Iodoxide - instructions for use, dose, side effects, contraindications

active substance: povidone-iodine (povidone-iodine 30/06) 200.0 mg (with povidone-iodine activity 11%, in case of other activity of the drug, respectively, reduce or increase the amount of the base);

Excipients: polyethylene oxide base: macrogol-1500 (polyethylene oxide-1500) 2.66 g, macrogol-400 (polyethylene oxide-400) 0.14 g

Description:

Suppositories from brown to dark brown, torpedo-shaped. Marble surface is allowed.

Pharmacotherapeutic group:Antiseptic

ATX: & nbsp

D.08.A.G.02 Povidone-iodine

Pharmacodynamics:Antiseptic preparation. It blocks amino groups of cellular proteins. Has a wide spectrum of antimicrobial action. It is active against bacteria (including Escherichia coli, Staphylococcus aureus), fungi, viruses, protozoa. The active substance of the drug - iodine - is in the form of a complex with polyvinylpyrrolidone (povidone), which refers to iodophors, which bind iodine. The concentration of active iodine is 0.1-1%. After contact with skin and mucous membranes iodine gradually and evenly released, having a bactericidal effect on microorganisms. At the application site, a thin colored layer remains, which is retained until the entire amount of iodine is freed.

Pharmacokinetics:

Suction and distribution

When povidone-iodine comes into contact with the mucous membrane, iodine absorption and an increase in its content in the blood are possible (the concentration returns to the initial value 7-14 days after the last drug administration).In patients with normal thyroid function, increased absorption of iodine does not cause significant changes in its hormonal function.

Excretion

Iodine is excreted mainly by the kidneys. Half-life (T_1/2) after intravaginal application is about 48 hours.

Indications:

Acute and chronic infectious and inflammatory diseases of the vagina (trichomonas, fungal, viral, nonspecific, mixed infections); bacterial vaginitis.

Prevention of infectious and inflammatory complications before gynecological interventions (artificial termination of pregnancy, installation and removal of the intrauterine device, diathermocoagulation of the cervix, hysterosalpingography and others).

Contraindications:

Hypersensitivity to iodine and other components of the drug, thyrotoxicosis (hyperthyroidism), herpetiform dermatitis of Dühring, adenoma of the thyroid gland, simultaneous application of radioactive iodine, children up to 8 years.

Carefully:

Chronic kidney failure, pregnancy, the period of breastfeeding, old age.

Pregnancy and lactation:

Iodine penetrates the placental barrier and is excreted in breast milk. The use of the drug Yodoxid® is not recommended from the second trimester of pregnancy and during breastfeeding. The use of Yodoxid® in these periods is only possible if the intended benefit to the mother exceeds the potential risk to the fetus and the baby. If you need to use the drug in these cases, treatment is possible under individual medical supervision. In newborns and infants whose mothers used Iodoxid®, it is necessary to monitor the function of the thyroid gland.

Dosing and Administration:

Intravaginal. Preliminarily releasing the suppository from the contour cell packaging, it is injected, lying on its back, deep into the vagina.

In acute vaginitis - 1 suppository 2 times a day for 7 days, with subacute and chronic vaginitis - 1 suppository 1 time per day before bedtime for 14 days (regardless of the phase of the menstrual cycle).

Side effects:

Reactions of hypersensitivity to the drug at the site of application: hyperemia, pruritus. Allergic reactions are possible,including contact dermatitis with the formation of psoriasis-like red small bullous elements. If these phenomena occur, the drug should be discontinued.

Overdose:

Symptoms: for acute iodine intoxication are characteristic: metallic taste in the mouth, increased salivation, burning sensation or pain in the mouth or throat; irritation and swelling of the eyes; skin reactions; gastrointestinal disorders and diarrhea; impaired renal function and anuria; circulatory insufficiency; edema of the larynx with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

Treatment: symptomatic therapy and maintenance of vital organs and systems (including electrolyte balance, kidney and thyroid function).

Interaction:

Povidone-iodine is incompatible with oxidants, alkali salts and substances with acid reaction. It is not recommended to use povidone-iodine simultaneously with hydrogen peroxide and products containing mercury, silver and enzymes.

Special instructions:

In the presence of blood, the bactericidal action of povidone-iodine may decrease.

In the case of non-hypnotic hyperthyroidism and other thyroid diseases (especially inelderly patients) the drug is used only under strict indications and under constant medical supervision.

Due to the oxidative properties of povidone-iodine, its traces can lead to false-positive results of some types of studies for the detection of latent blood in feces, as well as blood or glucose in the urine.

During the application of povidone iodine, iodine absorption by the thyroid gland may decrease, which may affect the results of some diagnostic studies (for example, thyroid scintigraphy, determination of protein-bound iodine, measurements with radioactive iodine), and also interaction with iodine preparations used for the treatment of diseases of the thyroid gland. To obtain undistorted results of thyroid scintigraphy after long-term povidone-iodine therapy, it is recommended to withstand a sufficiently long period of time without this drug. If symptoms of hyperthyroidism occur during the course of treatment, the function of the thyroid gland should be checked.

Caution should be observed with regular use of the drug in patients with previously diagnosed kidney failure.

You should avoid the regular use of the drug Yodoxid® in patients receiving lithium preparations.

It is recommended to be careful when introducing vaginal suppositories to virgins.

Coloring on the skin and tissues is easily washed off with water.

Suppositories have a spermicidal effect, and therefore it is not recommended to use them in persons planning a pregnancy.

During the use of suppositories, the use of sanitary napkins can be recommended.

After contact with the drug, avoid contact with the product in the eyes.

Effect on the ability to drive transp. cf. and fur:

Does not affect the ability to drive and other mechanisms.

Form release / dosage:

Vaginal suppositories, 200 mg.

Packaging:

For 5 suppositories are placed in a contour mesh package from the film with polyvinyl chloride laminated polyethylene.

2 contour mesh packages together with instructions for medical use of the drug are placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:P N001506 / 01

Date of registration:11.04.2012 / 24.01.2013

Expiration Date:Unlimited

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Manufacturer: & nbsp

NIZHFARM, JSC Russia

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp29.11.2017

Illustrated instructions

Instructions

Iodoxid® (Iodoxid®)