L-Thyroxin Henning 100

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L-Thyroxin Henning 100

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Overview of L-Thyroxin Henning 100

L-Thyroxin Henning 100 is classified as a Prescription-only Endocrine Agent and a Thyroid Hormone Preparation. Its sole active ingredient is Levothyroxine sodium, which is supplied in the form of an oral tablet used for hormone replacement therapy.


Quick Facts: L-Thyroxin Henning 100

Property Description
Active ingredient Levothyroxine sodium
Form Tablet
Pharmacological class Thyroid hormone preparation, Endocrine agent
Common purpose Hormone replacement
Origin Synthetic (identical to natural T4)

What Type of Medicine is L-Thyroxin Henning 100?

L-Thyroxin Henning 100 is an Endocrine Agent belonging to the pharmacological class of Thyroid Hormone Preparations. The medicine's core purpose is to provide a precise substitute for the hormone that the body's thyroid gland cannot produce adequately. It contains only one active compound, Levothyroxine sodium, making it a single-ingredient product designed to correct hormonal deficiencies. This classification means the product functions not by treating symptoms directly, but by restoring a fundamental, missing chemical element to the body's endocrine system to manage thyroid deficiency states.


Is Levothyroxine in L-Thyroxin Henning 100 Synthetic or Natural?

The Levothyroxine in L-Thyroxin Henning 100 is a synthetic compound, chemically manufactured to be identical to the natural T4 (thyroxine) produced by the thyroid gland. This synthetic origin ensures a standardized dose and high purity, which is critical for consistent treatment. The number 100 in the name signifies the standardized dose of 100 micrograms (µg) of Levothyroxine sodium contained in each tablet. Levothyroxine is a synthetic analogue of the naturally occurring thyroid hormone. The product, associated with the manufacturer Henning, is widely used. The administration is via the oral route, ensuring simple and consistent daily intake to maintain stable hormone levels.


What is the General Purpose of Taking Thyroid Hormone Preparations?

The general purpose of taking this medication is Physiological Replacement to achieve Metabolic Normalization. The medication provides the body with the specific hormone required to regulate core metabolic processes, ensuring they proceed at a normal rate. By replacing the missing natural hormone, Levothyroxine sodium supports the proper function of key physiological systems throughout the body. The fundamental benefit is the sustainment of the body's overall endocrine balance, which is vital for energy use and cellular activity.

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What side effects are possible with L-Thyroxin Henning 100?

Possible side effects and safety information

Official regulatory documents state that the majority of adverse reactions associated with Levothyroxine sodium are primarily those of hyperthyroidism and arise from therapeutic overdosage or supratherapeutic hormone levels. As the occurrence of effects is dose-dependent, specific tiered frequency classifications are generally not assigned. Reactions that occur are typically systemic and affect multiple organ classes, which may include the following categories.

System-Organ Class Examples of Documented Adverse Reactions (Overdosage)
Cardiac Disorders Palpitations, Tachycardia, Arrhythmias
Nervous/Psychiatric Tremors, Nervousness, Insomnia, Headache
General/Dermatologic Excessive Sweating, Heat Intolerance, Fever, Rash, Hair Loss
Gastrointestinal Diarrhea, Abdominal Cramps, Vomiting

Serious adverse reactions documented in regulatory labeling include life-threatening cardiac events, such as myocardial infarction, cardiac arrest, and serious arrhythmias. The medicine is formally contraindicated in patients with uncorrected adrenal insufficiency or untreated thyrotoxicosis, conditions that define key limitations for its use.

Population and Duration Safety Considerations

The safety profile includes specific notes for certain groups. Older adults and individuals with underlying cardiovascular disease have an increased risk of severe cardiac adverse reactions if treated with an excessive dose. For postmenopausal women, long-term therapy with over-replacement doses is associated with an increased risk of decreased bone mineral density. Furthermore, temporary hair loss may be observed, particularly at the initiation of therapy, and overtreatment in pediatric patients is associated with risks to bone development.

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Overdose and Emergency Response

Overdosage with Levothyroxine sodium, the active ingredient in L-Thyroxin Henning 100, results in clinical manifestations consistent with a state of hyperthyroidism or thyrotoxicosis. Documented manifestations involve the cardiovascular system, presenting as palpitations, tachycardia, increased blood pressure, and arrhythmias. Central Nervous System (CNS) effects are also listed in regulatory documents, including tremors, nervousness, hyperactivity, insomnia, and headache. The onset of overdose symptoms may be delayed, sometimes taking up to five or six days to fully manifest following acute exposure.

