Brand Name : Tolsama
Composition : Tolvaptan
Strength availability : 30mg
Manufactured by : MSM Laboratories
Tab Count : 10 Tablets in 1 strip
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Tolsama 30mg 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.
Tolsama 30mg is needed to cure hyponatremia (low levels of sodium in your blood) in people with heart failure, and certain hormonal imbalances.
Tolsama 30mg improves urine flow without causing the body to lose too much sodium as you urinate
Tolsama 30mg is used for the treatment of patients with hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Tolsama 30mg 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 Tolsama should be without food
Grape juice should be avoided during therapy with Tolsama
There is no essential antitoxin for Tolsama intoxication. 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
Tolsama 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. Tolsama is especially useful for heart failure patients as they have higher serum levels of vasopressin.
Time to peak plasma concentration of Tolsama is 2-4 hours The absolute bioavailability is unknown.
Volume of distribution in healthy subjects is 3L/kg.
The plasma protein bounding of Tolsama is 99%
Tolsama is metabolism occurs by CYP3A4 enzyme in the liver.
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 Tolsama is 12 hours.
• Tolsama 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
• Tolsama 30mg produce Osmotic demyelination syndrome is a harm along with too-fast correction of hyponatremia
• When Tolvaptan interaction with P-gp inhibitors will have reductions in the dose of Tolsama 30mg
• Concomitant use of rifampin and Tolsama 30mg decrease exposure to tolvaptan by 85%.
• Combination with moderate CYP3A4 inhibitors will increase in exposure of Tolsama 30mg.
• Combination of lovastatin, digoxin, furosemide, and hydrochlorothiazide has no clinically relevant impact on the exposure to Tolsama 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.
Tolsama 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
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.
Store the Tolsama 30mg at 25℃ (77℉)
Keep away from the children’s reach.
Dispense only in original containers.