Profar

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Profar

Method of action: Progestogen

Treatment option: Miscarriage

Medically reviewed

Laura Arias

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 Profar

Quick Facts

Property Description
Active ingredient Allylestrenol (or Allyloestrenol)
Form Oral tablet
Pharmacological class Progestogen (Estren derivative)
Common use Hormonal support for gestation
Origin Synthetic

What is Profar and its Composition?

Profar is a prescription-only medication whose active ingredient is Allylestrenol, a substance used in gynaecology to provide hormonal support. It is an estren derivative within the broader class of Progestogens.

The central component, Allylestrenol (or Allyloestrenol), is a chemically synthesized Estrane steroid derived from the 19-nortestosterone series. Profar is a single-ingredient product supplied in an oral tablet dosage form, making it an orally active agent. This compound is used for targeted hormonal replacement.

What Pharmacological Type Does Allylestrenol Belong To?

Allylestrenol belongs to the pharmacological class of Progestogens (also known as Progestins), which are compounds that activate the progesterone receptors in the body. As a progesterone receptor agonist (PR agonist), Allylestrenol mimics the physiological effects of natural progesterone, a hormone necessary for regulating and sustaining reproductive functions.

Its structure allows Allylestrenol to function as a progestogen without significant androgenic, estrogenic, or glucocorticoid activity. This targeted action allows the drug to serve as a gynaecological agent focused on stabilizing the progestational environment.

General Purpose and Foundational Benefit

The general purpose of Profar is to provide hormonal stability within the uterus. The medication helps promote uterine quiescence by suppressing myometrial contractions and reducing the uterus's sensitivity to stimulating factors.

Allylestrenol provides hormonal support for pregnancy maintenance by helping to stabilize the gestational environment. This foundational benefit is linked to the drug's placentotrophic activity, which supports the health and function of the placenta. Profar serves as an agent for pregnancy support in cases where exogenous progestational assistance is required.

What side effects are possible with Profar?

The safety profile of Profar (Allylestrenol) is documented in regulatory sources by classifying possible adverse reactions and outlining specific use limitations. Reactions are grouped by System-Organ Classes, providing a structured overview of potential effects.

Officially Classified Adverse Reactions

Commonly reported adverse effects in regulatory summaries are typically Gastrointestinal (e.g., nausea, vomiting, bloating) and Nervous System (headache, dizziness). Other frequently listed effects involve the Reproductive System (breast tenderness/swelling, irregular periods) and general conditions such as fluid retention (Oedema) and changes in body weight.

Serious Adverse Reactions

While generally infrequent, serious adverse reactions documented in official information include Thromboembolic Events (formation of blood clots) and Severe Liver Dysfunction (e.g., jaundice). Regulatory labels mandate immediate cessation of treatment if symptoms of sudden Visual Disturbances occur, such as loss of vision or double vision (diplopia).

Safety Restrictions and Specific Populations

Profar is Contraindicated in individuals with conditions such as severe liver disease, known or suspected hormone-dependent carcinoma (e.g., breast or uterine cancer), and undiagnosed vaginal bleeding. Safety constraints also apply to certain groups: the medication is not recommended for use in children under 16 years (safety not established) or during breast-feeding. Caution is officially advised for patients with a history of thromboembolic disorders, kidney problems, or depression.

Overdose and Emergency Response

Profar Overdose and when to seek help

The information regarding overdose for Profar (Allylestrenol) is based on documented regulatory guidance and the known profile of the progestogen class. Specific clinical data on severe or life-threatening manifestations of Allylestrenol overdose are not explicitly detailed in publicly available government regulatory sources.


Overdose Scope

Field Content
Documented overdose presentations: Specific, clinically severe manifestations are not explicitly documented in official prescribing information.
Physiological systems affected: Specific affected systems are not documented in official overdose sections.
Dose-related or exposure-related factors: No specific dose levels are documented in the official overdose sections that correlate to severe outcomes.
Population-specific overdose notes: No population-specific risks are explicitly documented in official regulatory overdose text.
Emergency-response statements: Management should include symptomatic and supportive treatment.
When immediate medical help is required: Immediate medical attention must be sought for all suspected overdose cases.

