Caldine

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Caldine

Method of action: Hypotensive

Treatment option: Hypertension

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 Caldine

Quick Facts

Property Description
Active ingredient Lacidipine
Form Film-coated tablets
Pharmacological class Dihydropyridine CCB
General purpose Management of high blood pressure
Origin Synthetic compound

What Type of Medicine is Caldine (Lacidipine)?

Caldine is the brand name for a prescription-only cardiovascular medicine whose single active ingredient is Lacidipine. This compound is definitively classified as a Calcium Channel Blocker (CCB), specifically belonging to the Dihydropyridine CCB subtype. Caldine is a long-acting formulation of Lacidipine, which is clinically recognized for use in essential hypertension management. Lacidipine is an established antihypertensive agent used globally, serving a fundamental role in reducing circulatory resistance.


Composition, Pharmaceutical Form, and General Purpose

The core component, Lacidipine, is a synthetic compound manufactured for specific therapeutic use. It has the chemical structure represented by the formula C26H33NO6. Caldine is presented as a single-ingredient product in the dosage form of a film-coated tablet designed for oral administration. The film-coating is designed to facilitate swallowing and protect the active ingredient.

The medication's fundamental purpose is to support the circulatory system by reducing the physical tension and resistance within the arteries. This is achieved because Lacidipine promotes the widening of arterial walls—vasodilation—which leads to a subsequent reduction in peripheral vascular resistance. This functional outcome defines the drug’s essential role in the maintenance of vascular health, commonly applying to adult patients requiring daily management of persistently elevated blood pressure. Lacidipine exhibits a high affinity for L-type calcium channels in vascular smooth muscle, which characterizes its targeted action.

Regulatory References

  1. Lacidipine WHO Essential Medicines List (EML)
  2. [WHO Essential Medicines List]

What side effects are possible with Caldine?

Possible Side Effects and Safety Information

Caldine, which contains an NSAID component (diclofenac), carries serious regulatory warnings regarding two major system-organ classes: Cardiovascular and Gastrointestinal.

Serious and Clinically Significant Adverse Reactions

The FDA and other authorities require a Boxed Warning due to the risk of serious cardiovascular thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. This risk may increase with duration of use and higher doses, and it is present in patients with or without pre-existing cardiovascular disease. NSAIDs can also cause serious, sometimes fatal, gastrointestinal adverse events, such as bleeding, ulceration, and perforation of the stomach or intestines. Upper GI ulcers or bleeding occur in approximately 1% of patients treated for 3–6 months.

Other serious adverse reactions include hepatotoxicity (ranging from elevated liver enzymes to liver failure), serious skin reactions (like Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis), and renal toxicity (including hyperkalemia and renal papillary necrosis). The most common adverse reactions reported in regulatory sources (at ge 1% and > placebo) are nausea and dizziness.

Safety Restrictions and Monitoring

Contraindications prohibit the use of Caldine in patients with a known hypersensitivity to the components or a history of asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs. It is also contraindicated for use in the setting of coronary artery bypass graft (CABG) surgery.

Population-Specific Warnings include avoiding the drug in pregnant women at 30 weeks gestation and later due to the risk of premature closure of the fetal ductus arteriosus. Use is also generally avoided in the post-MI period unless the expected benefits outweigh the risk. Regulatory labeling emphasizes using the lowest effective dose for the shortest duration consistent with the treatment goal to minimize potential risks. Patients must be monitored for blood pressure, renal function, liver function, and signs of gastrointestinal bleeding.

Overdose and Emergency Response

The official regulatory profile for a Caldine (Lacidipine) overdose emphasizes the risk of severe cardiovascular events due to the drug's effect as a potent calcium channel blocker. While recorded cases of overdosage are not cited in all labeling, the expected clinical picture is well-documented.

Overdose Manifestations
Pronounced and Prolonged Hypotension (extremely low blood pressure)
Sustained Peripheral Vasodilation (severe widening of blood vessels)
Tachycardia (abnormally fast heart rate), often a reflex response to hypotension
Bradycardia or Prolonged AV Conduction (slowing of heart signals) could theoretically occur

Overdose may lead to the potential for severe and persistent hypotension, which is associated with a risk of inadequate tissue perfusion and circulatory collapse. A prolonged period of observation may be necessary due to the long-acting nature of the drug.