Official regulatory documents state that overdosage can lead to serious or even life-threatening toxicity. Severe cardiovascular events are a documented risk, including myocardial ischemia, myocardial infarction, and cardiac arrest. This risk is notably increased in the elderly population and in patients with pre-existing cardiovascular disease.

Due to the risk of life-threatening manifestations, regulatory guidance mandates that patients seek immediate medical attention for a suspected overdose or if severe symptoms occur, such as chest pain, severe palpitations, high fever, confusion, or fits/seizures. Treatment is officially described as symptomatic and supportive, as no specific antidote is known. Management involves close observation, monitoring of hemodynamic parameters, and may include the use of agents like beta-blockers to control acute thyrotoxic symptoms.

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Therapeutic Uses of L-Thyroxin Henning 100

Main Uses of L-Thyroxin Henning 100

L-Thyroxin Henning 100 is a medication used to supplement or replace the thyroid hormone thyroxine when the body does not produce enough on its own. It contains levothyroxine sodium, which is synthetic thyroxine that acts in the same way as the natural hormone produced by the thyroid gland.

Treatment of Hypothyroidism

The primary use of this medication is the treatment of hypothyroidism, a condition where the thyroid gland is underactive. By providing a synthetic source of thyroxine, the medication helps restore normal hormone levels, which is essential for maintaining the body's metabolic processes. This includes management of various forms of hypothyroidism, whether they are congenital or acquired later in life.

Management of Goiter

L-Thyroxin Henning 100 is used to treat benign goiter (an enlarged thyroid gland) in patients with normal thyroid function. In these cases, the medication works by reducing the production of thyroid-stimulating hormone (TSH), which can help shrink the enlarged gland or prevent further growth. It is also used as a preventive measure to stop goiter from recurring following thyroid surgery.

Concomitant Therapy

In patients undergoing treatment for an overactive thyroid (hyperthyroidism) with antithyroid medications, this medication may be prescribed as a companion therapy once a normal metabolic state has been achieved. This approach helps ensure a stable hormonal balance during the treatment period.

Support in Oncology and Diagnostics

This medication is used as part of the management plan for patients with thyroid cancer, specifically to suppress tumor growth by inhibiting TSH production. Additionally, it may be utilized in diagnostic procedures, such as the thyroid suppression test, to evaluate the function of the thyroid gland.

Benefits of Treatment

Metabolic Regulation

Thyroxine is critical for regulating the body's energy consumption and metabolism. Effective treatment helps ensure that the heart, brain, muscles, and other organs function correctly. By restoring hormone levels, the medication addresses the systemic slowing of physical and mental processes associated with hormone deficiency.

Prevention of Complications

Consistent use of the medication helps prevent the long-term complications associated with untreated thyroid disorders. This includes the prevention of further thyroid enlargement and the management of symptoms such as fatigue, cold intolerance, and cognitive slowing that arise from insufficient hormone levels.

Regulatory References

  1. French Public Medicines Database
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Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use L-Thyroxin Henning 100 — official regulatory information

Eligibility scope

Scope Item Official Regulatory Statement
Populations for whom use is allowed (as stated in label) Adult and Pediatric Patients (including neonates) are indicated for replacement therapy in hypothyroidism.
Populations for whom use is not recommended (if applicable) The drug is not indicated for the suppression of benign thyroid nodules in iodine-sufficient patients.
Populations for whom use is contraindicated Patients with Untreated Thyrotoxicosis, Uncorrected Adrenal Insufficiency, Acute Myocardial Infarction, or Acute Myocarditis/Pancarditis.
Age-related eligibility rules Elderly patients and those with underlying cardiovascular disease require caution and lower starting doses. Neonates need careful monitoring, especially if low birth weight.
Condition-specific eligibility rules Patients with Diabetes Mellitus or a history of epilepsy require monitoring due to conditional use status.
Pregnancy and lactation eligibility status (if explicitly documented) Pregnancy: Use is acceptable, but dose requirements often increase. Lactation: Use is generally acceptable.
Eligibility-related restrictions Postmenopausal women require careful monitoring to avoid over-replacement and potential decrease in bone mineral density.

