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CYTOMEL®(liothyronine sodium)
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CYTOMEL® Quick Finder
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
- Thyroid hormones, including CYTOMEL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.
- ...
1 INDICATIONS AND USAGE
1.1 Hypothyroidism
CYTOMEL is indicated as a replacement therapy in primary (thyroidal...
2 DOSAGE AND ADMINISTRATION
2.1 General Principles of Dosing
The dose of CYTOMEL for hypothyroidism or pituitary...
3 DOSAGE FORMS AND STRENGTHS
Tablets (round, white to off-white) available as follows:
- 5 mcg: debossed with KPI on one side and 115 on the other side
- 25 mcg: scored on one side and debossed...
4 CONTRAINDICATIONS
CYTOMEL is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3...
5 WARNINGS AND PRECAUTIONS
5.1 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease
...
6 ADVERSE REACTIONS
Adverse reactions associated with CYTOMEL therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5.4) and...
7 DRUG INTERACTIONS
7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics
Many drugs can exert effects on thyroid hormone pharmacokinetics (e.g. absorption,...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Experience with...
10 OVERDOSAGE
The signs and symptoms of overdosage are those of hyperthyroidism [see Warnings and Precautions (5.4) and Adverse Reactions (6)]. In addition,...
11 DESCRIPTION
CYTOMEL tablets contain the active ingredient, liothyronine (L-triiodothyronine or LT3), a synthetic form of a thyroid hormone liothyronine in sodium salt form. It is chemically...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis....
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies have not been performed to evaluate the carcinogenic potential,...
16 HOW SUPPLIED/STORAGE AND HANDLING
CYTOMEL tablets (round, white to off-white) are supplied as follows:
17 PATIENT COUNSELING INFORMATION
Dosing and Administration
- Instruct patients that CYTOMEL should only be taken as...
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