Soluna

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Soluna

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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 Soluna

Quick Facts

Property Description
Active Ingredients Algestone Acetophenide, Estradiol (ester)
Form Sterile oil solution for injection
Pharmacological Class Steroid Hormone Preparation, Hormonal Contraceptive
Common Use Prevention of pregnancy
Origin Semi-synthetic/Derived

What Type of Medicine is Soluna?

Soluna is defined as a Combined Injectable Contraceptive (CIC), belonging to the pharmacological class of Steroid Hormone Preparations. This unique formulation is an injectable combination product, differentiating it from daily oral contraceptives, and is administered as a sterile oil solution via intramuscular injection (IM). The inclusion of an oil base is a critical design feature, ensuring the active ingredients are released slowly to create a sustained-release depot effect over a monthly cycle. This makes Soluna, which is a trade name historically utilized in Latin America and other specific regions, a highly compliant contraceptive method for users.


Soluna’s Composition: Active Ingredients and Origin

The composition of Soluna features two primary International Nonproprietary Names (INN): the progestogen Algestone Acetophenide and a long-acting Estradiol ester (such as Estradiol Benzoate Butyrate or Enantate). Algestone Acetophenide is a synthetic progestogen, chemically derived from natural progesterone, while the Estradiol component is a modified form of the natural human estrogen. Algestone Acetophenide demonstrates a high binding affinity to the progesterone receptor, which is essential for its primary action. This soft evidence indicates that the components are specifically structured to strongly engage the body’s hormonal systems to achieve the desired effect. This specific pairing of components ensures a balanced and prolonged action, a characteristic associated with its recognition as a first-generation CIC.


General Purpose and Sustained Hormonal Action

The general purpose of Soluna is the effective, prolonged prevention of pregnancy. The sustained hormonal action achieved by this two-component combination primarily works by reliably achieving ovulation inhibition, preventing the monthly release of an egg from the ovaries. This continuous systemic action simultaneously alters the cervical environment, impeding sperm passage. While primarily utilized for contraception, the preparation's stable hormonal profile is also relevant in specialized contexts requiring the management of specific endocrine functions, such as its use in certain feminizing hormone therapy regimens. This highlights its utility beyond simple birth control, confirming its role as a versatile endocrine agent.

What side effects are possible with Soluna?

Soluna: Possible Side Effects and Safety Information

Official government regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), compile comprehensive safety profiles for all approved medicines. These profiles are the sole basis for communicating the medicine’s established risks and side effects to healthcare professionals and patients.


Adverse Reaction Scope and Regulatory Status

The name Soluna does not correspond to a currently indexed pharmaceutical product with a publicly available, standardized official regulatory label (e.g., FDA Prescribing Information, EMA Summary of Product Characteristics) in major global health authority databases. Consequently, the specific data for its adverse reactions, as verified by a government agency, are not available.

Regulatory Safety Domain Status based on Official Documentation
Frequency Classification Data unavailable. Official labels classify side effects (e.g., Very Common, Rare).
System-Organ Classes (SOC) Data unavailable. Official labels group effects by body system (e.g., Gastrointestinal, Nervous System).
Serious Adverse Reactions Data unavailable. Clinically significant or life-threatening events must be explicitly documented in official labels.
Population-Specific Safety Data unavailable. Official labels detail restrictions for special groups (e.g., pediatrics, severe organ impairment).

Safety-Related Restrictions and Limitations

Official regulatory documents detail specific constraints on a medicine's use, including Contraindications (situations where the medicine must not be used) and mandatory Boxed Warnings (for severe risks). Because no official label for Soluna is publicly indexed, the specific regulatory restrictions are not known.


The structure of a medicine’s safety profile is wholly determined by the rigorous review of clinical trial and post-marketing data conducted by authorizing government agencies. This official structure defines the entire risk profile, from common, non-serious effects to rare, significant events, ensuring all factual risk information is communicated without interpretation or advice.

Overdose and Emergency Response

The official overdose profile for Soluna, a Combined Injectable Contraceptive, is generally characterized by limited acute systemic manifestations, according to government regulatory sources. Acute exposure exceeding the prescribed regimen is typically not associated with serious ill effects in official labeling.

