Dofetilide
دوفتیلید
❤️ Cardiovascular SystemClass III antiarrhythmic
Market / country: 🇺🇸 USA
Tikosyn (US)
🧮 Dose calculator
Atrial fibrillation / anticoagulation · Regimen source: FDA Tikosyn · Dosage and Administration
🛡️ Safety & information
Contraindications
- ⛔ Long QT syndrome; baseline QTc >440 ms (500 with ventricular conduction abnormalities); CrCl <20; verapamil, cimetidine, trimethoprim, ketoconazole, prochlorperazine, megestrol, dolutegravir, hydrochlorothiazide. FDA Tikosyn · Contraindications
Warnings
- • Boxed warning: ventricular arrhythmia (torsade) — initiate or re-initiate only with ECG monitoring and CrCl calculation. FDA Tikosyn · Boxed WarningFDA Tikosyn · Dosage and Administration
Formulations
- 125 mcg capsule — capsule 🇺🇸 USA FDA Tikosyn · How Supplied
- 250 mcg capsule — capsule 🇺🇸 USA FDA Tikosyn · How Supplied
- 500 mcg capsule — capsule 🇺🇸 USA FDA Tikosyn · How Supplied
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Tikosyn · Pregnancy
“Dofetilide has been shown to adversely affect in utero growth and survival of rats and mice when orally administered during organogenesis at doses of 2 or more mg/kg/day.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Tikosyn · Nursing Mothers
“There is no information on the presence of dofetilide in breast milk.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Tikosyn · Pediatric Use
“The safety and effectiveness of TIKOSYN in children (<18 years old) has 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 Tikosyn · Geriatric Use
“Because elderly patients are more likely to have decreased renal function with a reduced creatinine clearance, care must be taken in dose selection (see DOSAGE AND ADMINISTRATION ).”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA020931
- DailyMed (FDA label)FDA Tikosyn
- MedlinePlus (NIH)Dofetilide
- WHO ATC/DDDC01BD04
- Darooyab (Iran)Dofetilide
🇮🇷 Not found in Iran list Darooyab · G-1650/Dofetilide
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Tikosyn · How SuppliedFDA Tikosyn · Dosage and AdministrationFDA Tikosyn · ContraindicationsFDA Tikosyn · Boxed WarningFDA Tikosyn · PregnancyFDA Tikosyn · Nursing MothersFDA Tikosyn · Pediatric UseFDA Tikosyn · Geriatric UseFDA Tikosyn · SPL approval / marketing category
- 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-1650/Dofetilide
- Clinical review⚠ Unverified