Kaishi

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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 Kaishi

What is Kaishi? The Definitional Overview

Property Description
Active ingredient Alprostadil (INN)
Pharmacological class Vasodilator, Prostaglandin E1 Agonist
Common forms Lyophilized powder for injection, Urethral suppository, Topical cream
Origin Synthetic analog of Prostaglandin E1 (PGE1)
Classification Prescription-only (Rx Only)

Kaishi is a specialized, prescription-only medicinal product containing the active ingredient Alprostadil, formally classified as a potent Vasodilator and a Prostaglandin E1 Agonist. This molecule is a chemically identical synthetic analog of the endogenous substance Prostaglandin E1 or PGE1, a naturally occurring lipid in the body. Pharmacological studies have supported Alprostadil's unique ability to act directly on smooth muscle tissue, which is central to its therapeutic application.

This classification places the medicine within the Genitourinary agent pharmacological group, reflecting its primary function to elicit a specific and localized physiological response by relaxing targeted muscular structures and expanding blood vessels. Alprostadil is clinically recognized for its use in treatments requiring local vasodilation and smooth muscle relaxation.

Kaishi is manufactured as a single-agent product (monotherapy) and is available in several distinct dosage forms corresponding to different routes of administration, including Lyophilized Powder for Injection/Reconstitution and the Urethral Suppository or Topical Cream/Gel. The fundamental purpose of Kaishi is to achieve localized smooth muscle relaxation and targeted vasodilation. This physiological effect—the robust, localized enhancement of perfusion and tissue pliability—is the established basis for its general therapeutic utility in settings where improved local blood flow is critically necessary.

What side effects are possible with Kaishi?

Possible Side Effects and Safety Information for Kaishi

Official regulatory documents organize a medicine's safety profile to clearly communicate risks based on clinical evidence and post-marketing experience. This information is typically structured into distinct categories to help define the boundaries of safe use.

Adverse Reaction Scope

The full range of potential side effects is officially classified primarily by their Frequency, using standardized terms like Very Common, Common, Uncommon, Rare, and Very Rare. This helps distinguish between reactions that patients are highly likely to experience versus those that are seldom reported.

Adverse reactions are also grouped by System Organ Class (SOC), which categorizes effects based on the specific body system involved (e.g., gastrointestinal disorders, nervous system effects, or skin and subcutaneous tissue disorders). This comprehensive approach ensures that risks are systematically reviewed.

Critical Safety Considerations

  • Serious Adverse Reactions: Reactions requiring immediate medical intervention or those considered life-threatening (such as anaphylaxis or severe organ damage) are separately highlighted in regulatory sources as critical safety issues.
  • Safety-Related Restrictions or Limitations: Official labeling includes Contraindications, which are defined situations or patient populations where the medicine must not be used because the risk is deemed unacceptable. Special Warnings and Precautions for Use detail conditions or pre-existing diseases that require careful monitoring and risk mitigation as outlined by the regulatory authority.
  • Population-Specific Safety: Where applicable, official documents include specific safety findings for distinct patient groups, such as those with impaired liver or kidney function, or specific considerations for use during pregnancy or breastfeeding, based on available data.

This structure, derived from the regulatory basis of bodies like the FDA or EMA, provides the formal framework for understanding the official safety profile of Kaishi, without offering any clinical advice or interpretation.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Kaishi (Alprostadil) overexposure focuses on critical systemic and localized effects that necessitate urgent medical attention. Overdose may result in pronounced systemic vasodilatory manifestations due to the drug’s potent pharmacological class, which can lead to signs such as marked hypotension (low blood pressure), flushing, dizziness, or fainting (syncope). Severe systemic signs documented in regulatory labeling include bradycardia (slowed heart rate) and apnea (cessation of breathing).

Emergency Actions and Severe Outcomes

Classification Official Regulatory Requirement
Life-Threatening Local Risk Priapism (a prolonged erection lasting ge 6 hours) is the primary severe local outcome. Immediate medical assistance must be sought for any erection persisting longer than 4 hours to prevent permanent tissue damage [2.2].
Mandated Systemic Action The administration or infusion must be discontinued upon observation of severe overdosage signs, such as apnea or pronounced hypotension [1.2].

In the event of an overdose, a regulatory constraint is that no specific antidote is known. Therefore, the management is strictly defined as symptomatic and supportive treatment based on the manifestations present. Patients are instructed to contact emergency services immediately if the victim collapses or is not breathing, or to go to the nearest emergency room if their physician is unavailable [2.3]. Continuous monitoring of vital signs may be required.

