PRODUCT MONOGRAPH

Pr

CYTOMEL

(liothyronine sodium)

Tablets
5 and 25 g

HYPOTHYROIDISM THERAPY

Pfizer Canada Inc.

17300 Trans Canada Highway
Kirkland, Quebec
H9J 2M5

Control Number: (157860)

Date of Revision:
Dec 7 2012 (L3)

INDICATIONS AND CLINICAL USES

Cytomel is indicated in conditions of inadequate endogenous thyroid production.
These: include:
a. HYPOTHYROIDISM: As replacement or supplemental therapy in patients with
hypothyroidism of any etiology except transient hypothyroidism during the recovery
phase of subacute thyroiditis
b. SIMPLE (non-toxic) GOITER: Cytomel may be tried therapeutically in an attempt to
reduce the size of such a goiter, the rationale being that suppression of pituitary thyroid
stimulating hormone (TSH) removes at least one of the growth-promoting factors.
Cytomel may be used in the T3 suppression test to differentiate suspected hyperthyroidism from
euthyroidism. (See special instructions under ADMINISTRATION AND DOSAGE),
Cytomel can be used in patients allergic to dessicated thyroid or thyroid extract derived from
pork or beef.
Use in Pregnancy: See WARNINGS and PRECAUTIONS
Use in Nursing Mothers: See WARNINGS and PRECAUTIONS
Pediatric Use: See WARNINGS and PRECAUTIONS and DOSAGE and ADMINISTRATION
Geriatic Use: See WARNINGS and PRECAUTIONS and DOSAGE and ADMINISTRATION

CONTRAINDICATIONS

Patients with an apparent hypersensitivity to liothyronine sodium or any of the inactive

product constituents.

Patients with uncorrected adrenal insufficiency, as thyroid hormones increase tissue

demands for adrenocortical hormones and may thereby precipitate acute adrenal crisis
(see WARNINGS AND PRECAUTIONS).

Patients with acute myocardial infarction

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions
The use of Cytomel or other thyroid preparations in the therapy of obesity is unjustified and
dangerous. 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 anorectic effects.

General
Cytomel has a narrow therapeutic index and has a relatively short half-life compared to
levothyroxine. Regardless of the indication for use, careful dosage titration is necessary to avoid
the consequences of over or under treatment. These consequences include, among others, effects
on growth and development, cardiovascular function, bone metabolism, reproductive function,
emotional state and gastrointestinal function. Many drugs interact with liothyronine sodium,
necessitating adjustments in dosing to maintain therapeutic response (See DRUG
INTERACTIONS).
Cardiovascular
Since Cytomel is a metabolic stimulant, it is not recommended for use in patients with
compromised cardiovascular systems, particularly the coronary arteries. These include patients
with angina pectoris, ischemic states, and the elderly (in whom there is a greater likelihood of
occult cardiac disease). However, if it is used in such patients, caution should be exercised and
the starting dosage should never be more than 5 g daily. If the dosage is increased, it should be
in increments of no more than 5 g daily at two-week intervals. (See DOSAGE and
ADMINISTRATION).
Endocrine and Metabolism
Patients with Nontoxic Diffuse Goiter or Nodular Thyroid Disease
Exercise caution when administering liothyronine sodium to patients with nontoxic diffuse goiter
or nodular thyroid disease in order to prevent precipitation of thyrotoxicosis. Based on shared
pharmacological effect of thyroid hormones, the below caution may apply to liothyronine:
In those patients, particularly the elderly or those with underlying cardiovascular disease,
levothyroxine therapy is contraindicated if the serum TSH level is already suppressed due to the
risk of precipitating overt thyrotoxicosis. If the serum TSH level is not suppressed, levothyroxine
should be used with caution in conjunction with careful monitoring of thyroid function for
evidence of hyperthyroidism and clinical monitoring for potential associated adverse
cardiovascular signs and symptoms of hyperthyroidism.
Myxedematous patients are sensitive to thyroid substances; dosage should be started at a very
low level and increased gradually (See DOSAGE and ADMINISTRATION).
Diabetes
Patients with diabetes mellitus may require upward adjustments of their antidiabetic therapeutic
regimens when treated with liothyronine sodium (see DRUG INTERACTIONS).

