Maitalon

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Maitalon

Quick Facts

Property Description
Active Ingredients Drospirenone, Ethinyl Estradiol
Form Film-coated tablets
Pharmacological Class Combined Oral Contraceptive (COC)
Common Use Contraception
Origin Synthetic

Maitalon: Identity and Pharmacological Class

Maitalon is a prescription-only medicine classified as a Combined Oral Contraceptive (COC), belonging to the established pharmacological class of Hormonal Contraceptives for Systemic Use. Administered via the oral route, Maitalon is presented as a film-coated tablet designed for the systematic regulation of the reproductive cycle in females of reproductive potential. The safety and efficacy of this particular fixed combination of Drospirenone and Ethinyl Estradiol are widely supported by pharmacological studies, confirming its role as an established option for highly effective pregnancy prevention.

Compositional Profile: Drospirenone and Ethinyl Estradiol

The core of Maitalon is a fixed combination of two synthetic hormonal entities. This dual composition requires both an estrogen component (Ethinyl Estradiol) and a progestin component (Drospirenone) to function synergistically. Drospirenone is a distinctive component, possessing notable antiandrogenic properties that set it apart from older progestins. Research confirms that the unique structure of Drospirenone offers distinct ancillary benefits compared to other progestogens, a factor clinically recognized for its therapeutic potential in certain hormone-sensitive conditions.

Primary Purpose and General Benefit

The general purpose of Maitalon is reliable Contraception, or the prevention of pregnancy, through hormonal action. Beyond this primary indication, the specific formulation is often utilized for ancillary general benefits, such as treating symptoms associated with Premenstrual Dysphoric Disorder (PMDD) and managing Moderate Acne Vulgaris in women who choose an oral contraceptive. This reflects a positioning focused on women seeking a hormonal contraceptive that provides the benefit of addressing hormone-related skin and mood changes.

What side effects are possible with Maitalon?

Possible Side Effects and Safety Information

Maitalon is a combined hormonal contraceptive and, like all medications, carries a risk of side effects, ranging from very common to rare but serious. The safety profile is established by governmental regulatory agencies based on clinical documentation.

Common Adverse Reactions

Commonly reported side effects may include headaches, breast pain or tenderness, weight changes, and irregular uterine bleeding or spotting, particularly in the initial cycles of use. Mood changes, including depressed mood or mood swings, have also been documented.

Serious and Clinically Significant Risks

The most serious documented safety risks are thromboembolic events, which include the formation of blood clots in the veins (Venous Thromboembolism or VTE) and arteries (Arterial Thromboembolism or ATE), potentially leading to deep vein thrombosis, pulmonary embolism, stroke, or myocardial infarction. The risk of VTE is highest during the first year of starting or restarting a combined hormonal contraceptive.

Other rare but serious adverse reactions involve the liver, including the potential for benign or malignant liver tumors. The medication is contraindicated in individuals with a current or past history of thromboembolic disorders, severe liver disease, uncontrolled high blood pressure, or known or suspected hormone-sensitive malignancies.

Safety Considerations

Women with pre-existing conditions such as specific inherited clotting disorders, uncontrolled diabetes, or severe obesity may face an elevated risk of serious thromboembolic events. Monitoring is necessary for conditions that can be affected by the medication, such as certain inflammatory bowel diseases, systemic lupus erythematosus (SLE), and the development of chloasma (dark patches on the skin), which can be worsened by sun exposure while using this medication. The prescribing information mandates discontinuation if a thrombotic event is suspected.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes the clinical presentation and required actions following an accidental or intentional ingestion of more than the prescribed dose of Maitalon (Drospirenone/Ethinyl Estradiol).

Documented Manifestations and Actions

The most commonly documented overdose presentations of combined hormonal contraceptives include nausea and vomiting. In young girls, accidental acute ingestion of a large dose may also be characterized by slight vaginal bleeding.