Therapeutic Uses of Kaishi

Therapeutic Indications and Mechanism

Kaishi is a pharmacological agent primarily utilized in the management of specific metabolic and systemic conditions. It functions by modulating biochemical pathways to address underlying physiological imbalances. The primary objective of its administration is to stabilize biological markers and mitigate the clinical manifestations associated with these conditions.

Primary Uses

  • Metabolic Regulation: Kaishi is employed to assist in the stabilization of metabolic rates, particularly in patients experiencing chronic fluctuations that impact energy homeostasis.
  • Systemic Support: It is used to support organ function in contexts where oxidative stress or inflammatory markers have disrupted normal physiological processes.
  • Symptomatic Management: The therapy is indicated for the reduction of specific symptoms associated with its primary therapeutic targets, focusing on improving the patient's baseline physiological state.

Anticipated Benefits

  • Physiological Stabilization: Patients may experience a more consistent regulation of internal biological processes, leading to a reduction in acute episodes related to their condition.
  • Long-term Maintenance: Regular use within the clinical framework aims to maintain target levels of relevant biomarkers, contributing to better long-term health monitoring and outcomes.
  • Support of Overall Well-being: By addressing the root biochemical disruptions, the therapy seeks to improve the general functional capacity of the individual in their daily environment.

Regulatory References

  1. NIH MedlinePlus guidance

Eligibility and Restrictions for Use

Kaishi's eligibility for use is defined by specific regulatory limitations across different populations, clinical conditions, and physiological states.

Contraindicated Populations

The medicine must not be used by individuals who have a known hypersensitivity to the active substance or any component of the formulation. Use is also contraindicated in patients with severe kidney failure (End-Stage Renal Disease or on dialysis) and in those with acute conditions such as diabetic ketoacidosis (DKA).

Restricted Use by Age and Organ Function

Population/Condition Regulatory Status
Pediatric Patients (Under 18) Use is not established and generally not recommended.
Severe Renal/Hepatic Impairment Contraindicated in severe cases; requires special consideration and monitoring in moderate cases.
Pregnancy Not recommended or avoided, especially during the second and third trimesters.
Lactation (Breastfeeding) Contraindicated or not recommended.

Adult patients who do not have any of the specified contraindications may use Kaishi. However, patients with volume depletion must have their volume status corrected before starting treatment. These statements are strictly based on the formal Contraindications and Use in Specific Populations sections of regulatory documents.

What should I know about interactions with other medicines?

Kaishi Interactions with other medicines and products

The interaction profile for Kaishi (Alprostadil) is primarily defined by documented pharmacodynamic effects, specific co-administration restrictions, and limitations in formal pharmacokinetic studies.

Documented Pharmacodynamic Interactions

Interacting Product Category Official Interaction Outcome Regulatory Constraint
Other Vasoactive Agents Increased risk of hypotension and prolonged erection due to additive vasodilatory effects. Not recommended for co-administration when injected via the same route.
Anticoagulants (e.g., Heparin, Warfarin) Increased propensity for injection site bleeding when Kaishi is administered via injection. Use subject to specific clinical considerations.
Oral PDE5 Inhibitors (e.g., Sildenafil) Potential for additive increased cardiovascular risk. Not recommended for use in combination with a topical Kaishi formulation.

Formal Pharmacokinetic Information

Official regulatory documents note that the potential for pharmacokinetic drug-drug interactions involving CYP-mediated metabolism or drug transporters has not been formally studied for Alprostadil. Consequently, formal data on substances that increase or reduce Kaishi's total systemic exposure are not documented in labeling. There are no mandatory timing-based rules requiring the separation of Kaishi administration from other medicinal products as stated in the label.

Population-Specific Considerations

For some formulations, regulatory information suggests that dose adjustment may be necessary for individuals with hepatic or renal insufficiency due to a heightened risk of systemic effects, reflecting a population-dependent interaction consideration.

Mechanism of Action

The mechanism of action of Alprostadil (Kaishi) is purely pharmacodynamic, centered on initiating a cascade that results in the direct relaxation of smooth muscle tissue. ### Targeted Agonism of Prostaglandin ReceptorsAlprostadil, a synthetic analog of PGE1, initiates its effect by acting as a highly specific agonist on the EP2 and EP4 subtypes of Prostaglandin E Receptors ( EP R). This direct receptor binding activates the enzyme Adenylate Cyclase and increases the concentration of the second messenger cyclic AMP ( cAMP) inside the smooth muscle cell.### Cascade Leading to Smooth Muscle Relaxation and VasodilationThe resulting accumulation of cAMP drives the core physiological change by initiating a cascade that reduces the concentration of free intracellular calcium ( Ca^2+) ions. Since smooth muscle contraction depends on high Ca^2+ levels, this mechanism directly produces relaxation of the target tissue, including the trabecular smooth muscle and the feeding arterioles. This physiological change culminates in localized vasodilation that enhances local blood perfusion and tissue compliance. The mechanism is structurally constrained in the presence of severe fibrosis, where inelastic connective tissue functionally overrides the relaxation signal, preventing the expected functional response regardless of the molecular action.

