Dixi

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Dixi

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 Dixi

Quick Facts

Property Description
Active ingredient Cyproterone acetate and Ethinylestradiol
Form Oral tablet
Pharmacological class Steroidal Antiandrogen and Estrogen combination
General purpose Management of androgen-dependent conditions
Origin Synthetic

Dixi is a synthetic combination preparation administered as an oral tablet for systemic hormonal therapy, clinically recognized for its antiandrogenic properties in women. This prescription-only medication is classified under the ATC code G03HB01, which specifically includes antiandrogens and estrogens when used in combination.

Dixi: Classification and Definition as a Combination Preparation

The core identity of Dixi is defined by its pharmacological class as a steroidal antiandrogen combined with an estrogen in a fixed oral preparation. The formulation uses the strong progestin Cyproterone acetate, which possesses pronounced antiandrogenic activity, alongside Ethinylestradiol, a synthetic estrogen component. This combination places it within a specialized group of hormonal medications developed for managing conditions linked to hyperandrogenism, distinguishing it from standard hormonal contraceptives that lack this high level of antiandrogen specificity.

Composition: The Role of Cyproterone Acetate and Ethinylestradiol

The active ingredients are the antiandrogen and progestin Cyproterone acetate (CPA) and the synthetic estrogen Ethinylestradiol (EE). Cyproterone acetate's primary mechanism involves the ability to bind to the androgen receptor, thereby acting as an androgen receptor antagonist. This specific function is a cornerstone of its therapeutic action. The tablets are synthesized using solid pharmaceutical excipients, which facilitate the oral route of administration and systemic delivery of these steroid derivatives. The same essential active ingredient combination is also found in other formulations, such as Co-cyprindiol.

General Purpose: Managing Androgen-Dependent Conditions

The general purpose of this combination preparation is to provide foundational management of symptoms and conditions driven by an excess effect of male hormones (androgens) in women, such as severe acne or hirsutism. The resulting systemic effect involves the dual action of blocking androgen effects at the tissue level and reducing the total amount of circulating free androgens by suppressing ovarian hormone production. Consequently, this hormonal composition inherently functions as a form of effective hormonal birth control, which is a necessary co-benefit of its structure.

What side effects are possible with Dixi?

Dixi: Possible Side Effects and Safety Information

This section outlines the officially documented adverse reactions and safety restrictions for Dixi, based strictly on government regulatory documents (e.g., FDA, EMA, MedlinePlus).

Adverse reactions are formally categorized by their frequency and by the body system affected:

Classification Frequency System-Organ Class (SOC) Involvements
Very Common ge 1/10 Nervous System Disorders (e.g., Headache), Gastrointestinal Disorders (e.g., Dry Mouth)
Common ge 1/100 to <1/10 Psychiatric Disorders (e.g., Anxiety, Insomnia), Metabolism and Nutrition Disorders (e.g., Weight Loss)
Uncommon / Rare < 1/100 Cardiac Disorders, Hypersensitivity Reactions

Serious Adverse Reactions

Regulatory documents highlight the risk of serious events, including sudden death and serious cardiovascular events, particularly in patients with pre-existing heart defects or severe heart problems. The emergence of new psychotic or manic symptoms has also been documented, leading to specific warnings and precautions.

Safety-Related Restrictions and Limitations

The medicine is contraindicated and must not be used in the presence of:

  • Advanced arteriosclerosis or symptomatic cardiovascular disease.
  • Moderate to severe hypertension, hyperthyroidism, or glaucoma.
  • Known hypersensitivity to the active substance or other sympathomimetic amines.
  • Agitated states or a history of drug abuse.
  • Use during or within 14 days following the administration of monoamine oxidase inhibitors (MAOIs) due to the risk of hypertensive crisis.

Population-Specific Considerations

  • Pediatric and Adolescent Patients: Specific warnings detail the risk of sudden death in children and adolescents, especially those with structural cardiac abnormalities. Monitoring for aggressive behavior or hostility is mandated.
  • Pregnancy and Lactation: Use during pregnancy requires professional consultation; breastfeeding is not recommended while taking this medicine.

These official regulatory domains structure the drug's safety profile, identifying the full range of risks from frequent, generally milder side effects to rare, critical safety restrictions, without suggesting clinical actions or therapeutic benefits.

