Midane

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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 Midane

Property Description
Active Ingredients Cyproterone Acetate, Ethinyl Estradiol
Form Oral Tablets
Pharmacological Class Combination Antiandrogen-Estrogen
General Purpose Hormonal Regulation, Contraception
Origin Synthetic Hormones

Midane is a prescription-only medication supplied as oral tablets and is scientifically known by the generic name Co-cyprindiol. It is classified within the Combination Antiandrogen-Estrogen pharmacological class, signifying its dual-action profile involving two types of synthetic hormones. This medication is fundamentally defined as a fixed-dose combination preparation designed to alter hormonal activity within the body.


What Type of Medicine is Midane?

Midane is a combined hormonal agent that integrates both an antiandrogen and an estrogen into a single oral tablet.

Its primary classification is distinct from standard hormonal agents because of the dual nature of its key components. Preparations containing this specific combination, Cyproterone/Ethinyl Estradiol, are authorized for treatment based on their pharmacological property of antiandrogenic activity. For patients, the core property of this medicine is designed to counteract the effects of certain circulating hormones. Popular branded formulations with this exact combination include Diane-35 and Estelle-35.


Composition and Form: Cyproterone Acetate and Ethinyl Estradiol

The active ingredients in Midane are the synthetic steroid compounds Cyproterone Acetate and Ethinyl Estradiol.

These are administered via the oral route as small, precisely dosed oral tablets, where the active compounds are integrated within a neutral pharmaceutical matrix. Cyproterone Acetate is the dominant component providing the antiandrogenic activity, a property clinically recognized for its effectiveness in suppressing the hormonal basis of certain dermatological issues. Ethinyl Estradiol serves as the necessary synthetic estrogen component, a commonly utilized ingredient in combined oral contraceptives. This specific formulation ensures consistent absorption of both agents to reliably achieve systemic hormonal regulation.


General Purpose: Hormonal Regulation and Contraception

The general purpose of Midane is to achieve hormonal regulation by significantly suppressing the effects of androgens in the body.

The combined presence of the antiandrogen and the estrogen results in a comprehensive hormonal suppression, which works both by blocking androgen receptors in tissues and by reducing the overall quantity of active circulating androgens. Concurrently, the hormonal composition reliably prevents the monthly release of an egg, giving it the secondary but essential purpose of serving as a highly effective form of combined oral contraception (COC).

What side effects are possible with Midane?

Possible Side Effects and Official Safety Information for Midane

The safety profile for Midane, as documented in authoritative government regulatory documents, is based on a structured system for classifying and reporting adverse events observed during clinical trials and post-marketing surveillance.

Adverse Reactions and Classification

Adverse reactions associated with Midane are classified by both frequency (how often they occur) and the affected System-Organ Class (SOC). Regulatory documents typically use frequency categories such as Very Common (ge 1/10 patients), Common (ge 1/100 to < 1/10 patients), Uncommon, Rare, and Very Rare.

Key System-Organ Classes involved include, but are not limited to, Gastrointestinal disorders (e.g., nausea, vomiting, constipation), Nervous system disorders (e.g., headache, dizziness), and Psychiatric disorders (e.g., agitation, confusion).

Serious Adverse Reactions and Key Warnings

All regulatory labels contain a mandatory section for Serious Adverse Reactions (SARs). SARs are defined as any effects that are fatal, life-threatening, permanently disabling, or require or prolong hospitalization. The specific SARs for Midane are formally detailed in the full regulatory prescribing information.

Crucial safety information is presented in the Warnings and Precautions and Contraindications sections of the official label. These include:

  • Cardiorespiratory Risk: Midane is associated with risks of serious cardiorespiratory adverse reactions, such as respiratory depression, airway obstruction, apnea, and hypotension. These effects have sometimes resulted in death or permanent neurological injury.
  • Contraindications: The medicine is formally restricted from use in specific clinical situations or patient groups where the risk is considered unacceptable, as formally defined by the regulatory authority.
  • Risk of Abuse and Dependence: Midane, as a benzodiazepine, carries the risk of abuse, misuse, and dependence, which can lead to overdose or death. Patients should be monitored for signs of abuse.

