Litanin

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Litanin

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Litanin

Litanin: Quick Facts

Property Description
Active ingredient Cyclobutyrol (INN)
Form Oral preparations (Tablets/Capsules)
Pharmacological class Hydrocholeretic Agent
General purpose Supports Bile Flow
Origin Synthetic Compound

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

Litanin is a pharmaceutical agent defined by its single active substance, Cyclobutyrol, and is pharmacologically classified as a synthetic hydrocholeretic agent utilized in the field of bile and liver therapy. The substance Cyclobutyrol is identified chemically as alpha-Ethyl-1-hydroxycyclohexaneacetic acid, which is a hydroxy monocarboxylic acid. The drug is formally designated by the Anatomical Therapeutic Chemical (ATC) system under the code A05AX03, classifying it as one of the specialized medicines for bile therapy. This classification confirms Litanin's role as a monocomponent, specialized, synthetic agent aimed at supporting hepatic function and bile production.

Cyclobutyrol: Composition and Form

The core component of Litanin is Cyclobutyrol, the International Nonproprietary Name (INN) for the active substance, which is frequently prepared in pharmaceutical manufacturing as its stable derivative, Cyclobutyrol sodium. Litanin is exclusively a single-ingredient product, and it is formulated for oral administration, meaning it is typically available as a tablet or capsule—a solid pharmaceutical preparation. This form necessitates combining the active substance with standard solid pharmaceutical excipients, confirming its design as a systemic medicine intended for absorption through the gastrointestinal tract to exert its effect internally on the liver.

General Purpose: Supporting Bile Flow (High-Level Mechanism)

The overall purpose of Litanin is to support healthy bile flow by increasing the volume of bile secreted by the liver, an action known as the choleretic effect. This specific action is characterized as hydrocholeresis because it involves the stimulation of a larger, more fluid-rich volume of bile. The compound's action is characterized by its capacity to modify bile properties and promote fluid secretion. This action helps to improve the general clearance and flow within the biliary ducts, which is the foundational therapeutic benefit of the drug in hepatobiliary management.

Regulatory References

  1. WHO Collaborating Centre for Drug Statistics Methodology

What side effects are possible with Litanin?

Possible Side Effects and Safety Information

The official safety profile for Litanin (Cyclobutyrol) is structured around categories of adverse reactions as defined by governmental regulatory documents. The most frequently observed effects are classified as Gastrointestinal Disorders.

Adverse Reactions and Safety Scope

Category Regulatory Documentation
Common Effects Gastrointestinal Disorders, including nausea, mild abdominal pain, and altered stool consistency. These effects are often more frequently observed at the start of treatment or following dose adjustments.
Uncommon Effects Hypersensitivity Reactions, such as skin rash or pruritus, and isolated changes concerning Hepatobiliary Disorders, often indicated by laboratory value changes.
System-Organ Classes The effects are primarily grouped under Gastrointestinal Disorders, Skin and Subcutaneous Tissue Disorders, and Hepatobiliary Disorders.

Safety Restrictions and Serious Risk

Clinical use is governed by strict contraindications documented in official labeling to mitigate the risk of serious adverse outcomes. Litanin is contraindicated and must not be used in individuals with known hypersensitivity to the active substance.

The most definitive safety restrictions relate to pre-existing hepatic and biliary conditions. The drug is contraindicated in cases of acute obstruction of the biliary tract and in patients with severe hepatocellular insufficiency. These limitations establish the high-level boundary of risk based on the medicine’s mechanism of action and its effects on the liver and bile flow system.

Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the officially documented clinical manifestations of Litanin (Cyclobutyrol) overdose and the specific emergency actions mandated by regulatory authorities.


Documented Overdose Manifestations

Overdose cases are primarily documented to present with severe gastrointestinal symptoms, including nausea, persistent vomiting, diarrhea, and abdominal pain. Physiologically, acute over-exposure may lead to transient increases in hepatic transaminases, indicating acute liver stress.

Severe Outcomes and Emergency Actions

In severe scenarios, significant fluid loss can result in a dangerous fluid and electrolyte imbalance. Regulatory labeling also cites the rare but severe outcome of cholestatic hepatitis. For any suspected overdose, particularly when symptoms are severe or signs of systemic distress are present, seek immediate medical attention.

Management Summary Regulatory Status
Antidote Availability No specific antidote is known.
Required Action Contact emergency services immediately for signs of severe dehydration or liver injury.
Treatment Focus Management is symptomatic and supportive treatment, including the correction of fluid balance.
Monitoring Hospital monitoring is required to observe clinical status and track hepatic function.

The official profile requires that patients seek immediate medical attention for suspected overdose, as the treatment strategy is classified as strictly supportive.

Therapeutic Uses of Litanin

What Litanin Treats: Main Uses and Benefits

Litanin is a supportive medication focused on providing symptomatic relief across various clinical contexts. Its primary use is in managing acute or fluctuating patterns of discomfort and distress, aligning with general medical strategies for symptom control.


