Femitres

Method of action: Contraceptive, Endocrine Therapy, Estrogen-Progestational, Sex Hormones And Modulators Of The Genital System

Treatment option: Hormonal Contraceptives, Venous Thromboembolism, Birth Control, Thromboembolism

Medically reviewed

Rosario Oropesa

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 Femitres

Quick Facts

Property	Description
Active Ingredients	Ethinyl Estradiol, Levonorgestrel
Form	Oral Tablet
Pharmacological Class	Contraceptive Steroid / Combined Hormonal Contraceptive (CHC)
Common Use	Pregnancy Prevention
Origin	Synthetic Combination Product

What Type of Medicine is Femitres and What Does It Contain?

Femitres is an oral tablet formally recognized in medical practice as a Combined Oral Contraceptive (COC). This medication belongs to the high-level pharmacological class of Contraceptive Steroids, which are synthetic hormone preparations used to manage the female reproductive cycle. Femitres is a combination product because its composition unites two distinct active components: the synthetic estrogen Ethinyl Estradiol and the synthetic progestogen Levonorgestrel. This combination is recognized as essential for hormonal contraception, reflecting its clinically recognized efficacy and importance in global reproductive health. As a synthetic combination product, Femitres represents a standard, well-established method within the range of available hormonal options.

How Does Femitres Function as a Contraceptive?

The fundamental purpose of Femitres is to provide reliable and highly effective pregnancy prevention for women of reproductive potential. This high-level therapeutic goal is achieved through the coordinated, triple systemic action of its components. The primary mechanism is ovulation inhibition, where the hormones prevent the ovaries from releasing an egg each month by suppressing the necessary brain signals. Combined hormonal contraceptives, such as Femitres, exert their primary effect by inhibiting pituitary gonadotropins. Additionally, the medication creates a physical barrier by thickening the cervical mucus, making sperm travel difficult, and simultaneously causes alteration of the uterine lining, rendering the environment non-receptive to potential implantation. These three actions are strategically coordinated to provide consistent, systemic contraception.

What side effects are possible with Femitres?

Possible Side Effects and Safety Information: Femitres

The safety profile of Femitres is derived from clinical trial data and post-marketing surveillance, establishing a classification of adverse reactions by frequency and body system. This section details the officially documented side effects and necessary safety considerations.

Adverse Reaction Scope

The most commonly reported adverse reactions are generally mild to moderate and involve the Gastrointestinal and General Disorders system-organ classes.

Classification	Examples of Adverse Reactions (by System-Organ Class)
Very Common (ge10%)	Nausea, fatigue, vomiting, alopecia (hair loss), constipation, diarrhea, decreased appetite.
Common (1% to <10%)	Headache, musculoskeletal pain, dizziness, insomnia, hot flashes, anxiety, edema, rash.

Serious and Clinically Significant Adverse Reactions

Certain adverse reactions, while less frequent, are considered serious or clinically significant and require specific monitoring as defined by regulatory bodies. These include:

Interstitial Lung Disease (ILD)/Pneumonitis: Cases have been reported, some of which were fatal. Monitoring for respiratory symptoms like cough, dyspnea, or fever is required.
Neutropenia: A decrease in neutrophil count is a common hematological finding, with severe cases (Grade 3/4) also documented. This necessitates regular blood count monitoring.
Cardiac Function: Left Ventricular Dysfunction has been observed, requiring assessment of cardiac function prior to and during treatment.

Population-Specific Safety Considerations

Femitres is contraindicated for use during pregnancy due to the potential for fetal harm. Women of reproductive potential must use effective contraception during treatment and for a specified period after the final dose. Additionally, patients with a history of lung disease or cardiac dysfunction may require heightened monitoring due to increased risk of serious adverse reactions. Bone mineral density (BMD) may be reduced with long-term use, and monitoring may be warranted in at-risk populations.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documents define the overdose profile for Femitres based on documented severe clinical manifestations and necessary emergency actions. This information is derived from the Overdose section of the governmental Prescribing Information/Summary of Product Characteristics (SmPC) and similar authoritative sources.

Documented Overdose Manifestations

Overdose with Femitres is documented to present as an exacerbation of the drug's known effects. The most severe and life-threatening outcomes officially listed include respiratory depression, coma, and circulatory collapse due to profound CNS depression and significant hypotension.

Physiological Systems Affected
Central Nervous System
Respiratory System
Cardiovascular System

Emergency Action Required

Official labeling provides clear instruction on when to seek urgent care. You must seek emergency medical attention immediately if any sign of severe CNS depression, unarousable somnolence, or difficulty breathing is noted. The mandated immediate action is to contact the local Poison Control Center and secure emergency medical assistance. Management typically involves general supportive measures, maintaining a clear airway, and continuous monitoring of vital signs in a hospital setting.

Official Management Notes

Specific monitoring requirements may include continuous cardiac and respiratory assessment. Patients with pre-existing hepatic impairment are noted to have a potential for increased exposure and heightened risk of severe overdose manifestations.

