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Rx Item-Jynarque- Tolvaptan 15Mg-45Mg Tab

NDC Code(s): 59148-087-07, 59148-087-28, 59148-088-07, 59148-088-28, view more 

Packager: Otsuka America Pharmaceutical, Inc.
Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None 
Marketing StaBRAND: JYNARQUE NDC: RX59148-0087-07 ,RX59148008707  UPC: 035914-808707,35914808707 NDC Code(s): 59148-087-07, 59148-087-28, 59148-088-07, 59148-088-28, view more 

Packager: Otsuka America PharmaceutOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Jynarque- Tolvaptan 15Mg-45Mg Tab

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item No.:RX59148-0087-07 NDC No.RX59148008707 UPC No.:35914808707 Item No.:RX59148-0087-07 NDC Code(s): 59148-087-07, 59148-087-28, 59148-088-07, 59148-088-28, view more
Packager: Otsuka America Pharmaceutical, Inc.
Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: New Drug Application Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,

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Otsuka Pharmaceutical Co., Ltd. Treatment for: Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease Jynarque (tolvaptan) is a selective vasopressin V2-receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). These highlights do not include all the information needed to use JYNARQUE safely and effectively. See full prescribing information for JYNARQUE. JYNARQUE� (tolvaptan) tablets for oral use Initial U.S. Approval: 2009 WARNING: RISK OF SERIOUS LIVER INJURY See full prescribing information for complete boxed warning. JYNARQUE (tolvaptan) can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported (5.1) Measure transaminases and bilirubin before initiating treatment, at 2 weeks and 4 weeks after initiation, then continuing monthly for the first 18 months and every 3 months thereafter (5.1) JYNARQUE is available only through a restricted distribution program called the JYNARQUE REMS Program (5.2) INDICATIONS AND USAGE JYNARQUE is a selective vasopressin V2-receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) (1) DOSAGE AND ADMINISTRATION Recommended dosage (2.1) Initial Dosage Titration Step Target Dosage 1st Dose 45 mg 1st Dose 60 mg 1st Dose 90 mg 2nd Dose (8 hours later) 15 mg 2nd Dose (8 hours later) 30 mg 2nd Dose (8 hours later) 30 mg Total Daily Dose 60 mg Total Daily Dose 90 mg Total Daily Dose 120 mg Dose adjustment is recommended for patients taking moderate CYP 3A inhibitors (2.4, 5.4, 7.1) DOSAGE FORMS AND STRENGTHS Tablets: 15 mg, 30 mg, 45 mg, 60 mg and 90 mg (3) CONTRAINDICATIONS History of signs or symptoms of significant liver impairment or injury, does not include uncomplicated polycystic liver disease (4) Concomitant use of strong CYP 3A inhibitors is contraindicated (4) Uncorrected abnormal blood sodium concentrations (4, 5.3) Unable to sense or respond to thirst (4) Hypovolemia (4) Hypersensitivity to tolvaptan or any of its components (4) Uncorrected urinary outflow obstruction (4) Anuria (4) WARNINGS AND PRECAUTIONS Hypernatremia, dehydration and hypovolemia: May require intervention (5.3) ADVERSE REACTIONS Most common observed adverse reactions with JYNARQUE (incidence >10% and at least twice that for placebo) were thirst, polyuria, nocturia, pollakiuria and polydipsia (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Avoid concomitant use with: Strong CYP 3A Inducers (7.1) OATP1B1/3 and OAT3 Transporter Substrates (7.2) BCRP Transporter Substrates (7.3) V2-Receptor Agonists (7.4) USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm (8.1) Lactation: Breastfeeding not recommended (8.2) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 4/2018

NDC Code(s): 59148-087-07, 59148-087-28, 59148-088-07, 59148-088-28, view more 

Packager: Otsuka America Pharmaceutical, Inc.
Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None 
Marketing Sta
RX ITEM-Jynarque- Tolvaptan 15Mg-45Mg Ta
NDC Code(s): 59148-087-07, 59148-087-28, 59148-088-07, 59148-088-28, view more Packager: Otsuka America Pharmaceutical, Inc. Category: HUMAN PRESCRIPTION DRUG LABEL DEA Schedule: None Marketing Sta

BRAND: JYNARQUE NDC: RX59148-0087-07 ,RX59148008707  UPC: 035914-808707,35914808707 NDC Code(s): 59148-087-07, 59148-087-28, 59148-088-07, 59148-088-28, view more 

Packager: Otsuka America Pharmaceut
Jynarque- Tolvaptan 15Mg-45Mg Tab
BRAND: JYNARQUE NDC: RX59148-0087-07 ,RX59148008707 UPC: 035914-808707,35914808707 NDC Code(s): 59148-087-07, 59148-087-28, 59148-088-07, 59148-088-28, view more Packager: Otsuka America Pharmaceut

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.