Overdose Classifications

Field Content
Severity classification: No formal classification of severity is documented in the official overdose sections.
Regulatory basis: Information aligns with the standardized regulatory framework for managing overdoses where specific findings are limited.
Overdose-context constraints: Treatment is constrained to symptomatic and supportive measures, reflecting the lack of a known antidote.

Official Overdose Statements

  • No specific antidote is known for Allylestrenol.
  • Immediate medical attention must be sought for all suspected overdose cases.
  • Management should be restricted to symptomatic and supportive treatment only.

Connection to the overall overdose profile

The official regulatory profile is primarily structured around the fact that no specific antidote is known and that specific severe manifestations are not explicitly documented. This framework dictates that any suspected overdose scenario requires immediate action to seek urgent medical assessment, with subsequent treatment being limited to general supportive care.

Therapeutic Uses of Profar

What Profar Treats: Main Uses and Benefits

Profar is a medication used in symptomatic management, applied to address a range of conditions where functional stability becomes affected due to hormonal factors, and is utilized where additional symptomatic support is needed. This medication is relevant for easing symptoms linked to conditions characterized by periods of heightened symptoms.

It is generally used in clinical settings that involve acute or unstable symptom patterns, often during phases when symptoms become more noticeable. Profar supports the patient during difficult episodes by helping to ease the overall symptom load, contributing to improved comfort.

Quick Note: May assist with symptoms that interfere with daily functioning

This supportive relief assists patients in coping more steadily with symptom fluctuations. It may be part of symptomatic management when the goal is to help maintain a sense of stability during noticeable symptom increases. Profar's role is primarily to provide short-term symptomatic assistance when symptoms interfere with routine activities.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Official Eligibility Profile for Profar (Allylestrenol)

The eligibility for using Profar is strictly defined by regulatory documents based on a patient’s medical history, age, and physiological status. The medicine is primarily intended for Adult Women of Childbearing Age who are currently in the specific physiological state of pregnancy for hormonal support.

Category Regulatory Status
Use Allowed Adult women during the established gestational period.
Use Not Recommended Children under 16 years; breastfeeding mothers.

Populations for Whom Use Is Contraindicated

The medicine is absolutely contraindicated (must not be used) in patients with the following conditions, as stated in official product labeling:

  • Severe Hepatic Impairment (severe liver disease).
  • Hormone-Dependent Carcinoma (e.g., breast or uterine cancer) or a history of these conditions.
  • Thromboembolic Disorders (history of blood clots) or cerebral apoplexy (stroke).
  • Hypersensitivity to Allylestrenol or any excipient.
  • Undiagnosed Vaginal Bleeding or Incomplete Abortion.

Conditional and Restricted Use

Profar is formally designated for Use with Caution in individuals with pre-existing renal dysfunction, heart disease (e.g., congestive heart failure), epilepsy/seizure disorders, migraine headaches, or respiratory diseases (e.g., asthma, COPD). The regulatory profile specifies that use is not established in the geriatric population.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes the officially documented interaction patterns for Profar (Allylestrenol), a progestogen, based strictly on authoritative government regulatory information.

Interaction Scope

Property Details
Medicinal products with documented interactions Antiepileptic agents (e.g., Phenytoin, Carbamazepine, Phenobarbital) and Anti-infectives (e.g., Rifampicin, Griseofulvin).
Mechanistic basis Pharmacokinetic Interaction classified as Hepatic Enzyme Induction, which accelerates the metabolism of Allylestrenol.
Exposure outcome Co-administration with enzyme inducers results in Reduced Plasma Exposure (decreased AUC/ C max) of Allylestrenol.
Herbal product interactions The herbal product St. John's Wort (Hypericum perforatum) is formally listed as a strong enzyme inducer whose co-administration may reduce Allylestrenol exposure.
Population-specific note The drug is formally restricted for use and contraindicated in the presence of Severe Hepatic Impairment, a condition that affects metabolic clearance.

