Regcor® Tablets — Amlodipine 5 mg & 10 mg — Dihydropyridine Calcium Channel Blocker — EIPICO
1. Disclaimer
This medical commentary is intended for educational and informational purposes for healthcare professionals and appropriately informed readers. It does not replace the approved prescribing information, clinical judgment, individualized medical assessment, or advice from a qualified healthcare professional. Treatment decisions must consider the patient's clinical condition, medical history, concurrent medications, and applicable local prescribing regulations.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
2. Summary
Regcor® is an oral cardiovascular medication containing amlodipine, a long-acting dihydropyridine calcium channel blocker. It is used primarily to manage arterial hypertension and certain forms of angina pectoris associated with coronary artery disease.
Amlodipine acts predominantly on vascular smooth muscle, causing arterial relaxation, reducing peripheral vascular resistance, and lowering systemic blood pressure. Its antianginal effects result from reduced myocardial oxygen demand and improved coronary blood flow, particularly in conditions involving coronary vasospasm.
The medication has a prolonged elimination half-life, permitting once-daily administration and sustained antihypertensive activity throughout a 24-hour dosing interval.
Regcor is available in tablet strengths containing 5 mg and 10 mg of amlodipine. The appropriate dose depends on the indication, therapeutic response, tolerability, age, hepatic function, and concurrent treatment.
Amlodipine is generally well tolerated. Peripheral edema, headache, flushing, dizziness, fatigue, and palpitations are among its recognized adverse effects. Particular attention is required in patients with severe hepatic impairment, significant hypotension, certain structural cardiac abnormalities, or advanced heart failure.
3. Brand Name
Regcor®
Available strengths identified for the Egyptian market:
- Regcor 5 mg Tablets.
- Regcor 10 mg Tablets.
The brand is associated with Egyptian International Pharmaceutical Industries Company (EIPICO).
4. Category
Pharmacological classification:
- Dihydropyridine calcium channel blocker.
- Selective calcium channel blocker with predominantly vascular effects.
- Antihypertensive agent.
- Antianginal agent.
- Peripheral arterial vasodilator.
ATC Classification: C08CA01 — Amlodipine.
Therapeutic category: Cardiovascular medication.
5. Active Ingredient
Amlodipine (as amlodipine besylate).
Each tablet contains amlodipine besylate equivalent to either:
- Amlodipine 5 mg.
- Amlodipine 10 mg.
Amlodipine besylate is the benzenesulfonate salt of amlodipine. The stated tablet strengths represent the quantity of amlodipine, rather than the total weight of its besylate salt.
Inactive ingredients:
The formulation described for Regcor contains:
- Microcrystalline cellulose.
- Anhydrous dibasic calcium phosphate.
- Sodium starch glycolate.
- Colloidal silicon dioxide.
- Magnesium stearate.
Excipients should be confirmed against the current product packaging or officially approved formulation when assessing ingredient-specific hypersensitivity.
6. Pharmaceutical Form & Strength
Pharmaceutical form: Tablets for oral administration.
Available strengths:
Regcor 5 mg: Each tablet contains 5 mg amlodipine as amlodipine besylate.
Regcor 10 mg: Each tablet contains 10 mg amlodipine as amlodipine besylate.
Pack presentation: The documented Egyptian presentation consists of a carton containing one aluminum/PVC blister strip of 10 tablets.
Packaging configurations may change according to manufacturing or regulatory arrangements. The marketed pack should be checked for the applicable presentation.
Both strengths are intended for once-daily oral administration.
A 2.5 mg amlodipine dose may be clinically appropriate for selected patients, but a Regcor 2.5 mg presentation is not established here. Tablet splitting should not be assumed to provide accurate dosing unless the particular tablet is confirmed to be suitable for subdivision.
7. Manufacturer & Marketing Authorization Holder
Manufacturer and brand-associated pharmaceutical company:
Egyptian International Pharmaceutical Industries Company (EIPICO).
Country: Egypt.
EIPICO is identified in Egyptian pharmaceutical industry records as the company associated with Regcor 5 mg and Regcor 10 mg tablets.
The legally designated marketing authorization holder, registration particulars, and currently authorized presentations should be confirmed through the Egyptian Drug Authority and the applicable product labeling.
8. Mechanism of Action
Amlodipine is a long-acting dihydropyridine calcium channel blocker that inhibits calcium entry through voltage-dependent L-type calcium channels.
These channels regulate the movement of extracellular calcium ions into vascular smooth muscle and cardiac muscle cells. Calcium entry contributes to muscle contraction.
By reducing calcium influx, amlodipine decreases vascular smooth muscle contraction and promotes arterial relaxation.
Its effects are more pronounced in vascular smooth muscle than in cardiac muscle at therapeutic concentrations.
Antihypertensive action
Amlodipine relaxes peripheral resistance arteries and arterioles, reducing systemic vascular resistance.
This reduction in afterload lowers arterial blood pressure and decreases the pressure against which the left ventricle must eject blood.
Its antihypertensive action is sustained for approximately 24 hours after once-daily administration.
In most patients, long-term treatment does not produce a clinically significant persistent increase in resting heart rate.
Antianginal action
Amlodipine reduces myocardial ischemic burden through two principal mechanisms.
