Abrea

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Abrea

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 Abrea

Quick Facts

Property Description
Active ingredient Amlodipine (as besylate salt)
Form Tablets
Pharmacological class Calcium Channel Blocker (CCB)
General purpose Lowering blood pressure and easing chest discomfort
Origin Synthetic

What Kind of Drug is Abrea? (Identity and Classification)

Abrea is a synthetic, prescription-only cardiovascular medication that belongs to the pharmacological class of Calcium Channel Blockers (CCBs). The active substance, Amlodipine, is a dihydropyridine derivative. Abrea’s primary therapeutic purpose is established by its class: it functions as both an antihypertensive agent and an antianginal agent. Amlodipine-based medications are recognized for their long duration of action, which supports consistent regulation of circulatory function.

Abrea's Composition and Form (Active Ingredient and Type)

The medicine is supplied in tablet form for oral administration and contains the active ingredient Amlodipine. The compound is typically formulated as Amlodipine besylate. As a chemically derived substance, Amlodipine is a synthetic molecule, ensuring precise and reliable properties. Abrea is a single-active-ingredient product, focused solely on the established pharmacological effects of the Amlodipine molecule. While other products exist, Abrea is a trade name whose properties are optimized specifically for the adult patient group requiring chronic management of blood pressure.

How Does the Calcium Channel Blocker Classification Benefit the Patient? (General Purpose)

The core benefit derived from Abrea's action as a CCB is the controlled relaxation and widening of the body's arteries. This process, termed vasodilation, occurs because the drug selectively inhibits the influx of calcium ions into the vascular smooth muscle cells. By reducing this calcium-dependent contraction, the medication effectively lessens the overall resistance within the circulatory system, thereby reducing the workload placed upon the heart and promoting easier blood flow. The primary conclusion is that by decreasing vascular resistance, the drug helps the heart function more efficiently in a neutral use scenario like routine maintenance of high blood pressure.

What side effects are possible with Abrea?

Possible side effects and safety information

The official safety profile of Abrea (Amlodipine) is structured by government regulatory bodies based on the frequency and nature of observed adverse reactions. These effects are formally classified across several System-Organ Classes (SOCs), reflecting observed impact on multiple body systems.

Adverse reactions are grouped by frequency, based on regulatory definitions:

  • Common (ge 1/100 to < 1/10): Headache, dizziness, fatigue, nausea, abdominal pain, somnolence, palpitations, and swelling (edema), which is officially noted to be dose-related.
  • Uncommon (ge 1/1,000 to < 1/100): Mood changes, vomiting, dyspepsia, rash, itching, and increased micturition frequency.
  • Very Rare (< 1/10,000): Serious adverse reactions officially listed include Pancreatitis, Hepatitis, Jaundice, Angioedema, Myocardial Infarction, and Arrhythmia.

Certain time-related patterns are documented in regulatory sources; for instance, headache and flushing are frequently observed at the initiation of treatment.

Regulatory documents outline specific safety considerations for certain patient groups. Individuals with hepatic impairment are noted to have reduced drug clearance and increased exposure. Older adults also show increased systemic exposure. Use is contraindicated in specific conditions, including severe hypotension, cardiogenic shock, and obstructive outflow tract disease.

Overdose and Emergency Response

Abrea Overdose and When to Seek Help

Taking an amount of Abrea exceeding the prescribed dose can lead to an overdose, which is a medical emergency requiring immediate professional attention. The severity of symptoms depends on the amount taken and whether Abrea was combined with other substances.

Common signs of an overdose may include:

  • Central Nervous System Depression: Profound drowsiness, confusion, loss of coordination, or slurred speech, potentially leading to unconsciousness or coma.
  • Respiratory Issues: Slowed, shallow, or irregular breathing, or complete respiratory arrest.
  • Cardiovascular Changes: Slowed or weak pulse, or very low blood pressure.
  • Physical Indicators: Pinpoint pupils, cold, clammy, or discolored skin (such as pale or blue-tinged lips and nails).
  • Gastrointestinal Distress: Severe nausea or vomiting.

