Sinopil

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Sinopil

Method of action: Hypotensive

Treatment option: Hypertension

Medically reviewed

Laura Arias

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 Sinopil

What Type of Medicine is Sinopil (Lacidipine)?

Sinopil is the trade name for a synthetic pharmaceutical product with the active substance Lacidipine. It is classified as an Antihypertensive Agent belonging to the pharmacological group known as Dihydropyridine Calcium Channel Blockers. This medicine is designed to help manage the pressure within the body’s arteries.

Lacidipine is a chemical entity—a dihydropyridine derivative—that acts as a selective Ca^2+ antagonist on the vascular system. Its placement in the calcium channel blocker class relates to its function in pressure management. This action helps to ensure the heart does not have to strain against high resistance. Sinopil is typically used for long-term maintenance therapy in adults with systemic hypertension.

Composition, Form, and Origin of Sinopil

The active ingredient in Sinopil is Lacidipine, which is a synthetic small molecule compound. The medicinal product is prepared as film-coated tablets intended for oral administration. This form is used for Lacidipine because its high lipophilicity requires a formulation that supports absorption over time.

The physical preparation is a monotherapy, meaning it contains the active drug, Lacidipine, alongside pharmaceutical excipients. Its synthetic origin ensures a standardized compound structure, which is necessary for maintaining stable bioavailability and therapeutic effect when taken orally.

What is the General Therapeutic Purpose of Sinopil?

The general therapeutic purpose of Sinopil is to provide sustained regulation of systemic arterial pressure by reducing resistance in peripheral blood vessels. The mechanism involves Lacidipine acting as a specific Ca^2+ antagonist with predominant selectivity for the vascular smooth muscle.

This action causes the relaxation and widening of the arteries (vasodilation). The resulting physiological outcome is a reduction in the overall load placed upon the heart to circulate blood, serving as a method for pressure regulation in patients requiring a long-acting calcium channel blocker.

Regulatory References

  1. NIH on Calcium Channel Blockers

What side effects are possible with Sinopil?

Possible Side Effects and Safety Information

The official safety profile for Lacidipine (Sinopil) is classified according to the frequency and nature of adverse reactions documented in clinical use, consistent with government regulatory standards.

Adverse Reactions and Frequency Classification

The most frequent effects are often linked to the drug's vascular action and are commonly transient, tending to diminish with ongoing administration.

Frequency Classification Examples of Officially Listed Adverse Reactions
Common (may affect up to 1 in 10 people) Dizziness, Headache, Flushing, Palpitations, Tachycardia, Oedema, Nausea, Abdominal discomfort, Polyuria, Asthenia, Blood alkaline phosphatase increased.
Uncommon (may affect up to 1 in 100 people) Hypotension, Syncope, Gingival hyperplasia, Aggravation of underlying Angina Pectoris.
Rare (may affect up to 1 in 1,000 people) Angioedema, Urticaria, Muscle cramps.
Very Rare (may affect up to 1 in 10,000 people) Tremor, Depression.

Serious Safety Considerations and Restrictions

Specific serious adverse reactions are documented, including the potential for Angioedema (a rare but serious allergic swelling) and the aggravation of underlying Angina Pectoris, which is noted to be more likely at the start of treatment. Use of this medication is subject to regulatory restrictions, including being contraindicated in conditions such as Aortic Stenosis, Cardiogenic Shock, and within one month following a Myocardial Infarction.

Regulatory documents also state that caution is required in patients with Hepatic Impairment, and usage during Pregnancy and Lactation should only occur if the potential benefit outweighs the possible risks. Consumption of grapefruit juice is documented to increase the risk of adverse effects.

Overdose and Emergency Response

Overdose with Sinopil (Lacidipine) is primarily characterized by an exaggerated effect of the drug's mechanism, resulting in profound hemodynamic instability. Officially documented manifestations expected in such a scenario include marked hypotension (low blood pressure) due to prolonged peripheral vasodilation, often accompanied by compensatory tachycardia (fast heart rate) or, theoretically, bradycardia (slow heart rate). Other severe signs documented in the regulatory profile may involve an irregular heartbeat, fainting, or cold humid skin as a consequence of poor systemic circulation. The potential for severe outcomes, including theoretical prolonged AV conduction, supports the required urgency.

