Tevalet

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Tevalet

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 Tevalet

Tevalet is a prescription-only medication classified as a Combined Oral Contraceptive (COC) pill, serving as a hormonal pharmaceutical preparation taken by oral administration.

Property Description
Active ingredients Ethinyl Estradiol, Gestodene
Form Oral Tablet
Pharmacological class Hormonal Contraceptive / Gonadotropin Inhibitor
Common use Prevention of pregnancy (Contraception)
Origin Synthetic

What Type of Medicine is Tevalet? (Identity and Classification)

Tevalet is a fixed combination product, utilizing both a synthetic estrogen and a synthetic progestogen to achieve its primary objective of birth control. Combined hormonal agents are recognized as effective for contraception. This classification defines it as a potent, systemic method intended for the prevention of pregnancy.

The Composition of Tevalet: Synthetic Hormonal Agents

The specific active components are the steroid compounds Ethinyl Estradiol and Gestodene. Ethinyl Estradiol functions as the synthetic estrogen, while Gestodene is the synthetic progestogen element, confirming that the entire medication is synthetic in origin. This pairing places the medication within the pharmacological class of Gonadotropin Inhibitors, reflecting the hormones’ action in modulating the female endocrine system. Gestodene belongs to the third generation of progestogens used in these combination pills, contributing to the overall pharmacological profile of the contraceptive.

General Purpose and Primary Use

The definitive therapeutic use and general indication of Tevalet is contraception. This general purpose is achieved through the fundamental, high-level effect of suppression of ovulation, preventing the monthly release of an egg, alongside changes to cervical and uterine environments. The overall benefit is the provision of a systemic, highly effective method of hormonal birth control for the intended patient group.

What side effects are possible with Tevalet?

Possible Side Effects and Safety Information

Tevalet is associated with specific serious risks that are managed through a mandatory, government-required drug safety program called a Risk Evaluation and Mitigation Strategy (REMS). The REMS is required to help mitigate the risks of Cytokine Release Syndrome (CRS) and neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which can be life-threatening or fatal. Due to these risks, patients are required to be hospitalized for monitoring following the administration of all doses within the initial step-up dosing schedule.


Common and Serious Adverse Reactions

The most common adverse reactions (ge 20%) observed in clinical trials include pyrexia (fever), Cytokine Release Syndrome (CRS), musculoskeletal pain, fatigue, and infections such as upper respiratory tract infection and pneumonia. The most frequent severe (Grade 3 or 4) laboratory abnormalities (ge 20%) reported are decreases in lymphocytes, neutrophils, white blood cells, and hemoglobin.

Serious safety considerations documented in official labeling also include:

  • Infections: Risk of severe, life-threatening, or fatal infections.
  • Hepatotoxicity: Potential for serious liver toxicity, including fatalities, which requires regular monitoring of liver enzymes.
  • Neutropenia: Clinically significant low white blood cell counts requiring frequent monitoring.
  • Embryo-Fetal Toxicity: The drug may cause harm to a fetus. Females of reproductive potential must be advised on this risk and must use effective contraception.

Overdose and Emergency Response

Overdose and When to Seek Help

If you suspect an overdose of Tevalet (valproate), you must seek immediate emergency medical attention by calling 911 or Poison Control. Overdose is a serious medical emergency that requires prompt clinical intervention.

Documented Overdose Symptoms

The central nervous system (CNS) is primarily affected in an overdose, with documented presentations including somnolence, deep coma (especially in massive overdosage), and in some cases, hyperammonemic encephalopathy leading to changes in mental status. Other reported symptoms are heart block, hypotension, tachycardia, nystagmus, and tremor. Severe overdose can involve complications such as metabolic acidosis and a significantly prolonged drug half-life.

Life-Threatening Risks

Beyond acute overdose symptoms, urgent medical help is required for signs of severe, life-threatening adverse reactions that can occur during treatment, including fatal hepatotoxicity and life-threatening pancreatitis. Symptoms requiring prompt evaluation are persistent abdominal pain, nausea, vomiting, lethargy, facial edema, weakness, and loss of seizure control.