Hypothalamic/Pituitary Hormone Deficiencies

In patients with secondary or tertiary hypothyroidism, additional hypothalamic/pituitary hormone
deficiencies should be considered, and, if diagnosed, treated (see WARNINGS AND
PRECAUTIONS, Autoimmune Polyglandular Syndrome for adrenal insufficiency).
Severe and prolonged hypothyroidism can lead to a decreased level of adrenocortical activity
commensurate with the lowered metabolic state. When thyroid replacement therapy is
administered, the metabolism increases at a greater rate than adrenocortical activity. This can
precipitate adrenocortical insufficiency. Therefore, in severe and prolonged hypothyroidism,
supplemental adrenocortical steroids may be necessary.
In rare instances, the administration of thyroid hormone may precipitate a hyperthyroid state or
may aggravate existing hyperthyroidism. In infants, excessive doses of thyroid hormone
preparations may produce cradiosynostosis.
Morphologic hypogonadism and nephrosis should be ruled out before the drug is administered. If
hypopituitarism is present, the adrenal deficiency must be corrected before Cytomel therapy is
started.
Bone Mineral Density
In women, long-term thyroid hormones therapy has been associated with increased bone
resorption, thereby decreasing bone mineral density, especially in post-menopausal women on
greater than replacement doses or in women who are receiving suppressive doses of thyroid
hormones. Therefore, it is recommended that patients receiving thyroid hormones be given the
minimum dose necessary to achieve the desired clinical and biochemical response.
Immune
Autoimmune Polyglandular Syndrome
Occasionally, chronic autoimmune thyroiditis may occur in association with other autoimmune
disorders such as adrenal insufficiency, pernicious anemia, and insulin dependent diabetes
mellitus. Patients with concomitant adrenal insufficiency should be treated with replacement
glucocorticoids prior to initiation of treatment with liothyronine sodium. Failure to do so may
precipitate an acute adrenal crisis when thyroid hormone therapy is initiated, due to increased
metabolic clearance of glucocorticoids by thyroid hormone.

Special Populations
Nursing mothers: Thyroid hormones are excreted in human milk in minimal amounts which are
not associated with serious adverse reactions. Nevertheless, caution should be exercised when
liothyronine sodium is administered to a nursing woman.
Pregnancy: Thyroid hormones do not readily cross the placental barrier. The clinical experience
to date does not indicate any adverse effect on fetuses when thyroid hormones are administered
to pregnant women. Thyroid replacement therapy to hypothyroid women should not be
discontinued during pregnancy.

Pregnant women who are maintained on liothyronine sodium should have their TSH measured
periodically and liothyronine sodium dose adjusted as necessary. Serum TSH level should be
obtained six to eight weeks postpartum to adjust dosage.
Pediatrics: Clinical assessment of growth, development, and thyroid status should be monitored
frequently (See DOSAGE AND ADMINISTRATION).
Geriatrics: Clinical studies of liothyronine sodium did not include sufficient numbers of subjects
aged 65 and over to determine whether they respond differently from younger subjects. This
drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this
drug may be greater in patients with impaired renal function. Because elderly patients are more
likely to have decreased renal function, care should be taken in dose selection and renal function
should be monitored. Because of the increased prevalence of cardiovascular disease among the
elderly, liothyronine therapy should not be initiated at the full replacement dose (See DOSAGE
and ADMINITRATION).
Monitoring and Laboratory Tests
Periodic measurements of thyroid function tests should be performed guided by the patients
condition.