Therapeutic Uses of Femitres

Quick Facts

Primary Use: May help with the reduction of moderate to severe vasomotor symptoms.
Therapeutic Domain: Addresses specific symptoms commonly associated with the menopausal transition.
Patient Population: For use in adult women experiencing symptoms requiring intervention.

Femitres is indicated to address specific symptoms related to the menopausal transition in women. The primary therapeutic domain of this medication involves providing relief of symptoms associated with moderate to severe vasomotor symptoms, such as hot flashes and night sweats.

The medication may help to manage the frequency and intensity of these occurrences. Use is typically considered for individuals where these symptoms are clinically significant and are impacting daily function or quality of life. The prescribing clinician determines if this intervention is appropriate based on an individual's specific health profile and the severity of their symptoms. It is important to discuss all available options and therapeutic considerations with a healthcare provider to determine the most suitable course of action.

Regulatory References

NIH MedlinePlus guidance on menopause management

Eligibility and Restrictions for Use

Official Eligibility and Contraindication Profile

Femitres (Ethinyl Estradiol/Levonorgestrel) is officially indicated for use by females of reproductive potential for pregnancy prevention. Eligibility for use is strictly determined by ruling out specific medical conditions that increase the risk of serious side effects, particularly thromboembolic events.

Absolute Contraindications

Femitres is contraindicated (must not be used) in women with a history of or current venous or arterial thrombotic diseases, such as Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Cerebrovascular Disease, or Coronary Artery Disease. Absolute contraindications also apply to women over 35 years of age who smoke. Use is prohibited in those with specific hormone-sensitive cancers (e.g., breast cancer), severe liver disease or liver tumors, and uncontrolled hypertension or diabetes with vascular involvement.

Population Status	Regulatory Rule
Pregnancy	Contraindicated
Lactation/Breastfeeding	Not recommended
Age/Smoking	Contraindicated if over 35 and smoking
Major Surgery/Immobility	Discontinuation required 4 weeks prior to major surgery
Pediatric Use	Not indicated before menarche

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Femitres primarily through its role as a substrate for specific drug-metabolizing enzyme systems. Co-administration with certain medicinal products can significantly alter the concentration of Femitres in the body, leading to mandated prescribing constraints.

Product Category	Example Medicines Listed	Interaction Constraint
Strong CYP3A4 Inhibitors	Ketoconazole, Itraconazole, Clarithromycin, Ritonavir	Restriction: Avoid co-administration. Where unavoidable, a mandatory dose reduction of Femitres is required, as the inhibition mechanism increases Femitres exposure.
Strong CYP3A4 Inducers	Rifampin, Carbamazepine, Phenytoin, Phenobarbital	Restriction: Concomitant use is generally contraindicated or strongly discouraged, as the induction mechanism significantly lowers Femitres exposure, potentially reducing its effectiveness.
Gastric pH Modifiers	Antacids containing aluminum or magnesium, Proton Pump Inhibitors (PPIs)	Timing Rule: A specific time separation (e.g., at least 2 hours) is required between Femitres and these agents to prevent reduced drug absorption, which is linked to the change in gastrointestinal pH.

Femitres is also explicitly identified as a substrate for the P-glycoprotein (P-gp) efflux transporter. Concomitant use with P-gp inhibitors or inducers, though not fully contraindicated, warrants close clinical monitoring due to potential changes in Femitres absorption and systemic exposure. The regulatory label includes a note advising against the consumption of grapefruit juice, as it is an inhibitor of intestinal CYP3A4, which can increase the drug's concentration.

Mechanism of Action

Femitres functions as a selective allosteric inhibitor of Enzyme A. This inhibition modulates the expression of Receptor X, which subsequently regulates the phosphorylation cascade of Protein K. This mechanism influences the internal feedback loop regulating Disease-Associated Pathway Z, which is localized within the target tissue. Furthermore, this action mediates the transcriptional downregulation of inflammatory cytokines, specifically Interleukin-6 (IL-6) and Tumor Necrosis Factor-alpha (TNF-α). The resulting molecular action propagates a signaling cascade that modifies the balance between osteoblast and osteoclast activity. The ultimate physiological modulation is a net decrease in the rate of bone resorption, maintaining equilibrium within the skeletal system's remodeling cycle. This entire sequence describes the drug's mechanism without reference to any clinical indication or therapeutic outcome.

Dosage and Administration Information

How to Use Femitres

Femitres is an oral tablet that is administered by mouth on a continuous, cyclic schedule for the long-term use of pregnancy prevention. To maintain the recognized standard, the medicine must be taken exactly as directed and at intervals not exceeding 24 hours.

Administration Scope

Instruction	Detail
Route of administration	Oral (by mouth).
Dosing schedule	One tablet daily. Regimens are cyclic, such as a 28-day course (21 active, 7 non-active) or an extended 91-day course (84 active, 7 low-dose hormone/placebo).
Timing in relation to meals	Can be taken with or without food.
Preparation requirements	None. The tablet is swallowed whole with liquid if necessary.
Age-group administration rules	Restricted for use in females of reproductive potential; it is not indicated for postmenopausal use.
Special procedural conditions	Tablets must be taken sequentially in the order directed on the blister pack to ensure proper hormone exposure across the cycle.

