Drug Interactions between tadalafil and Xelria Fe

Grapefruit juice may increase the blood levels of certain medications such as norethindrone. You may want to limit your consumption of grapefruit and grapefruit juice during treatment with norethindrone. However, if you have been regularly consuming grapefruit or grapefruit juice with the medication, then it is advisable for you to talk with your doctor before changing the amounts of these products in your diet, as this may alter the effects of your medication. Contact your doctor if your condition changes or you experience increased side effects. Orange juice is not expected to interact.

Tadalafil can lower blood pressure, and combining it with alcohol may further increase this effect. You may be more likely to experience symptoms such as dizziness, lightheadedness, fainting, flushing, headache, and heart palpitations. You should avoid or limit the use of alcohol to not more than 4 alcohol-containing drinks during a small period of time while being treated with tadalafil, and use caution when getting up from a sitting or lying position. You may also want to avoid drinking large amounts of grapefruit juice, since it may increase the blood levels and effects of tadalafil. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Ethinyl estradiol may increase the blood levels of caffeine. This may increase the risk and/or severity of side effects related to caffeine. Contact your doctor if your condition changes or you experience increased side effects. You may need a dose adjustment or more frequent monitoring to safely use both medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Information for this minor interaction is available on the professional version.

Information for this minor interaction is available on the professional version.

Information for this minor interaction is available on the professional version.

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 use of estrogens is contraindicated in patients with undiagnosed, abnormal vaginal bleeding. Prolonged (> 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.

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.

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.

The use of phosphodiesterase-5 (PDE5) inhibitors is not recommended in patients with preexisting cardiovascular disease for whom sexual activity is inadvisable due to the potential cardiac risk. Physicians should also consider the vasodilatory effect of these drugs and whether they may adversely affect patients with underlying cardio- and/or cerebrovascular conditions, in particular those who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; those with resting hypotension (BP < 90/50) or hypertension (BP > 170/110); and those with unstable angina associated with cardiac failure or coronary artery disease. There are no controlled clinical data on the safety or efficacy in such patients. Other adverse cardiovascular effects reported include angina pectoris, myocardial infarction, AV block, ventricular arrhythmia, tachycardia, palpitation, hypotension, postural hypotension, syncope, cerebral thrombosis, cerebrovascular hemorrhage, transient ischemic attack, cardiac arrest, heart failure, and hypertension. Many of these events occurred in patients with cardiovascular risk factors and during or shortly after sexual activity.

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 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 use of phosphodiesterase-5 (PDE5) inhibitors is not recommended in patients with preexisting cardiovascular disease for whom sexual activity is inadvisable due to the potential cardiac risk. Physicians should also consider the vasodilatory effect of these drugs and whether they may adversely affect patients with underlying cardio- and/or cerebrovascular conditions, in particular those who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; those with resting hypotension (BP < 90/50) or hypertension (BP > 170/110); and those with unstable angina associated with cardiac failure or coronary artery disease. There are no controlled clinical data on the safety or efficacy in such patients. Other adverse cardiovascular effects reported include angina pectoris, myocardial infarction, AV block, ventricular arrhythmia, tachycardia, palpitation, hypotension, postural hypotension, syncope, cerebral thrombosis, cerebrovascular hemorrhage, transient ischemic attack, cardiac arrest, heart failure, and hypertension. Many of these events occurred in patients with cardiovascular risk factors and during or shortly after sexual activity.

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 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 use of phosphodiesterase-5 (PDE5) inhibitors is not recommended in patients with preexisting cardiovascular disease for whom sexual activity is inadvisable due to the potential cardiac risk. Physicians should also consider the vasodilatory effect of these drugs and whether they may adversely affect patients with underlying cardio- and/or cerebrovascular conditions, in particular those who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; those with resting hypotension (BP < 90/50) or hypertension (BP > 170/110); and those with unstable angina associated with cardiac failure or coronary artery disease. There are no controlled clinical data on the safety or efficacy in such patients. Other adverse cardiovascular effects reported include angina pectoris, myocardial infarction, AV block, ventricular arrhythmia, tachycardia, palpitation, hypotension, postural hypotension, syncope, cerebral thrombosis, cerebrovascular hemorrhage, transient ischemic attack, cardiac arrest, heart failure, and hypertension. Many of these events occurred in patients with cardiovascular risk factors and during or shortly after sexual activity.