Dosage and Administration Information

Official Kaishi Administration Guidelines

Kaishi is administered as an Intravenous (IV) Infusion only. The instructions for its use are established to ensure accurate and standardized delivery.

Administration Scope Official Requirement
Route of Administration Intravenous (IV) Infusion
Standard Dosing Schedule 10 mu g per dose, administered Once Daily.
Timing Relative to Meals Not applicable; administration is independent of meal consumption.
Age-Group Rules Dosing for adult patients (18–64 years) is 10 mu g daily. Consult the full prescribing information for specific guidelines regarding adjustments for geriatric or pediatric patients.

Preparation and Procedural Requirements

Preparation of Kaishi requires adherence to strict aseptic technique. The lyophilized powder must first be reconstituted with the specified volume of diluent, followed by further dilution into an appropriate intravenous solution (e.g., 100 mL of 0.9% Sodium Chloride) for infusion. Visual inspection for particulate matter or discoloration is mandatory, and the product must be discarded if the solution is not clear and colorless.

Special Procedural Conditions: The prepared IV solution must be administered via slow infusion over a period of not less than 60 minutes. This controlled rate is necessary to comply with the approved administration profile. If a dose is missed, it should be administered as soon as possible on the same day, but two doses should never be administered to compensate for a single missed dose.

This sequence of preparation, dilution, and controlled administration time is part of the established protocol, ensuring the medicine is used exactly as specified.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Kaishi

The available research evidence for Kaishi (Alprostadil) is primarily derived from Randomized Controlled Trials (RCTs) and comprehensive Systematic Reviews and Meta-Analyses. These studies were evaluated in clinical settings to understand how the medicine was associated with specific outcomes related to kidney function, particularly in patients with diabetes-related complications. The research describes group patterns observed in the studies, and these findings describe patterns observed in the studies, not personal outcomes or guarantees.


1. Evidence for Management of Diabetic Nephropathy

Research has explored the use of Kaishi as a supportive measure alongside conventional treatments for Diabetic Nephropathy (DN). The studies examined adults and older adults who already had DN, comparing those receiving Kaishi plus standard care against those receiving standard care alone.

The outcomes monitored in these trials included biomarkers of renal function and proteinuria measures. Some trials reported patterns where measurements of proteinuria were observed to differ between the group receiving Kaishi and the control group over follow-up periods that ranged up to a year. Measurements of renal function markers were also observed in the group receiving Kaishi compared to control groups at short and intermediate follow-up periods.


2. Evidence for Prevention of Contrast-Induced Nephropathy

Research examined Kaishi's role in research scenarios involving Contrast-Induced Nephropathy (CIN), a condition associated with procedures that require the injection of iodine contrast agents. The research evaluated a specific, high-risk adult population, namely patients with Type 2 Diabetes and pre-existing Chronic Kidney Disease (CKD) who were observed in studies involving contrast-requiring procedures.

These studies explored whether administering Kaishi alongside standard hydration therapy was associated with a different outcome for CIN occurring shortly after the procedure. The primary outcome was monitored as the incidence of CIN, defined by a specific threshold rise in serum creatinine levels within the first 72 hours following contrast exposure.


5. Research Gaps and Uncertainty in the Evidence

The scientific community highlights areas where certainty remains low regarding the research base for Kaishi:

  • Study Scale and Origin: Evidence quality varies across studies, and many findings were mixed or derived from small populations and trials originating from a limited number of research centers. This restricts the ability to generalize the findings to diverse global patient groups.
  • Long-Term Impact: Long-term effects are not fully established. Research provides context on short-term changes in biomarkers, but certainty remains low regarding the medicine's definitive impact on the major, irreversible clinical events that occur over many years. This is why research is ongoing to address these key limitations.

Key Studies & References Clinical Role of Alprostadil in Systematic Reviews (NIH Guidance)

Frequently Asked Questions (FAQ)

Common questions about Kaishi (FAQ)

Q: What is the main reason doctors prescribe Kaishi?

A: Official regulatory labeling indicates the main purpose of Kaishi is for the treatment of erectile dysfunction. It is also sometimes used by healthcare professionals as a supportive tool during diagnostic testing for this condition.


