Tolvaptan
تولواپتان
❤️ Cardiovascular SystemVasopressin V2 receptor antagonist
Market / country: 🇺🇸 USA
Samsca (US)
🧮 Dose calculator
Hyponatraemia · Regimen source: FDA Samsca · 2.1
- • Start only in hospital; over-rapid correction causes osmotic demyelination. Increase to 30 then up to 60 mg at ≥24-h intervals. FDA Samsca · 2.1FDA Samsca · Boxed Warning
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypovolaemic hyponatraemia; inability to sense or respond to thirst; strong CYP3A inhibitors; anuria; ADPKD outside REMS; hypersensitivity. FDA Samsca · 4
Warnings
- • Boxed warning: initiate and re-initiate only in hospital with sodium monitoring; not for ADPKD. FDA Samsca · Boxed Warning
Formulations
- 15 mg tablet — tablet 🇺🇸 USA FDA Samsca · 3
- 30 mg tablet — tablet 🇺🇸 USA FDA Samsca · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Samsca · 8.1
“Risk Summary Available data with SAMSCA use in pregnant women are insufficient to determine if there is a drug-associated risk of adverse developmental outcomes.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Samsca · 8.2
“Because of the potential for serious adverse reactions, including electrolyte abnormalities (e.g., hypernatremia), hypotension, and volume depletion in breastfed infants, advise women not to breastfeed during treatment with SAMSCA.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Samsca · 8.4
“Safety and effectiveness of SAMSCA in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Samsca · 8.5
“Of the total number of hyponatremic subjects treated with SAMSCA in clinical studies, 42% were 65 years old and over, while 19% were 75 years old and over.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA022275
- DailyMed (FDA label)FDA Samsca
- MedlinePlus (NIH)Tolvaptan (kidney disease)Tolvaptan (low blood sodium)
- WHO ATC/DDDC03XA01
- Darooyab (Iran)Tolvaptan
🇮🇷 Registered in Iran Darooyab · G-4897/Tolvaptan
Dosage forms with Iranian generic codes, per Darooyab.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Samsca · 3FDA Samsca · 2.1FDA Samsca · Boxed WarningFDA Samsca · 4FDA Samsca · SPL approval / marketing categoryFDA Samsca · 8.1FDA Samsca · 8.2FDA Samsca · 8.4FDA Samsca · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-4897/Tolvaptan
- Clinical review⚠ Unverified