Lessina 28

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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 Lessina 28

Quick Facts

Property Description
Active Ingredients Ethinyl Estradiol and Levonorgestrel
Form Oral Tablet (Monophasic, 28-day pack)
Pharmacological Class Combined Oral Contraceptive (COC)
Common Use Prevention of Pregnancy
Origin Synthetic Hormonal Compounds
Status Prescription-only (Rx)
Manufacturer Teva Pharmaceuticals USA, Inc.

What Type of Medicine is Lessina 28 and What is its Composition?

Lessina 28 is a brand-name, prescription-only hormonal preparation classified as a Combined Oral Contraceptive (COC). Its primary general purpose is the prevention of pregnancy in women of reproductive potential. The medication is a combination product containing two synthetic steroid hormones: Ethinyl Estradiol (a synthetic estrogen) and Levonorgestrel (a synthetic progestin).

Lessina 28 belongs to the pharmacological class of estrogen-progestin combinations. The specific formulation is clinically recognized for its use in systemic fertility control, a finding supported by authoritative pharmacological studies. This combination approach provides a robust mechanism for modulating the female reproductive cycle. This product is specifically indicated for use by females of reproductive potential to prevent pregnancy.

Understanding the Lessina 28 Tablet Form and Structure

The medication is supplied for daily oral administration in a tablet dosage form within a 28-day cycle package. Lessina 28 is classified as a monophasic oral contraceptive, meaning the active hormonal tablets maintain the same constant concentration of both Ethinyl Estradiol and Levonorgestrel throughout the cycle duration they are taken.

The 28-day package structure systematically includes 21 tablets containing the active hormone combination and 7 subsequent inactive (placebo) tablets. While the placebo tablets contain only inert ingredients, they are included to support adherence to a consistent daily dosing schedule, which is critical for maintaining the drug's intended contraceptive efficacy.

Regulatory References

  1. Lessina (Levonorgestrel and Ethinyl Estradiol) Label

What side effects are possible with Lessina 28?

Possible side effects and safety information

The safety profile of Lessina 28 (Ethinyl Estradiol and Levonorgestrel) is defined by officially documented adverse reactions and strict regulatory constraints, as outlined by governmental health authorities. Reactions are formally classified by frequency and affected body systems.

Frequency-Classified Adverse Reactions

Adverse effects listed in regulatory labeling range widely:

Classification Examples of Officially Documented Effects
Very Common Headache, Nausea, Vomiting, Irregular or heavy uterine bleeding.
Common Abdominal pain, Breast pain/tenderness, Weight changes, Migraine, Depression.
Rare Venous Thromboembolism (VTE), Arterial Thromboembolism, Retinal vein thrombosis.

These effects are formally categorized into System-Organ Classes including Vascular Disorders, Hepatobiliary Disorders, Reproductive System and Breast Disorders, and Nervous System Disorders.


Serious Adverse Reactions and Safety Constraints

The official label highlights the risk of Serious Adverse Reactions, which are rare but clinically significant. These include Thromboembolic Disorders (e.g., Deep Vein Thrombosis, Pulmonary Embolism, Stroke, Myocardial Infarction) and Hepatic Neoplasia (liver tumors). Use is Absolutely Contraindicated for specific populations, most notably for smokers over the age of 35 due to a significantly increased risk of cardiovascular events.

Safety notes also describe Time-Related Patterns; for example, the risk of vascular events is highest during the first year of use, and unscheduled bleeding is most common during the initial three months of treatment.

Furthermore, use is Contraindicated with certain Hepatitis C combination drug regimens. Temporary discontinuation is also required before major surgery or during prolonged immobilization to mitigate the documented risk of thromboembolism.

Overdose and Emergency Response

Lessina 28 Overdose and When to Seek Help

The official regulatory profile for an overdose of Lessina 28 (Ethinyl Estradiol and Levonorgestrel) is defined by its documented clinical manifestations and mandated emergency procedures. Acute overdose is generally not associated with severe or life-threatening outcomes, according to authoritative regulatory labeling.

Documented Manifestations and Outcomes

The recognized symptoms of an overdose are typically non-severe and self-limiting. Manifestations listed in prescribing information include gastrointestinal disturbances such as nausea and vomiting. Unexpected vaginal bleeding, often characterized as withdrawal bleeding, is also a documented presentation. Other listed clinical signs include tiredness and breast tenderness. Regulatory documents specifically note that this potential withdrawal bleeding can occur in females of all ages, including prepubescent children.

Required Emergency Actions and Treatment

Regulatory authorities mandate that medical help must be sought right away if an overdose of Lessina 28 is suspected or if any concerning symptoms are present. The official labeling confirms that no specific antidote is known for this combination product. Therefore, the required clinical management is symptomatic and supportive treatment, focused entirely on addressing the specific manifestations that occur following the overdose event.