1. Reduction of myocardial oxygen demand
By decreasing peripheral arterial resistance, amlodipine reduces cardiac afterload and myocardial workload.
This contributes to a reduction in myocardial oxygen requirements during physical activity.
2. Improvement of coronary vascular tone
Amlodipine promotes dilation of coronary arteries and helps prevent coronary arterial spasm.
This is particularly relevant in vasospastic angina, where transient coronary vasoconstriction reduces blood supply to the myocardium.
Effects on cardiac contractility
Although negative inotropic effects can be demonstrated experimentally, clinically significant direct myocardial depression is generally not observed with therapeutic oral doses in patients with preserved cardiac function.
This does not eliminate the need for caution in patients with significant cardiac dysfunction.
Onset and duration
Amlodipine has a gradual onset of action and a prolonged duration of effect because of its pharmacological and pharmacokinetic characteristics.
It is appropriate for long-term blood pressure control and prevention of anginal symptoms.
It is not intended to provide immediate relief of an acute angina attack or rapid treatment of a hypertensive emergency.
9. Spectrum of Activity
A conventional antimicrobial spectrum of activity is not applicable because amlodipine is not an antibiotic, antifungal, antiviral, or antiparasitic medication.
Its principal pharmacological activities are:
- Relaxation of peripheral arterial smooth muscle.
- Reduction of systemic vascular resistance.
- Reduction of arterial blood pressure.
- Reduction of cardiac afterload.
- Prevention and reduction of certain anginal symptoms.
- Inhibition of coronary artery vasospasm.
Amlodipine does not directly dissolve atherosclerotic plaques or reverse established coronary artery obstruction.
Its benefit in coronary artery disease is primarily related to vascular effects, relief of ischemic symptoms, and reduced need for certain coronary-related hospitalizations or interventions in appropriately selected patients.
10. Pharmacokinetics
Absorption
Following oral administration, amlodipine is absorbed gradually from the gastrointestinal tract.
Maximum plasma concentrations are generally reached approximately 6–12 hours after administration.
Its estimated absolute oral bioavailability is approximately 64–90%.
Food does not significantly affect amlodipine bioavailability.
Distribution
Amlodipine is extensively distributed into body tissues.
Approximately 93% of circulating amlodipine is bound to plasma proteins, according to studies in hypertensive patients.
Its extensive tissue distribution and relatively slow elimination contribute to sustained therapeutic activity.
Metabolism
Amlodipine undergoes extensive hepatic metabolism, mainly involving CYP3A4-mediated pathways, to pharmacologically inactive metabolites.
Approximately 90% of the absorbed drug is metabolized.
Because hepatic metabolism is the primary elimination pathway, patients with impaired liver function may experience increased systemic exposure and prolonged drug elimination.
Elimination
Approximately 10% of the administered drug is excreted unchanged in urine, while approximately 60% is recovered in urine as metabolites.
The terminal plasma elimination half-life is approximately 30–50 hours in most adults.
The half-life may be longer in patients with hepatic impairment.
Steady-state concentrations
Steady-state plasma concentrations are generally achieved after approximately 7–8 days of consecutive once-daily dosing.
The prolonged half-life supports continuous 24-hour blood pressure control.
Effect of renal impairment
Renal impairment does not substantially alter amlodipine pharmacokinetics.
Consequently, routine initial dose adjustment solely because of renal impairment is generally unnecessary.
Amlodipine is not effectively removed by hemodialysis.
Effect of age
Older adults may have reduced amlodipine clearance, resulting in increased plasma exposure.
Systemic exposure, expressed as area under the plasma concentration–time curve (AUC), may increase by approximately 40–60%.
A lower initial dose may therefore be appropriate in frail or elderly patients.
Effect of hepatic impairment
Patients with hepatic insufficiency may experience an approximately 40–60% increase in AUC.
The elimination half-life is prolonged, and cautious dose selection with slower titration is advisable.
Patients with severe hepatic impairment require particular monitoring.
Pharmacodynamic characteristics
Amlodipine lowers blood pressure in both supine and standing positions.
Its blood pressure reduction is generally greater in patients with higher pretreatment blood pressure.
With chronic use, therapeutic doses ordinarily do not cause clinically significant alterations in plasma catecholamine concentrations or resting heart rate.
In patients with hypertension and preserved renal function, amlodipine may reduce renal vascular resistance and increase renal blood flow. These physiological effects should not be interpreted as an established kidney-protective indication independent of blood pressure management.
11. Indications
11.1 Hypertension
Regcor is indicated for the treatment of arterial hypertension in appropriate patients.
It may be administered alone or in combination with other antihypertensive agents.
Lowering elevated blood pressure helps reduce cardiovascular complications, particularly stroke and myocardial infarction.
Amlodipine may be combined with medications from other antihypertensive classes when additional blood pressure control is required.
Selection of combination therapy should account for clinical guidelines, comorbidities, blood pressure targets, and individual tolerability.
11.2 Chronic stable angina
Amlodipine is indicated for symptomatic treatment of chronic stable angina pectoris.
It can reduce the frequency of angina attacks and improve exercise tolerance in suitable patients.
It may be prescribed alone or alongside other antianginal medications, such as beta-blockers or nitrates, when clinically indicated.
