VASONORM
1. Disclaimer
This information is provided for educational and general informational purposes only and is not a substitute for the official product leaflet, prescribing information, or individualized advice from a qualified physician or pharmacist. Medication selection, dosing, monitoring, and treatment decisions should be based on the patient’s clinical condition and the most current officially approved product information.
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
VASONORM contains amlodipine, a long-acting dihydropyridine calcium-channel blocker (CCB). It is used primarily for the treatment of hypertension and for the symptomatic treatment of chronic stable angina; it is also indicated for vasospastic (Prinzmetal/variant) angina. Amlodipine produces predominantly arterial vasodilation, reducing systemic vascular resistance and blood pressure, while also improving coronary blood flow and reducing myocardial oxygen demand in angina.
3. Brand Name
VASONORM
The Egyptian market listings reviewed identify the following presentations:
- Vasonorm 5 mg — 10 tablets
- Vasonorm 10 mg — 10 tablets
Both are listed with amlodipine as the active ingredient and Pharco as the manufacturer.
4. Category
Therapeutic category: Antihypertensive; antianginal
Pharmacological class: Calcium-channel blocker
Subclass: Dihydropyridine calcium-channel blocker
ATC: C08CA01 — Amlodipine
5. Active Ingredient
Amlodipine
The product is formulated as amlodipine besylate equivalent to the stated amount of amlodipine. The available VASONORM strengths are 5 mg and 10 mg.
6. Pharmaceutical Form & Strength
Pharmaceutical form: Scored oral tablets
Available strengths: 5 mg and 10 mg amlodipine per tablet
Pack size: 10 tablets per pack for the currently listed Egyptian presentations.
7. Manufacturer & Marketing Authorization Holder
Manufacturer: Pharco Pharmaceuticals, Alexandria, Egypt.
Available Egyptian product sources consistently associate VASONORM with Pharco. Historical Egyptian registration material also identifies both VASONORM 5 mg and VASONORM 10 mg as Pharco products.
Marketing Authorization Holder: Pharco Pharmaceuticals is the company publicly associated with the Egyptian product in the sources reviewed. A separately named, current Marketing Authorization Holder could not be independently verified from a publicly accessible Egyptian regulatory record; therefore, no additional company is stated.
8. Mechanism of Action
Amlodipine is a long-acting dihydropyridine calcium-channel blocker. It inhibits the transmembrane influx of calcium ions through voltage-dependent L-type calcium channels, with its principal clinical effect occurring in vascular smooth muscle.
This causes relaxation and dilation of peripheral arteries and arterioles, reducing systemic vascular resistance and lowering blood pressure. In patients with angina, the reduction in afterload decreases myocardial oxygen demand, while coronary vasodilation can improve myocardial oxygen supply. Amlodipine has relatively little direct effect on sinoatrial-node or atrioventricular conduction at therapeutic oral doses compared with non-dihydropyridine calcium-channel blockers.
9. Spectrum of Activity
Not applicable in the antimicrobial sense. Amlodipine is not an anti-infective drug and does not have a bacterial, viral, fungal, or parasitic spectrum of activity.
Its pharmacological effects are cardiovascular and include:
- Reduction of elevated arterial blood pressure.
- Relief of symptoms associated with chronic stable angina.
- Treatment of vasospastic (Prinzmetal/variant) angina.
- Arterial vasodilation with reduction of systemic vascular resistance.
10. Pharmacokinetics
Amlodipine is well absorbed after oral administration. Peak plasma concentrations are generally reached approximately 6–12 hours after administration. Absolute bioavailability has been estimated at approximately 64–90%, and food does not significantly alter its bioavailability.
Amlodipine is extensively metabolized in the liver, primarily to inactive metabolites. Approximately 10% of the parent drug and about 60% of its metabolites are excreted in urine. It is highly protein bound, with approximately 93% of circulating drug bound to plasma proteins in hypertensive patients.
The terminal elimination half-life is approximately 30–50 hours, supporting once-daily administration. Steady-state plasma concentrations are generally reached after approximately 7–8 days of repeated daily dosing.
Renal impairment does not have a major effect on amlodipine pharmacokinetics, and usual initial dosing can generally be used in patients with renal impairment. In elderly patients and patients with hepatic impairment, clearance may be reduced and exposure increased; lower starting doses and slower titration may therefore be appropriate.
11. Indications
VASONORM (amlodipine) is used for:
- Hypertension, alone or in combination with other antihypertensive agents.
- Chronic stable angina, alone or in combination with other antianginal agents.
- Vasospastic (Prinzmetal’s or variant) angina, alone or in combination with other antianginal agents.
Amlodipine is also an established treatment option in patients with documented coronary artery disease in the indications specified by the applicable product labeling.
