HARNAL D Tamsulosin Hydrochloride 200mcg Tablet 1's
RXDRUG-DR-XY34109-1pc
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Features
Brand
Harnal D
Full Details
Dosage Strength
200 mcg
Drug Ingredients
- Tamsulosin
Drug Packaging
Tablet 1's
Generic Name
Tamsulosin Hydrochloride
Dosage Form
Tablet
Registration Number
DR-XY34109
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
For bladder outlet obstruction associated with benign prostatic hyperplasia.
Dosage/Direction for Use
The recommended adult oral dosage is 200 mcg of tamsulosin hydrochloride once daily after meals.
The dosage may be adjusted depending on the patient's age and symptoms or as prescribed by the physician.
The dosage may be adjusted depending on the patient's age and symptoms or as prescribed by the physician.
Administration
Should be taken with food: Place on the tongue & allow to dissolve. Then, swallow w/ saliva or water. Do not chew/crush.
Contraindications
Patients with known hypersensitivity to this drug or any of its components.
Special Precautions
Careful Administration (Harnal D Tablet should be administered with care in the following patients.)
Patients with orthostatic hypotension (Symptoms may be exacerbated).
Patients with serious hepatic dysfunction (Plasma drug concentrations may be increased).
Patients with severe renal dysfunction (An increase in plasma drug concentrations may result)(see Pharmacology: Pharmacokinetics under Actions).
The elderly patients (see Use is Elderly as follows).
Patients with a past history of severe hypersensitivity to sulfonamide (An allergic reaction may occur).
Important Precautions: The tablet disintegrates in the mouth, but is not absorbed through the oral mucosa. Therefore, the patients should be instructed to swallow the dissolved tablet with saliva or a drink of water.
Use with caution concerning dosage and administration. Overdosage may cause a decrease in blood pressure.
Blood pressure in the orthostatic position may decrease. Patients must be watched for any changes in blood pressure occurring with postural change.
The drug does not eliminate the cause of the disease, but gives symptomatic relief. If the expected response does not result, surgical therapy or other alternative procedures should be considered.
Since this product may induce the symptoms such as dizziness, patients should be cautioned against performing hazardous activities, such as working at altitudes or driving a car.
Before the start of treatment, patients should be asked whether they are taking any antihypertensive drugs. If any such drugs are used, blood pressure during treatment should be monitored closely. If a decrease in blood pressure is observed, the treatment should be discontinued, or other appropriate measures taken.
Intraoperative floppy iris syndrome (IFIS, a variant of small pupil syndrome) considered to be due to α1-blocking action has been observed during cataract and glaucoma surgery in some patients on or previously treated with tamsulosin.
Ophthalmologists should be aware of possible occurrence of IFIS during cataract and glaucoma surgery.
Use in Elderly: The elderly are more likely to have a renal dysfunction. Such patients should be carefully monitored. If efficacy is not noted at 200 mcg, the dose should not be increased further, and other appropriate measures must be taken.
Patients with orthostatic hypotension (Symptoms may be exacerbated).
Patients with serious hepatic dysfunction (Plasma drug concentrations may be increased).
Patients with severe renal dysfunction (An increase in plasma drug concentrations may result)(see Pharmacology: Pharmacokinetics under Actions).
The elderly patients (see Use is Elderly as follows).
Patients with a past history of severe hypersensitivity to sulfonamide (An allergic reaction may occur).
Important Precautions: The tablet disintegrates in the mouth, but is not absorbed through the oral mucosa. Therefore, the patients should be instructed to swallow the dissolved tablet with saliva or a drink of water.
Use with caution concerning dosage and administration. Overdosage may cause a decrease in blood pressure.
Blood pressure in the orthostatic position may decrease. Patients must be watched for any changes in blood pressure occurring with postural change.
The drug does not eliminate the cause of the disease, but gives symptomatic relief. If the expected response does not result, surgical therapy or other alternative procedures should be considered.
Since this product may induce the symptoms such as dizziness, patients should be cautioned against performing hazardous activities, such as working at altitudes or driving a car.
Before the start of treatment, patients should be asked whether they are taking any antihypertensive drugs. If any such drugs are used, blood pressure during treatment should be monitored closely. If a decrease in blood pressure is observed, the treatment should be discontinued, or other appropriate measures taken.
