic, thromboembolic, or thrombophilic disorders. The use of estrogen-containing oral contraceptives is additionally deemed contraindicated in patients with a history of such disorders and/or current cerebrovascular or coronary artery disease. Females with a history of migraines with aura are at an increased risk for stroke and this stroke risk may be further increased in females who have migraines with aura with use of combination oral contraceptives. Hypercoagulability and changes in various clotting factors and blood components have been observed in women receiving estrogen therapy. Known preexisting risk factors for increased thromboembolic or cardiovascular events include smoking, especially over age of 35; hypertension; hyperlipidemia; obesity; diabetes; age over 40; and lupus. Therapy with estrogens should be administered cautiously in the lowest effective dosage and only after careful consideration of risks and benefits. Estrogens should be avoided in patients with a history of thrombotic and thromboembolic disorders associated with estrogen use, except when used in the treatment of metastatic breast or prostatic malignancy.

The norethindrone in Junel 1.5/30 has a major potential interaction with History, Thrombotic/Thromboembolic Disorder.

The use of progestogens, in general, is considered by manufacturers to be contraindicated in patients with active thrombophlebitis, cerebrovascular disease, or a current or past history of thromboembolic disorders. While the role of progestogens in the development of thromboembolic events associated with hormonal therapy is often unclear and thought to be secondary to that of estrogens, it may not be insignificant. Medroxyprogesterone, a common progestational agent, has been shown to produce a hypercoagulable state in high dosages. Whether or not this effect contributes to the development of thrombotic events is unknown. However, thrombophlebitis and pulmonary embolism have been reported with megestrol, an antineoplastic and progestational agent. In addition, an increased risk of nonfatal venous thrombosis has been associated with oral contraceptive combinations containing desogestrel or gestodene relative to those that contain other progestins (e.g., levonorgestrel, norethindrone), suggesting some degree of hemostatic effect by progestogens.

buPROPion has a major potential interaction with Hypoglycemia.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

buPROPion has a major potential interaction with Hyponatremia.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

The ethinyl estradiol in Junel 1.5/30 has a major potential interaction with Ischemic Heart Disease.

The use of estrogens is considered by manufacturers and some authorities to be contraindicated in patients with active thrombotic, thromboembolic, or thrombophilic disorders. The use of estrogen-containing oral contraceptives is additionally deemed contraindicated in patients with a history of such disorders and/or current cerebrovascular or coronary artery disease. Females with a history of migraines with aura are at an increased risk for stroke and this stroke risk may be further increased in females who have migraines with aura with use of combination oral contraceptives. Hypercoagulability and changes in various clotting factors and blood components have been observed in women receiving estrogen therapy. Known preexisting risk factors for increased thromboembolic or cardiovascular events include smoking, especially over age of 35; hypertension; hyperlipidemia; obesity; diabetes; age over 40; and lupus. Therapy with estrogens should be administered cautiously in the lowest effective dosage and only after careful consideration of risks and benefits. Estrogens should be avoided in patients with a history of thrombotic and thromboembolic disorders associated with estrogen use, except when used in the treatment of metastatic breast or prostatic malignancy.

buPROPion has a major potential interaction with Liver Disease.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

The norethindrone in Junel 1.5/30 has a major potential interaction with Liver Disease.

The use of progestogens, in general, is contraindicated in patients with impaired hepatic function or liver disease. There are little or no data concerning the pharmacokinetic disposition of the different progestogens in patients with hepatic disease. However, most hormones, including progestational hormones, are known to be extensively metabolized by the liver. Medroxyprogesterone should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur.

buPROPion has a moderate potential interaction with Liver Disease.

Bupropion is primarily metabolized by the liver. The systemic exposure and half-life of bupropion and its metabolites may be increased in patients with liver dysfunction. A reduced dose and/or dosing frequency should be considered in patients with mild liver dysfunction (Child-Pugh score: 5 to 6). A dosage reduction is required in patients with moderate to severe liver dysfunction (Child-Pugh score: 7 to 15) who are using a single-ingredient bupropion product; the dosage should not exceed 75 mg/day with immediate-release bupropion hydrochloride (HCl), 100 mg/day or 150 mg every other day with sustained-release bupropion HCl, 150 mg every other day with extended-release bupropion HCl, and 174 mg every other day with extended-release bupropion hydrobromide. Bupropion-dextromethorphan is not recommended for patients with severe liver dysfunction (Child-Pugh C), and no dose adjustment of bupropion-dextromethorphan is recommended in patients with mild or moderate liver dysfunction (Child-Pugh A or B).

The ethinyl estradiol in Junel 1.5/30 has a moderate potential interaction with Liver Disease.

