Оргаметрил

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Оргаметрил

Medically reviewed

Marina Burgos

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.

Overview of Оргаметрил

Quick Facts

Property Description
Active ingredient Lynestrenol (INN)
Form Tablet
Pharmacological class Progestin / Synthetic Progestogen
Common purpose Hormonal regulation and support
Origin Synthetic (Estrane steroid derivative)

Оргаметрил is a synthetic prescription medication where the sole active component is Lynestrenol, an international non-proprietary name (INN) for an estrane steroid derivative. This compound is clinically recognized and classified as a Progestin or Synthetic Progestogen, meaning it is chemically designed to mimic the functions of the body's natural progesterone hormone. The medication is presented as a tablet intended for oral administration, distinguishing it as a systemic, single-active-ingredient product.

Lynestrenol is described as a synthetic prodrug; the compound itself is inactive upon ingestion and depends on the body’s metabolism to convert it into the active substance, Norethisterone. This metabolic conversion is a defining feature of Lynestrenol's action, ensuring the progestogen is delivered systemically following absorption. This reliance on the conversion pathway differentiates its action profile from those progestins that are active in their administered form. Pharmacological data indicates the compound's capacity to stabilize and control the menstrual cycle and the uterine lining.

The general purpose of Оргаметрил is to provide hormonal support and regulation by activating progesterone receptors. This progestogenic activity is utilized to stabilize the menstrual cycle, regulate the uterine lining (endometrium), or achieve the inhibition of ovulation, establishing its therapeutic context for women requiring consistent hormonal management.

Regulatory References

  1. WHO Lists of Essential Medicines

What side effects are possible with Оргаметрил?

Possible side effects and safety information

The safety profile of Lynestrenol ( Orgametril) details adverse reactions and safety restrictions as classified by governmental regulatory authorities. Adverse effects are grouped by frequency and the body system affected, distinguishing between common, expected events and rare, serious concerns.

Adverse Reaction Classification

Official labeling documents adverse reactions across several System-Organ Classes (SOCs):

Classification Area Examples of Documented Effects
Reproductive/Endocrine Irregular vaginal bleeding, spotting, amenorrhoea, breast pain, weight increase.
Nervous System Headache, migraine, depressed mood, nervousness.
Gastrointestinal Nausea, abdominal pain, vomiting, diarrhoea, constipation.
Skin Acne, chloasma (skin pigmentation), rash, increased hair growth.
Metabolic Edema (fluid retention), decreased glucose tolerance.

Adverse effects are often categorized by frequency: common effects may include headache and irregular bleeding, while severe reactions are classified as rare.

Serious Adverse Reactions and Safety Constraints

The regulatory safety profile highlights several serious adverse reactions, including the risk of thromboembolic disorders (such as Deep Vein Thrombosis and Pulmonary Embolism) and the potential for hormone-dependent tumours (e.g., liver tumours and breast cancer). The medicine is formally contraindicated (restricted) in individuals with active thromboembolic disorders, severe hepatic (liver) impairment, known hormone-sensitive malignancies, and undiagnosed abnormal vaginal bleeding.

Time-related safety patterns are noted: side effects are often more common during the first few weeks of treatment, and the risk of certain serious conditions may be associated with the duration of use.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation, as outlined by national medicines authorities, characterizes the overdose profile for Lynestrenol (Оргаметрил) as having a low risk of acute serious toxicity. The regulatory text does not explicitly document any specific severe or life-threatening outcomes following an acute overdose, nor is any specific high-risk dose level defined.

Documented Overdose Manifestations Overdosage may present with a specific, officially documented cluster of clinical signs. These manifestations primarily affect the gastrointestinal and reproductive systems and include: Nausea, Vomiting, and Vaginal Bleeding (often characterized as withdrawal bleeding).

Required Emergency Actions Regulatory authorities mandate a clear course of action upon suspected exposure:

Element Official Regulatory Description
Immediate Help Contact your doctor immediately or seek medical advice immediately upon the suspicion of an overdose.
Antidote Status No specific antidote is known for Lynestrenol overdosage.
Management Protocol Management is limited to officially described measures, primarily symptomatic and supportive treatment.

Urgent medical attention is required immediately to ensure proper clinical assessment and the initiation of this supportive management protocol. This mandate to seek help applies immediately upon suspicion of overdose, consistent with the official regulatory framework, with no specific population-based differences in overdose severity officially documented.