Intraoperative floppy iris syndrome (IFIS, a variant of small pupil syndrome) considered to be due to α1-blocking action has been observed during cataract and glaucoma surgery in some patients on or previously treated with tamsulosin.
Ophthalmologists should be aware of possible occurrence of IFIS during cataract and glaucoma surgery.
Use in Elderly: The elderly are more likely to have a renal dysfunction. Such patients should be carefully monitored. If efficacy is not noted at 200 mcg, the dose should not be increased further, and other appropriate measures must be taken.
Adverse Reactions
NOTE: Harnal Capsule and Harnal D Tablet are bioequivalent (see Pharmacology: Pharmacokinetics: Bioequivalence under Actions).
Adverse reactions (including abnormal clinical laboratory values) appeared in 104 cases (2.2%) out of 4,724 used for the analysis of safety at the time of approval and during post-marketing surveillance for Harnal Capsules. The most frequently observed adverse reactions were dizziness and stomach discomfort (at the end of the Harnal Capsules re-examination period).
Clinically significant adverse reactions: Syncope/unconsciousness (Incidence unknown): As transient unconsciousness or etc. may appear with the decrease of blood pressure, the patient should be observed carefully. If such reactions are observed during treatment, discontinue treatment and institute appropriate medical therapy.
Hepatic dysfunction or jaundice (Incidence unknown): As increases of AST (GOT), ALT (GPT), or jaundice may appear, the patient should be observed carefully. If such reactions are observed during treatment, appropriate measures such as drug discontinuation should be taken.
Other adverse reactions: (See Table 5.)
Adverse reactions (including abnormal clinical laboratory values) appeared in 104 cases (2.2%) out of 4,724 used for the analysis of safety at the time of approval and during post-marketing surveillance for Harnal Capsules. The most frequently observed adverse reactions were dizziness and stomach discomfort (at the end of the Harnal Capsules re-examination period).
Clinically significant adverse reactions: Syncope/unconsciousness (Incidence unknown): As transient unconsciousness or etc. may appear with the decrease of blood pressure, the patient should be observed carefully. If such reactions are observed during treatment, discontinue treatment and institute appropriate medical therapy.
Hepatic dysfunction or jaundice (Incidence unknown): As increases of AST (GOT), ALT (GPT), or jaundice may appear, the patient should be observed carefully. If such reactions are observed during treatment, appropriate measures such as drug discontinuation should be taken.
Other adverse reactions: (See Table 5.)
Drug Interactions
[Precautions for coadministration] (Harnal D Tablet should be administered with care when coadministered with the following drugs.)
Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6 (see Pharmacology: Pharmacokinetics under Action). (See Table 6.)
Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6 (see Pharmacology: Pharmacokinetics under Action). (See Table 6.)
Caution For Usage
Caution in dispensing: Patients should be instructed to press the tablet out of a press-through package (PTP) and take it. [It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, resulting in severe complications such as medias tinitis].
Caution in oral administration: Patients should be instructed not to chew the Harnal D Tablet. Prolonged release particles of tamsulosin hydrochloride are contained in the tablet.
Crushing or chewing the tablet may destroy the prolonged release particles and may cause changes in pharmacokinetics (see Pharmacology: Pharmacokinetics under Actions).
The tablet can be soaked in saliva on the tongue, lightly mashed between the tongue and hard palate, and then swallowed with saliva alone.
The tablet should not be taken without water if the patient is lying down.
Caution in oral administration: Patients should be instructed not to chew the Harnal D Tablet. Prolonged release particles of tamsulosin hydrochloride are contained in the tablet.
Crushing or chewing the tablet may destroy the prolonged release particles and may cause changes in pharmacokinetics (see Pharmacology: Pharmacokinetics under Actions).
The tablet can be soaked in saliva on the tongue, lightly mashed between the tongue and hard palate, and then swallowed with saliva alone.
The tablet should not be taken without water if the patient is lying down.
Storage
Store at temperatures not exceeding 25°C.
Action
Pharmacology: Effects in humans: In a receptor binding assay using human prostate preparations, tamsulosin hydrochloride was 2.2 times more potent than prazosin hydrochloride and 40 times more so than phentolamine mesylate in α1-receptor blocking activity.
