Tolvaptan

【Product name】Samsca

[English common name]Tolvaptan

[Chinese common name]Tolvaptan

[English name]

[Chinese other name]

[indications]This product is used to treat clinically significant high-capacity normal capacityHyponatremia(blood sodium concentration <125mEq/L, or hyponatremia is not obvious but symptomatic and poorly curative effect), includingHeart failure,CirrhosisAnd patients with antidiuretic hormone abnormality syndrome (SIADH).

【Dosage】
1, the usual dose for adults
To evaluate the therapeutic effect of this product, and to correct hyponatremia too quickly can cause osmotic demyelination, resulting in dysarthria, mutism, dysphagia, lethargy, emotional changes, tonic limbs, soft palate, seizures , coma and death, so the patient's initial medication and re-medication should be carried out under hospitalization.
The usual starting dose of this product is 15mg, once a day, can be taken before and after meals. After taking the medicine for at least 24 hours, the dosage can be increased to 30 mg once a day. According to the serum sodium concentration, the maximum can be increased to 60mg once a day. During the initial dose and dose increase, changes in serum electrolytes and blood volume should be frequently tested and fluid intake should be avoided during the first 24 hours of treatment. Until the patient taking this product, drink even if you are thirsty.
2, the suspension of drug treatment
After the patient stops taking this product, the patient should be instructed to re-limit the fluid intake and detect changes in serum sodium concentration and blood volume.
If the serum sodium level of Boone is properly improved, other treatments should be considered to replace tolvaptan or to add other treatments based on Tobacco. For patients with appropriate improvements in serum sodium levels, their underlying disease and serum sodium levels should be monitored regularly to assess whether further tolvaptan therapy is needed. In the case of hyponatremia, the duration of treatment depends on the underlying disease and its treatment. It is expected that tolvaptan treatment will continue until the underlying disease is properly treated or hyponatremia is no longer a clinical problem.
3, special people
This product does not need to be adjusted according to the patient's age, gender, ethnicity, cardiac function, mild or moderate liver function damage.
Low renal function
Patients with mild to moderate renal dysfunction (creatinine clearance of 10 to 79 ml/min) do not need to be adjusted because the plasma concentration of tolvaptan does not increase. No assessment has been made of creatinine clearance <10 ml/min or administration of tolvaptan in dialysis patients. It is expected that no benefit will be given to patients who have no urine.
4. Combination with CYP3A inhibitor, CYP3A inducer and P glycoprotein inhibitor
CYP3A inhibitor
Since tolvaptan is metabolized by CYP3A and combined with a potent CYP3A inhibitor, the plasma concentration of tolvaptan can be significantly increased (up to 5 times). The effect of the intermediate-effect CYP3A inhibitor on the exposure to tolvaptan has not been evaluated. Avoid the combined application of this product and intermediate-effect CYP3A enzyme inhibitors.
CYP3A inducer
The combination of this product and a potent CYP3A inducer (such as rifampicin) can reduce the plasma concentration of tolvaptan by 85%. Therefore, the expected clinical effect of this product may not be obtained at the recommended dose. The dose should be adjusted according to the patient's reactivity.
P glycoprotein inhibitor
Tolvaptan is a substrate for P-glycoprotein. When this product is combined with a P-glycoprotein inhibitor (cyclosporin A, etc.), it is necessary to reduce the amount of this product.

[Storage] shading, sealed and stored.

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