Harnal Ocas 0.4mg Astellas supports the treatment of benign prostate hyperplasia (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Tamsulosin hydrochloride

Ingredient

Composition information	Content
Tamsulosin hydrochloride	0.4mg

Uses

Indications

Harnal OCAS 0.4mg is indicated in case of symptomatic treatment of the lower urinary tract (Luts) involving benign prostate hyperplasia (BPH).

Pharmacokic

receptor antagonist α1 - adrenergic.

ATC code: G04C A02. Preparations specializing in treating prostate diseases.

Mechanism of action: tamsulosin selectively connects and competes with receptors α1 - adrenergic after synap, especially with α1A subgroup. Tamsulosin relaxes the prostate smooth muscles and the urethra.

Pharmacological effect

Harnal Ocas tablets increase the maximum flow rate of urine. It reduces congestion by relaxing smooth muscles in the prostate and urethra thus improving the excretory symptoms.

The drug improves the symptoms of urinary retention in which bladder instability plays an important role.

These effects on urinary and excretory symptoms are maintained during long -term treatment. The need for surgery or significantly slowed catheter.

Adrenergic receptor antagonists can reduce blood pressure by reducing peripheral resistance. No observations of hypotension have any clinical significance in studies with Harnal OCAS tablets 0.4mg.

The population of children

A double, random, placebuarded study, different doses performed in children with neurological bladder disease. A total of 161 children (aged from 2 - 16) are randomly selected and treated at 1 of the three levels of tamsulosin (low (0.001-0.002mg/kg), average (0.002 - 0.004mg/kg), high (0.004 - 0.008mg/kg)), or placebo.

The end point is that the number of patients with reducing muscle pressure of the bladder at the urination (LPP)

pharmacokinetic

absorption

Harnal OCAS 0.4mg is a slow -release tablet belonging to the non -ion gel group. The OCAS formula creates a slow tamsulosin release, resulting in a complete absorption of 24 hours with a small oscillation. Tamsulosin is used in the form of Harnal Ocas tablets absorbed from the intestine, in hunger, about 57% of the dose is estimated to be absorbed.

The ratio and absorption level of Tamsulosin Hydrochlorid when taking Harnal Ocas tablets is not affected by low -fat meals. The level of absorption increased by 64% and 149% (corresponding to AUC, CMAX) with a meal rich in fat compared to hunger.

tamsulosin obeys linear pharmacokinetics.

After taking a single dose of Harnal Ocas in a state of hunger, Tamsulosin's peak concentration in plasma is achieved at an average time of 6 hours. In a stable state achieved on the 4th of the multi -dose use, the peak concentration of Tamsulosin in plasma is reached from 4 to 6 hours, in hunger and after eating. Peak concentration in plasma increases from 6ng/ml after the first dose to 11ng/ml in a stable state.

As a result of the slow release of Harnal Ocas tablets, the lowest concentration in the plasma of Tamsulosin is about 40% of the peak plasma concentration in hunger and after eating.

There is a significant change in plasma concentrations in each patient after single and multi -dose use.

Distribution

In humans, Tamsulosin is attached to plasma proteins about 99%. Small distribution volume (about 0.2L/kg).

Biological Change

tamsulosin has a low liver effect, slowly metabolized.

Most of the Tamsulosin in plasma is in the form of a constant active ingredient.

tamsulosin is metabolized in the liver.

In mice, it is difficult to find any liver enzyme induction in microsom due to tamsulosin.

There is no substance in the metabolites that are more active than the original compound.

In vitro results show that CYP3A4 as well as CYP2D6 are all involved in the transformation process, with a small part of Tamsulosin hydrochloride can be metabolized by other ISOZes CYP, inhibiting the enzyme metabolism CYP3A4 and CYP2D6 can lead to increased Tamsulosin hydrochloride concentration

Elimination

tamsulosin and its metabolites are mainly eliminated in urine. The amount of excretion in the form of constant active ingredients is estimated at 4-6% of the dose, when using the Harnal Ocas tablet.

After taking a single dose of Harnal Ocas and in a stable state, the sale time is measured about 19 hours and 15 hours, respectively.

Before taking Harnal Ocas 0.4mg Astellas supports the treatment of benign prostate hyperplasia (3 blisters x 10 tablets)

How to use

use Harnal Ocas by oral. Harnal Ocas tablets can be used regardless of food. Must swallow the tablet, do not be crushed or chewed because this hinders the slow release of the active ingredient.

Dosage

1 tablet daily.

No dose adjustments in patients with renal failure.

No dose adjustment in patients with mild to medium liver failure (see the contraindications).

There is no related indication for the use of Harnal Ocas tablets in children.

Safety and effectiveness of tamsulosin in children

What to do when overdose?

Symptoms

The overdose of Tamsulosin Hydrochlorid can cause severe hypotension. The effect of heavy hypotension has been observed at different levels of overdose.

Treatment

In the case of acute hypotension after an overdose, cardiovascular support is required. Blood pressure can recover and return to normal heart by letting patients rest. If ineffective should compensate and use vasodilators when needed. Need to monitor kidney function and apply general support measures. The subordinates are not necessarily useful because Tamsulosin is very strong with plasma proteins.

Measures such as vomiting can be used to prevent absorption. When overdose in large amounts, gastric lavage can be applied and active carbon and can be used by mercy like sodium sulphate.

What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not take twice the dose of Harnal Ocas 0.4mg specified.