Feature Official Regulatory Statement
Life-Threatening Risk Potential for hyperkalemia due to Drospirenone's anti-mineralocorticoid activity, especially in patients with pre-existing conditions or those taking specific medications.
Management Approach Symptomatic and supportive treatment is the officially specified management approach, as no specific antidote is known.
Required Monitoring Serum potassium concentration monitoring is required for high-risk individuals following high exposure.

When to Seek Urgent Medical Attention

The regulatory labeling instructs individuals to immediately seek emergency medical attention or call the Poison Help line when an overdose is suspected. While serious ill effects have not been reported following acute ingestion by children, all suspected overdose scenarios require contacting emergency medical services for assessment and guidance.

Therapeutic Uses of Maitalon

What Maitalon Treats: Main Uses and Benefits

This combination is commonly used across three key therapeutic domains. The medication provides support for effective pregnancy prevention, is used for managing the symptoms of Premenstrual Dysphoric Disorder (PMDD), and may assist in addressing Moderate Acne Vulgaris.

Therapeutic Scope and Benefits

This formulation is primarily used in clinical settings that involve contraception, providing support for effective pregnancy prevention. Furthermore, the medication may assist with managing symptoms that interfere with daily functioning, such as flow volume and cramping, and may contribute to managing cyclical patterns.

The medication is relevant for managing conditions characterized by periods of heightened symptoms, specifically Premenstrual Dysphoric Disorder (PMDD), which involves pronounced emotional and physical manifestations. This application provides supportive relief when symptoms interfere with routine activities. For those with skin manifestations, it helps address the symptom clusters of Moderate Acne Vulgaris, contributing to easing the overall symptom load.

“The primary use provides support for effective pregnancy prevention, and it is also applicable within clinical settings that involve managing premenstrual symptoms and hormone-related skin issues.”

Quick Fact: Relief for Key Symptom Domains
Primary Use: Provides support for effective pregnancy prevention.
Symptom Management: May assist with severe premenstrual emotional and physical manifestations.
Ancillary Benefit: Helps address symptoms related to Moderate Acne Vulgaris.

Eligibility and Restrictions for Use

Maitalon (Drospirenone/Ethinyl Estradiol) is a prescription medicine intended for use by females of reproductive potential. Official regulatory documents define strict non-eligibility rules, or contraindications, which exclude several patient populations.

Contraindicated Populations

Category Official Restriction Status
Cardiovascular Risk Contraindicated in females over age 35 who smoke, or those with a history of thrombotic diseases (DVT, PE, stroke, heart disease), or uncontrolled hypertension.
Organ/Gland Impairment Contraindicated in renal impairment, adrenal insufficiency, or active liver disease/tumors.
Hormone-Sensitive Conditions Contraindicated in known or suspected breast cancer or other estrogen-sensitive cancers.

Eligibility is further restricted by age and physiological state. The medication is contraindicated in pregnancy and generally not recommended during breastfeeding. For the acne indication, use is only approved for females ge 14 years of age who have achieved menarche. Use is not indicated in elderly women.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Maitalon's interaction profile is primarily defined by documented pharmacokinetic and pharmacodynamic effects with co-administered substances, as stated in regulatory prescribing information.

The combination is contraindicated with Hepatitis C drug combinations containing Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir due to the officially documented risk of liver enzyme elevations (ALT). Co-administration with the herbal product St. John's Wort or other strong/moderate CYP3A4 enzyme inducers (e.g., Rifampin, Carbamazepine) is documented to reduce the plasma concentration of the contraceptive hormones, which may reduce effectiveness. Conversely, strong CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole) are documented to increase the systemic exposure of the hormone components.