11.3 Vasospastic angina
Amlodipine is indicated for confirmed or suspected vasospastic angina, also known as Prinzmetal's or variant angina.
It helps prevent coronary artery spasm and reduces associated ischemic symptoms.
It may be used as monotherapy or combined with other appropriate antianginal treatment.
11.4 Angiographically documented coronary artery disease
Under certain regulatory labeling, amlodipine is indicated to reduce hospitalization for angina and the need for coronary revascularization procedures in patients with angiographically documented coronary artery disease who do not have heart failure or a left ventricular ejection fraction below 40%.
This indication is supported by clinical trial evidence in appropriately selected patients.
It should not be interpreted as proof that amlodipine reverses coronary atherosclerosis or independently reduces mortality in this particular population.
The applicability of this indication should be confirmed against the relevant national marketing authorization.
12. Administration
Route
Oral administration.
Tablets should be taken with water, with or without food.
Amlodipine is ordinarily administered once daily, preferably at approximately the same time each day.
Adult dosage for hypertension
Usual initial dose: 5 mg once daily.
Maximum recommended dose: 10 mg once daily.
Dose adjustments should be based on the patient's blood pressure, clinical response, and tolerability.
In general, allow approximately 7–14 days between dose adjustments so that the effect of the current dosage can be assessed.
More rapid titration may occasionally be appropriate under close clinical supervision.
Frail, elderly, or hepatically impaired patients
An initial dose of 2.5 mg once daily may be appropriate in selected patients, including:
- Small or frail adults.
- Some older adults.
- Patients with hepatic impairment.
- Patients receiving additional antihypertensive medications who may be particularly susceptible to hypotension.
The dosage should subsequently be adjusted according to response and tolerability.
Where a 2.5 mg dose is required, an appropriate authorized formulation or reliably divisible tablet should be used.
Adult dosage for angina
Recommended dosage: 5–10 mg once daily.
The lower dose may be preferred initially in older adults and patients with hepatic impairment.
Some patients require 10 mg daily for optimal symptom control, provided the dose is tolerated.
Pediatric dosage
For children and adolescents aged 6–17 years with hypertension:
Usual studied dosage range: 2.5–5 mg once daily.
According to UK product information, the recommended starting dose is 2.5 mg once daily, which may be increased to 5 mg once daily if the blood pressure target is not achieved after approximately four weeks.
Doses exceeding 5 mg daily have not been adequately studied for pediatric hypertension.
The safety and effectiveness of amlodipine for hypertension in children younger than 6 years have not been established in the referenced prescribing information.
Pediatric treatment requires individualized medical supervision and an appropriate dosage formulation.
Patients with renal impairment
Routine dose adjustment is generally unnecessary on the basis of renal impairment alone.
However, blood pressure, fluid status, and concurrent medication effects should be monitored.
Missed dose
Missed-dose instructions vary between product labels. According to U.S. Norvasc patient information, a missed dose may be taken as soon as remembered if no more than 12 hours have elapsed since its scheduled time; otherwise, it should be skipped. Some healthcare authorities advise skipping the missed dose and resuming the regular schedule. Patients should follow the instructions for their specific product.
Do not take a double dose to compensate for a missed dose.
Duration of treatment
Hypertension and chronic angina commonly require long-term therapy.
Patients should not independently discontinue treatment because blood pressure improves or symptoms become controlled.
Withdrawal or modification should be discussed with the treating clinician.
Monitoring during treatment
Monitoring may include:
- Blood pressure and treatment response.
- Orthostatic symptoms.
- Peripheral edema.
- Heart rate and cardiovascular symptoms.
- Angina frequency and exercise tolerance.
- Signs of worsening heart failure.
- Adverse effects following dose increases.
- Clinically indicated assessment of hepatic function and interacting medications.
Routine laboratory testing is not required solely because a patient is taking amlodipine, although underlying disease and concomitant treatment may require additional investigations.
13. Method of Preparation
No special preparation is required.
Regcor is supplied as a ready-to-administer oral tablet.
The tablet may be taken directly with water.
Reconstitution, dilution, or preparation of a suspension is not necessary for standard administration.
Crushing, dispersing, or splitting tablets should not be undertaken unless the suitability of the specific formulation has been confirmed by a pharmacist or other qualified healthcare professional.
For patients who cannot swallow tablets, an appropriate licensed amlodipine liquid formulation may be considered where available.
14. Contraindications
Established contraindication
Amlodipine is contraindicated in patients with known hypersensitivity to amlodipine or relevant formulation components.
A history of serious hypersensitivity to dihydropyridine calcium channel blockers also warrants avoidance or specialist assessment.
Additional contraindications in certain international product labels
Some regulatory summaries of product characteristics list the following conditions as contraindications:
- Severe hypotension.
- Shock, including cardiogenic shock.
- Significant left ventricular outflow obstruction, such as high-grade aortic stenosis.
- Hemodynamically unstable heart failure following acute myocardial infarction.
These restrictions are not identically worded across all international amlodipine labels. For example, some U.S. labeling identifies severe aortic stenosis as a major precaution rather than listing it under formal contraindications.
Prescribers should follow the locally approved labeling while applying appropriate clinical judgment to these high-risk conditions.
