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Povidone iodine external and oral antiseptic (topical): Drug information

Povidone iodine external and oral antiseptic (topical): Drug information
(For additional information see "Povidone iodine external and oral antiseptic (topical): Patient drug information" and see "Povidone iodine external and oral antiseptic (topical): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Aplicare Povidone-Iodine Scrub [OTC] [DSC];
  • Aplicare Povidone-Iodine [OTC] [DSC];
  • Betadine Antiseptic Dry Powder [OTC];
  • Betadine Antiseptic Gargle [OTC];
  • Betadine Antiseptic Rinse [OTC];
  • Betadine Antiseptic [OTC] [DSC];
  • Betadine Surgical Scrub [OTC];
  • Betadine Swabsticks [OTC];
  • Betadine [OTC];
  • Clorox Nasal Antiseptic [OTC] [DSC];
  • ExCel AP [OTC] [DSC];
  • First Aid Antiseptic [OTC];
  • PVP Prep [OTC] [DSC];
  • PVP Scrub [OTC] [DSC];
  • Scrub Care Povidone-iodine [OTC];
  • Summers Eve Disp Medicated [OTC]
Pharmacologic Category
  • Antiseptic, Topical;
  • Antiseptic, Vaginal;
  • Topical Skin Product
Dosing: Adult
Antiseptic

Antiseptic: Oral: 10 mL gargled up to 4 times daily.

Antiseptic: Topical: Apply to affected area 1 to 3 times daily.

Surgical scrub

Surgical scrub: Topical: Apply solution to wet skin or hands, scrub for ~5 minutes, rinse; refer to product labeling for specific procedure-related instructions.

Vaginal irritation

Vaginal irritation: Douche: Insert 0.3% solution vaginally once daily for up to 3 days.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Povidone iodine external and oral antiseptic (topical): Pediatric drug information")

Antiseptic

Antiseptic: Infants, Children, and Adolescents: Topical: Apply to affected area 1 to 3 times daily.

Preoperative skin preparation

Preoperative skin preparation: Infants, Children, and Adolescents: Topical: Apply solution to wet skin and lather, wash vigorously for at least 15 seconds, and then rinse.

Sore throat

Sore throat: Gargle solution 0.5%: Children ≥12 years and Adolescents: Oral topical: 10 mL gargled for 30 seconds and then expectorated up to 4 times daily.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also refer to Iodine monograph.

Frequency not defined:

Dermatologic: Localized erythema, severe dermatological reaction (localized; rare)

Hypersensitivity: Local hypersensitivity reaction

Local: Application site pain (persistent or increases), local irritation, local swelling

Contraindications

OTC labeling: When used for self-medication, do not use if hypersensitivity to iodine or any component of the formulation exists, in the eyes, or over large areas of the body. In addition, do not use vaginal formulation to prevent pregnancy, during pregnancy, or if trying to get pregnant; or to treat or prevent sexually transmitted disease or pelvic inflammatory disease. Do not use gargle in children <3 years of age, for >7 days, or in patients with thyroid conditions.

Warnings/Precautions

Other warnings/precautions:

• Appropriate use: When used as a topical antiseptic, improper use may lead to product contamination. Although infrequent, product contamination has been associated with reports of localized and systemic infections. To reduce the risk of infection, ensure antiseptic products are used according to the labeled instructions, avoid diluting products after opening, and apply single-use containers only one time to one patient and discard any unused solution (FDA Drug Safety Communication 2013). Topical products are for external use only. Do not use these products in the eyes or over large areas of the body. Avoid spraying the aerosol in the eyes. In preoperative prepping, avoid "pooling" beneath the patient.

• Self-medication (OTC use): Ask health care provider prior to applying topical formulations to deep or puncture wounds, animal bites, or serious burns; discontinue use and notify health care provider if condition persists or gets worse, if need to use product >1 week, or if redness, swelling, irritation, or pain develops, increases, or continues. Notify health care provider promptly if sore throat is severe, persistent, or accompanied by headache, high fever, nausea, or vomiting.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Aerosol Powder, External:

Betadine Antiseptic Dry Powder: 5% (56.7 g)

Cream, External:

Betadine Antiseptic: 5% (15 g [DSC])

Gel, External:

Aplicare Povidone-Iodine: 10% (118 mL [DSC]) [latex free]

Miscellaneous, External:

Generic: 10% (2 ea [DSC], 4 ea [DSC])

Ointment, External:

First Aid Antiseptic: 10% (28.4 g)

