DOSAGE AND ADMINISTRATION
General Administration Information
Administer TIROSINT-SOL as a single daily oral dose, on
an empty stomach, one-half to one hour before breakfast.
Administer TIROSINT-SOL at least 4 hours before or after
drugs known to interfere with TIROSINT-SOL absorption [see DRUG INTERACTIONS].
Evaluate the need for dose adjustments when regularly
administering within an hour of certain foods that may affect TIROSINT-SOL
absorption [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
TIROSINT-SOL may be administered in water or directly
into the mouth:
- To administer TIROSINT-SOL in water, squeeze the contents
of one single unit-dose ampule into a glass or cup containing water. Stir the
diluted TIROSINT-SOL and drink all of it immediately. Rinse the glass or cup
with additional water and drink the contents to ensure that the total dose is
taken. Do not dilute TIROSINT-SOL in a medium other than water. Open the ampule
and prepare the solution immediately before intake.
- To administer TIROSINT-SOL directly (without water),
either squeeze it into the mouth OR onto a spoon and immediately consume.
General Principles Of Dosing
The dose of TIROSINT-SOL 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-SOL 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-SOL 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-SOL is approximately 1.6 mcg per kg per day (for example: 100 to 125
mcg per day for a 70 kg adult).
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-SOL 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-SOL 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-SOL 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-SOL dosing per above instructions until the patient is clinically
euthyroid and the serum free-T4 level is restored to the upper half of the
Pediatric Dosage -Congenital Or Acquired Hypothyroidism
The recommended daily dose of TIROSINT-SOL in pediatric
patients with hypothyroidism is based on body weight and changes with age as
described in Table 1. Start TIROSINT-SOL at the full daily dose in most
pediatric patients. Start at a lower dose in newborns (0 to 3 months) at risk
for cardiac failure and children at risk for hyperactivity (see below). Monitor
for clinical and laboratory response [see Monitoring TSH and/or Thyroxine (T4) Levels].
Table 1: TIROSINT-SOL 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].
Newborns (0 to 3 months) at
risk for cardiac failure: Consider a lower starting dose in newborns at risk for
cardiac failure. Increase the dose in 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.
Preexisting Hypothyroidism: TIROSINT-SOL 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-SOL by 12.5 to
25 mcg per day and measure TSH every 4 weeks until a stable TIROSINT-SOL dose
is reached and serum TSH is within the normal trimester specific range. Reduce
TIROSINT-SOL dosage to pre-pregnancy levels immediately after delivery and
measure serum TSH levels 4 to 8 weeks postpartum to ensure the TIROSINT-SOL
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-SOL 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-SOL at 1.0 mcg per kg body weight per
day. Evaluate serum TSH every 4 weeks and adjust TIROSINT-SOL dosage until
serum TSH is within the normal trimester specific range [see Use in Specific
TSH Suppression In Well-Differentiated
Generally, TSH is suppressed to
below 0.1 mIU per Liter, and this usually requires a TIROSINT-SOL 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
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-SOL, may be evidence of inadequate
absorption, poor compliance, drug interactions, or a combination of these
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 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 mental and physical growth and development, 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 TIROSINT-SOL 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-SOL [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].
Secondary (Pituitary) And Tertiary
Monitor serum free-T4 levels
and maintain in the upper half of the normal range in these patients.
Dosage Forms And Strengths
TIROSINT-SOL oral solution is a
clear, colorless to slightly yellow solution supplied in a 1 mL white,
non-transparent, unit-dose ampule. Each ampule bears a colored label with the
dosage strength and the product name (TIROSINT-SOL):
sodium) oral solution is a clear, colorless to slightly yellow solution
supplied in a 1 mL white, non-transparent, unit-dose ampule. The dosage
strength is identified on the box and the pouch, and is associated with a
distinct color. Each ampule bears a colored label with the dosage strength and
the product name (TIROSINT-SOL).
Table 7: TIROSINT-SOL Packaging Description
||Box NDC (30 Unit-Dose Ampules)
||Pouch NDC (5 Unit-Dose Ampules)
|a Shown on box, pouch and ampule.
Storage And Handling
Store TIROSINT-SOL in the original container (closed
pouch) at 25°C (77°F); excursions permitted to 15°-30°C (59-86°F) [See USP
Controlled Room Temperature].
Use TIROSINT-SOL oral solution
within 15 days after opening the pouch. Keep the ampules in the pouch until
ready to use.
Manufactured for (distributor), by: IBSA Institut
Biochimique SA, 6915 Pambio-Noranco, Switzerland. Revised: Feb 2017