Top Content Directory Papua New Guinea: Betadine Vaginal Pessaries (Molnlycke Health Care )

Tuesday, September 20, 2016

Betadine Vaginal Pessaries (Molnlycke Health Care )

1. Name Of The Medicinal Product

Betadine Vaginal Pessaries.

2. Qualitative And Quantitative Composition

Povidone Iodine USP 200mg.

3. Pharmaceutical Form

Pessary.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of vaginitis due to candidal, trichomonal, non-specific or mixed infections and for pre-operative preparation of the vagina.

4.2 Posology And Method Of Administration

For intravaginal use. Adults and the elderly: Using the applicator, insert 1 pessary night and morning for up to 14 days. Each pessary should be wetted with water immediately prior to insertion, thus ensuring maximum dispersion of the active constituent and avoiding risk of local irritation. If menstruation occurs during treatment, it is important to continue treatment during the days of the period. Children: Contra-indicated for use in pre-pubertal children.

4.3 Contraindications

Known or suspected iodine hypersensitivity. Regular use is contra-indicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).

4.4 Special Warnings And Precautions For Use

Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Absorption of iodine from povidone iodine through either intact or broken skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.

4.6 Pregnancy And Lactation

Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

If local irritation, redness or swelling develops, discontinue treatment. Iodine is absorbed from the vagina and following prolonged use, thyroid dysfunction may develop. The product may be spermicidal and should not be used when conception is desired.

4.9 Overdose

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Povidone iodine is a complex of iodine which retains the broad-spectrum germicidal activity of elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue.

5.2 Pharmacokinetic Properties

Betadine Vaginal Pessaries are applied topically to the affected area.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polyethylene glycol 1000.

6.2 Incompatibilities

Compatibility with barrier contraceptives has not been established. Therefore this product should not be used with such methods of contraception as their reliability may be affected.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25^oC.

6.5 Nature And Contents Of Container

Strips of aluminium foil laminated to polyethylene; pre-formed PVC packaging with a polyethylene lining. Packs of 28.

6.6 Special Precautions For Disposal And Other Handling