Pisaurit

Quick links to important sections

Medically reviewed

Rosario Oropesa

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 Pisaurit

What is Pisaurit?

Pisaurit is a medicinal product containing the active substance inclisiran. It is used in adults with primary hypercholesterolaemia or mixed dyslipidaemia, conditions characterized by elevated levels of fats, such as cholesterol, in the blood.

Mechanism of Action

The active ingredient, inclisiran, belongs to a class of medications known as small interfering ribonucleic acids (siRNA). It works by interfering with the production of a specific protein in the liver called PCSK9 (proprotein convertase subtilisin/kexin type 9).

Under normal circumstances, PCSK9 reduces the number of receptors on the surface of liver cells that are responsible for removing low-density lipoprotein (LDL) cholesterol—often referred to as 'bad' cholesterol—from the bloodstream. By lowering the production of PCSK9, Pisaurit allows more receptors to be available on the liver cells, which increases the uptake of LDL cholesterol from the blood and subsequently lowers its levels.

Clinical Application

Pisaurit is typically used in the following scenarios:

  • In combination with a statin: For patients who are unable to reach their LDL cholesterol goals using the maximum tolerated dose of a statin alone.
  • Alone or with other lipid-lowering therapies: For patients who are intolerant to statins or for whom a statin is not considered appropriate.

Effective management of cholesterol levels is an important factor in cardiovascular health, as high levels of LDL cholesterol can lead to the buildup of fatty deposits in the arteries.

Regulatory References

  1. NIMH Treatment Information

What side effects are possible with Pisaurit?

Possible Side Effects and Safety Information

The safety profile of Pisaurit is based strictly on data documented in official governmental regulatory labeling, categorized by the frequency of occurrence and the affected body system.


Documented Adverse Reactions

Side effects are classified using standard international frequency categories (Very Common ge 1/10 to Rare < 1/1,000).

Classification Examples of Adverse Reactions (SOC)
Very Common & Common Headache, Dizziness, Nausea, Fatigue, Somnolence (Nervous/Gastrointestinal)
Uncommon & Rare Hypersensitivity reactions (Immune System), Clinically significant elevated liver enzymes (Hepatobiliary), Thrombocytopenia (Blood/Lymphatic)

Serious Adverse Reactions and Safety Constraints

Official labeling identifies specific Serious Adverse Reactions, which are rare but clinically critical, including severe hypersensitivity (e.g., Angioedema) and documented Severe Cutaneous Adverse Reactions (SCARs).

Population-Specific Safety: Use is often contraindicated or requires significant dose modification in patients with severe hepatic impairment (Child-Pugh Class C). Specific safety information is also provided for pediatric use and use during pregnancy and lactation.

Exposure-Related Patterns: Certain central nervous system effects are documented as being more frequent during the initial weeks of treatment. Routine monitoring of Liver Function Tests (LFTs) is a mandatory requirement at specified intervals during therapy.

Overdose and Emergency Response

Overdose and When to Seek Help

The most common symptoms observed following an acute overdose of non-steroidal anti-inflammatory drugs (NSAIDs), the class of medicine to which Pisaurit belongs, are generally limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain. These symptoms are typically reversible with supportive medical care.

However, in rare instances or with very large ingestions, more severe or complicated overdose effects have been reported with this drug class. These can include gastrointestinal bleeding, hypertension (high blood pressure), acute renal failure, respiratory depression, and coma.

Required Emergency Action

Immediate medical attention is required in the event of a suspected overdose. Patients should immediately contact emergency services (such as 911 or the local emergency number) or a certified poison control center.

Since no specific antidote exists for overdose with Pisaurit, management is focused on providing supportive and symptomatic care. Depending on the amount ingested and the time since ingestion, medical professionals may consider measures such as administering activated charcoal or an osmotic cathartic to help reduce drug absorption.

Seek emergency help right away if the individual has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

Therapeutic Uses of Pisaurit

Pisaurit is generally used for managing symptoms across several core therapeutic domains, and may assist with supportive relief when emotional, behavioral, and mood manifestations become highly disruptive to daily stability.

This medication is commonly used to help with Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder, Bulimia Nervosa, and Premenstrual Dysphoric Disorder (PMDD). It is considered relevant for easing distress in these conditions, particularly when symptoms intensify and supportive relief is needed.


Provides supportive relief when symptoms interfere with routine activities and supports general well-being during symptomatic phases.”