Side Effects

There may be some side effects when using Harnal Ocas:

Meddra's classical system group

or meet
(> 1/100,

1/100) rare
(> 1/10000,

Very rare

( (1.3%)
headache faint Stand Vomiting Tinh

Penis pain is reported while the drug is circulated on the market. These events are voluntarily reported from a certain size of the population, so it is not estimated that the frequency of the events is not estimated.
vision disorders: blurred vision, vision impairment.
In cataract surgery and glaucoma, the small pupils are called mushy iris syndrome in surgery (IFIS) associated with tamsulosin treatment during after -sales tracking (see the warning and prudent section especially when in use).
Skin and subcutaneous tissue disorders: Pottery dermatitis, diverse erythematosus.
respiratory disorders, chest and mediastinum: nosebleeds.
In addition to the harmful reactions listed above, atrial fibrillation, arrhythmia, tachycardia and shortness of breath, reported in a combination of drugs using Tamsulosin. However, the role of Tamsulosin in the cause of the above reactions cannot be determined firmly.
Notify the doctor with unwanted effects when using the drug.

Warnings

Contraindicated

Harnal Ocas 0.4mg contraindicated in the following cases:

Hypersensitivity to Tamsulosin Hydrochloride, including medication or hypersensitivity with any component of excipients.

Precautions when taking drugs

Read the instructions carefully before use. If you need more information, please consult your doctor.

This drug is only used by a doctor.

As well as other receptor antagonists α1 - adrenergic, hypotension may occur in separate cases while treatment with Harnal Ocas tablets, resulting in rare, fainting cases. When there are the first signs of hypotension (dizziness, weakness), patients should sit or lie down until the symptoms are lost.

Before the beginning of treatment with Harnal Ocas tablets 0.4mg, patients should be checked to eliminate other conditions that can cause similar symptoms to benign prostate hyperplasia, need to conduct rectal examination with fingers and when needed to determine the specific antigen of the prostate (PSA) before treatment and at regular distance later.

It is necessary to be cautious when treating patients with severe kidney failure (creatinine clearance "Intraoperative Floppy Iris Syndrome" - IFIS - a variant of small pupils) has been observed in cataract surgery and glaucoma in some patients being treated or previously treated with Tamsulosin. Ifis can lead to increased complications in the internal and after surgery. Stop tamsulosin 1-2 weeks before cataract surgery or glaucoma is considered useful, but the benefits of stopping treatment before cataract surgery have not been determined. Ifis has also been reported in patients who stop Tamsulosin for a long time before surgery.

Do not start treatment with tamsulosin in patients expected to surgery for cataracts or glaucoma. During the surgical evaluation, surgeons and scientists should consider whether the patient is about to have cataract surgery or Glaucoma is or has been treated with Tamsulosin to ensure appropriate measures to handle the pulp syndrome during surgery.

tamsulosin hydrochlorid is not used in combination with strong CYP3A4 inhibitors in patients with less metabolic CYP2D6 phenotype. Precautions when used combined with Tamsulosin hydrochlorid with strong and medium CYP3A4 inhibitors.

Cases of allergies to Tamsulosin in patients with a history of allergy to sulfonamide have been reported. If the patient reports a history of allergies to sulfonamide, should be cautious when using tamsulosin hydrochlorid.

Can observe the rest of the tablet in the feces.

The ability to drive and operate machinery

There has been no research that has been conducted on impact on the ability to drive and operate machinery. However, patients should know that dizziness, blurred vision, dizziness, fainting can occur.

Pregnancy and nursing mothers

Harnal Ocas tablets are only used for male patients.

Other special subjects (elderly, children, allergies)

There is no related indication for the use of Harnal Ocas tablets in children.

Safety and effectiveness of tamsulosin in children

Drug interaction

Interactive studies are only done on adults.

There is no interaction when Tamsulosin Hydrochlorid is simultaneously used with Atenolol, Enalapril or Theophylin.

Concentrated with cimetidine increases the concentration of tamsulosine in plasma while the Furosemid reduces, but because the concentrations remain in normal levels, the dose adjustments are not needed.

In vitro, both diazepam and propranolol, trichlormethiazid, chlormadinon, amitriptylin, diclofenac, glibenclamid, simvastatin and warfarin do not change the freedom of tamsulosin in human plasma. Tamsulosin also does not change the freedom of Diazepam, Propranolol, Trichlormethiazid and Chlormadinon. However, diclofenac and warfarin may increase the speed of tamsulosin elimination.

Simultaneous use of Tamsulosin Hydrochlorid with strong CYP3A4 inhibitors can lead to increased concentration of Tamsulosin Hydrochlorid. Concentrated with ketoconazole (known as a strong CYP3A4 inhibitor), the increase in AUC and CMAX of Tamsulosin Hydrochlorid is 2.8 and 2.2 times. Tamusulosin hydrochlorid is not combined with strong CYP3A4 inhibitors in patients with poor metabolic CYP2D6 phenotypes. Precautions when used combined with Tamsulosin hydrochlorid with strong and medium inhibitors CYP3A4.

Simultaneously tamsulosin hydrochlorid with paroxetin, a powerful inhibitor CYP2D6, the results of the increase of CMAX and AUC of Tamsulosin are 1.3 and 1.6 times, but these increase is not clinically related.

Concentrated use of receptor antagonists α1 - adrenergic can lead to hypotension effect.

Used with anesthesia can cause lower pressure.

Storage

You should store at room temperature, avoid moisture and avoid light. No storage in the bathroom or in the freezer. You should remember that each drug may have different storage methods. Therefore, you should read carefully storage instructions on the packaging or ask the pharmacist. Keep pills out of reach of children and pets.

Expiry date: 36 months from the date of manufacture.

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