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Doctors use Tolvaptan for hypervolemic or euvolemic hyponatremia. It is also used in autosomal dominant polycystic kidney disease.
Pharmacology
Tolvaptan is a selective vasopressin V2-receptor antagonist. Its affinity for the V2-receptor is 29 times greater than for the V1a-receptor. When taken by mouth in doses of 15 to 60 mg, Tolvaptan blocks the effect of vasopressin. This increases the amount of water passing out in the urine, which raises free water clearance (aquaresis) and lowers urine osmolality, and as a result serum sodium concentrations go up. Urinary excretion of sodium and potassium, and plasma potassium concentrations, are not significantly changed.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Hypervolemic or euvolemic hyponatremia
The usual starting dose of Tolvaptan is 15 mg once daily, and you can take it with or without meals. After at least 24 hours the dose can be increased to 30 mg once daily, and then up to a maximum of 60 mg once daily, as needed to reach the desired level of serum sodium. Don't use it for more than 30 days because of the risk of hepatotoxicity.
Autosomal dominant polycystic kidney disease (ADPKD)
Start with 60 mg/day in divided doses, given as 45 mg upon wakening and 15 mg 8 hours later. Then titrate according to response and tolerability, leaving at least 7 days between each titration. The first step is 90 mg/day in divided doses (60 mg upon wakening and 30 mg 8 hours later), followed by 120 mg/day in divided doses (90 mg upon wakening and 30 mg 8 hours later). Try to keep urine osmolality below 300 mOsm/kg if possible. If the maximum dose isn't tolerated, a lower dose is reasonable, with the goal of reaching a urine osmolality of 250 to 300 mOsm/kg.
Side Effects
The most common side effects of Tolvaptan are thirst, dry mouth, weakness and constipation. Some people also pass large amounts of urine and need to urinate often, and Tolvaptan can raise blood sugar levels.
Cautions & Contraindications
Warnings & Precautions
If serum sodium is corrected too quickly with Tolvaptan, it can cause serious neurologic problems.
Contraindications
Tolvaptan must not be given in cases of hypersensitivity to the active substance or to any of the excipients, anuria, volume depletion, hypovolemic hyponatremia or hypernatremia. It is also not for patients who cannot perceive thirst, or during pregnancy and breast-feeding.
Pregnancy & Breastfeeding
There is little or no data on the use of Tolvaptan in pregnant women. Animal studies have shown reproductive toxicity, but the possible risk to humans is not known. Tolvaptan is contraindicated during pregnancy, so it must not be used by a pregnant woman. Women who could become pregnant have to use effective contraception for as long as they are on Tolvaptan treatment. It is also not known whether Tolvaptan passes into human milk.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use: Safety and effectiveness of Vaptan in children have not been established.
Geriatric Use: In the clinical studies, 42% of the hyponatremic subjects treated with Vaptan were 65 and over, and 19% were 75 and over. No overall differences in safety or effectiveness were seen between these subjects and younger ones. Other reported clinical experience has not found differences in response between elderly and younger patients either, but some older people may be more sensitive, and this cannot be ruled out. Increasing age has no effect on Vaptan plasma concentrations.
Use in Patients with Hepatic Impairment: Moderate and severe hepatic impairment do not affect exposure to Vaptan to a clinically relevant extent. Even so, avoid using Vaptan in patients with underlying liver disease.
Use in Patients with Renal Impairment: No dose adjustment is necessary based on renal function. There are no clinical trial data in patients with CrCl<10 ml/min, and drug effects on serum sodium levels are likely lost at very low levels of renal function, so use in patients with a CrCl<10 ml/min is not recommended. No benefit can be expected in patients who are anuric.
Use in Patients with Congestive Heart Failure: Exposure to Vaptan in patients with congestive heart failure is not increased to a clinically relevant extent. No dose adjustment is necessary.
Overdose
In clinical trials with healthy volunteers, Tolvaptan was well tolerated at single doses up to 480 mg and at multiple doses up to 300 mg per day for 5 days. There is no specific antidote for Vaptan intoxication. In an acute overdose, the signs and symptoms are expected to come from too much of the medicine's own effect: a rise in serum sodium concentration, polyuria, thirst, and dehydration/hypovolemia (profuse and prolonged aquaresis).
If a Vaptan overdose is suspected, the patient's vital signs, electrolyte concentrations, ECG and fluid status should be assessed. Water and/or electrolytes must be replaced as needed, and this must continue until the aquaresis settles. Dialysis may not remove Vaptan effectively, because it binds very strongly to human plasma protein (>98%).
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Tolvaptan below 25°C in a dry place, away from light. Keep it out of reach of children.
Drug Interactions
Common questions about Tolvan 15 mg
What is Tolvan 15 mg Tablet?
Tolvan 15 mg Tablet is a medicine that contains Tolvaptan. It is made by Eskayef Pharmaceuticals Ltd. It belongs to the Selective vasopressin V2-receptor antagonist group of medicines.
What is Tolvan used for?
Doctors use Tolvaptan for hypervolemic or euvolemic hyponatremia. It is also used in autosomal dominant polycystic kidney disease.
What are the side effects of Tolvan?
The most common side effects of Tolvaptan are thirst, dry mouth, weakness and constipation. Some people also pass large amounts of urine and need to urinate often, and Tolvaptan can raise blood sugar levels.
Can I take Tolvan during pregnancy or while breastfeeding?
There is little or no data on the use of Tolvaptan in pregnant women. Animal studies have shown reproductive toxicity, but the possible risk to humans is not known. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Tolvan?
In clinical trials with healthy volunteers, Tolvaptan was well tolerated at single doses up to 480 mg and at multiple doses up to 300 mg per day for 5 days. There is no specific antidote for Vaptan intoxication. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Tolvan?
Keep Tolvaptan below 25°C in a dry place, away from light. Keep it out of reach of children.
Can I take other medicines with Tolvan?
Some medicines can interact with Tolvaptan, for example: Carbamazepine, Phenytoin, Rifampicin, Cyclosporine. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Tolvan is already among the lowest-priced brands of Tolvaptan at this strength.
Do I need a prescription for Tolvan?
Tolvan is a prescription (Rx) medicine. Take it as your doctor advises.