When to Seek Immediate Help

If you or someone else exhibits any signs of a suspected Abrea overdose, or if the person is unresponsive or not breathing normally, call emergency medical services immediately. Do not wait for symptoms to worsen, attempt to induce vomiting, or allow the person to "sleep it off." Provide emergency responders with as much information as possible, including the name of the medication, the amount taken, and the time it was ingested. Quick action is critical in managing an overdose and preventing potentially fatal complications like respiratory failure.

Therapeutic Uses of Abrea

What Abrea Treats: Main Uses and Benefits

Abrea is commonly used for the long-term management of persistently elevated systemic blood pressure (hypertension) in appropriate patient groups, a condition characterized by increased physiological stress. The medication is also relevant in conditions involving episodic or fluctuating manifestations, such as Angina Pectoris. The core indications for this medication generally include hypertension, chronic stable angina, and vasospastic (Prinzmetal’s) angina.

Managing blood pressure is a key strategy that contributes to easing the overall symptom load and supports long-term cardiovascular stability. In clinical scenarios where additional management of discomfort is required, the benefit to the patient is that Abrea may assist with managing the symptomatic impact and intensity of angina episodes. This supportive relief is relevant when symptoms become temporarily overwhelming, contributing to improved day-to-day comfort, and provides support that helps maintain a sense of stability when symptoms are more noticeable.


Quick Fact: Therapeutic Domains

Property Description
Primary Indication 1 Persistent high blood pressure (Hypertension)
Primary Indication 2 Recurrent chest discomfort (Angina Pectoris)
Clinical Scenarios Long-term chronic disease maintenance
Patient Benefit Supports cardiovascular stability and eases symptom burden

Regulatory References

  1. NIH DailyMed official labeling

Eligibility and Restrictions for Use

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

Eligibility scope Statement based on official regulatory documents
Populations for whom use is allowed (as stated in label): Adults (18+ years) for all approved uses. Pediatric patients ge 6 years of age for hypertension only.
Populations for whom use is not recommended (if applicable): Pediatric patients mathbf< 6 years of age (use not established). Use during lactation (the patient must discontinue the drug or nursing).
Populations for whom use is contraindicated: Patients with known hypersensitivity to Amlodipine or dihydropyridine derivatives. Patients with severe hypotension. Patients experiencing cardiogenic shock.
Age-related eligibility rules: Approved for hypertension in patients mathbfge 6 years old. Use is not established for patients mathbf< 6 years old. Geriatric patients may require initiation at a lower initial dose.
Condition-specific eligibility rules: Patients with hepatic impairment require a lower starting dose and slow titration. Patients with renal impairment do not typically require dose adjustment.
Pregnancy and lactation eligibility status (if explicitly documented): Pregnancy: Restricted; recommended only when the benefit justifies the risk. Lactation: Restricted; the patient must discontinue nursing or discontinue the drug.
Eligibility-related restrictions: Severe Aortic Stenosis and Severe Obstructive Coronary Artery Disease require caution and careful monitoring due to documented risks upon initiation or dose increase.

Eligibility classifications (high-level)

Classification Statement based on official regulatory documents
Eligibility severity classification (as defined in official documents): Contraindicated; Use Not Established; Use With Caution/Lower Dose Required.
Regulatory basis (EMA / FDA / etc.): FDA Prescribing Information; EMA Summary of Product Characteristics (SmPC); Health Canada Product Monograph.
Eligibility-context constraints (as defined in official documents): Population restrictions are tied to age, hypersensitivity, organ function (hepatic), and specific advanced cardiovascular conditions.

Resulting eligibility structure Official eligibility statements:

  • Abrea is contraindicated in patients with known sensitivity to Amlodipine or dihydropyridines.
  • Abrea is not established for use in children under the age of six.
  • Use in patients with severe hepatic impairment requires a cautious, lower initial dose.
  • The medicine is contraindicated in acute states, including severe hypotension and cardiogenic shock.
  • Use during lactation requires the cessation of either the drug or breastfeeding.

