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Ropivacaine

روپیواکائین

⚠ Unverified

🧠 Nervous SystemAmide local anaesthetic

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Safety not established 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA020533 ATC N01BB09

Market / country: 🇺🇸 USA

Naropin (US)

🧮 Dose calculator

Disease / regimen

Local anaesthesia (infiltration / dental) · Regimen source: FDA Naropin · 2.2, Table 1

⛔ Dose depends on site, concentration and volume (label Table 1). Up to 770 mg over 24 h (intraoperative block plus postoperative infusion) and epidural infusion up to 28 mg/h for 72 h have been tolerated. Aspirate before injecting; use a test dose. FDA Naropin · 2.2, Table 1

🛡️ Safety & information

Contraindications

⛔ Hypersensitivity to ropivacaine or other amide local anaesthetics. FDA Naropin · 4

Warnings

• Unintended intravascular injection (CNS and cardiac toxicity); chondrolysis with intra-articular infusion; methaemoglobinaemia; caution in hepatic and cardiac disease. FDA Naropin · 5

Formulations

5 mg/mL (0.5%), 30 mL vial — injection 🇺🇸 USA FDA Naropin · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Naropin · 8.1
“Risk Summary There are no available human data on use of Naropin (ropivacaine) Injection in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Naropin · 8.2
“Risk Summary One publication reported that ropivacaine is present in human milk at low levels following administration of ropivacaine in women undergoing cesarean section.”
👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Naropin · 8.4
“The safety and efficacy of NAROPIN in pediatric patients 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 Naropin · 8.5
“Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function [see Clinical Pharmacology ( 12.3 )] .”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA020533
DailyMed (FDA label)FDA Naropin
MedlinePlus (NIH)❌ None
WHO ATC/DDDN01BB09
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 Naropin · 3 FDA Naropin · 2.2, Table 1 FDA Naropin · 4 FDA Naropin · 5 FDA Naropin · SPL approval / marketing category FDA Naropin · 8.1 FDA Naropin · 8.2 FDA Naropin · 8.4 FDA Naropin · 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 · search
Clinical review⚠ Unverified

🔗 Similar drugs

Same class

Lidocaine (local anaesthetic injection)

For the same diseases

Articaine with epinephrine (dental cartridge)Bupivacaine Lidocaine with epinephrine (dental cartridge)Mepivacaine (dental cartridge)