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Пенкрофтон

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Пенкрофтон

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Treatment option: Pregnancy, Uterine Leiomyomata

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Пенкрофтон

What is Pencroftonum?

Quick Facts Description
Active Ingredient Mifepristone
Form Tablet (monopreparation)
Route Oral administration
Pharmacological Class Antiprogestational agent (Antiprogestin)
Origin Synthetic steroid
Status Prescription-only

Pencroftonum is a highly specialized, synthetic steroidal medication available by prescription, whose active component is Mifepristone. It is fundamentally defined by its primary action as an antiprogestational agent, or antiprogestin, a class of drugs that acts as a progesterone receptor antagonist. The use of Mifepristone is clinically recognized for its ability to modulate specific hormonal states.

Composition and Mechanism

The active ingredient in Pencroftonum is Mifepristone, supplied as a single-ingredient product in the form of a tablet for oral administration. The drug's mechanism is rooted in its competitive interaction with key hormone receptors. Mifepristone primarily works by preventing progesterone from binding to its receptor sites. This targeted action is the basis for its general therapeutic purpose: providing a controlled means to modulate hormone-dependent physiological processes.

Additionally, Mifepristone demonstrates a secondary action as a cortisol receptor blocker, particularly at higher concentrations. This antiglucocorticoid activity is another core property of the drug. Mifepristone is included on the Model List of Essential Medicines for its defined therapeutic uses. The drug’s combined functional properties offer a precise tool for interrupting or managing specific hormone signals when indicated in patient groups such as adults.

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What side effects are possible with Пенкрофтон?

Possible Side Effects and Safety Information

The safety profile of Pencroftonum (Mifepristone) is officially documented and categorized by the body system affected and the specific clinical use, as the frequency and nature of adverse reactions differ between indications.

Frequency-Classified Adverse Reactions

Adverse reactions are classified using standard regulatory frequency categories, such as Very Common and Common events. For instance, in the context of its use for early pregnancy resolution, Very Common effects include nausea, vomiting, diarrhea, uterine cramping, and heavy uterine bleeding. For the management of Cushing's syndrome, Common effects frequently documented are fatigue, headache, decreased blood potassium (hypokalemia), and peripheral edema.

Serious Adverse Reactions and Safety Constraints

Regulatory documents explicitly list several clinically significant, though less frequent, adverse reactions. These include the potential for Adrenal Insufficiency, the development of severe high-impact events like Serious Bacterial Infections/Septic Shock (related to the reproductive use), and Severe Cutaneous Adverse Reactions (SCARs).

Official safety documents also define specific Safety Constraints and Contraindications. The medicine should not be used in individuals with pre-existing conditions such as Chronic Adrenal Failure, Hereditary Porphyria, or uncontrolled Severe Asthma. Caution is also specified for populations with underlying Hepatic or Renal impairment due to the potential for altered medicine clearance.

Time-Related Patterns and Affected Systems

Adverse effects are formally grouped by System-Organ-Classes (SOC), including the Gastrointestinal, Nervous, Reproductive, and Musculoskeletal systems. The regulatory profile notes that the anti-glucocorticoid effect may persist for several days following administration, and symptoms of adrenal insufficiency may arise during the discontinuation or dose adjustment phase for the Cushing's indication.

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Overdose and Emergency Response

The official regulatory profile for Pencroftonum defines the potential risk following the ingestion of a massive overdose. This level of exposure is considered an event with the potential for a severe or life-threatening outcome. The primary physiological concern identified in regulatory documents is the risk of adrenal failure.

Documented Manifestations and Emergency Actions

If a massive dose has been ingested, regulatory guidance mandates that the patient should be observed closely by medical personnel. This intensive monitoring is specifically required to detect any signs of adrenal failure as rapidly as possible. Immediate medical help must be sought if any massive ingestion is suspected, or if symptoms related to severe toxicity arise. The adrenal system is the specific area of physiological concern requiring this heightened observation due to the drug's properties at extreme concentrations.

Toxicity Profile and Management

Regulatory tolerance studies in healthy adult male and non-pregnant female subjects established that single doses up to three times the recommended amount were generally well-tolerated without the report of serious adverse reactions. No specific antidote is specified in the official regulatory labeling for Pencroftonum overdose. Management of such an event is focused on providing continuous close observation and supportive treatment tailored to the patient’s clinical presentation.

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Therapeutic Uses of Пенкрофтон

Pencroftonum (Mifepristone) addresses two distinct, highly specialized therapeutic areas that generally require targeted hormonal modulation. The active ingredient is commonly used for these dual purposes in clinical settings.

