Animal NDC 13985-986-20 Thyro-tabs Canine
Levothyroxine Sodium

Animal Product Information

Field Name Field Value
Animal NDC Code 13985-986-20
Proprietary Name Thyro-tabs Canine What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Levothyroxine Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Mwi/vetone
Product Type Prescription Animal Drug
Usage Information
    INDICATION: For replacement therapy for diminished thyroid function in dogs.
Active Ingredient(s)
  • Levothyroxine Sodium
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141448 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Thyro-tabs Canine Images

Thyro-tabs Canine Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Synthetic thyroxine hormone

For oral use in dogs only.

USER SAFETY WARNINGS: Not for use in humans. Keep out of reach of children. In the event of accidental ingestion, seek medical advice immediately and show the product label to the physician. Wash hands after handling.

ANIMAL SAFETY WARNINGS: Keep Thyro-Tabs Canine in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

In humans and rodents, excess in utero exposure to thyroid hormones is associated with hypothalamic-pituitary-thyroid axis dysfunction and morphological thyroid gland defects in the offspring. The safefy of Thyro-Tabs Canine has not been evaluated In breeding, pregnant, or lactating dogs.

PRE-APPROVAL EXPERIENCE: In a 6-month US field study with 92 dogs, the most commonly reported adverse reactions by percentage of dogs experiencing the reaction included: anorexia (17%), dermatitis (15%), vomiting (15%), otitis externa (14%), lethargy (14%), polydipsia (13%), diarrhea (11 %), leukocytosis (9%), pruritus (8%), tachypnea (8%), polyuria (5%), hyperactivity (4%), and seborrhea (1 %).

One dog was withdrawn from the study at the owner's request because of increased water consumption and urination, which was possibly related to levothyroxine sodium.

Hematocrit and red blood cell counts exceeded the upper limit of the reference range in seven dogs by the end of the study. Liver enzyme (ALP, ALT, or AST) elevations related to levothyroxine administration were reported in three dogs. In two of the dogs with elevated ALT and AST, the elevations resolved by Day 70 and Day 126, respectively.

POST-APPROVAL EXPERIENCE (2022): The following adverse events are based on post-approval adverse drug experience reporting forThyro-Tabs Canine. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.

The following adverse events reported in dogs, are listed in decreasing order of reporting frequency: Pruritus, high or low serum thyroxine (T4) concentrations, tachypnea, weight loss, lethargy, anorexia, vomiting, polydipsia, alopecia, dermatitis, hyperactivity, diarrhea, and polyuria.

Allergic-type hypersensitivity reactions (including pruritus, hives, facial swelling, and dermatitis) have also been reported.

CONTACT INFORMATION: For a copy of the Safety Data Sheet (SDS) or to report suspected adverse drug events, contact LLOYD, Inc. at 1-800-831-0004. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888 FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth.

EFFECTIVENESS: In a US field study with 92 dogs, dogs were administered a starling daily dose of 0.1 mg/10 lb (0.022 mg/kg) body weight. The dose was administered either once every 24 hours or as 0.05 mg/10 lb (0.011 mg/kg) body weight every 12 hours. The dose could be increased or decreased (without a change in frequency) after 6, 10, and 18 weeks, based on clinical findings and serum thyroid hormone concentrations. The maJority of the dogs (80%) were dosed at 0.08-0.12 mg/10 lb (0.008-0.012 mg/lb; 0.018-0.026 mg/kg) by the end of the study, with the majority of dogs (69.7%) requiring one dose change.

The product was considered effective if the serum TT4, free thyroxine (fT4), and thyroid stimulating hormone (TSH) concentrations were all within the desired treatment ranges when collected 4 to 6 hours post-tablet administration after 182 ± 5 days of treatment (TT4: 15-94 nmol/L; fT4: 8-36 pmol/L; TSH: ≤ 37 mU/L). Of the 78 evaluable cases, 59 (75.6%) were considered treatment successes. There was no statistical difference in lhe success rate between the once daily or divided dose treatment groups.

Clinical signs of hypothyroidism (weight gain, lethargy, bradycardia, seborrhea, alopecia, hyperpigmentation, scaling, and hypercholesterolemia) generally improved by the end of the study (Day 182 ± 5). Respiratory rate, excluding panting dogs, increased during the study along with activity level.