15. Warnings & Precautions
15.1 Hypotension
Amlodipine may produce symptomatic hypotension, particularly in susceptible patients.
Risk may be increased by volume depletion, significant cardiac outflow obstruction, concomitant vasodilators, or multiple antihypertensive medications.
Patients should be assessed for dizziness, fainting, weakness, and other symptoms of excessive blood pressure reduction.
Severe hypotension requires prompt medical evaluation.
15.2 Severe aortic stenosis
Patients with severe aortic stenosis may be particularly vulnerable to excessive hypotension resulting from systemic vasodilation.
Amlodipine should not be initiated casually in such patients. Its use requires specialist assessment and compliance with applicable contraindications.
15.3 Worsening angina or myocardial infarction
Worsening angina or acute myocardial infarction can occasionally occur after initiating amlodipine or increasing its dosage, especially in patients with severe obstructive coronary artery disease.
New, severe, or worsening chest pain requires urgent evaluation.
Amlodipine is not a substitute for emergency treatment of acute coronary syndromes.
15.4 Hepatic impairment
Amlodipine clearance is reduced in patients with impaired liver function.
Treatment should be initiated cautiously, with particular care during dosage increases.
Slow titration and clinical monitoring are important in severe hepatic impairment.
15.5 Heart failure
Amlodipine is not an established disease-modifying treatment for heart failure.
Although studies have not demonstrated a consistent increase in mortality with amlodipine in selected patients with heart failure, increased reports of pulmonary edema have occurred in some clinical trials.
Patients with heart failure should be monitored for worsening breathlessness, fluid accumulation, weight gain, and peripheral edema.
Peripheral edema related to amlodipine can also occur without deterioration in cardiac function.
15.6 Peripheral edema
Ankle and leg swelling is a well-recognized, dose-related adverse effect.
It is associated primarily with changes in microvascular pressure caused by preferential arteriolar dilation rather than generalized sodium and water retention.
Persistent or troublesome edema requires assessment.
Possible management includes dose adjustment, modification of antihypertensive therapy, or selection of an alternative medication.
Diuretics are not necessarily effective for isolated amlodipine-induced edema.
15.7 Hypertensive emergencies
Amlodipine has a gradual onset of action.
It should not be relied upon to rapidly lower blood pressure in a hypertensive emergency involving acute target-organ injury.
Such emergencies require immediate evaluation and appropriately monitored treatment.
15.8 Discontinuation of beta-blockers
Amlodipine does not provide protection against the potential consequences of abrupt beta-blocker withdrawal.
Patients taking beta-blockers should not discontinue them suddenly without medical guidance.
When withdrawal is appropriate, gradual reduction may be required.
15.9 Driving and operating machinery
Dizziness, headache, fatigue, or other symptoms may impair the ability to drive or operate machinery.
Patients should establish how amlodipine affects them, especially when beginning treatment or following dosage increases.
15.10 Dental and gingival health
Gingival enlargement has been reported with amlodipine use.
Good oral hygiene, regular dental care, and assessment of persistent gingival changes are advisable.
15.11 Concomitant cardiovascular medications
The combined blood pressure-lowering effects of amlodipine and other cardiovascular agents can cause symptomatic hypotension.
Additional monitoring may be required when treatment is initiated or modified.
16. Drug Interactions
16.1 CYP3A4 inhibitors
Amlodipine is metabolized substantially through CYP3A4-dependent pathways.
Moderate or strong CYP3A4 inhibitors may increase amlodipine exposure and the risk of hypotension or peripheral edema.
Examples include:
- Clarithromycin.
- Itraconazole.
- Ketoconazole.
- Certain HIV protease inhibitors or pharmacokinetic boosters.
- Diltiazem.
- Some other clinically significant CYP3A4 inhibitors.
Patients receiving these combinations may require closer monitoring or dose adjustment.
16.2 CYP3A4 inducers
Enzyme-inducing medications may reduce or otherwise alter amlodipine exposure.
Examples include:
- Rifampicin.
- Carbamazepine.
- Phenytoin.
- St John's wort.
Blood pressure should be monitored during the introduction or discontinuation of potent enzyme inducers.
16.3 Simvastatin
Amlodipine increases systemic exposure to simvastatin.
This can increase the risk of statin-associated muscle toxicity.
When simvastatin is coadministered with amlodipine, the simvastatin dose should not exceed 20 mg daily under U.S. prescribing recommendations.
Alternative statins may be considered when greater lipid-lowering intensity is required.
16.4 Tacrolimus and cyclosporine
Amlodipine may increase systemic exposure to tacrolimus or cyclosporine.
Co-administration can increase the risk of concentration-dependent toxicity.
Monitoring of immunosuppressant trough concentrations and appropriate dose adjustment may be necessary.
16.5 Sildenafil and related medications
Sildenafil and other phosphodiesterase type 5 inhibitors have blood pressure-lowering properties.
When combined with amlodipine, their vasodilatory effects may be additive.
Patients should be monitored for dizziness, symptomatic hypotension, or fainting.
16.6 Other antihypertensive agents
Amlodipine may be combined with medications such as:
- ACE inhibitors.
- Angiotensin receptor blockers.
- Thiazide or thiazide-like diuretics.