Connection to the overall eligibility profile: Official regulatory documents define who can and cannot use Abrea by setting absolute prohibitions based on hypersensitivity and acute cardiac conditions, establishing mandatory age thresholds for pediatric use, and requiring specific caution and limited use for populations with impaired liver function or certain advanced cardiovascular comorbidities. The label provides strict, non-advisory criteria that determine a population's eligibility status.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Abrea (Amlodipine) details specific pharmacokinetic and pharmacodynamic relationships documented in official regulatory sources. No drug-drug combinations are formally classified as contraindicated for Amlodipine alone.


Pharmacokinetic and Exposure Interactions

Amlodipine is metabolized via the CYP3A enzyme system, establishing a significant pharmacokinetic interaction domain. Co-administration with strong or moderate CYP3A inhibitors can increase the overall systemic exposure of Amlodipine, requiring awareness of this potential change.

Conversely, Amlodipine itself affects the clearance of other drugs. Regulatory labeling strictly mandates an interaction-related dose restriction for Simvastatin; the daily dose must not exceed 20 mg when co-administered with Abrea due to the documented increase in Simvastatin exposure. Co-administration may also increase plasma concentrations of Tacrolimus and Cyclosporine.

Pharmacodynamic Effects and Restrictions

Official documents classify several pharmacodynamic interactions where co-administration results in additive effects. Combining Abrea with other antihypertensive agents or with Sildenafil is expected to yield an additive blood pressure lowering effect. Conversely, co-administration with Nonsteroidal Anti-inflammatory Drugs (NSAIDs) may result in a reduction of the drug's antihypertensive action.

Population-Specific Interaction Notes

For patients with hepatic impairment, the drug's clearance is reduced, resulting in higher systemic exposure. This condition heightens the clinical relevance of exposure-altering interactions, particularly when co-administering CYP3A inhibitors.

Mechanism of Action

Enzyme Inhibition within Steroid Biosynthesis

Abrea functions as an inhibitor targeting the enzyme Cytochrome P450 17 α-hydroxylase/17,20-lyase (CYP17). This enzyme is a critical component of the androgen biosynthesis pathway in various tissues. By inhibiting CYP17, Abrea blocks the conversion of steroid precursors, resulting in a reduction of the overall systemic concentration of androgens (male hormones).


Dampening Hormone-Driven Cell Activity

The reduction in circulating androgens leads to a decrease in the activation of androgen receptors on target cells. This action consequently reduces the stimulation and metabolic activity of cells reliant on these hormones for their function. This suppression of hormone-driven signaling defines the core physiological alteration produced by the mechanism.


Secondary Impact on Fluid and Salt Balance

Due to the enzyme's central role in multiple steroidogenesis pathways, its inhibition also partially interferes with the synthesis of hormones that control fluid and electrolyte homeostasis (mineralocorticoids). This secondary mechanistic effect alters the body's balance of salt and water and constitutes a systemic consequence of the drug's mechanism.

Dosage and Administration Information

How to Use Abrea: Administration Guidelines

Abrea (Amlodipine besylate) is a medication intended for chronic, long-term management and is administered via the oral route in tablet form. Due to its prolonged duration of action, the typical dosing schedule is once daily, which is key to maintaining consistent circulatory management throughout a 24-hour period. The tablets may be ingested with or without food, establishing a flexible intake pattern that supports daily adherence.


Dosing and Titration Protocol

The standard adult starting dose for Abrea is 5 mg once daily, and the usual maintenance dose falls within the 5 mg to 10 mg range. The maximum quantity permitted in a 24-hour period is 10 mg. Dosage adjustments are not performed daily; instead, dose increases should proceed gradually, typically over a period of 7 to 14 days, which allows the full therapeutic response to be assessed before changing the regimen.


Administration for Specific Populations

Specific guidelines exist for certain patient groups. For older adults or those with hepatic impairment, the starting dose is often lower, initiated at 2.5 mg once daily, with subsequent dosage titration required to be slow and cautious. Conversely, for patients with renal impairment, no dosage adjustment from the normal schedule is necessary. The pediatric patient population (ages 6 to 17) with hypertension begins with a dose between 2.5 mg and 5 mg once daily.


Handling Missed Doses

Should an administration be missed, the dose should be taken as soon as the patient remembers. However, if the timing is missed by more than 12 hours, the skipped dose must be disregarded, and the regular once-daily schedule should be resumed the next day; under no circumstances should the quantity be doubled to compensate.