Official Interaction Statements

  • Pharmacokinetic Impact: Co-administration with enzyme-inducing medicinal products may lead to a clinically significant acceleration of Allylestrenol clearance, resulting in reduced systemic exposure.
  • Regulatory Restriction: Use is formally restricted in individuals with Severe Hepatic Impairment, as compromised liver function may lead to altered drug accumulation or clearance.

The regulatory profile is defined by pharmacokinetic interactions with hepatic enzyme inducers, which dictates the requirement for caution with these co-administered substances. No mandatory timing-separation rules are explicitly documented in regulatory labeling for co-administration.

Mechanism of Action

How Profar Works: Three Distinct Mechanisms

Profar's action relies on three distinct yet synergistic mechanisms to modulate the physiological systems involved in uterine homeostasis.

Hormonal Stabilization via PR Agonism

This domain focuses on the molecule's primary action as an agonist of the Progesterone Receptor (PR), initiating a genomic cascade that leads to the secretory transformation of the endometrium. This sustained activation induces secretory transformation of the uterine lining and contributes to suppressing the myometrium's sensitivity to factors that trigger contractions.


Myometrial Quiescence and beta2-Adrenergic Modulation

The mechanism achieves uterine quiescence through a dual anti-spasmodic action, involving both PR-mediated dampening of contractile responsiveness and direct agonism of beta2-Adrenergic Receptors on the uterine muscle. This latter, non-genomic pathway rapidly decreases the intracellular calcium concentration, which is essential for smooth muscle contraction, resulting in myometrial smooth muscle relaxation.


Placentotrophic Action and Endocrine Support

Profar engages in a unique Placentotrophic mechanism by directly stimulating the syncytiotrophoblast cells of the placenta. This direct cellular action increases synthesis and output of endogenous hormones, including Human Chorionic Gonadotropin (hCG) and Progesterone, supporting the endocrine function of the gestational unit.

Dosage and Administration Information

The administration of Profar (Allylestrenol) is defined by established guidelines that govern its route, dosage, frequency, and duration of use.


Route and Preparation

Profar is supplied as an oral tablet and must be taken by mouth. The tablet should be swallowed whole without being crushed, broken, or chewed, a procedural constraint to ensure proper administration. Dosing consistency is maintained by taking the tablet at approximately the same time each day, and the medicine may be taken with or without food.


Dosing and Schedule

The specific dosage and frequency for Profar are highly variable and directly dependent on the clinical context, following patterns established in the prescribing information. The daily dose typically ranges from 5 mg to 40 mg. For the management of acute conditions, such as threatened symptomatic episodes, the regimen often requires up to 15 mg per day, administered in divided doses (e.g., three times daily).

Conversely, maintenance use may prescribe a lower dose, such as 5 mg to 10 mg per day. The total course of treatment is not fixed but is determined by the patient's status, requiring continuation until symptoms improve or beyond a specified risk period.


Special Administration Rules

There are specific rules governing the use of Profar in certain populations. The medicine is generally not recommended for use in children and adolescents under the age of 16 years. If a dose is missed, standard instructions advise taking it as soon as it is remembered, unless it is close to the time for the next scheduled dose, in which case the missed dose should be skipped to prevent taking a double dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Profar

Allylestrenol (Profar) is a hormonal support agent whose research has been focused primarily on obstetric and reproductive contexts. The evidence base consists mainly of randomized controlled trials (RCTs), retrospective analyses, and systematic reviews, which explore the compound's use in the context of high-risk pregnancies. Research provides context but not individual predictions, and findings describe group patterns, not personal outcomes.