Therapeutic Uses of Lessina 28

The primary purpose of Lessina 28 is to contribute to managing symptoms related to systemic imbalance, with the goal of fertility control for women of reproductive potential. Beyond this, it is commonly used to address symptoms related to systemic imbalance and heightened physiological activity. The therapeutic benefits generally include the management of menstrual pain (dysmenorrhea), the easing of excessive menstrual bleeding (menorrhagia), assisting with maintaining a more predictable monthly rhythm, and providing support for symptoms of hormonal acne.

This application is applied in addressing symptom clusters that may become intense or disruptive in conditions characterized by periods of heightened symptoms. It is used in clinical settings that involve acute or unstable symptom patterns. It provides support that helps ease the overall symptom burden, assisting with maintaining functional stability.


Quick Fact: Relief for Menstruation-Related Discomfort Lessina 28 is commonly used to help with symptomatic discomfort associated with the menstrual cycle, including pain and heavy flow, which may assist with maintaining functional stability.

Regulatory References

  1. NIH DailyMed Label for Lessina

Eligibility and Restrictions for Use

Who Can and Cannot Use Lessina 28?

Lessina 28 eligibility is determined by specific criteria outlined in official regulatory labeling, focusing primarily on cardiovascular risk, hormonal sensitivity, and age thresholds. This medication is contraindicated (must not be used) in several specific patient populations.


Populations for Whom Use is Prohibited

The most severe restrictions relate to thrombotic and oncological risk. Lessina 28 is contraindicated in women over age 35 who smoke, and in individuals with a history of or current blood clots (such as DVT or PE), stroke, or coronary artery disease. Use is also prohibited in patients with known or suspected breast cancer or other estrogen-sensitive cancers, liver tumors, severe liver disease, and uncontrolled hypertension.

Age and Physiological Restrictions

Lessina 28 is approved for use only in females of reproductive potential who have achieved menarche. The medication is not indicated for use in children before menarche or in geriatric women. Use is contraindicated during pregnancy and not recommended for women who are breastfeeding.

Restricted Use Conditions

Use requires conditional management in certain states. The product must be discontinued before major surgery or during prolonged immobilization. Additionally, use must not be started earlier than 4 weeks postpartum in women who are not breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents define specific interaction patterns for Lessina 28 (Ethinyl Estradiol and Levonorgestrel), primarily focusing on the risk of reduced contraceptive effectiveness and increased toxicity of co-administered drugs.

Official Interaction Statements

Classification Interacting Agents Official Regulatory Statement
Contraindicated Hepatitis C Drug Combinations (e.g., Ombitasvir/Paritaprevir/Ritonavir pm Dasabuvir); Tizanidine Co-administration is prohibited due to the risk of liver enzyme elevations or a severe increase in Tizanidine exposure (up to 7-fold).
Reduced Efficacy Risk Enzyme Inducers (e.g., Rifampin, Phenytoin, Carbamazepine, St. John's Wort) These agents accelerate the metabolic clearance (CYP3A4) of the hormones, leading to decreased plasma concentrations and a risk of contraceptive failure.
Increased Exposure Risk Ascorbic Acid (Vitamin C), Acetaminophen, Cyclosporine These substances may inhibit hormone metabolism or increase the exposure of co-administered drugs like Cyclosporine.
Pharmacodynamic Risk Tranexamic Acid Combination is not recommended due to an increased risk of thromboembolic events.

Interaction-Context Constraints

The most significant constraint documented is that tobacco use in females over age 35 is a formal contraindication. This restriction is imposed due to the documented, significantly increased risk of serious cardiovascular events (e.g., blood clots) when this hormonal product is combined with smoking in this specific population. Antibiotics like tetracyclines may also reduce hormone concentrations by interfering with the enterohepatic circulation.

Mechanism of Action

Central Regulation of the Ovarian Cycle

Lessina 28, a combination of ethinyl estradiol and levonorgestrel, acts through the synthetic hormones to provide strong negative feedback to the hypothalamic-pituitary-ovarian (HPO) axis. This action suppresses the release of the gonadotropins FSH and LH. This targeted pathway adjustment is the central mechanism resulting in the inhibition of ovulation (anovulation), which contributes to the suppression of reproductive capacity.

Peripheral Barrier Formation

The hormones modify the peripheral reproductive environment. Levonorgestrel alters the activity of cervical glands, causing the cervical mucus to become significantly thicker and less permeable. This forms a physical structure with increased resistance to sperm motility. Concurrently, the hormonal components alter the morphology and function of the uterine lining, leading to an altered endometrial state that resists blastocyst embedding.