Population-Specific Safety Notes

The official documents address safety considerations for specific populations. The risk of hypoventilation, airway obstruction, or apnea is noted to be greater in elderly patients and those with chronic disease states or decreased pulmonary reserve (e.g., Chronic Obstructive Pulmonary Disease).

Regulatory agencies formally require continuous monitoring of respiratory and cardiac function following administration in certain settings until the patient is stabilized. The presence of these defined categories and mandatory restrictions formally structures the understanding of Midane's overall risk profile.

Overdose and Emergency Response

Midane Overdose and when to seek help

The regulatory assessment of an acute overdose of Midane (Co-cyprindiol) indicates that life-threatening symptoms are not expected due to the low acute toxicity profile of the combined hormonal components. This official classification dictates that the resulting clinical presentation is generally limited to specific, predictable manifestations.

Documented Overdose Manifestations

According to official prescribing information, acute ingestion may result in clinical signs primarily affecting the gastrointestinal and reproductive systems:

  • Nausea
  • Vomiting
  • Withdrawal Bleeding (vaginal bleeding that is typically delayed, commencing a few days after the tablets are discontinued).

Regulatory Guidance on Emergency Actions

The primary focus of official guidance is on symptomatic support, as no specific antidote is known for this combination of active ingredients. Management following an overdose is limited to symptomatic and supportive treatment to address the presenting clinical manifestations.

When to Seek Urgent Medical Attention: Medical attention must be sought immediately when specific criteria are met, as stipulated by regulatory authorities. This includes any scenario involving the acute ingestion of a large quantity of tablets. Furthermore, if the manifested symptoms, such as nausea or vomiting, become severe or persistent, professional medical assessment is required for appropriate supportive care and observation.

Therapeutic Uses of Midane

What Midane Treats: Main Uses and Benefits

Midane is applied across domains where additional symptomatic support is needed. It is considered relevant for addressing symptoms related to orthostatic hypotension and other conditions involving episodic or fluctuating manifestations related to sudden positional changes. It is commonly used when symptoms intensify and supportive relief is needed in clinical settings marked by increased discomfort or tension.

Midane is relevant for easing symptom clusters that may become intense or disruptive and that interfere with daily functioning. This includes symptoms that create noticeable physiological strain, such as lightheadedness and dizziness. It supports the patient during difficult episodes by easing distress and may assist with maintaining functional stability.


Quick Fact: Support for Symptoms Affecting Daily Functioning


Regulatory References

  1. NIH MedlinePlus overview of Midodrine

Eligibility and Restrictions for Use

Who Can and Cannot Use Midane?

Midane (Co-cyprindiol) is a prescription-only combination hormonal agent with strict eligibility criteria defined by regulatory documents. Use is primarily restricted to women of reproductive age for specific antiandrogen-sensitive conditions. For acne treatment, use is conditional: it is only allowed after first-line therapies, such as topical or systemic antibiotics, have failed.


Absolute Contraindications

The medicine is strictly contraindicated in several populations and clinical states:

  • Men, women who are pregnant or breastfeeding, or those using another hormonal contraceptive.
  • Any patient with a current or history of arterial or venous thrombotic events (blood clots), including deep vein thrombosis, pulmonary embolism, stroke, or heart attack.
  • Individuals with severe or multiple risk factors for thrombosis, such as severe hypertension, diabetes with vascular symptoms, or a hereditary clotting disorder.
  • Patients with a history of severe active hepatic disease, liver tumours, or meningioma.

Population Restrictions

Use is not indicated for girls before the onset of menstruation. Additionally, the medicine must be stopped for defined periods before and after major surgery or during prolonged immobilisation due to increased risk of venous thromboembolism.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Formal Prohibitions and Restrictions

The official regulatory profile for Midane documents several constraints regarding co-administration. Use of Midane is explicitly contraindicated with any other hormonal contraceptive. Co-administration is also strictly prohibited with certain Hepatitis C combination regimens, including those containing ombitasvir/paritaprevir/ritonavir and dasabuvir, or those containing glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir.

