Volina

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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 Volina

Property Description
Active Ingredients Drospirenone (DRSP) and Ethinyl Estradiol (EE)
Form Film-coated tablet
Pharmacological Class Estrogens/Progestins (fixed combinations)
General Purpose Prevention of pregnancy (Contraception)
Origin Synthetic

Volina: Definition and Pharmacological Classification

Volina is a prescription-only medication classified as a Combined Oral Contraceptive (COC), which functions primarily to provide reliable and reversible reproductive control. It is administered orally as a film-coated tablet and belongs to the pharmacological group of Estrogens/Progestins (fixed combinations), which is used for contraception. The formulation is a fixed-dose combination, meaning it contains two distinct synthetic hormones designed for consistent, cyclic use. The medication is used for its effectiveness in adjusting the body's hormonal balance to prevent pregnancy in women of reproductive potential.


The Active Ingredients: Drospirenone and Ethinyl Estradiol

The active ingredients in Volina are the synthetic estrogen Ethinyl Estradiol (EE) and the synthetic progestin Drospirenone (DRSP). Both components are synthetic hormones engineered to modulate the body’s hormonal balance. Drospirenone is the distinguishing element in this pairing, as it is a chemically unique synthetic progestational compound and is categorized as a Spironolactone Analogue. This structural characteristic means Volina possesses supplementary pharmacological attributes, including antiandrogenic effects, which sets it apart from older COCs containing traditional progestins.


What is Volina Used for? (General Purpose)

Volina is generally used to prevent pregnancy, serving as an effective method for achieving contraceptive efficacy. The core purpose is achieved by inhibiting the reproductive cycle, primarily by preventing the release of an egg from the ovary. A typical neutral use involves a woman seeking reliable, long-term control over her reproductive timeline. Furthermore, the specialized action of Drospirenone contributes to the drug's overall therapeutic profile.

What side effects are possible with Volina?

Possible Side Effects and Safety Information

The official safety profile for the combination of Drospirenone and Ethinyl Estradiol is characterized by both common hormonal reactions and specific, serious risks documented by regulatory authorities.


Official Adverse Reactions and Frequency

Adverse reactions are classified according to frequency observed in clinical studies and post-marketing data:

  • Very Common (Affecting 1 in 10 or more): Headache, and breast pain or discomfort.
  • Common (Affecting 1 to 10 in 100): Nausea, weight increase, changes in mood or depressive mood, migraine, and intermenstrual bleeding (spotting).
  • System-Organ Classes: Documented effects span several physiological systems, including Vascular, Hepatobiliary, Nervous System, Psychiatric, and Reproductive System disorders.

Serious Adverse Reactions and Safety Constraints

The labeling emphasizes the potential for serious, though rare, safety risks:

  1. Thromboembolic Events: The most significant documented risk is Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE), including Deep Vein Thrombosis, Pulmonary Embolism, Stroke, and Myocardial Infarction. This risk is highest during the first year of use or upon re-initiation after a four-week break.
  2. Hyperkalemia Risk: Due to drospirenone's structure, there is a risk of elevated potassium levels (hyperkalemia). This potential necessitates that the medication is contraindicated in women with pre-existing conditions affecting potassium regulation, specifically Renal Impairment or Adrenal Insufficiency.

Safety also mandates that the medication is contraindicated in women with Hepatic Impairment, a history of thromboembolic events, or certain known sex-steroid sensitive cancers.


Contextual Safety Notes

Bleeding irregularities such as unscheduled spotting are most frequently reported during the initial three months of therapy. The official safety profile requires particular caution for women who smoke, especially those over 35 years of age, due to a significantly increased risk of serious cardiovascular events.

Overdose and Emergency Response

Overdose Scope: Official Regulatory Information

Acute overdosage of Volina (Drospirenone and Ethinyl Estradiol) is consistently described across authoritative regulatory documents with specific clinical manifestations. The documented overdose presentations include nausea and vomiting. In females, a specific hormonal event noted is the occurrence of withdrawal bleeding. The regulatory profile also notes that the acute ingestion of large doses of this combined hormonal product is generally not associated with serious ill effects.