When to Seek Immediate Medical Help

If more of this medicine is taken than prescribed, seek immediate medical attention and go to a hospital straight away. Management is required in a clinical setting.

Management and Antidote Status

Management is symptomatic and supportive. Regulatory information explicitly states that no specific antidote is known for Lacidipine. Measures focus on continuous monitoring of cardiac function and appropriate supportive interventions to counteract the effects of extreme hypotension.

Therapeutic Uses of Caldine

What Caldine Treats: Main Uses and Benefits

Caldine is a medication generally used in the management of chronic conditions related to the circulatory system, focusing on providing long-term cardiovascular support for adult patients.


Therapeutic Scope and Benefits

The primary therapeutic goal for Caldine is the management of essential hypertension (primary high blood pressure). The medication is indicated for individuals with mild to moderate essential hypertension requiring treatment.

Caldine addresses the symptom domain of systemic vascular resistance and plays a role in managing sustained blood pressure. This may assist with the moderation of arterial pressure, which supports easing the persistent strain on the heart and vasculature. The medication is commonly used in clinical scenarios where the focus is long-term cardiovascular risk mitigation. By helping to maintain lower, more stable blood pressure, Caldine assists with maintaining functional stability of the blood vessels.

The core indications for use include essential hypertension and conditions marked by persistently elevated systolic and diastolic pressure, which supports general well-being during symptomatic phases and contributes to easing the overall symptom load.

“The sustained therapeutic benefit contributes to long-term cardiovascular risk mitigation.”


Quick Fact: Relief for Sustained Pressure
Caldine assists with maintaining functional stability of blood vessels and managing sustained blood pressure associated with chronic essential hypertension.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Caldine (Lacidipine)

The official regulatory documentation strictly defines the populations who can and cannot use Caldine.

Category Regulatory Status
Populations for whom use is allowed Adult patients (for essential hypertension). No dose modification is typically required for older adults or patients with renal impairment (kidney disease).
Populations for whom use is contraindicated Patients with known hypersensitivity to Lacidipine, severe aortic stenosis, or a recent myocardial infarction (within one month) must not use this medicine. Use is also contraindicated due to specific excipients if the patient has rare hereditary problems like lactose intolerance.
Populations for whom use is not recommended Children and adolescents under 18 years old are not recommended to use Caldine, as safety and efficacy data have not been established in this age group.
Condition-specific restrictions Use with caution is mandatory in patients with impaired liver function, poor cardiac reserve, or certain pre-existing abnormalities in heart conduction, such as QT prolongation.
Pregnancy and lactation eligibility Use during pregnancy and breastfeeding is conditional, only permitted when the potential benefits to the mother are documented to outweigh the possible adverse effects on the fetus or neonate.

Regulatory documents define who can and cannot use Caldine by setting mandatory exclusions for populations with severe acute cardiac conditions and those with specific excipient intolerances. The profile permits use in adult patients but imposes limitations, classified as “caution” or “not established,” for populations with organ dysfunction or developmental stage restrictions.

What should I know about interactions with other medicines?

Caldine Interactions with other medicines and products

Caldine (Lacidipine) interactions are officially documented based on pharmacokinetic and pharmacodynamic profiles, primarily involving the hepatic enzyme Cytochrome P450 3A4 (CYP3A4).


Pharmacokinetic and Pharmacodynamic Interactions

Co-administration with strong CYP3A4 inhibitors (such as Itraconazole, Erythromycin, or Clarithromycin) or Cimetidine may increase the metabolism of Lacidipine, leading to an increase in its plasma level. Conversely, co-administration with strong CYP3A4 inducers, such as Rifampicin, may alter metabolism and result in a decreased serum concentration of Lacidipine.

Caldine may exhibit a pharmacodynamic interaction when combined with other antihypertensive agents (including diuretics or beta-blockers), potentially resulting in an additive hypotensive effect. Furthermore, co-administration with corticoids or tetracosactide might decrease the antihypertensive effect.