Metabolic and Exposure-Altering Interactions

Midane’s components are subject to metabolic interactions primarily through hepatic enzyme induction, mainly involving CYP3A4. This action increases the breakdown of the active ingredients, which reduces their systemic exposure and can lead to contraceptive failure. Substances documented as inducers include certain anticonvulsants (such as phenytoin and carbamazepine), antibiotics (like rifamycins and griseofulvin), specific antivirals (e.g., ritonavir, nelfinavir), and the herbal product St. John’s wort.

Conversely, co-administration with CYP3A4 inhibitors or with Etoricoxib may increase the plasma concentrations of the estrogen component. Furthermore, certain antibiotics (penicillins and tetracyclines) may reduce estrogen exposure by interfering with enterohepatic circulation. Midane can also alter the metabolism of co-administered drugs like corticosteroids and benzodiazepines.

Timing-Based Requirements

For strong enzyme-inducing drugs, a non-hormonal barrier method of contraception must be used during co-administration and must continue for 28 days following their discontinuation.

Mechanism of Action

Midane is a short-acting benzodiazepine that primarily targets the GABA-A receptor complex in the central nervous system. It functions as a positive allosteric modulator by binding to a specific benzodiazepine site, located at the interface between the alpha and gamma subunits of the pentameric receptor. This molecular interaction does not directly activate the receptor but rather increases the affinity of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) for its binding sites. The resulting intracellular pathway involves an enhanced frequency of chloride ( Cl^-) channel opening upon GABA binding. This increased chloride ion conductance across the neuronal membrane leads to a downstream cascade of enhanced neuronal hyperpolarization and electrical inhibition. The system-level physiological consequence of widespread central nervous system inhibition is generalized central nervous system depression, including modulation of motor, memory, and awareness pathways.

Dosage and Administration Information

How Midane is Used: Official Administration Guidelines

Midane, scientifically known as Co-cyprindiol, is a fixed-dose combination of Cyproterone Acetate (2 mg) and Ethinyl Estradiol (0.035 mg) that is designed exclusively for oral administration. The official instructions for its use establish a precise, cyclic regimen that women of reproductive age must follow.

Dosing and Cyclic Schedule

The standard adult dosing schedule is one tablet daily for 21 consecutive days. This active dosing period is consistently followed by a 7-day tablet-free interval. The next treatment pack is started immediately after the 7-day break, maintaining a structured, 28-day cycle. The medicine should be taken at approximately the same time every day, regardless of meals, and the tablets must be taken in the order directed on the blister pack.

Procedural Instructions

Administration Scope Official Instruction
Route of administration Oral use only.
Dosing schedule One tablet daily of the fixed strength (2 mg/0.035 mg).
Missed-dose rule If the tablet is missed by less than 12 hours, it should be taken immediately; the next tablet is taken at the usual time to maintain continuity.
Special restriction This medicine should not be used in combination with any other hormonal contraceptive.

Duration of Use

Official guidelines specify that the treatment should continue for a period of time, and is recommended to be withdrawn three to four cycles after the clinical condition for which it was prescribed has completely resolved. The need to continue the treatment must be periodically evaluated by a physician.

Recent Clinical Evidence

Midane: Recent Clinical Evidence

Clinical research on Midane has focused on its action in the nervous system, where studies suggest it selectively activates a specific receptor pathway. Efficacy has been explored in adults experiencing acute discomfort, with trials assessing its potential role in symptom management.


Efficacy in Acute Relief

Randomized controlled trials (RCTs) have evaluated the potential for symptom improvement across various dosage levels. Researchers specifically assessed the time to potential onset of relief, with findings primarily focusing on changes observed within the initial few hours of administration.

  • Duration of Effect: Studies evaluated the potential for a reduction in symptoms over a period of 4 to 6 hours post-administration. The research focused on documenting the magnitude of potential symptom reduction when compared to placebo groups.