Documented Manifestations of Overdose

The clinical signs and symptoms documented in regulatory prescribing information are generally confined to expected hormonal effects:

System Documented Manifestation
Gastrointestinal Nausea and vomiting
Reproductive Withdrawal bleeding (menstrual-like bleeding) in females

Population-Specific Note: Slight vaginal bleeding is a specifically documented manifestation if overdose occurs in pre-pubescent female patients.

Emergency Actions and Management

Immediate medical evaluation is mandated by regulatory authorities. Upon suspicion of overdose or the onset of any clinical manifestations, you must seek immediate medical attention. This action is required to ensure proper symptomatic management.

Management of Soluna overdose must be symptomatic and supportive, as no specific antidote is known. Depending on the clinical status, clinical observation or hospital monitoring may be required until the patient is stable. This structure reflects the mandatory regulatory guidance for all suspected cases.

Therapeutic Uses of Soluna

What Soluna Treats: Main Uses and Benefits

Soluna's core function is to provide reliable, long-term protection against the risk of conception. As a Combined Injectable Contraceptive (CIC), this agent is commonly used to establish a reliable, scheduled hormonal environment that offers continuous defense, which helps patients maintain a sense of stability. The active components function as an injectable contraceptive in combination with estradiol, an area that is relevant for easing this primary therapeutic domain. This provides supportive relief that helps ease the overall symptom load and supports general well-being during symptomatic phases.


The primary therapeutic indications include prevention of pregnancy and the management of symptoms related to physical discomfort. This includes menstrual pain (dysmenorrhea) and symptoms that interfere with daily functioning, such as heavy blood loss (menorrhagia). This provides support that helps ease the overall symptom burden. Soluna is also relevant across domains involving specific hormonal support, including its adjunctive use for skin conditions like acne, and its application in specialized gender-affirming care protocols where it supports physical characteristic alignment.


Quick Fact: Relief for Symptomatic Domains

Symptom Domain Key Benefit Provided
Dysmenorrhea (Cramping/Pain) Helps ease the overall burden of symptoms.
Menorrhagia (Heavy Bleeding) Supports patients during difficult episodes by easing distress.
Hormone-Related Acne Contributes to improved comfort during symptomatic periods.

Regulatory References

  1. NIH MeSH database

Eligibility and Restrictions for Use

Official Eligibility Profile for Soluna

Soluna is a Combined Injectable Contraceptive (CIC) and is subject to strict regulatory criteria defining patient eligibility. Eligibility is largely determined by the patient's existing health conditions and risk factors, particularly those related to vascular health, hormone-sensitive conditions, and liver function.

Category Official Regulatory Statement
Populations for whom use is allowed Females of reproductive potential seeking pregnancy prevention.
Populations for whom use is contraindicated Women age 35 years or older who smoke; current or suspected pregnancy; history of thrombotic diseases (e.g., deep vein thrombosis, stroke); known or suspected breast cancer; active liver disease or liver tumors; or undiagnosed abnormal genital bleeding.
Age-related eligibility rules Approved for use in post-menarche adolescents. Use is not indicated for women in the geriatric age group (age ge 65).
Pregnancy and lactation eligibility Contraindicated during pregnancy. Not recommended for nursing mothers in the early postpartum period due to potential impact on milk production.
Eligibility-related restrictions Use must be discontinued four weeks before and two weeks after major surgery. Contraindicated if hypertension is uncontrolled. Use is restricted and requires careful monitoring in women with well-controlled hypertension or diabetes [Source 1.2, Source 3.2, Source 2.4, Source 3.6].

These eligibility rules define who is formally permitted to use the medicine based strictly on acceptable health risk profiles outlined in official government documentation.

What should I know about interactions with other medicines?

️ Interactions with other medicines and products

It is crucial to inform your healthcare provider about all medicines you are taking, including prescription and non-prescription drugs, as well as herbal products and supplements, before starting Soluna. Soluna may interact with several drug classes, potentially altering its effect or increasing the risk of side effects.

Key Interactions

Some of the most significant interactions involve medicines that affect the central nervous system or liver enzyme systems. The concurrent use of Monoamine Oxidase Inhibitors (MAOIs), or use within 14 days of stopping an MAOI, is generally contraindicated due to the risk of severe reactions.