Emergency Actions

Overdose treatment focuses on general supportive measures, maintenance of vital functions, and correction of metabolic issues. Procedures such as gastric lavage and drug removal techniques like hemodialysis may be necessary. Naloxone has been reported to reverse the CNS depressant effects of overdose, but its use is carefully managed due to the potential to reverse the drug's intended anticonvulsant effects.

Therapeutic Uses of Tevalet

What Tevalet Treats: Main Uses and Benefits

Tevalet (Ethinyl Estradiol and Gestodene) is primarily used for reliable pregnancy prevention, which is an effective form of continuous hormonal contraception. Beyond this, the medication is considered relevant across therapeutic domains involving distressing symptoms due to hormonal effects.


Regularizing Unpredictable Cycles and Easing Pain

This medicine is generally applied across domains where additional symptomatic support is needed to manage conditions involving episodic or fluctuating manifestations. It helps establish a predictable cycle regularity, which helps reduce the strain associated with unpredictable periods. It is commonly used to help with symptoms related to physical discomfort, specifically providing support that helps ease the overall symptom burden of severe menstrual cramps (dysmenorrhea) and may assist with heavy menstrual bleeding. This provides supportive relief when symptoms interfere with routine activities.

Symptom Control for Hormone-Sensitive Conditions

This medication is relevant in contexts involving heightened systemic burden, as it helps address symptom clusters related to systemic imbalance and androgen sensitivity. It is commonly used to help with acne manifestations and may assist in easing the impact of excessive hair growth. Additionally, it plays a role in managing the challenging symptoms of Premenstrual Dysphoric Disorder (PMDD), supporting the patient during difficult episodes by easing distress. This stabilization is relevant for managing symptoms that create noticeable physiological strain for patients with conditions like PCOS.


Quick Fact: Symptom Support Focus
This medicine is commonly used to help with symptoms related to physical discomfort, assisting with the overall symptom load when patients experience significant period pain and heavy bleeding.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Tevalet

The eligibility for Tevalet (Ethinyl Estradiol and Gestodene), a combined oral contraceptive, is strictly defined by regulatory documents, primarily based on the risk of thromboembolism and hormone sensitivity. The medicine is indicated solely for females of reproductive potential for contraception.


Category Official Regulatory Status
Populations for whom use is allowed Females of reproductive potential for pregnancy prevention.
Populations for whom use is not recommended Nursing mothers (due to potential for decreased milk production).
Populations for whom use is contraindicated Females with a high risk of arterial or venous thrombotic diseases, current or history of breast cancer, severe liver disease or liver tumors, undiagnosed abnormal uterine bleeding, or who are pregnant.

Age-Related and Condition-Specific Rules

Category Classification Details
Age-related eligibility rules Use is strictly contraindicated in females over age 35 who smoke. Adolescents may use it only after the onset of menstruation (menarche). It is not indicated for use in elderly women.
Condition-specific eligibility rules Contraindicated in uncontrolled hypertension and diabetes mellitus with vascular disease. Must be discontinued if jaundice develops.

Connection to the overall eligibility profile

Official regulatory documents define non-eligibility through absolute contraindications centered on pre-existing conditions that significantly increase the risk of serious blood clotting events or hormone-sensitive cancers. Eligibility is further restricted by age combined with lifestyle (smoking) and the physiological state of pregnancy or severe hepatic impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define specific, clinically significant interactions for Tevalet that must be considered before and during therapy.


Contraindicated and Restricted Combinations

Interacting Product Category Constraint and Rationale
Monoamine Oxidase (MAO) Inhibitors Concomitant use is contraindicated. This restriction extends for 14 days following the last dose of an MAO inhibitor due to the risk of a hypertensive crisis.
Serotonergic Agents Use with caution. Co-administration with other serotonergic medicines (such as SSRIs, SNRIs, and Triptans) increases the risk of Serotonin Syndrome.

Agents Affecting Elimination

Interacting Product Category Effect on Tevalet Metabolite Practical Implication
Agents that Acidify Urine Decreased blood levels via altered urinary elimination. May reduce the drug's effectiveness.
Agents that Alkalinize Urine Increased blood levels via altered urinary elimination. May increase the risk of adverse events.