Generic: 10% (1 g [DSC], 28.35 g [DSC])

Pad, External:

Generic: 10% (1 ea [DSC], 100 ea, 200 ea [DSC])

Solution, External:

Aplicare Povidone-Iodine: 10% (59 mL [DSC], 118 mL [DSC], 237 mL [DSC], 473 mL [DSC], 946 mL [DSC], 3800 mL [DSC]) [latex free]

Aplicare Povidone-Iodine Scrub: 7.5% (59 mL [DSC], 118 mL [DSC], 473 mL [DSC], 946 mL [DSC], 3800 mL [DSC]) [latex free]

Betadine: 5% (88.7 mL); 10% (14.8 mL, 118 mL, 177 mL, 237 mL, 473 mL, 946 mL [DSC], 3780 mL)

Betadine Surgical Scrub: 7.5% (118 mL, 473 mL, 946 mL, 3780 mL)

PVP Prep: 10% (473 mL [DSC]) [latex free]

PVP Scrub: 7.5% (118 mL [DSC]) [latex free]

Scrub Care Povidone-iodine: 10% (118 mL)

Generic: 10% (30 mL [DSC], 236 mL, 237 mL, 473 mL, 3780 mL)

Solution, Mouth/Throat:

Betadine Antiseptic Gargle: 0.5% (237 mL) [contains propylene glycol, saccharin sodium]

Betadine Antiseptic Rinse: 0.5% (237 mL) [contains propylene glycol, saccharin sodium]

Solution, Vaginal:

Summers Eve Disp Medicated: 0.3% (274 mL) [contains disodium edta, sodium benzoate]

Swab, External:

Betadine Swabsticks: 10% (1 ea, 3 ea)

Clorox Nasal Antiseptic: 10% (4 ea [DSC])

ExCel AP: 7.50% (3 ea [DSC]) [latex free]

Generic: 7.5% (50 ea [DSC]); 10% (1 ea [DSC], 2 ea [DSC], 3 ea, 50 ea, 75 ea)

Generic Equivalent Available: US

May be product dependent

Pricing: US

Aerosol powder (Betadine Antiseptic Dry Powder External)

5% (per gram): $0.13

Pads (Povidone-Iodine External)

10% (per each): $0.05

Solution (Betadine Antiseptic Gargle Mouth/Throat)

0.5% (per mL): $0.03

Solution (Betadine Antiseptic Rinse Mouth/Throat)

0.5% (per mL): $0.03

Solution (Betadine External)

5% (per mL): $0.09

10% (per mL): $0.05

Solution (Betadine Surgical Scrub External)

7.5% (per mL): $0.01

Solution (Povidone-Iodine External)

10% (per mL): $0.02

Solution (Scrub Care Povidone-iodine External)

10% (per mL): $0.02

Solution (Summers Eve Disp Medicated Vaginal)

0.3% (per mL): $0.02

Swab (Betadine Swabsticks External)

10% (per each): $0.24

Swab (Povidone-Iodine External)

10% (per each): $0.13 - $0.16

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical, external: For external use only. Avoid contact with eyes, nose, or mouth. Refer to product labeling for additional instructions.

Topical, oral rinse: Gargle in mouth for 30 seconds; do not swallow. Only use dosing cup provided. May stain clothing or dental work. Avoid contact with jewelry, especially silver.

Vaginal: Refer to product labeling for detailed instructions.

Administration: Pediatric

Topical, external: For external use only. Do not use on deep puncture wounds, animal bites, or serious burns. Avoid contact with eyes, nose, or mouth. Refer to product labeling for additional instructions.

Topical, oral gargle: Gargle in mouth for 30 seconds; do not swallow. Only use dosing cup provided. May stain clothing or dental work. Avoid contact with jewelry, especially silver.

Use: Labeled Indications

Antiseptic, external: Antiseptic with broad microbicidal spectrum for the prevention or treatment of topical infections associated with surgery, burns, and minor cuts/scrapes.

Antiseptic, oral: Topical oral antiseptic for temporary relief of occasional sore throat.

Vaginal irritation: Temporary relief of minor vaginal irritation or itching.

