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Milnacipran

میلناسیپران

⚠ Unverified

🧠 Nervous SystemSNRI

🤰 Pregnancy:Use with caution 👶 Children:Dangerous / avoid 👴 Older adults:Use with caution 🇮🇷 Registered in Iran ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA022256 ATC N06AX17

Market / country: 🇺🇸 USA

Savella (US)

🧮 Dose calculator

Disease / regimen

Fibromyalgia · Regimen source: FDA Savella · 2.1

• Titration: day 1: 12.5 mg; days 2–3: 12.5 mg twice; days 4–7: 25 mg twice; then 50 mg twice daily. Better tolerated with food. Taper when stopping. FDA Savella · 2.1 FDA Savella · 2.4

Formulation

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🛡️ Safety & information

Contraindications

⛔ MAOIs concomitantly, within 14 days of stopping them, or within 5 days of stopping this drug; linezolid or IV methylene blue (serotonin syndrome). FDA Savella · 4.1

Warnings

• Boxed warning: suicidality with antidepressants in children and young adults; not approved for depression in the US. FDA Savella · Boxed Warning
• Serotonin syndrome; raised blood pressure and heart rate; seizures; hepatotoxicity; hyponatraemia; bleeding; activation of mania. FDA Savella · 5

Renal adjustment

• eGFR < 30: CrCl 5–29: reduce maintenance by 50% (25 mg twice daily); ESRD not recommended. FDA Savella · 2.2

Formulations

50 mg tablet — tablet 🇺🇸 USA FDA Savella · 3
25 mg tablet — tablet 🇺🇸 USA FDA Savella · 3
100 mg tablet — tablet 🇺🇸 USA FDA Savella · 3
12.5 mg tablet — tablet 🇺🇸 USA FDA Savella · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Savella · 8.1
“Risk Summary Based on data from published observational studies, exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.2 )] .”
🤱 BreastfeedingNo data
The source for this drug has no section for this group.
👶 ChildrenDangerous / avoid
Boxed warning in the label about children. FDA Savella · Boxed Warning
“SAVELLA is not approved for use in pediatric patients [see Indications and Usage ( 1 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )].”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Savella · 8.5
“SNRIs, SSRIs, and SAVELLA, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see Warnings and Precautions ( 5.8 )] .”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA022256
DailyMed (FDA label)FDA Savella
MedlinePlus (NIH)Milnacipran
WHO ATC/DDDN06AX17
Darooyab (Iran)Milnacipran

🇮🇷 Registered in Iran Darooyab · G-596/Milnacipran

Dosage forms with Iranian generic codes, per Darooyab.

13179 · MILNACIPRAM 25MG TAB · قرص میلناسیپرام ۲۵ میلی‌گرم

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Savella · 3 FDA Savella · 2.1 FDA Savella · 2.4 FDA Savella · 4.1 FDA Savella · Boxed Warning FDA Savella · 5 FDA Savella · 2.2 FDA Savella · SPL approval / marketing category FDA Savella · 8.1 FDA Savella · 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)✅ Present
Darooyab · G-596/Milnacipran
Clinical review⚠ Unverified