Drugplain

NP Thyroid 15 9.5 ug/1

LEVOTHYROXINE, LIOTHYRONINE · TABLET · Bryant Ranch Prepack

2 Recalls on RecordCurrently in Shortage
Plain English

NP Thyroid 15 is an oral tablet containing levothyroxine and liothyronine used to treat hypothyroidism and other thyroid conditions. This prescription medication combines two thyroid hormones to help replace or supplement the thyroid hormones your body is not producing enough of.

Key Facts

Brand Name
NP Thyroid 15
Generic Name
LEVOTHYROXINE, LIOTHYRONINE
NDC Code (Product)
63629-8265
Manufacturer
Bryant Ranch Prepack
Strength
9.5 ug/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
HUMAN PRESCRIPTION DRUG
Drug Class
Thyroxine [CS]; Triiodothyronine [CS]
Marketing Start
11/16/2016

Recall History

2 Recalls on Record
Class I09/17/2020

Acella Pharmaceuticals, LLC

Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.

TerminatedVoluntary: Firm initiated
Class I04/29/2021

Acella Pharmaceuticals, LLC

Subpotent Drug

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

product substitution issue5 reports
fatigue4 reports
asthenia3 reports
dizziness3 reports
arthralgia2 reports
disorientation2 reports
drug ineffective2 reports
dysarthria2 reports
feeling abnormal2 reports
hypoaesthesia2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE: NP Thyroid® tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.

Dosage & Administration

DOSAGE AND ADMINISTRATION: The dosage of thyroid hormones is determined by the indication and must in every case be individualized according to patient response and laboratory findings. Thyroid hormones are given orally. In acute, emergency conditions, injectable levothyroxine sodium may be given intravenously when oral administration is not feasible or desirable, as in the treatment of myxedema coma, or during total parenteral nutrition. Intramuscular administration is not advisable because of reported poor absorption. Hypothyroidism — Therapy is usually instituted using low doses, with increments which depend on the cardiovascular status of the patient. The usual starting dose is 30 mg NP Thyroid®, with increments of 15 mg every 2 to 3 weeks. A lower starting dosage, 15 mg/day, is recommended in patients with long standing myxedema, particularly if cardiovascular impairment is suspected, in which case extreme caution is recommended. The appearance of angina is an indication for a reduction in dosage. Most patients require 60 to 120 mg/day. Failure to respond to doses of 180 mg suggests lack of compliance or malabsorption. Maintenance dosages 60 to 120 mg/day usually result in nor

Warnings

WARNINGS Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects. The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective. Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.

Contraindications

CONTRAINDICATIONS: Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hypersensitivity to any of their active or extraneous constituents. There is no well-documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.

Drug Interactions

Drug Interactions — Oral Anticoagulants — Thyroid hormones appear to increase catabolism of vitamin K-dependent clotting factors. If oral anticoagulants are also being given, compensatory increases in clotting factor synthesis are impaired. Patients stabilized on oral anticoagulants who are found to require thyroid replacement therapy should be watched very closely when thyroid is started. If a patient is truly hypothyroid, it is likely that a reduction in anticoagulant dosage will be required. No special precautions appear to be necessary when oral anticoagulant therapy is begun in a patient already stabilized on maintenance thyroid replacement therapy.

Adverse Reactions

ADVERSE REACTIONS: Adverse reactions other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period, are rare (See OVERDOSAGE).

Frequently Asked Questions

What is NP Thyroid 15 used for?

NP Thyroid 15 is an oral tablet containing levothyroxine and liothyronine used to treat hypothyroidism and other thyroid conditions. This prescription medication combines two thyroid hormones to help replace or supplement the thyroid hormones your body is not producing enough of.

Is NP Thyroid 15 a controlled substance?

NP Thyroid 15 is not classified as a controlled substance by the DEA.

What is the generic name for NP Thyroid 15?

The generic name for NP Thyroid 15 is LEVOTHYROXINE, LIOTHYRONINE. There are 10 other brand versions of LEVOTHYROXINE, LIOTHYRONINE.

What is the NDC code for NP Thyroid 15 9.5 ug/1?

The NDC (National Drug Code) for NP Thyroid 15 9.5 ug/1 is 63629-8265, listed by Bryant Ranch Prepack.