Amlodipine Uses, Dosage, Side Effects & Warnings | DrugsAtlas
Authoritative Clinical Reference
Navigation
Therapeutic Class
Antihypertensive / Antianginal Agent
Subclass
Dihydropyridine Calcium Channel Blocker (CCB)
Speciality
Cardiology
Schedule (India)
Schedule H
Routes
Oral
Formulations
- Tablets: 2.5 mg, 5 mg, 10 mg
Fixed-Dose Combinations (FDCs) Available:
- Amlodipine + Atenolol
- Amlodipine + Metoprolol
- Amlodipine + Losartan
- Amlodipine + Telmisartan
- Amlodipine + Olmesartan
- Amlodipine + Ramipril
- Amlodipine + Lisinopril
- Amlodipine + Atorvastatin
- Amlodipine + Hydrochlorothiazide
- Amlodipine + Cilnidipine (dual CCB)
Adult indications
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Hypertension
| Parameter | Dose |
|---|---|
|
Starting dose
|
5 mg orally once daily |
|
Titration
|
Increase to 10 mg after 1–2 weeks if BP target not achieved |
|
Usual maintenance dose
|
5–10 mg once daily |
|
Maximum dose
|
10 mg once daily |
Clinical Notes:
- First-line antihypertensive option per ICMR Hypertension Guidelines 2020
- Can be taken at any time of day (morning or evening); once-daily dosing due to long half-life (~35–50 hours)
- Start at 2.5 mg in elderly, low body weight patients, or those with hepatic impairment
- Effective as monotherapy or in combination with ACE inhibitors, ARBs, thiazides, or beta-blockers
- Particularly useful in patients with concurrent diabetes, CKD (no dose adjustment needed), or isolated systolic hypertension in elderly
2. Chronic Stable Angina Pectoris
| Parameter | Dose |
|---|---|
|
Starting dose
|
5 mg orally once daily |
|
Titration
|
Increase to 10 mg after 7–14 days based on anginal frequency and BP response |
|
Usual maintenance dose
|
5–10 mg once daily |
|
Maximum dose
|
10 mg once daily |
Clinical Notes:
- Reduces myocardial oxygen demand by decreasing afterload (peripheral vasodilation)
- Can be used as monotherapy or added to beta-blockers/nitrates
- Do not discontinue abruptly — may precipitate rebound angina
- Preferred CCB in angina patients with LV dysfunction (compared to non-dihydropyridines)
3. Vasospastic (Prinzmetal's/Variant) Angina
| Parameter | Dose |
|---|---|
|
Starting dose
|
5 mg orally once daily |
|
Titration
|
Increase to 10 mg after 7–14 days if spasm frequency not controlled |
|
Usual maintenance dose
|
5–10 mg once daily |
|
Maximum dose
|
10 mg once daily |
Clinical Notes:
- Calcium channel blockers are first-line treatment for vasospastic angina
- Long-acting dihydropyridines (amlodipine, nifedipine ER) preferred over short-acting agents
- May be combined with nitrates for refractory cases
- Avoid beta-blockers as monotherapy in vasospastic angina (may worsen spasm)
Secondary Indications – Adults (Off-label)
| Indication | Dose | Duration | Supervision | Evidence Basis |
|---|---|---|---|---|
|
Raynaud's Phenomenon (OFF-LABEL)
|
Starting: 2.5–5 mg once daily; Maintenance: 5–10 mg once daily | Long-term; seasonal use in some patients | Specialist recommended (Rheumatology) | Case series; international guidelines; Indian specialist practice |
|
Hypertension in Pregnancy (2nd–3rd Trimester) (OFF-LABEL)
|
Starting: 2.5 mg once daily; Maintenance: 2.5–5 mg once or twice daily; Maximum: 10 mg/day | During pregnancy as needed | Specialist only (Obstetrics) | Increasing Indian obstetric practice; limited RCT data; not first-line |
|
Chronic Kidney Disease with Hypertension (as add-on to ACEI/ARB) (OFF-LABEL as specific indication)
|
5–10 mg once daily | Long-term | Not required | ACCOMPLISH trial; ICMR guidelines support CCB + ACEI/ARB combination; protects renal function |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
⚠️ Limited data in children below 6 years of age. Use only under paediatric cardiology or nephrology supervision in younger children.
