Betadine Mouthwash / Gargle

Composition:-
- Active ingredients: Contains 1% W/V Povidone iodine U.S.P. (Mundidone™)
- Inactive ingredients: Glycerin, Saccharine sodium, ethyl alcohol, sodium hydroxide, Methyl salicylate, Menthol, Purified water.
Pharmaceutical Form:-
Solution (mouth wash / gargle).
Pharmacological Actions:-
- BETADINE mouthwash / gargle has the broad microbicidal spectrum of iodine, but is free of the undesirable features
and disadvantages associated with elemental iodine.
- BETADINE mouthwash /gargle is lethal to Gram-positive and Gram-negative bacteria, fungi, protozoa, spores and viruses.
- BETADINE mouthwash / gargle is active against antibiotic-resistant microorganisms. No resistance to BETADINE mouthwash / gargle microbicides has been observed.
- BETADINE mouthwash / gargle has an immediate onset and prolonged duration of action. Its activity is not affected by blood
or pus.
- BETADINE mouth wash / gargle is highly effective microbicide in a pleasantly flavoured solution for the effective
topical treatment of the mouth, throat and for routine oral hygiene.
- BETADINE mouth wash / gargle eliminates offensive mouth odours even of garlic, onion, tobacco and alcohol.
- BETADINE mouthwash / gargle is non-irritating to the oral mucous membrane and non-staining to the teeth or denture
Pharmacokinetics:-
- Povidone iodine complex releases iodine on contact with skin or mucous membranes.
- The activity is thought to be due to the oxidizing properties of free molecular iodine and may also be due to the
combination of free iodine with cell proteins.
Indications:-
- For the relief of painful infections of the pharynx and mouth .
- Indications for primary or adjuvant therapy with BETADINE Mouth wash / Gargle are:
Inflammatory conditions of the mouth and pharynx caused by bacterial, monilial or viral infections.
• Pharyngitis.
• Tonsilitis.
• Aphthous ulcers.
• Stomatitis.
• Gingivitis.
• Glossitis.
- As a prophylactic mouth wash before and after oral and dental surgery.
- It is also indicated to deodorize and refresh the mouth.
- Bed- ridden patients and others who require the promotion of oral hygiene.
Dosage and Administration:-
- Use the gargle undiluted for 30 seconds.
- Repeat every 3 - 4 hours.
- As a mouth wash for routine use: Diluted with 2 parts of luke warm water.
Contraindications:-
- Discontinue in rare cases of local sensitivity.
- Preterm neonate of gestational age under 32 weeks.
- Avoid regular use in patients with thyroid disorders or those receiving lithium therapy.
- It should not be used in patients who are hypersensitive to iodine.
Side Effects:-
Rarely sensitivity and may interfere with thyroid function tests.
Drug Interaction:-
- Compound benzoin tincture.
- Hydrogen peroxide.
Pregnancy and Lactation:-
Used with caution in pregnancy and lactation "sufficient iodine may be absorbed to affect the fetal thyroid " ; so used
under medical supervision.
Precautions and Warnings:-
- Discontinue use in rare cases of local sensitivity.
- For external use only.
- In case of deep wounds or serious burns, consult physician.
- Do not heat prior to application.
- In rare instances of local irritation or sensitivity, or if irritation and redness
develop, discontinue use.
Package and Storage:-
-
Carton box contains bottle of 120 ml.
- Store below 30 °c.
- Keep away from light.
Instructions to Patients:-
- Keep out of reach of children.