Pharmacokinetic Interaction Profile

The product's metabolism is not primarily dependent on cytochrome P450 (CYP) enzymes. Official studies have shown minimal or no significant changes to its pharmacokinetic parameters when co-administered with drugs such as omeprazole, extended-release guanfacine, or extended-release venlafaxine, which helps define the boundaries of its metabolic interaction potential.

Mechanism of Action

Central Endocrine Suppression

Tevalet, containing the synthetic hormones Ethinyl Estradiol and Gestodene, exerts its primary action through negative feedback on the Hypothalamic-Pituitary-Ovarian (HPO) axis). By acting as agonists at the central Estrogen and Progesterone Receptors (ER/PR), the components inhibit the release of FSH and block the mid-cycle surge of LH from the pituitary gland. This mechanistic cascade results in anovulation—the physiological arrest of the egg release process.

Peripheral Tissue Modification

The secondary mechanism involves Gestodene's local action on the reproductive tract. Agonism at PR in the cervix alters the composition of cervical mucus, increasing its viscosity to create a sperm barrier. Furthermore, Gestodene induces asynchronous development of the uterine lining (endometrium), rendering the tissue non-supportive for implantation. These two independent physiological changes establish additional, localized steps.

Mechanistic Synergy and Concentration Dependence

The combination of both synthetic hormones creates a synergistic effect, enhancing the suppression of gonadotropin signaling. The mechanism is inherently concentration-dependent and relies on maintaining plasma levels above a specific threshold to sustain continuous negative feedback on the HPO axis.

Dosage and Administration Information

Recommended Dosage and Administration

Tevalet (ethinyl estradiol and gestodene) is a combination oral contraceptive prescribed to prevent pregnancy. It must be taken exactly as directed by a healthcare provider, following the 28-day regimen supplied in the tablet dispenser.

Daily Dosage

Take one tablet daily at the same time each day. This consistency is essential, as the effectiveness of the drug in preventing pregnancy relies on regular, scheduled intake.

Pill Type Tablets per Cycle Instructions
Active (Hormone) 21 tablets Take one daily for 21 consecutive days.
Inactive (Non-Hormone) 7 tablets Take one daily for the next 7 consecutive days.

A withdrawal bleed, similar to a menstrual period, should occur during the 7 days when the inactive tablets are taken. Begin a new 28-day pack immediately after finishing the last inactive tablet, even if bleeding continues.

Starting the Medication

There are two common ways to start the first pack:

  • Day 1 Start: Take the first active tablet on the first day of the menstrual period. No additional contraception is needed with this method.
  • Sunday Start: Take the first active tablet on the first Sunday after the menstrual period begins. If the period starts on a Sunday, take the first tablet that day. A non-hormonal backup method (such as condoms) must be used for the first 7 days of the first cycle until the medication's effect is established.

Missed Doses

If one active tablet is missed, take it as soon as remembered and continue the remaining tablets at the usual time. If two or more consecutive active tablets are missed, refer to the detailed instructions provided by your pharmacist or healthcare provider, as an additional non-hormonal contraceptive method may be necessary.


Recent Clinical Evidence

Research Evidence / Overview of Studies for Tevalet

Tevalet is a Combined Oral Contraceptive (COC) pill containing Ethinyl Estradiol and Gestodene. The evidence for its uses was studied for both its main purpose and specific symptom evaluation. This overview summarizes the structure of the evidence reported in scientific and regulatory sources, focusing on what types of studies have been conducted.


Evidence for Use in Contraception (Pregnancy Prevention)

The most extensive research on Tevalet was evaluated in the context of preventing pregnancy. In research exploring its effectiveness, researchers conducted Randomized Controlled Trials (RCTs). These studies research examined contraceptive efficacy. The main way effectiveness was monitored in these trials is through the Pearl Index (a calculation of unintended pregnancies per 100 women using the method for one year).

The findings describe patterns observed in the studies regarding low pregnancy rates. Large observational studies have been used to monitor the consistency of these patterns in broad populations of healthy women of reproductive age over extended time intervals.


Evidence for Managing Cycle-Related Symptoms and Conditions

Tevalet was studied for its relevance in conditions where symptoms may vary in intensity or become disruptive due to hormonal effects. The research base primarily was studied for short-term or episodic symptom patterns.

