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NATRISE 15MG

PRODUCT DETAILS

Brand Name : Tolvat
Active ingredient : Tolvaptan
Strength availability : 30mg
Manufactured by : MSN Laboratories
Dosage Form : Tablet
Packing : 10 tablets in 1 strips
Category : Nephrology
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Tolvat 30mg decrease the level of a hormone whichcontrols 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. Tolvat 30mg isneeded to cure hyponatremia (low levels of sodium in your blood) in people with heart failure, and certain hormonal imbalances. Tolvat 30mg improves urine flow without causing the body to lose too much sodium as you urinate

Tolvat 15mg used for;

Tolvat 30mgis used for the treatment of patients with hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH). Tolvat 30mgis 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.

DOSAGE

Hyponatremia
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
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
Administration of Tolvatshould be without food Grape juice should be avoided during therapy with Tolvat
Overdose :
There is no essential antitoxin for Tolvatintoxication. 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

Tolvatis 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. Tolvatis especially useful for heart failure patients as they have higher serum levels of vasopressin.

PHARMACOLOGICAL

Absorption: Time to peak plasma concentration of Tolvatis 2-4 hours.
The absolute bioavailability is unknown.
Distribution: Volume of distribution in healthy subjects is 3L/kg.
The plasma protein bounding of Tolvatis 99%
Metabolism: Tolvatis 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 Tolvatis 12 hours.

DRUG INTERACTION

• When Tolvaptan interaction with P-gp inhibitors will have reductions in the dose of Tolvat 30mg.
• Concomitant use of rifampin and Tolvat 30mg decrease exposure to tolvaptan by 85%.
• Combination with moderate CYP3A4 inhibitors will increase in exposure of Tolvat 30mg.
• Combination of lovastatin, digoxin, furosemide, and hydrochlorothiazide has no clinically relevant impact on the exposure to Tolvat 30mg
• 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.

CONTRAINDICATIONS

Tolvat 30mg 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 .

PRECAUTION

Tolvat 30mg 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
Tolvat 30mg produce Osmotic demyelination syndrome is a harm along with too-fast correction of hyponatremia

MISSED DOSE

If 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.

STORAGE

Store the Tolvat 30mg at 25℃ (77 ℉)
Keep away from the children’s reach.
Dispense only in original containers.

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