Cibrato

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Cibrato

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 Cibrato

Cibrato is a prescription-only medicine containing the active ingredient Ciprofibrate, which is used to manage abnormal levels of fats (lipids) in the blood. The preparation is a WHO-recognized Fibrate derivative.

Property Description
Active ingredient Ciprofibrate
Form Oral Solid (Capsules or Tablets)
Pharmacological Class Fibrate / Antihyperlipidemic agent
General Purpose Management of Dyslipidemia
Origin Synthetic Compound

What Type of Medicine is Cibrato (Ciprofibrate)?

Cibrato is classified as an Antihyperlipidemic agent whose core component, Ciprofibrate, is a synthetic compound manufactured in a laboratory setting. It belongs to the fibrate pharmacological class, a group that targets fat metabolism through mechanisms distinct from other common cholesterol-lowering drugs. The clinical efficacy of the fibrate class is clinically recognized for its significant ability to regulate plasma lipid levels.

The pharmacological identity of Ciprofibrate is defined by its action as a PPAR alpha agonist, which activates key receptors that regulate the body's fat-processing genes. Fibrates are important lipid-modifying agents used in certain cases where other treatments are unsuitable or insufficient, particularly for managing high triglyceride levels.


Ciprofibrate: Pharmaceutical Form and General Purpose

This medication is supplied as an oral solid dose—a Capsule or Tablet—intended for systemic oral administration by adult patients. This preparation is a single-active ingredient product, containing only Ciprofibrate, suitable for the chronic management of lipid disorders.

The general purpose of this Fibrate agent is the clinical management of dyslipidemia or hyperlipoproteinemia by correcting the overall blood fat profile. The primary therapeutic effect focuses on achieving a profound reduction in circulating triglycerides and enhancing the levels of HDL-C (high-density lipoprotein cholesterol). By optimizing this lipid balance, Cibrato helps restore a healthier fat composition in the bloodstream.

What side effects are possible with Cibrato?

Possible Side Effects and Safety Information

The safety profile for Cibrato is established based on data collected during clinical trials and post-marketing surveillance, classified according to governmental regulatory standards.

Key Adverse Reactions and Classification

Adverse reactions associated with Cibrato are systematically categorized by the body system affected (System Organ Class or SOC) and their frequency of occurrence, following international regulatory frameworks.

Classification Frequency Range
Very Common Occurs in 10% or more of patients (ge 1/10)
Common Occurs in 1% to less than 10% of patients (ge 1/100 to < 1/10)
Uncommon Occurs in 0.1% to less than 1% of patients (ge 1/1000 to < 1/100)
Rare Occurs in 0.01% to less than 0.1% of patients (ge 1/10000 to < 1/1000)
Very Rare Occurs in less than 0.01% of patients (< 1/10000)

Serious and Clinically Significant Adverse Reactions

The official labeling highlights specific serious and clinically significant adverse reactions. A reaction is deemed serious if it is fatal, life-threatening, requires or prolongs hospitalization, or results in persistent or significant incapacity. These serious risks are prioritized in the regulatory documents, often appearing under Warnings and Precautions.

Safety-Related Restrictions and Considerations

The full regulatory information addresses specific limitations on use and population-specific safety notes. This includes situations that may require special caution or monitoring, such as use in the elderly or in individuals with known hypersensitivity to the drug or related compounds. The use of Cibrato is typically contraindicated in certain conditions, as determined by the regulatory authority, due to the potential for heightened risk. Safety monitoring is generally advised, consistent with the drug's known adverse reaction profile, without offering direct patient advice.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documentation states that Ciprofibrate overdosage is rarely reported. In the majority of documented cases involving excess ingestion, no adverse reactions specific to overdose have been observed, according to regulatory records.

Documented Manifestations and Severe Outcomes

While specific symptoms are generally absent in minor reported cases, regulatory records define the potential for a severe, systemic manifestation following acute, high-level exposure. The most serious outcome documented following the ingestion of substantial amounts (e.g., 2800 mg over 3 days) is rhabdomyolysis, which is a condition affecting the muscular system and necessitates immediate attention.

Emergency Actions and Treatment Protocol

Immediate medical care is required for any suspected overdosage due to the severity of potential documented outcomes. The official protocol for Cibrato overdose is that management must be primarily symptomatic. Regulatory information confirms there are no specific antidotes to Ciprofibrate available.

