Naftol50 mg

Naftol is indicated for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult men.

• Established/labeled use: Relief of voiding symptoms (weak urinary stream, hesitancy, incomplete bladder emptying) and storage symptoms (urgency, frequency, nocturia) caused by benign prostatic hyperplasia/benign prostatic obstruction.
• Mechanistic rationale for storage symptoms: Because of its relatively selective action on alpha-1D adrenoceptors (concentrated in the bladder and spinal cord) in addition to alpha-1A receptors in the prostate, Naftol is particularly useful when overactive-bladder-type storage symptoms accompany BPH.

Naftol does not reduce prostate size and is not a treatment for prostate cancer; it treats urinary symptoms only.

Not indicated for use in women or in children, since benign prostatic hyperplasia is a condition specific to the male prostate gland.

Each tablet contains Naftopidil as the active pharmaceutical ingredient. As marketed in Bangladesh, Naftopidil is available as oral tablets in 25 mg, 50 mg, and 75 mg strengths.

Naftol is an orally administered, uroselective alpha-1 adrenergic receptor antagonist used to relieve the urinary symptoms of benign prostatic hyperplasia (BPH). Unlike some other alpha-blockers that act mainly on the alpha-1A subtype, Naftol shows relatively greater affinity for the alpha-1D adrenoceptor subtype, which is abundant in the bladder detrusor muscle and spinal cord in addition to the prostate and urethra.

This dual alpha-1D/alpha-1A activity allows Naftol to relax smooth muscle in the bladder neck, prostate, and urethra to ease urine outflow, while also reducing bladder overactivity that contributes to urgency, frequency, and nocturia. It is available as 25 mg, 50 mg, and 75 mg tablets, usually taken once daily after a meal.

Alpha-1 Adrenergic Receptor Antagonist (uroselective alpha blocker used for BPH) - active ingredient Naftol

Mechanism of Action

Naftopidil is a selective antagonist of alpha-1 adrenergic receptors with relatively higher affinity for the alpha-1D subtype compared with the alpha-1A and alpha-1B subtypes. Alpha-1D receptors are densely expressed in the bladder detrusor muscle and spinal cord, while alpha-1A receptors predominate in the prostate and bladder neck.

By blocking these receptors, Naftopidil relaxes smooth muscle in the prostate, bladder neck, and urethra, reducing outflow resistance and improving urine flow. Its additional alpha-1D blockade is thought to reduce detrusor overactivity, improving bladder storage symptoms such as urgency, frequency, and nocturia.

Pharmacokinetics

• Absorption: Well absorbed after oral administration; food may affect absorption, so it is generally taken after meals.
• Protein binding: Highly bound to plasma proteins.
• Metabolism: Extensively metabolized in the liver, mainly via hydroxylation and glucuronidation pathways involving cytochrome P450 enzymes, including CYP3A4.
• Elimination: Metabolites are excreted mainly via the kidneys and, to a lesser extent, in feces.

Take Naftol tablets by mouth after a meal, swallowing the tablet whole with a full glass of water, at approximately the same time each day. Do not stop or change the dose without consulting a physician.

Naftol has the following clinically significant interactions:

• Other antihypertensive agents and PDE5 inhibitors (e.g., medicines for erectile dysfunction): concurrent use with Naftol can produce an additive blood-pressure-lowering effect, increasing the risk of symptomatic hypotension and dizziness; dose adjustment and monitoring may be needed.
• Other alpha-1 adrenergic blockers: concomitant use is generally avoided, as it may compound hypotensive effects without added benefit.
• Strong CYP3A4 inhibitors (e.g., certain antifungal agents): may increase plasma levels of Naftol, raising the risk of hypotension and other adverse effects; use with caution.
• Anticoagulants and NSAIDs/analgesics: caution is advised with concurrent use, as altered protein binding or additive effects have been reported; monitor for unusual bleeding or reduced efficacy of either drug.

Always inform your physician or pharmacist about all medicines, supplements, and herbal products being used before starting Naftol.

The most commonly reported side effects of Naftol include:

• Dizziness and lightheadedness
• Headache
• Tiredness/fatigue
• Blurred vision
• Stomach discomfort/gastrointestinal upset

Less commonly, orthostatic (postural) hypotension can occur, particularly after the first dose or a dose increase (see Precautions and Warnings). Report any severe dizziness, fainting, palpitations, or vision changes to your physician promptly.

Naftol is indicated only for men and is not intended for use in women; therefore, there are no established pregnancy or lactation safety data, and it should not be used during pregnancy or breastfeeding.

If Naftol is inadvertently taken by a woman who is pregnant or breastfeeding, a physician should be consulted promptly for guidance.

Orthostatic Hypotension

Naftol can cause a drop in blood pressure on standing, especially with the first dose or after a dose increase. Patients should rise slowly from sitting or lying positions, particularly elderly patients, and use caution when driving or operating machinery until they know how the medicine affects them.

Intraoperative Floppy Iris Syndrome (IFIS)

Patients currently taking or who have previously taken Naftol or other alpha-1 blockers may develop IFIS during cataract surgery. Inform your ophthalmologist about current or past use of Naftol before any planned cataract surgery.

Concurrent Antihypertensives / PDE5 Inhibitors

See Interactions - combining Naftol with other blood-pressure-lowering medicines or PDE5 inhibitors increases the risk of hypotension.

Not for Use in Women or Children

Naftol is approved only for BPH in adult men and is not indicated for women or children.

Prostate Cancer Screening

Naftol does not treat or prevent prostate cancer and does not reduce prostate size. PSA testing and appropriate evaluation for prostate cancer should be performed before starting and periodically during treatment, as clinically indicated.

Hepatic Impairment / Diabetes / Electrolyte Imbalance

Use with caution in patients with hepatic impairment (contraindicated if severe - see Contraindications), diabetes, or electrolyte imbalance, as these may increase the risk of syncope from sudden blood pressure drops.

Overdose with Naftol may cause pronounced hypotension, dizziness, and fainting due to excessive alpha-1 blockade. If overdose is suspected, seek immediate medical attention or contact a poison control center. Supportive care (such as keeping the patient supine to help restore blood pressure, and monitoring cardiovascular status) should be provided by medical professionals; do not attempt specific home treatment.

Store at room temperature (below 30°C), in a dry place, protected from light and moisture. Keep out of reach of children.

Elderly

Elderly patients are more susceptible to orthostatic hypotension with Naftol (see Precautions and Warnings); caution when standing is advised.

Hepatic Impairment

Caution and possible dose reduction in mild-to-moderate impairment; contraindicated in severe hepatic impairment (see Contraindications).

Renal Impairment

No dose adjustment is generally required.

Women

Naftol is not indicated for use in women (see Pregnancy and Lactation).

Children

Naftol is not indicated in children (see Pediatric Uses).

Treatment with Naftol for BPH-related urinary symptoms is usually long-term and individualized according to symptom response, tolerability, and periodic physician review; there is no fixed treatment duration.

Alpha-1 Adrenergic Receptor Antagonists; Urological/BPH agents (Naftopidil)

Naftopidil selectively blocks alpha-1D and alpha-1A adrenergic receptors in the prostate, bladder neck, urethra, and bladder detrusor muscle, relaxing smooth muscle tone to relieve BPH-related voiding and storage symptoms.

Naftol is not indicated for use in children. Benign prostatic hyperplasia is a condition of the adult male prostate gland and does not occur in the pediatric population, so the safety and efficacy of Naftol in children have not been established, and it should not be given to pediatric patients.