Sular

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Sular

Treatment option: Hypertension

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 Sular

Quick Facts

Property Description
Active Ingredient Nisoldipine
Form Oral Extended-Release Tablet
Pharmacological Class Dihydropyridine Calcium Channel Blocker
General Purpose Vasodilation to improve blood flow
Status Prescription Only (Rx)

Sular (Nisoldipine): What Type of Medicine Is It?

Sular is a brand-name, prescription-only (Rx) medicine that contains the single active ingredient nisoldipine, which is a synthetic compound. It is formally classified as a dihydropyridine calcium channel blocker (CCB). This class of medicine is clinically recognized as a widely accepted option in medical guidelines, supported by pharmacological research for its general purpose of managing conditions where blood vessel relaxation is beneficial.

The core function of Sular is to cause vasodilation, meaning it helps to widen the blood vessels. This effect is achieved by blocking the entry of calcium into the smooth muscle cells lining the vessel walls, causing them to relax. Nisoldipine is characterized by a highly selective action on vascular smooth muscle, which helps to minimize effects on heart muscle. This medicine is designed to work by reducing resistance in the blood vessels.

Composition and Formulation: Understanding the Extended-Release Tablet

Sular is supplied as an oral tablet and its active component is nisoldipine. A key differentiating feature of Sular is its extended-release (ER) formulation, which utilizes a controlled-release tablet structure. Unlike immediate-release medications, Sular is specifically designed to ensure the medication is released slowly and consistently over a full 24-hour period.

This extended-release design is intended for maintaining effective, steady blood concentrations of nisoldipine. The extended-release technology provides a predictable, smooth delivery of the medication throughout the day, which is essential for achieving its long-term therapeutic goal.

What side effects are possible with Sular?

Possible Side Effects and Safety Information

The safety profile of Sular (nisoldipine) is based on clinical trial data and post-marketing reports, officially documenting the spectrum of possible adverse reactions and required precautions.

Adverse Reactions

The most frequent adverse reactions reported in clinical studies are typically related to the drug's vasodilatory effects. These common side effects (occurring in 1% to 10% of patients or more) include headache, peripheral edema (swelling of the ankles, feet, or hands), and flushing. Less common reactions may involve dizziness, nausea, rash, and the development of pharyngitis or sinusitis.

Serious Safety Precautions

Official regulatory documents emphasize the potential for serious cardiovascular events, particularly in patients with pre-existing coronary artery disease. These include the rare possibility of increased frequency, duration, or severity of chest pain (angina) or acute myocardial infarction (heart attack), especially when starting therapy or increasing the dosage. Clinically significant low blood pressure (hypotension) may also occur, requiring careful blood pressure monitoring.

Safety-Related Restrictions

Sular is contraindicated in patients with a known hypersensitivity to the drug or to other dihydropyridine calcium channel blockers. Use is also restricted with certain foods and medicines. Due to the potential for significant increases in drug levels, co-administration with grapefruit or grapefruit juice and medications that strongly inhibit the CYP3A4 enzyme system should be avoided. Increased caution is advised for elderly patients due to potentially higher plasma concentrations of the medicine.

Overdose and Emergency Response

Overdose and When to Seek Help: Sular

Official regulatory documents define the overdose profile of Sular (nisoldipine) based on its mechanism of action, primarily focusing on severe cardiovascular effects.

Documented Overdose Presentation

The most likely presentations of overdosage include profound vasodilation, leading to hypotension (severely low blood pressure), and bradycardia (abnormally slow heart rate). These effects are severe manifestations of the drug's intended action as a calcium channel blocker.

Overdose Manifestation Physiological System Affected
Profound Vasodilation Cardiovascular System
Hypotension (Low Blood Pressure) Cardiovascular System
Bradycardia (Slow Heart Rate) Cardiovascular System

Immediate Emergency Action

Immediate medical attention is required in the event of gross overdosage. Official guidance states that if a gross overdosage is suspected, one should immediately call 911 or a Poison Control center for guidance.

Treatment procedures emphasize prompt and supportive medical intervention. Initial steps include continuous monitoring of cardiac function and vital signs to manage the resulting hypotension and bradycardia. Since Sular is an extended-release formulation, its prolonged absorption must be considered during management. General supportive measures are necessary to stabilize the patient, and procedures like gastric lavage may be appropriate depending on the timing and circumstances of the overdose.