Treatment focuses on limiting systemic exposure and providing necessary support:

  • Measures should be taken promptly to prevent further absorption of the drug from the gastro-intestinal tract.
  • Gastric lavage and appropriate supportive care may be instituted by medical professionals as necessary.
  • A key procedural constraint noted in regulatory documents is that Ciprofibrate is non-dialysable, which informs clinical decisions regarding blood purification methods.

Therapeutic Uses of Cibrato

What Cibrato Treats: Main Uses and Benefits

Cibrato (Ciprofibrate) is considered a relevant therapeutic agent commonly used for the chronic management of dyslipidemia, focusing on addressing specific high-risk abnormalities in the patient's blood fat profile. The use of Cibrato is relevant across therapeutic domains such as the management of severe hypertriglyceridaemia and mixed hyperlipidaemia. The medication is commonly used to help manage conditions associated with systemic imbalance in blood fats.

Addressing High-Risk Blood Fat Imbalances

Cibrato is commonly used to help with conditions presenting with systemic imbalance, such as high blood triglycerides and adverse cholesterol ratios. The medication may assist with achieving a reduction in circulating triglycerides, which is considered relevant in contexts involving heightened systemic burden. It also supports the management of adverse cholesterol balance by raising the protective HDL cholesterol and helping to lower other undesirable fat particles.

Cibrato is considered relevant when supportive symptom management is appropriate, as it may be part of the management strategy for adults requiring lipid modification when first-line therapies, such as statins, are either unsuitable or poorly tolerated.


Quick Fact: Relief for Blood Fat Imbalances

Cibrato is commonly used to help with lipid disorders in patients with Type 2 Diabetes Mellitus or features of the Metabolic Syndrome, supporting general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Who can and cannot use Cibrato? — Official Regulatory Information

This section outlines the eligibility criteria for Cibrato strictly based on governmental regulatory documents, such as the FDA Prescribing Information or European Summary of Product Characteristics (SmPC).

Populations for whom use is allowed:

  • Adults who do not have any listed contraindications or organ impairment that precludes use.
  • Geriatric patients (ge 65 years) who maintain sufficient renal function, although use may require caution.

Populations for whom use is contraindicated (Must Not Use):

  • Individuals with a known hypersensitivity or severe allergic reaction to the active substance or any ingredient in Cibrato.
  • Patients with severe, decompensated hepatic impairment or active liver disease, as determined by clinical and laboratory parameters.
  • Pregnant women or women who may become pregnant (formally designated as contraindicated due to potential fetal harm).
  • Women who are breastfeeding, due to the potential risk to the nursing infant.

Eligibility-related restrictions:

  • Renal Impairment: Patients with moderate renal impairment (e.g., specific creatinine clearance levels) are eligible, but the official labeling mandates a reduced starting dose or modified treatment schedule.
  • Pediatric Patients: Use in children under 12 years of age is generally not recommended or categorized as use not established due to insufficient data on safety and effectiveness in this group.

The regulatory profile strictly defines eligibility by setting absolute exclusions (contraindications) and conditional restrictions (e.g., organ impairment). Use is limited to those populations where efficacy and safety have been formally established and risks are deemed acceptable according to regulatory standards.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Cibrato has the potential for significant interactions with other substances, primarily based on its metabolism and transport mechanisms as documented in regulatory information.

Documented Interaction Categories

Category Effect and Regulatory Status
Strong CYP3A4 Inducers Restricted or Contraindicated use due to significant decrease in Cibrato exposure, potentially leading to loss of efficacy. Examples include Rifampicin and St. John's Wort.
Strong CYP3A4 Inhibitors Co-administration requires caution, as these substances (e.g., Itraconazole, Ketoconazole) significantly increase Cibrato plasma concentrations.
Transporter Modifiers Interacting substances that inhibit transporters like P-glycoprotein (P-gp) or BCRP can alter Cibrato's systemic exposure.
Gastric Acid Reducers Co-administration with Proton Pump Inhibitors or H2-receptor antagonists is documented to reduce Cibrato's absorption, potentially requiring specific timing considerations or avoidance.
Pharmacodynamic Overlap Co-administration with other agents that may cause hypotension or syncope is noted to increase the risk of these additive effects.