Control of Severe Hypercortisolism Symptoms

The medication is generally used for managing the severe metabolic symptoms of endogenous Cushing's syndrome, particularly in adult patients. It is applied in contexts where pronounced, system-wide symptoms such as persistently high blood glucose and associated hypertension are driven by excess cortisol activity. Using this medication generally contributes to improved metabolic control, which helps to ease the overall symptom load and supports a sense of stability. The use may assist with maintaining functional stability.

Resolution of Early Intrauterine Pregnancy

In the domain of reproductive health, Pencroftonum is commonly used as part of a structured, multi-drug protocol designed for the medical resolution of early intrauterine pregnancy (typically through 70 days/10 weeks of gestation). This provides the key therapeutic benefit of a non-surgical option that assists with managing reproductive planning within a defined clinical framework. This use is aligned with clinical protocols requiring non-surgical management.

Quick Fact: Therapeutic Domains
Symptom Domain Hypercortisolism-related metabolic disturbances (e.g., hyperglycemia)
Clinical Context Management of severe or recurrent endogenous Cushing's syndrome
Primary Benefit Supports stability by contributing to improved metabolic control

Regulatory References

  1. NIH MedlinePlus Drug Information
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Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Пенкрофтон (Mifepristone) — Official Regulatory Information

The official eligibility criteria for using Mifepristone are strictly defined by regulatory bodies, focusing on patient health status, age, and reproductive condition. These rules determine who may use the medicine and who is formally prohibited.

Category Official Regulatory Statement or Restriction
Populations for whom use is allowed Adults (18 years and older) for both approved indications. Pregnant females aged 17 and younger are included under the specific indication for medical termination of pregnancy.
Populations for whom use is contraindicated Chronic adrenal failure and concurrent long-term corticosteroid therapy are absolute prohibitions. Contraindication also applies to patients with confirmed or suspected ectopic pregnancy, inherited porphyria, and uncontrolled severe asthma.
Age-related eligibility rules Pediatric Use: Safety and effectiveness are not established for the non-reproductive indication (Cushing’s syndrome) in patients under 18 years of age. Geriatric Use: No geriatric-specific problems have been officially documented to date.
Pregnancy and lactation eligibility status Pregnancy: Contraindicated when used for the non-reproductive indication. Lactation: Breastfeeding is not recommended during long-term therapy, and the manufacturer advises consulting a healthcare provider after a single dose.
Eligibility-related restrictions Use is generally not recommended for patients with severe hepatic impairment or severe renal impairment due to insufficient pharmacokinetic data. Hemorrhagic disorders or concurrent anticoagulant therapy are contraindications for the reproductive indication.

Connection to the Overall Eligibility Profile:

Regulatory documentation strictly defines patient eligibility based on two primary constraints: the drug's potent anti-hormonal activity and the lack of established safety data in certain groups. The profile mandates absolute exclusion for populations whose pre-existing conditions (e.g., adrenal failure, severe bleeding risk) are incompatible with the drug's actions, while also applying formal restrictions for age groups and those with significant organ impairment where regulatory data is insufficient.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Pencroftonum (Mifepristone) is defined by its role in metabolic pathways and its specific pharmacological activity as an antiglucocorticoid agent, leading to several documented restrictions and contraindications in regulatory documents.

Contraindicated Combinations

Co-administration with strong CYP3A4 inducers, such as Rifampin, Phenytoin, or Carbamazepine, is strictly prohibited due to the significant risk of reducing Mifepristone's plasma concentrations. The medication is also formally contraindicated with CYP3A4 substrates that have a narrow therapeutic index, including immunosuppressants (Cyclosporine, Sirolimus) and certain statins (Lovastatin, Simvastatin), as Mifepristone's inhibitory effect can substantially increase their exposure.

Furthermore, combining Pencroftonum with long-term corticosteroid therapy is contraindicated, as the drug's anti-glucocorticoid effect can lead to functional adrenal insufficiency. For the reproductive health indication, co-administration is prohibited with agents like anticoagulants or antiplatelet drugs due to an elevated risk of severe hemorrhage.

Clinically Significant Interactions

Interaction Type Interacting Agent Class Official Restriction Summary
Metabolic Exposure Strong CYP3A4 Inhibitors (e.g., Ketoconazole) Increases Mifepristone plasma levels; requires caution.
Pharmacodynamic Antidiabetic/Hypoglycemic Agents Increased risk of hypoglycemia due to additive effect.
Dietary/Herbal Grapefruit Juice / St. John's Wort Prohibited; alters Mifepristone's plasma concentrations.