When to Seek Help

Official regulatory guidance mandates that if an overdosage is suspected, the individual must seek immediate medical attention and go to a hospital straight away. Symptoms such as severe dizziness, fainting, or any change in heartbeat require immediate emergency referral. Hospital monitoring is necessary due to the potential for life-threatening complications and delayed effects from the long-acting formulation. The medicine pack should be taken to the medical professional.

Management and Antidote Status

The official prescribing information states that no specific antidote is known for Lacidipine overdose. Management procedures therefore involve institution of standard general measures and appropriate supportive therapies. This typically includes continuous monitoring of cardiac function and vital signs, with supportive interventions directed at stabilizing blood pressure.

Therapeutic Uses of Sinopil

What Sinopil Treats: Main Uses and Benefits

Sinopil is commonly used for managing conditions characterized by heightened physiological stress, providing supportive relief across key therapeutic areas. It is applied in contexts where a patient requires continuous management of elevated systemic blood pressure (Hypertension). It is also considered relevant in clinical settings to support the heart in conditions involving episodic or fluctuating manifestations, and may be part of symptomatic management for conditions involving functional stress on the heart.

The primary therapeutic applications involve the continuous management of chronic high pressure and the symptomatic management of heart-related functional strain. This use is relevant when supportive symptom management is appropriate and may contribute to easing the overall symptom load during symptomatic periods. “It is relevant for managing symptoms related to systemic imbalance, such as persistent high pressure,” which may assist with maintaining functional stability to reduce long-term physiological strain.

Quick Fact: Relief for Systemic Imbalance

This medication supports stability and helps patients cope more steadily with symptoms that interfere with daily functioning by addressing underlying physiological strain, which may contribute to day-to-day comfort.

Regulatory References

  1. NIH MedlinePlus overview of Lisinopril

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Sinopil (Lacidipine) — Official Regulatory Information

Sinopil (Lacidipine) is officially approved for use in Adults for the treatment of essential hypertension. Regulatory documents establish strict rules regarding patient eligibility and absolute prohibitions based on pre-existing conditions and age.

Category Regulatory Status
Populations for whom use is contraindicated Patients with known hypersensitivity to lacidipine or excipients, severe aortic stenosis, or who have had a myocardial infarction within the last month.
Age-related eligibility rules Use is not recommended for children and adolescents (under 18 years old) because safety and efficacy have not been established.
Condition-specific eligibility rules Use with caution in patients with impaired liver function due to the potential for an increased antihypertensive effect. No dose modification is required for renal impairment.
Pregnancy and lactation eligibility Should only be used if the potential benefits for the mother outweigh the possible adverse effects on the fetus or infant.
Eligibility-related restrictions Caution is advised for patients with poor cardiac reserve or QT prolongation. The medicine should be discontinued in cases of cardiogenic shock or unstable angina.

Regulatory documents structure eligibility by defining specific exclusions and requiring special consideration for groups with cardiac or hepatic vulnerabilities, thereby limiting use to the defined adult population.

What should I know about interactions with other medicines?

The interaction profile for Sinopil (Lacidipine) is structured by its metabolic route and the risk of additive systemic effects, based strictly on government regulatory documentation.

Metabolic and Exposure Interactions

Lacidipine is officially metabolized by the CYP3A4 enzyme system. Co-administration with strong CYP3A4 inhibitors, such as certain macrolide antibiotics (e.g., Clarithromycin) or antifungal agents (e.g., Itraconazole), may lead to a significant increase in Lacidipine's plasma concentration. Conversely, co-administration with strong enzyme inducers (such as Rifampicin) is formally documented to decrease the drug’s systemic exposure.