Managing Core Symptom Patterns

Pisaurit helps address symptom clusters that may intensify over time, such as profound sadness and loss of pleasure, or the recurring, unwanted intrusive thoughts and ritualized behaviors seen in OCD. It assists with maintaining functional stability by managing symptoms that interfere with daily comfort. This medication is applied in addressing symptoms that appear suddenly or fluctuate, such as acute surges of fear and specific dysfunctional eating patterns.

Quick Fact: Relief for Key Symptom Domains
Depression: Supports general well-being during symptomatic phases of MDD.
OCD: Is commonly used to help with symptoms that create noticeable functional strain.
Panic: Supports general well-being during symptomatic phases.
Bulimia/PMDD: May assist with supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. NIH MedlinePlus Drug Information on Fluoxetine

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Pisaurit — Official Regulatory Information

Pisaurit (Fluoxetine) is governed by strict eligibility rules, which define the patient populations authorized for its use and those for whom use is contraindicated or restricted, as documented in governmental regulatory labeling.


Category Official Regulatory Statement
Populations for whom use is contraindicated: Patients with known hypersensitivity to Fluoxetine or excipients; Patients using Monoamine Oxidase Inhibitors (MAOIs), including Linezolid or Methylene Blue (a mandatory washout period is required); Patients taking Pimozide or Thioridazine.
Age-related eligibility rules: Use is established in adults for all indications. Pediatric use is restricted to specific ages: 8 years and older for Major Depressive Disorder and 7 years and older for Obsessive-Compulsive Disorder. Use is not established in younger children.
Condition-specific eligibility rules: Use requires caution in patients with a history of seizures or mania/hypomania, as well as in those with conditions predisposing to cardiac arrhythmias.
Populations for whom use is not recommended: Breastfeeding women (due to excretion into milk); Pregnant women unless the potential benefit justifies the potential fetal risks.
Eligibility-related restrictions: Severe Hepatic Impairment requires that a lower or less frequent dosage may be appropriate due to prolonged drug half-life; use in Older Adults may also require dosage consideration.

Connection to the overall eligibility profile:

Official regulatory documents define who can and cannot use the medicine through both absolute prohibitions, such as contraindications with specific co-administered drugs, and through conditional use criteria based on age, reproductive status, and the presence of specific comorbidities or organ impairment. The structure limits use to populations where eligibility has been officially established.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Pisaurit has documented interactions based on its inhibition of the CYP2D6 enzyme and its impact on the serotonin system.

Contraindicated Combinations

Pisaurit must not be used with the following products due to the risk of serious side effects:

  • Monoamine Oxidase Inhibitors (MAOIs), including Linezolid (an antibiotic with MAOI activity) and intravenous Methylene Blue. This combination can cause Serotonin Syndrome, a potentially life-threatening reaction. A 5-week separation period after stopping Pisaurit and a 14-day separation period after stopping an MAOI are required.
  • Pimozide and Thioridazine (antipsychotics). Concomitant use is contraindicated due to the risk of QTc interval prolongation and potential heart rhythm abnormalities.

Significant Interaction Categories

  • CYP2D6 Substrates: Pisaurit is a potent inhibitor of the CYP2D6 enzyme. This can lead to significantly increased plasma concentrations of other medicines metabolized by CYP2D6, such as certain Tricyclic Antidepressants (TCAs) and some antipsychotics (e.g., Haloperidol, Clozapine). Dose adjustments and monitoring may be necessary.
  • Serotonergic Drugs: Co-administration with other serotonergic agents (e.g., triptans, Tramadol, Lithium, St. John’s Wort) increases the risk of Serotonin Syndrome.
  • Drugs that Interfere with Hemostasis: Concomitant use with drugs that affect blood clotting (e.g., NSAIDs, Aspirin, Warfarin) increases the potential risk of abnormal bleeding.

Mechanism of Action

Mechanism of Action

Pisaurit (Fluoxetine) exerts its function exclusively within the central nervous system through highly selective modulation of the serotonergic signaling pathway. The mechanism is a targeted molecular cascade that causes gradual neuronal adaptation.

Targeting the Serotonin Transporter (SERT)

Pisaurit operates as a highly selective inhibitor of the Serotonin Transporter (SERT), a protein responsible for clearing the neurotransmitter Serotonin (5-HT) from the synaptic cleft. By blocking 5-HT reabsorption, the mechanism immediately initiates an increase in the 5-HT concentration available to engage post-synaptic receptors.