Evidence from Research for Threatened Miscarriage

Research examining Profar's role when symptoms suggest a potential early pregnancy loss has been conducted through RCTs and various observational studies. These studies primarily focused on pregnant women in the first trimester presenting with acute physical symptoms, which is the setting that studies examined. Researchers applied the medicine in studies examining short-term or episodic symptom patterns and monitored the Live Birth Rate and the Ongoing Pregnancy Rate at specified milestones.

Researchers observed reported live birth measurements that were sometimes different between the group receiving the medicine and the control group. Evidence quality varies across studies, and existing research provides limited insight into long-term outcomes for the subsequent health and development of children born following the use of Profar.


Evidence from Research for Recurrent Spontaneous Abortion

Profar was examined in various clinical trials for women with a history of multiple spontaneous miscarriages (RSA). These studies monitored the pregnancy progression of women who were in conditions characterized by fluctuating or episodic manifestations of pregnancy loss. In this population, the studies explored whether the medicine was observed to have differences in the Live Birth Rate in a subsequent pregnancy between the study groups.

However, the evidence is limited and shows some inconsistencies, as some comprehensive reviews on progestogens for RSA have reported inconsistent findings. The research often relied on data from sample sizes that were modest, and follow-up durations were limited to the period of the specific pregnancy being supported, meaning that certainty regarding the compound's performance remains low.


Known Research Gaps and Uncertainties

While studies contribute to the broader evidence landscape, several key limitations are noted. Comparative evidence is lacking for specific scenarios, and limited information for long-term outcomes remains regarding the subsequent health of children born following maternal use of this medicine during pregnancy. Results apply only to the populations studied, and data for other complex groups remain insufficient.

Key Studies & References

  1. World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) Classification System: G03DC01 (Allylestrenol)
  2. National Institute for Health and Care Excellence (NICE) Guideline: Ectopic pregnancy and miscarriage: diagnosis and initial management

Frequently Asked Questions (FAQ)

Common questions about Profar (FAQ)

Q: Is Profar used for pain relief, or for something else entirely?

A: According to regulatory documents, Profar is a progestogen that is primarily used to provide hormonal support in specific gynaecological and obstetric situations. Its main function is to support the uterine environment, and it is not indicated or approved for general pain relief.

Q: How quickly does Profar start to show effects?

A: Regulatory information indicates that the active substance may begin to exert its pharmacological effects relatively quickly after ingestion. However, the full clinical benefit often depends on continuous use as directed by a healthcare professional.

Q: What are the long-term effects of using Profar for an extended time?

A: Official research acknowledges that there is limited long-term data on outcomes, especially concerning the subsequent health and development of children following maternal use of the medication. For this reason, the need for ongoing use is typically determined through medical supervision and monitoring.

Q: Are there any known severe allergic reactions associated with Profar?

A: Yes, hypersensitivity (severe allergy) to the active ingredient or any excipients is a formal contraindication, meaning the medicine should not be used. Symptoms of a severe allergic reaction may include rash, swelling, or breathing difficulty, and such symptoms would warrant immediate medical attention.

Q: Is it true that Profar is a relatively new medication?

A: While the product name may be newer, external resources supported by regulatory history indicate that the active ingredient, Allylestrenol, was initially developed and introduced into clinical practice during the 1960s. This means the compound itself has been studied for several decades.

Q: Can taking Profar cause temporary changes to vision?

A: Regulatory labels advise that if sudden visual disturbances occur, such as a loss of vision or double vision (diplopia), the treatment should be stopped immediately. These are considered serious symptoms and should be promptly evaluated by a healthcare professional.

Q: Why is Profar not recommended for people with [specific, high-level condition]?

A: Official information states that Profar is contraindicated (must not be used) in people with conditions such as severe liver disease and certain thromboembolic disorders (history of blood clots). This is due to known risks associated with progestogens and how the medicine is processed in the body.

Q: Is there evidence that Profar is safe for long-term use?

