AP 327 Pill — BROWN ROUND, 6mm — Levothyroxine

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ImprintAP / 327
ColourBROWN
ShapeROUND
Size6
StrengthLEVOTHYROXINE 9.5 ug;LIOTHYRONINE 2.25 ug
Dosage formTablet
ManufacturerAcella Pharmaceuticals, LLC
NDC42192-327
Schedule—
AvailabilityPrescription only
IngredientsLEVOTHYROXINE[LEVOTHYROXINE];LIOTHYRONINE[LIOTHYRONINE]

What does this imprint mean?

The imprint "AP 327" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Levothyroxine

Uses and warnings

BOXED WARNING: "Thyroid hormones should not be used for the treatment of obesity or for weight loss. Larger doses may produce serious or even life threatening manifestations of toxicity." Major Warnings: - Cardiac risks: "Over-treatment may cause an increase in heart rate, cardiac wall thickness, and cardiac contractility and may precipitate angina or arrhythmias"—especially in elderly and cardiac disease patients - Myxedema coma: Do not use oral products; requires intravenous administration - Adrenal crisis: Treat adrenal insufficiency with glucocorticoids before initiating therapy - Narrow therapeutic index: Risk of adverse effects on growth, cardiac function, metabolism, and cognitive function from over/undertreatment - Diabetic control: May "worsen glycemic control and result in increased antidiabetic agent or insulin requirements" - Bone density: Over-replacement increases bone resorption ---

Levothyroxine sodium tablets are indicated for: - Hypothyroidism: "replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism" - TSH Suppression: "as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer" Limitations: Not for benign thyroid nodules/nontoxic goiter in iodine-sufficient patients or hypothyroidism during recovery from subacute thyroiditis. ---

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 278e4c92-5f64-42c1-a557-6d07fd3415a1.xml