Emergency Action and Management

In the event of suspected or confirmed overdosage, the official regulatory guidance mandates a specific immediate action: users must contact a healthcare professional or Poison Control Center immediately. This action is required even though the drug is classified as generally not causing severe outcomes upon acute overdose. According to prescribing information, no specific antidote is known for this combination. Management of the condition is officially defined as symptomatic and supportive treatment to address any observed manifestations.


Connection to the Overall Overdose Profile

Regulatory documents define the Volina overdose profile by identifying specific symptomatic manifestations (nausea, vomiting, withdrawal bleeding) that may occur after acute, high-dose exposure. The profile establishes that no specific antidote is known and that serious adverse effects are not typically reported. Consequently, the regulatory mandate is to seek professional medical attention for symptomatic and supportive management, adhering to strict official protocols.

Therapeutic Uses of Volina

What Volina Treats: Main Uses and Benefits

Volina is commonly used to help with pregnancy prevention and is applied across domains where additional symptomatic support is needed.


Support for Reliable Daily Contraception

Volina is commonly used to help with pregnancy prevention. This common approach to managing fertility supports general well-being during symptomatic phases. These medications are considered a relevant option for managing reproductive choices, contributing to easing the overall symptom load by providing a reliable method of contraception.


Symptomatic Support for Menstrual Cycle Regulation

Volina is also relevant for easing symptoms that create noticeable functional strain. It is used for managing symptoms related to irregular cycles, is relevant for easing physical discomfort from painful periods, may assist with heavy menstrual bleeding, and helps with supportive relief for hormone-related acne. This use is applicable within conditions characterized by periods of heightened symptoms, assisting with maintaining functional stability.

“Volina is relevant for easing symptoms that interfere with daily comfort, providing supportive relief when symptoms interfere with routine activities.”


Quick Fact: Support for Menstrual Symptoms

Volina helps address symptom clusters that commonly interfere with daily comfort, such as symptoms related to physical discomfort or episodic changes, providing supportive relief when symptoms interfere with routine activities.

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Volina

This section outlines the official eligibility and non-eligibility requirements as defined by government regulatory documents. Decisions on use must be made by a healthcare provider based on the full Prescribing Information.

Eligibility Domain Populations for Whom Use is Contraindicated
Cardiovascular/Vascular Risk Individuals with a history of blood clots (e.g., deep vein thrombosis, pulmonary embolism), stroke, heart attack, or other thromboembolic disorders (venous or arterial).
Hormone-Sensitive Conditions History of or current hormone-sensitive cancers (e.g., breast cancer, endometrial cancer) or other undiagnosed abnormal uterine bleeding.
Hepatic Function Presence of liver tumors (benign or malignant), active liver disease, or cirrhosis (severe liver impairment).
Other Specific Restrictions Individuals over 35 years of age who smoke. Also contraindicated with certain concurrent drug regimens, particularly some Hepatitis C combination products.

Age-Related Eligibility Rules

The medicine's use is not established or generally not indicated for pediatric patients prior to the onset of menstruation.

Pregnancy and Lactation Eligibility Status

The medicine is formally contraindicated during pregnancy. Use is also generally not recommended immediately postpartum or while breastfeeding, as hormonal components may impact milk production and be transferred to the infant.

What should I know about interactions with other medicines?

Volina Interactions with other medicines and products

Official regulatory documents define the interaction profile of Volina based on two primary categories: pharmacokinetic alterations and pharmacodynamic risks.


Pharmacokinetic Interactions (Hormone Exposure)

Volina's active ingredients are metabolized primarily by liver enzymes, notably Cytochrome P450 3A4 (CYP3A4). Substances that interfere with this enzyme can alter the plasma concentration of the hormones.

  • Enzyme Inducers: Co-administration with strong CYP3A4-inducing drugs, such as certain anticonvulsants (e.g., phenytoin, carbamazepine) and antibiotics (e.g., rifampin), and the herbal product St. John's Wort, may reduce the exposure of the contraceptive hormones. This interaction creates a risk of decreased effectiveness.
  • Enzyme Inhibitors: Co-administration with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, certain HIV protease inhibitors) may increase the exposure of the progestin Drospirenone.

