Important Safety Information and Indications
LEVOXYL is available in 11 dosage strengths ranging from 25 to 200 mcg.
WARNING: Thyroid hormones, including LEVOXYL® (levothyroxine sodium), either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.
LEVOXYL is contraindicated in patients with untreated subclinical or overt thyrotoxicosis of any etiology, acute myocardial infarction, or uncorrected adrenal insufficiency. LEVOXYL is contraindicated in patients with hypersensitivity to any of its inactive ingredients.
LEVOXYL should not be used in patients with nontoxic diffuse goiter or nodular thyroid disease if serum TSH level is already suppressed. If the TSH is not suppressed, LEVOXYL should be used with caution and monitoring for evidence of hyperthyroidism.
LEVOXYL should not be used for the treatment of male or female infertility unless this condition is associated with hypothyroidism.
LEVOXYL has a narrow therapeutic index. Careful dosage titration is necessary to avoid the consequences of over- or under-treatment such as effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and glucose and lipid metabolism.
Decreased bone mineral density (BMD) has been associated with long term LEVOXYL therapy in women. It is recommended that LEVOXYL be given in the minimum dose necessary to achieve the desired response.
LEVOXYL should be initiated at lower doses in the elderly and in patients with cardiovascular disorders.
Many drugs affect thyroid hormone pharmacokinetics and metabolism. Thyroid hormones also affect the pharmacokinetics and action of other drugs. The prescriber should be aware of this fact and should consult appropriate reference sources.
Acute massive overdosage of LEVOXYL may be a life-threatening emergency. Symptomatic and supportive therapy should be instituted immediately.
Adverse reactions associated with LEVOXYL are primarily those of hyperthyroidism due to therapeutic overdosage: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating, headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia, tremors, muscle weakness, palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest, dyspnea, diarrhea, vomiting, abdominal cramps, hair loss, flushing, menstrual irregularities, impaired fertility, and rarely seizures. Also in children: pseudo tumor cerebri, slipped capital femoral epiphysis; overtreatment may result in craniosynostosis, and premature closure of the epiphyses.
When LEVOXYL was not taken with water the following adverse events have been reported: choking, gagging, tablet stuck in throat and dysphagia.
LEVOXYL is indicated for hypothyroidism—as replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism.
LEVOXYL is indicated for pituitary TSH suppression—in the treatment or prevention of various types of euthyroid goiters including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s thyroiditis) multinodular goiter and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
By participating in the LEVOXYL Savings Offer Program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- This Savings Offer is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, Tricare or other federal or state healthcare programs (including any state prescription drug assistance programs) and the Government Health Insurance Plan available in Puerto Rico (formerly known as "La Reforma de Salud")
- The Savings Offer is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs which reimburse you for the entire cost of your prescription drugs
- You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
- Eligible patients may save up to $5 for 3 prescription fills. By using the Savings Offer, eligible patients will receive a savings of up to $5 per fill off of their co-pay or out-of-pocket costs for 3 fills. The Savings Offer is good for a maximum savings of $15 per year ($5 per month x 3 months). For a mail-order 3-month prescription, your total maximum savings may be $15 ($5 x 3)
- This coupon is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs
- The Savings Offer is not valid for Massachusetts residents whose prescriptions are covered, in whole or in part, by third-party insurance
- This coupon is not valid where prohibited by law
- The Savings Offer cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription
- A coupon may not be redeemed more than once per month per patient
- The Savings Offer will be accepted only at participating pharmacies
- The Savings Offer is not health insurance
- This offer is good only in the U.S. and Puerto Rico
- The Savings Offer is limited to 1 per person during this offering period and is not transferable
- Pfizer reserves the right to rescind, revoke, or amend the program without notice
- No membership fees. The Savings Offer and Program expire on 12/31/19
Reference: 1. LEVOXYL® [package insert]. Bristol, TN: King Pharmaceuticals, Inc.; 2008.