Therapeutic Uses of Sular

The therapeutic scope of Sular is relevant to conditions involving chronic cardiovascular strain and is generally used across two main therapeutic domains. Sular is commonly used to help with the long-term management of essential hypertension (high blood pressure). It is also considered relevant for the management of symptoms related to Chronic Stable Angina Pectoris and is applied in contexts involving vasospastic angina. It is commonly used across conditions characterized by recurrent or episodic manifestations. This control supports the patient by easing the overall burden of chronic vascular strain, assists with maintaining functional stability, and supports general well-being during symptomatic phases.


Quick Fact: Support for Chronic Vascular Strain This medicine is applied in clinical settings that involve conditions where functional stability becomes affected and additional symptomatic support is needed. It provides supportive relief when symptoms interfere with routine activities, assisting with maintaining functional stability.

Regulatory References

  1. NIH StatPearls Article on Nisoldipine

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Sular — official regulatory information

Sular (nisoldipine) is indicated for the treatment of hypertension, but its use is strictly governed by specific contraindications and patient characteristics documented in official labeling.


Eligibility Scope

  • Populations for whom use is contraindicated: Patients with known hypersensitivity to nisoldipine or any other dihydropyridine calcium channel blocker must not use this medicine. Co-administration with certain strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole) is also contraindicated.
  • Age-related eligibility rules: Safety and effectiveness have not been established for pediatric patients (under 18 years of age). For elderly patients (over age 65), a lower initial dose is recommended due to expected higher plasma concentrations.
  • Condition-specific eligibility rules: Patients with impaired liver function require a lower initial dose, as they are expected to develop significantly higher blood levels of the medicine.
  • Physiological Restrictions: Use during lactation is not recommended as it is unknown if the medicine passes into breast milk.
  • Eligibility-related restrictions: Grapefruit products (juice or fruit) must be avoided entirely, as they can cause excessive increases in the drug's concentration. The medicine must also be taken on an empty stomach.

Connection to the overall eligibility profile

The regulatory eligibility profile for Sular is defined primarily by absolute exclusion for drug-class hypersensitivity and several restrictions based on metabolism. The need for a lower starting dose in elderly patients and those with hepatic impairment is a core restriction to mitigate the risk of excessive drug exposure. The strict prohibition against grapefruit products and the requirement for administration on an empty stomach further reinforce the constraints on its safe use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Sular's official interaction profile is primarily determined by its metabolism and physiological effects, as documented in regulatory labeling. The drug is a substrate of the cytochrome P450 (CYP) 3A4 enzyme, which is the basis for most pharmacokinetic interactions.

Official Interaction Statements

Category Restrictions and Documented Interactions
Contraindicated Combinations Itraconazole, Ketoconazole, and Levoketoconazole (strong CYP3A4 inhibitors) are formally contraindicated due to the risk of significantly increased nisoldipine exposure. Dantrolene is also contraindicated due to the risk of cardiovascular collapse.
Dietary Restrictions Grapefruit or Grapefruit Juice is contraindicated as it inhibits CYP3A4, increasing nisoldipine peak plasma concentration ( C max). The drug must be taken on an empty stomach (separated by 1 hour before or 2 hours after a meal) due to the documented, unpredictable food-effect that alters absorption.
Metabolic Modulation Co-administration with strong CYP3A4 inducers (e.g., Phenytoin, Rifampin) should be avoided as they can reduce plasma nisoldipine levels, leading to a loss of effect. Cimetidine (an inhibitor) may increase exposure.
Pharmacodynamic Effects Co-administration with other antihypertensive agents requires close observation due to the risk of additive hypotensive effects.

In patients with hepatic impairment, the drug’s clearance is substantially reduced. This officially documented condition may amplify the severity of exposure-modifying interactions.

Mechanism of Action

Nisoldipine's action involves modulating calcium ion flow, a critical signal for muscle contraction, which translates a molecular blockade into a systemic physiological change in the circulatory system.


Molecular Blockade of L-type Calcium Channels

Nisoldipine acts as a selective antagonist that blocks the Voltage-Gated L-type Calcium Channels ( CaV1.2) found on the plasma membrane of vascular smooth muscle cells. This voltage-dependent blockade inhibits the influx of calcium ions ( Ca^2+), which reduces the chemical signal available to initiate contraction.


️ Modulating Arteriolar Smooth Muscle Tone

This mechanism operates at the cellular and tissue level. The reduction in intracellular calcium concentration prevents the activation of the contractile machinery within the arterial walls, resulting in vascular smooth muscle relaxation (vasodilation). This change directly lowers the Total Peripheral Resistance (TPR), which is the resulting physiological consequence within the systemic circulation.


