Label: THYROMED  - levothyroxine sodium tablet, chewable 

  • NDC Code(s): 53701-201-11, 53701-201-12, 53701-202-11, 53701-202-12, view more
    53701-203-11, 53701-203-12, 53701-204-11, 53701-204-12, 53701-205-11, 53701-205-12, 53701-206-11, 53701-206-12, 53701-207-11, 53701-207-12, 53701-208-11, 53701-208-12
  • Packager: Diamond Animal Health, Inc..
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 11/12

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

  • DESCRIPTION

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

    DESCRIPTION:
    Each ThyroMed®  ChewableTablet (Levothyroxine Sodium, USP) 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 & USAGE

    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 (T 4) and liothyronine (T 3). ThyroMed Chewable Tablets (levothyroxine sodium) will provide levothyroxine (T 4) as a substrate for the physiologic deiodination to liothyronine (T 3). 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. Close
  • SPL UNCLASSIFIED SECTION

    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:


    Dermatological
    Atrophy of the epidermis, thickening of the dermis
    Surface and follicular hyperkeratosis, pigmentation
    Puffy face, blepharoptosis, tragic expression
    Dry, coarse, sparse hair coat, slow regrowth after clipping
    Retarded turnover of hair (carpet coat of boxers)

    Metabolic
    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

    Musculoskeletal
    Stiff and slow movements, dragging of the front feet
    Head tilt, disturbed balance, unilateral facial paralysis

    Reproductive
    Shortening or absence of estrus, lack of libido

    Gastrointestinal

    Dry feces, occasional diarrhea

    Clinical pathological
    Hypercholesterolemia
    Normochromic, normocytic anemia
    Elevated serum creatinine phosphokinase Close
  • CONTRAINDICATIONS

    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

    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.

    The material safety data sheet (MSDS) contains more detailed occupational safety information. For
    technical service, to report an adverse event or to obtain a copy of the MSDS, call 1−800−464−3752.

    KEEP OUT OF REACH OF CHILDREN

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  • ADVERSE REACTIONS

    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. Close
  • DOSAGE & ADMINISTRATION

    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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  • DOSAGE & ADMINISTRATION

    ADMINISTRATION:

    ThyroMed® Chewable Tablets may be given orally to dogs as a treat, or crumbled over their food at the
    veterinarian-prescribed dose. If crumbled over food, consumption should be monitored.
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  • HOW SUPPLIED

    HOW SUPPLIED:
    ThyroMed® Chewable Tablets are available in 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7
    mg and 0.8 mg strength chewable tablets. Tablets are bilaterally scored. The tablets are packaged in
    bottles of 180 tablets (with childproof caps) and 1,000 tablets.

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  • STORAGE AND HANDLING

    STORAGE:
    Store at controlled room temperature; 15° C to 30° C (59° F to 86° F) and protect from light.

    Dispense product in this container or another light, light-resistant container as defined in the USP.

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  • REFERENCES

    REFERENCES:
    Feldman EC, Nelson RW. Canine and Feline Endocrinology and Reproduction. W.B. Saunders, Co.,
    Philadelphia, PA 1996: 68−117.
    Scott DW, Miller WH, Griffen CE. Small Animal Dermatology. W.B. Saunders, Co., Philadelphia,
    PA 1995: 237−8, 894−5.
    Nelson RW. Current Veterinary Therapy X. R.W. Kirk (ed), W.B. Saunders, Co., Philadelphia, PA 1989:
    993−997.
    Evinger JV, Nelson RW. J Am Vet Med Assoc 1984; 185(3): 314−316.

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  • SPL UNCLASSIFIED SECTION

    Manufactured by Diamond Animal Health, Inc.

    A wholly owned subsidiary of Heska Corporation

    Des Moines, Iowa 50327

    HESKA

    Smarter, TogetherTM

    ©2011 Heska Corporation.
    All Rights Reserved. HESKA and ThyroMed are registered trademarks and
    Smarter, Together is a trademark of Heska Corporation in the U.S. and other countries.
    02256 Close
  • PRINCIPAL DISPLAY PANEL

    ThyroMed®
    Chewable Tablets
    (Levothyroxine Sodium)
    N 053701-201-11
    0.1mg
    (100 mcg)
    180 Tablets

    0.1 mg tablet label

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  • PRINCIPAL DISPLAY PANEL

    ThyroMed®
    Chewable Tablets
    (Levothyroxine Sodium)
    N 053701-202-11
    0.2mg
    (200 mcg)
    180 Tablets

