Soloxine

Dosage Form: FOR ANIMAL USE ONLY
Soloxine®

(LEVOTHYROXINE SODIUM)

TABLETS

Description

Each Soloxine® (Levothyroxine Sodium, USP) Tablet provides synthetic crystalline levothyroxine sodium (L-thyroxine).

The structural formula for levothyroxine sodium is:

Levothyroxine Sodium Action

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.

Indications

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 in the Dog

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:

 

Lethargy, lack of endurance, increased sleeping

 

Reduced interest, alertness and excitability

 

Slow heart rate, weak apex beat and pulse, low voltage on ECG

 

Preference for warmth, low body temperature, cool skin

 

Increased body weight

 

Stiff and slow movements, dragging of front feet

 

Head tilt, disturbed balance, unilateral facial paralysis

 

Atrophy of epidermis, thickening of dermis

 

Surface and follicular hyperkeratosis, pigmentation

 

Puffy face, blepharoptosis, tragic expression

 

Dry, coarse, sparse coat, slow regrowth after clipping

 

Retarded turnover of hair (carpet coat of boxers)

 

Shortening or absence of estrus, lack of libido

 

Dry feces, occasional diarrhea

 

Hypercholesterolemia

 

Normochromic, normocytic anemia

 

Elevated serum creatinine phosphokinase

Contraindications

Levothyroxine sodium therapy is contraindicated in thyrotoxicosis, acute myocardial infarction and uncorrected adrenal insufficiency. Use in pregnant bitches has not been evaluated.

Precautions

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.

Adverse Reactions

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.

Dosage

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.

Administration

Soloxine tablets may be administered orally or placed in the food.

Dosage forms available

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.

Storage

Store at controlled room temperature 15°C to 30°C (59°F to 86°F).

References

1. Evinger, J.V. and Nelson, R.W.; JAVMA 314. 1984, pg 185, 314-316.


2. Richard Nelson, DVM; Current Veterinary Therapy X. Edited by R. W. Kirk, W. B. Saunders, Co., Philadelphia, PA 1989, pg 994.


3. Edward Feldman, DVM and Richard Nelson, DVM; Canine and Feline Endocrinology and Reproduction. W. B. Saunders 1987, pg 82.

Virbac AH, Inc.

Fort Worth, TX 76137

For More Information Call

1-800-338-3659

11/09

301787-02

PRINCIPAL DISPLAY PANEL - 0.1 mg Tablet Bottle Label

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

PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Bottle Label

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

PRINCIPAL DISPLAY PANEL - 0.3 mg Tablet Bottle Label

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

PRINCIPAL DISPLAY PANEL - 0.4 mg Tablet Bottle Label

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

PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label

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

PRINCIPAL DISPLAY PANEL - 0.6 mg Tablet Bottle Label

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

PRINCIPAL DISPLAY PANEL - 0.7 mg Tablet Bottle Label

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

PRINCIPAL DISPLAY PANEL - 0.8 mg Tablet Bottle Label

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

PRINCIPAL DISPLAY PANEL - 1.0 mg Tablet Bottle Label

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

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-831 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.1 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;1 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-831-10 1000 TABLET In 1 BOTTLE None 2 51311-831-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-832 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.2 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PINK Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-832-10 1000 TABLET In 1 BOTTLE None 2 51311-832-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-833 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.3 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color GREEN Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;3 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-833-10 1000 TABLET In 1 BOTTLE None 2 51311-833-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-834 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.4 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color RED (Maroon) Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;4 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-834-10 1000 TABLET In 1 BOTTLE None 2 51311-834-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-835 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.5 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;5 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-835-10 1000 TABLET In 1 BOTTLE None 2 51311-835-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-836 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.6 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PURPLE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;6 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-836-10 1000 TABLET In 1 BOTTLE None 2 51311-836-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-837 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.7 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color ORANGE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;7 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-837-10 1000 TABLET In 1 BOTTLE None 2 51311-837-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-838 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 0.8 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BLUE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 0;8 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-838-10 1000 TABLET In 1 BOTTLE None 2 51311-838-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Soloxine  levothyroxine sodium  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 51311-830 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levothyroxine sodium (levothyroxine) levothyroxine sodium 1 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN (Beige) Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 1 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51311-830-10 1000 TABLET In 1 BOTTLE None 2 51311-830-25 250 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/07/2009

Labeler - Virbac AH, Inc. (131568396)

Establishment
Name	Address	ID/FEI	Operations
Virbac Bridgeton		808558100	MANUFACTURE

Revised: 12/2009Virbac AH, Inc.