TARGET ANIMAL SAFETY: In a laboratory study, levothyroxine sodium was administered to 32 healthy, 7-10 month old, euthyroid Beagle dogs (4 males and 4 females per group) at 0×, 2×, 6×, and 10× the initial dose of 0.10 mg/10 lb (0.01 mg/lb) once daily for 26 weeks. Increased serum TT4 and fT4 concentrations were directly proportional to an increasing dose of levothyroxine sodium. Decreased serum TSH concentrations were inversely proportional to an increasing dose of levothyroxine sodium. Dogs treated with levothyroxine sodium had elevated red blood cell indices (hemoglobin, hematocrit, and red blood cell count) and ALT but these did not exceed the normal reference ranges. Dogs treated with levothyroxine sodium had lower albumin, calcium, globulins, and total protein values but these did not fall below the normal reference ranges. Vomiting, diarrhea, excitation, rapid respiration, tachycardia, and feces with blood were observed in all treatment groups, but were seen with greater frequency in dogs treated with levothyroxine sodium. Decreased pituitary gland and thyroid/parathyroid gland organ weights were also observed in euthyroid dogs treated with levothyroxine sodium.

Approved by FDA under NADA # 141-448

Manufactured by:
LLOYD, Inc.
Shenandoah, IA 51601

Distributed by: MWI
Boise, ID 83705
www.VetOne.net

VET one®

Rev. 05/23

For technical questions, call 1-800-831-0004


Warnings



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


Description



DESCRIPTION: Thyro-Tabs® Canine (levothyroxine sodium tablets), USP contains synthetic crystalline L-3,3' ,5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the canine thyroid gland. Levothyroxine sodium has an empirical formula of C15H10I4N NaO4 ∙ H2O, molecular weight of 798.85 g/mol (anhydrous), and structural formula as shown:


Veterinary Indications



INDICATION: For replacement therapy for diminished thyroid function in dogs.


Dosage & Administration



DOSAGE AND ADMINISTRATION: The initial total daily dose is 0.1 mg/10 pounds (0.01 mg/lb; 0.022 mg/kg) body weight as a single dose every 24 hours or as a divided dose every 12 hours.

The dose may then be adjusted by monitoring the serum total thyroxine (TT4) concentrations 4 to 6 hours post-tablet administration, along with clinical response, of the dog every 4 to 8 weeks until an adequate maintenance dose is established.

To minimize day-to-day variations in serum TT4 concentrations (see CLINICAL PHARMACOLOGY), owners should consistently administer Thyro-Tabs Canine either with or without food.

When switching from another levothyroxine sodium formulation to Thyro-Tabs Canine, monitor serum TT4 concentrations and clinical response due to potential differences in recommended starting doses and potential differences in bioavailability.


Contraindications



CONTRAINDICATIONS: Do not use in dogs with thyrotoxicosis or uncorrected adrenal insufficiency.


Precautions



PRECAUTIONS: Dogs with underlying cardiac disease that are diagnosed with hypothyroidism should be closely monitored during the dose establishment phase. Adjustment of cardiac medication or levothyroxine sodium dosage may be needed depending on clinical response.1-4


Clinical Pharmacology



CLINICAL PHARMACOLOGY: Levothyroxine sodium has poor oral bioavailability in dogs (10-20%) with peak serum TT4 concentrations wilhin 4 to 6 hours (fasted state). Administration of levothyroxine sodium with food reduces oral bioavailability.5 In most dogs, the estimated half-life is approximately 10-14 hours. Levothyroxine sodium is excreted in the feces.


Storage And Handling



STORAGE CONDITIONS: Store at controlled room temperature 20°-25°C (68°-77°F) with excursions allowed between 15° and 30'C (59° and 86°F). Protect from light and moisture.


How Supplied



HOW SUPPLIED: Thyro-Tabs Canine (levothyroxine sodium tablets), USP is available as scored, color coded ovoid tablets in 9 strengths: 0.1 mg-yellow; 0.2 mg-pink; 0.3 mg-green; 0.4 mg-maroon; 0.5 mg-white; 0.6 mg-purple; 0.7 mg-orange; 0.8 mg-blue; and 1.0 mg-tan, in bottles of 120 and 1,000 tablets.