Effects in animals: Blockade of α-adrenergic receptors: In a receptor binding assay using isolated rat cerebral membrane and an in vitro experiment using isolated rabbit aorta, tamsulosin hydrochloride inhibited α1-receptors selectively and competitively. Its action was 1/2.2 to 22 times more potent than prazosin hydrochloride and 45 to 140 times more potent than phentolamine mesylate.
In vitro experiments using isolated rabbit aorta, isolated rat vas deferens and isolated guinea pig intestine, tamsulosin hydrochloride proved to be 5,400 to 24,000 times more selective for α1-receptors than for α 2-receptors.
Effect on the lower urinary tract (urethra and urinary bladder) and prostate: In a receptor binding assay using isolated smooth muscle from the rabbit urethra, prostate and urinary bladder base, tamsulosin hydrochloride was 23 to 98 times more potent than prazosin hydrochloride in α1-receptor blocking activity, and 87 to 320 times more potent than phentolamine mesylate. In anesthetized dogs, the drug inhibited the α1-agonist (phenylephrine)-induced increase in intrauretheral pressure with 13 times greater potency than the increase in diastolic blood pressure.
Improvement of bladder outlet obstruction: In anesthetized male dogs, tamsulosin hydrochloride decreased urethral pressure in the prostatic zone of the intraurethral pressure curve. In anesthetized rats, however, the drug did not affect rhythmic bladder contraction or threshold intravesical pressure.
Pharmacodynamics: Mechanism of Action: Tamsulosin hydrochloride decreases urethral pressure in the prostatic zone of the intraurethral pressure curve by inhibiting α1-receptors in the urethra and prostate, thus improving bladder outlet obstruction associated with benign prostatic hyperplasia.
Clinical studies: Tamsulosin hydrochloride significantly decreased intraurethral pressure in the prostatic urethra, and improved urinary flow rate and residual urine volume in a dose-dependent manner. The evaluation results of overall improvement in 309 cases are presented in the following table. Results of a double-blind comparative study showed that Harnal Capsule administered in a 0.2 mg once daily dose was clinically useful in easing the symptoms of benign prostatic hyperplasia. (See Table 2.)
Effects in animals: Blockade of α-adrenergic receptors: In a receptor binding assay using isolated rat cerebral membrane and an in vitro experiment using isolated rabbit aorta, tamsulosin hydrochloride inhibited α1-receptors selectively and competitively. Its action was 1/2.2 to 22 times more potent than prazosin hydrochloride and 45 to 140 times more potent than phentolamine mesylate.
In vitro experiments using isolated rabbit aorta, isolated rat vas deferens and isolated guinea pig intestine, tamsulosin hydrochloride proved to be 5,400 to 24,000 times more selective for α1-receptors than for α 2-receptors.
Effect on the lower urinary tract (urethra and urinary bladder) and prostate: In a receptor binding assay using isolated smooth muscle from the rabbit urethra, prostate and urinary bladder base, tamsulosin hydrochloride was 23 to 98 times more potent than prazosin hydrochloride in α1-receptor blocking activity, and 87 to 320 times more potent than phentolamine mesylate. In anesthetized dogs, the drug inhibited the α1-agonist (phenylephrine)-induced increase in intrauretheral pressure with 13 times greater potency than the increase in diastolic blood pressure.
Improvement of bladder outlet obstruction: In anesthetized male dogs, tamsulosin hydrochloride decreased urethral pressure in the prostatic zone of the intraurethral pressure curve. In anesthetized rats, however, the drug did not affect rhythmic bladder contraction or threshold intravesical pressure.
Pharmacodynamics: Mechanism of Action: Tamsulosin hydrochloride decreases urethral pressure in the prostatic zone of the intraurethral pressure curve by inhibiting α1-receptors in the urethra and prostate, thus improving bladder outlet obstruction associated with benign prostatic hyperplasia.
Clinical studies: Tamsulosin hydrochloride significantly decreased intraurethral pressure in the prostatic urethra, and improved urinary flow rate and residual urine volume in a dose-dependent manner. The evaluation results of overall improvement in 309 cases are presented in the following table. Results of a double-blind comparative study showed that Harnal Capsule administered in a 0.2 mg once daily dose was clinically useful in easing the symptoms of benign prostatic hyperplasia. (See Table 2.)
