IOSAT- potassium iodide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)

Available from:

Anbex Inc.

INN (International Name):

POTASSIUM IODIDE

Composition:

POTASSIUM IODIDE 130 mg

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. IOSAT™ (Potassium Iodide tablets, USP, 130 mg) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

Product summary:

IOSAT™ (Potassium Iodide Tablets, USP 130 mg) Each white, round tablet, cross-scored on one side and the IOSAT name on the other, contains 130 mg potassium iodide. NDC 51803-001-01: 14 Unit dose, Foil Sealed, 130 mg Tablets. NDC 51803-001-10: 10 X 14 Unit dose, Foiled Sealed 130 mg tablets (140 tablets) in a Clear Plastic Bag. Also available: IOSAT™ (Potassium Iodide Tablets, USP 65 mg) Packages of 20 tablets. Each white, round tablet, cross-scored on one side and the IOSAT name on the other, contains 65 mg potassium iodide. NDC 51803-002-01: 2 X 10 Unit dose, Foil Sealed, 65 mg Tablets (20 Tablets).

Authorization status:

New Drug Application

Summary of Product characteristics

IOSAT- POTASSIUM IODIDE TABLET
ANBEX INC.
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IOSAT™ - (POTASSIUM IODIDE TABLETS, USP, 130 MG)
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH TABLET )_
Potassium iodide 130 mg
_PURPOSE_
Thyroid blocking
_USES_
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
swelling
skin rash
trouble breathing, speaking or swallowing
fever and joint pain
DO NOT USEIF 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 IFYOU 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 heartbeat 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
tablets can be whole or crushed and mixed in milk, baby formula,
water, orange juice,
flat soda like cola, or raspberry syrup
THE LIQUID MIXTURE SHOULD BE GIVEN TO INFANTS, YOUNG CHILDREN, AND
OTHERS WHO
CANNOT SWALLOW TABLETS; SEE CONSUMER PACKAGE INSERT ON HOW TO MAKE A
LIQUID MIXTURE.
AGE
DOSE
ADULTS OVER 18 YEARS
1 tablet (whole or crushed) daily (130 mg)
CHILDREN OVER 12 YEARS TO 18 YEARS WHO WEIGH AT LEAST
150 POUNDS
1 tablet (whole or crushed) daily (130 mg)
CHILDREN OVER 12 YEARS TO 18 YEARS WHO WEIGH LESS
THAN 150 POUNDS
1/2 tablet (whole or crushed) daily (65 mg)
CHILDREN OVER 3 YEARS TO 12 YEARS
1/2 tablet (whole or crushed) daily (65 mg)
CHILDREN OVER 1 MONTH TO