Primary Indication: Hypertension in Children
Weight-Based Dosing (Children ≥6 years):
| Weight / Age | Starting Dose | Titration | Maximum Dose |
|---|---|---|---|
|
6–17 years, <20 kg
|
0.05–0.1 mg/kg once daily | Increase based on BP response after 2–4 weeks | 0.3 mg/kg/day (maximum 5 mg/day) |
|
6–17 years, ≥20 kg
|
2.5 mg once daily | Increase to 5 mg after 2–4 weeks if needed | 5 mg/day (up to 10 mg/day in adolescents under specialist guidance) |
| Parameter | Dose |
|---|---|
|
Starting dose
|
0.05–0.1 mg/kg/day OR 2.5 mg once daily (whichever appropriate) |
|
Titration
|
Increase after 2–4 weeks based on BP response |
|
Usual maintenance dose
|
2.5–5 mg once daily |
|
Maximum dose
|
5 mg/day (10 mg/day in adolescents ≥30 kg under specialist care) |
Safety Monitoring:
- Blood pressure (seated and standing if age-appropriate)
- Heart rate
- Peripheral oedema
- Growth parameters
Clinical Notes:
- Once-daily dosing improves adherence in children
- Tablets may need to be compounded for accurate low-dose administration in small children
- Monitor for reflex tachycardia and peripheral oedema
Secondary Indications – Paediatrics (Off-label)
| Indication | Age | Dose | Duration | Supervision | Evidence Basis |
|---|---|---|---|---|---|
|
Post-operative Hypertension (Cardiac Surgery) (OFF-LABEL)
|
≥1 year | 0.05–0.1 mg/kg once daily; Maximum 0.3 mg/kg/day or 5 mg | Short-term | Specialist only (Paediatric Cardiology/PICU) | Case series; paediatric cardiac surgery protocols |
|
Hypertensive Crisis (Oral Step-down) (OFF-LABEL)
|
≥6 years | 0.1–0.2 mg/kg once daily | After IV stabilisation | Specialist only (PICU/Nephrology) | Hospital protocols; IAP guidance |
Age Restrictions:
- Not recommended below 6 years of age except under specialist supervision
- Use in infants (below 1 year) only in exceptional circumstances with paediatric cardiology input
Renal Adjustments
No dose adjustment required in renal impairment.
| Renal Function | Recommendation |
|---|---|
|
Mild to Severe Impairment (all eGFR levels)
|
No dose adjustment required |
|
Haemodialysis
|
No supplemental dose required; amlodipine is not dialysable (high volume of distribution, high protein binding) |
|
Peritoneal Dialysis
|
No dose adjustment required |
Note: Amlodipine is preferred in CKD patients as it does not require renal dose adjustment and provides effective BP control. Often combined with ACE inhibitors/ARBs for renoprotection.
Hepatic adjustment
Contraindications
- Known hypersensitivity to amlodipine or other dihydropyridine CCBs
- Severe hypotension (SBP <90 mmHg)
- Cardiogenic shock
- Haemodynamically significant aortic stenosis (risk of worsening coronary perfusion)
- Unstable angina (as monotherapy without beta-blocker)
- Acute myocardial infarction with haemodynamic instability or pulmonary oedema
Cautions
- Heart failure (NYHA Class III–IV) — may use with caution in stable compensated HF; avoid in decompensated HF
- Severe left ventricular dysfunction (LVEF <40%) — initiate at low dose with close monitoring
- Elderly patients — increased sensitivity to hypotensive effects; start low
- Low body weight patients — consider starting at 2.5 mg
- Hepatic impairment — reduced clearance; start low
- Concurrent use with strong CYP3A4 inhibitors — may increase amlodipine levels
- Aortic stenosis (non-severe) — use with caution
- Hypertrophic cardiomyopathy with outflow obstruction
- Sick sinus syndrome (without pacemaker) — use with caution
- Patients prone to peripheral oedema
Pregnancy
| Parameter | Information |
|---|---|
|
Overall Safety
|
Limited human data; not officially approved for pregnancy; classified as Category C equivalent |
|
Risk
|
Theoretical risk of reduced uterine blood flow with hypotension; no confirmed teratogenicity |
|
Preferred Alternatives
|
Labetalol (first-line for chronic hypertension in pregnancy); Nifedipine ER (most commonly used CCB in pregnancy); Methyldopa |
|
When Use May Be Justified
|
Second/third trimester when labetalol or nifedipine not tolerated; postpartum hypertension; obstetric specialist supervision required |