Estrogens are primarily metabolized by the liver. Use of estrogen therapy is contraindicated in patients with liver dysfunction or disease. Patients with impaired hepatic function may be at increased risk for adverse effects associated with estrogen administration due to decreased drug clearance. Patients with hepatic hemangiomas are at increased risk of exacerbation with use of estrogens. Therapy with estrogens should be administered cautiously in patients with cholestatic jaundice associated with past estrogen use or with pregnancy. In addition, clinicians should be aware that estrogen therapy may affect liver function tests.

buPROPion has a minor potential interaction with Malnourishment.

The use of bupropion is associated with weight alterations. Both weight gain and weight loss may occur, although the latter is much more common. Weight loss greater than 2.27 kg was reported in up to 28% of patients, which may be undesirable in patients suffering from anorexia, malnutrition, or excessive weight loss. Weight change should be monitored during therapy if bupropion is used in these patients.

buPROPion has a moderate potential interaction with Mania.

Bupropion is not approved for the treatment of bipolar depression. Antidepressant therapy can trigger a manic, mixed, or hypomanic episode; the risk appears increased in patients with bipolar disorder or with risk factors for bipolar disorder. Before starting bupropion, patients should be screened for history of bipolar disorder and risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). Depressed patients treated with bupropion have had various neuropsychiatric signs/symptoms, including delusions, hallucinations, psychosis, concentration disturbance, confusion, and paranoia; some of these patients had a diagnosis of bipolar disorder. In some cases, these symptoms abated with dose reduction and/or discontinuation of therapy. Bupropion should be discontinued if such reactions occur.

The ethinyl estradiol in Junel 1.5/30 has a moderate potential interaction with Melasma.

The use of exogenous estrogens may occasionally cause chloasma, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking combination oral contraceptives.

The ethinyl estradiol in Junel 1.5/30 has a major potential interaction with Migraine.

The use of estrogens is considered by manufacturers and some authorities to be contraindicated in patients with active thrombotic, thromboembolic, or thrombophilic disorders. The use of estrogen-containing oral contraceptives is additionally deemed contraindicated in patients with a history of such disorders and/or current cerebrovascular or coronary artery disease. Females with a history of migraines with aura are at an increased risk for stroke and this stroke risk may be further increased in females who have migraines with aura with use of combination oral contraceptives. Hypercoagulability and changes in various clotting factors and blood components have been observed in women receiving estrogen therapy. Known preexisting risk factors for increased thromboembolic or cardiovascular events include smoking, especially over age of 35; hypertension; hyperlipidemia; obesity; diabetes; age over 40; and lupus. Therapy with estrogens should be administered cautiously in the lowest effective dosage and only after careful consideration of risks and benefits. Estrogens should be avoided in patients with a history of thrombotic and thromboembolic disorders associated with estrogen use, except when used in the treatment of metastatic breast or prostatic malignancy.

The ethinyl estradiol and norethindrone in Junel 1.5/30 both have a moderate potential interaction with Migraine.

Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.

The ethinyl estradiol in Junel 1.5/30 has a major potential interaction with Neoplasia, Estrogen Dependent.

The use of estrogens is generally contraindicated in patients with known or suspected estrogen-dependent neoplasia such as breast and endometrial cancer, since it may stimulate tumor proliferation. High dosages of estrogens may be used for the palliative treatment of inoperable, metastatic breast cancer, but only in appropriately selected men and postmenopausal women.

The ethinyl estradiol in Junel 1.5/30 has a moderate potential interaction with Pancreatitis.

Estrogens may cause adverse lipid changes. Use of estrogens has been associated with elevations in triglyceride levels, particularly in women with pre-existing hypertriglyceridemia. Discontinue therapy if elevated triglycerides lead to pancreatitis. Manage hypercholesterolemia appropriately as indicated.

buPROPion has a moderate potential interaction with Renal Dysfunction.

Bupropion and its metabolites, some of which are pharmacologically active with one-fifth to one-half the potency of the parent drug, are cleared renally and may accumulate in patients with renal dysfunction (GFR less than 90 mL/min) to a greater extent than usual. Therefore, bupropion should be used with caution in patients with renal dysfunction. A reduced dose and/or dosing frequency should be considered, and patients should be closely monitored for adverse effects that could indicate high bupropion or metabolite exposures. Bupropion-dextromethorphan is not recommended for patients with severe renal dysfunction (estimated GFR 15 to 29 mL/min/1.73 m2); dosage adjustment of bupropion-dextromethorphan is recommended in patients with moderate renal dysfunction (estimated GFR 30 to 59 mL/min/1.73 m2).

The ethinyl estradiol and norethindrone in Junel 1.5/30 both have a moderate potential interaction with Renal Dysfunction.

Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.

buPROPion has a major potential interaction with Seizures.