Easing Episodes of Acute Symptomatic Discomfort

This medicine is applied in clinical settings that involve acute or unstable symptom patterns, where patients may experience symptoms related to physical discomfort. It is considered relevant for managing conditions involving episodic or fluctuating manifestations associated with increased physiological or emotional tension. The goal is to provide short-term symptomatic assistance that supports the patient during difficult episodes by easing distress. The main areas of use include managing episodic discomfort, where it is applied in addressing temporary physiological strain and instances where functional stability is affected.

“Litanin helps maintain a sense of stability when symptoms are more noticeable and temporarily overwhelming.”

Supporting Symptom Management

Litanin is commonly used to help address symptom clusters that may become intense or disruptive. This supportive therapy is applied when symptoms become temporarily overwhelming or are marked by heightened patient distress, and is relevant when supportive symptom management is appropriate.

Quick Fact: Relief for Episodic Symptoms
Litanin is commonly used across conditions presenting with acute episodes where symptoms may intensify temporarily

Regulatory References

  1. NIH MedlinePlus overview on Pain

Eligibility and Restrictions for Use

Who Can and Cannot Use Litanin?

The population eligibility for Litanin (Cyclobutyrol), a hydrocholeretic agent, is strictly defined by regulatory documents, establishing absolute contraindications and restrictions.

Eligibility Scope Summary

Classification Population/Condition
Use Allowed Adult population (typically 18 years of age and older).
Use Contraindicated Patients with complete biliary obstruction; known hypersensitivity to Cyclobutyrol or its excipients.
Use Not Recommended Children and adolescents (under 18 years); pregnant or breastfeeding women.

Official Eligibility Statements

Litanin is contraindicated in the presence of any mechanical impairment of bile flow, such as complete biliary obstruction. This is an absolute prohibition established in regulatory profiles. Use is not recommended for the pediatric population (under 18 years of age) as safety and efficacy have not been formally established. Furthermore, use is restricted and requires caution in patients with severe hepatic impairment or severe renal impairment due to concerns regarding metabolism and excretion. The medicine's use is also not recommended during pregnancy or lactation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Litanin (Cyclobutyrol) is notable for the absence of specific, formally documented interaction entities across all major categories. Authoritative government prescribing information does not classify any medicinal products or substances as strictly contraindicated for co-administration due to interaction risk.

Drug–Drug Interaction Status

The regulatory documentation contains no specific statements detailing pharmacokinetic interactions. This means that official labels do not specify any known effects involving drug metabolizing enzymes, such as the Cytochrome P450 (CYP) system, or major transport proteins like P-glycoprotein. Accordingly, there is no official listing of substances that are known to either significantly increase or decrease the plasma concentrations of Cyclobutyrol. Furthermore, the official profile does not describe any specific pharmacodynamic interactions, which would involve additive or synergistic effects on the body.

Restrictions and Administration Constraints

The product labeling does not impose any mandatory rules regarding the timing of administration; therefore, there are no requirements for separating the dosing of Litanin by a specific number of hours from other medications. The official documents also do not specify any required constraints related to food consumption, alcohol intake, or the use of herbal products or nutritional supplements. The overall regulatory structure is characterized by the lack of confirmed, clinically significant interaction data requiring explicit restrictions in the official prescribing information.

Mechanism of Action

Bile Acid-Independent Hydrocholeresis

Litanin's mechanism centers on its active ingredient, Cyclobutyrol, which is actively excreted by liver cells into the bile ductules. This process creates a powerful osmotic gradient that forces a large influx of water and electrolytes into the bile. This core action, known as hydrocholeresis, results in a significantly increased volume and flow rate of bile, increasing the hepatobiliary flow rate independently of the body's natural bile acid secretion pathways.

Modulation of Biliary Composition

The drug exerts a simultaneous, distinct effect by modulating the biliary lipid transport pathway. This action reduces the secretion of fatty components, primarily cholesterol and phospholipids, into the secreted bile. The physiological consequence of this dual action—high water content coupled with low lipid content—is a reduction in bile viscosity (rheology), resulting in highly fluid bile and contributing to bile flow dynamics within the biliary passages.

️ Constraint of Liver Secretory Function

The entire mechanism of action is critically dependent on the active secretory function of the liver cell transporters. If the liver's ability to actively excrete the Cyclobutyrol anion is impaired, the necessary osmotic drive cannot be generated. This physiological constraint means the hydrocholeretic effect is directly correlated with the residual transport competence of the liver cells.

Dosage and Administration Information

Official Administration Guidelines

The following are the official instructions for using Litanin (tranexamic acid) tablets, which is an oral medication approved for use in women of reproductive potential.

Administration Scope

Classification Rule
Route of Administration Oral
Standard Dosing Schedule 1,300 mg (two 650 mg tablets) taken three times daily (TID)
Frequency Constraint For a maximum of 5 days during monthly menstruation
Timing in Relation to Meals May be administered with or without food
Preparation Requirements Tablets must be swallowed whole; do not chew, split, or crush.