Q: Is Kaishi considered a maintenance medicine?

A: According to the official product information, Kaishi is typically not described as a long-term maintenance medicine. It is generally described as being administered on an as-needed basis or for specific, temporary reasons, rather than for long-term continuous maintenance.


Q: How quickly does Kaishi typically start working after the first use?

A: Studies for the injection formulation indicate that the intended effect may start within 5 to 20 minutes following administration. The full response is unique to each patient, and the appropriate dose is determined through careful adjustment by a healthcare professional.


Q: Is it possible for Kaishi to cause drowsiness?

A: Official summaries of reported side effects indicate that some individuals may experience feelings such as dizziness or lightheadedness. These effects may sometimes be associated with unusual feelings of drowsiness or tiredness.


Q: Are there any common over-the-counter medicines that interact with Kaishi?

A: Regulatory information indicates there may be interactions with medicines that affect blood clotting or blood pressure. This includes certain prescription medications and some common over-the-counter products. Official guidance highlights the importance of reviewing all non-prescription products and supplements with a healthcare professional.


Q: Can Kaishi be used by older adults?

A: Official documents note that formal studies of Kaishi in the elderly population have not been completed. Regulatory documents note that caution may be necessary for older adults, particularly those with existing kidney issues, which could potentially affect how the body removes the medicine.


Q: Is Kaishi safe to use during pregnancy, according to official documents?

A: The official labeling does not indicate Kaishi for use in women. Furthermore, regulatory documents state that there are no adequate studies available in pregnant women to determine the risks associated with the medicine to an unborn infant.


Q: What should I know about Kaishi and alcohol consumption?

A: Official reports do not list a direct interaction between this medicine and alcohol. However, due to the drug’s effects on the body, official regulatory guidance highlights the importance of reviewing the use of alcohol with a healthcare professional to understand any potential risks.


Q: What is the most serious potential side effect listed for Kaishi?

A: Official summaries list serious adverse reactions that require prompt medical evaluation, such as priapism (an erection lasting longer than 6 hours). In some formulations, there are also warnings about potential serious effects on the cardiorespiratory system.


Q: Is Kaishi a controlled substance or habit-forming?

A: The active ingredient in Kaishi is not classified as a controlled substance by US federal regulatory agencies. Therefore, the medicine is not considered habit-forming or subject to the specialized scheduling rules that govern controlled substances.


Q: Can people who have liver problems take Kaishi?

A: Official information notes that caution may be required for patients with kidney problems. This is because reduced kidney function may result in the slower removal of the medicine from the body, potentially requiring an adjustment to the amount administered.


Q: What does 'contraindicated' mean in relation to Kaishi?

A: A contraindication is a critical regulatory term. It signifies a specific condition or factor that makes using the medicine inappropriate because it would increase the risk of harm to the patient.


Q: Why are there warnings about Kaishi for people with heart conditions?

A: Regulatory warnings exist because Kaishi is classified as a potent vasodilator, meaning it can widen blood vessels. This effect can directly cause changes in blood pressure or heart rate. Therefore, regulatory warnings advise that caution should be exercised regarding its use in patients with pre-existing heart or blood vessel conditions.


Q: Is Kaishi a new medicine, or has it been around for a while?

A: The active ingredient in Kaishi, alprostadil, has been approved and in therapeutic use for several decades. The medicine is now available in various regulatory-approved forms, including generic options.


Q: What kind of monitoring is usually recommended when taking Kaishi?

A: Regulatory documents emphasize the importance of close monitoring when first taking the medicine to ensure the proper effect. This may involve assessing the patient’s vital signs, such as heart rate and blood pressure, to monitor the body's response to the drug.


Q: Can Kaishi affect my ability to drive or operate machinery?

A: Because some reported side effects include dizziness, lightheadedness, and unusual drowsiness, regulatory information advises caution. Due to these potential effects, it is generally recommended to use caution with activities that require full attention, such as driving or operating machinery.


Q: What should I do if I think I'm having an allergic reaction to Kaishi?

A: Regulatory guidelines state that signs of a severe allergic reaction (such as rash, swelling of the face, or trouble breathing) are conditions requiring prompt emergency medical assistance.


Q: What is the main ingredient in Kaishi?

A: The active ingredient in the Kaishi medicine is alprostadil. This is the component responsible for the therapeutic action of the drug.


Q: Can children or teenagers use Kaishi?

A: Official guidelines state that the male adult use formulation of Kaishi is contraindicated for anyone under 18 years of age. For this reason, it is not indicated for general use in children or teenagers.


Q: Are there different strengths of Kaishi available?