ADVERSE REACTIONS
Adverse reactions associated with liothyronine sodium are primarily those of hyperthyroidism,
due to therapeutic overdosage (see WARNINGS and PRECAUTIONS, General and
Overdosage). They include the following:
General: excessive sweating, fatigue, increased appetite, weight loss, heat intolerance, fever.
Cardiovascular: cardiac arrhythmias, angina pectoris, palpitations, tachycardia, increased pulse,
increased blood pressure, heart failure
Central Nervous System: headache, nervousness, hyperactivity, anxiety, irritability, emotional
lability, insomnia
Hypersensitivity: rare instances of allergic skin reactions have been reported
Endocrine: decreased bone mineral density
Gastrointestinal: diarrhea
Musculoskeletal: tremors, muscle weakness
Reproductive: menstrual irregularities
Respiratory: dyspnea
Medication should be interrupted until symptoms disappear, then resumed in smaller doses.
Therapy can usually be resumed after one or two days.

DRUG INTERACTIONS
Overview:
Any agent that alters thyroid hormone synthesis, secretion, distribution, effect on target tissues,
metabolism, or elimination may alter the optimal therapeutic dose of Cytomel (liothyronine
sodium). A listing of drug-thyroidal axis interactions is contained in the Table below:

Drug or Drug Class

Effect
Drugs that alter thyroid hormone secretion
Drugs that may decrease thyroid hormone secretion, which may result in hypothyroidism
Aminoglutethimide
Long-term lithium therapy can result in goiter in up
Amiodarone
to 50% of patients, and either subclinical or overt
Iodide (including iodine-containing
hypothyroidism, each in up to 20% of patients. The
radiographic contrast agents)
fetus, neonate, elderly and euthyroid patients with
Lithium
underlying thyroid disease (e.g., Hashimotoss
Thioamides
thyroiditis or with Graves disease previously
- Methimazole
treated with radioiodine or surgery) are among those
- Propylthiouracil (PTU)
individuals who are particularly susceptible to
- Carbimazole
iodine-induced hypothyroidism. Oral
Sulfonamides
cholecystographic agents and amiodarone are
Tolbutamide
slowly excreted, producing more prolonged
hypothyroidism than parenterally administered
iodinated contrast agents. Long-term
aminoglutethimide therapy may minimally decrease
T4 and T3 levels and increase TSH, although all
values remain within normal limits in most patients.
Drugs that may decrease T3 absorption, which may result in hypothyroidism
Bile Acid Sequestrants
Cholestyramine binds orally administered thyroid
- Cholestyramine
hormones in the intestine, impairing their
absorption. In vitro studies indicate that the binding
is not easily overcome. Therefore, four to five hours
should elapse between administration of
cholestyramine and thyroid hormones.
Drugs that may alter T3 serum transport
Drugs that may increase serum TBG Concentration
Drugs that may decrease serum TBG Concentration
Clofibrate
Androgens/Anabolic Steroids
Estrogen-containing Oral Contraceptives
Asparaginase
Estrogens (oral)
Glucocorticoids
Heroin/Methadone
Slow-Release Nicotinic Acid
5-Fluorouracil
Mitotane
Tamoxifen
Miscellaneous
Oral Anticoagulants
Thyroid hormones appear to increase the catabolism
of vitamin K-dependent clotting factors. Patients
stabilized on oral anticoagulants may require dosage
adjustment, through close monitoring of
Prothrombin time, when thyroid therapy is started.
No special precautions appear to be necessary when
oral anticoagulant therapy is begun in a patient
already stabilized on maintenance thyroid therapy.
Tricyclic Antidepressants
Use of thyroid products with imipramine and other
tricyclic antidepressants may increase receptor
sensitivity and enhance antidepressant activity;
transient cardiac arrhythmias have been observed.
Thyroid hormone activity may also be enhanced.
Insulin or Oral Hypoglycemics
Initiating thyroid replacement therapy may require
increases in insulin or oral hypoglycemic
requirements. The effects seen are poorly
understood and depend upon a variety of factors
such as dose and type of thyroid preparations and
endocrine status on the patient.