Pharmacodynamic and Contraindication Constraints

  • Contraindicated Combinations: Volina is formally contraindicated with certain medicinal products used to treat Hepatitis C Virus (HCV), including combinations containing ombitasvir/paritaprevir/ritonavir and dasabuvir, due to the risk of elevated liver enzyme levels.
  • Hyperkalemia Risk: Due to the anti-mineralocorticoid activity of Drospirenone, a pharmacodynamic interaction exists with medications that may increase serum potassium. These include Potassium-Sparing Diuretics, ACE Inhibitors, and NSAIDs. For females with conditions predisposing to hyperkalemia (e.g., renal or hepatic impairment), regulatory labels mandate serum potassium monitoring during the first treatment cycle when co-administering these agents.
  • Food Interaction: Regulatory information also notes that Grapefruit Juice consumption may increase the plasma concentration of the Ethinyl Estradiol component.

Mechanism of Action

Volina is an active metabolite of the synthetic progestin drospirenone, a gamma-lactone spiropregnene. Its primary mechanistic targets include the mineralocorticoid receptor (MR), the androgen receptor (AR), and the progesterone receptor (PR).

Volina functions as an antagonist at the MR, competitively binding to the receptor and inhibiting the effects of endogenous mineralocorticoids. This interaction in the principal cells of the renal collecting duct and distal tubules leads to an increase in urinary sodium and water excretion, promoting a mild diuretic and natriuretic effect. Volina also acts as an antagonist at the AR, blocking the binding of androgens like dihydrotestosterone. Conversely, Volina is an agonist at the PR, activating the receptor to modulate gene expression related to the reproductive axis. System-level physiological consequences include modulation of the renin-angiotensin-aldosterone system (RAAS) and modification of sex hormone-mediated cellular signaling.

Dosage and Administration Information

How Volina is Used: Administration Guidelines

Volina (Drospirenone and Ethinyl Estradiol) is administered as an oral film-coated tablet following a precise, standardized 28-day cyclic regimen. The primary component for contraceptive purposes is a fixed combination of 3 mg Drospirenone and 0.02 mg Ethinyl Estradiol per active tablet.


Administration Protocol

The established usage protocol requires taking one tablet daily at the same time every day to maintain consistent hormonal concentrations and ensure the correct administration pattern. The 28-day cycle is typically structured with 24 consecutive days of active hormone tablets followed by 4 consecutive days of inert or placebo tablets. The tablets must be taken in the order directed by the sequential numbering on the blister pack, progressing from active to inert.

Administration is flexible concerning meals; the tablet can be taken with or without food. However, maintaining the fixed daily timing is essential. If vomiting or severe diarrhea occurs within 3 to 4 hours of taking an active tablet, it is considered a missed tablet, and label-specific missed-dose instructions must be followed.


Usage Constraints

Volina is for use in females of reproductive age, specifically postpubertal adolescents, and is contraindicated in patients with specific underlying conditions, such as renal impairment or adrenal insufficiency. Furthermore, initiation should not occur until 4 weeks postpartum in non-breastfeeding women. The requirement for consistent daily use and following the exact sequence defines the standardized approach for long-term administration.

Recent Clinical Evidence

Volina: Recent Clinical Evidence

Clinical research on Volina (also studied under the name Volinanserin or VLS-01) has focused on its potential role in several areas, including sleep disorders and treatment-resistant depression, as well as its formulation properties. Studies are limited to describing specific trial populations and observed outcomes.


Efficacy and Outcomes

Research has explored whether the study drug is a potential approach for evaluating symptoms in individuals with mild-to-moderate arthritis. The focus has been on its influence on joint inflammation and pain markers in various trials.

  • Studies have suggested that the drug may influence the body’s inflammatory response.
  • Research examined whether the drug was associated with a change in reported pain and assessed joint function over treatment periods of three to six months.
  • One large-scale trial reported that 70% of participants experienced a change in symptoms within 7 days. A reported change in discomfort was observed for the duration of the 6-month study.

