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PRODUCT DETAILS

Brand Name : Tvaptan
Composition : Tolvaptan
Strength availability : 15mg
Manufactured by : Centaur Pharmaceuticals Pvt Ltd
Tab Count : 10 Tablets in 1 strip
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Tvaptan 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.
Tvaptan 15mg is needed to cure hyponatremia (low levels of sodium in your blood) in people with heart failure, and certain hormonal imbalances.
Tvaptan 15mg improves urine flow without causing the body to lose too much sodium as you urinate

USED FOR

Tvaptan 15mg is used for the treatment of patients with hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Tvaptan15mg 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.

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 :
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 Tvaptan should be without food
Grape juice should be avoided during therapy with Tvaptan
Overdose :
There is no essential antitoxin for Tvaptanintoxication. 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

Tvaptan is 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 rise in urine volume, reduce urine osmolality, and increase electrolyte-free water clearance to reduce intravascular volume and an increase serum sodium levels. Tvaptanis especially useful for heart failure patients as they have higher serum levels of vasopressin.

ADME

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

PRECAUTION

Tvaptan 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
Tvaptan 15mg produce Osmotic demyelination syndrome is a harm along with too-fast correction of hyponatremia

DRUG INTERACTION

• When Tolvaptan interaction with P-gp inhibitors will have reductions in the dose of Tvaptan 15mg
• Concomitant use of rifampin and Tvaptan 15mg decrease exposure to tolvaptan by 85%.
• Combination with moderate CYP3A4 inhibitors will increase in exposure of Tvaptan 15mg.
• Combination of lovastatin, digoxin, furosemide, and hydrochlorothiazide has no clinically relevant impact on the exposure to Tvaptan 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.

CONTRAINDICATION

Tvaptan 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

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 Tvaptan 15mg at 25℃ (77℉)
Keep away from the children’s reach.
Dispense only in original containers.

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