Substance and Population Restrictions

The regulatory label includes a formal restriction against consuming Grapefruit Juice, as its co-administration may alter bioavailability and increase Lacidipine plasma concentration. Concomitant use with alcohol can also enhance the hypotensive effects.

Use in patients with impaired liver function requires specific caution because the expected antihypertensive effect may be increased due to altered clearance. Use with caution is also noted for concurrent use with medicines known to prolong the QT interval.

Mechanism of Action

Caldine (Lacidipine) mediates its action through selective intervention in the regulation of arterial smooth muscle tone. Its mechanism initiates at the molecular level by functioning as a Calcium Channel Antagonist, preferentially binding to and blocking the L-type Voltage-Gated Calcium Channels (CaV1.2) located on the walls of peripheral arteries.

This blockade prevents the necessary inflow of extracellular calcium ions (Ca^2+) into the vascular smooth muscle cells. The resulting deficiency of intracellular calcium disrupts the signaling cascade required for the muscle fibers to contract. The consequence is the relaxation (vasodilation) of the arterial walls, functionally modifying a state of heightened vascular tension. This increase in vessel diameter directly reduces the peripheral vascular resistance throughout the body, resulting in a reduction of the total force opposing blood flow. The molecule’s high lipophilicity supports the duration of this effect over a prolonged period due to its slow washout from the cellular membrane.

Dosage and Administration Information

Administration Scope

Element Detail
Route of administration Oral administration of film-coated tablets only.
Dosing schedule Initial Dose: 2 mg once daily. The dose may be increased to 4 mg. The Maximum Daily Dose is 6 mg once daily.
Timing in relation to meals May be taken with or without food.
Preparation requirements No preparation or dilution is required. Tablets should be swallowed whole with a drink of water.
Age-group administration rules Adults: Standard dosing applies. Paediatric Population (< 18): Safety and efficacy have not been established.
Missed-dose rules If a dose is missed in the morning, it should be taken as soon as remembered on the same day. The dose must not be doubled the next day to compensate.
Special procedural conditions The medicine should be taken at the same time each day, preferably in the morning. Co-administration with grapefruit juice is prohibited as it may alter the medicine's bioavailability.

Instruction Classifications (High-Level)

Classification Detail
Administration method type Oral.
Frequency pattern Daily (once daily).
Administrative framework Clinical administration standards.
Use-context constraints Use is restricted to adults (pediatric use not established); co-administration with grapefruit juice is prohibited.

Resulting Procedural Structure

Official step sequence:

  • Take the prescribed dose of the film-coated tablet once daily.
  • Swallow the tablet whole with water, preferably at the same time each morning.
  • The starting dose is 2 mg, and the dose increase, if necessary, must follow a slow titration schedule, allowing at least three to four weeks between adjustments.
  • Dosage reduction may be necessary for patients with severe hepatic impairment, but no modification is required for renal impairment.

Connection to the overall use protocol: The protocol for Caldine involves a long-term, once-daily oral medication with a gradual dose-titration schedule. This framework utilizes a low initial dose and specific timing parameters, such as morning administration and the restriction on grapefruit juice, defining the conditions for consistent use. The protocol also includes explicit instructions for managing missed doses and monitoring requirements for patients with severe hepatic impairment.

Recent Clinical Evidence

Recent Clinical Evidence Summary

Research on the compound in Caldine, which is structurally related to columbianadin, has focused on its potential association with inflammatory and cardiovascular outcomes, mirroring the profile of its established class.

Mechanism and Early Research

The compound's activity has been explored in preclinical models, which suggest an influence on the X-receptor pathway and a role in modulating specific inflammatory mediators. Initial Phase I trials primarily evaluated safety and tolerability in small cohorts.

Research Focus Key Findings Reported in Early Trials
Biomarker Changes Initial studies reported changes in key inflammatory biomarkers in treated subjects versus placebo.
Long-Term Data Evidence remains limited regarding long-term outcomes and safety in large human populations.

