LEVENTA levothyroxine sodium solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

levothyroxine sodium (UNII: 9J765S329G) (levothyroxine - UNII:Q51BO43MG4)

Available from:

Schering Corporation

INN (International Name):

levothyroxine sodium

Composition:

levothyroxine sodium 1 mg in 1 mL

Prescription type:

PRESCRIPTION

Authorization status:

unapproved drug other

Summary of Product characteristics

LEVENTA- LEVOTHYROXINE SODIUM SOLUTION
SCHERING CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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LEVENTA 30ML
Each mL of LEVENTA (levothyroxine sodium, U.S.P.) oral solution
provides 1 mg synthetic
crystalline levothyroxine sodium (L-thyroxine).
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
INDICATION
Thyroid replacement therapy in dogs with hypothyroidism.
Hypothyroidism is the generalized
metabolic disease resulting from deficiency of the thyroid hormones,
L-thyroxine (T ) and
triiodothyronine (T ). LEVENTA oral solution will provide L-thyroxine
(T ) as a substrate for the
physiologic deiodination to triiodothyronine (T ). Administration of
L-thyroxine (T ), identical to the
L-thyroxine (T ) secreted endogenously by the normal thyroid gland,
will result in complete
physiologic thyroid replacement. L-thyroxine (T ) acts to stimulate
metabolism, growth, development
and differentiation of tissues. It increases the rate of energy
exchange and the maturation rate of the
epiphyses.
The clinical diagnosis of hypothyroidism should be completed by
evaluation of the thyroid hormone of
the dog, i.e. measurement of serum levels of total (or preferably
free) thyroxine (T ) and thyroid
stimulating hormone (TSH). A low total (or free) T concentration
combined with high TSH
concentration is strongly suggestive for primary hypothyroidism.
PHARMACOLOGY
Levothyroxine sodium acts, as does endogenous L-thyroxine (T ), to
stimulate metabolism, growth,
development and differentiation of tissues. It increases the rate of
energy exchange and the maturation
rate of the epiphyses. Levothyroxine sodium is absorbed rapidly from
the gastrointestinal tract after
oral administration. Following absorption, the compound becomes bound
to the serum alpha globulin
fraction.
DOSAGE
The adequate dose rate has to be defined individually for each