When utilized in the multi-drug regimen, the regulatory label mandates a mandatory timing interval, specifying that the co-administered Misoprostol component must be taken within 24 to 48 hours following the dose of Mifepristone.

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Mechanism of Action

Пенкрофтон (Mifepristone) functions as a dual-acting competitive antagonist against key intracellular hormone receptors, resulting in specific alterations to hormonal signaling cascades and downstream physiological responses.


Competitive Blockade of Progesterone Receptor (PR)

This mechanism involves the drug binding to the Progesterone Receptor with high affinity, thereby physically blocking endogenous progesterone from exerting its effects. By interrupting progesterone-mediated gene transcription, the drug removes the hormonal signal that maintains tissue stability and uterine relaxation. This action modulates uterine function, directly leading to the transition from a quiescent to an active, contractile smooth muscle state and the breakdown of hormone-dependent tissue.


Antagonism of the Glucocorticoid Receptor (GR) and HPA Axis Modulation

The drug also acts as an antagonist at the Glucocorticoid Receptor, particularly influencing the central regulation of the stress hormone system. Blocking the GR in the pituitary disrupts the negative feedback loop that normally regulates cortisol release. This interruption causes a compensatory surge in ACTH and cortisol levels, but the drug's sustained presence on target tissue GRs results in a functional antiglucocorticoid effect at the cellular level, despite the systemic hormonal increase.

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Dosage and Administration Information

How to Use Пенкрофтон

Пенкрофтон (Mifepristone) is a prescription medication administered exclusively via the oral route. Its administration protocol varies significantly based on the therapeutic context, detailing two distinct usage schedules.

1. Administration for Hypercortisolism Symptoms

The regimen for managing hyperglycemia secondary to hypercortisolism is a long-term, titrated schedule. The starting dose is 300 mg, taken once daily. The tablet must be consumed with a meal and must be swallowed whole, ensuring it is not split, crushed, or chewed. Dose adjustments proceed gradually; titration occurs in 300 mg increments no more frequently than once every two to four weeks, up to a maximum daily dose of 1200 mg. For patients with documented renal or mild-to-moderate hepatic impairment, the maximum recommended daily dose is restricted to 600 mg. If treatment is interrupted, reinitiation must begin at the 300 mg starting dose.

2. Administration for Early Pregnancy Resolution

In this highly structured protocol, Пенкрофтон is administered as a single 200 mg oral dose on Day 1 of the regimen. This specific administration is completed only under the supervision of a certified healthcare provider within a structured program. The entire process is time-bound, requiring a mandatory follow-up assessment by the healthcare provider 7 to 14 days after the initial administration to confirm the outcome.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Пенкрофтон

The clinical research for Pencroftonum (Mifepristone) has explored the research context for two distinct, highly specialized indications. The following overview describes the types of studies that have been conducted, the outcomes they measured, and areas where evidence remains limited.


Evidence for Managing Severe Symptoms of Cushing's Syndrome

Research exploring systemic imbalance associated with hypercortisolism primarily relies on uncontrolled, open-label, multicenter clinical trials and case reports, a design necessitated by the rarity of the disease. Studies were applied in adult populations with persistent or severe symptoms, including those with associated hypertension or impaired glucose tolerance. Researchers examined changes in metabolic markers (like blood glucose control and diastolic blood pressure) and a composite measure of overall patient status (GCR). Studies report changes measured during the study period, and data indicate patterns related to these monitored outcomes. However, follow-up durations were limited to the short- and intermediate-term, meaning that long-term effects are not fully established, and comparative evidence is lacking due to the study design.


Evidence for Resolution of Early Intrauterine Pregnancy

The research exploring the structured protocol involving this medication for pregnancy resolution is primarily derived from numerous Randomized Controlled Trials (RCTs) and comprehensive Systematic Reviews. Studies were evaluated in populations with confirmed intrauterine pregnancy up to 70 days gestation. The central outcome monitored was the rate of complete resolution without the need for a surgical procedure. Studies consistently reported the measured completion rates for resolution, and the rate of ongoing pregnancy was observed to be low across the systematic reviews. Confirmation typically required a short-term follow-up assessment within one to two weeks. Findings may vary when explored at the latest end of the studied gestational period.


