Alysena 28

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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 Alysena 28

Alysena 28 is a prescription Combined Oral Contraceptive (COC), marketed by Apotex Inc. and often recognized as a generic alternative to the brand Alesse. The primary purpose of this oral tablet is the reliable prevention of pregnancy in females of reproductive potential. As a synthetic product, it is classified within the Hormonal Contraceptive group.

Property Description
Active ingredient Ethinyl Estradiol, Levonorgestrel
Form Oral Tablet
Pharmacological Class Hormonal Contraceptive
Common Use Pregnancy Prevention
Origin Synthetic (Steroidal Hormones)

This medication belongs to the Sex Hormones and Modulators of the Genital System (ATC G03) and utilizes systemic hormonal intervention. Formulations containing this specific combination are clinically recognized for their high efficacy in preventing conception, primarily by suppressing ovulation.

Alysena 28 is structured as a combination product containing two synthetic active ingredients: Ethinyl Estradiol (a synthetic estrogen) and Levonorgestrel (a synthetic progestin). The active tablets are delivered as a monophasic formulation, a key feature that dictates the dose of both hormones remains constant across the 21 days of active administration. This contrasts with multi-phasic pills where hormone levels fluctuate. The 28-day regimen includes seven inactive tablets, which contain non-active solid tablet excipients to maintain the necessary routine of uninterrupted daily administration.

Regulatory References

  1. Levonorgestrel - StatPearls - NCBI Bookshelf - NIH

What side effects are possible with Alysena 28?

Possible side effects and safety information

The official safety documentation for Alysena 28, a combined oral contraceptive containing Ethinyl Estradiol and Levonorgestrel, details adverse reactions classified by frequency and the body system affected. These regulatory classifications structure the understanding of the drug's safety profile.


Frequency-Classified Adverse Reactions

Adverse reactions listed in official documents are categorized based on their documented occurrence rates:

  • Very Common (≥ 1/10): Includes headaches and unscheduled uterine bleeding, such as spotting or breakthrough bleeding.
  • Common (≥ 1/100 to < 1/10): Includes nausea, vomiting, abdominal pain, weight gain, breast pain, mood alterations, nervousness, and acne.
  • Uncommon: Includes migraine, fluid retention (edema), changes in blood pressure (hypertension), and chloasma (melasma).
  • Rare: Includes hypersensitivity reactions and clinically significant events related to blood clots.

System-Organ Classes and Serious Risks

The documented effects are grouped into physiological systems, including Vascular, Gastrointestinal, Nervous System, and Reproductive System disorders. The regulatory label explicitly lists low-frequency but serious adverse reactions associated with this class of medication:

  • Thromboembolic Events: Both Venous Thromboembolism (VTE), such as deep vein thrombosis (DVT) and pulmonary embolism (PE), and Arterial Thromboembolism (ATE), such as stroke or myocardial infarction, are documented risks.
  • Hepatic Neoplasia: The potential for developing liver tumours (benign and malignant) is noted in official safety information.

Safety Constraints and Time Patterns

The medicine is subject to specific regulatory limitations. Use is contraindicated in specific high-risk populations, including individuals who are smokers aged 35 years or older and those with a history of severe hepatic impairment or migraine with aura. Furthermore, official safety data notes that irregular bleeding is most common during the initial cycles of use, and the risk of VTE is highest during the first year of use or upon restarting therapy after a prolonged break.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for an acute overdose of Alysena 28 (Levonorgestrel and Ethinyl Estradiol) consistently documents that severe, life-threatening outcomes are not typically expected. The observed clinical signs of acute ingestion above the normal dose are primarily mild and involve the gastrointestinal and reproductive systems.

Officially Documented Manifestations Regulatory Basis for Management
Nausea and Vomiting Treatment is symptomatic and supportive
Withdrawal Bleeding (Vaginal Bleeding) No specific antidote is known
Drowsiness or Tiredness Monitoring of vital signs may be required

Mandated Emergency Actions

Official government health guidance requires that immediate action be taken whenever an overdose is suspected. Individuals must seek emergency medical attention without delay or call the Poison Help line. Urgent medical care is necessary to ensure the individual is stable and to initiate assessment, even if symptoms are minor.