Bupropion is contraindicated in patients with a seizure disorder. Bupropion can cause seizure; the risk is dose-related. In 1 study, the seizure incidence was about 0.4% with immediate-release bupropion hydrochloride (HCl) in the range of 300 to 450 mg/day (equal to 348 to 522 mg/day of extended-release bupropion hydrobromide [HBr]); the incidence of seizures increases dramatically at higher dosages (almost 10-fold between 450 and 600 mg/day as bupropion HCl [equal to 522 and 696 mg/day as bupropion HBr]). The risk of seizures (related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold) should be considered before starting bupropion. Bupropion is also contraindicated in patients with current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizures was observed in such patients treated with immediate-release bupropion) and in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Bupropion should be administered with caution in patients with conditions that increase the risk of seizure or who have other predisposing conditions including severe head injury; arteriovenous malformation; CNS infection or CNS tumor; severe stroke; metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, hypoxia); excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates; use of illicit drugs (e.g., cocaine); abuse/misuse of prescription drugs (e.g., CNS stimulants); diabetes mellitus treated with oral hypoglycemic agents or insulin; use of anorectic agents; and concomitant use of medications that lower the seizure threshold. The risk of seizure can be reduced if the maximum recommended dosage is not exceeded (e.g., 450 mg/day [as 150 mg 3 times a day] for immediate-release bupropion HCl; 400 mg/day [as 200 mg twice a day] for sustained-release bupropion HCl; 450 mg once a day for extended-release bupropion HCl; 522 mg once a day for extended-release bupropion HBr), and the titration rate is gradual. Bupropion should be discontinued and should not be restarted if the patient has a seizure.

The ethinyl estradiol and norethindrone in Junel 1.5/30 both have a moderate potential interaction with Seizures.

Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.

The ethinyl estradiol in Junel 1.5/30 has a major potential interaction with Smoking.

Cigarette smoking increases the risk of serious cardiovascular events from estrogen-containing combination oral contraceptives (COC). This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in females who are over 35 years of age and smoke.

The ethinyl estradiol in Junel 1.5/30 has a major potential interaction with Thrombotic/Thromboembolic Disorder.

The use of estrogens is considered by manufacturers and some authorities to be contraindicated in patients with active thrombotic, thromboembolic, or thrombophilic disorders. The use of estrogen-containing oral contraceptives is additionally deemed contraindicated in patients with a history of such disorders and/or current cerebrovascular or coronary artery disease. Females with a history of migraines with aura are at an increased risk for stroke and this stroke risk may be further increased in females who have migraines with aura with use of combination oral contraceptives. Hypercoagulability and changes in various clotting factors and blood components have been observed in women receiving estrogen therapy. Known preexisting risk factors for increased thromboembolic or cardiovascular events include smoking, especially over age of 35; hypertension; hyperlipidemia; obesity; diabetes; age over 40; and lupus. Therapy with estrogens should be administered cautiously in the lowest effective dosage and only after careful consideration of risks and benefits. Estrogens should be avoided in patients with a history of thrombotic and thromboembolic disorders associated with estrogen use, except when used in the treatment of metastatic breast or prostatic malignancy.

The norethindrone in Junel 1.5/30 has a major potential interaction with Thrombotic/Thromboembolic Disorder.

The use of progestogens, in general, is considered by manufacturers to be contraindicated in patients with active thrombophlebitis, cerebrovascular disease, or a current or past history of thromboembolic disorders. While the role of progestogens in the development of thromboembolic events associated with hormonal therapy is often unclear and thought to be secondary to that of estrogens, it may not be insignificant. Medroxyprogesterone, a common progestational agent, has been shown to produce a hypercoagulable state in high dosages. Whether or not this effect contributes to the development of thrombotic events is unknown. However, thrombophlebitis and pulmonary embolism have been reported with megestrol, an antineoplastic and progestational agent. In addition, an increased risk of nonfatal venous thrombosis has been associated with oral contraceptive combinations containing desogestrel or gestodene relative to those that contain other progestins (e.g., levonorgestrel, norethindrone), suggesting some degree of hemostatic effect by progestogens.

The ethinyl estradiol and norethindrone in Junel 1.5/30 both have a moderate potential interaction with Thyroid Disease.

When administering estrogen and/or progestogen therapy in patients with thyroid disorders, clinicians should be aware that these hormones may affect thyroid function tests. Patients on thyroid replacement therapy may require higher doses of thyroid hormone and appropriate monitoring. Changes have mostly been reported with the use of combination oral contraceptives. Specifically, thyroid-binding globulin (TBG) may be increased, resulting in elevated circulating total thyroid hormone, as measured by PBI (protein-bound iodine), T4 by column or radioimmunoassay, or T3 by radioimmunoassay. Free T3 resin uptake may be decreased. On the contrary, a decrease in TBG and, consequently, thyroxine concentration, has been reported by the manufacturers of the progestin-only (norethindrone) oral contraceptives.

The norethindrone in Junel 1.5/30 has a minor potential interaction with Weight Loss.

Progestogens can cause weight gain, which may be significant (as is the case with parenteral medroxyprogesterone) and undesirable in obese patients attempting to lose weight.