Digitalis

Cytokines
- Interferon-alpha
- Interleukin-2

Growth Hormones
- Somatrem
- Somatropin
HMG-CoA reductase inhibitors (statins)
- Lovastatin

Ketamine

Methylxanthine Bronchodilators
- (e.g., Theophylline)
Radiographic agents
Sympathomimetics/Catecholamines

Diazepam
Ethionamide
Metoclopramide
Para-aminosalicylate sodium
Perphenazine
Resorcinol (excessive topical use)

Thyroid preparations may potentiate the toxic

effects of digitalis. Thyroid hormonal replacement
increases metabolic rate, which requires an increase
in digitalis dosage.
Therapy with interferon-alpha has been associated
with the development of antithyroid microsomal
antibodies in 20% of patients and some have
transient hypothyroidism, hyperthyroidism, or both.
Patients who have antithyroid antibodies before
treatment are at higher risk for thyroid dysfunction
during treatment.
Interleukin-2 has been associated with transient
painless thyroiditis in 20% of patients. Interferonbeta and gamma have not been reported to cause
thyroid dysfunction.
Excessive use of thyroid hormones with growth
hormones may accelerate epiphyseal closure.
However, untreated hypothyroidism may interfere
with growth response to growth hormone.
Some statins may increase thyroid hormone
requirements. It is unknown if this occurs with all
statins. Close monitoring of thyroid function and
appropriate thyroid hormone dose adjustments may
be necessary when thyroid hormones and statins are
co-prescribed.
When administered to patients on a thyroid
preparation, the parenteral anesthetic may cause
hypertension and tachycardia. Use with caution and
be prepared to treat hypertension, if necessary.
Decreased theophylline clearance may occur in
hypothyroid patients; clearance returns to normal
when the euthyroid state is achieved.
Thyroid hormones may reduce the uptake of 123I,
131
I, and 99mTc.
Concurrent use may increase the effects of
sympathomimetics, catecholamines or thyroid
hormone. Thyroid hormones may increase the risk
of coronary insufficiency when sympathomimetic or
catecholamine agents are administered to patients
with coronary artery disease.
These agents have been associated with thyroid
hormone and/or TSH level alterations by various
mechanisms.

DRUG/LABORATORY TEST INTERACTIONS

Since liothyronine is not as firmly bound to serum protein as thyroxine, the PBI usually remains
at levels below normal during full replacement therapy. As with all thyroid preparations, thyroid
gland-function reflected by 131I uptake may be depressed by Cytomel, particularly when dosage

exceeds 75 g daily. This effect disappears rapidly, and useful 131I uptake values may be
obtained usually within two weeks following discontinuance of the drug.
The following drugs or moieties are known to interfere with laboratory tests performed in
patients on thyroid hormone therapy: androgens, corticosteroids, estrogens and estrogencontaining oral contraceptives, iodine-containing preparations and salicylates.
Changes in TBG concentration should be taken into consideration in the interpretation of T4 and
T3 values, which necessitates measurement and evaluation of unbound (free) hormone and/or
determination of the free-T4 index (FT4I). Pregnancy, infectious hepatitis, estrogens and
estrogen-containing oral contraceptives, and acute intermittent porphyria increase TBG
concentration. Decreases in TBG concentrations are observed in nephrosis, severe
hypoproteinemia, severe liver disease, acromegaly and after androgen or corticosteroid therapy.
Familial hyper- or hypo-thyroxine binding- globulinemias have been described.
The binding of thyroxine by thyroxine-binding prealbumin (TBPA) is inhibited by salicylates.
Medicinal or dietary iodine interferes with all in vivo tests of radioiodine uptake, producing low
uptakes which may not be reflective of a true decrease in hormone synthesis.
Drug-Food Interactions: interactions with food products have not been established.
Drug-Herb Interactions: interactions with herbal products have not been established.

DOSAGE AND ADMINISTRATION

Dosing Considerations
Optimum dosage is usually determined by the patients clinical response. Confirmatory tests
include: Radioactive Iodine T3 Resin Uptake, 131I-T3 Red cell Uptake, BMR, and the Achilles
Tendon Reflex Test. Comparatively small doses (as little as 5 g daily) may be fully effective in
some cases; however, in other instances, a satisfactory clinical response may not be achieved
until recommended dosage levels have been exceeded. Daily doses of up to 150 g may be
required in a few resistant patients.
Recommended Dose and Dosage Adjustment
It is not necessary to divide daily maintenance doses. Although Cytomel has a rapid cut-off, its
metabolic effects persist for a few days following discontinuance.
Mild Hypothyroidism: Recommended starting dose is 25 g daily. Daily dosage then
may be increased by 12.5 or 25 g every one or two weeks. Usual maintenance dosage is
25 75 g daily. Smaller doses may be fully effective in some patients, while 100 g
may be required in others.