- Beta-blockers.
- Other appropriate antihypertensive medications.
These combinations are frequently used therapeutically.
Nevertheless, excessive blood pressure reduction may occur, particularly during treatment initiation or adjustment.
16.7 Antianginal medications
Amlodipine can be used with appropriate antianginal agents, including long-acting nitrates, short-acting nitroglycerin, and beta-blockers.
The combination should be individualized according to clinical response and cardiovascular status.
16.8 Atorvastatin, digoxin, and warfarin
Clinical pharmacokinetic studies have not demonstrated major effects of amlodipine on atorvastatin exposure, digoxin concentrations, or the warfarin prothrombin-time response.
These observations do not eliminate the need for routine monitoring appropriate to each medication and the patient's underlying condition.
16.9 Cimetidine and antacids
Cimetidine and magnesium/aluminum-containing antacids have not demonstrated clinically significant effects on amlodipine pharmacokinetics in the referenced studies.
16.10 Grapefruit and grapefruit juice
Some international product information recommends avoiding grapefruit or grapefruit juice because amlodipine exposure and its blood pressure-lowering effects may increase in certain individuals.
However, controlled pharmacokinetic studies referenced in U.S. labeling have not consistently demonstrated a significant interaction.
Given this variation in regulatory guidance, avoidance is a reasonable precaution, particularly in patients susceptible to hypotension or receiving interacting medications.
16.11 Alcohol
Alcohol may increase dizziness or symptomatic hypotension associated with amlodipine.
Excessive alcohol consumption should be avoided.
16.12 Intravenous dantrolene
Some European product information advises avoiding concomitant administration of intravenous dantrolene and calcium channel blockers in patients susceptible to malignant hyperthermia.
This precaution is based largely on experimental and class-related safety concerns rather than a well-established amlodipine-specific clinical interaction.
16.13 Mechanistic target of rapamycin (mTOR) inhibitors
Amlodipine is a weak CYP3A inhibitor and may increase systemic exposure to mTOR inhibitors such as sirolimus, everolimus, and temsirolimus.
Clinical monitoring and appropriate dose adjustment of the interacting medication may be required during concomitant treatment.
17. Side Effects
Amlodipine is generally well tolerated at recommended doses.
Most reported adverse effects are mild or moderate, although clinically important reactions can occur.
Common adverse effects
Reported adverse reactions include:
- Peripheral edema, particularly ankle swelling.
- Dizziness.
- Headache.
- Flushing.
- Palpitations.
- Fatigue.
- Nausea.
- Abdominal discomfort.
- Somnolence.
Peripheral edema is among the most characteristic adverse effects and generally becomes more frequent with increasing dosage.
Dose-related adverse reactions
The following frequencies were reported in controlled clinical trials of amlodipine formulations and should not be interpreted as Regcor-specific incidence estimates.
| Adverse reaction | Amlodipine 5 mg | Amlodipine 10 mg |
|---|---|---|
| Peripheral edema | 3.0% | 10.8% |
| Dizziness | 3.4% | 3.4% |
| Flushing | 1.4% | 2.6% |
| Palpitations | 1.4% | 4.5% |
Other reactions reported in placebo-controlled trials included fatigue (4.5%), nausea (2.9%), abdominal pain (1.6%), and somnolence (1.4%) in amlodipine-treated patients.
Adverse-event rates depend on the study population, dose, observation period, and methods of reporting.
Less commonly reported adverse events
Cardiovascular:
Hypotension, postural dizziness, syncope, tachycardia, bradycardia, chest pain, and arrhythmias.
Nervous system:
Paresthesia, hypoesthesia, tremor, peripheral neuropathic symptoms, and vertigo.
Gastrointestinal:
Vomiting, constipation, diarrhea, dyspepsia, flatulence, appetite changes, dysphagia, and gingival enlargement.
Musculoskeletal:
Muscle cramps, myalgia, arthralgia, and back pain.
Psychiatric and sleep-related:
Insomnia, anxiety, mood changes, depression, abnormal dreams, and sexual dysfunction.
Skin:
Rash, pruritus, and other cutaneous reactions.
Respiratory:
Dyspnea and epistaxis.
Special senses:
Visual disturbances, tinnitus, diplopia, and eye discomfort.
Urinary:
Increased urinary frequency, nocturia, and other urinary symptoms.
Other reported events:
Dry mouth, increased sweating, weight changes, and general weakness.
Some of these events were observed during clinical studies or postmarketing surveillance without a confirmed causal relationship to amlodipine.
Serious or clinically important reactions
Reported serious reactions include:
- Severe symptomatic hypotension.
- Syncope.
- Worsening angina or myocardial infarction in susceptible patients.
- Angioedema.
- Severe hypersensitivity reactions.
- Erythema multiforme.
- Stevens–Johnson syndrome and exfoliative dermatitis (very rare in UK product information), and toxic epidermal necrolysis (frequency not known).
- Hepatitis or cholestatic liver injury.
- Jaundice and clinically significant liver enzyme elevations.
- Pancreatitis.
- Rare hematological abnormalities, including thrombocytopenia and leukopenia.
Postmarketing observations
Gynecomastia and possible extrapyramidal movement disorders have also been reported during postmarketing surveillance.