Mechanism-Driven Neuronal Adaptation

The prolonged exposure to increased synaptic 5-HT leads to the desensitization of presynaptic 5-HT autoreceptors, removing an inhibitory brake on 5-HT release. This combined cascade results in a predictable, long-term neuroplastic adaptation of the brain's circuitry, leading to altered activity within key serotonergic neuronal circuits.

Dosage and Administration Information

The administration of Pisaurit is strictly for oral use, available in standardized preparations including capsules, tablets, and an oral solution. The medication may be taken with or without food, establishing flexible intake conditions, though it is typically administered once daily in the morning. Dosage adjustments, or titration, are a procedural requirement and are considered only after several weeks (e.g., three to four weeks) to ensure the patient is maintained at the lowest effective level.

For most approved indications, such as Major Depressive Disorder and Obsessive-Compulsive Disorder in adults, the initial dosage is typically 20 mg daily. The standard maintenance dosage ranges from 20 mg to 60 mg, with a maximum limit of 80 mg daily. The established regimen for Bulimia Nervosa involves a fixed 60 mg dose administered once daily. A distinct 90 mg delayed-release capsule is approved for once-weekly dosing, but this use mandates a seven-day interval following the last daily dose of 20 mg before the weekly dose is initiated.

Dosing is officially modified for specific populations: a lower or less frequent schedule is advised for patients with hepatic impairment, and use in older adults often begins at a reduced dose, generally not to exceed 40 mg to 60 mg. Official guidance also supports use in pediatric patients (ge 8 years for MDD) beginning at 10 mg daily.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Pisaurit

Evidence for use in Major Depressive Disorder (MDD)

Research has explored the use of Pisaurit in individuals with Major Depressive Disorder (MDD), a condition characterized by functional limitations, including profound sadness and loss of pleasure. Research included numerous short-term (6 to 12 week) and longer-term (up to 25 week) Randomized Controlled Trials (RCTs), as well as Meta-analyses. Studies monitored outcomes related to systemic or functional imbalance by measuring standardized Symptom Scores and assessed the rates at which participants were observed to meet defined criteria for response or remission. Findings describe patterns observed in the studies of adults over the observation periods, but research does not determine whether an individual will respond similarly.


Evidence for use in Obsessive-Compulsive Disorder (OCD)

Research exploring short-term symptom changes was studied for Obsessive-Compulsive Disorder (OCD). Studies primarily used Randomized Controlled Trials (RCTs) across adults, adolescents, and children (age 7 and older). Studies measured changes in outcomes related to physical discomfort, including OCD symptom severity using scales like the CY-BOCS. Limited information exists that compares very high trial doses to standard high trial doses in the research that was conducted.


Long-Term Studies and Follow-Up

Research examined the durability of assessed outcomes in some conditions, particularly in MDD, where trials included maintenance phase assessments lasting up to 25 weeks or longer. These studies monitored the rate of relapse/recurrence in observed populations. While this research provides insight into short-term changes, there is limited information for long-term outcomes that fully characterize the duration of assessed changes in all conditions. Most data are derived from relatively short follow-up durations.


What is Still Uncertain About Pisaurit (Evidence Gaps)

Despite the volume of research, study findings are variable for MDD in youth, with mixed observations across trials examining children and adolescents. Long-term effects are not fully established across all indications, and sample sizes were modest in some specific population groups. Research highlights what is known, but it is important to acknowledge areas where the research is ongoing.

Key Studies & References

  1. Depression: Treatment Information
  2. Fluoxetine Drug Information (MedlinePlus)
  3. NICE Guideline: Obsessive-compulsive disorder and body dysmorphic disorder: treatment

Frequently Asked Questions (FAQ)

Common questions about Pisaurit (FAQ)

Q: Is Pisaurit a type of antibiotic or a different class of medicine?

According to the official product information, Pisaurit is classified as a Selective Serotonin Reuptake Inhibitor (SSRI). It works by influencing chemical messengers in the brain, known as neurotransmitters. Pisaurit is not an antibiotic and is not used to treat bacterial infections.


Q: How quickly should I expect Pisaurit to start having an effect?

Studies and official information indicate that the full therapeutic effect of Pisaurit may take several weeks to become noticeable. Initial assessment for therapeutic changes often occurs after 4 to 6 weeks of consistent use.


