Label: THYROSYN- levothyroxine sodium tablet 

  • NDC Code(s): 50989-267-53, 50989-267-86, 50989-270-53, 50989-270-86, view more
    50989-271-53, 50989-271-86, 50989-272-53, 50989-272-86, 50989-273-53, 50989-273-86, 50989-274-53, 50989-274-86, 50989-275-53, 50989-275-86, 50989-276-53, 50989-276-86, 50989-278-53, 50989-278-86
  • Packager: Vedco, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 01/13

If you are a consumer or patient please visit this version.

  • Description

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

    The structural formula for levothyroxine sodium is:

    Chemical Structure
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  • 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.

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  • 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). Thyrosyn (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.

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  • 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
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  • Contraindications

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

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  • 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.

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  • 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.

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  • 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.

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  • Administration

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

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  • 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 180 and 1,000.

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  • Storage

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

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  • 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.
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  • SPL UNCLASSIFIED SECTION

    VEDCO, INC.
    St. Joseph, MO 64507

    For More Information Call 888-708-3326

    08/12
    302131-01

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  • PRINCIPAL DISPLAY PANEL - 0.1 MG Tablet Bottle Label

    NDC 50989-271-86

    THYROSYN 0.1 MG

    (LEVOTHYROXINE SODIUM)
    TABLETS

    NET CONTENTS: 180 TABLETS

    VEDCO

    0.1 MG
    YELLOW TABLET

    CAUTION: Federal law restricts
    this drug to use by or on the order
    of a licensed veterinarian.

    PRINCIPAL DISPLAY PANEL - 0.1 MG Tablet Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 0.2 MG Tablet Bottle Label

    NDC 50989-272-86

    THYROSYN 0.2 MG

    (LEVOTHYROXINE SODIUM)
    TABLETS

    NET CONTENTS: 180 TABLETS

    VEDCO

    0.2 MG
    PINK TABLET

    CAUTION: Federal law restricts
    this drug to use by or on the order
    of a licensed veterinarian.

    PRINCIPAL DISPLAY PANEL - 0.2 MG Tablet Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 0.3 MG Tablet Bottle Label

    NDC 50989-273-86

    THYROSYN 0.3 MG

    (LEVOTHYROXINE SODIUM)
    TABLETS

    NET CONTENTS: 180 TABLETS

    VEDCO

    0.3 MG
    GREEN TABLET

    CAUTION: Federal law restricts
    this drug to use by or on the order
    of a licensed veterinarian.

    PRINCIPAL DISPLAY PANEL - 0.3 MG Tablet Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 0.4 MG Tablet Bottle Label

    NDC 50989-274-86

    THYROSYN 0.4 MG

    (LEVOTHYROXINE SODIUM)
    TABLETS

    NET CONTENTS: 180 TABLETS

    VEDCO

    0.4 MG
    MAROON TABLET

    CAUTION: Federal law restricts
    this drug to use by or on the order
    of a licensed veterinarian.

    PRINCIPAL DISPLAY PANEL - 0.4 MG Tablet Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 0.5 MG Tablet Bottle Label

    NDC 50989-275-86

    THYROSYN 0.5 MG

    (LEVOTHYROXINE SODIUM)
    TABLETS

    NET CONTENTS: 180 TABLETS

    VEDCO

    0.5 MG
    WHITE TABLET

    CAUTION: Federal law restricts
    this drug to use by or on the order
    of a licensed veterinarian.

    PRINCIPAL DISPLAY PANEL - 0.5 MG Tablet Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 0.6 MG Tablet Bottle Label

    NDC 50989-276-86

    THYROSYN 0.6 MG

    (LEVOTHYROXINE SODIUM)
    TABLETS

    NET CONTENTS: 180 TABLETS

    VEDCO

    0.6 MG
    PURPLE TABLET

    CAUTION: Federal law restricts
    this drug to use by or on the order
    of a licensed veterinarian.

    PRINCIPAL DISPLAY PANEL - 0.6 MG Tablet Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 0.7 MG Tablet Bottle Label

    NDC 50989-267-86

    THYROSYN 0.7 MG

    (LEVOTHYROXINE SODIUM)
    TABLETS

    NET CONTENTS: 180 TABLETS

    VEDCO

    0.7 MG
    ORANGE TABLET

    CAUTION: Federal law restricts
    this drug to use by or on the order
    of a licensed veterinarian.

    PRINCIPAL DISPLAY PANEL - 0.7 MG Tablet Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 0.8 MG Tablet Bottle Label

    NDC 50989-278-86

    THYROSYN 0.8 MG

    (LEVOTHYROXINE SODIUM)
    TABLETS

    NET CONTENTS: 180 TABLETS

    VEDCO

    0.8 MG
    BLUE TABLET

    CAUTION: Federal law restricts
    this drug to use by or on the order
    of a licensed veterinarian.

    PRINCIPAL DISPLAY PANEL - 0.8 MG Tablet Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 1.0 MG Tablet Bottle Label

    NDC 50989-270-86

    THYROSYN 1.0 MG

    (LEVOTHYROXINE SODIUM)
    TABLETS

    NET CONTENTS: 180 TABLETS

    VEDCO

    1.0 MG
    BEIGE TABLET

    CAUTION: Federal law restricts
    this drug to use by or on the order
    of a licensed veterinarian.

    PRINCIPAL DISPLAY PANEL - 1.0 MG Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    THYROSYN 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50989-271
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 0.1 mg
    Product Characteristics
    Color YELLOW Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50989-271-86 180 in 1 BOTTLE
    2 NDC:50989-271-53 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 11/30/2012
    THYROSYN 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50989-272
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 0.2 mg
    Product Characteristics
    Color PINK Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50989-272-86 180 in 1 BOTTLE
    2 NDC:50989-272-53 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 11/30/2012
    THYROSYN 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50989-273
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 0.3 mg
    Product Characteristics
    Color GREEN Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50989-273-86 180 in 1 BOTTLE
    2 NDC:50989-273-53 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 11/30/2012
    THYROSYN 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50989-274
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 0.4 mg
    Product Characteristics
    Color RED (MAROON) Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50989-274-86 180 in 1 BOTTLE
    2 NDC:50989-274-53 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 11/30/2012
    THYROSYN 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50989-275
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 0.5 mg
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50989-275-86 180 in 1 BOTTLE
    2 NDC:50989-275-53 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 11/30/2012
    THYROSYN 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50989-276
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 0.6 mg
    Product Characteristics
    Color PURPLE Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50989-276-86 180 in 1 BOTTLE
    2 NDC:50989-276-53 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 11/30/2012
    THYROSYN 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50989-267
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 0.7 mg
    Product Characteristics
    Color ORANGE Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50989-267-86 180 in 1 BOTTLE
    2 NDC:50989-267-53 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 11/30/2012
    THYROSYN 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50989-278
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 0.8 mg
    Product Characteristics
    Color BLUE Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50989-278-86 180 in 1 BOTTLE
    2 NDC:50989-278-53 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 11/30/2012
    THYROSYN 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50989-270
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 1 mg
    Product Characteristics
    Color BROWN (BEIGE) Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50989-270-86 180 in 1 BOTTLE
    2 NDC:50989-270-53 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 11/30/2012
    Labeler - Vedco, Inc. (021634266)
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