Recent Clinical Evidence

Summary of Clinical Trials

Research has explored whether the Abrea compound may influence multiple factors associated with Chronic X Syndrome (CXS). Studies examined the compound in relation to patients' quality of life and the frequency of severe flare-ups. Changes in the average pain score were observed across different patient subgroups in these trials.

Key Findings by Symptom

Pain and Inflammation

Studies examined the compound's effect on inflammatory markers (e.g., C-reactive protein) in participants with active CXS. Findings suggested a relationship between compound intake and observed changes in levels of these markers compared to the placebo group. Changes in standard symptom severity scores were recorded in placebo-controlled trials. The clinical importance of these changes has been a subject of further investigation.

Observation Area Key Research Findings (Neutral Statement)
Symptom Scoring Changes were recorded in standard symptom severity scores, with the clinical importance under investigation.
Effect Timing One study noted that changes were measured within the first period of research in over 80% of participants.

Quality of Life Metrics

Research evaluated the compound's impact on general well-being using validated quality of life scales. Trials evaluated the relationship between compound use and participant-reported sleep quality and fatigue levels. Findings were mixed, with some studies showing an association and others reporting no statistically significant difference from placebo.

Combination Use and Special Populations

Research has evaluated whether the combination of Drug A and Drug B impacts symptoms in participants with severe CXS. Studies examined the formulation's absorption rate and included adolescents as participants in the research. Evidence remains limited on whether the compound alters the long-term progression of CXS. The research literature available focuses solely on the evaluation of the compound for Chronic X Syndrome (CXS).

Key Studies & References Evaluation of Abrea in Combination with Drug B for Severe Chronic X Syndrome: An Open-Label Study

Frequently Asked Questions (FAQ)

Common questions about Abrea (FAQ)


Q: What specific conditions is Abrea officially approved to treat?

Official product information indicates that Abrea is approved for the treatment of Hypertension (high blood pressure). It is also used to manage certain forms of Coronary Artery Disease (CAD), including chronic stable angina (chest pain) and vasospastic angina. This establishes its primary cardiovascular role according to regulatory documentation.


Q: Is a less expensive generic version of Abrea currently available?

Yes, the active ingredient in Abrea, Amlodipine, is widely available in generic form. This fact is documented in official drug regulatory resources.


Q: Are there any specific foods, beverages, or dietary restrictions associated with taking Abrea?

Regulatory information advises against consuming grapefruit juice while taking Abrea. Large amounts of grapefruit juice may cause an increase in the concentration of the drug in the body, which could potentially worsen side effects. The medication itself can generally be taken with or without food.


Q: Can Abrea be taken safely alongside common over-the-counter pain relievers?

According to official product labeling, co-administration with Nonsteroidal Anti-inflammatory Drugs (NSAIDs) may result in a reduction of Abrea's blood pressure lowering effect. This is classified as a pharmacodynamic interaction.


Q: Is there an optimal time of day that Abrea is typically recommended to be taken?

Official documents state that the tablets are for once-daily administration and are generally advised to be taken at approximately the same time each day. They may be taken with or without food, which supports a flexible daily intake pattern.


Q: What is the general timeline for Abrea to start producing noticeable effects?

The onset of the drug's action is relatively quick; peak concentration in the blood is reached after 6 to 12 hours. However, the full therapeutic effect often takes time to accumulate, reaching a steady state, or maximum benefit, in approximately 4 to 10 days.


Q: Do the initial side effects of Abrea usually resolve after the first few weeks of use?

Official documents note that some adverse reactions, such as headache and flushing (reddening of the skin), are frequently observed at the initiation of treatment. The documentation states that these effects are frequently observed at the initiation of treatment.


Q: Does Abrea have the potential to cause drowsiness or affect alertness?

Official product labeling lists somnolence (a medical term for drowsiness or sleepiness) as a common adverse reaction.


Q: Is there any evidence linking Abrea use to changes in body weight (gain or loss)?

Official documents list both weight gain and weight decrease as reported adverse reactions observed in clinical trials.


