Indomethacin
ایندومتاسین
🦴 Musculo-Skeletal SystemNSAID
Market / country: 🇺🇸 USA
Indocin (US)
🧮 Dose calculator
Rheumatoid arthritis · Regimen source: FDA Indomethacin · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity; history of asthma, urticaria or allergic reaction to aspirin or NSAIDs; perioperative pain in CABG. FDA Indomethacin · 4
Warnings
- • Boxed warning: risk of serious thrombotic cardiovascular events and GI bleeding, ulceration and perforation. FDA Indomethacin · Boxed Warning
Formulations
- 25 mg capsule — capsule 🇺🇸 USA FDA Indomethacin · 3
- 50 mg capsule — capsule 🇺🇸 USA FDA Indomethacin · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Indomethacin · 8.1
“Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including indomethacin capsules, can cause premature closure of the fetal ductus arteriosus ( see Data ).”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Indomethacin · 8.2
“Risk Summary Based on available published clinical data, indomethacin may be present in human milk.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Indomethacin · 8.4
“Safety and effectiveness in pediatric patients 14 years of age and younger has 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 Indomethacin · Boxed Warning
“Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ( 5.2 ) Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial …”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Indomethacin · 8.3
“Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including indomethacin capsules, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.”
🔗 Reference links
- FDA (approval record)ANDA091276
- DailyMed (FDA label)FDA Indomethacin
- MedlinePlus (NIH)IndomethacinIndomethacin Rectal
- WHO ATC/DDDM01AB01
- Darooyab (Iran)Indomethacin
🇮🇷 Registered in Iran Darooyab · G-104/Indomethacin
Dosage forms with Iranian generic codes, per Darooyab.
- 01541 · INDOMETHACIN 1% OPH DROP · قطره چشمی ایندومتاسین ۱ درصد
- 00668 · INDOMETHACIN 100MG SUPP · شیاف ایندومتاسین ۱۰۰ میلیگرم
- 06467 · INDOMETHACIN 100ML SUSP · سوسپانسیون ایندومتاسین ۱۰۰ میلیلیتر
- 00669 · INDOMETHACIN 25MG CAP · کپسول ایندومتاسین ۲۵ میلیگرم
- 00670 · INDOMETHACIN 50MG SUPP · شیاف ایندومتاسین ۵۰ میلیگرم
- 19235 · INDOMETHACIN 50MG/2ML INJ · فرآورده تزریقی ایندومتاسین ۵۰ میلیگرم / ۲ میلیلیتر
- 01542 · INDOMETHACIN AMP · آمپول ایندومتاسین
- 00671 · INDOMETHACIN SR 75MG TAB · قرص آهستهرهش ایندومتاسین ۷۵ میلیگرم
- 02139 · INDOMETHACIN SR 80MG TAB · قرص آهستهرهش ایندومتاسین ۸۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Indomethacin · 3FDA Indomethacin · 2.2FDA Indomethacin · 2.4FDA Indomethacin · 4FDA Indomethacin · Boxed WarningFDA Indomethacin · SPL approval / marketing categoryFDA Indomethacin · 8.1FDA Indomethacin · 8.2FDA Indomethacin · 8.4FDA Indomethacin · 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)✅ PresentDarooyab · G-104/Indomethacin
- Clinical review⚠ Unverified