Active ingredient : Tolvaptan
Strength availability : 15mg
Dosage Form : Tablet
Packing : 10 tablets in 1 strips
Category : Nephrology
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Tolvamac 15mg decrease the level of a hormone which controls the balance of water and salt (sodium) in the body. Peak levels of this hormone can lead an imbalance which results in low sodium levels and fluid retention.
Tolvamac 15mg is needed to cure hyponatremia (low levels of sodium in your blood) in people with heart failure, and certain hormonal imbalances. Tolvamac 15mg improves urine flow without causing the body to lose too much sodium as you urinate
Tolvamac 15mg used for;
Tolvamac 15mg is used for the treatment of patients with hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Tolvamac 15mg is also used for hypervolemic and euvolemic hyponatremia (sodium concentration <125 mmol l–1) with heart failure and cirrhosis in patients. In this US country use this medicine frequently.
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
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 Tolvamacshould be without food
Grape juice should be avoided during therapy with Tolvamac
There is no essential antitoxin for Tolvamacintoxication. The signs and symptoms of an acute overdose can be expected to be those of extra pharmacologic effect: a increase in serum sodium concentration, polyuria, thirst, and dehydration/hypovolemia. 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
MECHANISM OF ACTION
Tolvamacis a selective and competitive arginine vasopressin receptor 2 antagonist. Vasopressin acts on the V2 receptors found in the walls of the vasculature and luminal membranes of renal collecting ducts. By stopping V2 receptors in the renal collecting ducts, aquaporins avoid entering themselves into the walls thus preventing water absorption. This action finally results in an rises in urine volume, reduce urine osmolality, and increase electrolyte-free water clearance to reduce intravascular volume and an increase serum sodium levels. Tolvamacis especially useful for heart failure patients as they have higher serum levels of vasopressin.
Absorption: Time to peak plasma concentration of Tolvamacis 2-4 hours
The absolute bioavailability is unknown.
Distribution: Volume of distribution in healthy subjects is 3L/kg.
The plasma protein bounding of Tolvamacis 99%
Metabolism: Tolvamacis 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 Tolvamacis 12 hours.
• When Tolvaptan interaction with P-gp inhibitors will have reductions in the dose of Tolvamac 15mg
• Concomitant use of rifampin and Tolvamac 15mg decrease exposure to tolvaptan by 85%.
• Combination with moderate CYP3A4 inhibitors will increase in exposure of Tolvamac 15mg.
• Combination of lovastatin, digoxin, furosemide, and hydrochlorothiazide has no clinically relevant impact on the exposure to Tolvamac 15mg
• Tolvaptan co administration with strong CYP3A4 inhibitors like ketoconazole will have highest labelled dose would be normal to cause an even heavy increase in exposure.
Tolvamac 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
* Tolvamac 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.
* The conditions like Hypernatremia, hypovolemia, and/or dehydration; provoke patient to drink whenever thirsty
* Risk of potassium level increased
* Tolvamac 15mg produce Osmotic demyelination syndrome is a harm along with too-fast correction of hyponatremia
MISSED DOSEIf the patient is missed, then take the tablet dose immediately before the next dose timing arrives or skip the missed dose and continue the regular schedule.
Avoid having of double dose at a time.
Consult the doctor for further details.
STORAGEStore the Tolvamac 15mg at 25℃ (77 ℉)
Keep away from the children’s reach.
Dispense only in original containers.