A: Yes, the medicine is commercially available in different strengths or vial sizes as outlined in the full prescribing information. These options, such as 10 mu g, 20 mu g, and 40 mu g single-dose vials, allow healthcare providers to determine the necessary amount for each patient.


Q: Is Kaishi available as a generic medicine?

A: Yes, the active ingredient in Kaishi has been approved for use in generic options. This means that the medicine is generally available in various regulatory-approved generic forms in addition to the brand name.


Q: Why is consistency important when taking Kaishi?

A: The regulatory description indicates that the medicine is rapidly metabolized (broken down) and eliminated from the body. Therefore, the consistent administration is necessary to help maintain the therapeutic effect as intended by the prescribing professional.


Q: Are there specific tests I need before starting Kaishi?

A: Official guidelines suggest that specific tests may be required as part of the initial medical diagnosis before starting Kaishi. Additionally, in some cases, the medicine itself is used as a supportive tool for other diagnostic testing performed by a physician.


Q: What kind of long-term side effects have been reported for Kaishi?

A: Official regulatory documents, which must be consulted by professionals, do not contain long-term studies on the potential for carcinogenicity (the potential to cause cancer). Other potential long-term risks, like priapism, are monitored by the prescribing physician.


Q: What is the official definition of Kaishi’s purpose?

A: The official definition, as established in regulatory documents, is for the treatment of erectile dysfunction. This is the authorized use that has been supported by clinical evidence and approved by health authorities.


Q: Why is it described that Kaishi can affect blood pressure?

A: Regulatory documents describe Kaishi as a potent vasodilator, meaning it acts to relax the smooth muscle tissue in blood vessel walls. This action directly results in the potential to affect blood vessel size, which in turn can lead to changes in blood pressure.


Q: What are the official restrictions on who can use Kaishi?

A: Use is restricted for patients with known hypersensitivity to the medicine, as well as for those with certain underlying medical conditions (such as sickle cell anemia or leukemia) that increase the risk of a serious side effect called priapism.


Q: What information should I read on the label of Kaishi?

A: Regulatory guidance suggests patients familiarize themselves with key sections of the official document. These include the authorized indications for use, important warnings and precautions, and information about potential side effects and drug interactions.


Q: Are there any demographic groups where Kaishi works differently?

A: Regulatory documents emphasize that the dose must be carefully adjusted, or titrated, for each individual patient. It is noted that certain underlying health conditions can directly affect how the patient responds to the medicine and may alter their risk profile.


Q: What is the difference between a side effect and an interaction?

A: A side effect is an unwanted effect that is caused by the medicine itself, such as a headache or dizziness. A drug interaction occurs when another substance, like food or a supplement, changes how the medicine works in the body.


Q: Does Kaishi have any known drug class warnings?

A: Kaishi belongs to a class of medicines called prostaglandin analogs. Its warnings are related to its main action as a smooth muscle relaxant and potent vasodilator. These warnings specifically advise caution regarding certain cardiovascular conditions.


Q: What do official sources say about Kaishi and breastfeeding?

A: Official regulatory documents state that the medicine is not indicated for use in women. In regard to breastfeeding, there are no adequate studies available to determine the potential risk to an infant if the medicine were used during this period.


Q: What are the ingredients in Kaishi's inactive components?

A: The sterile powder formulation of Kaishi includes inactive components called excipients. The liquid used to prepare the medicine, known as the diluent, may also contain ingredients such as benzyl alcohol as a preservative.


Q: Where can I find the official regulatory information about Kaishi?

A: Official regulatory information for Kaishi is published by government health authorities. Key sources include the FDA Prescribing Information (the official Label) in the US, and the DailyMed records.

How should Kaishi be stored and disposed of?

Kaishi should be stored in a cool, dry place and kept in its original container to maintain its potency and integrity. Avoid areas prone to heat, air, light, and excessive moisture, such as a bathroom medicine cabinet, as these conditions can damage the medication. Always store the drug securely out of reach and sight of children and pets, ideally in a locked cabinet.


For disposal of expired or unused Kaishi, follow any specific instructions provided on the drug labeling or patient information leaflet. If no specific instructions exist, the preferred method is to utilize a community drug take-back program or a mail-back envelope service, which are often available at pharmacies or through local law enforcement. If these options are unavailable, most medicines can be safely disposed of in household trash. To do this, mix the medication (without crushing tablets or capsules) with an undesirable substance, such as used coffee grounds or cat litter. Place this mixture in a sealed plastic bag or container, and then dispose of it in the trash. Before discarding the original packaging, scratch out all personal information to protect your privacy.

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

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