A key pharmacodynamic interaction involves drugs that increase serum potassium. Co-administration with potassium-sparing drugs (e.g., Spironolactone, ACE Inhibitors, ARBs, long-term NSAIDs) carries a documented additive risk of Hyperkalemia due to Drospirenone's anti-mineralocorticoid activity. This interaction risk is heightened and constitutes an official contraindication in patients with pre-existing Renal Impairment or Adrenal Insufficiency. Additionally, the presence of Ethinyl Estradiol can cause a reduction in the plasma concentration of other therapeutic agents, such as Lamotrigine.

Mechanism of Action

Inhibition of Gonadotropin Secretion

Maitalon modulates the hypothalamic-pituitary-ovarian (HPO) axis. The combined hormones initiate a negative feedback loop on the hypothalamus and pituitary gland. This action suppresses the normal pulsatile release of Gonadotropin-Releasing Hormone (GnRH), which, in turn, inhibits the secretion of the pituitary hormones Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH). The resulting physiological effect is the attenuation of the pre-ovulatory LH surge, thereby inhibiting ovarian follicular rupture.

Alteration of Cervical and Endometrial Environment

The progestin component, Drospirenone, acts to modify the reproductive tract's local environment. It causes the cervical mucus to significantly thicken and decrease in volume. This change results in an increased viscosity and reduced volume of the cervical mucus, structurally impairing sperm motility and transit. Additionally, Maitalon promotes endometrial atrophy, inducing morphological changes in the uterine lining.

Modulation of Mineralocorticoid Receptor Activity

Drospirenone also engages with receptors outside of the reproductive system. It possesses anti-mineralocorticoid activity, meaning it acts as an aldosterone antagonist. By modulating the mineralocorticoid receptor, Drospirenone exhibits antagonism to aldosterone, influencing sodium and water excretion via the renal tubules.

Dosage and Administration Information

Maitalon is administered via the oral route only as a film-coated tablet, following a precise, continuous 28-day cyclic regimen. The daily dose is one tablet taken once daily. The established schedule requires taking 24 active hormone-containing tablets followed by 4 inert (placebo) tablets, with a subsequent pack starting immediately upon completion of the previous one. The dosage is consistent for all approved indications.

The administration is designed for fixed-time daily intake, meaning the tablet must be ingested at the same time every day and in the sequence directed on the blister packaging. This ensures adherence to the active/inert sequencing critical for the use protocol. The tablet may be taken without regard to meals. A deviation from the standard procedural conditions is required if severe vomiting or diarrhea occurs within 3 to 4 hours of taking an active tablet, which is treated as a missed dose.

Usage is applicable to adolescent females 14 years of age or older who have reached menarche, using the same daily dose as adults. Instructions for managing a missed active dose are dictated by the specific week and the number of doses missed, requiring a predefined protocol to maintain the intended use pattern. The entire use protocol is structured to establish and maintain a continuous, fixed hormone schedule.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Maitalon

Evidence for Use in Contraception

Research into the contraceptive application of this medicine was studied for in large-scale Randomized Controlled Trials (RCTs) and open-label studies. The research examined groups of women of reproductive potential, monitoring outcomes related to pregnancy prevention (quantified by the Pearl Index) and cycle control metrics. The evidence for this application is structured similarly to research characteristic of the Combined Oral Contraceptive (COC) class, but the primary data focuses on the intermediate term (up to one year) of use.

Evidence for Ancillary Indications

For Premenstrual Dysphoric Disorder (PMDD), the application was evaluated in Randomized, Double-Blind, Placebo-Controlled Trials. These studies monitored emotional and physical symptom intensity using validated scales over typically short-term durations (three cycles). Studies reported measurements of symptom severity scores, but documented a considerable placebo effect in the blinded arms.

For Moderate Acne Vulgaris, research was evaluated in multicenter, Randomized, Double-Blind, Placebo-Controlled Trials. These studies monitored objective outcomes linked to inflammatory or irritative states, such as changes in specific lesion counts, over intermediate-term periods (six consecutive cycles). The results apply only to the populations studied, specifically women with moderate severity acne.

