THYROSHIELD- potassium iodide solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE I-125 - UNII:V1UJ6I93CL)

Available from:

Fleming & Company, Pharmaceuticals

INN (International Name):

POTASSIUM IODIDE

Composition:

POTASSIUM IODIDE 65 mg in 1 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Thyroid blocking Helps prevent radioactive iodine from getting into the thyroid gland during a nuclear radiation emergency. Use along with other emergency measures recommended by public officials. ThyroShield® (Potassium Iodide Oral Solution) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

Product summary:

ThyroShield® (Potassium Iodide Oral Solution) is supplied in 1 oz (30 mL) bottles. Each mL contains 65 mg potassium iodide. Store at 25º C (77º F). Excursions permitted to 15-30º C (59-86º F). [See USP Controlled Room Temperature.] Keep container tightly closed and in carton, protected from light. Manufactured by Fleming & Company, Pharmaceuticals, Fenton, St. Louis Co., MO 63026 1-800-343-0164. L240 Rev. 0207

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

THYROSHIELD- POTASSIUM IODIDE SOLUTION
FLEMING & COMPANY, PHARMACEUTICALS
----------
THYROSHIELD - POTASSIUM IODIDE ORAL SOLUTION
ACTIVE INGREDIENT
Potassium iodide (USP) 65 mg
PURPOS E
Thyroid blocking
US ES
Helps prevent radioactive iodine from getting into the thyroid gland
during a nuclear radiation
emergency. Use along with other emergency measures recommended by
public officials.
WARNINGS
Allergy alert: Iodine may cause an allergic reaction with 1 or more of
the following symptoms:
shortness of breath or wheezing
skin rash
trouble breathing, speaking or swallowing
swelling
fever and joint pain
DO NOT USE IF YOU HAVE EVER HAD
an allergic reaction to iodine
nodular thyroid disease with heart disease
hypocomplementemic vasculitis
dermatitis herpetiformis
STOP USE AND ASK A DOCTOR IF YOU HAVE
an allergic reaction. Get medical help right away if you have trouble
breathing, speaking or
swallowing; shortness of breath; wheezing; swelling of the mouth,
tongue or throat; or rash.
irregular heart or chest pain. Get medical help right away.
swelling of the hands or feet, fever, or joint pain.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help
or contact a Poison Control
Center right away.
DIRECTIONS
use as directed by public officials in the event of a nuclear
radiation emergency.
do not take more than 1 dose in 24 hours.
Dosing Chart
(dropper inside)
ADULTS OVER 18 YEARS
2 mL every day (130 mg)
and
CHILDREN OVER 12 YEARS TO 18 YEARS
WHO WEIGH AT LEAST 150 POUNDS
2 mL every day (130 mg)
CHILDREN OVER 12 YEARS TO 18 YEARS
WHO WEIGH LESS THAN 150 POUNDS
1 mL every day (65 mg)
AND
CHILDREN OVER 3 YEARS TO 12 YEARS
1 mL every day (65 mg)
CHILDREN OVER 1 MONTH TO 3 YEARS
0.5 mL every day (32.5 mg)
BABIES AT BIRTH TO 1 MONTH
0.25 mL every day (16.25 mg)
IF PREGNANT, BREASTFEEDING, HAVE A BABY UP TO 1 MONTH OF AGE OR HAVE
THYROID DISEASE (EXCEPT
NODULAR THYROID DISEASE WITH HEART DISEASE), take as directed above
and contact a doctor as soon
as possible.
OTHER INFORMATION
store at 25°C (77°F). Excursions p