SOLOXINE- levothyroxine sodium tablet
Virbac AH, Inc.
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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Each SOLOXINE® (Levothyroxine Sodium, USP) Tablet provides synthetic crystalline levothyroxine sodium (L-thyroxine).
The structural formula for levothyroxine sodium is:
Levothyroxine sodium acts, as does endogenous thyroxine, to stimulate metabolism, growth, development and differentiation of tissues. It increases the rate of energy exchange and increases 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. For purposes of comparison, 0.1 mg of levothyroxine sodium elicits a clinical response approximately equal to that produced by one grain (65 mg) of desiccated thyroid.
Provides thyroid replacement therapy in all conditions of inadequate production of thyroid hormones. Hypothyroidism is the generalized metabolic disease resulting from deficiency of the thyroid hormones levothyroxine (T4) and liothyronine (T3). Soloxine (levothyroxine sodium) will provide levothyroxine (T4) as a substrate for the physiologic deiodination to liothyronine (T3). Administration of levothyroxine sodium alone will result in complete physiologic thyroid replacement.
Canine hypothyroidism is usually primary, i.e., due to atrophy of the thyroid gland. In the majority of cases the atrophy is associated with lymphocytic thyroiditis and in the remainder it is non-inflammatory and as of yet unknown etiology. Less than 10 percent of cases of hypothyroidism are secondary, i.e., due to deficiency of thyroid stimulating hormone (TSH). TSH deficiency may occur as a component of congenital hypopituitarism or as an acquired disorder in adult dogs, in which case it is invariably due to the growth of a pituitary tumor.
Hypothyroidism usually occurs in middle-aged and older dogs although the condition will sometimes be seen in younger dogs of the larger breeds. Neutered animals of either sex are also frequently affected, regardless of age. The following are clinical signs of hypothyroidism in dogs:
Levothyroxine sodium therapy is contraindicated in thyrotoxicosis, acute myocardial infarction and uncorrected adrenal insufficiency. Use in pregnant bitches has not been evaluated.
The effects of levothyroxine sodium therapy are slow in being manifested. Overdosage of any thyroid drug may produce the signs and symptoms of thyrotoxicosis including, but not limited to: polydipsia, polyuria, polyphagia, reduced heat tolerance and hyperactivity or personality change. Administer with caution to animals with clinically significant heart disease, hypertension or other complications for which a sharply increased metabolic rate might prove hazardous.
There are no particular adverse reactions associated with levothyroxine sodium therapy at the recommended dosage levels. Overdosage will result in the signs of thyrotoxicosis listed above under precautions.
The initial recommended dose is 0.1 mg/10 lb. (4.5 kg) body weight twice daily. Dosage is then adjusted by monitoring the thyroid blood levels of the dog every four weeks until an adequate maintenance dose is established. The usual maintenance dose is 0.1 mg/10 lb. (4.5 kg) once daily.
A maximum of 0.8 mg to 1.0 mg total daily dose will be sufficient in most dogs over 80 pounds in body weight.
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg and 1.0 mg tablets in bottles of 250 and 1,000.
Virbac
ANIMAL HEALTH
NDC 051311-831-25
SOLOXINE®
(LEVOTHYROXINE SODIUM)
TABLETS
0.1 mg
250 TABLETS
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
Virbac AH, Inc. • P.O. Box 162059
Fort Worth, TX 76161 • (800) 338-3659
Virbac
ANIMAL HEALTH
NDC 051311-832-25
SOLOXINE®
(LEVOTHYROXINE SODIUM)
TABLETS
0.2 mg
250 TABLETS
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
Virbac AH, Inc. • P.O. Box 162059
Fort Worth, TX 76161 • (800) 338-3659
Virbac
ANIMAL HEALTH
NDC 051311-833-25
SOLOXINE®
(LEVOTHYROXINE SODIUM)
TABLETS
0.3 mg
250 TABLETS
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
Virbac AH, Inc. • P.O. Box 162059
Fort Worth, TX 76161 • (800) 338-3659
Virbac
ANIMAL HEALTH
NDC 051311-834-25
SOLOXINE®
(LEVOTHYROXINE SODIUM)
TABLETS
0.4 mg
250 TABLETS
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
Virbac AH, Inc. • P.O. Box 162059
Fort Worth, TX 76161 • (800) 338-3659
Virbac
ANIMAL HEALTH
NDC 051311-835-25
SOLOXINE®
(LEVOTHYROXINE SODIUM)
TABLETS
0.5 mg
250 TABLETS
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
Virbac AH, Inc. • P.O. Box 162059
Fort Worth, TX 76161 • (800) 338-3659
Virbac
ANIMAL HEALTH
NDC 051311-836-25
SOLOXINE®
(LEVOTHYROXINE SODIUM)
TABLETS
0.6 mg
250 TABLETS
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
Virbac AH, Inc. • P.O. Box 162059
Fort Worth, TX 76161 • (800) 338-3659
Virbac
ANIMAL HEALTH
NDC 051311-837-25
SOLOXINE®
(LEVOTHYROXINE SODIUM)
TABLETS
0.7 mg
250 TABLETS
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
Virbac AH, Inc. • P.O. Box 162059
Fort Worth, TX 76161 • (800) 338-3659
Virbac
ANIMAL HEALTH
NDC 051311-838-25
SOLOXINE®
(LEVOTHYROXINE SODIUM)
TABLETS
0.8 mg
250 TABLETS
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
Virbac AH, Inc. • P.O. Box 162059
Fort Worth, TX 76161 • (800) 338-3659
Virbac
ANIMAL HEALTH
NDC 051311-830-25
SOLOXINE®
(LEVOTHYROXINE SODIUM)
TABLETS
1.0 mg
250 TABLETS
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
Virbac AH, Inc. • P.O. Box 162059
Fort Worth, TX 76161 • (800) 338-3659
SOLOXINE
levothyroxine sodium tablet |
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levothyroxine sodium tablet |
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Labeler - Virbac AH, Inc. (131568396) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Virbac Bridgeton | 829166276 | MANUFACTURE |