Interactions between Inpefa and Sildenafil

Sildenafil has a moderate potential interaction with Alcoholism.

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.

Sildenafil has a moderate potential interaction with Bleeding Associated with Coagulation Defect.

The safety of sildenafil in patients with bleeding disorders or active peptic ulceration is unknown. In clinical studies, the incidence of bleeding (i.e., epistaxis) was increased in patients with pulmonary arterial hypertension secondary to connective tissue disease and in patients on concomitant therapy with an oral vitamin K antagonist. There have been postmarketing reports of bleeding events in patients treated with sildenafil for erectile dysfunction.

Sildenafil has a moderate potential interaction with Bleeding Disorder.

The safety of sildenafil in patients with bleeding disorders or active peptic ulceration is unknown. In clinical studies, the incidence of bleeding (i.e., epistaxis) was increased in patients with pulmonary arterial hypertension secondary to connective tissue disease and in patients on concomitant therapy with an oral vitamin K antagonist. There have been postmarketing reports of bleeding events in patients treated with sildenafil for erectile dysfunction.

Sildenafil has a major potential interaction with Cardiovascular Conditions and Disorders.

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.

Sildenafil has a major potential interaction with Cerebral Vascular Disorder.

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.

Sildenafil has a moderate potential interaction with Hearing Loss.

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.

Sildenafil has a major potential interaction with History - Cerebrovascular Disease.

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.

Sildenafil has a major potential interaction with History - Myocardial Infarction.

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.

Sildenafil has a major potential interaction with Hypotension.

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 sotagliflozin in Inpefa has a moderate potential interaction with Hypotension.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors cause intravascular volume contraction which may lead to symptomatic hypotension after treatment initiation, especially in older adult patients, patients with impaired renal function, patients with low systolic blood pressure, or those using diuretics. Volume status should be assessed and corrected before starting treatment and patients should be monitored during therapy.

The sotagliflozin in Inpefa has a moderate potential interaction with Infection.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors increase the risk of genital mycotic infections. Care should be exercised when using an SGLT2 inhibitor in patients who have a history of chronic or recurrent genital mycotic infections or who are uncircumcised as these patients are more likely to develop genital mycotic infections. Patients should be monitored and treated appropriately.

The sotagliflozin in Inpefa has a major potential interaction with Liver Disease.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors ertugliflozin and canagliflozin are not recommended for use in patients with severe hepatic impairment due to lack of clinical data. Sotagliflozin is not recommended for use in patients with moderate to severe hepatic impairment. Dapagliflozin has not been studied in patients with severe hepatic impairment and caution is recommended. The manufacturer's product labeling should be consulted for specific dosing of SGLT2 inhibitors in patients with hepatic impairment.

Sildenafil has a moderate potential interaction with Liver Disease.

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.

Sildenafil has a moderate potential interaction with Myeloproliferative 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.

Sildenafil has a moderate potential interaction with Optic Nerve Disorder.

Sildenafil 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 sildenafil 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 sildenafil; patients taking sildenafil for ED should immediately stop treatment. Most patients who developed NAION during therapy with sildenafil had underlying anatomic or vascular risk factors, including low cup to disc ratio ("crowded disc").

Sildenafil has a moderate potential interaction with Penis 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.

Sildenafil has a moderate potential interaction with Peptic Ulcer.

The safety of sildenafil in patients with bleeding disorders or active peptic ulceration is unknown. In clinical studies, the incidence of bleeding (i.e., epistaxis) was increased in patients with pulmonary arterial hypertension secondary to connective tissue disease and in patients on concomitant therapy with an oral vitamin K antagonist. There have been postmarketing reports of bleeding events in patients treated with sildenafil for erectile dysfunction.

Sildenafil has a moderate potential interaction with Peyronie Disease.

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.

The sotagliflozin in Inpefa has a major potential interaction with Renal Dysfunction.

The glucose lowering effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors are decreased in patients with worsening renal function. Additionally, patients with impaired renal function (estimated GFR less than 60 mL/min/1.73 m2), older adult patients, and patients on loop diuretics may be more likely to experience adverse reactions related to volume depletion such as hypotension and acute kidney injury during therapy. Renal function should be evaluated prior to treatment initiation and monitored regularly in at-risk patients. Volume status should be assessed and volume depletion corrected before initiating therapy. The use of SGLT2 inhibitors in patients undergoing dialysis is either contraindicated or not recommended. The manufacturer product information should be consulted for contraindications and indication specific renal dosing.

The sotagliflozin in Inpefa has a moderate potential interaction with Renal Dysfunction.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors cause intravascular volume contraction which may lead to symptomatic hypotension after treatment initiation, especially in older adult patients, patients with impaired renal function, patients with low systolic blood pressure, or those using diuretics. Volume status should be assessed and corrected before starting treatment and patients should be monitored during therapy.

Sildenafil has a moderate potential interaction with Renal Dysfunction.

Exposure to sildenafil is increased in patients with renal dysfunction. Lower starting doses of sildenafil for the treatment of erectile dysfunction (ED) are recommended in patients with severe renal impairment (CrCl less than 30 mL/min). When sildenafil is used for the treatment of pulmonary arterial hypertension, no dose adjustment is recommended for any degree of renal impairment.

Sildenafil has a moderate potential interaction with Retinitis Pigmentosa.

Sildenafil 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 sildenafil 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 sildenafil; patients taking sildenafil for ED should immediately stop treatment. Most patients who developed NAION during therapy with sildenafil had underlying anatomic or vascular risk factors, including low cup to disc ratio ("crowded disc").

Sildenafil has a moderate potential interaction with Seizures.

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.

Sildenafil has a moderate potential interaction with Sickle Cell Anemia.

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.

Sildenafil has a moderate potential interaction with Sickle Cell Anemia.

The safety and efficacy of sildenafil for the treatment of pulmonary hypertension secondary to sickle cell disease has not been established; vaso-occlusive crises requiring hospitalization were more commonly reported in this population.

Sildenafil has a moderate potential interaction with Tinnitus.

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.

Sildenafil has a moderate potential interaction with Visual Defect/Disturbance.

Sildenafil 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 sildenafil 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 sildenafil; patients taking sildenafil for ED should immediately stop treatment. Most patients who developed NAION during therapy with sildenafil had underlying anatomic or vascular risk factors, including low cup to disc ratio ("crowded disc").