The use of phosphodiesterase-5 (PDE5) inhibitors is not recommended in patients with preexisting cardiovascular disease for whom sexual activity is inadvisable due to the potential cardiac risk. Physicians should also consider the vasodilatory effect of these drugs and whether they may adversely affect patients with underlying cardio- and/or cerebrovascular conditions, in particular those who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; those with resting hypotension (BP < 90/50) or hypertension (BP > 170/110); and those with unstable angina associated with cardiac failure or coronary artery disease. There are no controlled clinical data on the safety or efficacy in such patients. Other adverse cardiovascular effects reported include angina pectoris, myocardial infarction, AV block, ventricular arrhythmia, tachycardia, palpitation, hypotension, postural hypotension, syncope, cerebral thrombosis, cerebrovascular hemorrhage, transient ischemic attack, cardiac arrest, heart failure, and hypertension. Many of these events occurred in patients with cardiovascular risk factors and during or shortly after sexual activity.

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 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 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 use of phosphodiesterase-5 (PDE5) inhibitors is not recommended in patients with preexisting cardiovascular disease for whom sexual activity is inadvisable due to the potential cardiac risk. Physicians should also consider the vasodilatory effect of these drugs and whether they may adversely affect patients with underlying cardio- and/or cerebrovascular conditions, in particular those who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; those with resting hypotension (BP < 90/50) or hypertension (BP > 170/110); and those with unstable angina associated with cardiac failure or coronary artery disease. There are no controlled clinical data on the safety or efficacy in such patients. Other adverse cardiovascular effects reported include angina pectoris, myocardial infarction, AV block, ventricular arrhythmia, tachycardia, palpitation, hypotension, postural hypotension, syncope, cerebral thrombosis, cerebrovascular hemorrhage, transient ischemic attack, cardiac arrest, heart failure, and hypertension. Many of these events occurred in patients with cardiovascular risk factors and during or shortly after sexual activity.

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 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.

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 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.

Tadalafil tablet for the treatment of pulmonary arterial hypertension (PAH) should not be used in patients with pulmonary veno-occlusive disease (PVOD) as it may significantly worsen the cardiovascular status of these patients. If signs of pulmonary edema develop during therapy, the possibility of associated PVOD should be considered.

Tadalafil tablet for the treatment of pulmonary arterial hypertension (PAH) should not be used in patients with pulmonary veno-occlusive disease (PVOD) as it may significantly worsen the cardiovascular status of these patients. If signs of pulmonary edema develop during therapy, the possibility of associated PVOD should be considered.

The plasma clearance of phosphodiesterase-5 (PDE5) inhibitors may be decreased in patients with severe renal impairment, resulting in drug accumulation. Therapy with these agents should be avoided in patients with severe renal disease or on renal dialysis. Dose adjustments might be needed based on individual renal assessment and tolerability if used in these patients.

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 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 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.

Alcohol consumption may intensify the pressure-lowering effects of mild vasodilators, such as phosphodiesterase 5 (PDE5) inhibitors. Therefore, patients that consume alcohol should be warned to limit alcohol intake while receiving these agents.

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

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.

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.

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours) have been reported during treatment with phosphodiesterase-5 (PDE 5) inhibitors. Priapism may result in penile tissue damage and permanent loss of potency if not treated promptly. These agents should be used cautiously in patients with conditions that may predispose them to priapism such as sickle cell anemia, multiple myeloma, or leukemia, and those with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). If an erection persists longer than 4 hours, the patient should seek immediate medical assistance.

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.

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 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.

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.

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.

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.

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.

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.

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.

Use of phosphodiesterase-5 (PDE5) inhibitors has been associated with sudden decrease or loss of hearing, which may be accompanied by tinnitus or dizziness. Patients with hearing problems should stop taking these agents and seek prompt medical care.

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.

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.

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.

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.

Phosphodiesterase 5 (PDE-5) inhibitors are cleared predominantly by hepatic metabolism. The pharmacokinetic disposition of these agents has not been assessed in patients with severe hepatic impairment. No dosage modification is recommended for patients with mild to moderate hepatic impairment, however, therapy with these agents should not be administered to patients with severe hepatic impairment. In patients with mild hepatic impairment a lower dose of these agents should be used as initial therapy.