Pharmacokinetics: Plasma concentration: When a single dose of Harnal D 200 mcg Tablet or Harnal 200 mcg Capsule is orally administered to healthy male adults using a cross-over method, the plasma concentration of unchanged tamsulosin hydrochloride is shown as follows. (See Figure 1 and Table 3.)
The plasma concentration of the unchanged drug reached its peak 7 to 8 h after a single oral administration of 0.1 to 0.6 mg Harnal Capsule to healthy male adults.
The half-life was 9.0 to 11.6 h. The Cmax and AUC increased in a nearly dose dependent manner. In a 7-day repeated oral administration study, the half-life was slightly prolonged and plasma concentrations reached a steady state on day 4. (See Table 4.)
The half-life was 9.0 to 11.6 h. The Cmax and AUC increased in a nearly dose dependent manner. In a 7-day repeated oral administration study, the half-life was slightly prolonged and plasma concentrations reached a steady state on day 4. (See Table 4.)
Harnal 0.2 mg Capsule was orally administered to 11 patients with renal dysfunction. Their blood pressure did not decrease, but an increase in the plasma concentration of tamsulosin hydrochloride was observed in 2 patients with serious renal impairment. The plasma concentrations of the drug were intimately correlated with an increase in the plasma concentration of α1-AGP (α1-acid glycoprotein).
This increase in the plasma concentration of the drug may be caused by the binding of the tamsulosin hydrochloride to plasma α1-AGP. However, the plasma concentration of the unbound drug, which is presumed to be directly related to the appearance of the effects and adverse reactions of tamsulosin hydrochloride, was almost the same for these patients as for persons with normal renal function, regardless of the plasma concentration of α1-AGP.
Metabolism: In vitro experiments show Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6.
Excretion: Single doses of Harnal Capsule at 0.1 to 0.6 mg were orally administered to healthy male adults. The excretion rate of the unchanged drug in the urine up to 30 h after administration remained almost constant at 12 to 14%. No significant changes in the excretion rate after repeated administrations were observed.
Bioequivalence: When Harnal D Tablet or Harnal Capsule was orally administered to humans, the plasma concentration-time profile of the unchanged drug was almost equivalent between the two formulations, demonstrating their bioequivalence.
Drug Interaction: PK studies in healthy volunteers revealed that concomitant administration with strong inhibitors of CYP3A4 or CYP2D6 may lead to an increased exposure to tamsulosin. Concomitant administration with ketoconazole (a known CYP3A4 inhibitor) resulted in a Cmax and AUC of tamsulosin that had increased by a factor of 2.2 and 2.8, respectively. Concomitant administration with paroxetine (a known CYP2D6 inhibitor) resulted in a Cmax and AUC of tamsulosin that had increased by a factor of 1.3 and 1.6, respectively.
This increase in the plasma concentration of the drug may be caused by the binding of the tamsulosin hydrochloride to plasma α1-AGP. However, the plasma concentration of the unbound drug, which is presumed to be directly related to the appearance of the effects and adverse reactions of tamsulosin hydrochloride, was almost the same for these patients as for persons with normal renal function, regardless of the plasma concentration of α1-AGP.
Metabolism: In vitro experiments show Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6.
Excretion: Single doses of Harnal Capsule at 0.1 to 0.6 mg were orally administered to healthy male adults. The excretion rate of the unchanged drug in the urine up to 30 h after administration remained almost constant at 12 to 14%. No significant changes in the excretion rate after repeated administrations were observed.
Bioequivalence: When Harnal D Tablet or Harnal Capsule was orally administered to humans, the plasma concentration-time profile of the unchanged drug was almost equivalent between the two formulations, demonstrating their bioequivalence.
Drug Interaction: PK studies in healthy volunteers revealed that concomitant administration with strong inhibitors of CYP3A4 or CYP2D6 may lead to an increased exposure to tamsulosin. Concomitant administration with ketoconazole (a known CYP3A4 inhibitor) resulted in a Cmax and AUC of tamsulosin that had increased by a factor of 2.2 and 2.8, respectively. Concomitant administration with paroxetine (a known CYP2D6 inhibitor) resulted in a Cmax and AUC of tamsulosin that had increased by a factor of 1.3 and 1.6, respectively.
MedsGo Class
Drugs for Bladder & Prostate Disorders
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