Betadine Vaginal (Povidone-Iodine)

BETADINE® Vaginal Preparations

Purdue Frederick


Bactericidal – Trichomonacidal – Fungicidal

Action And Clinical Pharmacology: Betadine is iodine complexed with povidone (polyvinyl-pyrrolidone). The compound is soluble in water forming a golden brown solution. Like iodine, the solution of the iodine complex is bactericidal, trichomonacidal, fungicidal and virucidal. Unlike solutions of iodine it is nonstaining to skin and natural fabrics. The antiseptic action is due to the available iodine present in the complex.

Indications And Clinical Uses: For treatment of vaginal infections including nonspecific vaginitis, vaginitis and vulvovaginitis associated with Trichomonas vaginalis and monilial infection. Douche only: also indicated for adjunctive use in preoperative vaginal prepping and for routine cleansing and deodorizing.

Contra-Indications: Hypersensitivity to iodine.

Manufacturers’ Warnings In Clinical States: Douching is reported to be associated with Pelvic Inflammatory Disease (PID), a serious infection of the reproductive system which can lead to infertility and/or tubal (ectopic) pregnancy. Symptoms of PID and a sexually transmitted disease (STD) include pain and tenderness in the lower part of the abdomen and pelvis; vaginal discharge and/or bleeding; nausea and/or fever; frequent urination; genital sores, and genital ulcers. If you suspect you have an STD or PID, stop using this product and see a doctor immediately. When to stop use: If symptoms persist after 5 days of use, or redness, swelling or pain develops, discontinue use and consult a doctor.

Pregnancy and Lactation: Betadine is spermicidal and should not be used if pregnancy is desired. Douching does not prevent pregnancy, nor should it be used for self-treatment or prevention of an STD. Do not use during pregnancy, while breast-feeding, or when symptoms of PID or an STD are present, except with the approval of your doctor.

Serum PBI may increase temporarily in some patients after povidone-iodine application.

Adverse Reactions: Although rare, local hypersensitivity reactions have occurred.

Dosage And Administration: Therapeutic Use: Use gel, suppositories or douche in the morning and in the evening. The products may be interchanged as desired.

Gel: 5 g application/dose.

Suppositories: 1 suppository/dose.

Douche: Therapeutic Use: Betadine Concentrate 25 mL in 1 L of lukewarm water/dose. Routine cleansing and deodorizing: 6 to 12 mL in 1 L, no more than once or twice a week.

Treatment should be continued for up to 14 days and should be continued during menstruation. Since Betadine may stain synthetic fabrics, use of a feminine hygiene pad is recommended.

Availability And Storage: Gel: Each g of mahogany-colored gel contains: povidone-iodine USP 10% (1% available iodine) in a base of diffusible, water-soluble polyethylene glycols. pH: 3.5 to 4.5. Tubes of 85 g complete with applicator.

Suppositories: Each suppository contains: povidone-iodine USP 200 mg (20 mg available iodine) in a polyethylene glycol base. Packages of 14, complete with applicator.

Douche: Each mL of scented mahogany-colored solution contains: povidone-iodine USP 10% (1% available iodine). pH diluted: 3.0 to 3.5. May be used with any type of douching apparatus (purchased separately). Bottles of 100 and 250 mL. Protect from excessive heat.

BETADINE® Vaginal Preparations Purdue Frederick Povidone-Iodine Bactericidal – Trichomonacidal – Fungicidal

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