LEVOTHYROXINE SODIUM injection, solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4)

Fáanlegur frá:

Hikma Pharmaceuticals USA Inc.

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma. Limitations of Use : The relative bioavailability between Levothyroxine Sodium Injection and oral levothyroxine products has not been established.  Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium Injection as accurate dosing conversion has not been studied. None Risk Summary The clinical data in pregnant women treated with oral levothyroxine to treat hypothyroidism do not indicate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are no data available on the use of Levothyroxine Sodium Injection in pregnant women. There are risks to the mother and fetus associated with myxedema coma in pregnancy (see Clinical Considerations) . No developmental or reproductive toxicity studies in animals have been conducted with Levothyroxine Sodium Injection. The estimated background risks of major birth defects and miscarriage for the in

Vörulýsing:

Levothyroxine Sodium Injection 100 mcg/mL is a clear, colorless to slightly yellow solution, supplied as1 mL per vial. Package of 1 single-dose vial: NDC 24201-002-01 Protect from light and store product at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Drug product is preservative free.  Discard any unused portion. Manufactured for: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 www.hikma.com/us Revised: 11/2022 INS-0017-R2

Leyfisstaða:

New Drug Application

Vara einkenni

LEVOTHYROXINE SODIUM- LEVOTHYROXINE SODIUM INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOTHYROXINE SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVOTHYROXINE
SODIUM INJECTION
LEVOTHYROXINE SODIUM INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1969
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
THYROID HORMONES, INCLUDING LEVOTHYROXINE SODIUM INJECTION, SHOULD NOT
BE USED FOR
THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS. (5.3) LARGER DOSES MAY
PRODUCE SERIOUS OR
EVEN LIFE-THREATENING MANIFESTATIONS OF TOXICITY. (6)
INDICATIONS AND USAGE
Levothyroxine Sodium is an L-thyroxine product. Levothyroxine (T )
Sodium Injection is indicated for the
treatment of myxedema coma. (1) (1)
IMPORTANT LIMITATIONS OF USE: (1)
The relative bioavailability of this drug has not been established.
Use caution when converting patients
from oral to intravenous levothyroxine. (1) (1)
DOSAGE AND ADMINISTRATION
Consider the patient’s age, general physical condition, cardiac risk
factors, as well as the clinical
severity of myxedema and duration of myxedema symptoms when
determining dosages of
Levothyroxine Sodium Injection. (2.1)
Start with lower doses in elderly patients and in patients with
underlying cardiovascular disease. (2.1)
An initial intravenous loading dose of Levothyroxine Sodium Injection
between 300 to 500 mcg followed
by once daily intravenous maintenance doses between 50 and 100 mcg
should be administered, as
clinically indicated, until the patient can tolerate oral therapy.
(2.1)
Do not add to other IV fluids. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mcg/mL in a single-dose vial. Ready-to-use solution.
(3) (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
_Cardiac Adverse Reactions in the Elderly and in Patients with
Underlying Cardiovascular Disease:_
Overtreatment may cause arrhythmias, tachycardia, myocardial ischemia
and infarction, or