Amlodipine Schedule (India)

Schedule H

Amlodipine Routes

Oral

Amlodipine 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)

Amlodipine Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

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

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)

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

Amlodipine 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

Amlodipine Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation
Haemodialysis	No supplemental dose required; amlodipine is not dialysable (high volume of distribution, high protein binding)
Peritoneal dialysis	No dose adjustment required
eGFR (ml/min/1.73m²)	Recommendation

Amlodipine 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

Note: Amlodipine is extensively hepatically metabolised; elimination half-life increases to ~60 hours in hepatic impairment.

Amlodipine 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

Amlodipine 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

Amlodipine 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

Amlodipine 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

Amlodipine 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

Amlodipine 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

Amlodipine 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

Amlodipine 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.

Amlodipine 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

Amlodipine 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

Amlodipine 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)

Amlodipine Price range (INR)

Formulation	Approximate Price (per tablet)

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

Amlodipine 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

Amlodipine Tags

hypertension; calcium-channel-blocker; CCB; dihydropyridine; angina; vasospastic-angina; renal-safe; NLEM-India; elderly-suitable; diabetic-hypertension; peripheral-oedema; Schedule-H

Amlodipine Version

RxIndia v1.0 — 26 May 2025

Amlodipine 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)

RxIndia

The Drug Registry

Amlodipine