A Step Toward Greater Patient Access Even established patients are willing to leave their providers when care is not readily available , studies suggest . It stands to reason , then , that new patients , who are vitally important to cardiologists , are going to be less likely to wait for weeks or months to see a new provider — especially when others physicians are available . Though it won ’ t solve the entirety of the patient

SAMSCA ® ( tolvaptan )

anaphylactic shock and rash generalized [ see Contraindications ( 4.6 )]. DRUG INTERACTIONS : Effects of Drugs on Tolvaptan : Ketoconazole and Other Strong CYP 3A Inhibitors : SAMSCA is metabolized primarily by CYP 3A . Ketoconazole is a strong inhibitor of CYP 3A and also an inhibitor of P-gp . Coadministration of SAMSCA and ketoconazole 200 mg daily results in a 5-fold increase in exposure �� administered [ see Dosage and Administration ( 2.3 ) and Contraindications ( 4.4 )]. Moderate CYP 3A Inhibitors : �� has not been assessed . A substantial increase in the exposure to tolvaptan would be expected when SAMSCA is co-administered with moderate CYP 3A inhibitors . Co-administration of SAMSCA with moderate CYP3A inhibitors should therefore generally be avoided [ see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.5 )]. Grapefruit Juice : Co-administration of grapefruit juice and SAMSCA results in a 1.8-fold increase in exposure to tolvaptan [ see Dose and Administration ( 2.3 ) and Warnings and Precautions ( 5.5 )]. P-gp Inhibitors : Reduction in the �� [ see Dose and Administration ( 2.3 ) and Warnings and Precautions ( 5.5 )]. Rifampin and Other CYP 3A Inducers : Rifampin is an inducer of CYP 3A and P-gp . Co-administration of rifampin and SAMSCA reduces exposure to tolvaptan �� have to be increased [ Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.5 )]. Lovastatin , Digoxin , Furosemide , and Hydrochlorothiazide : �� the exposure to tolvaptan . Effects of Tolvaptan on Other Drugs : Digoxin : Digoxin is a P-gp substrate . Co-administration �� Warfarin , Amiodarone , Furosemide , and Hydrochlorothiazide : Co-administration of tolvaptan does �� Lovastatin : SAMSCA is a weak inhibitor of CYP 3A . Co-administration of lovastatin and SAMSCA �� Pharmacodynamic Interactions : �� rate than does furosemide or hydrochlorothiazide . Concomitant administration of tolvaptan �� and potassium sparing diuretics compared to administration of these medications with placebo . Serum potassium levels should be monitored during concomitant drug therapy . As a V 2 receptor �� 2�� Factor VIII activity . It is not recommended to administer SAMSCA with V 2 agonist . USE IN SPECIFIC POPULATIONS : �� [ see Clinical Pharmacology ( 12.3 )]. Pregnancy : Pregnancy Category C . There are no adequate and well controlled studies of �� weights and delayed fetal �� ( reduction in body w�� there were reductions in maternal body weight gain and food consumption at all �� [ see Nonclinical Toxicology ( 13.3 )]. Labor and Delivery : The effect of SAMSCA on labor and delivery in humans is unknown . Nursing Mothers : It is not known whether SAMSCA is excreted into human milk . Tolvaptan is excreted into the milk of lactating rats . Because many drugs are excreted into human milk �� importance of SAMSCA to the mother . Pediatric Use : Safety and effectiveness of SAMSCA in pediatric patients have not been established . Geriatric Use : Of the total number of hyponatremic subjects treated with SAMSCA in clinical �� no effect on tolvaptan plasma concentrations . Use in Patients with Hepatic Impairment : Moderate and severe hepatic impairment do not affect exposure to tolvaptan to a clinically relevant extent . No dose adjustment of tolvaptan is necessary . Avoid use of tolvaptan in patients with underlying liver disease . Use in Patients with Renal Impairment : No dose adjustment is necessary based on renal �� anuric [ see Contraindications 4.5 ) and Clinical Pharmacology ( 12.3 )]. Use in Patients with Congestive Heart Failure : The exposure to tolvaptan in patients with congestive heart failure is not clinically relevantly increased . No dose adjustment is necessary . access problem by itself , advanced access does allow patients to get in the door more effectively and efficiently , benefiting patients and providers alike . ■

OVERDOSAGE : �� tolvaptan intoxication . The signs and symptoms of an acute overdose can be anticipated to be �� mortality was observed in rats or dogs following single oral doses of 2000 mg / kg ( maximum �� performed . The possibility of multiple drug involvement should be considered . �� pressure monitoring and water / electrolyte supplements as needed . A profuse and prolonged �� ranges . Dialysis may not be �� PATIENT COUNSELING INFORMATION : �� [ see FDA-Approved Medication Guide ( 17.3 )]. Concomitant Medication : Advise patients to inform their physician if they are taking or plan to take any prescription or over-the-counter drugs since there is a potential for interactions . Strong and Moderate CYP 3A inhibitors and P-gp inhibitors : Advise patients to inform their physician if they �� [ see Dosage and Administration ( 2.3 ), Contraindications ( 4.4 ), Warnings and Precautions ( 5.5 ) and Drug Interactions ( 7.1 )]. Nursing : Advise patients not to breastfeed an infant if they are taking SAMSCA [ see Use In �� SAMSCA is a registered trademark of Otsuka Pharmaceutical Co ., Ltd ., Tokyo , 101-8535 Japan

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