Because spontaneous reports lack a defined denominator, their true frequencies cannot be reliably estimated, and causality is not established for every reported event.
Laboratory effects
Amlodipine is not ordinarily associated with clinically significant changes in routine measurements of serum potassium, glucose, lipids, uric acid, urea, or creatinine.
However, individual adverse reactions and changes related to underlying disease or concurrent treatment remain possible.
When urgent medical care is required
Immediate assessment is necessary if treatment is associated with:
- Severe or persistent chest pain.
- Fainting or profound hypotension.
- Significant breathing difficulty.
- Rapidly progressive swelling accompanied by respiratory symptoms.
- Swelling of the face, lips, tongue, or throat.
- Severe allergic reactions.
- Extensive skin blistering, peeling, or painful mucosal lesions.
- Jaundice or symptoms suggesting serious liver injury.
18. Use in Special Populations
Pregnancy
Human pregnancy data for amlodipine remain less extensive than those for several alternative antihypertensive medications.
Available evidence has not established a consistent major teratogenic signal, but the data are insufficient to exclude all fetal risks.
Uncontrolled maternal hypertension itself increases the risks of pre-eclampsia, placental complications, fetal growth restriction, premature delivery, and other adverse outcomes.
For hypertension during pregnancy, medications such as labetalol and extended-release nifedipine are generally preferred according to major clinical guidelines.
Amlodipine may occasionally be considered when the clinical benefits justify its use and suitable alternatives are inappropriate or ineffective.
Treatment during pregnancy requires individualized obstetric and medical supervision.
Breastfeeding
Amlodipine passes into human breast milk in measurable amounts.
Available lactation studies generally indicate relatively low infant exposure. In one published study, the median relative infant dose was estimated at 4.2% of the maternal weight-adjusted dose (interquartile range: 3.1–7.3%). Estimates vary between studies, and the available pharmacokinetic data have limitations.
Published studies have not identified a consistent pattern of adverse effects in breastfed infants, although the total available evidence remains limited.
Current LactMed guidance indicates that maternal amlodipine treatment is not, by itself, a reason to discontinue breastfeeding when the medication is clinically required.
The decision should consider maternal treatment needs, infant age, prematurity, feeding characteristics, and possible alternatives.
Breastfed infants, particularly premature or medically vulnerable infants, may require monitoring for unusual drowsiness, poor feeding, lethargy, or signs of hypotension.
Fertility
Human clinical data on the effects of amlodipine on fertility are limited. Reversible biochemical changes in spermatozoa have been reported with some calcium channel blockers, and certain animal studies have identified effects on male fertility. The clinical relevance of these findings in humans remains uncertain.
Pediatric patients
Amlodipine can reduce blood pressure in children and adolescents aged 6–17 years.
The usual studied dose range is 2.5–5 mg once daily.
Dosage should be individualized using age-appropriate blood pressure assessment and suitable pharmaceutical preparations.
The available evidence does not establish routine use for hypertension in children younger than 6 years.
Elderly patients
Older adults may experience increased systemic exposure due to reduced clearance.
Cautious dose selection is advised, especially in frail patients or those with multiple medical conditions.
Blood pressure, dizziness, orthostatic symptoms, and peripheral edema should be monitored.
Hepatic impairment
Patients with hepatic impairment may have a prolonged elimination half-life and increased plasma exposure.
Initiation at the lower end of the dose range and gradual titration are recommended.
Severe hepatic impairment requires particularly careful monitoring.
Renal impairment
No routine initial dose adjustment is generally required solely because of renal dysfunction.
Patients with chronic kidney disease may still require individualized monitoring because of associated cardiovascular disease and concurrent medications.
Hemodialysis does not meaningfully remove amlodipine.
Heart failure
Amlodipine may be used in selected patients with heart failure when there is an appropriate indication, but it is not a substitute for established guideline-directed heart failure therapies.
Monitor patients for fluid accumulation, worsening dyspnea, or pulmonary edema.
Patients with diabetes or dyslipidemia
Amlodipine is commonly used for blood pressure control in patients with diabetes mellitus or lipid disorders.
It is generally metabolically neutral with respect to routine glucose and lipid measurements.
Overall cardiovascular risk management remains essential.
Patients with coronary artery disease
Amlodipine may improve anginal symptoms and reduce certain coronary-related healthcare events in selected patients.
It does not replace lipid-lowering therapy, antiplatelet treatment when indicated, smoking cessation, or other proven coronary risk-reduction interventions.
19. Storage Conditions
Store Regcor tablets in a dry place at a temperature not exceeding 30°C, according to the product's documented storage instructions.
Additional recommendations:
- Keep tablets in their original packaging until use.
- Protect from excessive heat and moisture.
- Avoid storage in humid environments.
- Keep out of the sight and reach of children.
- Do not use after the expiration date.
- Avoid using tablets with unusual appearance or evidence of deterioration.
The temperature and storage conditions printed on the currently supplied package take precedence.
20. Additional Sections
20.1 Clinical evidence
Amlodipine has been extensively evaluated for hypertension and coronary artery disease.
Clinical trials demonstrate sustained blood pressure reduction and improvement in symptoms of chronic stable or vasospastic angina.
