KALII IODIDUM 65mg

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT
Kalii iodidum Ramcopharm, 65.0 mg tabl.

1.QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active ingredient - Potassium iodide 65 mg (equivalent to 50 mg iodine).

For a full list of excipients, see section 6.1.

2. PHARMACEUTICAL FORM

Tablet.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications
Used for blocking or reducing the accumulation of radioactive isotopes of iodine in the thyroid gland and consequently reducing the risk of hypothyroidism and thyroid cancer in terms of accidents involving radioactive contamination and separation of iodine and technetium radionuclides (accidents at nuclear power plants, terrorist acts etc.).

4.2. Posology and method of administration
- Adults and children over 18 years: 2 tablets of 65 mg Kalii iodidum

- Pregnant and breastfeeding women: 2 tablets of 65 mg Kalii iodidum
It is recommended that women who are pregnant or breastfeeding should take only a single dose of Kalii iodidum and be immediately taken out to a safe uncontaminated place.
- Children from 3 to 18 years: 1 tablet of 65 mg Kalii iodidum
Adolescents with body weight 70 or more 70 kg should take the adult dose.
- Children from 1 month to 3 years: ½ tablet of 65 mg Kalii iodidum

- Nursing infants (up to 1 month): ¼ tablet of 65 mg Kalii iodidum

Recommended doses summarized above should be administered as soon as possible after an accident and alleged exposure (within 3 hours after an accident). 1 dose per 24 hours should be administered until there is a risk of exposure (by inhalation or taking up of contaminated food and drink). Newborns (under 1 month), pregnant and breastfeeding women are advised to take only a single dose (See 4.4. Special warnings and precautions). Tablets should be administered after meals and may be swallowed whole with plenty of liquid or be crushed and mixed with drinks or milk.

4.3 Contraindications

The medicinal product is contraindicated in patients with:

-presence of active thyroid disease or a history of such diseases;

-known iodine sensitivity;

-dermatitis herpetiformis;

-hypocomplementaemic vasculitis.

4.3 Special warnings and precautions

- To ensure maximum efficiency of Kalii iodidum it is necessary to be taken immediately after exposure or just before that. Potassium iodide does not provide protection against the immediate effects induced by ionizing radiation and does not inhibit the absorption of ionizing radiation by the body. Prevention with this medicinal product does not invalidate the need for immediate evacuation, especially for nursing infants, young children, pregnant and breastfeeding women from areas adjacent to the accident and does not preclude the need for shelter and supply of uncontaminated food, water, etc. Single dose of potassium iodide provides effective protection against accumulation of radioactive iodine isotopes for about 24 hours, but when evacuation or provision of uncontaminated food is impossible the medicinal product should be taken daily within the exposure as it is advisable that the period of Kalii iodidum administration should not exceed 10 days.

- Nursing infants aged up to 1 month are particularly sensitive to the immediate and deferred effects of radioactive isotopes of iodine on the thyroid gland. At the same time, the risk of occurrence of adverse effects of potassium iodide (hypothyroidism) is greatest. For this reason, nursing infants (aged less than one month) are advised to take a single dose of Kalii iodidum providing protection to the thyroid gland from accumulation of radioactive iodine isotopes for 24 h and also be provided with uncontaminated food and immediate evacuation. It is advisable to avoid prolonged administration of this medicinal product in this group of patients. In carrying out prevention with Kalii iodidum nursing infants under the age of 1 month should be monitored closely for signs of hypothyroidism.

- In children and adolescents (from 1 month to 18 years) there is a high risk of thyroid gland damage from radioactive isotopes of iodine but the risk of Kalii iodidum side effects is relatively low. Therefore, in cases where the exposure (by inhalation or intake of contaminated milk or food) is prolonged the recommended dose should be taken daily. It is advisable that the duration of intake should not exceed 10 days.

- Adult patients, incl. pregnant and breastfeeding women should avoid taking more than one dose of Kalii iodidum except in cases where there is prolonged exposure (by inhalation or administration with contaminated food). Intake of potassium iodide by pregnant and breastfeeding women may lead to rashes or hypothyroidism in the newborn/nursing infant. It is advisable that the function of the thyroid gland should be traced in the newborn/nursing infant especially in cases where the mother has taken several doses of potassium iodide. Breastfeeding women are advised to temporarily stop breastfeeding for the period during which they are taking potassium iodide (usually 1-2 days) until evacuation to a safe area.

- In people aged over 40 years the risk of thyroid cancer after radiation exposure is extremely low, while with the increase of age the risk of side effects of potassium iodide also increases. In these patients, prevention with potassium iodide is shown only at doses of ionizing radiation of the order of 5 cGy, which may realistically be expected only in patients located in areas not far from the accident.

- The risk of occurrence of adverse reactions of Kalii iodidum (especially hyperkalemia) increases in patients having kidney diseases and therefore the condition of such patients should be monitored more carefully.

- The medicinal product should be used with caution in patients with congenital myotonia and hyperkalemia under careful monitoring of potassium levels. In patients with tuberculosis Kalii iodidum should be used with caution because of the risk of significantly enhancing the expectoration.

4.4. Interaction with other medicinal products and other forms of interaction

Concomitant use of potassium-sparing diuretics, ACE inhibitors and other potassium-containing medicinal products or food supplements increases the risk of occurrence of hyperkalemia and related effects on cardiac function. Taking Kalii iodidum with lithium salts or thyreostatics can enhance hypothyroid and strumigenic effects of these drugs. Concomitant use of Kalii iodidum and iodophores such as amiodarone, clioquinol and diagnostic contrast agents increases the risk of damage to the thyroid gland. The use of iodine-containing antiseptics for treatment of large skin surfaces combined with oral administration of potassium iodide should be avoided, especially in nursing infant age because of the risk of systemic resorption and increase in adverse effects on the thyroid gland.

