✔️ Medically Reviewed by: Dr. Ahmad Baker, PharmD

BETADINE® 1% w/v Mouthwash & Gargle is a widely used antiseptic solution designed to treat and prevent infections in the mouth and throat. This blog post provides a detailed overview of the product, including its composition, indications, warnings, dosage, side effects, and more. All information is derived directly from the official patient information leaflet, ensuring accuracy and reliability.

What is BETADINE® 1% w/v Mouthwash & Gargle?

BETADINE® 1% w/v Mouthwash & Gargle is an antiseptic solution that effectively kills bacteria, fungi, spores, yeasts, protozoa, and viruses. It is primarily used for treating infected inflammatory conditions of the mouth and pharynx, such as stomatitis [inflammation of the mouth], gingivitis [gum inflammation], aphthous ulcers [mouth ulcers], pharyngitis [sore throat], tonsillitis [inflammation of the tonsils], monilial infections [fungal infections caused by Candida], common colds, and influenza [flu]. Additionally, it is used as a prophylactic [preventive measure] during and after surgeries, such as tonsillectomy [removal of tonsils] and dental procedures, and for routine oral hygiene.

Composition of BETADINE® 1% w/v Mouthwash & Gargle

The active ingredient in BETADINE® 1% w/v Mouthwash & Gargle is Povidone-Iodine. The other excipients [inactive ingredients] include Glycerol, Menthol, Methyl Salicylate, Ethanol, Saccharin Sodium, and Purified Water. The product is a yellow-brown liquid supplied in beige polyethylene containers with a polyethylene-spraying insert and a polypropylene cap. It is available in various sizes, including 50ml, 60ml, 120ml, 125ml, and 250ml.

Indications for Use

BETADINE® 1% w/v Mouthwash & Gargle is indicated for:

Treating infected inflammatory conditions of the mouth and pharynx, including stomatitis, gingivitis, aphthous ulcers, pharyngitis, tonsillitis, monilial infections, common colds, and influenza.
Prophylactic use during and after surgeries, such as tonsillectomy and dental procedures.
Routine use to promote oral hygiene.

Warnings and Precautions

Before using BETADINE® 1% w/v Mouthwash & Gargle, it is important to be aware of the following warnings and precautions:

Do not use if you are allergic to Povidone-Iodine or any other ingredients listed in the product.
Avoid use in patients with hypersensitivity to iodine or thyroid disorders, such as nodular colloid goiter [a type of thyroid enlargement], endemic goiter [thyroid enlargement due to iodine deficiency], or Hashimoto’s thyroiditis [an autoimmune thyroid disease].
Do not use in patients taking lithium [a medication used to treat bipolar disorder] or before, during, and after radio-iodine administration [a treatment for thyroid conditions].
Avoid use in patients using products containing mercury.
Not recommended for children under 6 years of age.

Special precautions include:

Regular applications to broken skin in patients with pre-existing renal insufficiency [kidney dysfunction] should be done with caution.
Thyroid function tests may be affected by iodine-containing products.
Povidone-Iodine may cause false-positive results in tests for detecting occult blood [hidden blood] in faeces or blood in urine.
Remove false teeth, braces, or other dental appliances before use, as they may become discolored.

Dosage and Administration

BETADINE® 1% w/v Mouthwash & Gargle should be used as follows:

Adults, Elderly, and Children over 6 years: Use undiluted or diluted with two parts of water.
Prophylactic Use: Allow the solution to act in the mouth for at least 30 seconds.
Existing Lesions: Rinse the mouth with the solution for two minutes, four times a day, especially after meals.
Do not swallow the solution.

If symptoms do not improve after 2-5 days of regular use, consult your doctor.

Possible Side Effects

Like all medicines, BETADINE® 1% w/v Mouthwash & Gargle can cause side effects, although not everyone experiences them. Possible side effects include:

Very Rare: Irritation of the lining of the mouth and sensitivity reactions.
Long-Term Use: Excessive absorption of iodine may lead to systemic adverse effects such as metabolic acidosis [a condition where the body produces too much acid], hypernatraemia [high sodium levels in the blood], and renal impairment [kidney dysfunction].

If you experience any side effects, stop using the product and consult your doctor or pharmacist immediately.

What to Do in Case of Overdose

In the event of accidental or deliberate ingestion of large quantities of BETADINE® 1% w/v Mouthwash & Gargle, contact your doctor or nearest hospital immediately. Symptoms of overdose may include:

Metallic taste in the mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling in the eyes, breathing difficulties due to pulmonary oedema [fluid accumulation in the lungs], skin reactions, gastrointestinal upset, and diarrhoea.
Severe cases may lead to renal impairment [kidney dysfunction], tachycardia [rapid heart rate], hypotension [low blood pressure], circulatory failure, oedema of the glottis [swelling of the vocal cords], seizures, fever, and metabolic acidosis.

Therapy: Symptomatic and supportive treatment should be provided, with special attention to electrolyte balance and renal and thyroid function. In severe cases, haemodialysis [a procedure to filter waste from the blood] may be required.

How to Store BETADINE® 1% w/v Mouthwash & Gargle

Keep the medicine out of the sight and reach of children.
Do not use after the expiry date stated on the label and carton.
Store at or below 25°C in the original packaging.
Do not dispose of medicines via wastewater or household waste. Consult your pharmacist for proper disposal methods.

Other Important Information

Pregnancy and Breastfeeding: Povidone-Iodine passes into the placenta and is secreted in breast milk. Use should be avoided unless the potential benefit to the mother justifies the potential risk to the foetus and neonate [newborn]. Consult your doctor before use.
Fertility: Limited human fertility data is available for Povidone-Iodine. Consult your doctor if you have concerns.
Driving and Using Machinery: No influence has been reported.

Latest Information

This leaflet was last revised in 08/2022. For the most up-to-date information, consult your healthcare provider or visit the official website of the manufacturer.

Conclusion

BETADINE® 1% w/v Mouthwash & Gargle is a versatile antiseptic solution for treating and preventing oral and throat infections. By following the guidelines provided in this blog post, you can ensure safe and effective use of the product. Always consult your doctor or pharmacist if you have any questions or concerns.

Note: This blog post is intended for informational purposes only and should not replace professional medical advice. Always consult your healthcare provider before starting any new treatment.