Myxedema: Myxedematous patients are very sensitive to thyroid substances; dosage

should be started at a very low level and increased gradually.
Recommended starting dosage is 5 g daily. This may be increased by 5 or 10 g daily
every one or two weeks. Usual maintenance dosage is 50 to 100 g daily.
Cretinism: Since the mother provides little or no thyroid hormone to the fetus, infants
with thyroid dysfunction will require replacement therapy from birth. Treatment should
be initiated as early as possible to avoid permanent physical and mental changes.
Recommended starting dosage is 5 g daily, with a 5 g increment every three to four
days until the desired response is achieved. Infants a few months old may require only 20
g daily for maintenance. At one year, 50 g daily may be required. Above 3 years, full
adult dosage may be necessary.
Simple (non-toxic) Goiter: recommended starting dosage is 5 g daily. This dosage may
be increased by 5 to 10 g daily every one to two weeks. When 25 g daily is reached,
dosage may be increased every week or two by 12.5 or 25 g. Usual maintenance dosage
is 75 g daily.
Special Populations
Pediatrics: Treatment should be initiated immediately upon diagnosis and maintained for life,
unless transient hypothyroidism is suspected, in which case, therapy may be interrupted for 2 to
8 weeks after the age of 3 years to reassess the condition. Gradual cessation of therapy is
justified in patients who have maintained a normal TSH during those 2 to 8 weeks. Therapy
should be started with 5 g daily and increased only by 5 g increments at the recommended
intervals. See WARNINGS and PRECAUTIONS.
Geriatrics: Therapy should be started with 5 g daily and increased only by 5 g increments at
the recommended intervals. In general, dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. See
WARNINGS and PRECAUTIONS.
Switching to Cytomel from thyroid, L-thyroxine or thyroglobulin medication
When switching a patient to Cytomel from thyroid, L-thyroxine or thyroglobulin, discontinue
the other medication, initiate Cytomel at a low dosage, and increase gradually according to the
patients response. When selecting a starting dose, bear in mind that this drug has a rapid onset
of action, and that residual effects of the other thyroid preparation may persist for the first
several weeks of therapy.
Special Instruction for T3 Suppression Test: When 131I thyroid uptake is in the borderline-high
range, administer 75-100 of Cytomel daily for 7 days, then repeat 131I thyroid uptake test. In the
hyperthyroid patient, 24-hour 131I thyroid uptake will not be affected significantly. In the
euthyroid patient, 24-hour 131I thyroid uptake will drop to less than 20%.

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Missed Dose
The missed dose should be taken as soon as possible. If it is almost time for the next dose, the
missed dose should not be taken. Instead, the next regularly scheduled dose should be taken.
Doses should not be doubled.

OVERDOSAGE
For management of a suspected drug overdose, contact your regional Poison Control Centre.

Symptoms: see WARNINGS AND PRECAUTIONS, General and ADVERSE

REACTIONS. Angina pectoris or congestive heart failure may be induced or aggravated. Shock
may also develop. Massive overdosage may result in symptoms resembling thyroid storm.
Chronic excessive dosage will produce the signs and symptoms of hyperthyroidism.
Treatment: Dosage should be reduced or therapy temporarily discontinued if signs and symptoms
of overdosage appear. Treatment may be reinstituted at a lower dosage. In normal individuals,
normal hypothalamic-pituitary-thyroid axis function is restored in 6 to 8 weeks after thyroid
suppression.
Treatment of acute massive thyroid hormone overdosage is aimed at reducing gastrointestinal
absorption of the drugs and counteracting central and peripheral effects, mainly those of
increased sympathetic activity. Vomiting may be induced initially if further gastrointestinal
absorption can reasonably be prevented and barring contraindications such as coma, convulsions,
or loss of the gagging reflex. Treatment is symptomatic and supportive. Oxygen may be
administered and ventilation maintained. Cardiac glycosides may be indicated if congestive heart
failure develops. Measures to control fever, hypoglycemia, or fluid loss should be instituted if
needed. Antiadrenergic agents, particularly propranolol, have been used advantageously in the
treatment of increased sympathetic activity.

