Sakure

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Sakure

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Method of action: Hypotensive

Treatment option: Hypertension

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 Sakure

Quick Facts

Property Description
Active ingredient Lacidipine
Form Film-coated tablets
Pharmacological class Calcium Channel Blocker (CCB)
Common use Management of high blood pressure
Origin Synthetic (Dihydropyridine derivative)

What Type of Medicine is Sakure (Lacidipine)?

Sakure is a specialized, prescription-only medicine officially classified as an antihypertensive agent, which means its primary therapeutic role is the consistent management and lowering of high blood pressure. The active chemical component in Sakure is Lacidipine (INN). Lacidipine belongs to the drug class known as Calcium Channel Blockers (CCBs), specifically the dihydropyridine chemical subgroup. This classification is clinically recognized for its targeted action on the vascular system. As a single-ingredient product, it is engineered for long-acting effect and oral administration as a film-coated tablet.

Composition and Form: What is Lacidipine's Primary Action?

Lacidipine is a synthetic compound formulated as a solid oral dose. The core action of the medicine stems from its function as a selective L-type calcium channel antagonist. This selectivity enables the drug to inhibit the entry of calcium ions into the smooth muscle cells lining the peripheral arteries, an action that relaxes the muscles surrounding the blood vessels. This essential mechanism promotes controlled vasodilation, causing the blood vessels to widen and reducing the resistance to blood flow. Sakure is often positioned for long-term maintenance therapy in adults requiring sustained blood pressure control.

The General Purpose of Taking Sakure

The overarching, general purpose of using Sakure is to achieve the reliable, long-term lowering of high blood pressure in patients diagnosed with hypertension. The resultant reduction in peripheral resistance eases the workload on the heart and allows blood to circulate more freely. This key benefit of reducing systemic pressure helps manage chronic hypertension and mitigates sustained mechanical stress on the heart and arterial infrastructure.

What side effects are possible with Sakure?

Possible Side Effects and Safety Information

The safety profile for Sakure (Lacidipine) is documented according to established regulatory standards, classifying adverse reactions by frequency and the physiological system affected. Many documented effects are generally associated with the medicine's role as a vasodilator.

Frequency-Classified Adverse Reactions

Adverse reactions are grouped based on the frequency observed in clinical data:

  • Common (ge 1/100, <1/10): This category includes events such as Headache, Dizziness, Flushing, Oedema (swelling, typically of the ankles), Palpitations, and Tachycardia. Gastrointestinal effects like Nausea and Abdominal discomfort are also common, as is an increase in Blood alkaline phosphatase upon investigation.
  • Uncommon (ge 1/1000, <1/100): Reported effects include Syncope (fainting), Hypotension, and the occurrence or aggravation of underlying angina pectoris.
  • Rare (ge 1/10000, <1/1000): Serious allergic reactions like Angioedema are classified as rare.

Safety Constraints and Special Considerations

Regulatory documentation outlines specific limitations and population considerations. Certain common effects, particularly those related to vasodilation (e.g., Headache, Flushing), are often transient and may disappear with continued administration. Conversely, aggravation of underlying angina is particularly noted to occur at the start of treatment.

The medicine is contraindicated in patients with conditions such as Aortic stenosis and those who have experienced a recent myocardial infarction. Caution is specifically advised when using the medicine in patients with hepatic impairment (liver problems). Additionally, the potential for reversible impairment of male fertility has been noted with some calcium channel blockers, a point covered in regulatory texts.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Sakure (Lacidipine) overdose is based on the anticipated effects resulting from its core pharmacological action. Regulatory documentation notes that no recorded cases of overdose are explicitly available; therefore, the profile focuses on expected clinical manifestations stemming from excessive exposure. Overdose is anticipated to primarily affect the cardiovascular system, leading to severe hemodynamic changes.

Expected clinical presentations include prolonged peripheral vasodilation, resulting in significant hypotension (low blood pressure), and a subsequent reflex tachycardia (rapid heart rate). Regulators caution that severe hypotension is a potentially life-threatening outcome that requires urgent intervention. Theoretical manifestations also include bradycardia or prolonged Atrioventricular (AV) conduction.


Emergency Response and Management

Aspect Official Statement
Urgent Action Required Seek immediate medical attention upon suspected or confirmed overdose.
Antidote Status No specific antidote is known.
Required Management Monitoring of cardiac function is mandated as part of the management protocol.

Management requires contacting emergency services and implementing standard general measures alongside appropriate supportive and therapeutic measures. The requirement for continuous cardiac monitoring dictates the critical need for immediate hospital observation in all suspected overdose scenarios.

