Dalfaz^® (Tablets) Instructions for Use

ATC Code

G04CA01 (Alfuzosin)

Active Substance

Alfuzosin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug used for urination disorders associated with benign prostatic hyperplasia. Alpha₁-adrenergic blocker

Pharmacotherapeutic Group

Alpha1-adrenergic blocker

Pharmacological Action

An alpha-adrenergic blocker acting primarily on postsynaptic α₁-adrenergic receptors. By blocking α₁-adrenergic receptors located in the trigone and sphincter of the bladder, and in the urethra, Alfuzosin relieves spasm of smooth muscle fibers, which leads to a reduction in resistance to urine outflow.

It reduces the tone of the smooth muscles of arteries and veins. It decreases total peripheral vascular resistance and systemic blood pressure.

Pharmacokinetics

After oral administration, Alfuzosin is absorbed from the gastrointestinal tract. The C_max in plasma is reached after 3 hours and is 10.3 ng/ml. The differences between maximum and minimum plasma concentrations are insignificant. Food intake does not affect absorption.

Plasma protein binding is about 90%. It is metabolized in the liver. The T_1/2 is 8 hours. 15-30% of inactive metabolites are excreted in the urine, 75-91% in the feces. 11% of alfuzosin is excreted unchanged in the urine.

In patients over 75 years of age, higher plasma concentrations and bioavailability of alfuzosin are observed (possibly due to reduced liver metabolism). In patients with severe renal impairment, an increase in the clearance of alfuzosin is observed (possibly due to lower plasma protein binding).

Indications

Treatment of functional manifestations of benign prostatic hyperplasia when surgical intervention is not possible, as well as in cases of progressive growth, especially in elderly patients.

ICD codes

Dosage Regimen

Administer Dalfaz^® tablets orally with a glass of water. Swallow the tablet whole; do not crush or chew.

The standard adult dosage is 2.5 mg three times daily. Maintain consistent intervals between doses.

For patients over 65 years of age, initiate therapy at a reduced dose of 2.5 mg twice daily, typically in the morning and evening.

If tolerated, the dose may be titrated upward based on clinical response. The maximum daily dose must not exceed 10 mg.

Monitor patients for therapeutic effect and signs of orthostatic hypotension, especially during the initial dose titration phase and in elderly patients.

Do not administer concurrently with other alpha₁-adrenergic blocking agents due to the risk of additive hypotensive effects.

For patients with severe renal impairment, use with caution and monitor closely. No specific dosage adjustment is provided, but increased sensitivity is possible.

Exercise particular caution in patients over 75 years of age due to potentially higher plasma concentrations. Adhere strictly to the recommended initial and maximum doses.

Adverse Reactions

From the digestive system epigastric pain, nausea, diarrhea; rarely – dry mouth.

From the central nervous system dizziness, headache; rarely – drowsiness.

From the cardiovascular system rarely – tachycardia, orthostatic hypotension.

Allergic reactions rarely – skin rash, itching.

Other malaise; rarely – edema, chest pain.

Contraindications

History of orthostatic hypotension, concurrent use of other alpha-adrenergic blockers, hypersensitivity to alfuzosin.

Use in Pregnancy and Lactation

The drug is not intended for use in women.

Use in Renal Impairment

Use with caution in patients with severe renal impairment.

Pediatric Use

The drug is not intended for use in children.

Geriatric Use

For patients over 65 years of age – the initial dose is 2.5 mg 2 times/day (in the morning and evening); subsequently, the dose may be increased (but not more than 10 mg/day).

Use with caution in patients over 75 years of age.

Special Precautions

Use with caution in patients with coronary artery disease, angina pectoris. If worsening of angina is observed, Alfuzosin should be discontinued.

Use with caution in patients over 75 years of age and in patients with severe renal impairment.

Drug Interactions

With the concurrent use of alfuzosin with antihypertensive agents (especially calcium channel blockers), a pronounced decrease in blood pressure is possible, up to the development of collapse.

With the concurrent use of alfuzosin with agents for general anesthesia, instability of blood pressure during anesthesia is likely.

It is incompatible with other alpha₁-adrenergic blockers.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.