- 1 Important to know about Betadine ?
- 2 Betadine indication and Uses :
- 3 Betadine Dosage :
- 4 How it works Betadine :
- 5 Betadine Side Effects :
- 6 Betadine Interactions :
- 7 Betadine Warnings and Precautions :
- 8 Drive and use machines:
- 9 Betadine and PREGNANCY / BREAST FEEDING / FERTILITY:
- 10 Breastfeeding:
- 11 What should I do if I miss a dose?
- 12 What happens if I overdose from Betadine ?
- 13 What is Forms and Composition Betadine?
Important to know about Betadine ?
This medicine is an antiseptic solution (containing iodine) for mouthwash.
It is an adjunctive local treatment for infections of the oral cavity and it allows post-operative care in stomatology.
Betadine indication and Uses :
Adjunctive local treatment of infections of the oral cavity and postoperative care in stomatology.
Betadine Dosage :
About 5 ml of product should be applied to the skin surface with a sterile pad for at least 10 seconds and with a drying time of about 30 seconds before the minor surgery procedure.
Surgical antisepsis: preparation of the operative field
· Skin cleansing with Betadine Scrub.
· Rinse with 10 ml of physiological saline.
· Drying by sterile compress.
· Skin antisepsis in 2 successive applications of one minute of 5% alcoholic Betadine separated by a spontaneous drying time of one minute in the air.
How it works Betadine :
PREPARATIONS FOR ODONTOSTOMATOLOGY / OTHER AGENTS FOR LOCAL / VARIOUS ORAL TREATMENT.
ATC Code: A01AD11.
Povidone iodine is an iodophoric product.
It is an organic complex composed of about 10% active iodine available.
Its spectrum of activity is that of iodine (antiseptic bactericide on all bacteria and fungicide on yeasts and filamentous fungi).
Betadine Side Effects :
Exceptionally, hypersensitivity reactions: urticaria, angioedema, anaphylactic shock, anaphylactoid reaction, have been described with products containing povidone, including specialties BETADINE.
Possibility of irritation manifesting itself in the mucous membranes.
In case of repeated administrations and excessive use, this product may, on the one hand be irritating to the mucous membranes, on the other hand it can occur iodized overload likely to cause thyroid dysfunction.
Due to the presence of terpene derivatives and in case of non-compliance with the recommended doses, possibility of agitation and mental confusion in the elderly.
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers
Betadine Interactions :
RECOMMENDED ASSOCIATIONS :
Mercurial antiseptics : erythema, phlyctenes, and even mucocutaneous necrosis (formation of a caustic complex when concomitant use of iodized and mercurial antiseptics). The interaction depends on the stability of the organomercurial at the cutaneous level and the individual sensitivity.
Betadine Warnings and Precautions :
If symptoms persist for more than 5 days and / or associated fever, the course of action should be evaluated again.
Due to possible absorption of iodine through the mucosa, repeated or prolonged treatment may pose a risk of systemic effects , particularly thyroid dysfunction.
In case of a history of epilepsy, take into account the presence of terpene derivatives (mint flavor).
Precautions for use
The indication does not justify a prolonged treatment, especially as it could expose to an imbalance of the normal microbial flora of the oral cavity with a risk of bacterial or fungal diffusion.
Given the possible interference (antagonism, inactivation), the simultaneous or successive use of antiseptics should be avoided.
Possible interference with functional exploration of the thyroid
Drive and use machines:
Betadine and PREGNANCY / BREAST FEEDING / FERTILITY:
Studies in animals have not shown any teratogenic effect. In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in humans have been teratogenic in animals in well-conducted studies on two species.In clinical practice, there are currently no data of sufficient relevance to evaluate the possible malformative effect of povidone iodine when administered at 1
trimester of pregnancy:
Since the fetal thyroid begins to fix iodine after 14 weeks of amenorrhea, no repercussions on the fetal thyroid are expected in case of prior administrations.
Iodine overload, very likely with prolonged use of this product after this term, can lead to fetal hypothyroidism, biological or even clinical (goiter).
Consequently, prolonged use of this drug is against-indicated from 2 e quarter. Its use, on an ad hoc basis, should only be considered if necessary.
In case of breastfeeding, it is preferable not to use this drug due to the absence of kinetic data on the passage of terpene derivatives in milk and the potential neurological toxicity on the infant.Iodine passes into breast milk at concentrations higher than maternal plasma. Because of the risk of hypothyroidism in infants, breastfeeding is contraindicated in case of prolonged treatment with this drug.
What should I do if I miss a dose?
do not take a double dose to make up for it. Resume the normal course of your treatment.
What happens if I overdose from Betadine ?
overdose is not expected under normal conditions of use.
In case of massive oral ingestion likely to lead to serious intoxication, it is to be treated in a specialized environment: gastrointestinal and / or electrolytic disorders, especially in patients with renal insufficiency. Monitoring of thyroid function is recommended.
What is Forms and Composition Betadine?
|FORMS and PRESENTATIONS|
Solution for mouthwash: 125 ml bottle. Solution for mouthwash and gargle: 10 ml single dose containers, box of 10.
|p bottle of 125 ml||single dose of 10 ml|
|Povidone iodine||12.5 g||1 g|
Excipients (common): 85% glycerol, mint flavor (mint essential oil, alcohol), sodium saccharin, sodium hydroxide, purified water.