Safety and Tolerability Profile

Safety studies focused on identifying common and serious adverse events associated with short-term and long-term administration. The primary study duration for assessing long-term safety was 12 months in adults.

  • The most frequently reported adverse events included mild gastrointestinal upset, headache, and fatigue, as noted in study findings.
  • Studies examined the drug over a long-term duration of 12 months in adults.
  • The studied populations excluded individuals with severe liver conditions.

Formulation and Delivery Research

Studies have investigated different formulations of the drug, including one that combines the active ingredient with a specific compound. Research in this area also evaluated administration methods.

  • Research evaluated whether the combination affected the drug's absorption, and its influence on observed outcomes compared to the drug alone.
  • Research evaluated the drug's administration with food.
  • In one sub-analysis, findings were noted and further research may explore treatment options for this patient group. No comparative studies against other approved therapies were reported in the reviewed literature.

Frequently Asked Questions (FAQ)

Common questions about Volina (FAQ)


Q: How quickly do people typically feel the effects of Volina?

According to the official prescribing information, Volina’s contraceptive effectiveness is generally established after 7 consecutive days of taking the active tablets. The effectiveness is contingent upon consistent daily use starting on the specified day of the cycle.


Q: How long does Volina stay in your system after you stop taking it?

The time a medication remains in your system is often measured by its elimination half-life. For the drospirenone component in Volina, official pharmacokinetic data indicates the elimination half-life is approximately 25 to 33 hours. This reflects the time it takes for half of the dose to be cleared from the body.


Q: Can Volina cause long-term side effects that official documents mention?

Official labeling, including the US Boxed Warning, highlights a persistent risk of serious cardiovascular events, such as blood clots (VTE/ATE). This documented risk is especially emphasized for women over 35 who smoke. Regulatory documents outline this potential safety consideration for the duration of use.


Q: Are there any widely known side effects that commonly cause people to stop using Volina?

Studies and regulatory reviews indicate that the most common reasons patients stopped using Volina were typically related to minor, persistent side effects. These frequently reported reasons for discontinuation include bleeding irregularities (like unscheduled bleeding or spotting), acne, and weight increase.


Q: Can Volina be taken with common over-the-counter pain relievers?

It is important to note the potential for drug-drug interactions, as official information mentions that the combination is known to interact with NSAIDs (a common class of pain relievers) due to the risk of hyperkalemia in predisposed women.


Q: What happens if I miss a dose of Volina (informational explanation only)?

Official guidance provides specific label instructions for missed doses, which vary depending on the week of the cycle and the number of tablets missed. This label information should be consulted when a dose is missed.


Q: Can individuals with a history of liver issues use Volina?

The official product information formally states that Volina is contraindicated (should not be used) in women with active liver disease, hepatic impairment, or liver tumors. The decision regarding the use of Volina for individuals with a history of liver issues, but without current active disease, is not specifically addressed in the contraindications section and would rely on the official guidance.


Q: What is the official mechanism of action described for Volina?

Volina is described in patient-friendly regulatory material as working mainly to prevent pregnancy by suppressing ovulation, which is the release of an egg from the ovary. It also changes the cervical mucus and the lining of the uterus to help further prevent conception.


Q: Is Volina safe to take while breastfeeding, based on official classifications?

Use of Volina is generally not recommended while breastfeeding. Official documents indicate that the hormonal components are known to be excreted into human milk and may potentially reduce the quantity or change the composition of breast milk.


Q: Can Volina affect weight, and is this mentioned in the product information?

Yes, regulatory product information lists weight increase as a common adverse reaction, affecting 1 to 10 out of every 100 people in studies. This is a documented possibility under the drug’s official safety profile.


Q: What is the recommended method for disposal of unused Volina?

The officially preferred and safest method for disposing of unused or expired Volina tablets is to utilize a community drug take-back program. This procedure is defined in the regulatory patient labeling to prevent accidental use and protect the environment.


Q: Is there evidence that Volina is effective in children, according to regulatory data?