12. Administration
Amlodipine is administered orally once daily, with or without food. It is preferable to take it at approximately the same time each day.
For adults with hypertension, the usual recommended starting dose is 5 mg once daily, with a maximum recommended dose of 10 mg once daily. Some patients, including small or frail patients, elderly patients, or patients with hepatic impairment, may appropriately start at 2.5 mg once daily.
For chronic stable or vasospastic angina, the usual dose range is 5–10 mg once daily, with the lower dose generally favored initially in elderly patients and patients with hepatic impairment. Many patients may require 10 mg for adequate symptomatic control.
Dosage should be individualized according to the indication, blood-pressure response, tolerability, age, hepatic function, and concomitant therapy.
13. Method of Preparation
No preparation, dilution, or reconstitution is required. VASONORM tablets are ready for oral administration.
Where a half-tablet dose is specifically prescribed, a scored tablet may be divided only when the dosage form is designed to permit such splitting and the physician or pharmacist has instructed the patient to do so. The strength and dosing instructions on the actual package should always be followed.
14. Contraindications
VASONORM should not be used in patients with known hypersensitivity to amlodipine or to any component of the specific formulation.
15. Warnings & Precautions
Amlodipine is generally well tolerated, but several precautions are clinically important.
Hypotension: Symptomatic hypotension may occur, particularly in susceptible patients and in those with severe aortic stenosis. Because amlodipine has a gradual onset of action, abrupt severe hypotension is less typical than with rapidly acting vasodilators.
Severe aortic stenosis: Use with particular caution because the reduction in systemic vascular resistance may contribute to symptomatic hypotension.
Severe coronary artery disease: In susceptible patients with severe obstructive coronary artery disease, worsening angina or acute myocardial infarction may occur after initiation or following an increase in dose.
Hepatic impairment: Amlodipine is extensively metabolized by the liver. In severe hepatic impairment, clearance is reduced and the half-life may be prolonged; treatment should therefore be started cautiously and titrated slowly.
Heart failure: Amlodipine is not contraindicated solely because of heart failure. However, patients with significant heart failure, particularly severe or decompensated disease, require appropriate clinical monitoring. Clinical studies have not demonstrated a general worsening of heart failure with amlodipine, although increased pulmonary edema was reported in one severe-heart-failure population.
Driving and machinery: Dizziness, headache, fatigue, or nausea may impair the ability to drive or operate machinery, particularly when treatment is initiated or the dose is increased.
16. Drug Interactions
Amlodipine has clinically relevant interactions with several classes of medicines.
CYP3A inhibitors: Moderate or strong CYP3A inhibitors can increase amlodipine exposure and may increase the risk of hypotension and edema. Patients receiving such combinations should be monitored and dosage adjustment considered when clinically appropriate. Examples include certain azole antifungals, macrolides, protease inhibitors, verapamil, and diltiazem.
Sildenafil: Concomitant use may produce additional blood-pressure lowering; patients should be monitored for hypotension.
Simvastatin: Amlodipine increases systemic exposure to simvastatin. The simvastatin dose should be limited to 20 mg daily in patients receiving amlodipine.
Cyclosporine and tacrolimus: Amlodipine may increase systemic exposure to these immunosuppressants. Appropriate therapeutic-drug monitoring and dose adjustment may be required.
Amlodipine can also be administered with many other cardiovascular medicines when clinically indicated. The former blanket statement that combinations of a calcium-channel blocker with a beta-blocker should be avoided is not appropriate as a general rule for amlodipine; concomitant use can be clinically appropriate and should be individualized. Clinical studies have not shown clinically important adverse ECG effects from such combinations in hypertension or angina.
17. Side Effects
Amlodipine is generally well tolerated, but adverse reactions can occur and are often dose related.
The most characteristic and common adverse reaction is peripheral edema, particularly at higher doses. Other commonly reported reactions include:
- Headache
- Dizziness
- Flushing
- Palpitations
- Fatigue
- Nausea
- Abdominal discomfort or pain
- Somnolence
- Ankle swelling/edema
Less common or post-marketing reactions may include hypotension, syncope, arrhythmias, rash, pruritus, angioedema, gastrointestinal disturbances, gingival hyperplasia, elevated hepatic enzymes or jaundice, and other uncommon events.
Sexual dysfunction: Sexual dysfunction has been reported, but it is not appropriate to state categorically that such effects are "unlikely" or absent. Available labeling includes sexual dysfunction among reported adverse events, with low frequency and uncertain causality in some reports.
Routine laboratory abnormalities are not a characteristic feature of amlodipine therapy, and clinical trials did not show clinically significant changes in several routine laboratory parameters.
18. Use in Special Populations
Elderly: Start toward the lower end of the dosing range and increase cautiously. Elderly patients may have reduced clearance and increased drug exposure.