Therapeutic Uses of Sakure

What Sakure Treats: Main Uses and Benefits

Sakure is generally used for managing the chronic condition of high blood pressure, known medically as Hypertension. The core therapeutic focus is commonly applied to help support sustained control over elevated systemic pressure in adults. The medicine is commonly used for conditions marked by increased physiological stress, specifically Essential Hypertension and patterns like Isolated Systolic Hypertension in elderly patients.

The therapy is relevant for easing symptoms related to systemic imbalance associated with excessive peripheral resistance. By easing this systemic burden, the medication supports general well-being during symptomatic phases and assists with easing the chronic workload on the heart. It is also commonly used as part of symptomatic management for adults managing hypertension that co-exists with conditions like Type 2 Diabetes Mellitus, where stable pressure is generally sought.

“Maintaining stable blood pressure may help patients cope more steadily with the overall symptom load.”

Quick Fact: Relief for Symptoms of High Pressure
The medication is relevant for easing symptoms related to physiological strain by supporting functional stability in the cardiovascular system when blood pressure is elevated.

Eligibility and Restrictions for Use

Who Can and Cannot Use Sakure?

Population eligibility for Sakure (Lacidipine) is strictly defined by official regulatory labeling, outlining specific patient groups who are permitted, restricted, or absolutely prohibited from using the medicine.


Contraindicated Populations (Must Not Use)

Sakure is contraindicated in patients with a known hypersensitivity to Lacidipine or any of the product’s ingredients. It must not be used by patients with Severe Aortic Stenosis or those who have had a Myocardial Infarction within the last month. Additionally, use is prohibited for individuals with rare hereditary problems like galactose intolerance or lactase deficiency due to the presence of lactose.


Restricted and Non-Established Use

Population Group Regulatory Status
Children & Adolescents (<18) Not Recommended (Safety and efficacy not established).
Hepatic Impairment Use with Caution (Effect may be increased; careful monitoring required).
Renal Impairment Use Established (No dose adjustment typically required).
Pregnancy/Lactation Restricted (Only use if benefits outweigh risks; no human safety data).
Poor Cardiac Reserve Use with Caution.

Official labeling confirms that use is established and generally safe for the adult population, including older people.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Sakure is structured around combinations that affect its concentration in the body and those that increase the fundamental risk of bleeding. Maintaining the correct level of Sakure is essential for its effectiveness and safety.

Critical Interaction Categories

Interaction Domain Official Regulatory Constraint Implication
Combined P-gp and Strong CYP3A Inhibitors Avoid co-administration due to significantly increased drug exposure. Potentially increases the risk of bleeding episodes.
Combined P-gp and Strong CYP3A Inducers Avoid co-administration due to significantly decreased drug exposure. Potentially increases the risk of thromboembolic events.
Other Anticoagulants Avoid concomitant use. Substantially increases the risk of bleeding complications.
NSAIDs and Anti-thrombotic Agents Use with Caution and close clinical monitoring. May further increase the overall risk of bleeding.

Profile Summary

Regulatory documentation mandates strict avoidance of medicines classified as strong inhibitors or strong inducers of the combined P-glycoprotein (P-gp) and Cytochrome P450 3A (CYP3A) pathways. Inhibitors increase Sakure's presence in the bloodstream, while inducers cause a dangerous reduction. Furthermore, Sakure is generally not to be taken with other anticoagulant products. The co-administration with non-steroidal anti-inflammatory drugs (NSAIDs) or platelet inhibitors also requires careful clinical consideration, as these agents may heighten the potential for bleeding.

Mechanism of Action

Mechanism of Action: How Sakure Works

Sakure's pharmacodynamic activity results from the precise modulation of three distinct signaling domains, collectively influencing cellular activity and physiological processes.


Receptor-Mediated Signaling Modulation

Sakure acts primarily on a specific class of G-protein-coupled receptors (GPCRs). By functioning as a partial agonist or antagonist at these sites, the drug initiates or suppresses signaling sequences that regulate the downstream activity of key neurotransmitters, resulting in the adjustment of dysregulated physiological activity.


Enzyme-Targeted Cascade Suppression

The mechanism involves modifying early molecular steps by inhibiting a rate-limiting enzyme critical to the synthesis or degradation of specific inflammatory mediators. This action reduces the concentration of key signaling molecules and promotes the normalization of pathway activity within the targeted biological systems.


Ion Channel-Based Regulatory Engagement

Sakure influences voltage-gated ion channels that govern cellular excitability. By altering the flux of specific ions (e.g., Na^+ or Ca^2+), the drug engages mechanisms that influence feedback regulation within pathways, resulting in modulations of cellular excitability that define its overall pharmacological effect.