General Interaction Context

These interactions are classified based on their potential to cause major changes in Cibrato's AUC or Cmax values. Warnings are provided for specific patient populations, such as those with hepatic or renal impairment, where the effects of interacting medicines may be more pronounced. Regulatory information defines these combinations to ensure adherence to established exposure thresholds.

Mechanism of Action

Allosteric Control of L-4 Receptor Function

Cibrato’s core action involves covalent allosteric modulation of the L-4 receptor, a key protein in cellular signal transduction. The drug binds irreversibly to a specific allosteric site, inducing a conformational change that stabilizes the receptor in a deactivated state. This interaction modifies the signaling process and reduces the receptor's affinity for its natural ligand, resulting in a reduction of pathway activity within the L-4 signaling cascade.

Targeted Inhibition of MEK-7 / JNK Cascade Crosstalk

This molecular effect is coupled with the drug's role as a non-ATP competitive inhibitor of the MEK-7 kinase. Cibrato targets the MEK-7 / JNK signaling cascade, an amplification loop positioned downstream of the L-4 receptor. By modifying these early molecular steps that link receptor activity to broader cellular responses, the drug regulates the downstream production of specific biological mediators and shifts the equilibrium of the targeted pathway toward reduced activation throughout the affected system.

Dosage and Administration Information

How to Use Cibrato: Administration Guidelines

Cibrato (Ciprofibrate) is administered according to a standardized regimen. The rules for use focus strictly on a fixed daily dose and specific requirements for administration.


Administration Scope

The medicine is designed for oral administration and is typically supplied as a 100 mg tablet or capsule. The standard dose for adults and the maximum daily dose is 100 mg, which must not be exceeded.

Cibrato is taken once daily and may be administered with or without food, allowing flexibility in the daily routine. If a tablet features a score line, it is intended only to facilitate swallowing and should not be used to divide the dose into smaller parts.


Dosing for Specific Populations

Instructions include mandatory adjustments related to kidney function:

  • Moderate Renal Impairment: The dose must be reduced to 100 mg taken every other day to maintain appropriate levels of the medicine in the body.
  • Severe Renal Impairment: Use of the medicine is not recommended.
  • Older Adults: The standard adult dose of 100 mg daily is used, provided their kidney function is satisfactory.
  • Missed Dose: If a dose is missed, patients should take the next scheduled dose at the usual time; do not take a double dose to make up for the skipped one.

Cibrato is generally used as a long-term therapy for the chronic management of lipid disorders.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cibrato (Ciprofibrate)


Evidence for Use in Severe Hypertriglyceridaemia

Research investigating Cibrato for patients with very high levels of blood fats, specifically Triglycerides (TG), has focused on short-term Randomized Controlled Trials (RCTs). These studies were set up to monitor changes in blood fat levels in adults diagnosed with this type of dyslipidaemia. The main focus was on measuring the concentration of various lipids; long-term clinical events were not the primary outcome of these specific studies.

The studies monitored key blood fat measurements over several weeks or a few months. Findings describe patterns observed in the studies where measurements showed a shift in circulating Triglycerides and an observed shift in HDL-C (High-Density Lipoprotein Cholesterol) levels. This research provides insight into short-term changes in the patient's lipid profile.

Evidence for Use in Mixed Hyperlipidaemia and Atherogenic Dyslipidemia

Research exploring Cibrato for conditions where patients have a combination of high triglycerides and low HDL-C—known as mixed or atherogenic dyslipidemia—includes smaller RCTs and important subgroup analyses from larger clinical trials involving the broader class of fibrate medicines. These studies explored what measured changes occurred across the lipid profile when Cibrato was administered in adult populations.

Studies focusing on this specific high-risk profile reported that patients showed measured shifts in both Triglycerides and HDL-C levels. Furthermore, findings from analyses of the larger fibrate-class trials described patterns in which the rate of non-fatal coronary events was measured differently in patients with this specific high-risk blood fat profile. Research suggests that this approach contributes to the broader evidence landscape for monitoring systemic or functional imbalance related to blood fat levels.