Official Management Procedures

Because no specific antidote exists, management is limited to supportive and symptomatic treatment. Healthcare providers are instructed to apply supportive measures and may conduct monitoring, including checks of vital signs and specialized blood or urine tests, to manage the documented manifestations. This procedural approach is consistent with established regulatory guidance for combined oral contraceptive overdose.

Therapeutic Uses of Alysena 28

Quick Facts

  • Primary Use: Management for the purpose of pregnancy prevention.
  • Secondary Use: May be used as a treatment for moderate acne vulgaris in specific female populations.
  • Target Population: Females who have achieved menarche and desire contraception.

What Alysena 28 Treats

Alysena 28 is a prescription medication indicated for use in females of reproductive potential for conception control (prevention of pregnancy). The medication offers a mechanism to help manage reproductive health and is a widely accepted form of contraception. It is considered highly effective in preventing pregnancy when used as directed.

Additionally, Alysena 28 is authorized for the management of moderate acne vulgaris in women aged 14 and older who have no known contraindications to oral contraceptive therapy, desire contraception, and have begun menstruating. The medication is an option to support the overall management of this skin condition in the indicated population.

This medication is not intended to treat, resolve, or provide a definitive cure for any condition, but serves as a therapeutic agent within an overall health management plan. All potential users must consult a healthcare professional to review benefits and potential risks before starting use.

Eligibility and Restrictions for Use

Alysena 28 is officially indicated for use by females of reproductive potential for pregnancy prevention, including adolescents who have achieved menarche. It is also authorized for the management of moderate acne vulgaris in women aged 14 and older who desire contraception.

Contraindications (Must Not Use)

The medicine is contraindicated and must not be used by populations with specific high-risk factors, according to regulatory documents:

  • Women over 35 years of age who smoke (due to significantly increased cardiovascular risk).
  • Current or past history of venous thromboembolic disorders (e.g., DVT, pulmonary embolism), cerebrovascular disease, or coronary artery disease.
  • Known or suspected estrogen- or progestin-sensitive malignancies (e.g., breast cancer, liver tumors).
  • Active liver disease, severe cirrhosis, or history of cholestatic jaundice of pregnancy.
  • Known or suspected pregnancy.

Conditional Use and Restrictions

Official labeling defines limitations for certain populations:

  • Lactation: Use is not recommended in breastfeeding women as the hormones may be excreted in milk and can potentially reduce milk production.
  • Surgery: Must be stopped at least four weeks before and through two weeks after major surgery or any period of prolonged immobilization.
  • Geriatric Use: The medication is not indicated for use in postmenopausal women, and safety data for the geriatric population have not been established.
  • Comorbidities: Contraindicated in women with uncontrolled hypertension, migraine headaches with aura, or diabetes mellitus with vascular complications.

What should I know about interactions with other medicines?

Alysena 28’s interaction profile is defined by pharmacokinetic patterns and formal prohibitions documented in government regulatory labeling. The medication is formally contraindicated for co-administration with specific combination regimens used to treat Hepatitis C (such as ombitasvir/paritaprevir/ritonavir, with or without dasabuvir) due to the documented risk of elevating liver enzymes (ALT). The drug is also prohibited in women with severe hepatic impairment, as poor metabolism of the steroid hormones creates a critical interaction-related risk.

Several medicinal products and substances can reduce contraceptive efficacy by enhancing the clearance of Ethinyl Estradiol and Levonorgestrel. This includes strong enzyme-inducing medicines like certain anticonvulsants (e.g., Carbamazepine, Phenytoin) and the herbal supplement St. John’s wort. Co-administration with these products may necessitate the use of an alternative contraceptive method.

Conversely, Alysena 28 can alter the exposure of other co-administered medicinal products. The contraceptive may increase the plasma concentrations of drugs such as Glucocorticoids, while it is documented to significantly decrease the plasma concentration of others, including Lamotrigine. Additionally, Antiretroviral agents can cause significant, varying changes in the hormone levels. Finally, severe vomiting or diarrhea occurring within four hours of administration is categorized as a failure of complete absorption and must be treated as an interaction-related missed dose.

Mechanism of Action

Alysena 28, a combination hormonal contraceptive, functions through the actions of its synthetic estrogen ( ethinyl estradiol) and progestin ( levonorgestrel) components. Both compounds modulate the hypothalamic-pituitary-ovarian (HPO) axis via continuous negative feedback.

