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

Synthetic thyroxine hormone
For oral use in dogs only.

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

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:

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

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

WARNINGS:

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

ADVERSE REACTIONS:

CLINICAL PHARMACOLOGY: Levothyroxine sodium has poor oral bioavailability in dogs (10-20%) with peak serum TT4 concentrations within 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.

EFFECTIVENESS: In a US field study with 92 dogs, dogs were administered a starting 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 the 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.

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: 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.

Approved by FDA under NADA # 141-448

Manufactured by: LLOYD, Inc.
Shenandoah, IA 51601

Rev. 0523; CIM-03-00

REFERENCES:

1. Phillips DE, Harkin KR. Hypothyroidism and myocardial failure in two Great Danes. J Am Anim Hosp Assoc 2003;39:133-137.
2. Flood JA, Hoover JP. Improvement in myocardial dysfunction in a hypothyroid dog. Can Vet J 2009;50:828-834.
3. 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.
4. Sangster JK, Panciera DL, Abbott JA. Cardiovascular effects of thyroid disease. Compend Contin Educ Vet 2013;35:E5.
5. 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.

LLOYD
P.O. Box 130
Shenandoah, IA 51601 U.S.A.
712-246-4000

NDC 11789-251-20

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

0.1 mg

Approved by FDA under NADA # 141-448

1,000 Tablets

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

LLOYD_®

NDC 11789-252-20

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

0.2 mg

Approved by FDA under NADA # 141-448

1,000 Tablets

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

LLOYD_®

NDC 11789-253-20

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

0.3 mg

Approved by FDA under NADA # 141-448

1,000 Tablets

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

LLOYD_®

NDC 11789-254-20

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

0.4 mg

Approved by FDA under NADA # 141-448

1,000 Tablets

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

LLOYD_®

NDC 11789-255-20

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

0.5 mg

Approved by FDA under NADA # 141-448

1,000 Tablets

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

LLOYD_®

NDC 11789-256-20

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

0.6 mg

Approved by FDA under NADA # 141-448

1,000 Tablets

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

LLOYD_®

NDC 11789-257-20

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

0.7 mg

Approved by FDA under NADA # 141-448

1,000 Tablets

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

LLOYD_®

NDC 11789-258-20

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

0.8 mg

Approved by FDA under NADA # 141-448

1,000 Tablets

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

LLOYD_®

NDC 11789-268-20

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

1.0 mg

Approved by FDA under NADA # 141-448

1,000 Tablets

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

LLOYD_®