4.6. Pregnancy and lactation

Application of Kalii iodidum during pregnancy is imperative, given the risk of accumulation of radioactive isotopes of iodine in the thyroid of the fetus. It is recommended that pregnant and lactating women receive 2 tablets of 65 mg as a single dose and immediately be taken away from the site of exposure. Kalii iodidum should be taken again just in case of inevitable long-term exposure. It is advisable that newborns should be monitored closely for signs of suppression of thyroid function and/or struma.
Due to the risk of overdose and with the purpose of more accurate dosing for the nursing infant discontinuation of breastfeeding is recommended (for 1-2 days) when breastfeeding women are taking potassium iodide.
Iodine is excreted in breast milk as ¼ of the amount administered by the mother can be eliminated in breast milk for 24 hours. Only a single dose of this medicinal product is advisable to be applied to lactating women (except in cases of prolonged exposure). In cases where more than one tablet of the medicinal product is needed the nursing infants should be monitored closely for signs of iodism, suppression of thyroid function or rashes.

4.7. Effects on ability to drive and use machines

No effect.

4.8. Undesirable effects

The following may occur: hypersalivation, metallic taste in the mouth, lacrimation, painful teeth and gums, irritation of the lining of the stomach, headache, swelling of the salivary glands and diarrhea. Serious allergic reactions such as angioedema, arthralgia, eosinophilia and swollen lymph nodes are very rare and require careful monitoring and discontinuation of product administration. Iodism events (burning mouth and throat, irritation of the stomach, copious watery salivation, severe headache and acne-like rash and other skin lesions) and potassium toxicity (confusion, numbness, weakness or numbness of the hands and/or legs, fatigue, cardiac arrhythmias) are seen in case of long administration of this medicine. The risk of suppression of thyroid function in single dose is negligible but in prolonged exposure involving the application of potassium iodide within a few days effects of hypothyroidism may occur, especially in newborns and elderly patients.

4.9. Overdose

Early symptoms following an overdose of potassium iodide include stimulating exocrine glands with rhinorrhea, conjunctivitis and cough with separation of serous exudates. Consequently, the following may occur: metabolic acidosis, hyperosmolarity, hypernatremia, hyperkalemia, acute respiratory distress, congestive heart failure, kidney failure, coma and death. There is no specific antidote.

PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties ATC : V03AB21-Antidotes
Potassium iodide accumulates selectively in the thyroid and saturates transport proteins, providing transport of iodine in the gland thus preventing the accumulation of radioactive isotopes of iodine (131I, 132I, 133I, 135I) and technetium. Thus, it provides protection of the thyroid gland from immediate and deferred effects of ionizing radiation emitted by the radionuclides. Taking Kalii iodidum simultaneously or immediately before exposure to iodine radionuclides leads to 97 % blocking of the accumulation of radioactive iodine in the gland. If Kalii iodidum is taken 12 hours before possible exposure, it again provides about 90 % protective effect on the intake of radioactive iodine by the thyroid gland. In the event that the intake of potassium iodide is 24 h before exposure, it blocks about 70 % of the accumulation of 131I. The application of this medicinal product 4-6 hours after contact with iodine radionuclides blocks their accumulation in the thyroid by only about 50 %, while intake of potassium iodide after 8 h virtually has no protective effect.

5.2. Pharmacokinetic properties

Kalii iodidum is absorbed rapidly and completely in the gastrointestinal tract, within 30-60 minutes following oral administration. Iodide anions are concentrated in the thyroid, where thyroid peroxidase turns them into molecular iodine, which is used for synthesis of thyroid hormones; selective accumulation of iodides is carried out also in the salivary glands, breast and kidney. Iodide ions unused by the thyroid are eliminated unchanged in the urine by means of glomerular filtration and to a minor extent with faeces.

5.3. Preclinical safety data

According to the Hodge & Sterner Scale, potassium iodide given orally is less toxic with LD50 of 500 to 5000 mg/kg. In subchronic toxicity experiments with rats is found that adolescent animals are more susceptible to toxic effects of potassium iodide than adult animals. At low doses potassium iodide is not teratogenic, carcinogenic, embryo-and fetotoxic.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients:

Each tablet contains the following excipients:

Cellulose, microcrystalline           - Ph. Eur. IV      0.0725 g
Sodium hydrogen carbonate        - Ph. Eur. IV      0.0100 g
Silica, colloidal anhydrous            - Ph. Eur. IV      0.0015 g
Magnesium stearate                   - Ph. Eur. IV      0.0010 g

6.2. Incompatibilities

None known.

6.3. Shelf-life
5 years

6.4. Special precautions for storage
Store in original container in dry and dark place at temperatures below 25°C. Keep out of reach of children.

6.5. Nature and contents of container
PVC aluminium foil blister packs of 10 tablets.
1 blister in cardboard box with instructions for use.

7. MANUFACTURER AND MARKETING AUTHORISATION HOLDER:
Ramcopharm Ltd., 5A Plachkovitsa Str., 1164 Sofia
Pharma PLC, 13 Neofit Rilski Str., Dupnitsa

8. MARKETING AUTHORISATION NUMBER – II-10982 / 17.06.2005

9. DATE OF LAST REVISION:
NOVEMBER, 2010