Studies Examining Cycle Regularity and Dysmenorrhea

Research has studies explored Tevalet in the context of outcomes related to physical discomfort, particularly severe menstrual cramps (dysmenorrhea). Trials tracked how symptoms evolved in the observed populations, describing short-term patterns of change in outcomes related to physical discomfort and the establishment of patterns related to menstrual cycle regularity.

Research for Hormone-Sensitive Skin Conditions

Tevalet was evaluated in trials for its potential role in conditions presenting with cycles of stability and flare-ups, such as acne vulgaris. The studies research examined changes in visible skin conditions, with measurable outcomes generally reported over a period of three to six months of use.


What Research Is Still Uncertain or Limited for Tevalet

While the research base is extensive for contraception, the scientific literature highlights areas where certainty remains low or evidence is still emerging. Long-term effects are not fully established regarding the maintenance of clear skin or the potential for symptom patterns to change after stopping the medication. Comparative evidence is lacking for certain therapeutic comparisons, and the findings for some specific symptomatic outcomes may be mixed.

Key Studies & References

  1. Label: MYVLAR - gestodene, ethinyl estradiol tablet (Regulatory document providing product-specific composition and regulatory status)

Frequently Asked Questions (FAQ)

Common questions about Tevalet (FAQ)

Q: How quickly should I expect Tevalet to start working?

Official information indicates that the contraceptive effect of the medicine requires time to establish itself. Regulatory guidelines often state that a non-hormonal backup method (such as condoms) is generally recommended during the first seven days of the first cycle until the medicine's full effect is established.

Q: Are there any side effects of Tevalet that might go away over time?

According to official reports on this class of medicine, some side effects are most common when a person first starts taking the tablets. These transient effects, such as breakthrough bleeding and nausea, may lessen or resolve entirely within the first few months of use as the body adjusts to the hormones.

Q: Can Tevalet interact with over-the-counter pain relievers like ibuprofen?

Regulatory documents indicate that when certain oral contraceptives are taken with Nonsteroidal Anti-inflammatory Drugs (NSAIDs) such as ibuprofen, there is a possibility that it could affect potassium levels. Monitoring of potassium levels may be considered when this class of medicine is taken alongside NSAIDs.

Q: Which supplements or vitamins should not be taken with Tevalet?

Herbal remedies such as St. John's wort are listed in official product information as potential interactions. Taking St. John's wort may reduce the medicine's effectiveness as a contraceptive. Official patient information emphasizes the importance of sharing a complete list of all supplements with a healthcare provider.

Q: Does consuming alcohol while taking Tevalet increase side effects?

Reports suggest that the medicine may increase the effects and blood levels of alcohol. Although individual reactions vary, caution is advised as this may result in a stronger impact from alcohol while using the medicine.

Q: Is Tevalet safe to use for older adults (seniors)?

Official drug information explicitly states that this medicine is not indicated (not recommended or studied for use) in elderly women. This medication is intended solely for females of reproductive potential.

Q: Can Tevalet be taken by teenagers or children?

The medicine is contraindicated in females who have not yet reached menarche (the onset of menstruation). Official information indicates that use is generally considered only after menstruation has begun (menarche). Specific use and dosing for those under 15 should be discussed with a healthcare provider.

Q: What are the long-term safety data for Tevalet?

The extensive safety database submitted for the medicine and its class shows no evidence of unexpected or higher frequency adverse events compared to similar combination oral contraceptives (COCs). Long-term use of this class of medicine is associated with a risk of serious blood clotting events, which is detailed in the official safety information.

Q: What makes Tevalet different from older medications in its class?

Tevalet contains Gestodene, which is noted in official sources as a third-generation progestogen. This component is highly potent and has a high ratio of progestogenic to androgenic effects. Official information indicates this component contributes to the medicine's pharmacological profile.

Q: Can Tevalet affect sleep patterns?

In reports for combination oral contraceptives, common side effects can include sleep-related issues such as trouble sleeping. Tiredness or other mood changes may also be reported.

Q: Is Tevalet known to cause stomach upset or digestive issues?

Yes, common side effects reported in official drug labeling include gastrointestinal issues. These frequently reported issues are nausea, vomiting, and abdominal or stomach pain.

Q: Does Tevalet carry a risk of dependence or addiction?

