NORMALIX SR 1.5MG/30TAB

Indications

Approved Uses

Essential hypertension (for this product: indapamide 1.5 mg modified-release).

Off-Label Uses

Adjunct in heart failure-related fluid overload (off-label depending on jurisdiction) and secondary stroke prevention as part of antihypertensive regimens (e.g., indapamide-based BP lowering); nephrogenic diabetes insipidus is a recognized class off-label use but is less commonly used with indapamide specifically.

Dosage & Administration

Dosing by Condition

Hypertension: 1.5 mg modified-release orally once daily in the morning (this product).

Initial Dose

1.5 mg once daily in the morning for hypertension

Maintenance Dose

1.5 mg once daily for hypertension

Maximum Dose

1.5 mg once daily (modified-release) for this product

Children's Dosage

Not approved for children.

Dose Adjustment Notes

No routine titration for indapamide 1.5 mg modified-release; avoid dose escalation of SR for BP control-add another antihypertensive if needed; avoid/use with great caution in severe renal impairment and severe hepatic impairment (risk of encephalopathy) and monitor closely in elderly.

How to Take

Swallow whole with water; do not crush, chew, or split the modified-release tablet; take preferably in the morning

Side Effects

Common Side Effects

Electrolyte disturbances (especially hypokalemia, hyponatremia), dizziness, headache, fatigue, orthostatic hypotension; may increase uric acid (hyperuricemia/gout) and cause GI upset (nausea).

Side Effect Frequency

Common (1-10%): dizziness, headache; electrolyte disturbances such as hypokalemia can occur (frequency varies by dose/population). Uncommon (<1%): nausea/vomiting, rash/pruritus/photosensitivity. Rare/very rare: pancreatitis, significant arrhythmias/QT prolongation (usually secondary to electrolyte imbalance).

Safety & Warnings

Contraindications

Hypersensitivity to indapamide or sulfonamide-derived drugs; severe renal impairment/anuria; hepatic encephalopathy or severe hepatic impairment; hypokalemia

Warnings & Precautions

Monitor electrolytes (Na+, K+) and renal function, especially elderly or those on digoxin/QT-prolongers; correct hypokalemia to reduce arrhythmia risk; caution in hepatic impairment (encephalopathy risk); caution in gout/hyperuricemia and diabetes (may worsen uric acid/glucose); avoid dehydration and monitor with NSAIDs/RAAS blockers; photosensitivity and sulfonamide allergy precautions; counsel to seek urgent care for sudden eye pain/vision changes (angle-closure glaucoma)

Age Restriction

Not approved under 18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Lithium (↑ lithium levels/toxicity); NSAIDs (↓ antihypertensive/diuretic effect, ↑ renal risk); other antihypertensives (additive hypotension); ACE inhibitors/ARBs (first-dose hypotension/renal function changes especially if volume-depleted); digoxin (hypokalemia ↑ toxicity); systemic corticosteroids/laxatives (↑ hypokalemia); QT-prolonging/antiarrhythmic drugs (torsades risk if hypokalemia); iodinated contrast (AKI risk if dehydrated); metformin (lactic acidosis risk in dehydration/renal impairment)

Interaction Severity

MAJOR: Lithium (increased lithium levels/toxicity). MODERATE: NSAIDs (reduced antihypertensive/diuretic effect and renal risk), digoxin (toxicity risk if hypokalemia), other QT-prolonging/arrhythmogenic drugs when hypokalemia present (torsades risk), systemic corticosteroids/laxatives (additive hypokalemia).

Food Interaction

No restriction.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children.

Elderly

Standard adult dosing (1.5 mg once daily); monitor electrolytes and renal function more frequently due to increased risk of hyponatremia and hypokalemia

Kidney Impairment

No dose adjustment in mild-moderate renal impairment with monitoring; contraindicated in severe renal impairment/anuria (often operationalized as CrCl/eGFR <30 mL/min)

Liver Impairment

Mild-to-moderate hepatic impairment: use with caution, monitor closely. Severe hepatic impairment or hepatic encephalopathy: contraindicated

Storage & Patient Advice

Storage Conditions

Store below 30°C

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next dose, skip the missed dose; do not double.

Stopping the Medicine

Do not stop abruptly without clinician advice; stopping may lead to loss of blood-pressure control (monitor BP after discontinuation)

Overdose

Symptoms: hypotension, dehydration, nausea/vomiting, dizziness/confusion, polyuria/oliguria, and electrolyte disturbances (hyponatremia, hypokalemia) with possible arrhythmias; Management: urgent medical care, supportive treatment with IV fluids and electrolyte correction, ECG monitoring, and decontamination (activated charcoal) if early

Patient Counseling

Take once daily in the morning; swallow modified-release tablet whole (do not crush/chew); expect increased urination early; rise slowly to reduce dizziness; maintain hydration; avoid excess alcohol; attend periodic blood tests for electrolytes/renal function; report muscle weakness/cramps, palpitations, severe dizziness, or gout symptoms.

Monitoring Requirements

Monitor BP; serum electrolytes (Na+, K+ ± Mg2+), renal function (SCr/eGFR) at baseline and periodically; uric acid (and glucose in patients at risk/diabetes).

Pharmacology

Mechanism of Action

Thiazide-like diuretic: inhibits NaCl reabsorption in the distal convoluted tubule (cortical diluting segment), increasing natriuresis/diuresis; also reduces peripheral vascular resistance via direct vascular effects.

Onset of Action

Diuretic effect begins within hours; blood pressure-lowering effect may be seen within several days to 1 week, with maximal antihypertensive effect typically achieved over 4-8 weeks.

Duration of Effect

Diuretic/antihypertensive effect provides approximately 24-hour coverage with once-daily modified-release dosing.

Half-Life

Approximately 14-25 hours (effective terminal half-life; may be described as biphasic).

Bioavailability

High oral absorption; absolute bioavailability is high (commonly reported around >90% for indapamide immediate-release; SR has high absorption with modified release of drug).

Metabolism

Extensively metabolized in the liver to inactive metabolites.

Excretion

Primarily renal (~70% of dose in urine, mainly as metabolites) with the remainder via feces (~20-25%).

Protein Binding

Approximately 79% protein binding (mainly to plasma proteins, including albumin).

Product Information

Available Dosage Forms

Modified-release tablet (this product).

Composition per Dose

Each modified-release tablet: 1.5 mg indapamide

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

Diuretic

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