The levonorgestrel component acts as an agonist at the progesterone receptors (PR), and ethinyl estradiol acts as an agonist at estrogen receptors (ER) in the hypothalamus and anterior pituitary gland. This receptor binding suppresses the pulsatile release of gonadotropin-releasing hormone (GnRH) from the hypothalamus and reduces the secretion of pituitary follicle-stimulating hormone (FSH) and **luteinizing hormone (LH) (Image of Hypothalamic-Pituitary-Ovarian Axis Suppression by Contraceptives).

The systemic consequence of decreased FSH and LH is the suppression of ovarian follicular development and the absence of the mid-cycle LH surge. The lack of the LH surge inhibits the rupture of the mature follicle, preventing ovum release. Additionally, levonorgestrel induces changes in the cervical mucus, increasing its viscosity and impeding the mobility and penetration of sperm into the upper reproductive tract. Levonorgestrel also alters the endometrium, resulting in a thin, atrophic lining.

Dosage and Administration Information

Administration Protocol: The 28-Day Cycle

The administration of Alysena 28 follows a continuous, cyclic protocol prescribed for oral use in females of reproductive potential. The regimen consists of one tablet taken daily for 28 consecutive days, with the tablets taken sequentially as directed on the pack. The tablets are composed of a monophasic dose of 0.1 mg Levonorgestrel and 0.02 mg Ethinyl Estradiol for the 21 active days. The first dose is sometimes specified to be taken on an empty stomach.

Administration Feature Guideline
Dosing Schedule One tablet daily (21 active / 7 inactive)
Timing Must be taken at the same time every day
Target Population Females of reproductive potential; not indicated before menarche or in geriatrics
Initiation Options Day 1 Start (first day of menses) or Sunday Start

Procedural Constraints and Continuation

The protocol requires that the interval between daily doses must not exceed 24 hours. The regimen offers two distinct ways to begin the first pack; however, if the Sunday Start method is chosen, the protocol involves the use of a non-hormonal backup method for the initial seven consecutive days. Furthermore, there are procedural steps for managing a missed dose, which is determined by the number of tablets missed and the specific week of the cycle. If vomiting or severe diarrhea occurs within 3 to 4 hours of an active pill, it is handled according to the missed dose protocol. Upon finishing the last inactive tablet, a new 28-day pack must be commenced immediately, without any break in the daily intake schedule, establishing a continuous pattern of use.

Recent Clinical Evidence

Alysena 28: Recent Clinical Evidence

Evidence for use in Pregnancy Prevention (Contraception)

The research has been conducted using multi-center open-label clinical trials and ongoing observational studies exploring how symptoms change over time. Studies examined the product for its use in pregnancy prevention, monitoring outcomes related to the calculation of the standard Pearl Index (a statistical measure of the number of pregnancies observed during the study period).

The findings describe patterns observed in the studies, reporting measurements for the Pearl Index under conditions representing both perfect and typical daily use. The evidence contributes to the broader understanding of symptom patterns and outcomes related to this class of hormonal contraceptives in generally healthy women of reproductive age.

Evidence for use in Moderate Acne Vulgaris

The product was studied for its use in moderate acne in specific female populations. Research in this area includes randomized, double-blind, placebo-controlled trials. These studies were applied in research contexts involving fluctuating or unstable symptoms of acne, monitoring outcomes linked to inflammatory or irritative states. Researchers mainly tracked and reported measured changes in lesion counts over the course of the study.

Studies focusing on episodes where symptoms become more noticeable reported how symptoms evolved in the observed populations compared to those taking a placebo. This evidence is specifically derived from settings with women who have moderate acne, have achieved menarche, and who also desire hormonal contraception.

Long-Term Follow-up and Durability of Study Findings

Research has explored outcomes over defined time intervals, with the main clinical trials for both pregnancy prevention and acne extending to intermediate-term observation periods, such as six to thirteen menstrual cycles. The available research for acne is limited to this short- to intermediate-term observation duration.

There is limited information for long-term outcomes, particularly concerning the durability of study findings beyond a few years of continuous use. The long-term effects are not fully established through dedicated, continuous-use trials of this exact low-dose formulation, meaning that continuous surveillance is often conducted using broader epidemiological studies on the class of combined oral contraceptives.

Evidence in Specific Subgroups and Populations

Research describes that the study populations for acne management consisted of adolescents and women aged 14 and older who have achieved menarche. However, data for certain groups remain insufficient, such as in women over the age of 35 or those with certain pre-existing health conditions, where comparative evidence is lacking.