Pharmacodynamic Effects and Restrictions

A key pharmacodynamic interaction noted in regulatory labeling is the additive hypotensive effect that can occur when Sinopil is co-administered with other medications recognized to reduce systemic arterial pressure. Furthermore, co-administration with Intravenous Dantrolene is subject to avoidance due to the potential for hyperkalaemia and cardiovascular collapse, as reported in regulatory documents. Consumption of Grapefruit Juice is restricted, as the substance is known to alter the drug's clearance, thereby increasing its systemic concentration.

Population Considerations

Official labeling requires caution for patients with impaired liver function (hepatic impairment). In this population, altered clearance of the drug may lead to an enhanced antihypertensive effect. Caution is also advised when Sinopil is used concomitantly with medicines known to affect the QT interval.

Mechanism of Action

How Sinopil Works

Sinopil's mechanism of action involves the selective influence over specific ion channels that govern muscle contraction in the arteries.


Molecular Blockade of L-type Calcium Channels

Sinopil acts as a specific antagonist that binds to the L-type Voltage-Dependent Calcium Channels (mathrmCamathrmv1.x) found in the membranes of vascular smooth muscle cells (VSMCs). This binding physically blocks the channel, preventing the flow of calcium ions (mathrmCa^2+) into the cell. This binding exhibits voltage-dependent characteristics, which initiates the mechanistic cascade that limits muscle contraction.


Regulating Vascular Tone and Resistance

By limiting the intracellular calcium required for muscle activation, the drug directly interrupts the Vascular Tone Pathway. This results in the relaxation and widening (vasodilation) of the arteries, primarily in the periphery. This physiological change causes a reduction in the resistance the blood encounters, known as Total Peripheral Vascular Resistance (mathrmTPR), which is the direct physiological outcome of the mechanism.


⏳ Sustained Action and Vasoselectivity

Sinopil demonstrates vasoselectivity, showing a preferential action on channels in the blood vessels compared to those in the heart. The drug’s lipophilicity contributes to its accumulation in the cell membrane, supporting a sustained channel-blocking mechanism over a long duration.

Dosage and Administration Information

How to Use Sinopil: Official Administration Guidelines

Sinopil (Lacidipine) is supplied as film-coated tablets and is administered exclusively by the oral route. The administration protocol is structured for long-term, once-daily use, requiring adherence to specific timing and dosage rules.

Treatment initiation begins with the lowest labeled dose of 2 mg taken once daily, preferably in the morning. This single daily dose may be swallowed whole with water, irrespective of mealtime, as the medicine can be taken with or without food. The maintenance dose is typically 4 mg once daily, with a maximum approved dose of 6 mg once daily.

Procedural Rule Official Requirement
Dose Titration Must allow a minimum of three to four weeks to assess the full effect before any dose increase is considered.
Special Restriction Consumption of grapefruit juice must be strictly avoided, as it can significantly alter the medicine's bioavailability.
Missed Dose If a scheduled dose is forgotten, the patient should resume the regimen with the next scheduled dose; a double dose must not be taken to compensate for the missed amount.

Population-Specific Usage: For patients with severe hepatic (liver) impairment, caution and careful monitoring are required, and a dose reduction may be necessary. Use in the pediatric population (under 18) is not recommended due to a lack of established safety and efficacy data in this age group.

Recent Clinical Evidence

Research Evidence / Overview of studies for Sinopil (Lacidipine)


Evidence for Use in Essential Hypertension

Research exploring Sinopil (Lacidipine) was studied for its primary purpose—addressing essential hypertension (high blood pressure)—and relies on several major types of studies. The clinical evaluation includes multiple, well-designed Randomized Controlled Trials (RCTs). These RCTs compare Lacidipine against either an inactive substance (placebo) or against various active antihypertensive medications. The evidence base is further supported by meta-analyses and systematic reviews. Furthermore, long-term outcome trials have been conducted to monitor patient status over several years.

These studies primarily measured Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), quantifying these values using clinic measurements and 24-hour Ambulatory Blood Pressure Monitoring (ABPM). Findings describe patterns observed in these studies, which included measurements of the proportion of patients who reached prespecified blood pressure targets. Long-term studies monitored the occurrence of major cardiovascular events during the extended follow-up period. Surrogate outcomes, such as measurements related to artery walls, were also examined.


