Betadine 10% Solution 3780ml

Povidone-iodine is an iodophor, a complex of polyvinylpyrrolidone (PVP) and iodine. It acts by slowly releasing free iodine when in contact with skin and mucous membranes. Free iodine rapidly penetrates microbial cell walls and oxidizes proteins, nucleotides, and fatty acids, leading to cell death. It has a broad spectrum of activity against bacteria (including spores), fungi, viruses, and protozoa.

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin, with or without fever
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to monitor your response to the medication. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Irritation at the site where the drug was applied

Reporting Side Effects
This list does not include all possible side effects. If you have concerns about side effects or experience any symptoms not listed here, consult your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or through their website at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have recently experienced an animal bite or a deep puncture wound.
If you have a severe burn or cut.
If the affected area is large and requires extensive treatment.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the prescribed dosage and duration of treatment, and do not use this drug more frequently or for an extended period than recommended.

If accidental ingestion occurs, this medication can be harmful. In such an event, immediately contact a doctor or a poison control center for assistance.

If you are pregnant, planning to become pregnant, or are currently breast-feeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.

• Mercury-containing compounds (e.g., mercuric chloride, thimerosal) - can form corrosive compounds.

• Lithium (systemic absorption of iodine can exacerbate lithium-induced hypothyroidism)

• Thyroid function tests (can interfere with results due to absorbed iodine, leading to falsely elevated protein-bound iodine or altered thyroid hormone levels)
• Other topical antiseptics/disinfectants (potential for inactivation or irritation)

• Skin irritation (redness, itching, burning, rash)
• Allergic reactions (hives, swelling, difficulty breathing - rare but possible)
• Signs of systemic iodine toxicity (if extensively absorbed): metallic taste, increased salivation, burning in mouth/throat, sore gums/teeth, headache, GI upset (nausea, vomiting, diarrhea), skin eruptions, rhinitis, conjunctivitis, swelling of salivary glands.
• Signs of thyroid dysfunction (if extensively absorbed, especially in susceptible individuals): fatigue, weight changes, changes in heart rate, mood changes.

Use with caution and only if clearly needed. Avoid prolonged or extensive use, especially during the second and third trimesters, due to the potential for systemic iodine absorption and subsequent fetal hypothyroidism or goiter. Iodine readily crosses the placenta.

Use with caution. Iodine is excreted in breast milk. Avoid prolonged or extensive use to minimize infant exposure, which could lead to infant hypothyroidism. Monitor infant thyroid function if significant maternal exposure occurs.

Use with extreme caution in neonates and infants, and avoid if possible, due to their immature thyroid function and higher skin surface area to body weight ratio, leading to increased systemic iodine absorption and risk of hypothyroidism. For older children, use sparingly and avoid large areas or prolonged application.

Generally safe for topical use in the elderly. No specific dose adjustments are typically needed. However, caution should be exercised in patients with pre-existing thyroid conditions, as they may be more susceptible to iodine-induced thyroid dysfunction if significant absorption occurs.

• Povidone-iodine is inactivated by organic matter (e.g., blood, pus), which may necessitate reapplication or higher concentrations in heavily contaminated wounds.
• While effective, it can cause skin irritation or allergic reactions in some individuals, especially with prolonged use or on sensitive skin.
• The brown color indicates the presence of active iodine; if the solution loses its color, it has lost its antiseptic activity.
• Avoid using povidone-iodine with hydrogen peroxide or silver sulfadiazine, as these can inactivate iodine or cause adverse reactions.
• Though generally safe for topical use, systemic absorption of iodine can occur, particularly with large surface area application, broken skin, or prolonged use, potentially affecting thyroid function, especially in susceptible individuals (e.g., those with pre-existing thyroid disease, neonates, pregnant/lactating women).

• Chlorhexidine gluconate (e.g., Hibiclens)
• Alcohol (e.g., Isopropyl alcohol)
• Hydrogen peroxide
• Benzalkonium chloride
• Octenidine dihydrochloride (not widely available in all regions)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.