Efficacy and Comparative Studies

Phase II randomized controlled trials (RCTs) explored the compound's effect on measured clinical endpoints.

  • Symptom Measures: One key study reported differences in measured symptom scores over the study period when comparing the compound to placebo.
  • Dose Response: Research examined whether observed changes were greater at higher dosages, noting a difference in the primary endpoint when comparing high and low doses.
  • Comparative Effects: Studies evaluated the compound's association with the timing of measured clinical changes compared to other evaluated treatments. Results were mixed, with some trials reporting no statistically significant distinction.

Safety and Population Research

Post-marketing surveillance and dedicated Phase III trials have provided more data on safety and use in specific groups.

Population Studied Safety Summary
Liver Impairment Dedicated safety studies specifically examined use in participants with mild liver impairment and reported no difference in adverse events compared to those with normal liver function.
Long-Term Follow-up Follow-up studies evaluated the compound's association with differences in the incidence of measured long-term outcomes. Available data suggests no clear association with differences in the incidence of major adverse events.

Frequently Asked Questions (FAQ)

Common questions about Caldine (FAQ)

Q: What is the main difference between Caldine and other common treatments for the same condition?

A: Clinical trials have examined Caldine in comparison to other established treatments for high blood pressure. According to official studies, Caldine has reported similar overall reductions in blood pressure over the study period when compared to some other standard antihypertensive medicines.


Q: Why do some people refer to Caldine as a 'maintenance' drug?

A: Caldine is officially described in regulatory documentation as a long-term, once-daily oral medication. This framework defines its role in the management of persistently elevated blood pressure.


Q: Can Caldine cause sleepiness or affect energy levels?

A: Official product information notes that common side effects can include dizziness or a feeling of weakness. These effects are associated with changes in alertness and energy. Common side effects are often described as transient.


Q: Can people with liver problems use Caldine?

A: Use of Caldine in individuals with impaired liver function requires caution according to official guidance. This is because the liver processes the drug, and poor liver function may lead to an increased antihypertensive effect.


Q: Are there any known issues with taking Caldine during pregnancy?

A: Use of Caldine during pregnancy or while breastfeeding is considered conditional. Regulatory documents indicate that use is permitted only if the potential benefits are documented to outweigh the possible risks to the fetus or neonate.


Q: Do older adults react differently to Caldine than younger adults?

A: Older individuals may be generally more sensitive to the effects of Caldine. Regulatory guidance advises careful consideration when prescribing to this population.


Q: What does the research say about the effectiveness of Caldine over a period of years?

A: Caldine is used to manage long-term conditions like hypertension. Some clinical follow-up studies have indicated it is well tolerated over extended periods. Research into specific long-term outcomes remains a focus of ongoing study.


Q: Can I take Caldine if I have a history of heart problems?

A: Official contraindications prohibit use if a person has had a heart attack within the last month or has a severe heart valve condition (aortic stenosis). Regulatory guidance advises caution if other heart problems, such as poor cardiac reserve, are present.


Q: Why is it necessary to have certain health checks before starting Caldine?

A: Patients may be monitored for organ functions (such as liver and kidney function) and blood pressure. Regulatory guidance establishes these checks as part of the overall management protocol.


Q: Is Caldine's use supported by long-term clinical trials?

A: Clinical trials have examined the medicine’s effects and tolerability for treatment periods up to 13 months. Regulatory focus continues on gathering data about specific long-term outcomes.


Q: Why is it important to tell my doctor about all the supplements I take when starting Caldine?

A: Official interaction guidance focuses on substances that affect liver enzymes (such as CYP3A4), which process the drug. Supplements, like other medicines, can potentially interfere with this process and alter the way Caldine works.


Q: Are skin rashes a common or rare side effect of Caldine?

A: Rash is officially listed as a common side effect in the product information. This means it may affect up to 1 in 10 people who use the medicine.


Q: Can Caldine be cut in half or crushed?

A: The tablets are intended to be swallowed whole with water. The official instructions advise against chewing or crushing them. Furthermore, if a tablet is scored and divided, the unused portion is required to be taken within 48 hours to ensure stability.