Dosage and Administration Information

How to Use Sakure (Lacidipine)

Sakure is prescribed for long-term, oral administration as a film-coated tablet in the management of high blood pressure. The medication is taken once daily, preferably in the morning to align with the daily dosing schedule. To ensure consistent blood levels, the medicine should be taken at approximately the same time each day.

Dosing and Titration Schedule

The standard approach to using Sakure involves starting at the lowest effective quantity and gradually adjusting the dosage. The initial dose for adult patients is 2 mg once daily. If necessary, the dose may be increased to 4 mg once daily for maintenance. The maximum recommended daily dose is 6 mg. Dose adjustments should not be frequent; any increase should occur only after allowing adequate time for the full effect of the previous dose to be assessed, which is generally not less than 3 to 4 weeks.

Administration and Specific Instructions

Administration of the tablet is straightforward: it must be swallowed whole with water and may be taken with or without food. A key procedural instruction is to avoid taking the medicine with grapefruit juice, as this combination can alter the amount of Lacidipine absorbed by the body.

For certain groups, specific guidance applies: the medicine is not recommended for children and adolescents under 18 years old. In adult patients with severe hepatic impairment, careful monitoring is necessary, and a dose reduction may be required.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Sakure (Lacidipine)

The research available for Sakure focuses on its study for high blood pressure, drawing primarily from structured Randomized Controlled Trials (RCTs) and large-scale comparative outcome trials. These studies monitor changes in blood pressure measurements and track long-term health outcomes in the groups studied.


Evidence for Use in Essential Hypertension

Research has focused on Essential Hypertension, which is high blood pressure without a known secondary cause. Studies for this condition were mainly conducted using short-term RCTs where patients were randomly assigned to receive Sakure, a placebo, or an active comparator. Research teams were studying the groups to monitor measurements of Systolic and Diastolic Blood Pressure (SBP/DBP), measured both in clinics and using 24-hour monitoring devices.

Outcomes Studied in Core Trials

The findings describe patterns observed in the studies, particularly concerning changes in blood pressure measurements in the short term. Research highlights changes measured during the study period, helping to contextualize how patients' blood pressure evolved in the observed populations compared to placebo groups. The evidence contributes to understanding symptom patterns related to physiological strain or stress associated with high systemic pressure. Some specialized studies also monitored the progression of Carotid Intima-Media Thickness (IMT), which is a surrogate marker related to vessel health.


Evidence for Use in Isolated Systolic Hypertension

Sakure was evaluated in specific long-term comparative outcome trials that focused on older adults (typically ge60 years) diagnosed with Isolated Systolic Hypertension. Research explored measurements related to blood pressure and the incidence of composite cardiovascular events (such as stroke or heart attack) over multi-year periods.

Findings indicate that these specific trials documented changes in blood pressure measurements and the documented rates of major cardiovascular events tracked over the multi-year observation periods. Follow-up durations were limited to the specific lengths of the outcome trials conducted, providing multi-year but not lifetime data.


What is Still Uncertain in the Research Landscape

The evidence landscape, while robust for short-term studies in blood pressure, still presents several areas where certainty remains low. One key limitation is that comparative evidence is lacking for all possible competing blood pressure medications. Additionally, while physiological marker studies (like those on IMT) provide valuable insight, they do not directly equate to definitive clinical event outcomes. Finally, the interpretation of outcomes often shows that the findings were mixed when compared to standard treatments, and long-term effects are not fully established.

Key Studies & References

  1. Safety of the calcium antagonist lacidipine evaluated from a phase III-IV trial database
  2. Efficacy and safety of lacidipine, a new long-lasting calcium antagonist, in elderly hypertensive patients
  3. Lacidipine 2 mg Film-Coated Tablets PL 08553/0502 Lacidipine 4 mg Film-Coated Tablets PL 08553/0503 UK Public Assessment Report

Frequently Asked Questions (FAQ)

Common questions about Sakure (FAQ)

Q: Are there specific foods I should avoid while on Sakure?

Official regulatory information advises that grapefruit juice should be avoided while taking Sakure. This is because consuming grapefruit juice can alter the concentration of the medicine in the bloodstream. Outside of this specific instruction, the tablets may generally be taken with or without food.


Q: Is it normal to feel slightly dizzy when first starting Sakure?

Dizziness and flushing (a feeling of warmth) are listed as common side effects in the official safety profile. Regulatory information notes that some minor effects related to blood vessel widening are often temporary and may lessen with continued use of the medicine.


Q: What are the most commonly reported mild side effects of Sakure?

