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Jynarque Dosage

Drug Detail:Jynarque (Tolvaptan [ tol-vap-tan ])

Generic Name: TOLVAPTAN 15mg; TOLVAPTAN 45mg

Drug Class:

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Recommended Dosage

The initial dosage for JYNARQUE is 60 mg orally per day as 45 mg taken on waking and 15 mg taken 8 hours later. Titrate to 60 mg plus 30 mg then to 90 mg plus 30 mg per day if tolerated with at least weekly intervals between titrations. Patients may down-titrate based on tolerability. Encourage patients to drink enough water to avoid thirst or dehydration.

Monitoring

To mitigate the risk of significant or irreversible liver injury, perform blood testing for ALT, AST and bilirubin prior to initiation of JYNARQUE, at 2 and 4 weeks after initiation, monthly for 18 months and every 3 months thereafter . Monitor for concurrent symptoms that may indicate liver injury [see Warnings and Precautions (5.1)] .

Missed Doses

If a dose of JYNARQUE is not taken at the scheduled time, take the next dose at its scheduled time.

Co-Administration with CYP 3A Inhibitors

CYP 3A Inhibitors

Concomitant use of strong CYP 3A inhibitors is contraindicated [see Contraindications (4) and Warnings and Precautions (5.4)] .

In patients taking concomitant moderate CYP 3A inhibitors, reduce the dose of JYNARQUE per Table 1. Consider further reductions if patients cannot tolerate the reduced dose [see Warnings and Precautions (5.4) and Drug Interactions (7.1)] . Interrupt JYNARQUE temporarily for short term therapy with moderate CYP 3A inhibitors if the recommended reduced doses are not available.

Table 1: Dose adjustment for patients taking moderate CYP 3A inhibitors
Standard Morning and Afternoon Dose (mg) Dose (mg) with Moderate CYP 3A Inhibitors
90 mg and 30 mg 45 mg and 15 mg
60 mg and 30 mg 30 mg and 15 mg
45 mg and 15 mg 15 mg and 15 mg
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