Levothyroxine Sodium (Page 2 of 7)

Newborns (0-3 months) at Risk for Cardiac Failure

Consider a lower starting dose in newborns at risk for cardiac failure. Increase the dose every 4 to 6 weeks as needed based on clinical and laboratory response.

Children at Risk for Hyperactivity

To minimize the risk of hyperactivity in children, start at one-fourth the recommended full replacement dose, and increase on a weekly basis by one-fourth the full recommended replacement dose until the full recommended replacement dose is reached.

Pregnancy

Pre-Existing Hypothyroidism

Levothyroxine sodium tablets dose requirements may increase during pregnancy. Measure serum TSH and free-T4 as soon as pregnancy is confirmed and, at minimum, during each trimester of pregnancy. In patients with primary hypothyroidism, maintain serum TSH in the trimester-specific reference range. For patients with serum TSH above the normal trimester-specific range, increase the dose of levothyroxine sodium tablets by 12.5 to 25 mcg/day and measure TSH every 4 weeks until a stable levothyroxine sodium tablets dose is reached and serum TSH is within the normal trimester-specific range. Reduce levothyroxine sodium tablets dosage to pre-pregnancy levels immediately after delivery and measure serum TSH levels 4 to 8 weeks postpartum to ensure levothyroxine sodium tablets dose is appropriate.

New Onset Hypothyroidism

Normalize thyroid function as rapidly as possible. In patients with moderate to severe signs and symptoms of hypothyroidism, start levothyroxine sodium tablets at the full replacement dose (1.6 mcg per kg body weight per day). In patients with mild hypothyroidism (TSH < 10 IU per liter) start levothyroxine sodium tablets at 1.0 mcg per kg body weight per day. Evaluate serum TSH every 4 weeks and adjust levothyroxine sodium tablets dosage until a serum TSH is within the normal trimester specific range [see Use in Specific Populations (8.1)] .

TSH Suppression in Well-Differentiated Thyroid Cancer

Generally, TSH is suppressed to below 0.1 IU per liter, and this usually requires a levothyroxine sodium tablets dose of greater than 2 mcg per kg per day. However, in patients with high-risk tumors, the target level for TSH suppression may be lower.

2.4 Monitoring TSH and/or Thyroxine (T4) Levels

Assess the adequacy of therapy by periodic assessment of laboratory tests and clinical evaluation. Persistent clinical and laboratory evidence of hypothyroidism despite an apparent adequate replacement dose of levothyroxine sodium tablets may be evidence of inadequate absorption, poor compliance, drug interactions, or a combination of these factors.

Adults

In adult patients with primary hypothyroidism, monitor serum TSH levels after an interval of 6 to 8 weeks after any change in dose. In patients on a stable and appropriate replacement dose, evaluate clinical and biochemical response every 6 to 12 months and whenever there is a change in the patient’s clinical status.

Pediatrics

In patients with congenital hypothyroidism, assess the adequacy of replacement therapy by measuring both serum TSH and total or free-T4. Monitor TSH and total or free-T4 in children as follows: 2 and 4 weeks after the initiation of treatment, 2 weeks after any change in dosage, and then every 3 to 12 months thereafter following dose stabilization until growth is completed. Poor compliance or abnormal values may necessitate more frequent monitoring. Perform routine clinical examination, including assessment of development, mental and physical growth, and bone maturation, at regular intervals.

While the general aim of therapy is to normalize the serum TSH level, TSH may not normalize in some patients due to in utero hypothyroidism causing a resetting of pituitary-thyroid feedback. Failure of the serum T4 to increase into the upper half of the normal range within 2 weeks of initiation of levothyroxine sodium tablets therapy and/or of the serum TSH to decrease below 20 IU per liter within 4 weeks may indicate the child is not receiving adequate therapy. Assess compliance, dose of medication administered, and method of administration prior to increasing the dose of levothyroxine sodium tablets [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)] .

Secondary and Tertiary Hypothyroidism

Monitor serum free-T4 levels and maintain in the upper half of the normal range in these patients.

3 DOSAGE FORMS AND STRENGTHS

Levothyroxine Sodium Tablets, USP are available containing 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg or 300 mcg of levothyroxine sodium, USP.

  • The 25 mcg tablets are orange, capsule-shaped, scored tablets debossed with L to the left of the score and 4 to the right of the score on one side of the tablet and M on the other side.
  • The 50 mcg tablets are white, capsule-shaped, scored tablets debossed with L to the left of the score and 5 to the right of the score on one side of the tablet and M on the other side.
  • The 75 mcg tablets are violet, capsule-shaped, scored tablets debossed with L to the left of the score and 6 to the right of the score on one side of the tablet and M on the other side.
  • The 88 mcg tablets are olive, capsule-shaped, scored tablets debossed with L to the left of the score and 7 to the right of the score on one side of the tablet and M on the other side.
  • The 100 mcg tablets are yellow, capsule-shaped, scored tablets debossed with L to the left of the score and 8 to the right of the score on one side of the tablet and M on the other side.
  • The 112 mcg tablets are rose, capsule-shaped, scored tablets debossed with L to the left of the score and 9 to the right of the score on one side of the tablet and M on the other side.
  • The 125 mcg tablets are gray, capsule-shaped, scored tablets debossed with L to the left of the score and 10 to the right of the score on one side of the tablet and M on the other side.
  • The 137 mcg tablets are turquoise, capsule-shaped, scored tablets debossed with L to the left of the score and 1 5 to the right of the score on one side of the tablet and M on the other side.
  • The 150 mcg tablets are blue, capsule-shaped, scored tablets debossed with L to the left of the score and 11 to the right of the score on one side of the tablet and M on the other side.
  • The 175 mcg tablets are lilac, capsule-shaped, scored tablets debossed with L to the left of the score and 12 to the right of the score on one side of the tablet and M on the other side.
  • The 200 mcg tablets are pink, capsule-shaped, scored tablets debossed with L to the left of the score and 13 to the right of the score on one side of the tablet and M on the other side.
  • The 300 mcg tablets are green, capsule-shaped, scored tablets debossed with L to the left of the score and 14 to the right of the score on one side of the tablet and M on the other side.

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