Follicular Development Arrest

By maintaining suppressed FSH levels, the drug modifies the early molecular steps within the ovary, ensuring the arrest of follicular development. This restriction limits the preparation of a dominant follicle for release.

Dosage and Administration Information

How to Use Lessina 28

Lessina 28 is an oral medication prescribed as a 28-day regimen for continuous, cyclic use. The standard procedure for taking the medication is established to ensure efficacy, primarily by maintaining the prescribed dosing schedule.

Official Dosing and Cycle Structure

The dosage for this combined oral contraceptive is one tablet daily by mouth, taken at the same time every day at intervals not exceeding 24 hours. The 28-day pack includes two types of tablets that must be taken in the sequential order printed on the dispenser:

  • Active Tablets: 21 tablets containing a fixed dose of levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg.
  • Inactive Tablets: 7 tablets that contain only inert ingredients (placebo).

After taking the last inactive tablet, a new 28-day course must be started immediately on the following day, regardless of whether bleeding has occurred or is still in progress.

Cycle Phase Duration Tablet Type Key Instruction
Active Phase 21 Days Hormonal Must be taken sequentially.
Inactive Phase 7 Days Placebo Supports adherence to the daily schedule.

Administration Requirements

Lessina 28 may be taken without regard to meals. To begin the first cycle, a patient may choose either a Day 1 Start (first day of menstrual period) or a Sunday Start (first Sunday after period onset).

If the Sunday Start method is chosen, or if the initial dose is taken later than Day 1 of the menstrual period, an additional non-hormonal contraceptive method must be used for the first seven consecutive days of active tablet administration. In case of severe vomiting or diarrhea, absorption may be incomplete, and additional contraceptive measures are necessary.

Recent Clinical Evidence

Lessina 28: Recent Clinical Evidence

Clinical evidence on Lessina 28 (an oral contraceptive containing levonorgestrel and ethinyl estradiol) primarily focuses on its established use in the prevention of pregnancy. This combination of hormones is widely studied, and its effectiveness is well-documented in large-scale observational studies and randomized controlled trials (RCTs) used for regulatory approval.


Efficacy and Contraceptive Outcomes

Studies consistently report a high degree of effectiveness when the drug is used according to instructions. The theoretical efficacy is often cited as greater than 99% in preventing pregnancy, based on consistent and correct use. Real-world efficacy, which accounts for typical use patterns, is generally reported to be around 91%.

Research has also investigated secondary non-contraceptive benefits, particularly related to menstrual cycle regulation. Clinical data suggest that the combination is associated with more predictable menstrual cycles and may be related to a reduction in the severity of menstrual cramps (dysmenorrhea) for some users.


Safety and Adverse Events

Recent evidence continues to focus on the known safety profile, particularly the risks of venous thromboembolism (VTE). Observational data confirm that the risk of VTE is increased in all users of combination oral contraceptives compared to non-users, but this risk remains very low in the general population of healthy young women. Researchers emphasize that VTE risk factors, such as smoking, obesity, and age, must be considered by healthcare providers when prescribing.

Reported common adverse events across trials include nausea, breast tenderness, and breakthrough bleeding, which are often documented as being temporary and tending to resolve within the first few cycles of use.

Key Studies & References

  1. Label: LESSINA- levonorgestrel and ethinyl estradiol kit - DailyMed - NIH
  2. Contraceptive efficacy: Trussell J, Hatcher RA, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition (New York NY: Irvington Publishers, 1998)
  3. Combined hormonal contraceptives and venous thromboembolism: review confirms risk is small - GOV.UK
  4. Combined hormonal contraception and the risk of venous thromboembolism: a guideline (2016) | American Society for Reproductive Medicine

Frequently Asked Questions (FAQ)

Common questions about Lessina 28 (FAQ)

Q: Does Lessina 28 protect against STIs?

According to the official product information, Lessina 28 is indicated for the prevention of pregnancy. This medication does not protect against HIV infection (AIDS) or other sexually transmitted diseases (STDs).


Q: Is Lessina 28 a form of emergency contraception?

No. Lessina 28 is a combination oral contraceptive intended for continuous, daily use to prevent pregnancy. It is not indicated or approved for use as a form of emergency contraception.


Q: Why does the Lessina 28 pack contain pills of different colors?

The different colors are used to help distinguish between the two types of tablets in the 28-day pack. The first 21 tablets are active, containing hormones, while the last 7 tablets are inactive (placebo). The color difference is an aid for maintaining the correct daily dosing schedule.


Q: How quickly does Lessina 28 start working for its main purpose?

Official information regarding administration specifies that if the medication is started later than the first day of the menstrual period, a non-hormonal backup method must be used. This additional protection is required for the first seven consecutive days of taking the active tablets.


