Tolvaptan 30mg Tablets — Generic Samsca® 30mg | Order Online

Tolvaptan 30mg Tablets are a prescription medicine containing tolvaptan 30mg as the active ingredient and the generic equivalent of Samsca® 30mg, the reference brand developed by Otsuka Pharmaceutical. Tolvaptan 30mg is a selective vasopressin V2 receptor antagonist — an aquaretic — that promotes free water excretion without significant electrolyte loss. In the hyponatraemia dosing schedule (Samsca®), 30mg is the first titration dose, reached after 24 hours on the 15mg starting dose where serum sodium correction has been inadequate and the medicine is tolerated. Under the brand Jinarc® (or Jynarque® in the USA), tolvaptan 30mg is also part of the split-dose titration schedule used in autosomal dominant polycystic kidney disease (ADPKD). Generic tolvaptan 30mg tablets are available internationally across the USA, UK, Australia, UAE, Germany, France, Russia, South Korea and worldwide.

Product Information

What Is Tolvaptan 30mg Used For?

Tolvaptan 30mg is used in the same two clinical settings as the other tolvaptan strengths — hyponatraemia and ADPKD — but occupies a specific role in the dose titration schedule for each.

Hyponatraemia — Samsca® indication

In the hyponatraemia dosing pathway, tolvaptan 30mg is the first dose increase following the mandatory 15mg starting dose:

• Day 1: Tolvaptan 15mg once daily — initiated in hospital with serum sodium monitoring
• Day 2 onwards: May be increased to tolvaptan 30mg once daily if serum sodium has not risen adequately and the 15mg dose was tolerated
• Subsequent: May be further increased to 60mg once daily if 30mg is insufficient after a further assessment period

The 30mg dose is the most commonly reached maintenance dose in clinical practice for many hyponatraemia patients, balancing efficacy with tolerability.

United States: Samsca® 30mg is FDA-approved as part of the titration schedule for hypervolaemic and euvolaemic hyponatraemia in hospitalised patients.

United Kingdom / EU: Tolvaptan 30mg (Samsca®) is indicated for hyponatraemia secondary to SIADH and is reached via titration from 15mg based on serum sodium response.

ADPKD — Jinarc® / Jynarque® indication

In the ADPKD indication, tolvaptan 30mg is part of the split-dose morning/evening titration schedule:

• The lowest Jinarc® starting regimen is 45mg/day (30mg morning + 15mg evening)
• Titration steps include 60mg/day (45mg morning + 15mg evening) and 90mg/day (45mg + 45mg)
• The 30mg tablet is therefore a component of the initial ADPKD dosing regimen

Jinarc® / Jynarque® prescribing for ADPKD operates under a separate risk management programme (REMS in the USA; Risk Minimisation Measures in the UK/EU) due to hepatotoxicity risk.

Australia: Tolvaptan 30mg products are subject to TGA registration. PBS eligibility depends on indication — confirm current status with your prescriber or pharmacist.

UAE / Gulf: Subject to UAE Ministry of Health registration. Consult a UAE-licensed physician for current tolvaptan 30mg UAE availability.

Germany: Tolvaptan 30mg Tabletten are available as Samsca® 30mg and Jinarc® 30mg. All are prescription-only (rezeptpflichtig).

France: Tolvaptane 30mg is available as Samsca® 30mg and Jinarc® 30mg in France, subject to HAS reimbursement.

Russia: Толваптан 30 мг is available as Самска® 30 мг in Russia, requiring a valid prescription.

South Korea: 톨밥탄 30mg is registered for prescription use per MFDS-approved labeling.

Always follow the prescribing information applicable to your country and the guidance of your licensed specialist.

How Tolvaptan 30mg Works

Tolvaptan 30mg works through the same mechanism as all tolvaptan strengths — selective competitive antagonism of the vasopressin V2 receptor in the renal collecting duct. By blocking vasopressin-driven water reabsorption, tolvaptan promotes aquaresis: the selective excretion of free water without significant sodium or potassium loss.

At the 30mg dose, the degree of aquaresis and resulting serum sodium correction is greater than at 15mg but less than at 60mg. This places the 30mg dose at the centre of the titration range — providing meaningful efficacy in patients where 15mg has proven insufficient, while reserving the maximum 60mg dose for cases where further correction is required.

In ADPKD, the 30mg component of the split-dose regimen begins suppressing cAMP-mediated cyst growth in renal tubular epithelial cells, contributing to the overall slowing of kidney cyst enlargement and preservation of eGFR.

Tolvaptan Full Dose Range — Where 30mg Sits

Generic Tolvaptan 30mg vs Samsca® 30mg / Jinarc® 30mg

Samsca® 30mg and Jinarc® 30mg are originator brand products containing tolvaptan 30mg for their respective indications. Generic tolvaptan 30mg tablets contain the same active ingredient at the same strength but may differ in inactive ingredients, tablet appearance, packaging and manufacturer. These are different branded products with different approved indications and risk management programmes — consult your specialist before switching products.

Key Safety Information — Tolvaptan 30mg

Hepatotoxicity
Serious and potentially fatal liver injury applies at all tolvaptan doses including 30mg. The risk increases with duration of use and is highest in the ADPKD indication. Liver function must be monitored before and throughout treatment. Tolvaptan must be discontinued immediately at the first signs of hepatic injury.

