LEVOTHYROXINE SODIUM INJECTION 100 MCG — DIN 02499924

What is LEVOTHYROXINE SODIUM INJECTION?

LEVOTHYROXINE SODIUM INJECTION 100 MCG contains LEVOTHYROXINE SODIUM : 100 MCG. It is listed in the Health Canada Drug Product Database under DIN 02499924, held by FRESENIUS KABI CANADA LTD, supplied as SOLUTION for INTRAMUSCULAR ; INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 10-Jun-2022. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is LEVOTHYROXINE SODIUM INJECTION used for?

Levothyroxine Sodium for Injection/Levothyroxine Sodium Injection are indicated for the treatment of overt hypothyroidism of any etiology when parenteral use is clinically warranted, such as when rapid repletion is required, or when oral administration is precluded.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Levothyroxine Sodium for Injection/Levothyroxine Sodium Injection can be used intravenously or intramuscularly in place of the oral dosage form when oral administration is precluded or when rapid repletion is required. The initial parenteral dosage should be between 48 to 74% of the previously established oral dosage form of Levothyroxine Sodium tablets. If cardiac symptoms develop or worsen, the cardiac disease should be evaluated and the dose reduced. Daily administration should be maintained until the patient can tolerate an oral dose and is clinically stable. For chronic treatment of hypothyroidism, an oral dosage form of levothyroxine should be used. For rapid repletion (e.g., Myxedema Coma), an initial intravenous loading dose of 300 to 500 mcg is given, followed by daily intravenous doses of 50 to 100 mcg. Reconstitution (for powder): Aseptically add 5 mL of 0.9% Sodium Chloride Injection, USP. Do not use Bacteriostatic Sodium Chloride Injection. Shake vial to ensure complete mixing. Use immediately after reconstitution. The resultant solution will have a final concentration of approximately 40 mcg per mL and 100 mcg per mL for the 200 mcg and 500 mcg vials, respectively. Administer as an intravenous injection at a rate not to exceed 100 mcg per minute. Do not add to other intravenous fluids. Subcutaneous route is not recommended. Parenteral products should be inspected for clarity. Unused portions should be discarded. Caution is advised for patients with cardiovascular disease, the elderly, and those with concomitant adrenal insufficiency. Missed Dose: Administer as soon as possible. If almost time for the next dose, skip the missed dose and administer the next regularly scheduled dose. Do not double doses.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. Patients with untreated subclinical or overt thyrotoxicosis of any etiology. Patients with acute myocardial infarction, acute myocarditis, or acute pancarditis. Patients with uncorrected/untreated adrenal insufficiency. Pregnant women with hyperthyroidism treated with anti-thyroid agents.

Warnings and precautions

Thyroid hormones, including levothyroxine, should not be used for the treatment of obesity or for weight loss in euthyroid patients, as doses within the normal range are ineffective and larger doses can cause serious or life-threatening toxicity, especially with sympathomimetic amines. Levothyroxine has a narrow therapeutic index, requiring careful dosage titration to avoid over- or undertreatment, which can affect growth, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and glucose and lipid metabolism. Many drugs interact with levothyroxine, necessitating dose adjustments. Before starting therapy, coronary failure, angina pectoris, arteriosclerosis, hypertension, pituitary insufficiency, adrenal insufficiency, and thyroid autonomy must be excluded or treated. Therapy may worsen symptoms of undiagnosed endocrine disorders like adrenal insufficiency, hypopituitarism, and diabetes insipidus. Seizures have been rarely reported with initiation of levothyroxine sodium therapy. Excessive bolus dosing (greater than 500 mcg) is associated with cardiac complications, particularly in the elderly and those with underlying cardiac conditions. Overtreatment can lead to adverse cardiovascular effects such as increased heart rate, cardiac wall thickness, contractility, and may precipitate angina or arrhythmias. Close observation is required after administration. If cardiac symptoms worsen, the dose should be reduced. Patients with coronary artery disease receiving levothyroxine should be closely monitored during surgical procedures due to increased risk of cardiac arrhythmias. Concomitant administration with sympathomimetic agents may precipitate coronary insufficiency. Caution is advised for patients with cardiovascular disorders and the elderly, initiating therapy at lower doses. In patients with secondary or tertiary hypothyroidism, other hypothalamic/pituitary hormone deficiencies should be considered and treated for adrenal insufficiency if diagnosed. Supra-physiological serum levels should be avoided in postmenopausal women with hypothyroidism and increased osteoporosis risk; close monitoring and minimum effective dose are recommended. T4 enhances anticoagulant effects; prothrombin time should be monitored. Patients with concomitant adrenal insufficiency should be treated with replacement glucocorticoids before initiating levothyroxine to prevent acute adrenal crisis. Diabetic patients may require upward adjustments of antidiabetic regimens. Serum biotin may interfere with thyroid function immunoassays; patients should abstain from biotin supplements for at least 2 days before specimen collection. For patients at risk of psychotic disorders, start with a low dose and slowly increase, monitoring for psychotic symptoms.