In studies involving selected patients with coronary artery disease, including CAMELOT, amlodipine reduced certain composite cardiovascular outcomes relative to placebo.
The observed differences were driven substantially by reductions in angina-related hospitalization and coronary revascularization procedures.
These findings should not be interpreted as evidence that amlodipine independently reduces every major cardiovascular endpoint.
20.2 Role in cardiovascular risk management
Antihypertensive treatment should be integrated into a broader strategy for reducing cardiovascular risk.
Depending on the patient's condition, this may include:
- Weight management.
- Reduced dietary sodium intake.
- Regular physical activity.
- Smoking cessation.
- Diabetes management.
- Lipid-lowering therapy.
- Appropriate antithrombotic treatment when indicated.
- Regular blood pressure monitoring.
Amlodipine contributes to risk reduction primarily through effective blood pressure control.
20.3 Peripheral edema management
Amlodipine-associated peripheral edema is often related to precapillary arteriolar dilation.
It may develop without generalized fluid overload.
Potential management approaches include reducing the dose, changing medication, or introducing an appropriate complementary antihypertensive agent.
Adding a renin–angiotensin system blocker may lessen edema in some patients when clinically appropriate.
Persistent swelling should be assessed to exclude heart failure, venous disease, renal disorders, and other causes.
20.4 Overdosage
Amlodipine overdose may cause profound and prolonged systemic vasodilation.
Potential manifestations include:
- Severe hypotension.
- Reflex tachycardia.
- Dizziness or loss of consciousness.
- Circulatory shock.
- Cardiac conduction or contractility disturbances in severe poisoning.
- Metabolic and organ perfusion abnormalities.
Rarely, noncardiogenic pulmonary edema may occur, sometimes with a delayed onset approximately 24–48 hours after ingestion.
Suspected significant overdose is a medical emergency, even when symptoms are initially absent.
Emergency management
Management should take place in an appropriately equipped medical facility, preferably with toxicology or poison-center consultation.
In life-threatening calcium channel blocker poisoning with hypotension, high-dose insulin and vasopressor therapy are recommended under specialist supervision. Depending on severity, management may include:
- Continuous cardiovascular and respiratory monitoring.
- Frequent blood pressure assessment.
- Careful intravenous fluid administration.
- Vasopressor support for significant hypotension.
- High-dose insulin therapy with close monitoring of glucose, potassium, and fluid balance.
- Intravenous calcium as a reasonable adjunct in severe poisoning.
- Advanced circulatory or respiratory support when required, including consideration of extracorporeal life support for refractory cardiogenic shock.
Gastrointestinal decontamination may be considered in selected recent ingestions under specialist guidance.
Because amlodipine is extensively protein bound, hemodialysis is not expected to provide clinically meaningful drug removal.
Management should be individualized, and patients should not attempt treatment of an overdose at home.
20.5 Treatment adherence
Amlodipine is frequently prescribed for prolonged treatment.
Patients may not experience noticeable symptoms from hypertension, even when blood pressure is dangerously elevated.
Therefore, absence of symptoms does not indicate that medication is unnecessary.
Regular administration and follow-up are important for sustained blood pressure control.
21. Frequently Asked Questions (FAQ)
Q1. What is Regcor used for?
Regcor contains amlodipine and is used primarily to treat high blood pressure and certain types of angina.
It may also have a role in selected patients with documented coronary artery disease, depending on clinical circumstances and authorized indications.
Q2. Is Regcor suitable for once-daily administration?
Yes.
Amlodipine has a long elimination half-life and ordinarily provides sustained blood pressure control with once-daily dosing.
Q3. What is the usual adult dose?
The usual starting dose for hypertension is 5 mg once daily.
The maximum recommended adult dose is generally 10 mg once daily.
A lower starting dose may be appropriate in selected patients.
Q4. Can Regcor be taken with food?
Yes.
Amlodipine may be taken with or without food because meals do not significantly affect its bioavailability.
Q5. Can Regcor cause swelling of the feet or ankles?
Yes.
Peripheral edema is a common, dose-related adverse effect.
Patients should seek medical assessment if swelling is persistent, severe, or accompanied by breathing difficulty or other concerning symptoms.
Q6. Does Regcor slow the heart rate?
Amlodipine ordinarily has little clinically significant effect on resting heart rate at therapeutic doses.
Unlike verapamil and diltiazem, it does not usually produce substantial suppression of atrioventricular nodal conduction.
However, individual cardiovascular responses may vary.
Q7. Can Regcor be used with other blood pressure medications?
Yes.
Amlodipine is commonly combined with other antihypertensive agents when clinically indicated.
The combination should be supervised because excessive blood pressure reduction may occur.
Q8. Is Regcor safe for patients with kidney impairment?
Amlodipine usually does not require dose adjustment solely because of impaired renal function.
Nevertheless, patients with kidney disease require appropriate clinical monitoring and individualized treatment.
Q9. Can Regcor be used in patients with liver disease?
It may be used in selected patients, but liver impairment can increase amlodipine exposure.
Lower initial doses, slower titration, and close monitoring may be necessary.
Q10. Can Regcor be used during pregnancy?
Amlodipine is not generally a preferred first-line treatment for hypertension during pregnancy.