|
Monitoring
|
Maternal blood pressure; fetal growth (if prolonged use); signs of maternal hypotension |
Lactation
| Parameter | Information |
|---|---|
|
Compatibility
|
Likely compatible; limited human data but expected low infant exposure based on pharmacokinetic properties |
|
Expected Drug Level in Milk
|
Low (highly protein-bound; large volume of distribution) |
|
Preferred Alternatives
|
Nifedipine ER (more breastfeeding safety data); Labetalol; Methyldopa |
|
Infant Monitoring
|
Drowsiness, feeding difficulties, hypotension (theoretical; rarely observed) |
|
Recommendation
|
May continue if already established on amlodipine with good BP control and no infant effects observed |
Elderly
| Parameter | Recommendation |
|---|---|
|
Starting dose
|
2.5 mg orally once daily |
|
Titration
|
Increase gradually (every 2–4 weeks) based on BP response and tolerability |
|
Maximum recommended
|
10 mg once daily |
|
Increased Risks
|
Postural hypotension, falls, peripheral oedema (often prominent), cognitive fluctuations in frail individuals |
|
Additional Precautions
|
Monitor standing BP in first few weeks; assess for oedema at each visit; consider bedtime dosing if postural symptoms occur; excellent choice for isolated systolic hypertension common in elderly |
Major drug interactions
| Interacting Drug | Mechanism | Effect | Management |
|---|---|---|---|
|
Strong CYP3A4 Inhibitors (ketoconazole, itraconazole, clarithromycin, erythromycin, ritonavir)
|
Inhibit amlodipine metabolism | Significantly increased amlodipine levels; enhanced hypotensive effect | Monitor BP closely; consider dose reduction to 2.5–5 mg; avoid if possible or use alternatives |
|
Simvastatin (>20 mg/day)
|
CYP3A4 inhibition by amlodipine increases simvastatin exposure | Increased risk of simvastatin-induced myopathy and rhabdomyolysis |
Limit simvastatin to ≤20 mg/day when combined with amlodipine; consider alternative statin (atorvastatin, rosuvastatin)
|
|
Cyclosporine
|
Reduced CYP3A4 metabolism | Increased cyclosporine levels and nephrotoxicity risk | Monitor cyclosporine levels; may need dose adjustment |
|
Tacrolimus
|
Reduced CYP3A4 metabolism | Increased tacrolimus levels | Monitor tacrolimus levels when initiating or adjusting amlodipine |
|
Dantrolene (IV)
|
Unknown mechanism | Risk of cardiovascular collapse reported with CCBs |
Avoid IV dantrolene with amlodipine if possible
|
Moderate drug interactions
| Interacting Drug | Effect | Management |
|---|---|---|
|
Strong CYP3A4 Inducers (rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's Wort)
|
Reduced amlodipine levels and efficacy | Monitor BP; may need to increase amlodipine dose or use alternative antihypertensive |
|
Beta-blockers
|
Additive effects on heart rate and BP | Commonly used combination; monitor for excessive bradycardia or hypotension |
|
Other Antihypertensives (ACE inhibitors, ARBs, diuretics)
|
Additive hypotensive effect | Often intentional combination; monitor BP; adjust doses as needed |
|
Sildenafil, Tadalafil (PDE5 inhibitors)
|
Additive hypotensive effect | Use with caution; counsel patient on potential hypotension; avoid if SBP <90 mmHg |
|
Lithium
|
Potential for lithium toxicity (mechanism unclear; possibly volume-related) | Monitor lithium levels if used concurrently |
|
Grapefruit Juice
|
CYP3A4 inhibition in gut wall | May increase amlodipine levels modestly; advise moderation |
|
NSAIDs
|
May reduce antihypertensive efficacy; fluid retention | Monitor BP; use lowest NSAID dose for shortest duration |
|
Digoxin
|
No significant pharmacokinetic interaction | No adjustment needed; safe combination |
Common Adverse effects
- Peripheral oedema (dose-related; most common; up to 10% at 10 mg)
- Headache
- Flushing
- Dizziness
- Fatigue, asthenia
- Palpitations
- Nausea
- Abdominal pain
- Somnolence/drowsiness
Note: Peripheral oedema is caused by precapillary arteriolar vasodilation (not fluid retention); it is dose-related and often improves with addition of ACE inhibitor/ARB or by lowering the dose.