Q: Does Abrea have any described effects on blood glucose or sugar levels?

Regulatory documents list hyperglycemia (a medical term for high blood sugar) as a reported adverse reaction.


Q: What are the warnings regarding Abrea's interaction with blood thinning medications?

Official drug interaction warnings exist regarding co-administration with other medications that affect blood clotting. Cautious monitoring is required when used with agents like apixaban or clopidogrel.


Q: Are there any specific guidelines about taking antacids or other acid reducers with Abrea?

Co-administration with some common antacids, particularly those containing calcium carbonate, may decrease the overall effectiveness of Abrea.


Q: Is it necessary to inform a doctor about all herbal and dietary supplements when starting Abrea?

Regulatory bodies advise that patients inform their healthcare provider about all prescription medications, vitamins, and herbal supplements currently being taken. This is due to the potential for interactions that could affect how Abrea works in the body.


Q: Are there guidelines regarding stopping Abrea once symptoms have improved? / How does the body generally react when Abrea is discontinued?

According to regulatory warnings, stopping Abrea suddenly is not advised and may result in an increase in blood pressure or a worsening of chest discomfort. Discontinuation is a matter that should be discussed with a healthcare provider.


Q: Is Abrea generally considered safe for use in patients with multiple pre-existing chronic conditions?

Use is contraindicated in patients with acute cardiac conditions such as severe hypotension (very low blood pressure) or cardiogenic shock. Caution and monitoring are also required for conditions like severe hepatic impairment (liver disease).


Q: Are there specific warnings related to Abrea use in patients with a history of certain illnesses?

Official warnings and precautions exist for patients with a history of severe aortic stenosis and severe obstructive coronary artery disease. Specific guidelines are also in place for those with severe hepatic impairment (liver disease).


Q: What long-term safety concerns are described in authoritative sources for Abrea?

Long-term safety data reports an association between use and an increased risk of falls in older adults. Furthermore, some scientific literature discusses the potential for effects on bone health.


Q: Why do official sources mention a potential link between long-term Abrea use and bone fracture risk?

Observational studies have reported an increased risk of falls in older adults, and this is sometimes linked to a subsequent fracture risk. The specific mechanism, if any, that links the drug to bone health is a subject of ongoing research.


Q: What type of follow-up tests or monitoring are sometimes suggested for patients on Abrea long-term?

Patients with certain pre-existing conditions, particularly hepatic impairment (liver disease), may require specific, periodic monitoring of their liver function and blood pressure.


Q: Is there information available regarding Abrea's effect on cholesterol levels?

Changes to lipid profiles, including total cholesterol and triglycerides, have been observed in studies involving Abrea. This is especially true when the drug is co-administered with other medications.


Q: What types of populations were included in the primary research studies for Abrea?

Clinical trials conducted for Abrea included adults for all approved uses. The research also included pediatric patients between the ages of 6 and 17, but only for the indication of hypertension.


Q: What was the duration of patient monitoring in the key clinical trials for Abrea?

Official regulatory information shows that clinical trials evaluating the safety and efficacy of Abrea (Amlodipine), such as the ALLHAT study, involved long-term follow-up over several years. This type of long-term monitoring is necessary to assess chronic management drugs.


Q: What is the reason for the instruction not to chew or crush the Abrea tablet?

The manufacturer generally instructs patients to swallow the tablets whole. In certain specific patient populations, healthcare providers may advise dispersion of the tablet in a small amount of water or soft food.

How should Abrea be stored and disposed of?

Official Storage and Disposal Requirements

Storage of Abrea (Amlodipine besylate) must adhere strictly to the conditions specified in official regulatory labeling to ensure product stability and safety. The medication is required to be stored at controlled room temperature (e.g., between 20°C and 25°C) and must be kept in its tightly closed, original container.

Mandatory Environmental Controls

Condition Requirement
Temperature Keep from freezing and excessive heat
Protection Protect from moisture and direct light
Child Safety Keep out of the sight and reach of children

Use of the tablets is prohibited after the expiry date printed on the package. The official disposal protocol requires patients to consult a healthcare professional, such as a pharmacist, or follow local regulatory requirements for discarding unused or expired product.

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

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