It should be used only when an appropriately qualified clinician determines that its potential benefits justify the treatment.
Patients should not independently stop an antihypertensive medication after discovering they are pregnant; prompt clinical review is necessary.
Q11. Is breastfeeding possible while taking Regcor?
Available evidence indicates that amlodipine enters breast milk in relatively small amounts and has not consistently been associated with harmful infant effects.
Breastfeeding may be continued in appropriate circumstances following individualized clinical assessment.
Q12. Can Regcor be stopped when blood pressure becomes normal?
Patients should not stop prescribed treatment independently.
Normal blood pressure during treatment often indicates that the medication is effective, rather than that the underlying hypertension has resolved.
Q13. How quickly does Regcor begin working?
Amlodipine begins exerting blood pressure-lowering effects after administration, but its action develops gradually.
The full effect of a particular daily dose may require approximately one to two weeks to assess.
It is not intended for emergency blood pressure reduction.
Q14. Can Regcor be used to stop sudden chest pain?
No.
Regcor is intended primarily for ongoing angina prevention and management.
It does not provide sufficiently rapid relief for an acute angina episode.
Patients should follow their prescribed emergency chest-pain plan and seek urgent medical assistance when indicated.
Q15. What happens if a dose is missed?
Follow the instructions supplied with the specific product. Under U.S. Norvasc patient guidance, a missed dose may be taken within 12 hours of its scheduled time; if more than 12 hours have elapsed, skip it and take the next dose at the usual time. Some other healthcare guidance recommends skipping the missed dose and continuing the usual schedule.
Do not double the dose.
Q16. Does amlodipine interact with cholesterol-lowering medications?
A clinically important interaction exists with simvastatin.
Under U.S. labeling, the simvastatin dose should not exceed 20 mg daily when used with amlodipine.
Other statin choices and doses should be reviewed according to their specific interaction profiles.
Q17. Does amlodipine cause potassium loss?
Amlodipine does not typically cause significant potassium depletion.
Unlike certain diuretics, it does not act primarily by increasing renal sodium and water excretion.
Electrolyte monitoring may still be necessary because of other medications or underlying medical conditions.
Q18. Is Regcor appropriate for hypertensive emergencies?
No.
Amlodipine has a gradual onset and is not appropriate as the primary agent for immediate blood pressure reduction in hypertensive emergencies.
These conditions require urgent medical evaluation and specifically selected therapies.
22. References
- U.S. National Library of Medicine — DailyMed. NORVASC (Amlodipine Besylate) Tablets: Prescribing Information. Official drug labeling covering pharmacology, indications, dosage, contraindications, interactions, adverse reactions, pregnancy, lactation, and clinical studies.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7367289c-b0b0-466a-83e2-558e2985c29f - U.S. National Library of Medicine — DailyMed. Amlodipine Besylate Tablets: Prescribing Information. DailyMed listing updated March 3, 2026; the prescribing-information text identifies December 2019 as its revision date.
https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=215ef2cb-d5b6-43d5-bbd5-195ec57cde2b - Electronic Medicines Compendium (emc). Amlodipine 10 mg Tablets — Summary of Product Characteristics. Includes European-style contraindications, precautions, interactions, pharmacokinetics, and therapeutic recommendations.
https://www.medicines.org.uk/emc/product/13534/smpc - National Institute for Health and Care Excellence (NICE). Hypertension in Pregnancy: Diagnosis and Management (NG133). Recommendations concerning antihypertensive treatment during pregnancy and the postnatal period.
https://www.nice.org.uk/guidance/ng133/chapter/recommendations - National Library of Medicine — Drugs and Lactation Database (LactMed®). Amlodipine. Last revised September 15, 2026. Evidence concerning breast milk transfer, infant exposure, and breastfeeding safety.
https://www.ncbi.nlm.nih.gov/books/NBK500665/ - American Heart Association. Part 10: Adult and Pediatric Special Circumstances of Resuscitation. Guidance on the management of life-threatening calcium channel blocker poisoning.
https://cpr.heart.org/en/resuscitation-science/cpr-and-ecc-guidelines/adult-and-pediatric-special-circumstances-of-resuscitation - National Health Service (NHS). Amlodipine: Medicine to Treat High Blood Pressure and Angina. Patient-oriented information on administration, missed doses, adverse effects, and medication precautions.
https://www.nhs.uk/medicines/amlodipine/ - Export Council for Medical Industries (ECMI), Egypt. Pharmaceutical Database. Product listings identifying Regcor 5 mg and 10 mg tablets as amlodipine products associated with EIPICO.
https://www.ecmi-eg.org/ecmi-pharmaceutical-database/ - Egyptian Drug Authority (EDA). GCP Inspections Registry, Updated December 31, 2024. Official registry identifying EIPICO as sponsor of a bioequivalence study involving Regcor 10 mg.
https://www.edaegypt.gov.eg/media/momjansn/gcp-inspections-registry-puplication-version-4.pdf - Egyptian International Pharmaceutical Industries Company (EIPICO). Pharmaceutical Product Catalogue. Regcor listed among cardiovascular calcium channel blockers, with amlodipine besylate tablet strengths of 5 mg and 10 mg.
https://www.eipico.com.eg/DataImages/HTML/File702.pdf