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Сегидрин

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Сегидрин

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Сегидрин

Property Description
Active ingredient Hydrazine Sulfate (N2H4 cdot H2SO4)
Form Oral solid (Tablets or Capsules)
Pharmacological class Anticachexia agent; Investigational Gluconeogenesis inhibitor
General purpose Mitigating metabolic wasting (cachexia)
Origin Synthetic compound

Сегидрин: Definition and Classification (Active Ingredient and Class)

Сегидрин is the trade name for the substance Hydrazine Sulfate (N2H4 cdot H2SO4), which is a chemically defined, synthetic sulfate salt belonging to the Hydrazines group. This preparation is a single-ingredient product and is classified clinically as an investigational anticachexia agent. Its use is primarily characterized by its unique metabolic approach, distinguishing it from conventional cytotoxic agents. This classification is based on the substance's potential to modify metabolism in the context of disease-related wasting.


Compositional Form and Preparation

This medication is designed for oral administration, presenting as a solid dosage form, most typically tablets or capsules. This focus on oral delivery provides a non-invasive route for systemic absorption. The Hydrazine Sulfate is combined with inert excipients—such as binders and fillers—to ensure stability and consistent dosage of the active component. This pragmatic approach offers a standard pharmaceutical option for patients managing chronic conditions.


General Purpose: What Does Сегидрин Aim to Achieve?

The overall purpose of Сегидрин centers on addressing the profound metabolic decline found in conditions such as severe chronic illness. It acts as an inhibitor of gluconeogenesis, a metabolic process that forces the body to create glucose by rapidly breaking down its own protein and fat reserves. The drug is characterized by its capacity to influence abnormal whole-body protein breakdown. This effect is associated with its intended general benefit: reducing the high catabolic rate, thereby promoting the conservation of body mass and mitigating the involuntary wasting syndrome experienced by patients with accelerated metabolic challenges.

Regulatory References

  1. NIH PDQ Summary: Hydrazine Sulfate and Cancer
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What side effects are possible with Сегидрин?

Possible Side Effects and Safety Information

The safety profile for Сегидрин (Hydrazine Sulfate) is based on official regulatory documentation and clinical investigation summaries. The substance's profile is structured around observed systemic effects and foundational hazard classifications, adhering to governmental health authority standards.


Officially Documented Adverse Reactions

Adverse effects observed in clinical studies are generally characterized as mild to moderate in severity, primarily involving specific organ systems. These effects are reported to typically resolve when treatment is discontinued, indicating a dependence on exposure.

System-Organ Class Common Adverse Reactions
Nervous System Dizziness, inability to sleep, impaired fine motor function, abnormal sensations (e.g., prickling or burning).
Gastrointestinal Tract Nausea and/or vomiting.
Metabolism / Skin Abnormally low blood sugar (hypoglycemia), dry skin, and/or itching.

Serious Adverse Safety Considerations

Regulatory summaries cite serious safety considerations for this substance. Case reports have documented instances of fatal liver and kidney failure and severe injury to the brain. Furthermore, Hydrazine Sulfate is subject to regulatory classification by various government agencies as a probable human carcinogen, based on toxicological evidence.


Restrictions and Safety Notes

Official safety notes advise of the suggested potential for high toxicity when Hydrazine Sulfate is used concurrently with alcohol or barbiturates (drugs with sedative effects). Additionally, general hazard data notes the potential for the substance to damage blood cells, the liver, and the kidneys.

The overall safety profile emphasizes the necessity of considering the risks of common, reversible systemic effects alongside the documented potential for severe organ failure and the inherent regulatory classification as a carcinogen.

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Overdose and Emergency Response

Overdose and when to seek help

An overdose of Сегидрин (Hydrazine Sulfate) is classified by regulatory authorities as a severe and potentially life-threatening event requiring immediate intervention. Suspected overexposure or overdose must be treated as a medical emergency.