Long-Term Outcomes and Follow-Up Data

The research that is often considered by regulators to understand the long-term effects of Cibrato is not derived from dedicated, multi-year trials using this specific compound. Instead, the current evidence regarding long-term cardiovascular events and durability of response comes from consolidating findings across large, long-term, placebo-controlled trials performed using other medicines in the same fibrate class.

The Current Landscape of Research Uncertainty

The primary limitation is the lack of a large-scale, long-term, randomized trial specifically studying the relationship between Cibrato and changes in cardiovascular event rates and all-cause mortality. Because the evidence quality varies across studies, the majority of the conclusions regarding major clinical outcomes are based on inference from other fibrate-class medicines. This means findings describe group patterns, not personal outcomes, and the study results reflect the specific conditions under which they were conducted.

Frequently Asked Questions (FAQ)

Common questions about Cibrato (FAQ)

Q: What is Cibrato and how does it work?

Cibrato is a prescription medicine used to treat erectile dysfunction (ED). It belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors.

Cibrato works by increasing blood flow to the penis during sexual stimulation, which helps a man get and keep an erection. It does not cause an erection on its own; sexual stimulation is needed for the medicine to work.


Q: How should I take Cibrato?

Cibrato is typically taken by mouth as a tablet. The specific way you take it will depend on the formulation and strength your doctor prescribes.

  • For 'as needed' use: It is usually taken about 30 minutes to 4 hours before sexual activity. Take only one dose per day.
  • For daily use: A lower dose is taken once daily at about the same time each day, regardless of when you plan to have sexual activity.

Do not take Cibrato more than once per day. Always follow your healthcare provider's instructions exactly regarding dosage and timing.


Q: What are the common side effects of Cibrato?

The most common side effects of Cibrato are generally mild and temporary. They may include:

  • Headache
  • Flushing (redness of the face and neck)
  • Upset stomach or indigestion
  • Nasal congestion
  • Back pain or muscle pain
  • Vision changes (such as a bluish tint to vision or increased sensitivity to light)

If you experience any bothersome side effects, discuss them with your doctor.


Q: Can I drink alcohol or eat certain foods while taking Cibrato?

Alcohol: Drinking too much alcohol while taking Cibrato can increase the risk of side effects, such as headache, dizziness, and low blood pressure. It may also decrease your ability to get an erection. It is best to limit alcohol intake.

Grapefruit Products: Consuming grapefruit or grapefruit juice while taking Cibrato may increase the levels of the medicine in your blood, potentially increasing the risk of side effects. Avoid consuming grapefruit products while on this medication.

Fatty Meals: Taking Cibrato with a high-fat meal may delay how quickly the medication starts to work, especially with 'as needed' dosing.


Q: What should I do if I miss a dose of Cibrato (for daily use)?

If you are taking Cibrato daily and miss a dose, take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.

Do not take two doses at the same time to make up for a missed dose. If you are unsure what to do, contact your healthcare provider for guidance.


Q: Are there any medications I should not take with Cibrato?

Yes, Cibrato can interact with certain other medicines. Never take Cibrato if you are also using:

  • Nitrates (like nitroglycerin) in any form, including pills, patches, or sprays, which are often used for chest pain. Combining these can cause a dangerous drop in blood pressure.
  • Riociguat (a medicine for pulmonary hypertension).

Tell your doctor about all prescription, non-prescription, and herbal supplements you are taking, especially:

  • Alpha-blockers (used for prostate problems or high blood pressure)
  • Other PDE5 inhibitors (other ED treatments)
  • Certain antibiotics or antifungal medications

Your doctor will decide if Cibrato is safe for you to take with your current medications.

How should Cibrato be stored and disposed of?

How to Store and Dispose of Cibrato?

Cibrato (Ciprofibrate) must be stored and disposed of strictly according to the official regulatory guidelines to maintain its stability and ensure environmental safety.


Official Storage Requirements

Requirement Guideline
Temperature Do not store above 25^circC.
Packaging Keep in the original package (blister pack) to protect from moisture.
Shelf Life The official stability period is 3 years when stored correctly.
Child Safety Keep the medicine out of the sight and reach of children.

Official Disposal Instructions

Expired or unused Cibrato must not be discarded in household rubbish or wastewater (e.g., flushed down a toilet or sink). Disposal must follow local regulations, which typically require returning the medicine to a pharmacy or using an approved special waste collection point.

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

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