Hepatic impairment: Use a low starting dose when appropriate and titrate slowly, particularly in severe hepatic impairment.
Renal impairment: No routine dosage adjustment is generally required solely because of renal impairment. Amlodipine is not meaningfully removed by dialysis.
Pregnancy: Human pregnancy data are limited. Available post-marketing data are insufficient to establish a definitive drug-associated risk of major birth defects or miscarriage. Amlodipine should therefore be used during pregnancy only when the expected maternal benefit justifies potential risk and under appropriate medical supervision.
Breast-feeding: Amlodipine passes into human milk. Limited clinical lactation data have reported a median relative infant dose of approximately 4.2%, with no adverse effects observed in the reported breastfed infants; however, information remains limited. The decision to continue treatment while breastfeeding should be individualized with the healthcare professional.
Children: Oral amlodipine has demonstrated efficacy for hypertension in patients 6–17 years at doses of 2.5–5 mg once daily. Its effect in children younger than 6 years is not established in the cited labeling.
19. Storage Conditions
Store the product according to the storage instructions printed on the VASONORM package or official leaflet and protect the tablets from inappropriate heat, moisture, and other unsuitable storage conditions.
Keep the medicine out of the reach of children.
Because storage specifications can be formulation- and manufacturer-specific, the package labeling should take precedence over generalized storage recommendations.
20. Additional Sections
Overdose
Amlodipine overdose is expected to produce excessive peripheral vasodilation with marked hypotension and may cause reflex tachycardia. Severe poisoning may result in significant cardiovascular compromise.
Suspected overdose requires urgent medical evaluation and supportive cardiovascular and respiratory management. Hemodialysis is unlikely to be useful because amlodipine is highly protein bound.
The older statement that routine treatment should consist of gastric lavage and that overdose characteristically causes bradycardia is not an adequate general description of modern amlodipine poisoning management. Management should be directed by emergency/toxicology professionals according to the clinical presentation.
Laboratory Tests
No specific routine laboratory-test interference is established as a characteristic effect of amlodipine. Clinical studies did not demonstrate clinically significant changes in several common biochemical laboratory parameters.
Missed Dose
Take a missed dose when remembered unless it is close to the next scheduled dose. Do not take two doses at once. The patient-specific instructions supplied by the treating healthcare professional should take precedence.
21. Frequently Asked Questions (FAQ)
What is VASONORM?
VASONORM is a brand of amlodipine, a long-acting dihydropyridine calcium-channel blocker used principally for hypertension and angina.
What strengths of VASONORM are available in Egypt?
The currently identified Egyptian market presentations are 5 mg/10 tablets and 10 mg/10 tablets, manufactured by Pharco.
How often is amlodipine taken?
It is generally taken once daily, with or without food.
Does amlodipine require dose adjustment in kidney disease?
Usually not solely because of renal impairment, because renal dysfunction has little effect on amlodipine pharmacokinetics. Individual clinical circumstances still determine treatment.
Why do swollen ankles occur with amlodipine?
Peripheral edema is the most characteristic adverse reaction and is dose related. It results largely from arteriolar vasodilation and increased capillary hydrostatic pressure rather than simply from generalized sodium retention.
Can amlodipine be taken with other blood-pressure medicines?
Yes. Amlodipine may be used alone or in combination with other antihypertensive drugs when clinically appropriate. Specific combinations can require monitoring for excessive blood-pressure lowering or other interactions.
Can amlodipine be used during pregnancy or breastfeeding?
Use during pregnancy requires individualized medical assessment because human safety data remain limited. Amlodipine is present in breast milk, so breastfeeding decisions should also be individualized.
Does amlodipine treat an acute attack of chest pain?
Amlodipine is used for the treatment and prevention of chronic stable and vasospastic angina, but it should not be regarded as a substitute for emergency assessment or an established rapid-acting treatment for an acute coronary syndrome or sudden severe chest pain.
22. References
- DailyMed — Amlodipine Besylate Tablets, U.S. prescribing information, including indications, dosing, contraindications, warnings, adverse reactions, interactions, special populations, overdose, and pharmacokinetics. Current label information reviewed from versions updated through 2026.
- European Medicines Agency (EMA) — Amlodipine product information, including pharmacokinetics, elimination half-life, hepatic impairment, and once-daily administration.
- Electronic Medicines Compendium (emc) — Amlodipine 10 mg Tablets, Summary of Product Characteristics, including dosing, hepatic and renal impairment, interactions, pregnancy, lactation, and adverse effects.
- WHO — Hypertension, identifying amlodipine among calcium-channel blockers used for hypertension.
- Egyptian market/product sources for VASONORM, identifying Vasonorm 5 mg/10 tablets and Vasonorm 10 mg/10 tablets as Pharco products.