UNIPROST 4/MG TAB 20/TAB

Indications

Approved Uses

Benign Prostatic Hyperplasia (BPH), Hypertension.

Off-Label Uses

Medical expulsive therapy for ureteral stones (selected patients); PTSD-associated nightmares (limited evidence, less established than prazosin).

Dosage & Administration

Dosing by Condition

Benign Prostatic Hyperplasia (BPH): initial: 1 mg once daily
titration: Increase to 2 mg, then 4 mg, then 8 mg once daily at 1-2 week intervals as needed/tolerated
maintenance: 2-8 mg once daily
max: 8 mg/day, Hypertension: initial: 1 mg once daily
titration: Increase to 2 mg, 4 mg, 8 mg, then up to 16 mg once daily at 1-2 week intervals as needed/tolerated
maintenance: 2-16 mg once daily
max: 16 mg/day

Initial Dose

1 mg once daily (evening) for both BPH and hypertension

Maintenance Dose

2-8 mg once daily for BPH; 2-16 mg once daily for hypertension

Maximum Dose

8mg daily for BPH; 16mg daily for hypertension

Childrens Dosage

Not approved for children.

Dose Adjustment Notes

Titrate slowly (typically at 1-2 week intervals) to minimize postural hypotension; first dose and dose increases preferably at bedtime; if therapy is interrupted for several days, restart at 1 mg once daily and re-titrate; use caution in hepatic impairment (consider lower starting dose/slow titration).

How to Take

Swallow tablet whole with water; may be taken with or without food; take once daily at the same time each day; the first dose and any dose increase should preferably be taken at bedtime to reduce first-dose/postural hypotension.

Side Effects

Common Side Effects

Dizziness, headache, fatigue/asthenia, somnolence (drowsiness), orthostatic hypotension, peripheral edema, nasal congestion/rhinitis, nausea.

Side Effect Frequency

Common (1-10%): dizziness, headache, somnolence, fatigue/asthenia, postural (orthostatic) hypotension, peripheral edema, nausea; Uncommon (<1%): syncope, palpitations/tachycardia, angina, priapism, rash

Safety & Warnings

Contraindications

Contraindicated in hypersensitivity to doxazosin/other quinazolines; use is contraindicated for BPH in patients with bladder outlet obstruction with complications such as upper urinary tract congestion/retention, chronic UTI, or bladder stones (per product-class labeling).

Warnings & Precautions

Key precautions: first-dose and dose-escalation orthostatic hypotension/syncope (start low, often bedtime dosing); caution in hepatic impairment; inform ophthalmologist before cataract surgery (IFIS); evaluate for prostate cancer before treating LUTS/BPH; additive hypotension with other BP-lowering drugs.

Age Restriction

Not routinely recommended/approved for patients <18 years; pediatric use only under specialist direction (off-label).

Drug Interactions

Drug Interactions

Clinically significant interactions: PDE-5 inhibitors (additive hypotension); other antihypertensives/vasodilators (additive BP lowering); strong CYP3A4 inhibitors (may increase exposure-monitor/titrate); other alpha-blockers (additive hypotension).

Interaction Severity

"MAJOR: PDE-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) - additive vasodilation may cause symptomatic hypotension/syncope (separate dosing and start low).
MODERATE: Other antihypertensives/diuretics - additive blood pressure lowering; Strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole/itraconazole, ritonavir) - may increase doxazosin exposure and hypotension risk.
MINOR: NSAIDs may blunt antihypertensive response in some patients."

Food Interaction

May be taken with or without food (immediate-release tablets).

Special Populations

Children

Not approved for children.

Kidney Impairment

No renal dose adjustment required.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered unless it is close to the next dose; if close, skip and resume the regular schedule-do not double doses; if several days are missed, contact the prescriber as re-initiation may need restarting at 1 mg.

Stopping the Medicine

Do not stop abruptly without prescriber advice; if therapy is interrupted for several days, restart at 1 mg and re-titrate.

Overdose

Expected toxicity: marked hypotension/syncope (± reflex tachycardia); management is supportive-supine positioning with leg elevation, IV fluids, vasopressors if needed; dialysis is unlikely to help due to high protein binding.

Patient Counseling

Take the first dose and any dose increase at bedtime to reduce the risk of dizziness or fainting. Rise slowly from sitting or lying positions to avoid lightheadedness. Avoid driving or operating machinery until you know how this medication affects you. Avoid alcohol as it can worsen dizziness and low blood pressure. Inform your eye surgeon that you are taking this medication before any cataract surgery. Do not stop taking this medication without consulting your doctor. Report any episodes of fainting, prolonged or painful erection, or severe dizziness immediately.

Monitoring Requirements

Monitor blood pressure (sitting/standing) and symptoms of orthostatic hypotension especially at initiation and dose changes; monitor for edema; consider liver function monitoring/clinical caution in hepatic impairment.

Pharmacology

Mechanism of Action

Competitive antagonism of postsynaptic alpha-1 adrenergic receptors in vascular smooth muscle and in the prostate/bladder neck, causing vasodilation (↓ peripheral resistance/BP) and reduced urinary outflow resistance (improved LUTS).

Onset of Action

Blood pressure lowering begins within ~1-2 hours with peak effect about 2-6 hours after a dose; improvement in BPH symptoms may take days to weeks (often ~1-2 weeks).

Duration of Effect

24 hours.

Half-Life

Approximately 19-22 hours (about 22 hours).

Bioavailability

Approximately 60-70% (commonly cited ~65%).

Metabolism

Extensive hepatic metabolism, primarily via CYP3A4 (with minor contributions from other pathways), producing inactive metabolites.

Excretion

Primarily fecal (63%) and urine (9%) as metabolites.

Protein Binding

Approximately 98% (highly protein bound, mainly to albumin and alpha-1-acid glycoprotein)

Product Information

Available Dosage Forms

Immediate-release tablet

Composition per Dose

Each tablet: 4 mg doxazosin (as doxazosin mesylate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Urological Condition

BPH

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