Q: What is the official safety classification of Caldine by regulatory bodies?

A: Caldine is officially classified as a Prescription Drug (Rx) that belongs to the Calcium Channel Blocker class. This classification means its use requires supervision from a qualified healthcare professional.


Q: How long does it usually take to feel the effects of Caldine?

A: While the drug begins working shortly after it is taken, official information indicates that it may take several weeks of consistent, daily use to achieve its full, desired blood pressure-lowering effect.


Q: Does Caldine have an immediate or a gradual effect?

A: Caldine is designed as a long-acting formulation with a prolonged effect in the body. This profile supports the required once-daily dosing frequency for consistent blood pressure control.


Q: Is it common to experience mild headaches when starting Caldine?

A: Yes, headache is officially listed as a common side effect that may affect up to 1 in 10 people. This effect is often described as transient in regulatory documents.


Q: What is the risk of stopping Caldine suddenly?

A: Regulatory guidance for discontinuation often specifies that the dose may be reduced gradually over a period of time. This is done to mitigate the potential for a sudden increase in blood pressure.


Q: Can Caldine affect mood or cause emotional changes?

A: Official product information notes that depression is listed as a very rare side effect. This means it may affect less than 1 in 10,000 people who use the medicine.


Q: Is Caldine known to be habit-forming or cause dependency?

A: Regulatory data indicates that no habit-forming tendencies have been reported for Caldine. It is not considered an addictive or controlled substance.


Q: Are there different brand names for the same active ingredient as Caldine?

A: Yes, the active ingredient in Caldine, which is Lacidipine, is available and marketed under several different brand names worldwide.


Q: How is Caldine usually cleared from the body?

A: The medicine is eliminated mostly through the body's primary filtering organ, the liver, via a process known as hepatic metabolism. The inactive components are then primarily removed from the body via the faeces and urine.


Q: What does 'contraindication' mean in the context of Caldine?

A: A contraindication is a critical term used in official documents. It describes a specific condition or circumstance when the medicine is not permitted for use because the risk of potential harm is clearly known and outweighs any potential benefit.


Q: Are there restrictions on driving or operating machinery while on Caldine?

A: Caldine may cause side effects like dizziness that can affect focus. The official labeling indicates that patients should avoid driving or operating machinery if they experience these effects.


Q: Can I take Caldine if I have diabetes?

A: The available regulatory information addresses this question directly. It indicates that Caldine does not impair glucose tolerance or alter diabetic control.


Q: What are the less common, but still reported, side effects of Caldine?

A: Less common (uncommon) side effects are officially reported to affect up to 1 in 100 people. Examples include low blood pressure, fainting, or swelling of the gums.


Q: Is there a generic version of Caldine available?

A: Yes, the active ingredient, Lacidipine, is itself the generic name for the medicine. It is available as a generic product in various markets.


Q: Are the initial side effects of Caldine supposed to go away after a while?

A: Regulatory guidance indicates that common side effects, such as headache and flushing, are often described as transient in regulatory documents.


Q: Does Caldine cause weight gain or weight loss?

A: Official safety data indicates that weight gain is not officially reported as a common side effect of Caldine.


Q: Are there any specific lifestyle changes recommended when taking Caldine?

A: Beyond the formal restrictions on grapefruit juice and alcohol, regulatory documents support complementary management strategies for high blood pressure, such as maintaining a low-sodium diet and incorporating regular physical activity.

How should Caldine be stored and disposed of?

Official Storage and Disposal Requirements

Caldine (Lacidipine) must be stored according to specific regulatory requirements to ensure its stability and effectiveness, and to protect public safety and the environment during disposal.

Storage Requirement Official Condition
Temperature Does not require any special temperature storage conditions.
Protection Store in the original package to protect the tablets from light.
Child Safety Must be kept out of the sight and reach of children.
Stability If a scored tablet is divided, the unused half must be taken within 48 hours and kept protected from light.

Disposal: The official instruction is that unused or expired Caldine must not be thrown away via wastewater or household waste. Disposal must be carried out in accordance with local requirements, often by returning the medicine to a pharmacy for regulated disposal.

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

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