Label: THYROKARE- levothyroxine sodium tablet 

  • Label RSS
  • NDC Code(s): 59051-9100-0, 59051-9100-8, 59051-9102-0, 59051-9102-8, view more
    59051-9104-0, 59051-9104-8, 59051-9106-0, 59051-9106-8, 59051-9108-0, 59051-9108-8, 59051-9110-0, 59051-9110-8, 59051-9112-0, 59051-9112-8, 59051-9114-0, 59051-9114-8
  • Packager: Neogen Corporation-Mercer Rd
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 10/12

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

  • DESCRIPTION

    ​FOR ANIMAL USE ONLY

    Each tablet contains:

    Levothyroxine Sodium, USP.......................0.3 mg

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  • ​Dosage:

    Initial dose:

    0.1 mg/10lb (4.5 kg) body weight PO BID

    Typical maintenance dose:

    0.1 mg/10lb (4.5 kg) body weight PO SID

    Blood thyroid hormone levels should be monitored every 2-4 weeks following initial dose suitable for the individual patient. Tablets may be administered orally or pladced in food.

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  • SPL UNCLASSIFIED SECTION

    Item No. 09104

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  • WARNINGS

    ​KEEP OUT OF REACH OF CHILDREN

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  • ​Indications:

    For use as a thyroid hormone replacement therapy in dogs with hypothyroidism or other condition in which natural thryoid hormone production is insufficient.

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  • ​Warning:

    Administer with caution to animals with primary hypertension, euthyroidism and clinically diagnosed heart disease.

    Use in pregnant bitches has not been evaluated.

    ​Store at 20°-25°C(68°-77°F) with excursions between 15°-30°C (59°-86°F) and protect from light.

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  • SPL UNCLASSIFIED SECTION

    Manufactured by Neogen Corporation

    Lexington, KY 40511 USA • 859/254-1221

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  • ​Package Insert

    ThyroKare

    ​LEVOTHYROXINE SODIUM TABLETS

    Caution:

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

    Administration:

    For use only in dogs, under the care of a veterinarian.

    Description:

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

    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, 0.2 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). Administration of 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 ususally primary, i.e. due to atrophy of the thyroid gland. In the majority of cases the atrophy is associated with lymphocytic thyroiditis; in the remainder it is non-inflamatory and of 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 to manifest. 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 connected with L-thyroxine therapy at the recommended dosage levels. Overdose will result in signs of thyotoxicosis listed above under Precautions.

    Dosage:

    The initial recommended dose is 0.1 mg/10lb (4.5 kg) body weight twice daily. Dosage is then adjusted according to patient's response by monitoring T4 blood levels at four-week intervals. The usual maintenance dose is 0.1 mg/10lb (4.5 kg) once daily.

    Administration:

    L-thyroxine tablets may be administered orally or placed in 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, tablets in bottles of 180 and 1000.

    Storage:

    Store at 20°-25°C (68°-77°F) with excursions betwen 15°-30°C (59°-86°F). Protect from light.

    References:

    1. Evinger JV, Nelson RW. JAVMA 1984l185(3):314-316

    2. Nelson RW. In Kirk RW, ed. Current Veterinary Terapy X.​ Philadelphia: WB Saunders; 1989:994.

    3. Feldman E, Nelson RW. Canine and Feline Endocrinology and Reproduction. Philadelphia: WB Saunders; 1987:82.

    _____________________________________________________________________________________________________________

    Lexington, KY 40511 • 859/254-1221 or 800/621-8829

    fax: 800/255-1168 • inform@neogen.com

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  • ​Principal Display Panel 0.1 mg 180 ct

    NDC: 59051-9100-0

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.1 mg

    ​Caution: ​Federal lawrestricts this drug to use by or on th order of a licensed veterinarian.

    NEOGEN.Vet

    Net Contents: 180 tablets

    ThyroKare 0.1 mg 180 Tablet Label

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  • ​Principal Display Panel 0.1 mg 1000 ct

    NDC: 59051-9100-8

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.1mg

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

    NEOGEN.Vet

    Net Contents: 1000 tablets

    ThyroKare 0.1 mg 1000 TabletLabel

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  • ​Principal Display Panel 0.2 mg 180 ct

    NDC: 59051-9102-0

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.2 mg

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

    NEOGEN.Vet

    Net Contents: 180 tablets

    ThyroKare 0.2 mg Tablet Label

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  • ​Principal Display Panel 0.2 mg 1000 ct

    NDC: 59051-9102-8

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.2 mg

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

    NEOGEN.Vet

    Net Contents: 1000 tablets

    ThyroKare 0.2 mg 1000 Tablet Label

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  • ​Principal Display Panel 0.3 mg 180 ct

    NDC: 59051-9104-0

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.3 mg

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

    NEOGEN.Vet

    Net Contents: 180 tablets

    ThyroKare 0.3 mg 180 Tablet Label

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  • ​Principal Display Panel 0.3 mg 1000 ct