Q: How long does Pisaurit typically stay in your body after the last dose?

Official regulatory documents state that Pisaurit and its active metabolite have a long elimination half-life. This long duration is related to the drug's long half-life, a recognized characteristic of the medication.


Q: Is Pisaurit meant for long-term treatment or is it usually short-term?

The official documentation indicates that Pisaurit is approved for both acute (short-term) treatment of certain conditions and for maintenance (long-term) therapy to help prevent recurrence.


Q: What is the standard procedure if a dose of Pisaurit is missed?

If a daily dose is missed, regulatory guidance suggests taking it as soon as you remember, unless it is close to the time of your next dose. It is advised not to double the next dose to compensate. Patients should review the specific directions provided by their prescriber.


Q: Can Pisaurit tablets be cut in half or crushed for easier swallowing?

Certain formulations of Pisaurit, such as the delayed-release capsules, must be swallowed whole and should not be cut, crushed, or chewed. If modification of the tablet form is necessary, patients should confirm safety with their healthcare provider.


Q: Does the time of day (morning vs. evening) affect how well Pisaurit works?

Pisaurit is typically recommended to be taken in the morning. This timing is generally intended to minimize the potential for side effects, such as insomnia (difficulty sleeping), which may disrupt sleep.


Q: What is the typical length of treatment prescribed for Pisaurit?

The required length of treatment varies significantly based on the condition. Clinical studies that demonstrated the effectiveness of Pisaurit typically assessed the acute phase of treatment over 6 to 12 weeks.


Q: Does taking Pisaurit cause weight gain or weight loss?

Official product information notes that both weight loss and weight gain have been reported as potential adverse reactions in clinical trials. Weight changes are possible and should be discussed with the prescribing healthcare professional.


Q: Are there any known permanent or long-lasting side effects associated with Pisaurit?

Regulatory safety reviews have specifically addressed reports of persistent sexual dysfunction in rare cases after individuals stopped using the medication. However, regulatory bodies have not established a definitive causal link for permanent effects.


Q: Is there a risk of dependency or addiction with Pisaurit?

Pisaurit is not classified as a controlled substance by regulatory bodies. Official information indicates that it is not associated with abuse potential or physical addiction like opioids or benzodiazepines.


Q: How might Pisaurit potentially affect a person's sleep patterns?

Regulatory documents list two common adverse reactions that relate to sleep: somnolence (drowsiness or fatigue) and insomnia (difficulty falling or staying asleep). It may affect sleep patterns differently for each individual.


Q: What are the recognized signs and symptoms of a serious allergic reaction to Pisaurit?

Serious reactions require immediate medical attention. Recognized signs can include a severe rash, hives, swelling of the face, mouth, or tongue (angioedema), or difficulty breathing. These symptoms are documented in the warnings and precautions section of the official label.


Q: Can Pisaurit cause emotional changes, such as mood swings or feelings of depression?

Official product labeling notes the potential risk of emotional changes, including the potential activation of mania or hypomania in vulnerable patients. Changes like anxiety, agitation, or irritability may also occur.


Q: How does Pisaurit affect or interact with blood pressure?

Regulatory information notes the risk of developing hyponatremia (abnormally low sodium levels), which can impact fluid balance. Caution is noted for individuals with a history of heart rhythm problems.


Q: Does Pisaurit have a known interaction with alcohol consumption?

Official labeling indicates that the use of Pisaurit with alcohol is advised against as alcohol can increase central nervous system side effects such as dizziness and drowsiness.


Q: Are there any specific vitamins, minerals, or herbal supplements that interact with Pisaurit?

The official regulatory label lists known interactions with other agents that affect serotonin levels. This specifically includes the herbal supplement St. John’s Wort, and using the two together may increase the risk of serious side effects.


Q: Does Pisaurit interact with common foods or caffeinated drinks?

While the drug can be taken with or without food, regulatory caution is advised regarding certain items. Patients should be mindful of high intake of caffeine and excessive consumption of tyramine-rich foods due to potential interaction risks.


Q: Are there any dietary restrictions or foods that should be avoided while using Pisaurit?

Dietary restrictions are generally minimal for Pisaurit. However, regulatory information advises caution with large amounts of tyramine-rich foods (such as aged cheeses or cured meats) and high amounts of caffeine.


Q: Can Pisaurit potentially reduce the effectiveness of hormonal birth control?