Eligibility classifications (high-level)

Classification Item Official Regulatory Statement
Eligibility severity classification (as defined in official documents) Contraindicated (e.g., in untreated thyrotoxicosis); Use with caution/monitoring (e.g., in elderly patients).
Regulatory basis (EMA / FDA / etc.) Based on the Contraindications, Warnings and Precautions, and Use in Specific Populations sections of official regulatory labels.
Eligibility-context constraints (as defined in official documents) The drug is prohibited for use in treatment of obesity or weight loss.

Resulting eligibility structure

Official eligibility statements:

  • L-Thyroxin Henning 100 is contraindicated in patients with acute myocardial infarction and untreated adrenal insufficiency.
  • Use is established across all age groups for hormone replacement therapy, but special monitoring is required for neonates and elderly patients.
  • Use is restricted and requires caution for patients with pre-existing cardiovascular disorders or diabetes mellitus.

Connection to the overall eligibility profile: Official regulatory documents strictly define the eligibility for Levothyroxine sodium, primarily through a clear set of absolute contraindications that exclude patients with specific acute cardiac or unmanaged endocrine conditions. Use is permitted for the broad population of adults and children requiring hormone replacement but is subject to conditional restrictions that mandate special care for those with underlying comorbidities.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines important drug-drug and drug-product interactions for L-Thyroxin that may require dose adjustment or monitoring.


Medicines that Affect L-Thyroxin Absorption

Certain products can reduce the amount of L-Thyroxin absorbed from the gut, requiring a strict separation in dosing time to maintain therapeutic efficacy. These include:

  • Gastrointestinal Agents and Supplements: Antacids containing aluminum, calcium, or magnesium; iron supplements; sucralfate; bile acid sequestrants (e.g., cholestyramine); and phosphate binders (e.g., sevelamer). Timing Rule: L-Thyroxin must be taken at least four hours before or after these products.
  • Gastric Acidity Reducers: Proton Pump Inhibitors (PPIs) and H2 receptor antagonists can reduce L-Thyroxin absorption by increasing stomach pH.

Medicines that Affect L-Thyroxin Efficacy or Clearance

  • Enzyme Inducers: Drugs like rifampin and certain anticonvulsants can increase the breakdown (clearance) of L-Thyroxin, potentially requiring a higher dose.
  • Estrogens and Androgens: These sex hormones alter the level of Thyroxine-Binding Globulin (TBG), which carries T4 in the blood, possibly affecting the required T4 dose.

Pharmacodynamic Interactions

  • Oral Anticoagulants (e.g., Warfarin): L-Thyroxin can increase the effect of these medicines, necessitating a lower anticoagulant dose and close monitoring of clotting times.
  • Antidiabetic Agents (e.g., Insulin, Metformin): L-Thyroxin may increase the requirement for antidiabetic medication; blood sugar levels must be carefully monitored.
  • Sympathomimetic Amines: Concomitant use with sympathomimetic agents (especially those for weight loss) is restricted due to the increased risk of serious cardiovascular events.
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Mechanism of Action

How L-Thyroxin Henning 100 Works

L-Thyroxin Henning 100 provides the inactive prohormone levothyroxine (T4), which must first undergo peripheral enzymatic conversion by iodothyronine deiodinases to become the active hormone, triiodothyronine (T3). T3 acts as a transcriptional agonist, binding to Thyroid Hormone Receptors (TRs) in the cell nucleus, where it modulates gene expression. This nuclear engagement initiates the time-dependent process of gene transcription and protein synthesis across the body's target tissues.

The newly synthesized proteins drive core physiological changes, including the upregulation of the basal metabolic rate and oxygen consumption in tissues. This mechanism also modulates the cellular machinery of systemic pacing by influencing T3-dependent gene targets that affect myocardial contractile elements and neural signaling characteristics. The resulting physiological effect is the modification of systemic energy utilization and metabolic throughput.

The necessity for enzymatic conversion and the inherent lag of gene transcription means the mechanism is time-dependent. Achieving full physiological modification requires several weeks of continuous input, as the effect is built up by the slow accumulation of new proteins.

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Dosage and Administration Information

How to Use L-Thyroxin Henning 100

The administration of L-Thyroxin Henning 100, which contains Levothyroxine sodium, is based on instructions for continuous, long-term hormone replacement. The medicine is administered via the oral route as a tablet. The established dosing schedule requires administration once daily to maintain stable hormone levels.

