Niacin (extended-release)
نیاسین (آهستهرهش)
❤️ Cardiovascular SystemLipid-modifying agent (nicotinic acid)
Market / country: 🇺🇸 USA
Niaspan (US)
🧮 Dose calculator
Hyperlipidemia / heterozygous familial hypercholesterolemia · Regimen source: FDA Niacin ER · 2.1FDA Niacin ER · 2.2
- • At bedtime after a low-fat snack. Do not increase by more than 500 mg in any 4 weeks. Above 2000 mg/day not recommended. FDA Niacin ER · 2.1FDA Niacin ER · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Active liver disease or unexplained transaminase elevation; active peptic ulcer; arterial bleeding; hypersensitivity. FDA Niacin ER · 4
Warnings
- • No reduction in cardiovascular events; myopathy (especially with statins); liver injury; raised glucose and uric acid; flushing. FDA Niacin ER · 5
Formulations
- 500 mg ER tablet (do not break) — tablet 🇺🇸 USA FDA Niacin ER · 3
- 1000 mg ER tablet (do not break) — tablet 🇺🇸 USA FDA Niacin ER · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Niacin ER · 8.1
“Risk Summary Discontinue niacin extended-release when pregnancy is recognized in patients receiving the drug for the treatment of hyperlipidemia.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Niacin ER · 8.2
“Because of the potential for serious adverse reactions in breastfeeding infants, including hepatotoxicity, advise patients not to breastfeed during treatment with niacin extended-release.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Niacin ER · 8.4
“Safety and effectiveness of niacin therapy in pediatric patients (≤ 16 years) 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 Niacin ER · 8.5
“Of 979 patients in clinical studies of niacin extended-release, 21% of the patients were age 65 and over.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA203578
- DailyMed (FDA label)FDA Niacin ER
- MedlinePlus (NIH)Niacin
- WHO ATC/DDDC10AD02
- Darooyab (Iran)Nicotinic-Acid
🇮🇷 Registered in Iran Darooyab · G-2915/Nicotinic-Acid
Dosage forms with Iranian generic codes, per Darooyab.
- 09226 · NICOTINIC ACID 1000MG TAB · قرص نیکوتینیک اسید ۱۰۰۰ میلیگرم
- 00898 · NICOTINIC ACID 100MG TAB · قرص نیکوتینیک اسید ۱۰۰ میلیگرم
- 00899 · NICOTINIC ACID 25MG TAB · قرص نیکوتینیک اسید ۲۵ میلیگرم
- 00900 · NICOTINIC ACID 500MG TAB · قرص نیکوتینیک اسید ۵۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Niacin ER · 3FDA Niacin ER · 2.1FDA Niacin ER · 2.2FDA Niacin ER · 4FDA Niacin ER · 5FDA Niacin ER · 8.1FDA Niacin ER · 8.2FDA Niacin ER · 8.4FDA Niacin ER · 8.5FDA Niacin ER · 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-2915/Nicotinic-Acid
- Clinical review⚠ Unverified