A: Official research states that evidence is currently limited regarding the long-term outcomes and subsequent health of children born following the use of Profar during pregnancy. The necessity of long-term use is determined based on individual clinical evaluation.

Q: Are there common but mild side effects of Profar to expect?

A: Commonly reported adverse effects in regulatory summaries include mild gastrointestinal issues such as nausea and bloating. Nervous system effects like headache and dizziness, as well as breast tenderness, are also frequently noted.

Q: Is it normal to feel a bit nauseous when first starting Profar?

A: Yes, nausea is specifically listed as a common adverse effect in official drug information. It can be particularly noticeable during the initial period as the body adjusts to the presence of the new medication.

Q: Do people gain weight while taking Profar?

A: Regulatory summaries list changes in body weight, which can include an increase, among the possible adverse reactions reported. Concerns about body weight changes should be discussed with a healthcare provider.

Q: Why do some people say Profar made them feel dizzy?

A: Dizziness is officially classified in regulatory documents as a commonly reported adverse effect affecting the nervous system. This experience is often temporary as the body adapts to the medicine.

Q: How long does one dose of Profar typically last in the system?

A: While specific duration is not stated, the dosing schedule for certain acute conditions often requires the medicine to be taken in divided doses (e.g., three times daily). This frequency suggests that the therapeutic effects may need regular replenishment throughout the day.

Q: Can Profar be taken alongside common blood pressure medications?

A: The medicine is not formally contraindicated with most blood pressure drugs. However, caution is advised in official labels for patients who have pre-existing heart disease or renal dysfunction, conditions often linked to blood pressure issues.

Q: Are there any vitamins or supplements that should not be taken with Profar?

A: Official interaction statements warn that the herbal product St. John's Wort (Hypericum perforatum) is a strong enzyme inducer that may significantly reduce the exposure of Profar in the body. All supplements and herbal products being used should be reviewed with a healthcare provider.

Q: Can taking Profar affect my ability to drive or operate machinery?

A: Official warnings note that adverse effects like dizziness or drowsiness may occur. Because of these potential effects, caution is advised regarding activities that require full mental alertness, such as driving or operating heavy machinery.

Q: Is Profar safe for older adults (seniors)?

A: The regulatory profile specifically states that the use of Profar has not been established in the geriatric population. This means there is insufficient data to make a formal safety recommendation for older adults.

Q: What happens if you suddenly stop taking Profar?

A: Abrupt discontinuation of hormonal support is often advised against. Regulatory guidance suggests that sudden cessation may lead to complications or hormonal imbalance, particularly when used for pregnancy support. Any decision to stop or change the medication should be made in consultation with a prescribing professional.

Q: Is Profar meant to be taken every day, or only as needed?

A: The required schedule for Profar is highly variable. Labeled regimens may require daily dosing for both acute conditions and maintenance use, with the total course of treatment determined by the patient's specific clinical needs.

Q: Can Profar affect the efficacy of birth control pills?

A: Official information indicates that co-administration with certain hormonal agents, such as some types of hormonal contraceptives, may require caution. This is because there is a potential for reduced effectiveness of one or both medications due to metabolism or interaction.

How should Profar be stored and disposed of?

How to Store and Dispose of Profar (Allylestrenol Tablets)

Official Storage Conditions

Category Requirement as per Regulatory Labeling
Temperature Store at controlled room temperature, typically below 30°C (86°F).
Protection The tablets must be protected from light and moisture and should not be refrigerated or frozen.
Container Keep the medicine in its original package or outer carton and ensure the container is tightly closed.

Handling and Disposal Requirements

All medications must be stored out of the sight and reach of children to prevent accidental ingestion, which is a universal regulatory mandate. For disposal, unused or expired Profar should be handled according to official local pharmaceutical waste regulations.

The official method involves using a drug take-back program or authorized collection site. To protect the environment, the tablets must not be disposed of via wastewater or household trash unless explicitly instructed otherwise by local authorities.

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

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