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Tolvaptan (trade names include Samsca, Jinarc, Jynarque, Natrise, Resodim, Tolvat, Vaptan) is an aquaretic drug, diuretic medication from vasopressin antagonists pharmacological group. This medicine is used for the treatment of low blood sodium levels (hyponatremia) associated with congestive heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone (SIADH). It works as a selective, competitive vasopressin receptor 2 (V2) antagonist.
Amiloride, Furosemide (Frumil)
Pharmacological and medical categories:
Vasopressin V2-receptor antagonist
C - Cardiovascular system
C03 - Diuretics
C03X - Other diuretics
C03XA - Vasopressin antagonists
C03XA01 - Tolvaptan
Hyperfunction of pituitary gland - E22
Syndrome of inappropriate secretion of antidiuretic hormone - E22.2
Other disorders of fluid, electrolyte and acid-base balance - E87
Hypo-osmolality and hyponatremia - E87.1
Heart failure - I50
Fibrosis and cirrhosis of liver - K74
Indications and usage:
Samsca (Tolvaptan) is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
Patients requiring intervention to raise serum sodium urgently to prevent or to treat seriousneurological symptoms should not be treated with Samsca.
It has not been established that Tolvaptan provides a symptomatic benefit to patients.
Dosage and administration:
Samsca (Tolvaptan) should be initiated and re-initiated in a hospital.
The recommended starting dose is 15 mg once daily. Dosage may be increased at intervals >= 24 hr to 30 mg once daily, and to a maximum of 60 mg once daily as needed to raise serum sodium.
Dosage forms and strengths:
Samsca (Tolvaptan) tablets: 15 mg and 30 mg.
Single oral doses up to 480 mg and multiple doses up to 300 mg once daily for 5 days have been well tolerated in studies in healthy subjects. There is no specific antidote for tolvaptan intoxication. The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: a rise in serum sodium concentration, polyuria, thirst, and dehydration/hypovolemia.
Use in patients with autosomal dominant polycystic kidney disease (ADPKD) outside of FDA-approved REMS
Need to raise serum sodium acutely
Patients who are unable to respond appropriately to thirst
Concomitant use of strong CYP3A inhibitors
Warnings and precautions:
Monitor serum sodium and neurologic status as serious neurologic sequelae can result from over rapid correction of sodium
Because of the potential increased risk of gastrointestinal bleeding in patients with cirrhosis, use in patients with cirrhosis only when the need to treat outweighs this risk
Dehydration and hypovolemia may require intervention
Avoid use with hypertonic saline
Avoid use with CYP 3A inducers and moderate CYP 3A inhibitors
Consider dose reduction if co-administered with P-gp inhibitors
Monitor serum potassium in patients with potassium > 5 mEq/L or on drugs known to increase potassium
Adverse reactions, side effects:
Most common adverse reactions ( >= 5% placebo) are thirst, dry mouth, asthenia, constipation, pollakiuria or polyuria, and hyperglycemia.
Use in specific populations:
Pregnancy: Based on animal data, may cause fetal harm
Nursing mothers: Discontinue drug or nursing taking into consideration importance of drug to mother
Pediatric Use: There are no studies
B3 - Australia
C - United States (Risk cannot be ruled out)
Salts and other forms:
Synonyms, international and chemical names:
Brands, generics, trade names:
Jinarc - Otsuka Pharmaceutical
Jynarque - Otsuka Pharmaceutical
Natrise - Sun Pharmaceutical Industries
Resodim - Lupin
Samsca - Otsuka Pharmaceutical
Tenax - Edallia Pharmaceuticals
Tolaqua - Abhay Pharma
Tolsama - MSN Laboratories, Mutual Medical Agencies
Tolvaptoris - Steris Healthcare
Tolvasca - Glenmark Pharmaceuticals, Mili Health Care
Tolvat - MSN Laboratories, Shaurya Internationa
Tvaptan - Lahar Pharmaceuticals
Vaptan - Steadfast MediShield
Tolvaptan main article on Wikipedia: https://en.wikipedia.org/wiki/Tolvaptan
Tolvaptan compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Tolvaptan
Tolvaptan on DrugBank: https://www.drugbank.ca/drugs/DB06212
Tolvaptan FAQ for low blood sodium on MedlinePlus: https://medlineplus.gov/druginfo/meds/a609033.html
Tolvaptan FAQ for kidney disease on MedlinePlus (revised 06/15/2020): https://medlineplus.gov/druginfo/meds/a620041.html
Samsca (Tolvaptan) tablets drug label info on DailyMed (revised October 26, 2020): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Jynarque (Tolvaptan) tablets and kit drug label info on DailyMed (revised March 31, 2020): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Tolvaptan for sale on Pharma Doctor: https://pharma-doctor.com/tolvaptan.html
Tolvaptan international drug names on Drugs.com: https://www.drugs.com/international/tolvaptan.html
Samsca (Tolvaptan) tablets for oral use 15 mg and 30 mg official prescribing information and medication guide from the U.S. FDA (revised 10/2012): https://www.accessdata.fda.gov/drugsatfda_docs/label...
Samsca (Tolvaptan) tablets for oral use 15 mg and 30 mg prescribing information and medication guide from Otsuka Pharmaceutical company (revised 05/2019): https://www.otsuka-us.com/media/static/Samsca-PI.pdf
Jynarque (Tolvaptan) tablets for oral use 15 mg, 30 mg, 45 mg, 60 mg and 90 mg prescribing information and medication guide from Otsuka Pharmaceutical company (revised 10/2020): https://www.otsuka-us.com/media/static/JYNARQUE-PI.pdf
Samsca (Tolvaptan) tablets official website: https://www.samsca.com/
Samsca (Tolvaptan) 7.5 mg, 15 mg, 30 mg tablets package information leaflet on Medicines.org.uk (revised 01/2020): https://www.medicines.org.uk/emc/files/pil.6635.pdf
Jinarc (Tolvaptan) 15 mg, 30 mg, 45 mg, 60 mg, 90 mg tablets package information leaflet on Medicines.org.uk (revised 04/2020): https://www.medicines.org.uk/emc/files/pil.6846.pdf
Resodim (Tolvaptan, Samsca generic) 15 mg tablets prescribing information on Practo: https://www.practo.com/medicine-info/resodim-15-tablet-46687
Revised: April 2021
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