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.

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.

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.

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours) have been reported during treatment with phosphodiesterase-5 (PDE 5) inhibitors. Priapism may result in penile tissue damage and permanent loss of potency if not treated promptly. These agents should be used cautiously in patients with conditions that may predispose them to priapism such as sickle cell anemia, multiple myeloma, or leukemia, and those with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). If an erection persists longer than 4 hours, the patient should seek immediate medical assistance.

Tadalafil for the treatment of erectile dysfunction (ED) should be used with caution and only if the benefit outweighs the risk in patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION) or with retinitis pigmentosa. Use of tadalafil for the treatment of pulmonary arterial hypertension is not recommended in patients with retinitis pigmentosa. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil; patients taking tadalafil for ED should immediately stop treatment. Most patients who developed NAION during therapy with tadalafil had underlying anatomic or vascular risk factors, including low cup to disc ratio ("crowded disc").

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours) have been reported during treatment with phosphodiesterase-5 (PDE 5) inhibitors. Priapism may result in penile tissue damage and permanent loss of potency if not treated promptly. These agents should be used cautiously in patients with conditions that may predispose them to priapism such as sickle cell anemia, multiple myeloma, or leukemia, and those with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). If an erection persists longer than 4 hours, the patient should seek immediate medical assistance.

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.

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.

Phosphodiesterase-5 (PDE5) inhibitors have been associated with transient impairment of color discrimination (blue/green) and blue- or color-tinged vision. These agents also inhibit phosphodiesterase-6 (PDE6), to a much lesser extent, which is involved in phototransduction in the retina. There are no controlled clinical data on the safety in patients with retinitis pigmentosa, a minority of whom may have genetic disorders of retinal phosphodiesterases. Therapy with these agents should be avoided in such patients.

Tadalafil for the treatment of erectile dysfunction (ED) should be used with caution and only if the benefit outweighs the risk in patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION) or with retinitis pigmentosa. Use of tadalafil for the treatment of pulmonary arterial hypertension is not recommended in patients with retinitis pigmentosa. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil; patients taking tadalafil for ED should immediately stop treatment. Most patients who developed NAION during therapy with tadalafil had underlying anatomic or vascular risk factors, including low cup to disc ratio ("crowded disc").

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.

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 use of phosphodiesterase 5 (PDE-5) inhibitors has been associated with seizures. Therapy with these agents should be administered cautiously in patients with preexisting seizure disorders.

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours) have been reported during treatment with phosphodiesterase-5 (PDE 5) inhibitors. Priapism may result in penile tissue damage and permanent loss of potency if not treated promptly. These agents should be used cautiously in patients with conditions that may predispose them to priapism such as sickle cell anemia, multiple myeloma, or leukemia, and those with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). If an erection persists longer than 4 hours, the patient should seek immediate medical assistance.

When administering estrogen and/or progestogen therapy in patients with thyroid disorders, clinicians should be aware that these hormones may affect thyroid function tests. 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. Patients on thyroid replacement therapy may require higher doses of thyroid hormone and appropriate monitoring.

When administering estrogen and/or progestogen therapy in patients with thyroid disorders, clinicians should be aware that these hormones may affect thyroid function tests. 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. Patients on thyroid replacement therapy may require higher doses of thyroid hormone and appropriate monitoring.

Use of phosphodiesterase-5 (PDE5) inhibitors has been associated with sudden decrease or loss of hearing, which may be accompanied by tinnitus or dizziness. Patients with hearing problems should stop taking these agents and seek prompt medical care.

Tadalafil for the treatment of erectile dysfunction (ED) should be used with caution and only if the benefit outweighs the risk in patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION) or with retinitis pigmentosa. Use of tadalafil for the treatment of pulmonary arterial hypertension is not recommended in patients with retinitis pigmentosa. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil; patients taking tadalafil for ED should immediately stop treatment. Most patients who developed NAION during therapy with tadalafil had underlying anatomic or vascular risk factors, including low cup to disc ratio ("crowded disc").

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.