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Amlodipine Uses, Dosage, Side Effects & Warnings | DrugsAtlas

Authoritative Clinical Reference

Drug Name: Amlodipine

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

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

Severity	Recommendation
Mild impairment	No dose adjustment required; monitor BP closely
Moderate impairment	Start with 2.5 mg once daily; titrate slowly based on BP response
Severe impairment (Cirrhosis)	Start with 2.5 mg once daily; titrate very cautiously; half-life significantly prolonged; consider specialist input

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)

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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.

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