Q: Can Lessina 28 be used by people over the age of 35?

Yes, official documents specify that the use of combination oral contraceptives is absolutely contraindicated only for women over the age of 35 who smoke. This restriction is based on a significantly increased risk of serious cardiovascular events in that specific group.


Q: What should I do if I feel dizzy after starting Lessina 28?

Dizziness is listed as a possible adverse reaction. If dizziness or headaches occur and persist or worsen over time, seeking guidance from a healthcare professional is generally recommended. The prescribing information notes that headache and migraine are common adverse reactions.


Q: Does Lessina 28 affect future fertility?

Combination oral contraceptives prevent pregnancy primarily by inhibiting ovulation while in use. Information on the effect on fertility after discontinuing use is not detailed in the official product labels.


Q: Does alcohol consumption impact how Lessina 28 works?

Official drug labeling does not list a specific interaction or reduction in effectiveness related to alcohol consumption. The label does, however, contain warnings regarding interactions with certain other drugs, herbal products, and food.


Q: Is Lessina 28 a generic version of another drug?

Lessina 28 is a brand name for a combination oral contraceptive containing levonorgestrel and ethinyl estradiol. This product is cited in regulatory sources as the bioequivalent and generic form of the combined oral contraceptive known as Nordette-28.


Q: What are the most common reasons people stop taking Lessina 28?

While regulatory sources do not explicitly summarize the exact reasons for discontinuation, the most common adverse reactions reported in clinical trials that may prompt users to stop the medication include headache, nausea, breast tenderness, and irregularities in bleeding patterns.


Q: Does Lessina 28 have any impact on bone density according to research?

The official product label does not contain a specific warning regarding a known adverse effect on bone mineral density. The primary safety concerns documented for this class of drug focus on thrombotic and cardiovascular risks.


Q: Does Lessina 28 affect cholesterol levels?

Combination oral contraceptives may affect carbohydrate and lipid metabolism. Due to this potential effect, regulatory information indicates that caution is appropriate for women with existing conditions like hyperlipidemias.


Q: Is it normal to miss a period while taking the inactive pills of Lessina 28?

A withdrawal bleed, or period, may be missed when taking the inactive tablets. Official product information states that if a period is missed for two consecutive cycles, the possibility of pregnancy should be taken into consideration.


Q: Does grapefruit juice interact with Lessina 28?

Regulatory information indicates that grapefruit juice may interact with the medicine. Because grapefruit juice is a CYP3A4 inhibitor, it has the potential to increase the levels of the hormones in the body. For this reason, the product information suggests that caution is appropriate, and observation for adverse effects is recommended.


Q: Is Lessina 28 known to worsen acne or improve it?

Acne is listed as a possible side effect in some drug information sources for this hormone combination, meaning it may sometimes occur or worsen. Lessina 28 is not officially approved for therapeutic use in the treatment of acne.


Q: Does Lessina 28 come with a Boxed Warning in the US?

Yes, combination oral contraceptives, including this product, carry a Boxed Warning. This warning is included to highlight the increased risk of serious cardiovascular events, which is particularly elevated in women over the age of 35 who smoke.


Q: What kind of changes in vision, if any, have been associated with Lessina 28 use?

Serious, rare events such as retinal vein thrombosis (a type of blood clot affecting the eye) have been associated with use. Additionally, contact-lens wearers who experience visual changes or changes in lens tolerance are advised to consult a healthcare provider.


Q: Can Lessina 28 be used in patients with diabetes?

Regulatory documents indicate that careful monitoring is appropriate for patients with diabetes. Use is strictly contraindicated for patients with diabetes who also have vascular disease, as the product can affect carbohydrate metabolism.


Q: Can Lessina 28 be used if I have a history of migraines?

Official guidance describes that this class of medication is typically restricted for women who have a history of migraines accompanied by focal neurological symptoms, such as aura. This restriction is related to a documented potential increase in the risk of stroke.

How should Lessina 28 be stored and disposed of?

How to Store and Dispose of Lessina 28?

Lessina 28 (levonorgestrel and ethinyl estradiol tablets) must be stored at Controlled Room Temperature, specifically between 20 C and 25 C (68 F to 77 F). The medication must be kept in its original container and be protected from light and moisture; avoid storage in high-humidity areas, such as a bathroom. It is mandatory to keep this product out of reach of children.


Disposal Instructions

Disposal should prioritize the use of an official drug take-back program. If a take-back option is unavailable, the unused or expired tablets should be mixed with an unappealing substance, such as dirt or used coffee grounds, and then sealed in a plastic bag before being placed in the trash. The medication is not on the FDA's Flush List and must not be flushed down a toilet.

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

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