Tolvaptan Online



How and where to order Tolvaptan (Samsca) 15 mg tablets online on NCCME website:

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Forms:Samsca (Tolvaptan) 15 mg tablets
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Type:Tolvaptan brand, Resodim brand, Samsca generic
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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.


Samsca (Tolvaptan) tablets 15 mg


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  • Prazosin (Minipress)
  • Propranolol (Inderal)
  • Torsemide (Demadex)
  • Valsartan (Diovan)


    Pharmacological and medical categories:

  • Aquaretic drugs
  • Diuretics
  • Vasopressin V2-receptor antagonist
  • Water pills
  • Water tablets


    ATC codes:

  • C - Cardiovascular system
  • C03 - Diuretics
  • C03X - Other diuretics
  • C03XA - Vasopressin antagonists
  • C03XA01 - Tolvaptan


    ICD-10 codes:

  • 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).

    Important Limitations:

  • 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.


    Overdosage:

    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.


    Contraindications:

  • 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
  • Hypovolemic hyponatremia
  • Concomitant use of strong CYP3A inhibitors
  • Anuria
  • Hypersensitivity


    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


    Pregnancy categories:

  • D - Australia
  • C - United States (Risk cannot be ruled out)


    Salts and other forms:

  • Tolvaptan Base


    Synonyms, international and chemical names:

  • Tolvaptana
  • Tolvaptano
  • Tolvaptanum


    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


    References:

  • 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 (revised September 2021): https://pharma-doctor.com/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: September 2021



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