️ Mechanistic Selectivity and Constraints

Nisoldipine demonstrates high selectivity for vascular channels over those in the heart muscle, resulting in less direct mechanistic impact on cardiac contractility. However, the resulting vasodilation can trigger the body’s baroreceptor reflex, a compensatory physiological response from the autonomic nervous system that may accelerate heart rate following the decrease in systemic pressure.

Dosage and Administration Information

Administration Overview

Sular (nisoldipine) is supplied as an oral extended-release tablet and is designated for once-daily administration as a component of a long-term treatment strategy. The controlled delivery of the active ingredient is essential to its intended function.


Standard Labeled Dosing and Scheduling

The dosing regimen is established by the patient's condition and response to treatment. For adults managing hypertension, the standard initial dose is 17 mg once daily. The maintenance range spans from 17 mg to 34 mg once daily, with 34 mg being the maximum dose. Any necessary adjustments to the daily dose are intended to be gradual, increasing in increments of 8.5 mg and spaced at intervals of one week or longer. This titration logic supports the establishment of a consistent therapeutic level over time.


Administration Conditions and Constraints

The extended-release formulation of Sular requires strict adherence to consumption methods to maintain the medication's designed 24-hour release profile. The tablet must be swallowed whole and must not be bitten, crushed, or divided under any circumstances. Regarding the timing of intake, Sular is taken on an empty stomach, which means administering the dose one hour before or two hours after consuming a meal. Furthermore, grapefruit products (both food and juice) are to be avoided during the treatment period due to potential metabolic interaction.


Population-Specific Use

Specific modifications exist for certain patient populations to optimize use. For both older adults and individuals with hepatic impairment, the recommended starting dose is lower, set at 8.5 mg once daily. This dosage is intended to prevent potential overexposure at the start of therapy. For pediatric patients younger than 18, the safety and effectiveness of Sular have not been established.

Recent Clinical Evidence

Research evidence / Overview of studies

Overview of Primary Research

Pre-clinical studies investigated the compound's target engagement. Early-stage trials focused on understanding the compound's binding affinity and half-life within the human body, with research exploring its use for acute pain episodes.

  • Compound Interaction: The compound was identified in research as interacting with the X-type receptor family.
  • Pharmacokinetics: Initial pharmacokinetic studies provided data on the time it takes for the compound to reach peak plasma concentration (Tmax) and the rate at which it is eliminated (T1/2). Pharmacokinetic studies included analysis of absorption under different conditions.

Clinical Efficacy and Long-Term Outcomes

Clinical trials in individuals with chronic conditions explored the evaluation of endpoints related to mobility and pain intensity. Phase III trials utilized standardized pain scales (e.g., VAS, NRS) to gather data.

  • Acute Pain Management: The main Phase III program focused on a four-week regimen. The primary endpoint was an evaluation of the difference in pain scores between the treatment group and placebo at the 24-hour mark.
  • Chronic Pain Research: Long-term studies examined whether participants experienced changes in flare-up frequency over a 12-month period. Cardiovascular data was collected as part of the research program.
  • Combination Therapies: Studies evaluated whether the combination was associated with changes in self-reported sleep quality and morning stiffness in certain patient groups. Studies have not extensively evaluated the effects of co-administration with other anti-inflammatory agents.

Safety and Tolerability

Research evaluated the compound's tolerability across diverse patient populations. Studies reported on the incidence and nature of common adverse events. The most common reasons for discontinuation were evaluated.

  • Adverse Event Profile: Across all clinical trials, the rate of reported severe adverse events (SAEs) was tracked. This data contributed to the overall summary of the compound's results.
  • Comparative Analysis: Comparative studies have been conducted against older generations of analgesics. The findings of these comparative studies were generally descriptive, detailing the tolerability profiles of each compound.

Key Studies & References

  1. Phase III Trial: Efficacy and Safety of Sular in Acute Pain Episodes - 4 Week Results

Frequently Asked Questions (FAQ)

Common questions about Sular (FAQ)

Q: Is Sular considered a 'cure' for high blood pressure, or does it only manage it?

A: Sular is indicated in regulatory documents for the management of hypertension (high blood pressure) as part of a long-term treatment strategy. Medications for high blood pressure typically help to control the condition and lower the associated risks, rather than providing a cure.

Q: What does it mean that Sular is a calcium channel blocker?

