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Viloxazine

ویلوکسازین

⚠ Unverified

🧠 Nervous SystemSelective norepinephrine reuptake inhibitor (non-stimulant)

🤰 Pregnancy:Dangerous / avoid 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA211964 ATC N06AX09

Market / country: 🇺🇸 USA

Qelbree (US)

🧮 Dose calculator

Disease / regimen

Attention-deficit/hyperactivity disorder · Regimen source: FDA Qelbree · 2.2

Formulation

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🛡️ Safety & information

Contraindications

⛔ MAOIs concomitantly or within 14 days (hypertensive crisis); sensitive or narrow-range CYP1A2 substrates (e.g. tizanidine, theophylline). FDA Qelbree · 4

Warnings

• Boxed warning: higher rates of suicidal thoughts and behaviour than placebo. FDA Qelbree · Boxed Warning
• Increased blood pressure and heart rate; mania; somnolence. FDA Qelbree · 5

Renal adjustment

• eGFR < 30: eGFR <30: start 100 mg, max 200 mg. FDA Qelbree · 2.4

Formulations

100 mg ER capsule — capsule 🇺🇸 USA FDA Qelbree · 3
200 mg ER capsule — capsule 🇺🇸 USA FDA Qelbree · 3
150 mg ER capsule — capsule 🇺🇸 USA FDA Qelbree · 3

👥 Special populations

🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Qelbree · 8.1
“Discontinue Qelbree when pregnancy is recognized unless the benefits of therapy outweigh the potential risk to the mother.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Qelbree · 8.2
“Risk Summary Available data from a lactation study in 15 women indicate that viloxazine and its metabolite, 5-HVLX-gluc, are present in breastmilk.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Qelbree · 8.4
“The safety and effectiveness of Qelbree in pediatric patients 6 to 17 years of age with ADHD have been established based on randomized, placebo-controlled studies in pediatric patients [see Adverse Reactions (6.1) and Clinical Studies (14) ] .”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Qelbree · 8.5
“Clinical trials of Qelbree in the treatment of ADHD did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA211964
DailyMed (FDA label)FDA Qelbree
MedlinePlus (NIH)Viloxazine
WHO ATC/DDDN06AX09
Darooyab (Iran)Viloxazine

🇮🇷 Not found in Iran list Darooyab · G-618/Viloxazine

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 Qelbree · 3 FDA Qelbree · 2.2 FDA Qelbree · 2.3 FDA Qelbree · 2.1 FDA Qelbree · 4 FDA Qelbree · Boxed Warning FDA Qelbree · 5 FDA Qelbree · 2.4 FDA Qelbree · 8.1 FDA Qelbree · 8.2 FDA Qelbree · 8.4 FDA Qelbree · 8.5 FDA Qelbree · 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-618/Viloxazine
Clinical review⚠ Unverified