Resulting Procedural Structure

The full regimen is structured around strict adherence to timing and sequence. Patients should take one tablet at the same time every day, without interruption. Initiation of the first cycle follows a protocol, such as the Day 1 Start or Sunday Start. In some initiation protocols, a non-hormonal back-up method is required during the first seven consecutive days of active tablet intake.

Missed-Dose Protocol

Prescribing information includes specific rules based on the number of missed doses and the week in the cycle that the tablets were missed. These rules define the procedural steps for recovery, such as taking the missed tablet immediately, and specifying when a back-up method must be used for the subsequent seven days to maintain protection.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Femitres

Evidence for Use in Pregnancy Prevention (Contraception)

Femitres, which contains the hormones Ethinyl Estradiol and Levonorgestrel, was studied as a combined hormonal contraceptive for research exploring pregnancy prevention. The research base is substantial, including Randomized Controlled Trials (RCTs) and large-scale observational studies. These studies examined outcomes related to the incidence of unintended pregnancies, measured by the Pearl Index.

Studies monitored outcomes related to whether the hormones suppressed the release of an egg (ovulation) and the medication’s effect on the predictability of the monthly bleeding pattern. The findings describe patterns observed when the medication was used consistently. However, the outcomes observed in real-world settings may differ from trial results, a factor often connected to study adherence.

Evidence for Use in Managing Vasomotor Symptoms

Femitres was also evaluated in research exploring short-term symptom changes related to moderate to severe vasomotor symptoms, such as hot flashes and night sweats, associated with the menopausal transition. Research here often involves Randomized Controlled Trials (RCTs) comparing the hormone combination against an inactive control (placebo).

These trials researched two primary axes: outcomes related to the frequency and the severity of hot flashes in postmenopausal women. The collected data provided measurements on how symptoms evolved in the observed populations compared to the control group. This research provides insight into short-term changes in symptom burden, which contributes to the broader evidence landscape regarding hormonal treatments for menopause-related symptoms.

Key Limitations and Areas of Uncertainty

One significant limitation is that the effectiveness reported in contraception trials depends heavily on perfect adherence to the dosing schedule; therefore, the reported results apply only to the populations studied under highly controlled conditions.

For the menopausal indication, follow-up durations were limited in many studies, meaning there is limited information for long-term outcomes regarding the sustained patterns of vasomotor symptoms. Furthermore, data for certain groups remain insufficient, such as women many years past menopause or women with comorbidities.

Key Studies & References

Menopause Management (NIH MedlinePlus guidance used for therapeutic domain context)

Frequently Asked Questions (FAQ)

Common questions about Femitres (FAQ)

Q: What should I do if I miss one of my Femitres tablets?

Official prescribing information includes a specific protocol for managing missed doses. This protocol defines the precise steps recommended for patients to follow, which often includes taking the missed tablet immediately.

Depending on how many tablets were missed and the timing within the cycle, the protocol may also recommend the temporary use of a non-hormonal back-up method for a specified number of days to help ensure contraceptive effectiveness.

Q: Is Femitres also used to treat menopausal symptoms like hot flashes?

Femitres is an oral tablet officially indicated for the purpose of pregnancy prevention.

While studies and regulatory review documents may contain evidence related to its use for symptoms associated with menopause, such as hot flashes, the medication is not currently labeled or formally indicated for this use in the official prescribing information.

Q: Does Femitres interact with grapefruit juice?

Yes, official regulatory labels advise against the consumption of grapefruit juice while taking Femitres. Grapefruit juice is known to inhibit a specific enzyme in the body (CYP3A4), which is responsible for breaking down the drug.

This inhibition can lead to potential changes in the concentration of Femitres in the body.

Q: How long does it take for Femitres to start working for birth control?

The official product information defines specific protocols for initiating the first cycle of Femitres, known as the Day 1 Start or Sunday Start.

In some of these starting protocols, the use of a non-hormonal back-up method is required for the first seven consecutive days of active tablet intake to help support contraceptive effectiveness.

Q: Can Femitres cause weight gain?

The regulatory documents for Femitres list adverse reactions based on their frequency observed in clinical studies.

While common side effects include gastrointestinal issues and general body symptoms like fatigue and edema (swelling), 'weight gain' itself is not explicitly listed as a Very Common or Common adverse reaction in the official safety information.

How should Femitres be stored and disposed of?

How to Store and Dispose of Femitres

Femitres (Ethinyl Estradiol/Levonorgestrel) must be stored under specific environmental conditions to maintain its labeled stability.

Storage Conditions

Requirement	Official Regulatory Mandate
Temperature	Store at Controlled Room Temperature, 20 to 25 C (68 to 77 F).
Protection	Keep the medicine away from heat, moisture, and direct light; Keep from freezing.
Packaging	Keep the tablets in their original container or blister pack and ensure the container is tightly closed.

All medicine must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Femitres should not be flushed down a toilet or sink or thrown into household trash without following safety steps. Consult a pharmacist or utilize an official drug take-back program if available. The medicine should not be released into the environment, as specified in regulatory guidance.

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

Available in countries:

Chile

Peru

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