    0.2 mg tablet label

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  • PRINCIPAL DISPLAY PANEL

    ThyroMed®
    Chewable Tablets
    (Levothyroxine Sodium)
    N 053701-203-11
    0.3mg
    (300 mcg)
    180 Tablets

    0.3 mg tablet label

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  • PRINCIPAL DISPLAY PANEL

    ThyroMed®
    Chewable Tablets
    (Levothyroxine Sodium)
    N 053701-204-11
    0.4mg
    (400 mcg)
    180 Tablets

    0.4 mg tablet label

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  • PRINCIPAL DISPLAY PANEL

    ThyroMed®
    Chewable Tablets
    (Levothyroxine Sodium)
    N 053701-205-11
    0.5mg
    (500 mcg)
    180 Tablets

    0.5 mg tablet label
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  • PRINCIPAL DISPLAY PANEL

    ThyroMed®
    Chewable Tablets
    (Levothyroxine Sodium)
    N 053701-206-11
    0.6mg
    (600 mcg)
    180 Tablets

    0.6mg tablet label

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  • PRINCIPAL DISPLAY PANEL

    ThyroMed®
    Chewable Tablets
    (Levothyroxine Sodium)
    N 053701-207-11
    0.7mg
    (700 mcg)
    180 Tablets

    0.7 mg tablet label

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  • PRINCIPAL DISPLAY PANEL

    ThyroMed®
    Chewable Tablets
    (Levothyroxine Sodium)
    N 053701-281-11
    0.8 mg
    (800 mcg)
    180 Tablets

    0.8 mg tablet label

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  • INGREDIENTS AND APPEARANCE
    THYROMED  
    levothyroxine sodium tablet, chewable
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:53701-201
    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 brown Score 2 pieces
    Shape OVAL Size 10mm
    Flavor MEAT Imprint Code 0;1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53701-201-11 180 in 1 BOTTLE, PLASTIC
    2 NDC:53701-201-12 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/01/2009
    THYROMED  
    levothyroxine sodium tablet, chewable
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:53701-202
    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 brown Score 2 pieces
    Shape OVAL Size 10mm
    Flavor MEAT Imprint Code 0;2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53701-202-11 180 in 1 BOTTLE, PLASTIC
    2 NDC:53701-202-12 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/01/2009
    THYROMED  
    levothyroxine sodium tablet, chewable
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:53701-203
    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 brown Score 2 pieces
    Shape OVAL Size 10mm
    Flavor MEAT Imprint Code 0;3
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53701-203-11 180 in 1 BOTTLE, PLASTIC
    2 NDC:53701-203-12 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/01/2009
    THYROMED  
    levothyroxine sodium tablet, chewable
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:53701-204
    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 brown Score 2 pieces
    Shape OVAL Size 10mm
    Flavor MEAT Imprint Code 0;4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53701-204-11 180 in 1 BOTTLE, PLASTIC
    2 NDC:53701-204-12 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/01/2009
    THYROMED  
    levothyroxine sodium tablet, chewable
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:53701-205
    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 brown Score 2 pieces
    Shape OVAL Size 10mm
    Flavor MEAT Imprint Code 0;5
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53701-205-11 180 in 1 BOTTLE, PLASTIC
    2 NDC:53701-205-12 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/01/2009
    THYROMED  
    levothyroxine sodium tablet, chewable
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:53701-206
    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 brown Score 2 pieces
    Shape OVAL Size 10mm
    Flavor MEAT Imprint Code 0;6
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53701-206-11 180 in 1 BOTTLE, PLASTIC
    2 NDC:53701-206-12 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/01/2009
    THYROMED  
    levothyroxine sodium tablet, chewable
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:53701-207
    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 brown Score 2 pieces
    Shape OVAL Size 10mm
    Flavor MEAT Imprint Code 0;7
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53701-207-11 180 in 1 BOTTLE, PLASTIC
    2 NDC:53701-207-12 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/01/2009
    THYROMED  
    levothyroxine sodium tablet, chewable
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:53701-208
    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 brown Score 2 pieces
    Shape OVAL Size 10mm
    Flavor MEAT Imprint Code 0;8
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53701-208-11 180 in 1 BOTTLE, PLASTIC
    2 NDC:53701-208-12 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/01/2009
    Labeler - Diamond Animal Health, Inc.. (102913878)
    Registrant - Heska Corporation (603631326)
    Establishment
    Name Address ID/FEI Business Operations
    Diamond Animal Health, Inc. 102913878 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Suzhou APAC Pharma Tech Co., Ltd. 421285264 api manufacture, analysis, pack, label
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