BETADINE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BETADINE (BETADINE).
Povidone-iodine is an iodophor that releases free iodine, which oxidizes and iodinates microbial proteins and enzymes, leading to rapid broad-spectrum microbicidal activity against bacteria, fungi, viruses, and protozoa.
| Metabolism | Povidone-iodine is not significantly metabolized; free iodine is rapidly reduced to iodide in the body and excreted renally. |
| Excretion | Renal: >90% as iodide; biliary/fecal <10%. |
| Half-life | 2-7 days for iodine, prolonged in renal impairment; clinical context: topical use has minimal systemic absorption. |
| Protein binding | Negligible (<5%); iodine loosely bound to serum proteins. |
| Volume of Distribution | Not well defined; primarily limited to local tissues due to poor systemic absorption; approximately 300-400 L for iodide ion after systemic absorption. |
| Bioavailability | Topical: <1% systemic absorption; oral rinse: minimal absorption; vaginal: <5%. |
| Onset of Action | Topical: <1 minute for antimicrobial effect; oral rinse: <30 seconds. |
| Duration of Action | Topical: up to 6 hours with single application; oral rinse: 1 hour; clinical note: prolonged with repeated use due to skin binding. |
| Action Class | Antiseptics and disinfectants |
| Brand Substitutes | Eradine Ointment, Healodine 10% Ointment, Iodiap Ointment, Sysdine 10% Ointment, Povipil Ointment, Intadine HS Solution, Wokadine 10% Solution, Piodine 10 Solution, Povishine Solution, Povinanz 10% Solution, Zevodine Ointment, Puradine 5% Ointment, Wokadine 5% Ointment, Bectodine 5% Ointment, Povinanz Ointment, Povar Cream, Peldine 5% Cream, Pricat 5% Cream, Neodine Cream, Saldin 5% Cream, Povidine 5% Solution, Povicidal 5% Solution, Intadine Solution, Zylo-P 5% Solution, Drez 5% Solution, Betaseptic 5% Solution, Povinanz 5% Solution |
Apply topically as a 10% povidone-iodine solution to the affected area 1-3 times daily; for preoperative skin preparation, apply as a single scrub for 5 minutes; for mouthwash/gargle, use 1% solution (diluted 1:10) 4 times daily; for vaginal use, 10% solution as a douche once daily. Not for systemic use.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No systemic absorption with topical use; no adjustment required for renal impairment. |
| Liver impairment | No systemic absorption with topical use; no adjustment required for hepatic impairment. |
| Pediatric use | Apply topically as a 10% solution to affected area 1-3 times daily; preoperative skin prep as a 5-minute scrub; mouthwash for children old enough to rinse and spit (2.5 mL of 1% solution, diluted 1:10, up to 4 times daily); neonatal use is contraindicated due to risk of iodine absorption and hypothyroidism. |
| Geriatric use | No specific dose adjustment; use with caution in elderly with thyroid disorders or compromised skin barrier; avoid prolonged use to minimize iodine absorption. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BETADINE (BETADINE).
| Breastfeeding | Iodine is excreted into breast milk; avoid prolonged use on large areas or broken skin due to risk of neonatal hypothyroidism. M/P ratio not established. |
| Teratogenic Risk | Topical iodine absorption may cause fetal thyroid dysfunction in the second and third trimesters; first-trimester data are limited but systemic absorption is minimal with intact skin. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known hypersensitivity to iodine or any component of the formulation","Avoid in neonates and infants due to risk of iodine-induced hypothyroidism","Not for use on deep or puncture wounds, animal bites, or serious burns"]
| Precautions | ["Avoid prolonged use on large wounds or burns due to risk of systemic iodine absorption and thyroid dysfunction","Not for use in individuals with known iodine sensitivity or Hashimoto's thyroiditis","May interfere with thyroid function tests","Do not use with other antiseptics containing mercury or silver","Use with caution in patients with renal impairment or thyroid disorders"] |
| Food/Dietary | No clinically relevant food interactions. Avoid ingestion; Betadine is for topical, oral (as a rinse) or vaginal use only. Accidental ingestion may cause gastrointestinal irritation, nausea, vomiting, and metabolic acidosis. |
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| Monitor maternal thyroid function if used extensively; assess fetal thyroid gland and growth if systemic absorption suspected. |
| Fertility Effects | No known adverse effects on fertility from topical use. |
| Clinical Pearls | Betadine (povidone-iodine) is a broad-spectrum antiseptic effective against bacteria, fungi, viruses, and protozoa. It should not be used on deep wounds, puncture wounds, or severe burns due to potential tissue irritation and delayed healing. Avoid use in patients with known iodine allergy or thyroid disorders (e.g., Hashimoto's, hyperthyroidism) as absorption can exacerbate these conditions. For surgical scrubs, allow a contact time of at least 2 minutes. In neonates, use sparingly to avoid hypothyroidism from iodine absorption. Do not combine with other antiseptics containing mercury or silver (e.g., silver sulfadiazine) due to potential formation of toxic compounds. In eye preparations, ensure solution is specifically labeled for ophthalmic use. |
| Patient Advice | Do not use on large areas of broken skin or deep wounds unless directed by your doctor. · Inform your healthcare provider if you have an iodine allergy or any thyroid condition. · Do not swallow or inject Betadine; it is for external use only. · If you are pregnant or breastfeeding, consult your doctor before using. · Store at room temperature away from light and do not freeze. · Discontinue use and seek medical attention if you experience a rash, swelling, or difficulty breathing. · Do not use with other antiseptic products containing mercury or silver. · For mouthwash or gargle, do not swallow; spit out after use. |