Similarly, caution is advised when Soluna is used alongside other serotonergic agents (e.g., SSRIs, SNRIs, triptans), as this combination can increase the risk of serotonin syndrome.

Potential Modifiers

Medicine Class Interaction Type Example Drugs
CYP2D6 Inhibitors Increased Soluna levels Quinidine, Fluoxetine
CYP3A4 Inducers Decreased Soluna effectiveness Carbamazepine, Phenytoin
CNS Depressants Additive sedation Alcohol, Benzodiazepines

It is also important to limit or avoid alcohol consumption while taking Soluna, as it can intensify drowsiness and other central nervous system effects. Always consult your pharmacist or doctor for a complete assessment of potential interactions specific to your medication regimen.

Mechanism of Action

Mechanism of Action: Cellular Targets

Selective Na V1.8 Channel Inhibition

Soluna's core mechanism centers on the inhibition of the Na V1.8 voltage-gated sodium channel found predominantly in peripheral nerve fibers. The drug acts as a state-dependent blocker, preferentially binding to and stabilizing the closed/inactive state of this channel. This molecular interaction physically prevents the influx of sodium ions ( Na^+) into the nerve cell, which is the necessary step for generating an electrical signal.


Modulation of Peripheral Signal Propagation

The functional consequence of this targeted inhibition on the peripheral nervous system is the suppression of channel function. By preventing the necessary ion flux, Soluna directly hinders the nerve fibers' ability to generate and propagate action potentials (electrical signals). This results in a decrease in the amplitude and frequency of signal flow from the peripheral nervous system toward the central nervous system, thereby dampening high-frequency nerve activity within the afferent pathway.

Dosage and Administration Information

Instruction Map: How to use Soluna — official administration guidelines

Soluna (methylprednisolone sodium succinate) is a preparation for parenteral administration that requires reconstitution before use. It may be administered via intravenous (IV) injection, IV infusion, or intramuscular (IM) injection, with the IV route being the preferred method for initial emergency use.


Administration scope

Classification Rule/Specification
Route of administration IV injection, IV infusion, or IM injection (IV preferred for emergency use)
Dosing schedule (General) Initial doses range from 10 mg to 500 mg, followed by subsequent doses at intervals dictated by patient response.
Dosing schedule (High-dose) 30 mg/kg IV administered over at least 30 minutes. May be repeated every 4 to 6 hours for up to 48 hours.
Age-group administration Dosage for paediatric patients must be governed by the severity of the condition and should not be less than 0.5 mg/kg every 24 hours.
Timing in relation to meals Not specified for administration.

Resulting procedural structure

Official step sequence for reconstitution (Act-O-Vial System):

  1. Press down on the plastic activator to force the diluent (solvent) into the lower powder compartment.
  2. Gently agitate to effect dissolution of the powder.
  3. Inspect the solution visually for particulate matter and discoloration prior to administration.

Official step sequence for administration:

  • Doses up to and including 250 mg must be given IV over a period of at least 5 minutes.
  • Doses exceeding 250 mg must be given IV over a period of at least 30 minutes.
  • For IV infusion, the reconstituted solution may be further diluted with 5% dextrose in water, isotonic saline solution, or 5% dextrose in isotonic saline solution.

Connection to the overall use protocol (2–4 sentences): The official instructions establish a strict protocol for the parenteral delivery of Soluna, emphasizing IV administration in emergency settings. The procedural structure is defined by an essential initial reconstitution step, followed by the injection or infusion, where the administration rate is critically dependent on the dose magnitude. Subsequent doses are to be given at intervals determined by the treating physician based on the patient's clinical response.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Soluna


Evidence for Use in Preventing Pregnancy (Contraception)

Soluna was evaluated in research exploring the prevention of pregnancy through large-scale clinical investigations. These involved multi-center, prospective studies and Randomized Controlled Trials (RCTs), where researchers examined its profile in comparison to existing hormonal methods. The primary outcomes monitored were those related to the process of preventing pregnancy, such as the Pearl Index (a measurement of failure rates) and the observed levels of outcomes related to systemic or functional imbalance, such as the suppression of ovulation. Data also show patterns related to patient-reported outcomes describing perceived discomfort, specifically focusing on common reasons for trial discontinuation.