Official Dosing and Timing Principles

To ensure consistent and optimal drug absorption, the dose is taken on an empty stomach, preferably one-half to one hour before breakfast. The dosing regimen is highly individualized, beginning with a specific starting dose that is subsequently adjusted. The typical adult full replacement dose is estimated at approximately 1.6 mug/kg daily. Dose adjustments are made in small increments of 12.5 mug to 25 mug and are typically spaced 4 to 6 weeks apart until the required stable level is achieved.

Special Administration Conditions
Must be separated by at least 4 hours from the intake of calcium or iron supplements and antacids.
Tablets should be swallowed with a full glass of water.

Population-Specific Administration

Guidelines recommend a lower initial dose, typically starting at 12.5 mug to 25 mug daily, for older adults or individuals with underlying cardiac conditions. For infants, the tablet may be crushed and suspended in a small amount of water for immediate administration, but the suspension must not be stored and should not be administered with soybean-based formulas.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for L-Thyroxin Henning 100


Evidence for Use as Replacement Therapy in Hypothyroidism

Research examined L-Thyroxin Henning 100 primarily through controlled studies and observational research. These studies were evaluated in adult patients diagnosed with low thyroid function, a condition characterized by systemic or functional imbalance. Researchers monitored outcomes related to thyroid hormone levels (TSH, T3, T4) and applied in studies examining patient-reported experiences related to physical discomfort and daily functioning.

Findings describe patterns observed in measured changes in thyroid hormone levels, describing efforts to return them to a typical reference range. This evidence contributes to the broader evidence landscape for research exploring this condition. However, long-term effects are not fully established regarding the durability of response over many years. While research describes short-term symptom changes, data for certain groups remain insufficient.


Evidence for Use in Thyroid-Stimulating Hormone (TSH) Suppression

The research in this area primarily involves studies conducted after patients have undergone initial treatment (such as surgery or radioiodine therapy) following a diagnosis of certain thyroid malignancies. L-Thyroxin Henning 100 was studied for its use in studies focusing on the level of Thyroid-Stimulating Hormone (TSH), which is a physiological strain or stress outcome. Studies explored how the medication was associated with TSH levels over defined time intervals.

Studies reported measurements of TSH levels, describing patterns related to the dose administered and the suppression target. What remains uncertain is the long-term impact on quality of life and side effects related to sustained TSH suppression. Evidence quality varies across studies, and data for certain groups remain insufficient.


What is Still Uncertain About L-Thyroxin Henning 100

The evidence base, while extensive for the general population with hypothyroidism, still has limitations. Subgroup findings are uncertain for patients with multiple complex health issues due to insufficient data. Comparative evidence is lacking to clearly show patterns against every potential medication that affects thyroid function. Furthermore, long-term effects are not fully established concerning the management of outcomes reflecting daily functioning over a patient's lifespan.

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Frequently Asked Questions (FAQ)

Common questions about L-Thyroxin Henning 100 (FAQ)


Q: Is lactose used as an ingredient in L-Thyroxin Henning tablets?

A: Official product information indicates that some levothyroxine formulations, including certain strengths of L-Thyroxin Henning, may contain lactose as an inactive ingredient, also known as an excipient. The specific ingredients are often detailed in the product leaflet. For patients with sensitivities, reviewing the specific formulation with a pharmacist or healthcare provider is noted.


Q: Can L-Thyroxin Henning cause changes in memory or concentration?

A: Regulatory information indicates that many adverse reactions are related to a higher-than-needed level of thyroid hormone (overdosage). While the official list of side effects typically includes central nervous system (CNS) effects such as nervousness and insomnia, changes to memory or concentration are not explicitly listed, but these effects are generally understood to be related to hormone levels that are either too high (overdosage) or remain too low (untreated hypothyroidism).


Q: Does L-Thyroxin Henning affect menstrual periods in women?

A: Yes, regulatory documents list changes in the menstrual cycle or menstrual periods among the possible adverse reactions. These effects are primarily documented in cases of therapeutic overdosage, where the body has a higher level of thyroid hormone than required.


Q: Can grapefruit or grapefruit juice interact with L-Thyroxin Henning?

