THYROKARE- levothyroxine sodium tablet 
Neogen Corporation-Mercer Rd

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.

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​FOR ANIMAL USE ONLY

Each tablet contains:

Levothyroxine Sodium, USP....................__ mg

​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.

​Indications:

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

​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.

Manufactured by Neogen Corporation

Lexington, KY 40511 USA • 859/254-1221

​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

​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

L751-072012

ThyroKare 0.1 mg 180 Tablet Label

​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

L776-072013

ThyroKare 0.1 mg 1000 TabletLabel

​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

L753-072012

ThyroKare 0.2 mg Tablet Label

​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

L777-072012

ThyroKare 0.2 mg 1000 Tablet Label

​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

L754-072012

ThyroKare 0.3 mg 180 Tablet Label

​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

L778-072012

Thyrokare 0.3 mg 1000 Tablet Label

​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

L768-072012

ThyroKare 0.4 mg 180 Tablet Label

​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

L779-072012

ThyroKare 0.4 mg 1000 Tablet Label

​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

L769-072012

ThyroKare 0.5 mg 180 Tablet Label

​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

L780-072012

ThyroKare 0.5 mg 1000 Tablet Label

​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

L770-071913

Rev0713-0.6mg 180 ct.jpg

​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

L781-071913

Rev0713-0.6mg 1000 ct.jpg

​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

L771-072012

ThyroKare 0.7 mg 180 Tablet Label

​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

L782-072012

iThyroKare 0.7 mg 1000 Tablet Label

​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

L772-072012

ThyroKare 0.8 mg 180 Tablet Label

​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

L783-072012

ThyroKare 0.8 mg 1000 Tablet Label

THYROKARE 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:59051-9100
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.1 mg
Product Characteristics
ColoryellowScore2 pieces
ShapeOVALSize5mm
FlavorImprint Code 0;1;T;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59051-9100-0180 in 1 BOTTLE, PLASTIC
2NDC:59051-9100-81000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/15/2012
THYROKARE 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:59051-9102
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.2 mg
Product Characteristics
ColorpinkScore2 pieces
ShapeOVALSize5mm
FlavorImprint Code 0;2;T;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59051-9102-0180 in 1 BOTTLE, PLASTIC
2NDC:59051-9102-81000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/15/2012
THYROKARE 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:59051-9104
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.3 mg
Product Characteristics
ColorgreenScore2 pieces
ShapeOVALSize5mm
FlavorImprint Code 0;3;T;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59051-9104-0180 in 1 BOTTLE, PLASTIC
2NDC:59051-9104-81000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/15/2012
THYROKARE 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:59051-9106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.4 mg
Product Characteristics
ColorpinkScore2 pieces
ShapeOVALSize5mm
FlavorImprint Code 0;4;T;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59051-9106-0180 in 1 BOTTLE, PLASTIC
2NDC:59051-9106-81000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/15/2012
THYROKARE 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:59051-9108
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.5 mg
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize5mm
FlavorImprint Code 0;5;T;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59051-9108-0180 in 1 BOTTLE, PLASTIC
2NDC:59051-9108-81000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/15/2012
THYROKARE 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:59051-9110
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.6 mg
Product Characteristics
ColorpurpleScore2 pieces
ShapeOVALSize5mm
FlavorImprint Code 0;6;T;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59051-9110-0180 in 1 BOTTLE, PLASTIC
2NDC:59051-9110-81000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/15/2012
THYROKARE 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:59051-9112
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.7 mg
Product Characteristics
ColororangeScore2 pieces
ShapeOVALSize5mm
FlavorImprint Code 0;7;T;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59051-9112-0180 in 1 BOTTLE, PLASTIC
2NDC:59051-9112-81000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/15/2012
THYROKARE 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:59051-9114
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.8 mg
Product Characteristics
ColorblueScore2 pieces
ShapeOVALSize5mm
FlavorImprint Code 0;8;T;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59051-9114-0180 in 1 BOTTLE, PLASTIC
2NDC:59051-9114-81000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/15/2012
Labeler - Neogen Corporation-Mercer Rd (042125879)
Establishment
NameAddressID/FEIBusiness Operations
Neogen Corporation-Mercer Rd042125879manufacture, analysis, label

Revised: 9/2014
Document Id: afbc46dd-c037-4934-a37c-21f8a3c482b3
Set id: a1fa4701-bbac-4442-9484-06894da52328
Version: 3
Effective Time: 20140930
 
Neogen Corporation-Mercer Rd