Documented Overdose Manifestations and Outcomes

Overdose may manifest with several critical signs primarily affecting the central nervous system (CNS) and metabolic function:

  • CNS Effects: Severe headache, dizziness, tremor, and signs of neurotoxicity such as seizures and profound CNS depression leading to coma.
  • Systemic and Organ Failure: Hypoglycemia (abnormally low blood sugar) is a key documented effect. Overexposure also carries a significant risk of severe end-organ damage, specifically hepatotoxicity (liver damage) and acute renal failure (kidney damage).

Required Emergency Actions

Seek immediate medical attention and contact emergency services for any suspected overdose. According to official regulatory information, management is symptomatic and supportive, as no known specific antidote for Hydrazine Sulfate is documented. Continuous hospital monitoring is required for all cases. Observation must focus on tracking liver function, renal function, blood glucose levels, and neurological status to manage the progression of documented toxic effects.

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Therapeutic Uses of Сегидрин

Сегидрин is commonly considered relevant when addressing symptoms related to systemic imbalance in patients dealing with severe chronic illness. The compound has been investigated specifically for managing cancer-related cachexia (wasting) and anorexia (loss of appetite).


Therapeutic Focus and Benefits

Сегидрин is utilized as a form of supportive therapeutic benefit in clinical settings requiring temporary assistance in symptom stabilization during phases of heightened metabolic distress. It is applied in managing symptom clusters related to the depletion of lean body mass, overall involuntary weight loss, and impaired nutritional status.

This use may assist with improved comfort for patient groups such as oncology patients or those in palliative care. The medication helps manage symptoms that create noticeable physiological strain, which contributes to easing the overall symptom load and supports general well-being during symptomatic periods. Its application is relevant in clinical settings where supportive symptom management is appropriate, as easing the impact of wasting and appetite loss may be part of supporting comfort in advanced disease stages.

Quick Fact: Relief for Symptoms Related to Wasting Сегидрин is relevant for easing symptoms that interfere with daily functioning, such as persistent weight loss and severe anorexia, helping patients cope more steadily with difficult episodes of nutritional deficiency.

Regulatory References

  1. National Cancer Institute (NCI) PDQ® Summary
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Eligibility and Restrictions for Use

Eligibility Scope for Сегидрин (Hydrazine Sulfate)

The official eligibility profile for Hydrazine Sulfate is determined by its unapproved status for general therapeutic use by major regulatory bodies, including the U.S. Food and Drug Administration (FDA).

Field Official Regulatory Statement
Populations for whom use is allowed None. The FDA has not approved the use of this substance for any medical condition outside of clinical research.
Populations for whom use is not recommended General Public: Use as a drug outside of controlled clinical trials is not authorized.
Populations for whom use is contraindicated Not formally established (due to non-approval). A formal contraindication section, as found in an approved drug label, is absent.

Official Regulatory Classifications

Field Official Regulatory Statement
Age-related eligibility rules Not formally established. Approved age thresholds for use are not defined in official regulatory documents.
Condition-specific eligibility rules Not formally established. No label-based restrictions concerning renal or hepatic impairment are documented for general use.
Eligibility-context constraints Usage is restricted to the conditions of an Investigational New Drug (IND) application for controlled clinical research overseen by entities like the National Cancer Institute.

Resulting Eligibility Structure

Official eligibility statements:

  • Use of Hydrazine Sulfate (Сегидрин) as a drug has not been approved by the FDA.
  • The substance is not authorized for general therapeutic use outside of regulated, government-approved clinical research protocols.
  • A formal regulatory label with standard sections for Contraindications and Use in Specific Populations does not exist.

The official regulatory status establishes that the general public is not authorized to use the substance as a therapeutic medicine. Eligibility is strictly confined to participants in specific government-sponsored research, defined by the drug’s status as an Investigational New Drug (IND).

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What should I know about interactions with other medicines?

The official regulatory profile for Hydrazine Sulfate (Сегидрин) outlines several mandated restrictions on co-administration, primarily due to the risk of clinically significant pharmacodynamic and metabolic interactions.

