Naftol®

Prescribing Details



Description

Naftol is a preparation of Naftopidil which is a selective a1 adrenergic receptor antagonist with higher antagonistic effect on am receptor. It works by relieving smooth muscle tension in urethra and prostate gland so urine is passed more easily. It also suppresses the overactivity of detrusor muscle.


Uses

No Data


Indications

Naftol is indicated in the treatment of benign prostatic obstruction and benign prostatic hyperplasia (BPH) associated lower urinary tract symptoms (LUTS). It does not decrease the size of the prostate.


Dosage and administration

Route of administration:

Naftol® should be taken orally after meal. Swallow it as a whole without crushing or chewing it.
In general, for adults, start with Naftol 25 once a day. If the effect is insufficient, the dosage may be gradually increased to 50 to 75 mg once a day at intervals of 1 to 2 weeks. The dosage may be adjusted according to age or symptoms. The maximum daily dose is 75 mg.

 

Hepatic impairment

Dosage adjustment may be required in severe hepatic impairment as this can affect the metabolism of the drug.

 

Renal impairment
Dosage adjustment is not required in patients with renal impairment.


Use in pregnancy & lactation

Pregnancy: There are no well controlled studies of pregnant women exposed to naftopidil of a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.


Lactation: There are no data on the presence of this combination in human milk, the effects on the breastfed infant, or the effects on milk production.


Use in children and adolescents
Safety and effectiveness have not been established in patients below 18 years of age.


Geriatric use
No Data

Precautions

Caution should be taken in patients with salt imbalance or orthostatic hypotension and diabetes before taking the medication. This medicine should be used with caution due to the increased risk of temporary loss of consciousness caused by a sudden decrease in the blood pressure.


Side effects

The most common side effects are dizziness, headache, tiredness, blurry vision and stomach discomfort.


Contraindications

It is contraindicated in patients with history of known hypersensitivity to naftopidil or any other components of this product.


Drug interactions

Drug interaction with medication:

Concomitant use of naftopidil with pain killers, blood thinner, medicines used for rheumatoid arthritis, antianxiety medicine, antifungals can cause some side effects.


Overdose

In case of overdose, treatment should be symptomatic and supportive measures instituted as required.


Preparation

No Data


Pharmaceutical precautions

No Data


Presentation

Naftol 25 tablet: Each tablet contains Naftopidil INN 25 mg.
Naftol 50 tablet: Each tablet contains Naftopidil INN 50 mg.
Naftol 75 tablet: Each tablet contains Naftopidil INN 75 mg.


Package quantities

Overdose
In case of overdose, treatment should be symptomatic and supportive measures instituted as required.

Storage
Store below 30'C in a dry place, protected from light. Keep away from the reach of childrenNaftol 25 tablet: Carton of 30 tablets in blister pack.

Naftol 50 tablet: Carton of 30 tablets in blister pack.

Naftol 75 tablet: Carton of 20 tablets in blister pack.