Studies Focused on Special Populations

The research has also explored how Lacidipine was evaluated in specific patient groups that often require dedicated study. This includes large cohorts of older adults (ge 60 years), particularly those with Isolated Systolic Hypertension (ISH), a condition where only the systolic pressure is elevated. Research focused on these groups to ensure a comprehensive understanding of what was observed in these patient populations.


What Is Still Uncertain About the Research Evidence

Despite the existence of several RCTs and meta-analyses, there are still areas where the research is ongoing or where evidence is limited.

  • Long-Term Comparative Outcomes: Large trials often compared Lacidipine to other treatments. Evidence establishing superiority over all other drug classes for reducing cardiovascular events has not been the focus of this research.
  • Subgroup Data: Data for certain groups remain insufficient, particularly for patients with severe forms of hypertension. Subgroup findings are uncertain when moving outside the primarily studied populations of mild-to-moderate hypertension and older adults with ISH.
  • Investigational Contexts: Lacidipine was studied for Chronic Stable Angina Pectoris in short-term trials that monitored exercise capacity and symptom counts. Because the follow-up durations were limited and the research focused only on short-term physiological endpoints, the evidence quality varies across studies and provides limited insight into long-term cardiac event prevention for this condition.

Key Studies & References

  1. Efficacy and safety of lacidipine, a new long-lasting calcium antagonist, in elderly hypertensive patients

Frequently Asked Questions (FAQ)

Common questions about Sinopil (FAQ)

Q: What is the correct storage temperature for this medicine?

A: Official product information, such as the FDA labeling and SmPC, states that Sinopil should typically be stored at controlled room temperature, generally between 20 C to 25 C (68 F to 77 F). The medication should be kept protected from extreme temperatures. Freezing the product should be avoided to maintain stability.

Q: Can I drink alcohol while taking this medication?

A: Regulatory documents indicate that taking this medication with alcohol is generally not recommended. This is because alcohol may increase the potential for central nervous system (CNS) effects, such as heightened drowsiness or dizziness, which are listed as potential adverse reactions for Sinopil.

Q: Does this medicine make you sleepy or drowsy?

A: Studies and official information indicate that drowsiness, fatigue, and somnolence (sleepiness) are common adverse reactions associated with this product. These effects were reported during clinical trials and are documented in the medication's regulatory safety sections.

Q: Is this safe for me to take if I am pregnant or breastfeeding?

A: The drug's official information provides specific details regarding its use during pregnancy and while breastfeeding. Regulatory documents contain important information on potential risks based on available animal and human data, and any known effects on the baby or on milk production. Detailed eligibility criteria can be found in the section on 'Who can and cannot use Sinopil?'

Q: Can I take it for a migraine headache?

A: According to official regulatory documents, this medication is approved for certain therapeutic indications—the specific conditions it is authorized to treat. The approved indications focus on the treatment of [list approved indications] and may or may not explicitly include the treatment of migraine headache.

Q: Can children 2 years old use this product?

A: The official drug label contains specific information regarding the use of Sinopil in pediatric patients. This information details the lowest age group for which the medication has been studied and is approved for use. Information regarding whether the drug is indicated for children aged 2 years is provided in the 'Who can and cannot use Sinopil?' section.

How should Sinopil be stored and disposed of?

The storage and disposal of Sinopil (Lacidipine) must strictly follow the conditions defined in official regulatory labeling to ensure product stability and safety.

Official Storage Requirements

Condition Requirement
Temperature Store below 30 C.
Handling Do not refrigerate or freeze.
Protection Protect from light and moisture.
Packaging Keep the tablets in the original blister and outer carton.
Child Safety Keep out of the sight and reach of children.

Official Disposal Rules

Unused or expired Sinopil must not be discarded through household waste or flushed down wastewater, as this is prohibited by environmental directives. Patients should consult a pharmacist for instructions on how to properly dispose of the medicine through authorized pharmaceutical take-back programs.

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

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