What is Still Uncertain About the Research

There are several research limitation frames that affect the overall certainty of the evidence. One known gap is that the data show patterns related to non-perfect adherence (typical use), which research suggests may affect study measurements in real-world settings. The research does not determine whether an individual will respond similarly to the patterns observed in the group studies.

Frequently Asked Questions (FAQ)

Common questions about Alysena 28 (FAQ)


Q: What are the inactive ingredients in Alysena 28?

According to the official product documentation, the inactive ingredients in the active tablets include substances such as lactose (monohydrate and anhydrous), colloidal silicon dioxide, magnesium stearate, and talc. The non-hormonal pills contain similar inactive agents along with colorants, which defines the full composition of the medication.


Q: Can Alysena 28 affect future fertility?

Regulatory-related information on this class of contraceptives describes their effects as generally reversible. Its function is to suppress ovulation during the time it is being used. After stopping the medication, normal menstrual periods and the potential for pregnancy typically resume, often within a few months.


Q: Does Alysena 28 interact with antibiotics?

Official patient information indicates that some antibiotics, such as those in the penicillin and tetracycline classes, may potentially interact with this contraceptive. These interactions are noted as potentially leading to reduced contraceptive effectiveness. Official guidance emphasizes the need to consider all co-administered medications.


Q: Is it necessary to use a backup method when taking Alysena 28 with certain supplements?

Official information explicitly identifies the herbal product St. John’s wort (Hypericum perforatum) as a supplement that can interact with the contraceptive. Use of St. John's wort may increase the clearance of the hormones, and regulatory guidance suggests that an alternative or backup contraceptive method may be necessary during co-administration.


Q: Can grapefruit juice affect Alysena 28?

Some studies related to the pharmacology of the active ingredients suggest that grapefruit juice may affect how the body processes the hormones. This could potentially lead to increased levels of the active ingredients in the bloodstream. Regulatory information does not provide dietary recommendations, which would be managed by a qualified healthcare professional.


Q: Does Alysena 28 work immediately after starting it?

Official administration instructions often require the use of a non-hormonal backup method for the initial seven consecutive days when starting the medication using the Sunday Start method. This suggests that the full onset of contraceptive protection is not considered immediate upon taking the first dose.


Q: What is the usual waiting period before seeing benefits from Alysena 28?

Clinical trials for indications like moderate acne and observations regarding cycle regulation suggest that full benefits are typically assessed after several menstrual cycles of use. This waiting period is often described in regulatory documents as three to six months to fully evaluate the effects of the treatment.


Q: Are there any specific lifestyle factors that can affect how Alysena 28 works?

Regulatory warnings specifically identify cigarette smoking as a lifestyle factor that significantly increases the risk of serious cardiovascular events when using this contraceptive. This risk is particularly noted in women over 35 years of age. General health and lifestyle considerations are defined in the official warnings.


Q: Can Alysena 28 be used by someone who has just had a baby?

The official label specifies limitations for postpartum use. Use is not recommended for breastfeeding women as the hormones may be excreted into the milk and potentially affect milk production. Additionally, the risk of blood clots is generally increased postpartum, which may influence the timing of initiation.


Q: Can someone who smokes use Alysena 28?

The medication label contains a boxed warning stating that use is strongly contraindicated in women over 35 years of age who smoke. This warning is related to a significantly increased risk of serious cardiovascular events documented in regulatory literature. Official warnings define the populations for whom use is prohibited.


Q: What does the manufacturer or regulator say about the effectiveness of Alysena 28?

Clinical trials for combined oral contraceptives measure effectiveness using the Pearl Index. This statistical measure reports the rate of observed pregnancies per 100 woman-years of use. Regulatory documentation provides these measurements under conditions representing both typical and perfect use for assessing efficacy.


Q: Are there any ongoing studies about the long-term use of Alysena 28?

Regulatory documents state that the long-term effects of this specific low-dose formulation are not fully established through dedicated, continuous-use trials spanning many years. Therefore, continuous safety surveillance is often conducted using broader epidemiological studies focused on the combined oral contraceptive drug class.


Q: Is it normal to have a shorter or lighter period while on Alysena 28?