Therapeutic Uses of Оргаметрил

What Оргаметрил Treats: Main Uses and Benefits

Lynestrenol is relevant across therapeutic areas in gynecology, where it assists in the management of hormone-sensitive conditions and supports the stabilization of the menstrual cycle.

This medication is indicated for use across several therapeutic domains. Key areas involve the management of menstrual disorders like heavy or prolonged menstrual bleeding (menorrhagia and metrorrhagia), frequent periods (polymenorrhoea), and the absence of menstruation (amenorrhoea). It is also relevant for easing symptoms related to endometriosis and endometrial hyperplasia.

The medication is commonly applied in scenarios involving symptomatic discomfort, such as temporary postponement of menstruation, symptomatic support for painful periods, or use as an adjunct in specific hormone therapies. This approach assists with maintaining functional stability and contributes to easing the overall symptom load during periods of heightened discomfort.


Quick Fact: Focus on Bleeding and Cycle Rhythm Management

Regulatory References

  1. Dutch Medicines Evaluation Board

Eligibility and Restrictions for Use

Eligibility and Contraindications

Оргаметрил (Lynestrenol) is primarily established for use in adult women of reproductive age who require hormonal management. Its use is not established for primary indications in prepubertal children or post-menopausal women.

The medicine is absolutely contraindicated for use in several populations, as defined by regulatory authorities:

  • Known or Suspected Pregnancy
  • Active or a history of arterial or venous thromboembolic disorders (blood clots).
  • Severe liver impairment or severe liver disease until liver function has normalized.
  • Known or suspected sex steroid-sensitive malignancies (e.g., certain types of breast or liver cancer).
  • Undiagnosed abnormal vaginal bleeding.

Use is generally considered compatible during breastfeeding as the substance does not significantly affect milk quality or quantity. However, patients with conditions like uncontrolled hypertension or diabetes mellitus require close observation and careful monitoring as part of conditional use defined by official labels.

What should I know about interactions with other medicines?

Lynestrenol, the active substance in Orgametril, is a progestogen that is a prodrug of norethisterone. Due to its metabolism, it has the potential to interact with a range of medicinal products and herbal supplements, primarily through effects on the liver's drug-metabolizing enzymes and through its influence on other hormonal systems and blood parameters.

Impact on Other Medicines

Lynestrenol may alter the effectiveness or increase the toxicity of certain drugs. For instance, it can potentially increase the effects of medications like cyclosporine, theophylline, and some beta-blockers, necessitating careful monitoring or dose adjustments. It may also decrease the effectiveness of insulin, requiring closer surveillance of blood glucose in patients with diabetes.

Impact on Lynestrenol

Certain classes of medicines can affect the metabolism of Lynestrenol, leading to reduced concentration and decreased therapeutic efficacy. These include, but are not limited to:

  • Anticonvulsants/Antiepileptics: Such as phenobarbital, phenytoin, primidone, and carbamazepine.
  • Anti-tuberculosis drugs: Notably rifampicin.
  • Herbal products: Specifically St. John's wort (Hypericum perforatum).

Concomitant use with these products may diminish the hormonal effects of Lynestrenol. Close consultation with a healthcare provider is essential to manage any potentially significant drug interactions.

Mechanism of Action

The active substance in Оргаметрил (Lynestrenol) functions as a prodrug, undergoing conversion in the liver into the active compound, Norethisterone. This active form acts as an agonist with high affinity for the body's Progesterone Receptors (PR). This molecular interaction initiates the drug's effect by establishing a sustained progestogenic influence on multiple biological systems.

The active metabolite exerts negative feedback on the Hypothalamic-Pituitary-Ovarian (HPO) axis. By binding to PRs in the brain centers, it suppresses the release of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH). This mechanistic pathway results in the inhibition of ovulation, preventing the normal hormonal surge and subsequent release of an egg.

At the tissue level, the drug induces changes in the reproductive system. It causes the endometrium (uterine lining) to shift from a proliferative state to a more stable, secretory/atrophic state, which leads to regulated shedding of the tissue. Simultaneously, it increases the viscosity of the cervical mucus, which modifies cellular permeability.

