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Tolvat is indicated in patients for the treatment of patients with hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH). Tolvat is also indicated for hypervolemic and euvolemic hyponatremia (sodium concentration <125 mmol l–1) in patients with heart failure and cirrhosis. In this US country use this medicine frequently.

Tolvaptan is a kind of selective and competitive arginine vasopressin receptor 2 antagonist. Vasopressin performs action on the V2 receptors found in the walls of the vasculature and luminal membranes of renal collecting ducts. By blocking V2 receptors in the renal collecting ducts, aquaporins do not go inside themselves into the walls hence prohibiting water absorption.

This action basically results in a rise in urine volume, lesser the urine osmolality, and increase electrolyte-free water clearance to decrease intravascular volume and a higher serum sodium levels. Tolvaptan is essentially required for heart failure patients as they have higher serum levels of vasopressin.



ADME properties

Absorption

Time to peak plasma concentration of Tolvat is 2-4 hours The absolute bioavailability is unknown. Food will not affect the bioavailability of Tolvat.

Distribution

Volume of distribution in healthy subjects is 3L/kg. The plasma protein bounding of Tolvat is 99%

Metabolism

Tolvat is metabolism occurs by CYP3A4 enzyme in the liver.

Elimination

Less than 1% is eliminated in the urine (unchanged form) and via faecal is very little amount of renal elimination. In oral dose, half-life of Tolvat is 12 hours.

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Brand : Tolvat
Ingredients : Tolvaptan
Strength : 15mg
Manufactured : MSN Laboratories
Package : 10 tablets in 1 strips

Dosage and administration of Tolvat 15mg
Hyponatremia

Tolvat tablet is Indicated for adults with clinically significant euvolemic or hypervolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia which is symptomatic and has opposed correction with fluid restriction), contains patients with heart failure, cirrhosis, and SIADH Initial: 15 mg PO qDay Maintenance: May increase to 30 mg qDay after at least 24 hr to achieve the optimal serum sodium level; not to exceed 60 mg/day Not to exceed 30 days of treatment

Polycystic Kidney Disease

In this case Tolvat tablet Indicated to slow kidney function reduce in adults at harm of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) Initial: 45 mg PO taken on waking and 15 mg taken 8 hr later (ie, 60 mg/day) Advice the patients to drink enough water to avoid thirst or dehydration Administration of Tolvat should be without food Grape juice should be avoided during therapy with Tolvat

OVERDOSE

Administrating monotherapy oral doses up to 480 mg and multiple doses up to 300 mg once in a day for 5 days have been well accepted in studies in healthy subjects. There is no essential antitoxin for Tolvat intoxication. The signs and symptoms of an acute overdose can be expected to be those of extra pharmacologic effect: an increase in serum sodium concentration, polyuria, thirst, and dehydration / hypovolemia.

Precaution

The conditions like Hypernatremia, hypovolemia, and/or dehydration; provoke patient to drink whenever thirsty Risk of potassium level increased Tolvat 15mg produce Osmotic demyelination syndrome is a harm along with too-fast correction of hyponatremia

Tolvat 15mg can develops serious and likely fatal liver injury; acute liver failure needed liver transplantation reported; discontinue if laboratory abnormalities or signs or symptoms of liver injury are apparent.



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Drug-drug interaction of Tolvat 15mg

Tolvat combination with moderate CYP3A4 inhibitors will increase in exposure of Tolvat 15mg . Combination of lovastatin, digoxin, furosemide, and hydrochlorothiazide has no clinically relevant impact on the exposure to Tolvat 15mg When interaction with P-gp inhibitors will have reductions in the dose of Tolvat 15mg

Concomitant use of rifampin and Tolvat 15mg decrease exposure to tolvaptan by 85%. Tolvat 15mg co administration with strong CYP3A4 inhibitors like ketoconazole will have highest labelled dose would be normal to cause an even heavy increase in exposure.

Contraindication

Tolvat 15mg is contraindicated with following condition as Patients with autosomal dominant polycystic kidney disease because the drug causes severe and possible fatal liver injury. Required in acutely raised serum sodium Patients inability to sense Hypovolemic /hyponatremia


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