DOSAGE AND ADMINISTRATION
General Administration Information
Administer TIROSINT as a single daily oral dose, on an
empty stomach, one-half to one hour before breakfast.
Administer TIROSINT at least 4 hours before or after
drugs known to interfere with TIROSINT absorption [see DRUG INTERACTIONS]
Evaluate the need for dose adjustments when regularly
administering within an hour of certain foods that may affect TIROSINT absorption
[see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Swallow TIROSINT capsules whole, do not cut, crush, or
General Principles Of Dosing
The dose of TIROSINT for hypothyroidism or pituitary TSH
suppression depends on a variety of factors including the patient's age, body
weight, cardiovascular status, concomitant medical conditions (including
pregnancy), concomitant medications, co-administered food, and the specific
nature of the condition being treated [see Dosing In Specific Patient Populations, WARNINGS
AND PRECAUTIONS, and DRUG INTERACTIONS]. Dosing must be
individualized to account for these factors and dose adjustments made based on
periodic assessment of the patient's clinical response and laboratory
parameters [see Monitoring TSH and/or Thyroxine (T4) Levels].
The peak therapeutic effect of a given dose of TIROSINT
may not be attained for 4 to 6 weeks.
Dosing In Specific Patient Populations
Primary Hypothyroidism In Adults And In Adolescents In Whom
Growth And Puberty Are Complete
Start TIROSINT at the full replacement dose in otherwise
healthy, non-elderly individuals who have been hypothyroid for only a short time
(such as a few months).The average full replacement dose of TIROSINT is
approximately 1.6 mcg per kg per day (for example: 100-125 mcg per day for a 70
Adjust the dose by 12.5 to 25 mcg increments every 4 to 6
weeks until the patient is clinically euthyroid and the serum TSH returns to normal.
Doses greater than 200 mcg per day are seldom required. An inadequate response
to daily doses greater than 300 mcg per day is rare and may indicate poor
compliance, malabsorption, drug interactions, or a combination of these
For elderly patients or patients with underlying
cardiovascular disease, start with a dose of 12.5 to 25 mcg per day. Increase
the dose every 6 to 8 weeks, as needed, until the patient is clinically
euthyroid and the serum TSH returns to normal. The full replacement dose of
TIROSINT may be less than 1 mcg per kg per day in elderly patients.
In patients with severe longstanding hypothyroidism,
start with a dose of 12.5 to 25 mcg per day. Adjust the dose in 12.5 to 25 mcg increments
every 2 to 4 weeks until the patient is clinically euthyroid and the serum TSH
level is normalized.
Secondary Or Tertiary Hypothyroidism
Start TIROSINT at the full replacement dose in otherwise
healthy, non-elderly individuals. Start with a lower dose in elderly patients with
underlying cardiovascular disease or patients with severe longstanding
hypothyroidism as described above. Serum TSH is not a reliable measure of
TIROSINT dose adequacy in patients with secondary or tertiary hypothyroidism,
and should not be used to monitor therapy. Use the serum free-T4 level to
monitor adequacy of therapy in this patient population. Titrate TIROSINT dosing
per above instructions until the patient is clinically euthyroid and the serum
free-T4 level is restored to the upper half of the normal range.
Pediatric Dosage - Congenital Or Acquired Hypothyroidism
Only administer TIROSINT to pediatric patients 6 years
and older who are able to swallow an intact capsule. The recommended daily dose
of TIROSINT in pediatric patients with hypothyroidism is based on body weight
and changes with age as described in Table 1. Start TIROSINT at the full daily
dose in most pediatric patients. Start at a lower dose in children at risk for hyperactivity
(see below). Monitor for clinical and laboratory response [see Monitoring TSH and/or Thyroxine (T4) Levels].
Table 1: TIROSINT Dosing Guidelines for Pediatric
||Daily Dose Per Kg Body Weighta
|Greater than 12 years but growth and puberty incomplete
|Growth and puberty complete
|a The dose should be adjusted based on
clinical response and laboratory parameters [see Monitoring TSH and/or Thyroxine (T4) Levels and Use In Specific Populations].
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.
TIROSINT dose requirements may increase during pregnancy.
Measure serum TSH and free-T4 as soon as pregnancy is confirmed and, at a
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 TIROSINT by 12.5 to 25 mcg per day and measure TSH every four weeks
until a stable TIROSINT dose is reached and serum TSH is within the normal
trimester specific range. Reduce TIROSINT dosage to pre-pregnancy levels
immediately after delivery and measure serum TSH levels 4 to 8 weeks postpartum
to ensure the TIROSINT 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
TIROSINT at the full replacement dose (1.6 mcg per kg body weight per day). In
patients with mild hypothyroidism (TSH < 10 mIU per Liter), start TIROSINT
at 1.0 mcg per kg body weight per day. Evaluate serum TSH every 4 weeks and
adjust TIROSINT dosage until serum TSH is within the normal trimester specific
range [see Use In Specific Populations].
TSH Suppression In Well-Differentiated Thyroid Cancer
Generally, TSH is suppressed to below 0.1 mIU per Liter,
and this usually requires a TIROSINT 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.
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 TIROSINT may
be evidence of inadequate absorption, poor compliance, drug interactions, or a
combination of these factors.
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.
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 is as follows: at 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
mental and physical growth and development, and bone maturation at regular
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 the pituitary-thyroid feedback. Failure of the serum T4
to increase into the upper half of the normal range within 2 weeks of
initiation of TIROSINT therapy and/or of the serum TSH to decrease below 20 mIU
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 TIROSINT [see WARNINGS AND PRECAUTIONS
and Use In Specific Populations].
Secondary (Pituitary) And Tertiary (Hypothalamic)
Monitor serum free-T4 levels maintain in the upper half
of the normal range in these patients.
Dosage Forms And Strengths
TIROSINT capsules are amber-colored, round/biconvex
capsules, imprinted with a dosage strength specific letter on one side and containing
a viscous amber-colored liquid and are available as follows:
TIROSINT (levothyroxine sodium) capsules are
amber-colored, round/biconvex capsules, imprinted with a dosage strength
specific letter on one side and containing a viscous amber-colored liquid. They
are supplied as follows:
Table 7: TIROSINT Packaging Description - Boxes of 30
capsules, consisting of 3 blisters with 10 capsules each
|*Shown on box and blister packing, not on individual
The dosage strength on each box is clearly identified in
several locations, and is associated with a distinct color. The color of the circles
on the blister is the same color as on the box. Each blister pack contains 10
capsules placed in individual cavities labeled with the dosage strength and the
product name (TIROSINT).
Storage And Handling
Store at 25°C (77°F); excursions permitted to 15°-30°C
(59-86°F) [see USP Controlled Room Temperature]. TIROSINT capsules should
be protected from heat, light and moisture.
Do not separate the individual cavities containing the
drug from the intact blister as important information may be lost (i.e., manufacturer/distributor
names, distributor contact phone number, lot number, and expiration date), and
do not remove the individual capsules from blister packaging until ready to
Manufactured for Akrimax Pharmaceuticals, LLC by: IBSA
Institut Biochimique SA, 6915 Pambio-Noranco, Switzerland. Distributed by: Akrimax
Pharmaceuticals, LLC, Cranford, NJ07016, USA. Revised : Dec 2017