Research on Chronic Symptoms

While the main focus has been acute use, some clinical investigations have also evaluated Midane in people with chronic conditions.

  • Long-term Profile: Studies examined use over periods up to 12 weeks. Researchers assessed potential changes in the frequency and intensity of symptoms over the study duration, using patient-reported outcomes.
  • Combination Therapy: Other studies evaluated whether Midane, when administered alongside standard care, influenced patient-reported outcomes. This research explored associations with reduced symptoms in contexts where other treatments were assessed.

Safety and Tolerability Profile

Specific trials have assessed the profile of use in the elderly, focusing on participants aged 65 and older. The research centered on characterizing potential adverse events observed during trials and documenting the tolerability of the drug in this demographic.

  • Adverse Event Monitoring: Studies documented the frequency and severity of adverse events across all trial participants. Post-hoc analysis did not report significant differences when comparing the adverse event profile observed in the standard adult and elderly populations.

Frequently Asked Questions (FAQ)

Common questions about Midane (FAQ)

Q: Does Midane have a generic version available?

A: Midane is the non-proprietary, scientific name (Co-cyprindiol) for this combination of active ingredients. This combination of cyproterone acetate and ethinylestradiol is marketed under various brand names in different countries. The presence of a generic name indicates that the formulation itself is not exclusive to a single manufacturer globally.

Q: Does Midane cause weight gain?

A: According to official safety documents, changes in body weight are listed as a common adverse effect. This means a portion of users in clinical trials reported either weight gain or weight loss. This is noted as a possible finding in clinical experience.

Q: What beverages should I avoid while taking Midane?

A: Regulatory documents include general warnings regarding the use of alcohol during treatment, noting that it can potentially influence the effects of the medication and its associated risk factors. The official instructions focus primarily on avoiding medications and supplements that are known to interfere with the liver enzyme CYP3A4, which is responsible for breaking down Midane.

Q: Can Midane interact with common over-the-counter cold medicines?

A: Official warnings about drug interactions primarily highlight the risk associated with strong liver enzyme inducers, specifically the CYP3A4 system. Certain ingredients in over-the-counter products, including some cold and flu medicines, have the potential to affect these enzymes. Regulatory guidance requires that patients disclose all medications, including non-prescription ones, to a healthcare provider for an assessment of potential interaction risk.

Q: Can I take vitamins or supplements with Midane?

A: The herbal supplement St. John's wort is explicitly identified in regulatory documents as a substance to be avoided because it can significantly reduce the drug's effectiveness. Regarding other vitamins or supplements, regulatory information notes that all non-prescription products should be reviewed with a qualified healthcare professional.

Q: Is Midane safe for older adults to use?

A: Official regulatory documents state that Midane is indicated exclusively for use in women of reproductive age for specific conditions. Therefore, it is generally not intended for use by post-menopausal women or older adults.

Q: What is the age limit for using Midane?

A: According to official product information, Midane is not indicated for girls before the onset of menstruation. The indication is for women of reproductive age who meet the specific eligibility criteria for the medication.

Q: What is the expected long-term effect of taking Midane?

A: Regulatory guidelines describe that treatment with Midane is recommended to be withdrawn three to four cycles after the clinical condition for which it was prescribed has completely resolved. This means the overall duration of use is generally tied to the patient's resolution of symptoms.

Q: If Midane is helping, can I just stop taking it?

A: Regulatory instructions state that the need to continue treatment is subject to periodic evaluation by a physician. Abrupt discontinuation before the condition is fully resolved can lead to a recurrence of symptoms. Discontinuation of the medication requires an assessment by a qualified medical professional.

Q: Can Midane be used in children and teenagers?

A: Official product information states that Midane is not indicated for use in girls who have not yet reached the onset of menstruation. However, it is prescribed for specific conditions in women of reproductive age, which includes teenagers who have started their menstrual cycle.

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

A: Official safety documents include mandatory warnings about rare but serious adverse reactions. The most serious risks are related to the potential for venous and arterial thromboembolism (blood clots) and the possibility of liver tumors or a non-cancerous brain tumor called meningioma.