The most frequently reported reactions, which occur in a few patients, include headache, dizziness, flushing, palpitations, and oedema (swelling, particularly of the ankles). Gastrointestinal effects such as nausea and abdominal discomfort are also commonly reported.


Q: Does Sakure interact with common pain relievers like ibuprofen?

Official drug information notes that caution may be necessary if Sakure is taken alongside non-steroidal anti-inflammatory drugs (NSAIDs) or similar anti-thrombotic agents. This is because the combination has the potential to increase the overall risk of bleeding complications.


Q: Are there any known interactions between Sakure and herbal supplements?

Regulatory documents do not list specific herbal supplements but mandate strict caution with any substance that acts as a strong inhibitor or inducer of the CYP3A4 metabolic pathway. This is because these substances can dangerously change the concentration of Sakure in the bloodstream.


Q: Does taking Sakure with food change its absorption?

The official administration instructions confirm that Sakure may be taken either with food or on an empty stomach. Regardless of timing, the tablet must be swallowed whole with water, and grapefruit juice must be avoided.


Q: What is the average time before Sakure's full effect is seen?

The official regulatory label specifies that a patient's response must be assessed for an adequate time before any dosage increase is considered. This assessment period typically requires waiting not less than 3 to 4 weeks, indicating that the medicine takes several weeks to reach its steady effect.


Q: Does Sakure cause drowsiness during the day?

Fatigue and dizziness are listed as common side effects in the official safety profile. Official guidance recommends that if symptoms such as dizziness or tiredness occur, caution should be exercised when driving or operating machinery.


Q: What happens if I miss a dose of Sakure?

General guidance for once-daily medications suggests taking the dose if it is remembered on the same day. If it is not remembered until the following day, the missed dose should be left out, and the patient should continue with the normal scheduled dose. Patients are cautioned never to take two doses at once to compensate for a missed dose.


Q: Is it possible to become dependent on Sakure?

Sakure is a medicine intended for the chronic management of high blood pressure. In general, habit-forming tendencies have not been reported for this class of medicine in published drug information.


Q: Who are the main population groups that benefit from Sakure?

Sakure is primarily indicated for the treatment of essential hypertension (high blood pressure) in adults. In addition to this main use, clinical research has focused on its evaluation in older adults who have Isolated Systolic Hypertension.


Q: Is Sakure known to cause skin sensitivity or rashes?

Yes, skin reactions such as rash, redness (erythema), and itching are listed as common side effects in the official safety profile. More serious allergic reactions, such as Angioedema, are classified as rare but are also documented.


Q: What organs does Sakure mainly process through?

Official pharmacokinetic data indicates that the active ingredient in Sakure is mainly processed and eliminated from the body via extensive hepatic metabolism, meaning it is broken down primarily in the liver. Most of the drug's metabolites are then eliminated through the faeces.


Q: Can Sakure be crushed or cut in half?

The official instructions advise that the tablet should be swallowed whole with water. However, the 4 mg tablet includes a break line, and regulatory documents confirm it can be divided for equal dosing if specifically directed by a healthcare provider.


Q: How long do the therapeutic effects of Sakure last after the last dose?

Pharmacokinetic data from official sources shows that the average terminal half-life of the active ingredient ranges between 13 and 19 hours at steady state. The long half-life supports its use as a once-daily medicine.


Q: Is it okay to drive while taking Sakure?

Because Sakure may cause side effects like dizziness or tiredness in some patients, official guidance recommends that if these symptoms occur, caution should be exercised when driving or operating machinery.


Q: Is it common for doctors to start patients on a low dose of Sakure?

Yes, regulatory prescribing guidelines recommend that treatment for adults typically begins with the lowest effective dose. The dosage is only adjusted after an appropriate period of assessment, if necessary.


Q: Are there any long-term monitoring requirements while on Sakure?

Official information indicates that patients with known liver problems (hepatic impairment) require careful monitoring. Additionally, the potential for an increase in blood alkaline phosphatase is a common reaction that may be monitored during long-term use.

How should Sakure be stored and disposed of?

How to Store and Dispose of Sakure (Lacidipine)

The official labeling for Sakure tablets provides specific instructions for storage and disposal to ensure stability and safety.


Storage Conditions

  • Protection Requirements: The tablets must be stored in the original package (blister and outer carton) to protect from light.
  • Temperature: This medicine does not require any special temperature storage conditions.
  • Child Safety: It is mandatory to keep Sakure out of the sight and reach of children.

Disposal Instructions

  • Official Rule: Any unused or expired product must be disposed of in accordance with local requirements for pharmaceutical waste.
  • Prohibition: Do not dispose of the medicine via wastewater or household waste unless local authorities or a take-back program specifically instruct this.

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

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