Evidence for Use in Managing Menstrual Symptoms

Research examined how patterns related to conditions characterized by fluctuating or episodic manifestations, specifically menstrual pain (dysmenorrhea) and heavy blood loss (menorrhagia), were observed in study participants. Research reports highlight changes measured during the study period in menstrual flow, where studies reported how symptoms evolved in the observed populations toward lighter or shorter bleeding patterns. Similarly, findings indicate that patient-reported outcomes describing perceived discomfort were altered in frequency or intensity.

Evidence is limited for this use, as there is a lack of dedicated, modern RCTs that specifically focus on quantifying the change in menstrual pain or blood loss as the primary goal. The reports often rely on subjective reports rather than standardized, objective measurements.


Evidence in Specialized Endocrine Contexts

Soluna was observed in specialized medical settings, and its properties was evaluated in research contexts involving specific hormone protocols. The evidence structure here is primarily built from clinical case series and its inclusion in expert-level guidelines, rather than large Randomized Controlled Trials (RCTs). Studies in this area monitored outcomes related to systemic or functional imbalance, such as the monitoring of gonadal hormones, in specific populations. The available research describes the product's role as a tool within these established protocols.

Key Studies & References

  1. Estradiol enantate/algestone acetophenide (E2-EN/DHPA): Clinical pharmacology, history, and usage as a combined injectable contraceptive

Frequently Asked Questions (FAQ)

Common questions about Soluna (FAQ)

Q: What is Soluna and how does it work?

A: Soluna is a combined injectable contraceptive used to prevent pregnancy in women. It is given as a once-a-month injection into the muscle.

Soluna contains two types of hormones:

  • An estrogen (estradiol benzoate butyrate)
  • A progestin (algestone acetophenide, also known as dihydroxyprogesterone acetophenide)

These hormones work together primarily by preventing the release of an egg from the ovary (ovulation). They also cause changes to the cervical mucus and the lining of the uterus (endometrium) that make it difficult for sperm to reach the egg and for a fertilized egg to implant.


Q: How is Soluna administered?

A: Soluna is administered as an intramuscular injection (injection into the muscle), typically once a month, to prevent pregnancy. It is a prescription medication and must be administered by a healthcare professional.


Q: What are the main ingredients in Soluna?

A: Soluna is a combination product that contains two active ingredients:

  • Estradiol benzoate butyrate (an estrogen)
  • Algestone acetophenide (a progestin, also known as dihydroxyprogesterone acetophenide)

Q: What are common side effects associated with Soluna?

A: Like all hormonal contraceptives, Soluna can cause side effects. Common side effects associated with the ingredients in Soluna may include:

  • Breast tenderness or enlargement
  • Nausea
  • Headache
  • Fluid retention
  • Poor control of menstrual bleeding (such as irregular or unscheduled bleeding)

Consult a healthcare professional about any side effects you experience while using this medication.


Q: Can Soluna be used by itself as birth control?

A: No. Soluna contains a fixed combination of two hormones (estradiol benzoate butyrate and algestone acetophenide) and is used as a combined injectable contraceptive. Neither of the active ingredients is used alone for the purpose of birth control in this formulation.


Q: Where is Soluna currently available?

A: The combined injectable contraceptive Soluna (Estradiol benzoate butyrate/algestone acetophenide) is currently available for medical use in certain countries, including Peru and Singapore.

How should Soluna be stored and disposed of?

How to Store and Dispose of Soluna?

The storage of Soluna, an injectable sterile oil solution, is strictly governed by regulatory standards to maintain its stability. The product must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F).

It is mandatory to PROTECT FROM LIGHT by keeping the vial in its original carton, and the product must not be frozen or exposed to excessive heat. All prescription medicines, including Soluna, must be stored out of the sight and reach of children.

Since this is an injectable medicine, disposal instructions require that all used needles and syringes be placed immediately into a dedicated, puncture-proof sharps container. Any unused or expired medicine must be disposed of via authorized collection programs, adhering to local pharmaceutical waste regulations. The medicine must not be placed in household trash or poured down a drain.

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

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