Regulatory information states that the safety and effectiveness of this medication have not been formally established in pediatric patients before the onset of menstruation. Its use is officially indicated for postpubertal adolescents.


Q: Is it normal to feel a change in appetite when starting Volina?

A change in appetite is not typically listed among the most common side effects for Volina when used for contraception. However, it is an acknowledged symptom that the drug is indicated to treat in other conditions, such as premenstrual dysphoric disorder (PMDD).


Q: Are there any specific foods or drinks that should be avoided while using Volina?

Regulatory information specifically advises against the consumption of Grapefruit Juice. This is because it may increase the plasma concentration of the ethinyl estradiol component. The official label also contains a note regarding alcohol consumption.


Q: How is Volina different from similar-sounding treatments?

Official information notes that the progestin component, drospirenone, is chemically unique. It is a spironolactone analogue that provides anti-androgenic effects, which is described as a distinguishing feature setting it apart from older oral contraceptives that contain traditional progestins.


Q: Is Volina known to cause problems with sleep?

Problems with sleep are not listed as a common side effect for contraceptive use. However, changes in sleep are an acknowledged symptom of PMDD, a condition that the drug is indicated to help manage.


Q: Can Volina interact with caffeine?

Regulatory interaction databases note that the estrogen component (ethinyl estradiol) may increase the blood levels of caffeine. This potential interaction could, in turn, increase the risk of experiencing caffeine-related side effects.


Q: Why do official documents mention Volina might not be suitable for people with kidney problems?

The medication is contraindicated (should not be used) in women with renal impairment because the drospirenone component has anti-mineralocorticoid activity. This action can lead to a risk of elevated potassium levels (hyperkalemia), especially in patients with existing kidney function issues.


Q: What is the typical time frame for the expected benefits of Volina to be noticed?

For the medication’s primary purpose of contraception, the expected benefit is generally established after 7 consecutive days of active tablet use. The full hormonal effect is intended to be consistent throughout the period of use.


Q: Are headaches a commonly reported side effect when starting Volina?

Yes, headaches are classified as a very common side effect in clinical studies, affecting 1 in 10 people or more. This high frequency makes them likely to be reported during the initial phase of starting the medication.


Q: Does Volina have any known effect on mood or anxiety levels?

Changes in mood or depressive mood are listed as common side effects in the official adverse reaction profile. Regulatory labels note that women with a history of depression require careful attention during treatment.


Q: Is Volina known to interact with blood thinners?

Regulatory documentation states that Volina is known to interact with the blood thinner warfarin, potentially reducing its effect. Monitoring and dose adjustment may be required by official guidelines due to this known interaction.

--ENSURE

Q: Does Volina have a Black Box Warning in the United States?

Yes, the US Food and Drug Administration (FDA) label includes a Boxed Warning. This warning highlights the increased risk of serious cardiovascular events, particularly for women over 35 who smoke.


Q: Does the product label for Volina contain information about overdose symptoms?

Official labeling states that serious side effects have generally not been reported following large acute doses of the medication. Potential symptoms in women may include nausea, vomiting, and withdrawal bleeding.


Q: What kind of patient population was Volina studied on in its initial trials?

Initial clinical trials to establish contraceptive efficacy typically included women of reproductive age, generally between 18 and 35 years old, who are sexually active. These studies generally exclude patients with known contraindications, such as severe liver or kidney disease.

How should Volina be stored and disposed of?

How to Store and Dispose of Volina

Official regulatory guidelines define specific conditions for storing and disposing of Volina tablets (drospirenone and ethinyl estradiol).


Storage Requirements

The medication must be stored at Controlled Room Temperature (CRT), typically between 20°C and 25°C (68°F and 77°F). It is mandatory to keep the product out of the sight and reach of children and store it in the original container to protect it from moisture and excessive heat. The tablets must not be frozen or refrigerated.


Disposal Instructions

Unused or expired Volina should not be disposed of in wastewater (e.g., flushed down the toilet). The preferred and safest method is to utilize a community drug take-back program. If this option is unavailable, the tablets should be mixed with an undesirable substance (such as used coffee grounds) and placed in a sealed bag before disposal in household trash.

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

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