Your browser does not support JavaScript! THYROSYN (LEVOTHYROXINE SODIUM) TABLET [VEDCO INC.]

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RxNorm Names

THYROSYN (levothyroxine sodium) tablet
[Vedco Inc.]


Category DEA Schedule Marketing Status
PRESCRIPTION ANIMAL DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

Caution

Federal law restricts this drug to use by or on the order of a licensed 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 0.1 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). 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. The 0.7 mg tablet contains FD&C yellow #5 (tartrazine) which has been associated with allergic type reactions (including bronchial asthma) in susceptible humans. It is unknown whether such a reaction could also occur in dogs. 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 the signs of thyrotoxicosis listed above under precautions.

Dosage

The initial recommended daily dose is 0.1 mg/10 lb body weight. Dosage is then adjusted according to patient's response by monitoring T4 blood levels at time intervals of four weeks.

Administration

L-thyroxine 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, and 0.8 mg.

Storage

Store at 15°-30°C (59°-86°F) and protect from light.

0210

PRINCIPAL DISPLAY PANEL - .1 MG Tablet Bottle Label

NDC 50989-197-53

THYROSYN .1 MG
TABLETS
SODIUM LEVOTHYROXINE
NET CONTENTS: 1000 TABLETS

VEDCO

.1 MG
YELLOW

PRINCIPAL DISPLAY PANEL - .1 MG Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - .2 MG Tablet Bottle Label

NDC 50989-200-53

THYROSYN .2 MG
TABLETS
SODIUM LEVOTHYROXINE
NET CONTENTS: 1000 TABLETS

VEDCO

.2 MG
RED

PRINCIPAL DISPLAY PANEL - .2 MG Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - .3 MG Tablet Bottle Label

NDC 50989-201-53

THYROSYN .3 MG
TABLETS
SODIUM LEVOTHYROXINE
NET CONTENTS: 1000 TABLETS

VEDCO

.3 MG
GREEN

PRINCIPAL DISPLAY PANEL - .3 MG Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - .4 MG Tablet Bottle Label

NDC 50989-284-53

THYROSYN .4 MG
TABLETS
SODIUM LEVOTHYROXINE
NET CONTENTS: 1000 TABLETS

VEDCO

.4 MG
MAROON

PRINCIPAL DISPLAY PANEL - .4 MG Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - .5 MG Tablet Bottle Label

NDC 50989-203-53

THYROSYN .5 MG
TABLETS
SODIUM LEVOTHYROXINE
NET CONTENTS: 1000 TABLETS

VEDCO

.5 MG
WHITE

PRINCIPAL DISPLAY PANEL - .5 MG Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - .6 MG Tablet Bottle Label

NDC 50989-240-53

THYROSYN .6 MG
TABLETS
SODIUM LEVOTHYROXINE
NET CONTENTS: 1000 TABLETS

VEDCO

.6 MG
PURPLE

PRINCIPAL DISPLAY PANEL - .6 MG Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - .7 MG Tablet Bottle Label

NDC 50989-283-53

THYROSYN .7 MG
TABLETS
SODIUM LEVOTHYROXINE
NET CONTENTS: 1000 TABLETS

VEDCO

.7 MG
ORANGE

PRINCIPAL DISPLAY PANEL - .7 MG Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - .8 MG Tablet Bottle Label

NDC 50989-204-53

THYROSYN .8 MG
TABLETS
SODIUM LEVOTHYROXINE
NET CONTENTS: 1000 TABLETS

VEDCO

.8 MG
BLUE

PRINCIPAL DISPLAY PANEL - .8 MG Tablet Bottle Label
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-197
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM0.1 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
MAGNESIUM STEARATE 
POVIDONE K29/32 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C YELLOW NO. 6 
D&C YELLOW NO. 10 
Product Characteristics
ColorYELLOWScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 0;1;T4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-197-86180 in 1 BOTTLE, PLASTIC
2NDC:50989-197-531000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/01/1990
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-200
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM0.2 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
MAGNESIUM STEARATE 
POVIDONE K29/32 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C RED NO. 40 
Product Characteristics
ColorPINKScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 0;2;T4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-200-86180 in 1 BOTTLE, PLASTIC
2NDC:50989-200-531000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/01/1990
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-201
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM0.3 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
MAGNESIUM STEARATE 
POVIDONE K29/32 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C YELLOW NO. 6 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 0;3;T4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-201-86180 in 1 BOTTLE, PLASTIC
2NDC:50989-201-531000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/01/1990
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-284
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM0.4 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
MAGNESIUM STEARATE 
POVIDONE K29/32 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
D&C RED NO. 7 
Product Characteristics
ColorPINKScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 0;4;T4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-284-86180 in 1 BOTTLE, PLASTIC
2NDC:50989-284-531000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/01/1990
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-203
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM0.5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
MAGNESIUM STEARATE 
POVIDONE K29/32 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 0;5;T4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-203-86180 in 1 BOTTLE, PLASTIC
2NDC:50989-203-531000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/01/1990
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-240
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM0.6 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
MAGNESIUM STEARATE 
POVIDONE K29/32 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
D&C RED NO. 30 
FD&C BLUE NO. 1 
Product Characteristics
ColorPURPLEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 0;6;T4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-240-86180 in 1 BOTTLE, PLASTIC
2NDC:50989-240-531000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/01/1990
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-283
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM0.7 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
MAGNESIUM STEARATE 
POVIDONE K29/32 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C YELLOW NO. 5 
FD&C RED NO. 40 
Product Characteristics
ColorORANGEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 0;7;T4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-283-86180 in 1 BOTTLE, PLASTIC
2NDC:50989-283-531000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/01/1990
THYROSYN 
levothyroxine sodium tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:50989-204
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM0.8 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
MAGNESIUM STEARATE 
POVIDONE K29/32 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 0;8;T4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-204-86180 in 1 BOTTLE, PLASTIC
2NDC:50989-204-531000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/01/1990
Labeler - Vedco Inc. (021634266)
Registrant - LLOYD, Inc. of Iowa (962286535)
Establishment
NameAddressID/FEIBusiness Operations
LLOYD, Inc. of Iowa962286535MANUFACTURE, LABEL, PACK
Establishment
NameAddressID/FEIBusiness Operations
LLOYD, Inc of Iowa007281942ANALYSIS

Revised: 10/2011
 
Vedco Inc.

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