No, regulatory information confirms that Tevalet is not classified as a controlled substance and does not carry a risk of dependence or addiction.

Q: Can Tevalet be taken during pregnancy (general question about its class)?

Official guidelines state that the drug is contraindicated during pregnancy because there is no medical need for pregnancy prevention with this medicine. The medicine is generally discontinued if a person becomes pregnant.

Q: Is Tevalet excreted in breast milk, generally speaking?

Yes, the contraceptive steroids are known to be excreted into human milk. The estrogen component may reduce the overall quantity of breast milk and can change its composition. For these reasons, use is generally not recommended for nursing mothers.

Q: What conditions make a person unable to take Tevalet?

The medicine is contraindicated (must not be used) in women with a history of certain severe conditions. These include blood clots, breast cancer, severe liver disease or tumors, and uncontrolled high blood pressure. Complete eligibility criteria are detailed in the official information.

Q: Does Tevalet have a black box warning, and what is it for?

The class of combination oral contraceptives carries a serious warning regarding cardiovascular risks. This primarily relates to an increased risk of serious blood clotting events, including stroke and myocardial infarction, especially in women over 35 who smoke.

Q: Are there known food interactions that reduce the effectiveness of Tevalet?

The official product information mentions that consumption of grapefruit or grapefruit juice may interact with the medicine. This interaction may lead to increased concentrations of the medicine in the blood, potentially raising the risk of side effects.

Q: Is Tevalet a preventive medication or a treatment for active symptoms?

The primary indication for Tevalet is the prevention of pregnancy (contraception), which is a preventive measure. However, it is also approved for the treatment of moderate acne in certain patients.

Q: Does Tevalet cause changes in mood or anxiety levels?

Yes, mood changes are listed among the reported side effects for combination oral contraceptives. These can include mood disorders such as depression or general changes in mood.

Q: Are there generic versions of Tevalet available?

Generic versions of the broader class of combination oral contraceptives are generally available. The availability of a direct generic for this specific combination of Ethinyl Estradiol and Gestodene depends on its current approval status and market release.

Q: Can Tevalet affect my liver or kidney function?

Official warnings note the potential for serious liver toxicity, and the medicine is poorly metabolized (broken down) in patients with impaired liver function. There is no specific formal data detailed regarding the effects on kidney function.

Q: What tests might a doctor run before prescribing Tevalet?

Official labeling recommends that a doctor check a patient's progress at regular visits, typically every 6 to 12 months. This includes monitoring general health and often involves checking the patient’s blood pressure.

Q: Does Tevalet interact with herbal remedies like St. John's wort?

Yes, St. John's wort is specifically noted in official drug interaction information. Its use may work against the contraceptive effect and is generally listed as a drug that should not be used concurrently.

Q: Are there any lifestyle changes recommended while taking Tevalet?

A critical warning is provided regarding lifestyle, as patients are advised not to smoke while using this medicine. Smoking, especially if over age 35, significantly increases the risk of serious cardiovascular events like stroke or heart attack.

Q: Can Tevalet cause vision changes or blurry vision?

Official warnings state that blurred vision, difficulty reading, or any other changes in vision should be discussed promptly with a healthcare provider.

Q: Does Tevalet affect blood pressure or heart rate?

The medicine may elevate blood pressure in some users. It is also contraindicated in women who already have uncontrolled high blood pressure.

Q: Are there specific times of day Tevalet is best taken?

Official instructions specify that the medicine should be taken at the exact same time each day to maintain consistent blood levels for maximum effectiveness. No specific recommendation for morning versus evening is provided.

How should Tevalet be stored and disposed of?

How to Store and Dispose of Tevalet?

Storage Requirements

Tevalet must be stored at controlled room temperature, typically between 20 C to 25 C (68 F to 77 F), with temporary excursions permitted from 15 C to 30 C (59 F to 86 F). To protect the medicine from moisture and excessive heat, it must be kept in its original container with the cap tightly closed.

Disposal Instructions

When disposing of unused or expired Tevalet, the medicine should be taken to a designated drug take-back location or a mail-back program when available. If a take-back option is not readily accessible, the medicine should be removed from its container, mixed with an undesirable substance such as dirt or used coffee grounds, sealed in a bag or container, and then placed in the household trash.

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

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