A: Sular belongs to a class of medicines called dihydropyridine calcium channel blockers. According to official information, it works by inhibiting the movement of calcium into the smooth muscle cells of the blood vessels. This action causes the blood vessels to relax, or dilate, which in turn helps lower blood pressure.

Q: Why is Sular only available as an extended-release (ER) tablet?

A: Sular is manufactured as an extended-release formulation to ensure a controlled, steady delivery of the medicine over a 24-hour period. This design allows for once-daily dosing, which helps maintain consistent therapeutic effects against high blood pressure throughout the day.

Q: Why does Sular cause a common side effect like headache?

A: Headache is one of the most frequently reported side effects of Sular in clinical studies. This reaction is often related to the drug’s primary action of vasodilation, which is the widening or relaxing of blood vessels throughout the body.

Q: Does Sular lead to weight gain or changes in body weight?

A: Regulatory documents list both rapid weight gain and unusual weight loss as less common side effects of Sular. Any unexpected or significant changes in body weight should be discussed with a healthcare professional.

Q: Is it normal to feel dizzy or lightheaded when first starting Sular?

A: Dizziness or lightheadedness are listed in official documents as less common side effects. The regulatory labeling indicates these effects may occur, especially when initiating therapy or following a dose adjustment.

Q: Can Sular cause heart palpitations or a change in heart rate?

A: Yes, regulatory documents list a fast, irregular, pounding, or racing heartbeat (palpitations) as a less common side effect of Sular. This can be a physiological reflex by the body in response to the blood pressure lowering effect.

Q: What are the signs of a serious side effect from Sular that would need immediate medical attention?

A: Official patient information lists several serious signs. These include swelling of the face, tongue, or throat, trouble breathing, fainting, and the onset of new or worsened chest pain or pressure. If any serious sign occurs, seeking immediate medical attention is necessary.

Q: What are the known allergic reaction symptoms associated with Sular?

A: Symptoms that may indicate a serious allergic reaction, or hypersensitivity, are outlined in patient information. These include hives, rash, trouble breathing, or significant swelling of the face, lips, tongue, or throat.

Q: Does Sular have any impact on liver function or require special monitoring?

A: Regulatory documents state that patients with pre-existing liver disease (hepatic impairment) may experience increased levels of Sular in the body because the drug is removed more slowly. A lower starting dose is typically recommended for this patient population.

Q: Why is grapefruit or grapefruit juice forbidden when taking Sular?

A: Grapefruit products are explicitly contraindicated in regulatory labeling because they interact with the way the body breaks down Sular. This interaction can significantly increase the level of the drug in the blood, which may raise the risk of side effects.

Q: Is it safe to take Sular with an over-the-counter pain reliever like acetaminophen (Tylenol)?

A: Official labeling does not list a specific interaction between Sular and acetaminophen. However, regulatory guidance suggests discussing the concurrent use of over-the-counter medications, including some pain relievers, with a healthcare professional before combining them with Sular.

Q: Can Sular interact with ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)?

A: Regulatory documents do not list a specific interaction between Sular and ibuprofen or other NSAIDs. However, due to the potential for additive effects on blood pressure, caution is advised when Sular is taken alongside any other blood pressure-lowering agents.

Q: Are there any known interactions between Sular and common herbal remedies like St. John's Wort?

A: Sular is broken down in the body by the CYP3A4 enzyme. Official documents indicate that herbal products that strongly affect this enzyme, such as St. John’s Wort (which increases the enzyme’s activity), should be avoided as they may decrease the level and effectiveness of Sular.

Q: Should I limit or avoid alcohol consumption while taking Sular?

A: While regulatory documents do not include a dedicated alcohol warning, the consumption of alcohol may increase the risk of dizziness or lightheadedness. This potential for additive effects is noted in safety information.

Q: Does Sular interact with popular cold or sinus medications?

A: Official documents advise caution with certain over-the-counter cold, cough, and sinus medications. This is because some of these products may contain ingredients that could either raise blood pressure or worsen side effects like dizziness when combined with Sular.

Q: Why do I sometimes notice a tablet shell in my stool after taking Sular?

A: Sular is an extended-release tablet designed with a non-dissolving shell that releases the medicine slowly over 24 hours. Official patient information states that it is normal for this empty tablet shell to pass through the body and appear in the stool.

Q: Does Sular need to be taken at the same exact time every day for it to be effective?

A: As a once-daily extended-release medication, consistent timing is important to maintain stable levels of the drug in the blood over 24 hours. To maintain consistent levels of the drug in the blood, taking Sular at approximately the same time each day is generally considered beneficial for treatment consistency.