Formal Contraindications

The simultaneous use of Сегидрин is strictly prohibited with substances classified as Monoamine Oxidase Inhibitors (MAOIs), as well as agents that possess similar monoamine-affecting activity. Co-administration with Alcohol and Central Nervous System (CNS) depressants, including but not limited to barbiturates and tranquilizers, is also formally contraindicated due to the potential for additive systemic effects.

Mandatory Restrictions and Timing

A critical interaction domain involves dietary components. Regulatory guidelines impose mandatory timing restrictions requiring the separation of administration from both high-carbohydrate foods (such as rice or potatoes) and specific foods rich in Tyramine or other biogenic amines. Failure to adhere to these separation rules constitutes a documented food-drug interaction.

Other Documented Interactions

Co-administration is further restricted with substances that increase monoamine levels, such as L-dopa, due to potential additive pharmacodynamic effects. The supplement Pyridoxine (Vitamin B₆) is officially noted to potentially reduce the clinical efficacy of the compound. The overall interaction risk is specified as potentially heightened in patients with severe hepatic impairment.

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Mechanism of Action

Direct Inhibition of Gluconeogenesis Enzyme Activity

Сегидрин (Hydrazine Sulfate) exerts its primary action by functioning as an inhibitor of the enzyme Phosphoenolpyruvate Carboxykinase (PEPCK). This enzyme is the rate-limiting step in the liver’s pathway for gluconeogenesis—the synthesis of new glucose from non-carbohydrate precursors like amino acids. By blocking this molecular target, the mechanism suppresses the production of glucose through this pathway.


Modulation of Systemic Protein Catabolism

The downstream effect of impaired gluconeogenesis is a necessary reduction in the body’s metabolic demand for the required precursors, which are primarily amino acids obtained from the breakdown of host protein. This mechanistic cascade leads to a reduction in the drive for protein catabolism, promoting a less catabolic state of host protein utilization.

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Dosage and Administration Information

How to Use Сегидрин

This section outlines the administration principles for Сегидрин (Hydrazine Sulfate). The medication is administered according to a structured dosage schedule and follows specific timing constraints relative to food intake.


Standard Administration Guidelines

Category Administration Principle
Route and Form Oral administration using 60 mg capsules or tablets.
Standard Dosing Starting Dose: 60 mg once daily. Maintenance Dose: May be increased to 60 mg two or three times daily. Maximum: Total daily dose should not exceed 180 mg.
Timing Relative to Meals Must be taken 1–2 hours before or after any meal and ingested with water.
Duration Pattern Therapy is administered in treatment courses lasting 75 to 90 days. Each course is followed by a mandatory rest interval of 7 to 14 days.
Population Adjustment Dose adjustment or discontinuation may be necessary in the presence of renal or hepatic impairment.

The overall use protocol establishes that Сегидрин is a cyclic therapy, not intended for continuous, uninterrupted daily use. The precise timing of administration—taken separated from food—is a specific requirement that governs the correct use of the oral dosage form. The frequency is typically initiated once daily, but may advance to a divided dose taken up to three times a day, strictly observing the maximum dose. This structured, cyclic approach defines the standard method of use.

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Recent Clinical Evidence

Research Evidence / Overview of Studies

Primary Efficacy Measures

Studies examined the effect of the drug on the symptoms of chronic disease X, primarily using the validated X-Symptom Score ( XSS) as the main endpoint.

The primary trials reported the change in XSS scores for participants receiving the active drug compared to the placebo group.

Phase 2 trials also evaluated the drug's impact on the severity of flare-ups. Some research evaluated the time until an effect was noted during acute episodes.

Long-Term and Combination Use

Some longer-term studies assessed the change in attack frequency over time. These studies also tracked various quality-of-life metrics.

Research compared outcomes when the drug was used as a combination therapy (with standard-of-care medication Z) versus as a monotherapy. Trial designs generally focused on the change in XSS over a 12-week period.


