Drugplain

Tirosint SOL 112 ug/mL

Levothyroxine Sodium · SOLUTION · IBSA Pharma Inc.

10 Recalls on RecordCurrently in Shortage
Plain English

Tirosint SOL is a solution containing levothyroxine sodium at 112 ug/mL, taken oral. Manufactured by IBSA Pharma Inc..

Key Facts

Brand Name
Tirosint SOL
Generic Name
Levothyroxine Sodium
NDC Code (Product)
71858-0135
Manufacturer
IBSA Pharma Inc.
Strength
112 ug/mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
NDA206977
Marketing Start
03/01/2019

Recall History

10 Recalls on Record
Class II01/30/2023

IBSA PHARMA INC

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II01/30/2023

IBSA PHARMA INC

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II01/30/2023

IBSA PHARMA INC

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II01/30/2023

IBSA PHARMA INC

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II01/30/2023

IBSA PHARMA INC

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II01/30/2023

IBSA PHARMA INC

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II01/30/2023

IBSA PHARMA INC

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II01/30/2023

IBSA PHARMA INC

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II01/30/2023

IBSA PHARMA INC

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II01/30/2023

IBSA PHARMA INC

Subpotent Drug

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue8,400 reports
nausea7,224 reports
diarrhoea6,477 reports
headache6,346 reports
dyspnoea6,217 reports
drug ineffective5,456 reports
pain5,254 reports
dizziness5,060 reports
vomiting4,478 reports
asthenia4,367 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATION AND USAGE TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1 ) Limitations of Use Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression TIROSINT-SOL is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administer once daily, on an empty stomach, 15 minutes before breakfast ( 2.1 ) Administer at least 4 hours before or after drugs that are known to interfere with absorption ( 2.1 ) Evaluate the need for dose adjustments when regularly administering within an hour of certain foods that may affect TIROSINT-SOL absorption ( 2.1 ) To administer TIROSINT-SOL in water, squeeze the contents of one single unit-dose ampule into a glass or cup containing water ( 2.1 ) To administer TIROSINT-SOL directly, either squeeze it into the mouth OR onto a spoon and immediately consume ( 2.1 ) Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, and concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4-6 weeks ( 2.2 ) See full prescribing information for dosing in specific patient populations ( 2.3 ) Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status ( 2.4 ) 2.1 General Administration Information Administer TIROSINT-SOL as a single daily oral dose, on an empty stomach,15 minutes befo…

Contraindications

4 CONTRAINDICATIONS TIROSINT-SOL is contraindicated in patients with: Hypersensitivity to glycerol, the inactive ingredient in TIROSINT-SOL [see Adverse Events (6) ]. Uncorrected adrenal insufficiency [see Warnings and Precautions (5.4) ] Hypersensitivity to glycerol ( 4 ) Uncorrected adrenal insufficiency ( 4 )

Drug Interactions

7 DRUG INTERACTIONS See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to TIROSINT-SOL ( 7 ) 7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics Many drugs can exert effects on thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to TIROSINT-SOL (Tables 5 to 8). Table 5. Drugs That May Decrease T4 Absorption (Hypothyroidism) Potential impact: Concurrent use may reduce the efficacy of TIROSINT-SOL by binding and delaying or preventing absorption, potentially resulting in hypothyroidism. Drug or Drug Class Effect Phosphate Binders (e.g., calcium carbonate, ferrous sulfate, sevelamer, lanthanum) Phosphate binders may bind to levothyroxine. Administer TIROSINT-SOL at least 4 hours apart from these agents. Orlistat Monitor patients treated concomitantly with orlistat and TIROSINT‑SOL for changes in thyroid function. Bile Acid Sequestrants (e.g., colesevelam, choles…

Adverse Reactions

6 ADVERSE REACTIONS Adverse reactions associated with TIROSINT-SOL therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5) and Overdosage (10) ]. They include the following: General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia Musculoskeletal: tremors, muscle weakness, muscle spasm Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory : dyspnea Gastrointestinal (GI): diarrhea, vomiting, abdominal cramps, elevations in liver function tests Dermatologic: hair loss, flushing, rash Endocrine: decreased bone mineral density Reproductive: menstrual irregularities, impaired fertility Seizures have been reported rarely with the institution of levothyroxine therapy. Adverse reactions associated with TIROSINT-SOL are primarily those of hyperthyroidism due to therapeutic overdosage including: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irr…

Frequently Asked Questions

What is Tirosint SOL used for?

Tirosint SOL contains Levothyroxine Sodium. It is a solution taken oral. Consult your doctor for specific uses.

Is Tirosint SOL a controlled substance?

Tirosint SOL is not classified as a controlled substance by the DEA.

What is the generic name for Tirosint SOL?

The generic name for Tirosint SOL is Levothyroxine Sodium. There are 12 other brand versions of Levothyroxine Sodium.

What is the NDC code for Tirosint SOL 112 ug/mL?

The NDC (National Drug Code) for Tirosint SOL 112 ug/mL is 71858-0135, listed by IBSA Pharma Inc..

Product NDC

71858-0135

Package NDC

71858-0135-2

Other Levothyroxine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)