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Esketamine (nasal)

اس‌کتامین (اسپری بینی)

⚠ Unverified

🧠 Nervous SystemNMDA antagonist

🤰 Pregnancy:Dangerous / avoid 🤱 Breastfeeding:Use with caution 👶 Children:Dangerous / avoid 👴 Older adults:No specific problem stated ⚥ Females & males of reproductive potential:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA211243 ATC N06AX27

Market / country: 🇺🇸 USA

Spravato (US)

🧮 Dose calculator

Disease / regimen

Major depressive disorder · Regimen source: FDA Spravato · 2.2 FDA Spravato · 2.3 FDA Spravato · 2.5

⛔ Only in a certified healthcare setting with ≥2 h observation after each session; check BP before and after. Weekly schedule per label Table 1. Acute suicidal ideation: 84 mg twice weekly for 4 weeks with an antidepressant. FDA Spravato · 2.2 FDA Spravato · 2.3 FDA Spravato · 2.5

🛡️ Safety & information

Contraindications

⛔ Aneurysmal vascular disease or AVM; history of intracerebral haemorrhage; hypersensitivity to esketamine or ketamine. FDA Spravato · 4

Warnings

• Boxed warning: sedation, dissociation, respiratory depression, abuse and misuse, suicidal thoughts; REMS only. FDA Spravato · Boxed Warning

Formulations

28 mg per device (two sprays) — nasal spray 🇺🇸 USA FDA Spravato · 3

👥 Special populations

🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Spravato · 8.1
“Based on published findings from pregnant animals treated with ketamine, the racemic mixture of arketamine and esketamine, SPRAVATO may cause fetal harm when administered to pregnant women (see Data ) .”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Spravato · 8.2
“Risk Summary Esketamine is present in human milk.”
👶 ChildrenDangerous / avoid
Boxed warning in the label about children. FDA Spravato · Boxed Warning
“( 5.5 ) Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants.”
👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Spravato · 8.5
“No overall differences in the safety profile were observed between patients 65 years of age and older and patients younger than 65 years of age.”
⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Spravato · 8.3
“Contraception Based on published animal reproduction studies, SPRAVATO may cause embryo-fetal harm when administered to a pregnant woman [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1) ].”

🔗 Reference links

FDA (approval record)NDA211243
DailyMed (FDA label)FDA Spravato
MedlinePlus (NIH)Esketamine Nasal Spray
WHO ATC/DDDN06AX27
Darooyab (Iran)❌ None

🇮🇷 Not found in Iran list Darooyab · search

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)✅ Present
FDA Spravato · 3 FDA Spravato · 2.2 FDA Spravato · 2.3 FDA Spravato · 2.5 FDA Spravato · 4 FDA Spravato · Boxed Warning FDA Spravato · SPL approval / marketing category FDA Spravato · 8.1 FDA Spravato · 8.2 FDA Spravato · 8.5 FDA Spravato · 8.3
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 · search
Clinical review⚠ Unverified

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