LODIPAM 10/MG FC TAB 30/TAB

Indications

Approved Uses

Hypertension, chronic stable angina, vasospastic angina (Prinzmetal's angina), angiographically documented coronary artery disease

Off-Label Uses

Raynaud’s phenomenon.

Dosage & Administration

Dosing by Condition

Hypertension (adults): 5 mg once daily initially; maintenance 5-10 mg once daily; max 10 mg/day. Chronic stable angina/vasospastic angina: 5-10 mg once daily; max 10 mg/day. Coronary artery disease: 5-10 mg once daily.

Initial Dose

5 mg once daily

Maintenance Dose

5-10 mg once daily

Maximum Dose

10mg once daily.

Children's Dosage

For hypertension in children 6-17 years: 2.5mg to 5mg once daily. Doses above 5mg have not been studied.

Dose Adjustment Notes

Elderly and hepatic impairment: consider lower initial dose (e.g., 2.5 mg once daily) and titrate slowly every 7-14 days based on response/tolerability; renal impairment: no dose adjustment generally required.

How to Take

Swallow tablet whole with a glass of water. Can be taken with or without food. Take at the same time each day.

Side Effects

Common Side Effects

Swelling of legs and ankles (edema), headache, dizziness, flushing, fatigue, nausea, abdominal pain, sleepiness, palpitations.

Side Effect Frequency

Very common: peripheral edema. Common: headache, dizziness, flushing, palpitations, fatigue, nausea, abdominal pain, somnolence. Uncommon: hypotension/syncope, dyspnea/rhinitis, dyspepsia/vomiting, rash/pruritus/alopecia/purpura, mood changes/insomnia/tremor, myalgia/arthralgia/muscle cramps/back pain, urinary frequency/nocturia, impotence/gynecomastia, weight changes.

Safety & Warnings

Contraindications

Known hypersensitivity to amlodipine (including amlodipine besilate) or other dihydropyridine calcium channel blockers (and/or any excipients).

Warnings & Precautions

Key warnings/precautions: risk of worsening angina/MI when starting or increasing dose in severe obstructive CAD; use caution in severe aortic stenosis; use caution in heart failure; use caution and titrate slowly in hepatic impairment; monitor for hypotension and peripheral edema; discontinue only under medical supervision (especially if treated for angina).

Age Restriction

Hypertension: approved for children ≥6 years (6-17 years); not established/approved <6 years. Angina/CAD: not established/approved in pediatrics (<18 years).

Driving Warning

No specific warning; may cause dizziness.

Drug Interactions

Drug Interactions

Clinically relevant interactions include: strong/moderate CYP3A4 inhibitors (e.g., clarithromycin, azoles, ritonavir) ↑ amlodipine exposure; CYP3A4 inducers (e.g., rifampin, St. John’s wort) ↓ exposure; simvastatin-limit simvastatin to max 20 mg/day with amlodipine; tacrolimus/cyclosporine-may ↑ calcineurin inhibitor levels (monitor/adjust); additive hypotension with other antihypertensives and PDE5 inhibitors. NSAIDs are not a specific major interaction for amlodipine (any BP effect is generally more relevant to ACEi/diuretics).

Interaction Severity

MAJOR/clinically significant: strong/moderate CYP3A4 inhibitors (e.g., clarithromycin, azole antifungals, ritonavir/cobicistat) → increased amlodipine exposure/hypotension risk. MODERATE: simvastatin (limit simvastatin to 20 mg/day with amlodipine), tacrolimus/cyclosporine (levels may increase-monitor and adjust), diltiazem/verapamil (increase amlodipine levels/additive BP effects). MINOR: CYP3A4 inducers (e.g., rifampin, St. John’s wort) may reduce effect; additive hypotension with other antihypertensives/PDE5 inhibitors (monitor).

Food Interaction

May be taken with or without food; grapefruit/grapefruit juice may increase amlodipine exposure-avoid or limit, especially if adverse effects (e.g., hypotension, edema) occur.

Special Populations

Pregnancy

Consult Doctor

Children

For hypertension in children 6-17 years: 2.5mg to 5mg once daily. Doses above 5mg have not been studied.

Elderly

Start at a lower dose of 2.5mg once daily and titrate slowly due to decreased clearance and increased drug exposure.

Kidney Impairment

No renal dose adjustment required; not significantly removed by dialysis.

Liver Impairment

Hepatic impairment: start at a lower dose (commonly 2.5 mg once daily) and titrate slowly; use caution especially in severe impairment due to prolonged half-life.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the time of the next dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop without prescriber advice; abrupt discontinuation is not typically associated with rebound hypertension, but in angina/CAD patients stopping suddenly may worsen angina-tapering/clinical supervision is prudent.

Overdose

Overdose may cause marked peripheral vasodilation with severe/prolonged hypotension (± reflex tachycardia) and shock; management is supportive (airway/IV fluids, vasopressors as needed), consider activated charcoal if recent ingestion, IV calcium may help; continuous cardiac/hemodynamic monitoring; amlodipine is not effectively removed by dialysis.

Patient Counseling

Take once daily at the same time, with or without food; do not stop without prescriber advice; expect possible ankle swelling, flushing, headache, dizziness-rise slowly and report troublesome edema or symptoms of hypotension; avoid/limit grapefruit; inform clinicians about interacting medicines (e.g., macrolides/azoles/ritonavir, simvastatin, tacrolimus/cyclosporine).

Monitoring Requirements

Monitor blood pressure (and clinical symptoms such as dizziness) and assess for peripheral edema; routine lab monitoring is not required in most patients, but consider liver function/clinical monitoring in hepatic impairment and monitor interacting drugs when applicable (e.g., tacrolimus/cyclosporine levels).

Pharmacology

Mechanism of Action

Dihydropyridine calcium-channel blocker that inhibits L-type calcium influx predominantly in vascular smooth muscle, causing peripheral and coronary arterial vasodilation and reduced peripheral vascular resistance (BP lowering).

Onset of Action

Gradual onset; peak plasma concentrations occur about 6-12 hours after a dose, with full antihypertensive effect typically developing over ~1-2 weeks after initiation or dose change.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

30-50 hours.

Bioavailability

64-90%.

Metabolism

Extensively metabolized in the liver, primarily via CYP3A4, to inactive metabolites.

Excretion

Renal (~60% as metabolites, ~10% unchanged), fecal (~20-25%)

Product Information

Available Dosage Forms

Film-coated tablet (oral)

Composition per Dose

Each film-coated tablet: 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

CCB

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