Medication Safety Issues
Sound-alike/look-alike issues:

Betadine may be confused with Betadine without povidone-iodine, Betagan, betaine

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Sodium Iodide I131: Povidone-Iodine (Topical) may diminish the therapeutic effect of Sodium Iodide I131. Management: Discontinue topical povidone-iodine at least 3 weeks before sodium iodide I-131 administration, and avoid concurrent use. Risk X: Avoid combination

Taurolidine: May enhance the adverse/toxic effect of Povidone-Iodine (Topical). Specifically, concomitant use of taurolidine and povidone-iodine may increase the risk of metabolic acidosis. Risk X: Avoid combination

Pregnancy Considerations

Vaginal products should not be used during pregnancy. Povidine-iodine is absorbed systemically as iodine following topical administration to the vaginal mucosa (Velasco 2009; Vorherr 1980). Following vaginal administration as a douche, iodine concentrations are increased in the maternal urine, amniotic fluid, cord blood and fetal thyroid (Bachrach 1984; Mahillon 1989). Transient hypothyroidism in the newborn has been reported following topical use prior to delivery (Danziger 1987). Refer to Iodine for additional information.

Breastfeeding Considerations

Iodine can be detected in breast milk following topical application of povidone-iodine (Koga 1995).

Mechanism of Action

Povidone-iodine is known to be a powerful broad spectrum germicidal agent effective against a wide range of bacteria, viruses, fungi, protozoa, and spores.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Absorbed systemically as iodine; amount depends upon concentration, route of administration, characteristics of skin

