Iodine Vitrum - instructions for use, dose, side effects, contraindications

¹ - Due to the peculiarities of the technological process, it is laid in the form of 1% of a mixture of potassium iodide in calcium sulfate in the amount of 14,30 and 28,6 mg respectively.

Excipients: calcium hydrophosphate, stearic acid, microcrystalline cellulose, croscarmellose sodium, silicon dioxide colloid, magnesium stearate.

Sheath: Opadrai II Gray (dye indigo carmine (E132), dye red charming AS (E129), dye yellow sunset sunset (E110), hypromellose, polydextrose, macrogol (polyethylene glycol), titanium dioxide, triacetin).

Description:

Film coated tablets 100 μg

The tablets are round, biconvex with a dividing risk on one side of the tablet and engraved "1" on the other side, coated with a film coat from light gray to dark gray. A specific odor is allowed.

View at the break: homogeneous mass from white to almost white.

Film coated tablets 200 μg

Tablets are round, biconvex with a dividing risk on one side of the tablet and engraving "2" on the other hand, covered with a film sheath from light gray to dark gray. A specific odor is allowed.

View at the break: homogeneous mass from white to almost white.

Pharmacotherapeutic group:Thyroxine synthesis regulator - iodine drug

ATX: & nbsp

H.03.C.A Preparations of iodine

Pharmacodynamics:

Iodine is a vital microelement. Exchange of iodine in the thyroid gland affects the work of the whole organism, regulates the activity of the brain, nervous and cardiovascular systems.

Deficiency of iodine can lead to a delay in physical and mental development, a violation of the intellect.

Iodine Vitrum® prevents the development of iodine deficiency diseases, prevents the development of goiter associated with a lack of iodine in food; normalizes the function of the thyroid gland.

Indications:

- Prevention of endemic goiter;

- treatment of diffuse euthyroid goiter caused by iodine deficiency in children, adolescents, adult patients of young age; pregnant and lactating women;

- prevention of recurrence of goiter after its surgical removal, as well as after completion of drug treatment with drugs of thyroid hormones.

Contraindications:

- Thyrotoxicosis (increased thyroid function);

- latent thyrotoxicosis (with doses exceeding 150 μg / day);

- hypersensitivity to iodine;

- toxic adenoma of the thyroid gland, nodular goiter when used at doses of more than 300 μg / day (with the exception of preoperative therapy for the purpose of blocking the thyroid gland);

- herpetiform (senile) dermatitis of Dühring.

The drug should not be taken with hypothyroidism, except in those cases; when the development of the latter is caused by a pronounced iodine deficiency.

Prescribing the drug should be avoided with radioactive iodine therapy, if there is or suspected thyroid cancer.

Carefully:Patients suffering from kidney failure, as against the intake of iodine may develop hyperkalemia.

Pregnancy and lactation:

Possible application Iodine Vitrum® during pregnancy and lactation (breastfeeding). During pregnancy and breastfeeding, the need for iodine increases. The drug is prescribed according to the indications, if the intake of iodine with food is less than 150 μg / day. Particular attention should be paid to the fact that the drug penetrates the placenta and can cause hypothyroidism and goiter in the fetus. Iodine excreted in breast milk. In this regard, during pregnancy and lactation, the drug Iodine Vitrum® should be used only at recommended doses.

Dosing and Administration:

Prophylaxis of endemic goiter:

Children under 12 years - 100 mcg (1 tablet Iodine Vitrum® 100).

Adolescents and adults: 100-200 mcg per day (1-2 tablets Iodine Vitrum® 100 or 1 tablet Iodine Vitrum® 200).

During pregnancy and breastfeeding: 200 mcg per day (2 tablets Iodine Vitrum® 100 or 1 tablet Iodine Vitrum® 200).

Treatment of euthyroid goiter:

Children under 12 years and adolescents: 100-200 mcg per day (1-2 tablets Iodine Vitrum® 100 or 1 tablet Iodine Vitrum® 200).

