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Duloxetine

دولوکستین

⚠ Unverified

🧠 Nervous SystemSNRI

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Dangerous / avoid 👴 Older adults:Use with caution 🇮🇷 Registered in Iran ⛔ 3 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA206653 ATC N06AX21

Market / country: 🇺🇸 USA

Cymbalta (US)

🧮 Dose calculator

Disease / regimen

Major depressive disorder · Regimen source: FDA Duloxetine · 2.2

• 20 mg twice daily up to 60 mg once or 30 mg twice daily. Swallow capsule whole. FDA Duloxetine · 2.2 FDA Duloxetine · 2

Formulation

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🛡️ Safety & information

Contraindications

⛔ With or within 14 days of an MAOI (including linezolid or IV methylene blue). FDA Duloxetine · 4
⚠️ Avoid in severe renal impairment (GFR <30) or hepatic impairment. FDA Duloxetine · 2.7
⚠️ Boxed warning: increased suicidal thoughts and behaviour in children, adolescents and young adults. FDA Duloxetine · Boxed Warning

Formulations

20 mg capsule — capsule 🇺🇸 USA FDA Duloxetine · 3
30 mg capsule — capsule 🇺🇸 USA FDA Duloxetine · 3
60 mg capsule — capsule 🇺🇸 USA FDA Duloxetine · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Duloxetine · 8.1
“Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Duloxetine · 8.2
“Risk Summary Data from published literature report the presence of duloxetine in human milk (see Data) .”
👶 ChildrenDangerous / avoid
Boxed warning in the label about children. FDA Duloxetine · Boxed Warning
“Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Duloxetine · 8.5
“SSRIs and SNRIs, including duloxetine have been associated with clinically significant hyponatremia in geriatric patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions ( 5.13 )] .”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)ANDA206653
DailyMed (FDA label)FDA Duloxetine
MedlinePlus (NIH)Duloxetine
WHO ATC/DDDN06AX21
Darooyab (Iran)Duloxetine

🇮🇷 Registered in Iran Darooyab · G-582/Duloxetine

Dosage forms with Iranian generic codes, per Darooyab.

18430 · DULOXETINE 20MG CAP · کپسول دولوکستین ۲۰ میلی‌گرم
08361 · DULOXETINE 20MG TAB · قرص دولوکستین ۲۰ میلی‌گرم
07845 · DULOXETINE 30MG CAP · کپسول دولوکستین ۳۰ میلی‌گرم
06448 · DULOXETINE 40MG CAP · کپسول دولوکستین ۴۰ میلی‌گرم
05970 · DULOXETINE 60MG CAP · کپسول دولوکستین ۶۰ میلی‌گرم

📚 Reference status for this drug

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

FDA label (DailyMed)✅ Present
FDA Duloxetine · 3 FDA Duloxetine · 2.2 FDA Duloxetine · 2 FDA Duloxetine · 2.3 FDA Duloxetine · 2.4 FDA Duloxetine · 2.5 FDA Duloxetine · 2.6 FDA Duloxetine · 4 FDA Duloxetine · 2.7 FDA Duloxetine · Boxed Warning FDA Duloxetine · 8.1 FDA Duloxetine · 8.2 FDA Duloxetine · 8.5 FDA Duloxetine · 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)✅ Present
Darooyab · G-582/Duloxetine
Clinical review⚠ Unverified