Dosage and Administration Information

The administration of Оргаметрил (Lynestrenol) is defined by its official oral route using the 5 mg tablet formulation. Proper usage is primarily categorized into either cyclic or continuous daily administration, with the specific schedule and dose determined by the clinical protocol being followed. Each tablet must be swallowed whole with some fluid, as specified in the administration instructions.

For protocols intended to regulate the menstrual cycle, such as the maintenance phase following acute abnormal bleeding, the typical regimen involves taking 5 mg (1 tablet) daily over a 10-to-12 day period within the cycle (e.g., from day 14 to day 25), a pattern often repeated over multiple cycles. In contrast, treatment for conditions like endometriosis, or protocols aiming for long-term suppression, require a continuous daily dose of 5 mg to 10 mg without a tablet-free interval, continuing for at least 6 months.

The required daily dosage is adjusted based on the specific context: while cycle regulation typically uses 5 mg, higher doses up to 10 mg or 15 mg are designated for the immediate control of acute uterine bleeding or for the postponement of menstruation. A clinical procedural condition for continuous use is the specified temporary dose increase to 10 mg or 15 mg for 3 to 5 days if breakthrough bleeding occurs, before returning to the standard daily maintenance dose.

Recent Clinical Evidence

Research evidence / Overview of studies for Оргаметрил

The research into Lynestrenol has spanned several decades and primarily focuses on the evaluation of specific patient outcomes in various gynecological conditions. Studies have monitored how symptoms evolved in observed populations and explored short-term changes in specific outcomes.


Evidence for Menstrual Cycle Regulation

For managing conditions like heavy menstrual bleeding (Menorrhagia) and irregular or absent periods, Lynestrenol was studied for its association with changes in menstrual cycle patterns. The foundational evidence includes older clinical trials and prospective open-label studies that examined its use in women of reproductive age, often lasting 3 to 6 menstrual cycles.

The findings describe patterns observed in the studies related to the measured change in menstrual blood volume and the incidence of more consistent bleeding cycles. Irregular bleeding was observed in some studies at a frequency that influenced participant continuation rates. Research also indicates that many older trials may not meet modern standards for randomization, and long-term effects regarding cycle stability after treatment stops are not fully established.

Evidence for Managing Endometriosis and Fibroids

Research examining Lynestrenol for Endometriosis primarily involves Randomized Controlled Trials (RCTs) that compared it against other hormonal therapies. These studies were used in research exploring how pelvic pain and painful periods evolved over time, and also monitored changes in the size of endometriotic lesions.

Findings indicated that research has explored whether the use of the medicine was associated with changes in pain reporting. However, when compared directly to other treatments in RCTs, the results regarding the measured reduction in the size of the lesions were mixed. Similarly, the evidence base for Uterine Myomas (Fibroids) is considered limited, consisting mostly of short-term comparative trials examining measured changes in fibroid volume before a planned surgical procedure.

Key Studies & References

  1. Summary of Product Characteristics (SmPC) for Orgametril (Lynestrenol) - Core Clinical Efficacy Data

Frequently Asked Questions (FAQ)

Common questions about Оргаметрил (FAQ)


Q: Why is Оргаметрил prescribed for heavy periods?

Official documents state that Оргаметрил is used to manage heavy menstrual bleeding, also known as Menorrhagia. The drug's mechanism is described as causing the uterine lining, or endometrium, to stabilize. This effect is used in the management of heavy bleeding to encourage the regulated shedding of the tissue.


Q: Can Оргаметрил be used to delay a period?

Official regulatory dosing protocols describe a regimen designated specifically for the postponement of menstruation. This short-term use is a recognized application described in the product information.


Q: Can drinking alcohol while taking Оргаметрил affect its action?

Official documentation states that the interaction with alcohol is generally unknown. Specific guidance is managed by a healthcare provider.


Q: Are there any specific foods or drinks that should be avoided when taking Оргаметрил?

According to official product documentation, the medicine is generally described as safe to take with or without meals. There are no specific restrictions on common foods or drinks that must be avoided while using this medication.


Q: What do research studies indicate about the long-term use of Оргаметрил?

Research evidence indicates that long-term effects regarding the return to a regular menstrual cycle stability after treatment stops are not fully established. Official regulatory safety information indicates that the risk of certain serious conditions (e.g., thromboembolic disorders) may be associated with the duration of use.