Overdose and Emergency Response

Dixi Overdose and When to Seek Help

Acute overdose with the Cyproterone acetate and Ethinylestradiol combination (Dixi) is generally characterized by regulatory authorities as having low acute toxicity. Official prescribing information, such as the Summary of Product Characteristics (SmPC), documents a specific symptom profile rather than severe or life-threatening outcomes.

The documented clinical manifestations of acute overdose are primarily nausea and vomiting. Additionally, a hormonal withdrawal effect, manifesting as slight vaginal bleeding, is also officially recognized. This specific manifestation is noted as a possibility in young girls before menarche following acute ingestion.


When to Seek Urgent Help

In the event of suspected acute ingestion beyond the prescribed dose, immediate medical attention is required for assessment and supportive management. Official regulatory documents confirm that no specific antidotes are known for this combination preparation. Consequently, the required treatment for overdose is restricted to being strictly symptomatic and supportive.

Clinical evaluation must be sought to provide care aimed at alleviating the presenting signs and symptoms, particularly due to the absence of a pharmacological reversal agent. This regulatory framework confirms that although acute overdose carries a low toxicity rating, professional medical evaluation is necessary for proper assessment and management.

Therapeutic Uses of Dixi

The Cyproterone acetate and Ethinylestradiol combination is applied across domains where additional symptomatic support is needed to address symptoms related to systemic imbalance driven by an excess effect of male hormones (androgens) in women. It is relevant in clinical settings marked by heightened patient distress.

Support for Androgen-Related Symptoms

This medication is commonly used to help with pronounced and often persistent severe acne lesions, chronic oily skin (seborrhea), and moderately severe hirsutism (excessive body and facial hair). It is applied when symptoms create noticeable physiological strain and have been unresponsive to other management approaches. It is considered relevant in addressing hyperandrogenic skin and hair manifestations associated with Polycystic Ovary Syndrome (PCOS). This provides supportive relief that generally helps ease the overall symptom load and contributes to improved day-to-day comfort during symptomatic periods. This combination may play a role in managing menstrual cycle irregularities linked to the syndrome, alongside addressing the visible skin and hair symptoms.


Quick Fact: Support for Androgen Excess
Relevant for: Severe, persistent dermatological symptoms.
Therapeutic Support: Helps ease the symptom burden associated with unwanted hair growth and inflammatory acne.
Typical Context: Used in situations where symptoms are unresponsive to other management approaches.

Regulatory References

  1. European Medicines Agency recommendation

Eligibility and Restrictions for Use

Dixi (a formulation of dextroamphetamine) is primarily prescribed to manage Attention-Deficit Hyperactivity Disorder (ADHD) and treat narcolepsy. It is a central nervous system stimulant and should only be used as part of a total treatment program, which may also include psychological and educational therapies.

Suitable Candidates

  • Patients diagnosed with ADHD, typically children from 3 to 6 years of age and older, as well as adults, depending on the specific dosage form.
  • Individuals with a diagnosis of narcolepsy.

Contraindications (Who Should Not Use Dixi)

This medication is not suitable for everyone. Do not use Dixi if you have a known hypersensitivity to amphetamine products or are currently taking or have recently taken (within 14 days) a Monoamine Oxidase Inhibitor (MAOI). The drug is also generally contraindicated in patients with:

  • Cardiovascular conditions, including advanced arteriosclerosis, symptomatic heart disease, moderate to severe hypertension, or structural heart defects, due to the risk of sudden death, heart attack, or stroke.
  • Hyperthyroidism (overactive thyroid).
  • Glaucoma (increased pressure in the eye).
  • A history of drug abuse.
  • States of marked anxiety, tension, or agitation.

Older adults (65 years and over) and pregnant or breastfeeding women should discuss the risks and benefits thoroughly with a healthcare provider, as alternative treatments are often preferred due to safety concerns.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Dixi (referring to dextroamphetamine-containing products) is known to have a defined interaction profile based on its classification as a central nervous system stimulant and its metabolic pathway.

Contraindicated Combinations (Major Interaction Risk)

  • Monoamine Oxidase Inhibitors (MAOIs): Co-administration is contraindicated, and a time interval of at least 14 days must pass between discontinuing an MAOI (including linezolid and intravenous methylene blue) and starting Dixi. This is due to the risk of a potentially fatal hypertensive crisis.