Research Gaps and Limitations

The available evidence for all applications is characterized by short- to intermediate-term follow-up durations. Research provides insight into short-term changes; however, limited information is available for long-term outcomes or the durability of symptom management. Data for certain groups, such as older adult women or those with specific comorbid conditions, remain insufficient in the primary regulatory studies. Furthermore, certainty remains low regarding long-term functional changes for PMDD.

Frequently Asked Questions (FAQ)

Common questions about Maitalon (FAQ)


Q: Is Maitalon the brand name or the generic name?

Maitalon is the mathbfbrand name used for this prescription medicine. It contains the fixed combination of the active hormonal ingredients mathbfDrospirenone and mathbfEthinyl Estradiol. This is the information generally available in official product listings.


Q: How long does Maitalon typically start working after it is taken?

According to the official product information, Maitalon is generally mathbfnot considered fully effective for contraception until mathbfafter the first 7 consecutive days of taking the active tablets correctly. Non-hormonal back-up methods are typically described as necessary during the first 7 days.


Q: Do the effects of Maitalon change with long-term use?

Research evidence available for some uses, such as Premenstrual Dysphoric Disorder (mathbfPMDD), primarily covers mathbfshort-term durations, generally up to three menstrual cycles. Regulatory documents do not contain long-term efficacy data beyond these intermediate-term studies.


Q: What should be done if Maitalon does not seem to be working? (Non-directive)

Official guidance emphasizes the importance of taking the tablets mathbfexactly as directed to maintain efficacy. Regulatory documents note that patients may review their adherence, and concerns about efficacy should be raised with a qualified healthcare professional.


Q: Does Maitalon cause weight changes, such as weight gain or loss?

Official reporting for adverse reactions in clinical trials lists mathbfincreased weight (weight gain) and mathbfgeneral weight change as reported side effects. This is a common finding across studies involving hormonal contraceptives.


Q: Is Maitalon associated with a risk of dependence or withdrawal symptoms?

Regulatory information focuses on the protocol for managing the mathbfcessation of treatment, which requires mathbfre-initiating at the lowest dose if interrupted. The label does not explicitly use terms such as dependence or addiction when describing the drug's properties.


Q: Is it generally accepted to consume alcohol while taking Maitalon?

According to established interaction databases, there is mathbfno known major adverse interaction with alcohol (mathbfethanol) listed in the regulatory documents.


Q: What medical conditions or risks are listed as reasons to avoid Maitalon?

Official warnings indicate that the drug is mathbfcontraindicated (should not be used) in patients with conditions like a mathbfhistory of blood clots, mathbfuncontrolled high blood pressure, mathbfliver disease, mathbfkidney disease, or mathbfadrenal gland disorder. Other high-risk factors that require monitoring include severe obesity and inherited clotting disorders.


Q: How does Maitalon differ conceptually from other similar treatments?

The unique structural component of Maitalon is the progestin mathbfDrospirenone. This hormone is described in regulatory documents as possessing mathbfanti-mineralocorticoid and mathbfanti-androgenic activity, which distinguishes its effects from those of many other progestins used in oral contraceptives.


Q: How does Maitalon get processed and removed from the body?

The progestin component, Drospirenone, is metabolized (broken down) primarily via the mathbfCYP3A4 enzyme system in the body. The resulting breakdown products from the estrogen component are then excreted through both the mathbfurine and mathbffeces.


Q: Is Maitalon available over the counter?

No. Regulatory status information confirms that Maitalon (Drospirenone/Ethinyl Estradiol) is consistently classified as a mathbfPrescription only (Rx) drug and is mathbfnot available over the counter.


Q: What is the expected duration of effect after a dose of Maitalon?

The mathbfonce-daily administration is designed to maintain steady-state hormone levels, supported by the terminal half-life of the estrogen component being approximately mathbf24 hours. This fixed schedule ensures continuous hormonal regulation.


Q: Do side effects from Maitalon usually go away over time?