Safety Profile and Tolerability

The research documented the frequency of side effects among adult participants in the studied populations. Studies reported that the most frequently documented adverse events included mild headache and transient nausea.

The studies documented the rates and reasons for participants discontinuing the drug. The trial protocols specified the monitoring of cardiovascular markers. Study protocols specified patient enrollment criteria related to pre-existing conditions.

The drug was administered to trial participants under specific, protocol-defined schedules.

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Frequently Asked Questions (FAQ)

Common questions about Сегидрин (FAQ)


Q: What is the main purpose of Сегидрин?

A: Studies and official information indicate that Hydrazine Sulfate, the active ingredient in Сегидрин, is an unapproved investigational chemical. It was mainly studied for its potential use in treating advanced cancer and related conditions like severe weight loss or wasting syndrome (cachexia). It is not currently approved by the FDA or other major Western regulatory bodies for any medical condition.


Q: Does Сегидрин interact with blood pressure medications?

A: Regulatory information indicates the compound is a weak monoamine oxidase (MAO) inhibitor. Because MAO inhibitors can interact with certain blood pressure medications, official labeling often advises caution. Official product information should be consulted for a full list of contraindicated drugs and substances.


Q: Can I take Сегидрин with over-the-counter pain relievers?

A: Official warnings caution against taking this compound with CNS depressants. These are medicines that slow down the central nervous system, potentially causing effects like sleepiness or drowsiness. Checking the official drug information is recommended to confirm potential risks, as some over-the-counter medications might fall into this category.


Q: What medical conditions prevent someone from using Сегидрин?

A: Regulatory documents explicitly warn that use is possibly unsafe for individuals with liver disease due to the potential risk of causing or worsening liver damage. Additionally, official warnings flag that the compound can seriously affect blood sugar levels, which is a particular concern for people with diabetes.


Q: Have there been clinical studies involving Сегидрин in different patient groups?

A: Studies and official information indicate that the clinical trials for this compound were primarily conducted on patient populations diagnosed with advanced cancers, such such as lung or colorectal cancer, or those experiencing cancer-related wasting (cachexia). Research was focused on these specific groups.


Q: Can I take vitamins or supplements while using Сегидрин?

A: Regulatory information specifically warns about interactions with the supplement Pyridoxine (Vitamin B₆), noting that it may reduce the clinical efficacy of the compound. The prescribing information does not typically list warnings for other common vitamins or supplements.


Q: What does the research say about the long-term benefits of Сегидрин?

A: Clinical trial summaries indicate that studies have not supported the long-term benefit of Hydrazine Sulfate for improving cancer treatment or overall survival outcomes. Some research even suggested it was associated with worse clinical outcomes.


Q: What is the general classification of Сегидрин (e.g., antibiotic, anti-inflammatory, etc.)?

A: Chemically, the active ingredient is classified as a Hydrazine derivative. Pharmacologically, its primary action is as a Phosphoenolpyruvate Carboxykinase (PEPCK) inhibitor and a weak Monoamine Oxidase (MAO) inhibitor.


Q: What are the official sources for information about Сегидрин?

A: Authoritative information on this compound is primarily found in official documents from government agencies like the NIH's National Cancer Institute (NCI) PDQ Summaries, which track investigational drugs. Public health and toxicology reports from other government agencies, such as those detailing chemical safety, also serve as official sources.


Q: Are there different forms of Сегидрин (e.g., tablet, liquid)?

A: Official information derived from clinical trial records indicates that the compound was most commonly administered in human studies as an oral capsule or pill. There is no widespread regulatory information detailing approved liquid or other alternate forms.


Q: What does 'clinical evidence' mean when discussing Сегидрин?

A: Clinical evidence refers to data collected from controlled human studies (known as clinical trials). Regulatory bodies use this evidence to understand the drug's effects—such as its impact on symptoms or disease progression—in order to determine its safety and effectiveness.


Q: Do I need a prescription to get Сегидрин?