Q: What is the expected timeframe for seeing results when treating endometriosis with Оргаметрил?

Official protocols for conditions like endometriosis specify that continuous daily treatment should be maintained for a significant duration, typically at least six months. The specific timeframe for the onset of symptomatic relief is not universally defined in the regulatory label.


Q: Is it typical to experience withdrawal bleeding after stopping Оргаметрил?

Following a cyclic regimen, a withdrawal bleeding usually occurs within three days after treatment stops, which is a common response noted in official documentation. This is related to the body's reaction to the cessation of the hormone.


Q: Is it normal to have a late period when starting Оргаметрил?

Official documents list irregular vaginal bleeding and amenorrhoea (the absence of periods) as documented adverse effects, particularly when starting treatment. These effects are noted to be common occurrences.


Q: Is Оргаметрил generally taken with or without food?

The medicine is generally described in documentation as being safe to take with or without meals. The tablet should be swallowed whole with some fluid, according to the administration instructions.


Q: Is Оргаметрил considered a type of hormone replacement therapy?

Official classification documents describe the drug as a Progestin or Synthetic Progestogen, intended for hormonal regulation and support to manage specific gynecological conditions.


Q: How quickly does Оргаметрил usually start affecting the menstrual cycle?

Pharmacokinetic studies focus on the absorption of the drug. These studies indicate that the active metabolite, norethisterone, reaches its peak blood levels within 2 to 4 hours after the tablet is taken orally.


Q: How long does the effect of Оргаметрил last after the last tablet is taken?

The duration of the drug's presence in the body is tracked through its elimination half-life. The active metabolite, norethisterone, has an elimination half-life that is noted to be approximately 16 or 17 hours.


Q: Is a person's age a factor in who can use Оргаметрил?

The medicine is primarily established for use in adult women of reproductive age. Regulatory documents indicate that age can be a factor for risk screening, as the risk of certain cancers may be considered higher in some populations, such as women over 40 years of age or those with a family history.


Q: Can Оргаметрил influence the results of laboratory blood tests?

Regulatory documentation indicates that the drug may influence the results of certain laboratory tests. Documented changes in parameters include those related to liver function, carbohydrate metabolism, blood clotting (haemostasis), and cholesterol levels (LDL and HDL-cholesterol).


Q: Does using Оргаметрил affect future fertility, according to official data?

Studies have documented women who discontinued the medication and subsequently reported normal pregnancies and gave birth to healthy infants, indicating the possibility of a return to fertility after stopping the treatment.


Q: What are the official descriptions of the symptoms that Оргаметрил helps to manage?

Official regulatory indications include managing symptoms such as irregular menstrual cycles, the absence of menstruation (secondary amenorrhea), and controlling heavy or prolonged menstrual bleeding.


Q: Does Оргаметрил have a known effect on blood pressure?

Official documents state that patients with uncontrolled hypertension require close monitoring while using this medication. The drug's effect on blood pressure in the general population is not described as a common or universal side effect.


Q: What are the official warnings about taking Оргаметрил before surgery?

The regulatory safety profile highlights a risk of thromboembolic disorders (such as blood clots), which is a general warning relevant to surgical procedures and should be discussed with a healthcare provider.


Q: Is it possible to have an allergic reaction to the inactive ingredients in Оргаметрил?

Official documentation states that the medicine should not be used in patients with a known allergy to the active substance or any of the inactive ingredients (excipients) present in the tablet formulation.

How should Оргаметрил be stored and disposed of?

How to Store and Dispose of Оргаметрил?

Оргаметрил (Lynestrenol) tablets must be stored according to official regulatory specifications to maintain product quality and ensure safety.

Storage Requirements

Storage Constraint Regulatory Requirement
Temperature Limit Do not store the medicine above 30°C (86°F).
Environmental Protection Keep the container tightly closed to protect from moisture.
Packaging Store in the original package to shield the contents from light.
Child Safety Must be kept out of the sight and reach of children.

Disposal Instructions

Official guidelines prohibit disposing of this medicine via household waste or by flushing it down the wastewater system. Unused or expired Oргаметрил must be discarded through proper channels, such as returning it to a pharmacist or utilizing an approved pharmaceutical waste disposal facility, in accordance with local regulations.

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

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