Symptoms requiring immediate medical attention:

• Unusual fatigue or weakness
• Loss of appetite, nausea or vomiting
• Right upper quadrant abdominal pain
• Jaundice (yellow skin or eyes)
• Dark or tea-coloured urine
• Pale stools

Osmotic Demyelination Syndrome
At 30mg, the aquaretic effect is greater than at 15mg, making serum sodium monitoring even more critical. Overly rapid correction of serum sodium can cause osmotic demyelination syndrome (ODS) — a potentially irreversible and fatal neurological complication. Serum sodium must be checked within 6 hours of the first 30mg dose and at regular intervals thereafter, per the treating physician’s protocol.

Contraindications

• Inability to sense or respond to thirst
• Hypovolaemic hyponatraemia
• Urgent need to raise serum sodium acutely
• Concurrent strong CYP3A4 inhibitors
• Anuria
• Severe hepatic impairment (refer to local SPC)
• Known hypersensitivity to tolvaptan or excipients
• For ADPKD (Jinarc®): elevated liver enzymes at baseline per risk management programme criteria

Unrestricted Water Access
Patients must have unrestricted access to water throughout tolvaptan treatment at all doses. Never restrict fluid intake during tolvaptan therapy.

Drug Interactions

• Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) — contraindicated
• CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St John’s Wort) — avoid
• P-glycoprotein inhibitors — increase tolvaptan exposure
• Loop diuretics — additive aquaretic effect; increased dehydration risk
• Hypertonic saline — concurrent use not recommended
• Grapefruit juice — avoid throughout treatment

Tolvaptan 30mg — Availability by Country

Frequently Asked Questions — Tolvaptan 30mg

What is Tolvaptan 30mg used for?
Tolvaptan 30mg is used in the treatment of hyponatraemia as the first titration dose after the 15mg starting dose, and as a component of the split-dose ADPKD treatment schedule (Jinarc®/Jynarque®). It is the most commonly reached maintenance dose for hyponatraemia in clinical practice.

Is Tolvaptan 30mg the generic for Samsca® 30mg?
Yes. Samsca® 30mg is the originator brand for the hyponatraemia indication. Generic tolvaptan 30mg tablets contain the same active ingredient and strength. Inactive ingredients, appearance and manufacturer may differ.

What is the difference between Tolvaptan 15mg and 30mg?
Tolvaptan 15mg is the mandatory starting dose for hyponatraemia. If sodium correction is inadequate after 24 hours and the 15mg dose is tolerated, the dose is increased to 30mg. The 30mg dose provides greater aquaresis and sodium correction than 15mg. Dose adjustment is always managed by the treating specialist.

What is the difference between Samsca® 30mg and Jinarc® 30mg?
Both contain tolvaptan 30mg but are approved for different indications under separate regulatory pathways. Samsca® 30mg is for hyponatraemia — used as a once-daily titration dose. Jinarc® 30mg is for ADPKD — used as the morning component of a split daily dosing regimen. They have different dosing schedules and risk management requirements.

Can Tolvaptan 30mg cause liver damage?
Yes. Hepatotoxicity risk applies at all tolvaptan doses including 30mg. Liver function must be monitored before and during treatment. Seek immediate medical attention if you develop fatigue, nausea, abdominal pain, jaundice or dark urine.

Why must serum sodium be monitored closely at the 30mg dose?
The 30mg dose produces greater aquaresis than 15mg, increasing the risk of overly rapid serum sodium correction and osmotic demyelination syndrome. Serum sodium must be checked within 6 hours of dose escalation to 30mg and at regular intervals thereafter.

Can I buy Tolvaptan 30mg tablets online?
Tolvaptan 30mg is prescription-only in the USA, UK, Australia, UAE and most markets worldwide. Due to hepatotoxicity and sodium monitoring requirements, it must be managed under direct specialist supervision.

Is Tolvaptan 30mg available in Australia?
Tolvaptan 30mg products are registered on the ARTG. PBS subsidisation depends on specific indication and eligibility. Confirm with your prescriber or pharmacist.

Does Tolvaptan 30mg interact with grapefruit?
Yes. Grapefruit and grapefruit juice inhibit CYP3A4 and significantly increase tolvaptan exposure at all doses including 30mg. Avoid grapefruit and grapefruit juice throughout tolvaptan treatment.

What is Tolvaptan 30mg in Germany?
Tolvaptan 30mg Tabletten are available in Germany as Samsca® 30mg and Jinarc® 30mg. Generic tolvaptan 30mg products may also be available. All are prescription-only (rezeptpflichtig).

Medical Disclaimer

This information is provided for educational and commercial reference purposes only and is not a substitute for professional medical advice, diagnosis or treatment. Tolvaptan 30mg is a prescription-only medicine with serious hepatotoxicity risk and strict serum sodium monitoring requirements. All tolvaptan dose changes must be managed in a hospital or specialist clinical setting. Always use according to the applicable prescribing information and the advice of a qualified healthcare professional licensed in your country.

Last Updated: September 25, 2026