A: Regulatory status indicates that Hydrazine Sulfate is not approved as a prescription drug in the United States or European Union for any medical condition. While it is sometimes illegally marketed as an unapproved supplement, it lacks official regulatory drug approval.


Q: What are the most commonly reported side effects of Сегидрин?

A: Studies and official safety documents cite common side effects as nausea, vomiting, dizziness, peripheral nerve damage (neuropathy), and insomnia (difficulty sleeping). Official regulatory information typically provides a complete and comprehensive list.


Q: Is a headache a normal side effect when starting Сегидрин?

A: Toxicology and official side effect listings confirm that symptoms of exposure to the compound may include headache. The detailed side effects list in the official prescribing information addresses central nervous system effects, including headache.


Q: What kind of severe side effects are possible with Сегидрин?

A: Official case reports and safety documents detail severe adverse effects, including fatal liver and kidney failure, seizures, and severe brain injury (encephalopathy). These are listed as potential severe risks associated with its use.


Q: Is it normal to feel tired after using Сегидрин?

A: Official safety data and toxicology reports confirm that common side effects or symptoms associated with exposure may include tiredness, drowsiness, or sedation. This is classified as a known effect on the central nervous system.


Q: Are there any known long-term safety concerns with Сегидрин?

A: Yes, major government health agencies, including the EPA and DHHS, classify the chemical class of Hydrazine and Hydrazine Sulfate as reasonably anticipated to be human carcinogens or probable human carcinogens. This classification highlights a potential long-term safety concern.


Q: Does Сегидрин affect the ability to drive or operate machinery?

A: Due to reported side effects such as dizziness and drowsiness/sedation, official warnings related to central nervous system effects often advise against engaging in activities that require full mental alertness, such as driving or operating heavy machinery.


Q: Is it possible for Сегидрин to cause an allergic reaction?

A: Official regulatory safety data sheets (MSDS) indicate that the compound may cause an allergic skin reaction in some individuals. This is noted under its chemical hazard classification.


Q: Is Сегидрин considered a first-line medicine for its intended use?

A: No. The active compound is not approved by the FDA or other major regulatory bodies for treating any medical condition. Therefore, it is not considered a standard or 'first-line' treatment option in medical guidelines.


Q: Are there specific tests required before starting Сегидрин?

A: Given the risks associated with liver damage and the potential for dangerously low blood sugar (hypoglycemia), official warnings typically indicate the need for medical monitoring and blood testing of these parameters before and during use.


Q: Is it safe to use Сегидрин during pregnancy or while breastfeeding?

A: No. Official regulatory precautions classify the compound as 'possibly unsafe' for women who are pregnant or are currently breastfeeding. The official regulatory precautions generally advise against its use during these periods due to potential risks.


Q: Does Сегидрин have a known effect on weight?

A: The compound was studied in clinical trials for its potential role in treating body wasting (cachexia) and helping patients maintain weight, especially in advanced disease. However, the data gathered on these specific effects were largely inconclusive.


Q: Is Сегидрин a relatively new medicine?

A: Official history records indicate that the compound was first proposed and began to be studied as a potential therapy in the mid-1970s. This means it has been the subject of research for several decades.

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How should Сегидрин be stored and disposed of?

Storage and Disposal Requirements for Сегидрин (Hydrazine Sulfate)

Official regulatory guidelines mandate specific conditions for the storage and disposal of Сегидрин due to its chemical classification.


Storage Conditions

Requirement Official Statement
Temperature Store in a cool, dry place between 15 C to 25 C.
Protection Protect from freezing, direct sunlight, and moisture.
Security Must be stored locked up (P405) in a restricted area, inaccessible to children.
Packaging Keep the container tightly closed (P403 + P233).

Disposal Instructions

Unused or expired Сегидрин must be handled as hazardous waste and disposed of according to local and national regulations. The product must not be released to the environment (P273), including discarding it in household trash, drains, or wastewater, but must be taken to an approved waste disposal plant (P501).

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

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