Interacting Medicinal Product Categories

Category Documented Interaction Mechanism Interaction Constraint
Serotonergic Drugs (e.g., SSRIs, SNRIs, Triptans, Fentanyl, St. John's Wort) Increased risk of Serotonin Syndrome. Initiate Dixi at lower doses and monitor closely, especially during initiation or dosage increase.
CYP2D6 Inhibitors (e.g., Paroxetine, Fluoxetine, Quinidine) May increase Dixi exposure and increase the risk of Serotonin Syndrome. Initiate Dixi at lower doses and monitor closely; discontinue if Serotonin Syndrome occurs.
Urinary Alkalinizing Agents (e.g., Sodium Bicarbonate, Acetazolamide) Increase drug absorption and decrease excretion, leading to higher blood levels and potentiated action. Co-administration should generally be avoided due to increased exposure.
Urinary/Gastrointestinal Acidifying Agents (e.g., Ascorbic Acid, Ammonium Chloride) Decrease drug absorption and increase excretion, leading to lower blood levels and reduced efficacy. May require an increase in Dixi dose based on clinical response.

Other agents, including Antihypertensive Agents and Adrenergic Blockers, may have their effects antagonized by Dixi. Conversely, Tricyclic Antidepressants may enhance the effects of Dixi, potentially increasing cardiovascular risk.

Mechanism of Action

Dixi is a selective estrogen receptor modulator (SERM). It exhibits high affinity for estrogen receptors (ERs) expressed in bone tissue.

By selectively binding to ERs in cellular components such as osteoblasts and osteoclasts, Dixi modulates the intricate signaling pathways that regulate the balance between bone formation and bone resorption.

Dixi acts as a functional antagonist on the estrogen receptor in osteoclast precursors. This action alters the signaling cascade that controls osteoclast differentiation and activity. This results in a net decrease in the cellular remodeling unit turnover rate and a physiological shift toward reduced bone resorption.

Concurrently, Dixi acts as an antagonist on estrogen receptors in endometrial tissue, contributing to its tissue-selective pharmacodynamic profile.

Dosage and Administration Information

The administration of Dixi (cyproterone acetate 2.0 mg / ethinylestradiol 0.035 mg) is based on a fixed, cyclic daily oral regimen. This medication is exclusively intended for women of reproductive age and is not indicated for use before the completion of puberty.


Administration Scope Official Instruction
Route of Administration Oral use
Dosing Schedule One coated tablet daily
Timing & Administration Take at about the same time every day with some liquid, without specific regard to food. Tablets must be consumed in the sequence directed by the pack.
Age-Group Rules Exclusively for women of reproductive age.
Missed-Dose Rule If the delay in taking a tablet exceeds 12 hours, additional non-hormonal barrier contraception must be used for the next 7 days, as contraceptive protection may be compromised.
Use-Context Constraint The product should not be prescribed or continued solely for the purpose of contraception.

Resulting Procedural Structure

The use of Dixi follows a structured 28-day cycle. One tablet is taken daily for 21 consecutive days. This is followed by a mandated 7-day tablet-free interval, during which the user does not take any tablets. The next 21-day cycle must begin immediately after this 7-day interval has passed.

The duration of use requires a minimum assessment period of at least three months. It is generally recommended that the regimen be continued for 3 to 4 cycles after the symptoms have completely resolved. The tablet-free interval must never be interrupted for longer than 7 days.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Dixi


Evidence for Use in Moderate to Severe Acne

The use of this combination preparation was studied in research exploring symptoms of persistent or severe acne, especially in women where the condition is linked to androgen sensitivity. Researchers primarily conducted Randomized Controlled Trials (RCTs) and comparative clinical trials to examine the patterns of change in this population. The main focus was on measuring objective outcomes like the reduction in the total count of inflammatory acne lesions and the overall severity of the acne using clinical scales. Findings describe measurements of change in acne scores over intermediate-term follow-up periods (typically 3 to 12 months). However, long-term effects are not fully established by extensive, controlled studies extending beyond one year, and evidence for symptom recurrence remains limited.