ACTION
There are two principal naturally occurring thyroid hormones, L-tetraiodothyronine (T4,
levothyroxine, L-thyroxine) and L-triiodothyronine (T3, liothyronine).
The mechanisms by which thyroid hormones exert their physiologic actions are not well
understood. It is generally believed that they exert most, if not all, of their actions through
control of protein synthesis.
At moderate concentrations, thyroid hormones increase the synthesis of RNA and protein,
followed by an increase in basal metabolic rate (BMR). They stimulate oxidative enzyme
systems generally, and enhance the release of free fatty acids from adipose tissue. They also
increase the intestinal absorption and peripheral utilization of glucose.

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At higher concentrations, thyroid hormones decrease protein synthesis, uncouple oxidative

phosphorylation and increase breakdown of glycogen, lipids and protein.

CLINICAL PHARMACOLOGY
Cytomel brand of liothyronine is the synthetic levo form of triiodothyronine, with all
pharmacologic activities of the natural substance. Its onset of action is rapid, occurring within a
few hours. Maximum pharmacologic response occurs within two or three days, providing early
clinical response.
Following oral administration, about 95% of the dose of thyronine is absorbed from the
gastrointestinal tract in four hours. Liothyronine, not firmly bound to serum protein, is readily
available to body tissues. Its biologic half-life is about 2 days.
Liothyronine has a rapid cut-off of activity which permits quick dosage adjustment and
facilitates control of the effects of overdosage should they occur.

SUPPLY
bottles of 100
5g: Round white to off-white flat face beveled-edge tablet, deposed KPI on one side and 115 on
the other.
25g: Round white to off-white flat face beveled-edge tablet, deposed KPI 116 on one side and a
single bisect on the other.

DIN:

01919458
01919466

5 g
25 g

COMPOSITION
Each Cytomel tablet contains liothyronine 5 g (present as liothyronine sodium 5.18 g) or 25
g (present as liothyronine sodium 25.9 g); 25 g of liothyronine is equivalent to
approximately 65 mg of dessicated thyroid or thyroglobulin and 0.1 mg of L-thyronine. The non
medicinal ingredients are: calcium sulfate, gelatin, starch (corn), stearic acid, sugar and talc.

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IMPORTANT: PLEASE READ

IMPORTANT: PLEASE READ

Serious Warnings and Precautions

PART III: CONSUMER INFORMATION

Cytomel , like other thyroid hormones, should not be

used for the treatment of obesity or for weight loss,
either alone or with other medicines. At normal doses,

Cytomel does not reduce body weight and at higher

doses, it can produce serious or even life-threatening side
effects.

Pr

CYTOMEL
(Liothyronine Sodium Tablets)
This leaflet is Part III of a three-part Product Monograph
published when Cytomel was approved for sale in Canada
and is designed specifically for Consumers. This leaflet is
a summary and will not tell you everything about

Cytomel . Contact your doctor or pharmacist if you have

any questions about this drug.
ABOUT THIS MEDICATION
What the medication is used for

Cytomel (liothyronine sodium) is used for the treatment

of:
Mild to severe hypothyroidism (thyroid gland
does not produce enough hormone);
Enlarged thyroid gland (simple goiter)
What it does

Cytomel (liothyronine sodium) is a synthetic form of a

hormone produced by the thyroid gland called
triiodothyronine.
When it should not be used

Cytomel should not be used if you have:

a hypersensitivity or allergy to thyroid hormones

(liothyronine sodium) or to any non medicinal

ingredients in Cytomel ;
uncorrected adrenal gland under-activity;
acute myocardial infarction (heart attack)

What the medicinal ingredient is

Liothyronine sodium
What the non medicinal ingredients are
Calcium sulfate, gelatin, starch (corn), stearic acid, sugar
and talc
What dosage form it comes in

Cytomel is available as round, white to off-white tablets.