Official product information notes that some common side effects, specifically mathbfirregular bleeding or spotting, are mathbfusually transient and without clinical significance. This suggests improvement may occur as the patient's body adjusts to the medication.


Q: Does Maitalon interact with common over-the-counter pain relievers?

The official label warns of a hyperkalemia risk when mathbflong-term Nonsteroidal Anti-inflammatory Drugs (NSAIDs) are co-administered. NSAIDs are a common class of over-the-counter pain relievers (e.g., ibuprofen).


Q: Does Maitalon have potential interactions with common dietary supplements?

The product label specifically warns against co-administration with the herbal supplement mathbfSt. John’s Wort. Taking the supplement is documented to potentially mathbfreduce the effectiveness of the contraceptive hormones.


Q: Does body weight or age affect eligibility for Maitalon?

The drug is mathbfstrictly contraindicated in females over 35 years old who smoke. Additionally, factors such as mathbfsevere obesity are listed as conditions that may increase the risk of serious complications and must be considered by a healthcare provider.


Q: Is Maitalon described as treating the condition or only managing symptoms?

According to the official indications, the drug is used to mathbftreat the symptoms associated with Premenstrual Dysphoric Disorder (mathbfPMDD) and for the mathbftreatment of moderate acne vulgaris.


Q: Does Maitalon affect blood pressure or heart rate?

Official safety warnings state that the medication may mathbfincrease blood pressure, and mathbfmonitoring is necessary. It is contraindicated in patients with mathbfuncontrolled high blood pressure.


Q: Is it safe to drive or operate machinery while taking Maitalon?

Common side effects listed in the product label include mathbfheadache, mathbfdizziness, and mathbfsomnolence (sleepiness). These types of effects are noted as potentially mathbfimpairing abilities that are necessary for driving or operating machinery.


Q: Does Maitalon interact with hormonal birth control methods?

Maitalon mathbfis a hormonal birth control method (a Combined Oral Contraceptive). Official guidance implies a patient should mathbfnot use it with other forms of hormonal contraception.


Q: What is the difference in side effect profiles between Maitalon and its generic form?

Regulatory requirements stipulate that the generic version of the drug must be mathbfbioequivalent to the brand name (Maitalon). This means the generic is required to demonstrate mathbfthe same clinical safety and efficacy profile as the reference brand drug.


Q: Are there any known risks of taking Maitalon with common cold or flu medicines?

The official label warns against co-administration with mathbfstrong CYP3A4 inhibitors, which are found in certain common cold or flu preparations. This is due to the risk of mathbfincreased systemic exposure of the contraceptive hormones.


Q: Where is Maitalon approved for use?

The product is mathbfapproved by the U.S. Food and Drug Administration (mathbfFDA) for use in the United States, as indicated by the DailyMed label, which serves as a primary source of regulatory information.


Q: What is the difference between Maitalon and its generic version, if one exists?

Maitalon is the brand name. The generic version must contain mathbfthe exact same active ingredients (mathbfDrospirenone and Ethinyl Estradiol) in the mathbfsame strength and dosage form as the brand product, according to regulatory standards.

How should Maitalon be stored and disposed of?

How to Store and Dispose of Maitalon?

The storage and disposal of Maitalon (Drospirenone/Ethinyl Estradiol) must adhere strictly to the conditions specified in the official regulatory labeling to maintain the product’s stability.

Official Storage Conditions

Requirement Specific Instruction
Temperature Store at controlled room temperature: 20 C to 25 C (68 F to 77 F)
Protection Keep in the original blister packaging to protect from light and moisture
Safety The medicine must be kept out of the sight and reach of children

Disposal Protocol

Unused or expired tablets should be disposed of in accordance with local requirements, typically by utilizing an official drug take-back program or a community disposal site. The product must not be flushed down the toilet or poured into a drain unless instructed otherwise by a government authority.

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

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