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Betadine | Betadine sore throat spray | Defodine | Povicenter | Savlon | Vaginal douche;
  • (AR) Argentina: Excelentia solucion antiseptica | Extra leci iodopovidonal | Fada iodopovidona | Iodomine | Iodopovidona | Iodopovidona denver farma | Iodopovidona sidus | Iopox | Pervinox | Pervinox d 125 | Povi complex | Povibac | Povitiol;
  • (AT) Austria: Betadona | Betaisodona;
  • (AU) Australia: Betadine | Betadine gauze pad | E z scrub povidone | Iodine | Isodine | Microguard 475 | Microshield pvp | Minidine | Nicepak jelly | Povidone iodine | Riodine;
  • (BD) Bangladesh: Betadine | Donadin | Povidex | Povisep;
  • (BE) Belgium: Betadermyl | Braunodine | Braunol | Iso Betadine | Povidone iodine Minims;
  • (BF) Burkina Faso: Betadine;
  • (BG) Bulgaria: Betadine;
  • (BR) Brazil: Betacare | Riodeine | Sabofen | Solucao pvpi;
  • (CH) Switzerland: Betadina | Betadine;
  • (CL) Chile: Difexon | Polividona yodada;
  • (CN) China: Dai wei | Povidone iodine | You nan;
  • (CO) Colombia: Bactrodine | Biocidil | Germex | Iofoam | Isodine | Isodine V | Yovidona;
  • (CZ) Czech Republic: Betadine;
  • (DE) Germany: Betaisodona | Braunol | Braunovidon | Traumasept | Vagisan sept;
  • (DO) Dominican Republic: Bacterodine | Isodine;
  • (EC) Ecuador: Povidine | Povidyn | Yopodine;
  • (EE) Estonia: Betadin | Jodogel;
  • (EG) Egypt: Betadine | Betavidone | Iodosept | Povidone iodine;
  • (ES) Spain: Braunoderm | Curadona;
  • (ET) Ethiopia: Povidone iodine;
  • (FI) Finland: Betadine;
  • (FR) France: Betadine | Betadine scrub | Betadine tulle | Minims povidone iodine | Poliodine dermique | Povidone Iodee Merck;
  • (GB) United Kingdom: Betadine | Betasept | Disphex | Savlon | Savlon care | Savlon Dry;
  • (GR) Greece: Betadine | Oxisept | Poviodine;
  • (HK) Hong Kong: Betadine | Betadine Feminine | Freka cid;
  • (HR) Croatia: Betadine;
  • (HU) Hungary: Betadine;
  • (ID) Indonesia: Betadine | Duvodine | Isodine | Orodin | Septadine;
  • (IE) Ireland: Betadine | Savlon Dry Antiseptic | Videne;
  • (IL) Israel: Iodispray | Polydine;
  • (IN) India: Betadine | Betakind | Cipladine | Drez | G dine | Oroclear | Ovidine | Povicidal | Povid | Povidone iodine | Povimax | Povina | Skin prep | Soludin | Wetadine | Wokadine;
  • (IT) Italy: Asepsan | Betadine | Betadine Pmc | Betadine sapone | Golasept | Oftasteril;
  • (JO) Jordan: Betadine | Femadine | Povidex | Povidone iodine;
  • (JP) Japan: Asadaame nodo cool | Bongol | Cakonal nodo | Coffgis | Ephstlin nodo | Homodon | Iodine | Isodine | Isodine obstetric | Kohudan nodo | Lookel nodo | Microshield pvp | Negmin | Negmin merck hoei | Neojodin | New nodotoful | Nodosyan | Popikuru | Popiyodon | Povidone iodine cotton ball kenei | Povidone iodine cotton swab kenei | Povidone iodine scrub kenei | Povidone-iodine meiji | Povidorine | Swabstick;
  • (KE) Kenya: Betadine dry powder | Betadine vaginal | Germidine | Povid | Povisep | Pyodine;
  • (KR) Korea, Republic of: Betadine | Betadine cool throat | Betascrub | Coolever | Dongindang povidone stick swab | Finici | Gargle | Greencool | Gynobetadine | Inocool throat spray | Porividone | Potadine | Povi | Poviclean | Povidide | Povidin | Povidine | Povidine throat | Povidone Stick Swab | Povigyn | Siwena | Sungkwang postick swab | Tydon;
  • (KW) Kuwait: Betadine;
  • (LB) Lebanon: Betadine | Betadine Repigel;
  • (LT) Lithuania: Betadine | Betaisodona | Jodine Povidone | Jodogel | Traumasept;
  • (LV) Latvia: Betadine | Betaisodona | Jodogels | Jodoxid | Traumasept;
  • (MA) Morocco: Betadine;
  • (MX) Mexico: Dermodine | Isodine | Isodine V;
  • (MY) Malaysia: Betadine | Povidone iodine | Pvp Iodine | Thermalife surgical scrub | Vinodine;
  • (NG) Nigeria: Pyodine | Wosan;
  • (NL) Netherlands: Betadine | Braunol jodium | Minims povidon jodium;
  • (NO) Norway: Iso-betadine nordic pill | Minims povidone iodine;
  • (NZ) New Zealand: Betadine | Savlon;
  • (PE) Peru: Isodine | Yodolaph | Yovisol;
  • (PH) Philippines: Alfa Fresh | Alfadine | Betadine | Ritemed Povidone-Iodine;
  • (PK) Pakistan: Abodine | Betadine | Povin | Pyodine;
  • (PL) Poland: Actisept | Betadine | Betadine Uno | Betadine Uro | Betaisodona | Jodi | Polseptol | Pvp Iodine | Traumasept;
  • (PR) Puerto Rico: Betadine | Grx dyne | Povidone iodine;
  • (PT) Portugal: Betadine | Dinasepte | Ectodine | Iodopovidona | Isodine | Septil;
  • (PY) Paraguay: Iodopovidona douglas | Iodopovidona dutriec | Iodopovidona empa | Iop | Nogerm | Sanimed ip;
  • (QA) Qatar: Betadine | Betadine Dry | Betadine Surgical Scrub | Claradone | Claradone Mouthwash | Iodosept | Piodine | Piodine VD | Povilon | Qdine | Videne Surgical Scrub;
  • (RO) Romania: Betadine | Cervincin;
  • (RU) Russian Federation: Betadine | Iodovidon | Iodoxyd | Iovidox | Jodosept | Octasept | Povidon iod | Povidone iodine;