Evidence for Use in Hirsutism (Excessive Hair Growth)

This combination was evaluated in research exploring patterns of change in hirsutism, which is excessive, unwanted hair growth in women. The research included both RCTs and systematic reviews that tracked objective measures of hair growth. The primary outcome studies monitored was the change in hirsutism scoring, most commonly using the standardized Ferriman-Gallwey (mFG) score. Follow-up durations were typically long-term (6 to 24 months). Research highlights changes measured during the study period in the mFG score. Comparative evidence is lacking for a definitive assessment against all other available pharmacological options for hirsutism, and the durability of the reduction after cessation are not fully established by controlled studies.


Research Limitations and Uncertainty

Evidence related to the hyperandrogenic symptoms of Polycystic Ovary Syndrome (PCOS) primarily addresses symptomatic outcomes (acne, hirsutism, and menstrual cycle regularity) rather than comprehensive systemic health. There is limited information for long-term outcomes regarding the broader health markers associated with PCOS, such as metabolic or cardiovascular risk. Evidence quality varies across studies, and many older trials featured sample sizes were modest. Findings describe group patterns, not personal outcomes, and study results reflect the specific conditions under which they were conducted.

Key Studies & References

  1. Cyproterone acetate/ethinylestradiol (Dianette/Diane-35) in the treatment of hirsutism: a systematic review and meta-analysis

Frequently Asked Questions (FAQ)

Common questions about Dixi (FAQ)


Q: What are the most common things people worry about when taking Dixi?

The most frequently reported adverse reactions, according to official regulatory documents, include headache, nausea, breast tenderness, and changes in mood such as anxiety or depression. The occurrence of these common concerns depends on which specific Dixi formulation a patient is using.


Q: Are there any long-term effects associated with Dixi use?

Official guidance states that the duration of use for the CPA/EE formulation should be minimized. Official guidance suggests that the regimen is typically stopped three to four cycles after the treated condition has fully resolved to limit long-term exposure.


Q: Do studies show Dixi is effective for all listed uses?

Official product information states that the medicine is indicated for its respective uses. The CPA/EE formulation is indicated for the management of severe acne and hirsutism. The Dextroamphetamine formulation is indicated for the treatment of ADHD and narcolepsy.


Q: How does Dixi compare to other treatments for the same condition in terms of research?

Official epidemiological studies on the CPA/EE formulation describe the VTE risk compared to certain other types of oral contraceptives. This data is used by regulators in assessing the overall safety profile of the medication.


Q: Can Dixi interact with common vitamins or supplements?

Yes, official regulatory documents describe potential interactions with certain supplements and vitamins. Substances that increase stomach acidity, such as high doses of Vitamin C, may reduce the absorption of the Dextroamphetamine formulation. Panax Ginseng may also increase the likelihood of stimulant-related side effects.


Q: Is it normal to feel [mild side effect] when starting Dixi?

Effects categorized as 'Very Common' or 'Common' in official safety documents are those frequently experienced by users. Such effects, which may include headache, nausea, or anxiety, are typically reported when first starting the medication.


Q: What is the difference between Dixi and a placebo in studies?

Clinical trials demonstrated that Dixi was associated with measured improvements in symptoms compared to a placebo. These improvements included the reduction of inflammatory acne lesions in the CPA/EE studies and improvement in ADHD symptoms for the Dextroamphetamine formulation.


Q: Do genetic factors affect how Dixi works?

Official product information notes that the medicine is processed by specific liver enzymes (CYP2D6, CYP3A4). Individual differences in the function of these enzymes, which are related to genetic factors, can affect how quickly the medicine is broken down and eliminated from the body.


Q: What is the difference between the brand name Dixi and its generic form?

The generic form of Dixi contains the same active ingredients at the same strength as the brand name version. For the CPA/EE formulation, the active combination (Cyproterone acetate and Ethinylestradiol) is also sold under several other brand names.


Q: How often do people report serious side effects from Dixi?

The risk of serious adverse reactions is formally described by frequency in official documents. For the CPA/EE formulation, a serious event like venous thromboembolism is categorized as 'Uncommon' (less than 1 in 100 users) or 'Rare' (less than 1 in 1,000 users).


Q: What is the mechanism of action of Dixi, simply explained?

The mechanism of action is described differently for the two primary formulations. The CPA/EE formulation works by blocking male hormones in the body and suppressing the release of an egg (ovulation). The Dextroamphetamine formulation is a central nervous system stimulant that changes the levels of certain natural chemicals in the brain.