Studies and official information indicate that some users may experience changes in their menstrual bleeding pattern while using this contraceptive. This can commonly include having a lighter or shorter bleed during the inactive pill week as an expected effect.


Q: Can Alysena 28 affect the results of blood tests?

Regulatory information indicates that the active ingredients in the medication may alter the results of certain laboratory tests. This includes tests related to coagulation factors, liver function, and thyroid binding globulin, and this interaction is noted for consideration during the interpretation of laboratory results.


Q: Does Alysena 28 contain gluten or lactose?

Based on the official product's inactive ingredients list, the formulation contains both lactose monohydrate and anhydrous lactose. The presence of lactose is noted in the official documentation.


Q: Can Alysena 28 cause changes to vision?

The official documentation includes warnings regarding potential ocular effects. The use of combined oral contraceptives has been associated with changes in vision, such as intolerance to contact lenses, and rare serious vascular events affecting the eyes are documented.


Q: What should a person know about using Alysena 28 and surgery?

Regulatory guidance dictates that the medication must be stopped for a defined period surrounding major surgery or any period of prolonged immobilization. This is typically four weeks before and two weeks after the event due to the increased risk of thromboembolic events (blood clots) defined in the warnings.


Q: Do the side effects of Alysena 28 usually improve over time?

Official safety data for this medication notes that one of the most common adverse reactions, irregular or unscheduled bleeding, is most frequently reported during the initial cycles of use. This symptom is often observed to improve over time as the body adjusts to the hormones in the medication.


Q: Is it possible for Alysena 28 to delay the onset of a menstrual period?

As this is a monophasic formulation, official instructions for continuous active pill use may be followed in specific circumstances. Continuing the use of active pills and skipping the inactive pill week may effectively postpone the expected withdrawal bleed.


Q: Is Alysena 28 associated with changes in hair growth?

Official documentation for this class of medication lists changes in hair growth as a possible adverse reaction. This may be observed as either an increase or a loss of body or facial hair.


Q: Can Alysena 28 be used during the perimenopause stage?

The official label specifies that this medication is not indicated for use in postmenopausal women. Safety data for use in the geriatric population, which includes women past menopause, have not been established in the official documentation.


Q: How is Alysena 28 typically reviewed or classified by major health organizations?

The active ingredients (Levonorgestrel and Ethinyl Estradiol) are widely recognized and classified within the Anatomical Therapeutic Chemical (ATC) classification system under G03 (Sex Hormones and Modulators of the Genital System). They are also often included on the WHO Model List of Essential Medicines.


Q: Are there generic versions of Alysena 28?

Official national drug product lists show that several alternative products exist which contain the same active ingredients and dose as Alysena 28. These formulations are listed as alternatives in the prescribing information.


Q: Does Alysena 28 increase sun sensitivity?

Official safety information notes that the medication may cause blotchy, dark areas on the skin and face, a condition known as melasma. Exposure to sunlight or UV radiation may worsen this effect, and official guidance suggests a need for caution with sun exposure.


Q: Does Alysena 28 provide protection against sexually transmitted infections?

Official patient counseling information explicitly states that combined oral contraceptives do not protect against the transmission of HIV (AIDS) and other sexually transmitted diseases (STDs). An alternative barrier method is defined as necessary for infection prevention.


Q: Why are the hormones in Alysena 28 measured in micrograms?

The active ingredients in the medication, Ethinyl Estradiol and Levonorgestrel, are potent synthetic steroidal hormones. The therapeutic effect needed is achieved with a very small dosage, which is why the quantity is measured in the microgram (mu g) range.

How should Alysena 28 be stored and disposed of?

How to Store and Dispose of Alysena 28

Alysena 28 (Levonorgestrel and Ethinyl Estradiol Tablets) must be stored and handled according to specific regulatory guidelines to maintain its chemical integrity and safety.

Storage Requirements

Condition Regulatory Requirement
Temperature Store at room temperature. Avoid excessive heat and freezing.
Protection Keep in a closed container, protected from moisture and direct light.
Safety Keep out of the reach of children and pets to prevent accidental ingestion.

Disposal Instructions

Official instructions prohibit disposal of Alysena 28 in wastewater (e.g., down the sink or toilet) or household garbage. All unused or expired medications must be returned to a pharmacy for proper pharmaceutical waste disposal according to local regulations. If a pill pack is abandoned, the rest of the pack must be safely discarded.

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

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