THYROSYN- levothyroxine sodium tablet 
Vedco, Inc.

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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THYROSYN
(LEVOTHYROXINE SODIUM) TABLETS

Description

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

The structural formula for levothyroxine sodium is:

Chemical Structure

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). 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.

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.

Administration

Thyrosyn 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 180 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.

VEDCO, INC.
St. Joseph, MO 64507

For More Information Call 888-708-3326

08/12
302131-01

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

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

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

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

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

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

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

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

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
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-271
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.1 mg
Product Characteristics
ColorYELLOWScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-271-86180 in 1 BOTTLE
2NDC:50989-271-531000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/30/2012
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-272
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.2 mg
Product Characteristics
ColorPINKScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-272-86180 in 1 BOTTLE
2NDC:50989-272-531000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/30/2012
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-273
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.3 mg
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-273-86180 in 1 BOTTLE
2NDC:50989-273-531000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/30/2012
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-274
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.4 mg
Product Characteristics
ColorRED (MAROON) Score2 pieces
ShapeOVALSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-274-86180 in 1 BOTTLE
2NDC:50989-274-531000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/30/2012
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-275
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.5 mg
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-275-86180 in 1 BOTTLE
2NDC:50989-275-531000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/30/2012
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-276
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.6 mg
Product Characteristics
ColorPURPLEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-276-86180 in 1 BOTTLE
2NDC:50989-276-531000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/30/2012
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-267
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.7 mg
Product Characteristics
ColorORANGEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-267-86180 in 1 BOTTLE
2NDC:50989-267-531000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/30/2012
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-278
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS0.8 mg
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-278-86180 in 1 BOTTLE
2NDC:50989-278-531000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/30/2012
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-270
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
levothyroxine sodium (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS1 mg
Product Characteristics
ColorBROWN (BEIGE) Score2 pieces
ShapeOVALSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-270-86180 in 1 BOTTLE
2NDC:50989-270-531000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/30/2012
Labeler - Vedco, Inc. (021634266)

Revised: 1/2013
Document Id: c6d096e1-5112-40ef-8ce3-addf84dff7e4
Set id: 85503033-7696-4fab-8e24-29c7a15a2f12
Version: 1
Effective Time: 20130114
 
Vedco, Inc.