    NDC: 59051-9104-8

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.3 mg

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

    NEOGEN.Vet

    Net Contents: 1000 tablets

    Thyrokare 0.3 mg 1000 Tablet Label

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  • ​Principal Display Panel 0.4 mg 180 ct

    NDC: 59051-9106-0

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.4 mg

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

    NEOGEN.Vet

    Net Contents: 180 tablets

    ThyroKare 0.4 mg 180 Tablet Label

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  • ​Principal Display Panel 0.4 mg 1000 ct

    NDC: 59051-9106-8

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.4 mg

    NEOGEN.Vet

    Net Contents: 1000 tablets

    ThyroKare 0.4 mg 1000 Tablet Label

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  • ​Principal Display Panel 0.5 mg 180 ct

    NDC: 59051-9108-0

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.5 mg

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

    NEOGEN.Vet

    Net Contents: 180 tablets

    ThyroKare 0.5 mg 180 Tablet Label

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  • ​Principal Display Panel 0.5 mg 1000 ct

    NDC: 59051-9108-8

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.5 mg

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

    NEOGEN.Vet

    Net Contents: 1000 tablets

    ThyroKare 0.5 mg 1000 Tablet Label

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  • ​Principal Display Panel 0.6 mg 180 ct

    NDC: 59051-9110-0

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.6 mg

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

    NEOGEN.Vet

    Net Contents: 180 tablets

    ThyroKare 0.6 mg 180 Tablet Label

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  • ​Principal Display Panel 0.6 mg 1000 ct

    NDC: 59051-9110-8

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.6 mg

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

    NEOGEN.Vet

    Net Contents: 1000 tablets

    ThyroKare 0.6 mg 1000 Tablet Label

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  • ​Principal Display Panel 0.7 mg 180 ct

    NDC: 59051-9112-0

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.7 mg

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

    NEOGEN.Vet

    Net Contents: 180 tablets

    ThyroKare 0.7 mg 180 Tablet Label

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  • ​Principal Display Panel 0.7 mg 1000 ct

    NDC: 59051-9112-8

    ThyroKare

    (Levothyroxine Sodium Tablets)

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

    NEOGEN.Vet

    Net Contents: 1000 tablets

    iThyroKare 0.7 mg 1000 Tablet Label

    Close
  • ​Principal Display Panel 0.8 mg 180 ct

    NDC: 59051-9114-0

    ThyroKare

    (Levothyroxine Sodium Tablets)

    0.8 mg

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

    NEOGEN.Vet

    Net Contents: 180 tablets

    ThyroKare 0.8 mg 180 Tablet Label

    Close
  • ​Principal Display Panel 0.8 mg 1000 ct

    NDC: 59051-9114-8

    ThryoKare

    (Levothyroxine Sodium Tablets)

    0.8 mg

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

    NEOGEN.Vet

    Net Contents: 1000 tablets

    ThyroKare 0.8 mg 1000 Tablet Label

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  • INGREDIENTS AND APPEARANCE
    THYROKARE 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:59051-9100
    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 5mm
    Flavor Imprint Code 0;1;T;4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59051-9100-8 1000 in 1 BOTTLE, PLASTIC
    1 NDC:59051-9100-0 180 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/15/2012
    THYROKARE 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:59051-9102
    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 5mm
    Flavor Imprint Code 0;2;T;4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59051-9102-8 1000 in 1 BOTTLE, PLASTIC
    1 NDC:59051-9102-0 180 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/15/2012
    THYROKARE 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:59051-9104
    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 5mm
    Flavor Imprint Code 0;3;T;4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59051-9104-8 1000 in 1 BOTTLE, PLASTIC
    1 NDC:59051-9104-0 180 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/15/2012
    THYROKARE 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:59051-9106
    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 pink Score 2 pieces
    Shape OVAL Size 5mm
    Flavor Imprint Code 0;4;T;4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59051-9106-8 1000 in 1 BOTTLE, PLASTIC
    1 NDC:59051-9106-0 180 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/15/2012
    THYROKARE 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:59051-9108
    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 5mm
    Flavor Imprint Code 0;5;T;4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59051-9108-8 1000 in 1 BOTTLE, PLASTIC
    1 NDC:59051-9108-0 180 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/15/2012
    THYROKARE 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:59051-9110
    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 5mm
    Flavor Imprint Code 0;6;T;4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59051-9110-8 1000 in 1 BOTTLE, PLASTIC
    1 NDC:59051-9110-0 180 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/15/2012
    THYROKARE 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:59051-9112
    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 5mm
    Flavor Imprint Code 0;7;T;4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59051-9112-8 1000 in 1 BOTTLE, PLASTIC
    1 NDC:59051-9112-0 180 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/15/2012
    THYROKARE 
    levothyroxine sodium tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:59051-9114
    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 5mm
    Flavor Imprint Code 0;8;T;4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59051-9114-8 1000 in 1 BOTTLE, PLASTIC
    1 NDC:59051-9114-0 180 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/15/2012
    Labeler - Neogen Corporation-Mercer Rd (042125879)
    Establishment
    Name Address ID/FEI Business Operations
    Neogen Corporation-Mercer Rd 042125879 manufacture, analysis, label
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