Soloxine

Generic Name: levothyroxine sodium
Dosage Form: FOR ANIMAL USE ONLY

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.

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 Item Code (Source) NDC: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
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 0;1
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-831-10 1000 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-831-25 250 TABLET (TABLET) in 1 BOTTLE
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 Item Code (Source) NDC: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
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 0;2
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-832-10 1000 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-832-25 250 TABLET (TABLET) in 1 BOTTLE
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 Item Code (Source) NDC: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
Product Characteristics
Color GREEN Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 0;3
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-833-10 1000 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-833-25 250 TABLET (TABLET) in 1 BOTTLE
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 Item Code (Source) NDC: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
Product Characteristics
Color RED (Maroon) Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 0;4
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-834-10 1000 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-834-25 250 TABLET (TABLET) in 1 BOTTLE
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 Item Code (Source) NDC: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
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 0;5
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-835-10 1000 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-835-25 250 TABLET (TABLET) in 1 BOTTLE
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 Item Code (Source) NDC: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
Product Characteristics
Color PURPLE Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 0;6
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-836-10 1000 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-836-25 250 TABLET (TABLET) in 1 BOTTLE
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 Item Code (Source) NDC: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
Product Characteristics
Color ORANGE Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 0;7
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-837-10 1000 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-837-25 250 TABLET (TABLET) in 1 BOTTLE
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 Item Code (Source) NDC: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
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 0;8
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-838-10 1000 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-838-25 250 TABLET (TABLET) in 1 BOTTLE
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 Item Code (Source) NDC: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
Product Characteristics
Color BROWN (Beige) Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 1
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-830-10 1000 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-830-25 250 TABLET (TABLET) in 1 BOTTLE
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: 12/2009
 
Virbac AH, Inc.
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