A: Official drug interaction information indicates that certain foods and juices, including grapefruit and grapefruit juice, have the potential to decrease or delay the absorption of levothyroxine. To maintain consistent absorption, official product information recommends a time separation from these substances.


Q: Does coffee drinking have an impact on the effectiveness of L-Thyroxin Henning?

A: Official administration instructions emphasize taking the medicine on an empty stomach to achieve consistent and optimal absorption. Some clinical studies suggest that consuming coffee too soon after taking the medicine may interfere with its absorption. The requirement for consistent administration often leads to a recommended time separation between the medicine and coffee.


Q: What happens if a dose of L-Thyroxin Henning is missed?

A: Patient information typically indicates that if a dose is missed, taking it upon remembering is an option, unless the next dose is due soon. Regulatory guidance consistently recommends against taking a double dose to compensate for a single missed dose.


Q: Why must L-Thyroxin Henning be taken on an empty stomach?

A: Regulatory instructions and pharmacokinetic data indicate that Levothyroxine is highly sensitive to substances in the digestive tract. Taking the medicine on an empty stomach is required to ensure the most consistent and optimal absorption into the bloodstream.


Q: Is it possible to crush L-Thyroxin Henning tablets if a person has difficulty swallowing?

A: Official dosing guidelines state that the tablets may be crushed and suspended in a small amount of water for administration to infants and children who cannot swallow pills. This practice is specifically described for pediatric patients. Regulatory guidelines indicate the suspension must be administered immediately after crushing and should not be stored.


Q: What is the role of L-Thyroxin Henning in managing goiter?

A: Levothyroxine, the active ingredient in L-Thyroxin Henning, is indicated for the management of certain types of goiter (enlarged thyroid gland). Official regulatory limitations specify that it is not indicated for suppressing benign thyroid nodules or non-toxic goiter in iodine-sufficient patients.


Q: Does L-Thyroxin Henning treat Hashimoto's thyroiditis?

A: Regulatory documents state that Levothyroxine is indicated as hormone replacement therapy for hypothyroidism (underactive thyroid) of any cause. Since Hashimoto's thyroiditis is a common cause of hypothyroidism, the medicine is used to replace the missing hormone in patients affected by this condition.


Q: When can a patient expect to see improvement in symptoms like fatigue?

A: Clinical pharmacology data indicate that the peak therapeutic effect of levothyroxine may take 4 to 6 weeks to be attained after initiating or changing the dose. This time frame corresponds to when patients may begin to notice the expected symptom improvements, such as the alleviation of fatigue.


Q: Is L-Thyroxin Henning considered compatible with breastfeeding?

A: Official regulatory information states that Levothyroxine use is generally acceptable during lactation. The amounts secreted into breast milk are typically very low and have not been associated with documented adverse effects in a nursing infant.


Q: How long does the active ingredient in L-Thyroxin Henning stay in the body after a dose?

A: According to pharmacokinetic data, the active ingredient, Levothyroxine ( T4), has a relatively long half-life of approximately 7 days. This extended duration of presence supports the established once daily dosing schedule, which helps maintain stable hormone levels.


Q: Is there a specific time of day that L-Thyroxin Henning is typically recommended to be taken?

A: Official guidance emphasizes taking the medicine once daily on an empty stomach. The typical recommendation is one-half to one hour before breakfast. Consistent timing from day to day is a key factor in maintaining the stable hormone levels required for treatment.


Q: Are there known interactions between L-Thyroxin Henning and herbal supplements like St. John's Wort?

A: Yes, official drug interaction warnings specifically mention St. John’s Wort as a potential concern. This supplement may increase the rate at which levothyroxine is broken down by the body, which could decrease its effectiveness and potentially lead to symptoms of hypothyroidism.

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How should L-Thyroxin Henning 100 be stored and disposed of?

How to Store and Dispose of L-Thyroxin Henning 100

The storage of L-Thyroxin Henning 100 tablets must adhere strictly to regulatory conditions to preserve the stability of Levothyroxine sodium.


Storage Requirements

Condition Requirement
Maximum Temperature Store not above 25 C
Protection Keep protected from light and moisture
Packaging Store in the original package

Handling and Disposal

The medicine must be kept out of the sight and reach of children. The documented shelf-life for the product is 2 years when stored correctly. Unused or expired L-Thyroxin Henning 100 must be discarded in accordance with local requirements. It is officially prohibited to dispose of the tablets via wastewater or general household waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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