The tablets are available in two strengths: 5 micrograms
and 25 micrograms. The 5 microgram has the letters KPI
on one side and 115 on the other. The 25 microgram has
the letters KPI 116 on one side and a single bisect on the
other.

WARNINGS AND PRECAUTIONS

BEFORE or WHILE YOU USE CYTOMEL , talk to

your doctor if you have the following condition:
any heart problems, such as a heart attack, angina
pectoris (chest pain)
a history problem with thyroid (myxedema), or
adrenal or pituitary gland
kidney disease
high blood sugar (diabetes)
decreased development of sexual organs
(hypogonadism)
bone thinning (osteoporosis)
pregnant or planning to become pregnant
breast feeding
blood clotting problem
INTERACTIONS WITH THIS MEDICATION

Before or while you use Cytomel tell your doctor or

pharmacist about all other medications you take including
medications that you bought without a prescription,
vitamins, and natural products. Particularly if you are
taking the following:
Blood thinner (anticoagulants)
Medications for high cholesterol levels such as
lovastatin, cholestyramine, clofibarate
Medications for high blood sugar or insulin
Medications that contain estrogen such as birth
control pills
Amiodarone
Medicines that contain iodine such as
radiographic contrast agents
Heroin/methadone
5-fluorouracil, mitotane, tamoxifen
Tricyclic antidepressant such as imipramine
Digoxin (digitalis)
Cyokines such as interferon-alpha, interleukin-2
Growth hormones
Ketamine
Theophylline
Diazepam
Ethionamide
Metoclopramide
Perphanazine
Resorcinol (topical products)
Para-aminosalicylate sodium
Some medicines may interfere with blood tests done to
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IMPORTANT: PLEASE READ

determine thyroid hormone levels (thyroid function tests).

It is important to inform your doctor of all medicines you
are taking before and at the time of blood tests.
The following drugs are known to interfere with laboratory
tests performed in patients on thyroid hormone therapy:
Androgens (male hormones)
Corticosteroids (eg., prednisone, dexamethasone)
Estrogens and estrogen-containing oral
contraceptives (birth control pills)
Preparations containing iodine
Salicylates (eg., aspirin)
PROPER USE OF THIS MEDICATION

You should take Cytomel as prescribed by your doctor.

Treatment is usually started with a low dose of Cytomel ,

then increased gradually according to your response.
Overdose
In case of drug overdose, contact your doctor or a Poison
Control Centre, or go to the emergency room of the
hospital near you immediately, even if there are no
symptoms.
Missed dose
If you miss a dose, take it as soon as you remember on the
same day. Skip that dose if you do not remember until the
next day.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects with Cytomel may include symptoms of
hyperthyroidism as follows: Headache, excessive
sweating, fatigue, increased appetite, weight loss, fever,
nervousness, anxiety, irritability, insomnia, cardiac
arrhythmias (heartbeats which are irregular or too fast),
angina pectoris (chest pain), diarrhea and menstrual
irregularities.
Tell your doctor about any other side effect that is not
included above or if you have any question. Your

doctor may ask you stop taking Cytomel until the

symptoms disappear, and re-start after one or two days
at a lower dose.

Store at room temperature (15-25oC or 59-77oF), away

from heat, light and moisture.
Keep container firmly closed and away from the reach of
children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions
associated with the use of health products to the
Canada Vigilance Program by one of the following 3
ways:
---------------------------------------------------------------------- Report online at
www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting
Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance
Reporting Form and the adverse reaction
reporting guidelines are available on the
MedEffect Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the
management of side effects, contact your health
professional. The Canada Vigilance Program does not
provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared
for health professionals can be found at:
http://www.pfizer.ca or by contacting the sponsor, Pfizer
Canada Inc., at:
1-800-463-6001.
This leaflet was prepared by Pfizer Canada Inc.
Last revised: Dec 7, 2012 (L3)

HOW TO STORE IT

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