Q: How reliable is the research evidence for Dixi?

Research documentation indicates that long-term safety data are not fully established beyond the specific clinical trial periods. Furthermore, official sources note that some older studies featured only modest sample sizes.


Q: What is Dixi used for, besides the main condition?

The uses of Dixi depend on the specific formulation. The CPA/EE formulation is also used for the management of severe unwanted hair growth (hirsutism). The Dextroamphetamine formulation is indicated for narcolepsy, in addition to ADHD.


Q: Is Dixi the same type of medicine as [similar generic drug]?

The CPA/EE formulation is defined by its two active ingredients: Cyproterone acetate and Ethinylestradiol. This same combination is found in other medications for androgen-dependent conditions, such as Co-cyprindiol.


Q: How quickly should Dixi start working?

The Dextroamphetamine formulation acts as a central nervous system stimulant. For the CPA/EE formulation, the full clinical benefit for conditions like acne may take a few months, but the concentration of the active ingredient in the blood increases significantly within the first few weeks.


Q: What happens if I stop taking Dixi suddenly?

When discontinuing the CPA/EE formulation, the treatment is typically stopped after the symptoms have completely resolved. Official guidance suggests that the medicine is typically discontinued three to four cycles after symptom resolution.


Q: Is Dixi considered safe for people with kidney problems?

The active ingredients in the CPA/EE formulation are primarily excreted through bile and, to a lesser extent, through the kidneys. Official product information notes that consultation with a healthcare provider is necessary when kidney function is impaired.


Q: Are there certain foods or drinks to avoid while using Dixi?

Official product information for the Dextroamphetamine formulation describes the possibility of interaction with certain dietary choices. Foods and juices that increase stomach acidity, such as citrus products, may lower the absorption of the medicine and are often taken at least one hour apart.


Q: Does alcohol change the way Dixi works?

Official documents for the Dextroamphetamine formulation warn that the use of alcohol while taking this medicine can increase the risk of cardiovascular side effects. These effects may include changes in heart rate or blood pressure.


Q: How long does Dixi stay in your system after the last dose?

The elimination half-life of the active ingredients in the CPA/EE formulation is approximately 1 to 2 days for Cyproterone acetate and around 24 hours for Ethinylestradiol.


Q: When was Dixi first approved for use?

The combination of Cyproterone acetate and Ethinylestradiol was first introduced as a birth control pill in 1978.


Q: Can Dixi affect fertility?

The CPA/EE formulation is intended to suppress ovulation, which prevents conception while the medicine is in use. The official product information indicates that fertility typically returns after the medication is stopped.


Q: Are there specific tests needed before starting Dixi?

Before beginning the CPA/EE formulation, regulatory documents state that a healthcare provider must formally exclude the possibility of pregnancy.


Q: Is Dixi considered a 'controlled' substance?

Yes. The formulation containing Dextroamphetamine is officially classified as a Schedule II controlled substance by regulatory bodies.


Q: Are there warning signs for severe side effects of Dixi?

Yes, official product information for the CPA/EE formulation lists specific warning signs for severe events. These include sudden severe headache, sudden visual disturbances, or unexplainable pain and swelling in the legs, which may indicate a blood clot.


Q: What happens if I take more Dixi than intended?

Official regulatory information for the CPA/EE formulation states that in cases of overdose, there is no specific antidote available. Treatment is focused on managing symptoms.


Q: What kind of monitoring is typically required while on Dixi?

For the CPA/EE formulation, official guidance states that the need to continue treatment should be evaluated periodically by a healthcare provider.

How should Dixi be stored and disposed of?

How to Store and Dispose of Dixi

The storage and disposal of Dixi (Cyproterone acetate/Ethinylestradiol) must adhere to official regulatory requirements to maintain product stability and ensure environmental safety.


Storage Requirements

Condition Requirement
Temperature Store below 30 C (86°F).
Protection The tablets must be protected from light and moisture.
Container Keep the medicine in the original blister pack and outer carton.

This medication must be kept out of the sight and reach of children.


Disposal Instructions

Expired or unused Dixi must not be disposed of via household waste or by flushing down the toilet due to its hormonal composition. The product must be disposed of according to local regulations for medicinal waste, typically by returning it to a pharmacy or designated collection point.

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

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