  • (SA) Saudi Arabia: Avalon plus | Betadine | Defadine | Minims povidone iodine | Piodine | Povidone iodine | Vaginal douche;
  • (SG) Singapore: Betadine | Betadine sore throat spray | Germidine | Povidone iodine;
  • (SI) Slovenia: Betadine | Braunoderm | Braunol 2000;
  • (SK) Slovakia: Betadine | Braunol;
  • (TH) Thailand: Bactedene | Betadine | Betamed | Dermofax | Eprodine | Freka cid | Germidine | Germiscrub | Isodine | Leopovidone | Patardine | Povidine | Povidone iodine | Povidone-iodine scrub | Providine | Pyrad Povidone | Safadine | Septyl | Upodine | Videne;
  • (TN) Tunisia: Betadine;
  • (TR) Turkey: Batol | Batticon | Betadin | Biokadin | Iodeks | Polyod | Poviseptin | Soliyod;
  • (TW) Taiwan: Betadine | Betaisodona | Happy mouth spray | Hou ni hao | New Touch | Polvidine | Popycle | Povidine | Pureclean | Saint-Iodin | Sutorusu | Throatec spray for throat | Vigill;
  • (UA) Ukraine: Betadine | Betaiod | Iodixol | Iodoxid | Povidin lh | Povisep | Vocadin;
  • (UG) Uganda: Pyodine;
  • (UY) Uruguay: Faryodo;
  • (VE) Venezuela, Bolivarian Republic of: Betadine | Norlidine | Podival | Povidine | Povidine herbal | Yodasep | Yodopovidona;
  • (VN) Viet Nam: Poginal;
  • (ZA) South Africa: Betadine | Biocream | Septisooth;
  • (ZM) Zambia: Vinodine | Wokadine
  1. Aplicare Povidone-Iodine Scrub Sponge Sticks (povidone-iodine 10%) [prescribing information]. Meriden, CT: Aplicare, Inc; 2017.
  2. Bachrach LK, Burrow GN, Gare DJ. Maternal-fetal absorption of povidone-iodine. J Pediatr. 1984;104(1):158-159. [PubMed 6690663]
  3. Betadine (povidone-iodine 5%) cream [prescribing information]. Stamford, CT: Avrio Health LP; received August 2020.
  4. Betadine (povidone-iodine 5%) spray [prescribing information]. Stamford, CT: Avrio Health LP; August 2018.
  5. Betadine (povidone-iodine 7.5%) surgical scrub [prescribing information]. Stamford, CT: Avrio Health LP; October 2018.
  6. Betadine (povidone-iodine 10%) solution [prescribing information]. Stamford, CT: Avrio Health LP; October 2018.
  7. Betadine (povidone-iodine 10%) solution swabstick [prescribing information]. Stamford, CT: Purdue Products LP; September 2011.
  8. Betadine Antiseptic (povidone-iodine 5%) cream [prescribing information]. Stamford, CT: Avrio Health LP; 2020.
  9. Betadine Antiseptic Sore Throat Gargle (povidone-iodine 0.5%) rinse [prescribing information]. Stamford, CT: Avrio Health LP; received January 2021
  10. Betadine Antiseptic Sore Throat gargle (povidone-iodine 5%) rinse [prescribing information]. Stamford, CT: Avrio Health LP; 2020.
  11. Betadine First Aid (povidone-iodine 10%) solution [prescribing information]. Stamford, CT: Avrio Health LP; October 2018.
  12. Betadine Skin Cleanser (povidone-iodine 7.5%) solution [prescribing information]. Stamford, CT: Purdue Products LP; January 2016.
  13. CVS Health Povidone Iodine Swabstick (povidone-iodine 10%) [prescribing information]. Woonsocket, RI: CVS Pharmacy; March 2019.
  14. Danziger Y, Pertzelan A, Mimouni M. Transient congenital hypothyroidism after topical iodine in pregnancy and lactation. Arch Dis Child. 1987;62(3):295-296. [PubMed 3566323]
  15. Dela Cruz F, Brown DH, Leikin JB, et al, “Iodine Absorption After Topical Administration,” West J Med, 1987, 146(1):43-5. [PubMed 3825108]
  16. First Aid Antiseptic ointment (poviodone Iodine USP 10%) [prescribing information]. Livonia, MI: Rugby Laboratories; November 2019.
  17. Food and Drug Administration. FDA Drug Safety Communication: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection. http://www.fda.gov/Drugs/DrugSafety/ucm374711.htm. Updated November 20, 2013. Accessed October 1, 2014.
  18. Koga Y, Sano H, Kikukawa Y, Ishigouoka T, Kawamura M. Effect on neonatal thyroid function of povidone-iodine used on mothers during perinatal period. J Obstet Gynaecol (Tokyo 1995). 1995;21(6):581-585. [PubMed 8640469]
  19. Mahillon I, Peers W, Bourdoux P, Ermans AM, Delange F. Effect of vaginal douching with povidone-iodine during early pregnancy on the iodine supply to mother and fetus. Biol Neonate. 1989;56(4):210-217. [PubMed 2804185]
  20. Povidone-Iodine Scrub Solution [prescribing information]. Waukegan, IL: Cardinal Health; November 2015.
  21. Summer's Eve Medicated Douche. Summer's Eve website. https://www.summerseve.com/feminine-hygiene-products/douche/medicated-douche. Accessed October 28, 2019.
  22. Velasco I, Naranjo S, López-Pedrera C, Garriga MJ, García-Fuentes E, Soriguer F. Use of povidone-iodine during the first trimester of pregnancy: a correct practice? BJOG. 2009;116(3):452-455. [PubMed 19187379]
  23. Vorherr H, Vorherr UF, Mehta P, Ulrich JA, Messer RH. Vaginal absorption of povidone-iodine. JAMA. 1980;244(23):2628-2629. [PubMed 7431610]
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