Serious Adverse effects
| Adverse Effect | Clinical Action |
|---|---|
|
Severe Hypotension
|
Reduce dose or discontinue; supportive care with IV fluids; patient should lie down with legs elevated |
|
Worsening Heart Failure (in predisposed patients)
|
Discontinue; cardiology evaluation; diuretics and standard HF management |
|
Angioedema (rare)
|
Discontinue permanently; emergency management if airway compromise |
|
Hepatotoxicity (rare; usually cholestatic pattern)
|
Monitor LFTs if symptoms (jaundice, pruritus, fatigue); discontinue if significant elevation |
|
Severe Bradycardia (rare; usually with concurrent beta-blocker or non-DHP CCB)
|
Reduce dose or discontinue offending agent; assess for conduction disease |
|
Gingival Hyperplasia (rare; with prolonged use)
|
Maintain oral hygiene; may require drug discontinuation if severe |
|
Erythema Multiforme / Exfoliative Dermatitis (very rare)
|
Discontinue immediately; dermatology consultation |
Monitoring requirements
| Timing | Parameters |
|---|---|
|
Baseline
|
Blood pressure (sitting and standing if elderly); heart rate; assessment for oedema; hepatic function if suspected liver disease |
|
After initiation / dose change (2–4 weeks)
|
Blood pressure; heart rate; peripheral oedema assessment; symptoms of hypotension (dizziness, fatigue) |
|
Long-term (every 3–6 months)
|
Blood pressure; heart rate; peripheral oedema; LFTs if symptoms of hepatic dysfunction; adherence assessment |
|
Special Situations
|
Monitor more frequently in elderly, hepatic impairment, or when initiating/stopping interacting drugs |
Brands in India
Monotherapy:
- Amlong™ (Micro Labs) — 2.5 mg, 5 mg, 10 mg
- Amlodac™ (Zydus) — 2.5 mg, 5 mg, 10 mg
- Stamlo™ (Dr. Reddy's) — 2.5 mg, 5 mg, 10 mg
- Amlopin™ (USV) — 2.5 mg, 5 mg, 10 mg
- Amlokind™ (Mankind) — 5 mg, 10 mg
- Amlopres™ (Cipla) — 2.5 mg, 5 mg, 10 mg
- Amlod™ (Lupin) — 5 mg, 10 mg
Fixed-Dose Combinations (Examples):
- Amlong-A™ (Amlodipine + Atenolol)
- Stamlo-Beta™ (Amlodipine + Metoprolol)
- Amlopress-AT™ (Amlodipine + Atenolol)
- Amlodac-L™ (Amlodipine + Losartan)
- Telma-AM™ (Amlodipine + Telmisartan)
- Olmy-AM™ (Amlodipine + Olmesartan)
- Cardace-AM™ (Amlodipine + Ramipril)
- Amlostat™ (Amlodipine + Atorvastatin)
- Cilacar-A™ (Amlodipine + Cilnidipine)
Price range (INR)
| Formulation | Price Range | Notes |
|---|---|---|
| 2.5 mg tablet | ₹0.50–₹2.00 per tablet | — |
| 5 mg tablet | ₹0.80–₹3.00 per tablet | NLEM listed |
| 10 mg tablet | ₹1.50–₹6.00 per tablet | — |
| FDCs | ₹3–₹15 per tablet | Variable based on combination |
Regulatory: Listed under NLEM 2022 (5 mg tablet); NPPA price controlled for scheduled strengths; widely available in government supply
Clinical pearls
- First-line choice in many settings — Amlodipine is one of the most widely prescribed antihypertensives in India due to once-daily dosing, effectiveness, low cost, and safety across diverse populations including diabetics, elderly, and CKD patients
- Peripheral oedema management — Oedema is dose-related and due to precapillary vasodilation (not fluid overload); it often improves with addition of ACE inhibitor/ARB (causes venodilation and reduces capillary hydrostatic pressure); diuretics are not effective for this indication
- Long half-life advantage — Half-life of ~35–50 hours provides smooth 24-hour BP control and forgiving pharmacokinetics if a dose is missed; steady state achieved in 7–8 days
- Simvastatin dose cap — Always limit simvastatin to ≤20 mg/day when combined with amlodipine; consider switching to atorvastatin or rosuvastatin (no dose restriction) if higher statin intensity needed
- Do not abruptly discontinue in angina — Sudden withdrawal may precipitate rebound angina or ischaemia; taper gradually if discontinuation required
- Hepatic impairment dosing — Start at 2.5 mg in patients with liver disease; half-life significantly prolonged; titrate slowly
Version
RxIndia v1.0 — 26 May 2025
Reference
- CDSCO Product Information
- Indian Pharmacopoeia (IP)
- National List of Essential Medicines (NLEM) 2022
- API Textbook of Medicine
- ICMR Guidelines for Management of Hypertension 2020
- AIIMS Drug Formulary and Treatment Protocols
- IAP Guidelines for Paediatric Hypertension
- Harrison's Principles of Internal Medicine
- Goodman & Gilman's The Pharmacological Basis of Therapeutics
- ACCOMPLISH Trial (CCB + ACEi combination evidence)
- Indian hospital protocols (AIIMS, CMC Vellore)
⚖️
Clinical Responsibility
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
Content Feedback
Is this information helpful?
Help us improve our clinical database for the medical community.