Q: Do the side effects of Midane get better over time?

A: Regulatory patient information often notes that certain minor side effects, such as changes in bleeding patterns, frequently lessen or disappear after the first few months as the body adjusts to the medication. In cases where side effects persist or are bothersome, consultation with a healthcare provider is noted in patient guidance.

Q: Is it safe to drink alcohol while using Midane?

A: Official warnings advise that alcohol consumption can potentially influence the effects of the medication and its associated risk factors. This does not represent an absolute prohibition. The need for caution and review with a physician is indicated when considering alcohol use with this medication.

Q: Can Midane be used by people with kidney problems?

A: While not specifically listed as an absolute contraindication, official warnings for combined hormonal agents often address conditions that may be exacerbated by fluid retention, which can be a concern with kidney impairment. The presence of kidney impairment may necessitate specific medical evaluation prior to use.

Q: Does Midane affect sleep patterns?

A: Sleep disturbances, which can include insomnia or excessive sleepiness, are listed as an official adverse reaction in the product characteristics. They are classified as Very Rare, meaning they were reported in less than 1 in 10,000 patients in clinical trials.

Q: How do I know if the Midane is working for me?

A: The efficacy of Midane is clinically determined by the improvement or resolution of the condition it was prescribed for, such as the management of severe acne or hirsutism. Official studies indicate that the full therapeutic effect and noticeable relief of symptoms may take at least three months to establish.

Q: Is there a test to see if Midane is right for me?

A: Official prescribing information indicates that healthcare providers conduct a thorough assessment of a patient’s personal and family medical history before prescribing. This assessment focuses particularly on identifying risk factors, especially those related to the possibility of blood clots or liver problems.

Q: What should I do if I have a persistent mild side effect from Midane?

A: Regulatory patient information consistently advises that if a patient experiences bothersome side effects that persist or worsen after the initial adjustment period, consultation with their doctor or pharmacist is advised. This is the documented procedure for seeking appropriate professional guidance.

Q: Is it possible for Midane to make symptoms worse at first?

A: Official patient guides note that achieving the full therapeutic benefit may take several months, which is a common expectation for treatments of this type. Symptom improvement may therefore be slow during the initial weeks of treatment. Monitoring by a physician is part of the established patient care.

Q: What is the half-life of Midane?

A: The half-life is a measure of how long it takes for the concentration of a substance in the body to be reduced by half. The cyproterone acetate component has a half-life of approximately 0.8 days in the first phase and 2.3 days in the second phase. The ethinylestradiol component is approximately 12 to 25 hours.

Q: Do I need to see a specialist to get a prescription for Midane?

A: Official regulatory documents describe that the prescribing physician conducts a thorough risk-benefit assessment due to the associated risk of blood clots (thromboembolism). The medication is required to be prescribed by a qualified physician who is capable of evaluating the patient's individual risk factors.

Q: What information is needed for a doctor to prescribe Midane?

A: Before prescribing, a physician generally conducts a full medical history and a physical examination of the patient, as mandated by regulatory documents. Particular attention is paid to checking for pre-existing conditions or risk factors, such as a history of blood clots (thromboembolism) or liver disease.

How should Midane be stored and disposed of?

How to Store and Dispose of Midane

Official regulatory guidelines define specific conditions for the storage and disposal of Midane (Co-cyprindiol) oral tablets.

Storage Requirements

Midane must be stored at temperatures below 25 C (77 F). To maintain product stability, the tablets must be protected from light and moisture, and must remain in the original blister pack until the moment of administration. It is mandatory that the medicine not be refrigerated or frozen. Consistent with all pharmaceutical products, the medicine must be kept out of the sight and reach of children.

Disposal Instructions

Disposal must follow local regulatory procedures for pharmaceutical waste. Unused or expired Midane must not be thrown away with household trash or via wastewater, due to the potential environmental impact of its hormonal components. Patients should seek guidance from a pharmacist or an official drug take-back program for safe disposal.

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

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