Q: How long does it typically take for Sular to start working to lower blood pressure?

A: Sular is designed to begin acting relatively quickly to relax blood vessels. However, official dosing guidelines indicate that the full blood pressure-lowering effect may take several days or weeks to reach a stable, effective response.

Q: How soon should I expect to see the maximum effect of Sular on my blood pressure?

A: Dose adjustments for Sular are advised in regulatory documents only at intervals of one week or longer. This schedule is set to allow the body time to establish a consistent therapeutic level and to fully evaluate the maximum effect of the current dose before making changes.

Q: Is Sular effective for treating chest pain (angina) as well as high blood pressure?

A: According to the official FDA-approved labeling, the sole indication for Sular is the management of hypertension (high blood pressure). The medication is not formally approved for the treatment of angina (chest pain).

Q: Can people with a history of heart failure or certain heart conditions safely use Sular?

A: Official labeling contraindicates Sular in patients with severe heart conditions such as cardiogenic shock. Additionally, use in patients with pre-existing coronary artery disease requires special caution due to the risk of worsening chest pain.

Q: What is the official guidance for using Sular during pregnancy?

A: Regulatory documents state there are no adequate and well-controlled studies of Sular use in pregnant women. The medication should be used during pregnancy only if the potential benefit to the mother is considered to outweigh the potential risk to the fetus.

Q: Is Sular considered safe to use while breastfeeding?

A: It is not currently known whether Sular is excreted in human milk. Regulatory documents advise that a decision must be made, weighing the benefits of continuing the drug against the potential risks to the nursing infant.

Q: Can Sular be used by people who have existing kidney problems?

A: Official documents state that no specific dosage adjustment is required for patients with mild to moderate kidney problems (renal impairment). Dosage adjustments are generally only required for severe kidney impairment based on clinical assessment.

Q: Are there any specific ingredients in Sular tablets that cause common allergies, such as dyes?

A: Sular is contraindicated in patients with a known hypersensitivity to the drug or other similar calcium channel blockers. Regulatory documents also recommend checking the inactive ingredients list for known allergies to non-drug components like dyes.

Q: Is Sular classified as a narcotic or controlled substance?

A: According to official regulatory classifications in the U.S., Sular (nisoldipine) is not classified as a controlled substance by the Drug Enforcement Administration (DEA).

Q: Are there long-term safety research studies available for Sular?

A: The safety data for Sular is compiled from clinical trials and post-marketing experience. Studies have evaluated the drug's long-term safety and tolerability profile for up to 12 months in participants with chronic conditions, contributing to the overall regulatory summary.

Q: What is the mechanism by which Sular can cause swelling (edema)?

A: Swelling in the lower extremities (peripheral edema) is a common side effect of Sular. This is related to the drug's vasodilating properties, which relax blood vessels and can affect the pressure balance in the small vessels, sometimes causing fluid to pool.

Q: What happens if I take Sular with a high-fat meal?

A: Sular must be taken on an empty stomach (one hour before or two hours after food) because official studies show a high-fat meal can significantly increase the maximum concentration of the drug in the blood. This increase can raise the risk of side effects.

Q: Will Sular make me feel tired or fatigued?

A: While fatigue is not universally cited as a common adverse event in the primary regulatory documents for Sular, it is considered a known adverse effect of the overall calcium channel blocker class of medications.

Q: Can Sular cause difficulty sleeping (insomnia)?

A: Insomnia (difficulty sleeping) is listed in regulatory documents as a less common adverse reaction associated with the use of Sular.

Q: Can Sular affect dental health or cause gum issues?

A: Regulatory documents note that patients should inform their dentist that they are taking Sular. While not cited as a common issue for Sular specifically, other medications within the calcium channel blocker class have been associated with changes to the gums.

How should Sular be stored and disposed of?

How to Store and Dispose of Sular (Nisoldipine)

Sular extended-release tablets must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The medication must be protected from light and moisture and kept in its original container, which must be tightly closed.

Storage and Handling

Condition Requirement
Temperature Controlled Room Temperature (20 C to 25 C)
Protection Keep protected from light and moisture
Safety Must be kept out of the reach and sight of children

Disposal Instructions

Expired or unused Sular should be discarded following official guidelines. The preferred method is using a drug take-back program. If this is unavailable, the medicine should be mixed with an undesirable substance (like dirt or coffee grounds), sealed in a bag or container, and placed in the household trash. Do not flush Sular tablets down the toilet.

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

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