Research Limitations and Areas of Uncertainty

The overall certainty for the Cushing’s indication remains low due to reliance on small sample sizes and predominantly uncontrolled study designs. For both indications, limited information for long-term outcomes exists; the research scope for pregnancy resolution does not typically extend to long-term follow-up. Data for certain groups, such as children in the Cushing's context, remain insufficient, and research is ongoing to explore how observed patterns may vary across different causes and severities of Cushing's syndrome.

Key Studies & References

  1. Mifepristone Drug Information: NIH National Library of Medicine
  2. Mifepristone for the Treatment of Hypercortisolism in Cushing's Syndrome (The SEISMIC Study)
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Frequently Asked Questions (FAQ)

Common questions about Пенкрофтон (FAQ)

Q: Does Pencrofton cause drowsiness?

Official product information indicates that drowsiness (somnolence) and dizziness have been reported as very common or common side effects in clinical studies for some indications. These central nervous system effects are facts documented in regulatory summaries of safety data.


Q: Can Pencrofton affect my ability to drive?

Official product information suggests a potential for impact because regulatory data includes dizziness and somnolence (drowsiness) among the reported common side effects. These effects could potentially affect a patient’s ability to drive or operate machinery. Patients should consult their healthcare provider for specific guidance before driving or operating machinery.


Q: Why might the instructions state that I cannot drink alcohol with Pencrofton?

Official regulatory warnings may indicate that consuming alcohol while taking this medication could potentially increase the risk of certain adverse effects. These effects may include gastrointestinal issues like nausea and vomiting, or an increased risk of bleeding. This restriction is based on safety data and risk mitigation.


Q: What should I do if a rash starts while taking Pencrofton?

Regulatory reports indicate that serious skin reactions, including generalized rash, urticaria (hives), and angioedema, have been reported following the medicine's use. Official safety documents indicate that patients should seek immediate medical attention if they experience a rash or other allergic reaction.


Q: Can Pencrofton be taken if a patient has diabetes?

The regulatory status of the drug indicates that for one approved use, it is specifically applied to help control hyperglycemia (high blood sugar) in adults with Type 2 Diabetes or impaired glucose tolerance secondary to Cushing's syndrome. This means that the medication may be used in the clinical management of glucose control, under the direction of a healthcare professional.


Q: What will happen if I take more Pencrofton than recommended, and what should I do?

The Overdosage section of the official prescribing information states that medical assistance should be sought immediately if a dose larger than recommended is taken. Managing an overdose typically involves providing appropriate supportive therapy and monitoring, as determined by a healthcare professional.


Q: Can Pencrofton be taken during pregnancy?

According to official prescribing information, use is contraindicated (prohibited) during pregnancy for the non-reproductive indication. Its use is based on its mechanism as a potent progesterone antagonist, which blocks the hormone necessary to sustain a pregnancy.


Q: How quickly is Pencrofton eliminated from the body?

Official pharmacokinetic data indicates that the medicine is eliminated slowly from the body. The active ingredient has a long terminal half-life, which is documented to be approximately 20 to 30 hours in most studied subjects.


Q: Is taking Pencrofton associated with weight gain?

Based on regulatory data from clinical trials for one indication, increased appetite or weight gain is not specifically listed as a common adverse event. Instead, common adverse events reported include decreased appetite and anorexia.


Q: Does Pencrofton affect the menstrual cycle?

The official mechanism of action indicates that the drug works by blocking the effects of the hormone progesterone. Progesterone is essential for maintaining early pregnancy and is also a key regulator of the menstrual cycle.


Q: Does Pencrofton affect potency?

The regulatory documents do not directly describe an effect on potency. However, less common adverse reactions involving the genitourinary system, such as pain during sexual intercourse, have been reported in post-marketing safety data.

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How should Пенкрофтон be stored and disposed of?

How to Store and Dispose of Pencroftonum (Mifepristone)

Official regulatory documents define strict conditions for the storage and disposal of Pencroftonum tablets to ensure product stability and safety. The medication must be kept at a controlled room temperature, specifically between 20 C to 25 C (68 F to 77 F). The product must be protected from excessive moisture and should not be frozen.

  • Container Rules: The tablets must be stored in the original container and kept tightly closed.
  • Child Safety: It is a mandatory requirement that the medicine be stored out of the sight and reach of children.
  • Disposal: Unused or expired Pencroftonum must not be flushed down the toilet or poured down a drain. Regulatory guidance recommends following instructions from a pharmacist or utilizing an official medicine take-back program where available.

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

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