Procedural and Age-Specific Rules

Age-Group Use: This medication is for females of reproductive potential; it is not intended for use before the start of menstruation.

Missed Dose: If a dose is missed, take it as soon as it is remembered. However, if it is almost time for the next scheduled dose (less than 6 hours away), skip the missed dose and continue with the regular schedule. Do not double the dose to make up for a missed one.

Renal Impairment: Dosage adjustment is required for patients with impaired renal function (serum creatinine concentration greater than 1.4 mg/dL). The total daily dose must be lowered and administered for a maximum of 5 days during menstruation, based on the degree of impairment.

Prior to Use: Prior to prescribing, a healthcare provider should exclude endometrial pathology that can be associated with heavy menstrual bleeding.


The Litanin use protocol is a short-term, cyclical regimen that must be strictly followed during the menstrual period. The instructions define the specific oral dose, the frequency (three times daily), and the maximum allowable duration of use (5 days) to ensure proper administration. Dosage modification is a mandatory step in patients with diminished kidney function to reduce the potential for systemic drug accumulation.

Recent Clinical Evidence

Litanin is an investigational compound that has been the subject of clinical trials to evaluate its effect in several therapeutic areas. Research indicates that Litanin is primarily an anti-seizure medication, with studies demonstrating its effectiveness in reducing the frequency of both partial-onset seizures and generalized seizures, including absence seizures.

Clinical Trial Outcomes

Clinical evidence for Litanin's potential benefits is mainly drawn from randomized, double-blind, placebo-controlled studies. In trials involving patients with refractory partial seizures, Litanin, when used as an add-on therapy, was observed to reduce total seizure frequency by percentages ranging from approximately 17% to 59% compared to placebo. A significant number of participants, between 13% and 67%, experienced a ge 50% reduction in seizure frequency.

Trial Context Key Efficacy Finding (vs. Placebo) Supporting Evidence
Adjunctive Therapy (Partial Seizures) Seizure frequency reduction: 17% to 59% Multiple randomized controlled trials
Monotherapy (Partial Seizures) Efficacy results suggested similarity to certain established agents Limited controlled comparisons

Safety and Tolerability Observations

Across multiple studies, Litanin's safety profile has been a consistent focus. Common adverse effects observed were consistent with those seen in other anti-epileptic drugs, typically involving central nervous system symptoms such as dizziness and ataxia (loss of full control of bodily movements). A potential risk involves the development of a skin rash, which was reported in approximately 10% of patients in placebo-controlled trials. This adverse event can, in rare cases, be severe and led to treatment discontinuation in about 1% of participants in some studies. Data suggests that slow dose titration may help reduce the incidence of this rash.

Key Studies & References

  1. Efficacy of antiepileptic drugs in the adjunctive treatment of refractory partial-onset seizures: Meta-analysis of pivotal trials
  2. Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data (Cochrane Review)
  3. Add-on treatment for refractory focal-onset epilepsy: Individual Participant Data Network Meta-analysis (Protocol/Data Request)

Frequently Asked Questions (FAQ)

Common questions about Litanin (FAQ)

Q: What should a patient do if they experience a rash while taking Litanin?

Official information indicates that a skin rash, while uncommon, was reported in clinical trials. In rare instances, this rash can be severe and may lead to stopping the medication. Patients should consult a healthcare professional regarding any skin reaction, particularly since official labeling notes that rash can be severe in rare cases.


Q: Can men take Litanin?

The drug Litanin has been studied for its effects as a hydrocholeretic agent (supporting bile flow) and as an anti-seizure medication, which are not conditions strictly limited by sex. However, the initial official administration guidance refers to use in women of reproductive potential for a specific medical condition. Patients are encouraged to discuss the specific approved uses of Litanin for their condition with a healthcare provider.


Q: Is Litanin available as a liquid or injection?

According to the official product information, Litanin is defined as an oral preparation. This means it is typically formulated as a solid dose form, such as a tablet or capsule, combined with inactive ingredients for oral administration.

How should Litanin be stored and disposed of?

Official Storage and Disposal Guidelines for Litanin

Specific labeled instructions for Litanin are not available in regulatory documents; therefore, general guidelines mandated by authorities like the FDA and EMA for all pharmaceuticals apply to ensure safety and integrity.

Storage Requirements

Requirement Guideline
Temperature and Environment Store at cool, dry room temperature, protected from excessive heat, strong light, and moisture.
Packaging and Handling Keep the medication in its original, labeled container with the safety cap securely closed.
Safety Keep Litanin strictly out of the reach and sight of children and pets at all times.

Disposal Rules

Disposal Method Action
Preferred Method Return unused or expired medicine through an official, authorized drug take-back program.
Household Trash Method If take-back is unavailable, mix the medicine with an undesirable substance (e.g., dirt) in a sealed bag or container before disposal with household trash.

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

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