Clinical evidence does not suggest that Pisaurit significantly affects the safety or efficacy of hormonal birth control methods, such as pills, patches, or rings.


Q: What information is available regarding the use of Pisaurit during pregnancy or breastfeeding?

Regulatory documents state that use during pregnancy is associated with potential risk to the newborn and requires careful assessment. The drug passes into breast milk in amounts that require cautious monitoring.


Q: Can people with pre-existing conditions like kidney or heart problems safely take Pisaurit?

Regulatory information indicates that Pisaurit requires caution and monitoring in patients with severe renal (kidney) impairment. Caution is also advised for those with a history of certain heart rhythm problems or recent heart attack.


Q: What medical conditions would typically make a person ineligible to use Pisaurit?

Pisaurit is contraindicated, meaning it must not be used, in patients with severe hepatic (liver) impairment. It is also contraindicated for people who are currently taking Monoamine Oxidase Inhibitors (MAOIs), or certain antipsychotics.


Q: Are there specific genetic factors that influence how a person responds to Pisaurit?

Research highlighted in regulatory sources suggests that individual genetic variations can influence a person's response to the medication. These variations may affect how the drug is metabolized in the body.


Q: Is Pisaurit available to buy without a prescription in any global market?

Pisaurit is an antidepressant that is classified as a prescription-only medication in major global markets. A healthcare provider’s supervision is required due to the necessity of medical oversight.


Q: Where is the best place to find the official drug label or prescribing information for Pisaurit?

The most complete official product information can be found directly on the websites of governmental health agencies. Examples include the FDA's DailyMed database or the European Medicines Agency (EMA) Summary of Product Characteristics (SmPC).


Q: Has a generic version of Pisaurit been approved or is it currently available?

Yes, regulatory records, such as the FDA Approved Drug Products list, confirm that a generic version of Pisaurit (fluoxetine) is approved and available for use in most markets.


Q: What were the key clinical trials that led to the regulatory approval of Pisaurit?

Regulatory documents summarize the pivotal short-term and long-term randomized, double-blind, placebo-controlled trials that served as the primary evidence. These studies demonstrated the efficacy for each of the approved indications.


Q: Does Pisaurit carry a 'Boxed Warning' (Black Box Warning) from the FDA?

Yes, the official FDA label includes a Boxed Warning. This is the most serious warning and concerns the increased risk of suicidal thinking and behavior in children, adolescents, and young adults.


Q: What is the chemical name of the active pharmaceutical ingredient (API) in Pisaurit?

The official product description identifies the active pharmaceutical ingredient (API) in Pisaurit as fluoxetine hydrochloride.


Q: How does Pisaurit affect a person's ability to operate machinery or drive a car?

Regulatory warnings state that Pisaurit has the potential to impair judgment, thinking, or motor skills. Patients are cautioned about operating hazardous machinery, including automobiles, until they know how the medication affects them.


Q: Why is Pisaurit exclusively a prescription-only medication?

The prescription-only classification is due to the necessity of a healthcare provider’s supervision. This is required for accurate diagnosis, careful dose monitoring, and the ongoing management of potential side effects.


Q: What patient monitoring (like blood tests) is generally required while taking Pisaurit?

Mandatory monitoring typically includes Liver Function Tests (LFTs) at specified intervals. Monitoring for changes in serum sodium levels (hyponatremia) may also be advised based on patient factors.

How should Pisaurit be stored and disposed of?

How to Store and Dispose of Pisaurit?

Pisaurit (Fluoxetine) must be stored and handled according to specific conditions mandated by regulatory labeling to maintain stability and ensure safety.

Storage Conditions

Requirement Specific Instruction
Temperature Store at Controlled Room Temperature (20 C to 25 C) [(68 F) to (77 F)]
Protection Keep away from excess moisture and light.
Container Must be kept in the original container and tightly closed.

Stability and Safety

The oral solution form of Pisaurit must be discarded 60 days after first opening to ensure stability. All forms must be stored out of the sight and reach of children and secured with locked safety caps to prevent accidental ingestion.

Disposal Instructions

Official disposal is primarily through a drug take-back program or mail-back envelope. If this is not available, the medication should be mixed with an unappealing substance, sealed in a plastic bag, and placed in the trash. Disposal via wastewater or flushing is prohibited by regulatory guidance.

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

Available in countries:

Equivalent of Pisaurit found in:

A-Z Index: