Schedule H

Oral

• Prolonged-release tablets: 2.5 mg, 5 mg, 10 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Essential Hypertension (Mild to Moderate)

Parameter Details

Starting dose 5 mg once daily in the morning

Titration Adjust after 2–4 weeks based on BP response; may reduce to 2.5 mg if hypotensive or increase if inadequate control

Usual maintenance dose 5–10 mg once daily

Maximum dose 10 mg once daily

Key clinical notes Prolonged-release tablets must be swallowed whole — do not crush, break, or chew. Administer in the morning. Lower starting dose (2.5 mg) recommended in elderly or hepatic impairment.

1. Chronic Stable Angina (Effort-Induced)

Parameter Details

Starting dose 5 mg once daily

Titration May increase to 10 mg once daily after 2–4 weeks if symptom control inadequate and drug tolerated

Usual maintenance dose 5–10 mg once daily

Maximum dose 10 mg once daily

Key clinical notes Generally considered second-line when beta-blockers are not tolerated or contraindicated. Not suitable for acute angina or unstable cardiac states.

Secondary Indications — Adults (Off-label)

Not commonly used off-label in India. No established off-label indications with adequate evidence basis.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable — Felodipine is not approved for use in patients below 18 years. No approved paediatric formulations available in India.

Secondary Indications — Paediatrics (Off-label)

Hypertension (OFF-LABEL)

• Dose: 0.1–0.2 mg/kg once daily (maximum 10 mg/day)

• Duration: Chronic use with regular review

• Specialist only: Paediatric cardiologist or nephrologist supervision mandatory

• Evidence basis: Limited data; extrapolated from adult pharmacology and small international studies; not validated in Indian paediatric population

Monitoring: Blood pressure, heart rate, peripheral oedema, flushing, headache

Age restriction statement: Not recommended below 18 years except under paediatric cardiologist supervision in exceptional circumstances where other antihypertensives are unsuitable.

Mild to moderate impairment No dose adjustment required

• Known hypersensitivity to felodipine or other dihydropyridine CCBs

• Severe hepatic impairment

• Decompensated heart failure

• Haemodynamically significant aortic stenosis

• Unstable angina pectoris

• Acute myocardial infarction (within first 1 month)

• Cardiogenic shock

• Pregnancy

• Heart failure with preserved ejection fraction — may worsen peripheral oedema

• Severe hypotension (systolic BP <90 mmHg)

• Sick sinus syndrome (if pacemaker not in situ)

• Mild to moderate hepatic impairment — start at lower dose

• Elderly patients — increased susceptibility to hypotensive effects

• Concurrent use with CYP3A4 inhibitors or inducers

• Gingival hyperplasia with long-term use — advise regular dental care

• Concomitant therapy with beta-blockers — additive haemodynamic effects

Parameter Details

Safety status Contraindicated — animal studies demonstrate embryotoxicity and fetotoxicity; no adequate human data

Risk Potential teratogenic effects; risk of fetal harm

Preferred alternatives Labetalol, methyldopa, nifedipine (extended-release) — established safety in Indian obstetric practice

When may be used Not recommended at any stage of pregnancy

Monitoring If inadvertent exposure: detailed fetal anomaly scan; switch to safer alternative immediately; specialist obstetric consultation

Parameter Details

Compatibility Not recommended — excretion into human breast milk unknown

Preferred alternatives Nifedipine, amlodipine (with monitoring) — more safety data available

Expected levels in milk Unknown

Infant monitoring If unavoidable exposure: monitor infant for poor feeding, lethargy, hypotension

Recommendation Avoid breastfeeding during treatment or consider alternative antihypertensive

• Recommended starting dose: 2.5 mg once daily

• Titration: Slow upward titration; increase only if well tolerated after 2–4 weeks

• Additional risks: Enhanced hypotensive response, orthostatic hypotension, increased fall risk (especially with polypharmacy), reduced renal perfusion. Age-related decline in hepatic function may reduce drug clearance.

• Monitoring: Regular BP monitoring including orthostatic measurements; assess for peripheral oedema and dizziness

Interacting Drug Effect / Mechanism Recommendation

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) Marked increase in felodipine plasma levels — risk of severe hypotension Avoid combination or reduce felodipine dose significantly

Grapefruit juice Potent CYP3A4 inhibition — can increase felodipine levels 2–3 fold Strictly avoid grapefruit consumption

CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, phenobarbital) Substantially reduced felodipine efficacy Monitor BP closely; may require dose increase or alternative antihypertensive

Ciclosporin Increased felodipine levels; possible increase in ciclosporin levels Avoid combination or use with close monitoring

Interacting Drug Effect / Mechanism Recommendation

Beta-blockers Additive hypotensive and negative inotropic effects Monitor BP and heart rate; generally beneficial combination but avoid in decompensated heart failure

Diltiazem / Verapamil CYP3A4 inhibition; additive cardiac effects Monitor for excessive bradycardia and hypotension

Other antihypertensives (ACEIs, ARBs, diuretics) Cumulative BP lowering effect Monitor for symptomatic hypotension

Digoxin Possible modest increase in digoxin levels Monitor digoxin levels if clinically indicated

NSAIDs (chronic use) May attenuate antihypertensive effect Monitor BP; avoid prolonged NSAID use

Erythromycin Moderate CYP3A4 inhibition Monitor for increased felodipine effect

Cimetidine Increased felodipine bioavailability Monitor BP; consider dose adjustment

• Headache

• Flushing

• Peripheral oedema (dose-related; ankle swelling)

• Dizziness

• Palpitations

• Fatigue

• Gingival hyperplasia (with prolonged use)

• Severe hypotension or syncope — requires dose reduction or discontinuation

• Angina exacerbation or new-onset chest pain at therapy initiation — warrants evaluation

• Hypersensitivity reactions including angioedema (rare) — immediate discontinuation required

• Tachyarrhythmias including atrial fibrillation (rare)

• Hepatic dysfunction with transaminase elevation (rare) — discontinue if significant

• Cardiac decompensation in at-risk patients

Action required: Immediate discontinuation for severe hypotension, angioedema, or cardiac decompensation.

After initiation/dose change BP and heart rate weekly for first 2–4 weeks; assess for oedema and dizziness

Long-term BP at each visit; periodic assessment (6–12 monthly) for peripheral oedema, gingival changes, LFTs if prolonged use

Single-ingredient formulations:

• Plendil® (AstraZeneca)

• Flodil® (Cipla)

• Felogard® (Torrent)

• Vasodura® (Elder)

• Fediprime® (Wockhardt)

• Felod® (Alkem)

Note: All formulations available as prolonged-release tablets only.

• Not listed under NLEM; prices not NPPA-controlled

• Considerable inter-brand price variation

1. Extended-release formulation only: Felodipine is available only as prolonged-release tablets in India — must be swallowed whole. Breaking or crushing destroys the release mechanism and may cause dose dumping.

1. Better reflex tachycardia profile: Compared to immediate-release nifedipine, felodipine causes less reflex tachycardia due to gradual onset of action.

1. Grapefruit interaction: Strictly counsel patients to avoid grapefruit juice — can increase plasma levels 2–3 fold, leading to significant hypotension.

1. Peripheral oedema management: Oedema is dose-related and due to precapillary vasodilation. Adding an ACEI or ARB can help mitigate this effect by reducing postcapillary pressure.

1. Not for acute use: Gradual onset makes felodipine unsuitable for acute BP lowering or hypertensive emergencies.

1. Gingival hyperplasia prevention: Advise good oral hygiene and regular dental review during long-term use to prevent or detect gingival overgrowth early.

hypertension; calcium channel blocker; dihydropyridine; angina; extended-release; CYP3A4 substrate; hepatic-avoid; pregnancy-contraindicated; elderly-caution; grapefruit-avoid

RxIndia v1.0 — 11 Jun 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia

• National Formulary of India (NFI)

• API Textbook of Medicine, 11th Edition

• AIIMS Drug Formulary

• Goodman & Gilman's The Pharmacological Basis of Therapeutics, 13th Edition

• Harrison's Principles of Internal Medicine (supportive reference)

• Indian tertiary hospital clinical practice protocols