References



REFERENCES:

  • Phillips DE, Harkin KR. Hypothyroidism and myocardial failure in two Great Danes. J Am Anim Hosp Assoc 2003;39:133-137.
  • Flood JA, Hoover JP. Improvement in myocardial dysfunction in a hypothyroid dog. Can Vet J 2009;50:828-834.
  • Chow B, French A. Conversion of atrial fibrillation after levothyroxine in a dog with hypothyroidism and arterial thromboembolism. J Small Anim Pract 2014;55:278-282.
  • Sangster JK, Panciera DL, Abbott JA. Cardiovascular effects of thyroid disease. Compend Contin Educ Vet 2013;35:E5.
  • Le Traon G, Burgaud S, Horspool LJ. Pharmacokinetics of total thyroxine in dogs after administration of an oral solution of levothyroxine sodium. J Vet Pharmacol Ther 2008;31:95-101.

Principal Display Panel - 0.1 Mg Tablet Bottle Label



NDC 13985-981-20

VET one®

Thyro-Tabs® Canine
(levothyroxine sodium tablets), USP

0.1 mg

For use in animals only.
Keep out of reach of children.

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

Approved by FDA under NADA # 141-448

V1 510155
1000 Tablets


Principal Display Panel - 0.2 Mg Tablet Bottle Label



NDC 13985-982-20

VET one®

Thyro-Tabs® Canine
(levothyroxine sodium tablets), USP

0.2 mg

For use in animals only.
Keep out of reach of children.

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

Approved by FDA under NADA # 141-448

V1 510157
1000 Tablets


Principal Display Panel - 0.3 Mg Tablet Bottle Label



NDC 13985-983-20

VET one®

Thyro-Tabs® Canine
(levothyroxine sodium tablets), USP

0.3 mg

For use in animals only.
Keep out of reach of children.

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

Approved by FDA under NADA # 141-448

V1 510159
1000 Tablets


Principal Display Panel - 0.4 Mg Tablet Bottle Label



NDC 13985-984-20

VET one®

Thyro-Tabs® Canine
(levothyroxine sodium tablets), USP

0.4 mg

For use in animals only.
Keep out of reach of children.

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

Approved by FDA under NADA # 141-448

V1 510161
1000 Tablets


Principal Display Panel - 0.5 Mg Tablet Bottle Label



NDC 13985-985-20

VET one®

Thyro-Tabs® Canine
(levothyroxine sodium tablets), USP

0.5 mg

For use in animals only.
Keep out of reach of children.

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

Approved by FDA under NADA # 141-448

V1 510163
1000 Tablets


Principal Display Panel - 0.6 Mg Tablet Bottle Label



NDC 13985-986-20

VET one®

Thyro-Tabs® Canine
(levothyroxine sodium tablets), USP

0.6 mg

For use in animals only.
Keep out of reach of children.

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

Approved by FDA under NADA # 141-448

V1 510165
1000 Tablets


Principal Display Panel - 0.7 Mg Tablet Bottle Label



NDC 13985-987-20

VET one®

Thyro-Tabs® Canine
(levothyroxine sodium tablets), USP

0.7 mg

For use in animals only.
Keep out of reach of children.

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

Approved by FDA under NADA # 141-448

V1 510167
1000 Tablets


Principal Display Panel - 0.8 Mg Tablet Bottle Label



NDC 13985-988-20

VET one®

Thyro-Tabs® Canine
(levothyroxine sodium tablets), USP

0.8 mg

For use in animals only.
Keep out of reach of children.

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

Approved by FDA under NADA # 141-448

V1 510169
1000 Tablets


Principal Display Panel - 1.0 Mg Tablet Bottle Label



NDC 13985-989-20

VET one®

Thyro-Tabs® Canine
(levothyroxine sodium tablets), USP

1.0 mg

For use in animals only.
Keep out of reach of children.

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

Approved by FDA under NADA # 141-448

V1 510171
1000 Tablets


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