Adults up to 40 years of age - 300-500 mcg per day (3-5 tablets Iodine Vitrum® 100 or 2 tablets Iodine Vitrum® 200).

For the prevention of recurrence of goiter after an operative intervention on the thyroid gland or after the end of medicinal treatment of goiter with thyroid hormone preparations: 100-200 mkg per day (1-2 tablets Iodine Vitrum® 100 or 1 tablet Iodine Vitrum® 200).

The drug is taken after a meal, squeezed with enough liquid.

Preventive drug intake should be carried out for several years, and often throughout life. To treat goiter in children, adolescents and adults usually takes 6-12 months or more.

The duration of treatment is determined by the doctor.

Side effects:

When applying Iodine Vitrum® at recommended doses of side effects is unlikely. In rare cases of prolonged use of high doses of the drug, the development of "iodism" is possible.

Allergic reactions are rare: extremely rare reactions are hypersensitivity combined with iodine rhinitis, iodine dermatitis, Quincke's edema, very rarely - iodine fever, iodine acne, edema of the salivary glands.

Overdose:

With the long-term administration of high doses of the drug (more than 300 micrograms per day), iodine-induced hyperthyroidism may develop.

When treated with high doses of iodine (more than 1000 micrograms per day), in some cases iodine-induced goiter and hypothyroidism may develop.

Symptoms: staining the mucous membranes in brown, reflex vomiting (if the food contains starch-containing components, vomit becomes blue), abdominal pain and diarrhea (possibly melena).

Treatment for acute intoxication: gastric lavage with starch solution, protein or 5% sodium thiosulfate solution until all traces of iodine are removed. Symptomatic therapy of disturbance of water balance, electrolyte balance, anti-shock therapy. Treatment for chronic intoxication: drug withdrawal.

Treatment of iodine-induced hypothyroidism: drug withdrawal, normalization of metabolism with the help of thyroid hormones.

Treatment of iodine-induced thyrotoxicosis: mild forms of treatment are not required; when the forms are expressed, a thyrostatic therapy is required (the effect of which is always delayed). In severe cases (thyrotoxic crisis), intensive therapy, plasmaphoresis and thyroidectomy are necessary.

Interaction:

As a result of the interaction of drugs, mutual strengthening or weakening of their action is possible. Therefore, before taking the drug for medical purposes - consult a doctor.

Deficiency of iodine increases, and excess iodine lowers the effectiveness of hyperthyroidism therapy with thyreostatic agents. In this regard, before or during treatment of hyperthyroidism, it is recommended, whenever possible, to avoid any intake of iodine. On the other hand, thyreostatic drugs inhibit the transition of iodine to an organic compound in the thyroid gland and, thus, can cause the formation of goiter.

Simultaneous treatment with high doses of iodine and lithium salts can promote the appearance of goiter and hypothyroidism. High doses of the drug in combination with potassium-sparing diuretics can lead to hyperkalemia.

Form release / dosage:Tablets coated with a film membrane 100 μg, 200 μg.

Packaging:

For 60 tablets coated with a film shell in a vial of polyethylene with a screw cap made of the same material and a safety valve made of foil and a protective strip of polyethylene. The label is attached to the bottle, the bottle is tightened with a polyethylene film and, together with the instruction for use, is placed in a cardboard box.

24 tablets coated with a film sheath in an aluminum foil / PVC blister. 2, 4, 5 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of 10 to 30 ° C, in a dry place.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-006273/08

Date of registration:06.08.2008

Expiration Date:Unlimited

The owner of the registration certificate:Unipharm, Inc.Unipharm, Inc. USA

Manufacturer: & nbsp

UNIPHARM ,, Inc. USA

Representation: & nbspUNIFARM, Inc. UNIFARM, Inc. USA

Information update date: & nbsp17.11.2017

Illustrated instructions

Instructions

Iodine Vitrum (Iodine Vitrum)