Prostacin 0.4

Indications

Prostacin Hydrochloride is prescribed for managing the functional symptoms associated with Benign Prostatic Hyperplasia (BPH).

Pharmacology

Tamsulosin, a selective alpha-1 adrenoceptor antagonist, specifically targets alpha-1A adrenoceptors within the human prostate. By blocking these receptors, Tamsulosin induces relaxation of the smooth muscles in the bladder neck and prostate, leading to improved urine flow and alleviation of BPH symptoms. The absorption of Tamsulosin hydrochloride 0.4 mg capsules is nearly complete (about 90%) when taken orally on an empty stomach. Peak concentration (Tmax) is typically reached within four to five hours when fasting, and six to seven hours with food intake. Tamsulosin is highly bound to plasma proteins (94% to 99%) and is extensively metabolized by cytochrome P450 enzymes in the liver, with less than 10% of the dose excreted unchanged in urine. The elimination half-life ranges from five to seven hours following intravenous or oral immediate-release forms. Due to the controlled absorption characteristics of Prostacin capsules, the effective half-life extends to approximately 9 to 13 hours in healthy individuals and 14 to 15 hours in those with BPH.

Dosage & Administration

The recommended dosage for Tamsulosin Hydrochloride is 0.4 mg (one capsule) daily, taken after dinner. If necessary, the dose may be increased to 0.8 mg (two capsules) once daily after 2 to 4 weeks. Should treatment be paused or interrupted for several days, therapy should resume with Tamsulosin Hydrochloride 0.4 mg (one capsule) daily. Capsules should be swallowed whole with approximately 150 ml of water while in a standing or sitting position; they should not be crushed or chewed to ensure the modified release of the active ingredient.
Always consult a registered healthcare professional before using this medication.

Interactions

Co-administration of other alpha-1 adrenoceptor antagonists may lead to hypotensive effects. No significant interactions were observed with atenolol, enalapril, or nifedipine. However, cimetidine may increase, while furosemide may decrease plasma levels of Prostacin, though adjustments in dosage are generally unnecessary. In vitro studies showed no interactions with amitriptyline, salbutamol, glibenclamide, or finasteride at the hepatic metabolism level. Note that diclofenac and warfarin could potentially increase the elimination rate of Prostacin.

Contraindications

Tamsulosin hydrochloride is contraindicated in individuals with known hypersensitivity, a history of orthostatic hypotension, or severe hepatic impairment. As with other alpha-1 blockers, some patients may experience a decrease in blood pressure, which could rarely lead to syncope. Patients should be advised to rest if they experience dizziness or weakness and to avoid situations that could lead to injury, such as driving or operating machinery.

Before initiating treatment with Tamsulosin, a thorough examination is essential to rule out other conditions that might cause similar symptoms to BPH. Digital rectal exams and prostate-specific antigen (PSA) testing should be performed prior to and at regular intervals during treatment.

Side Effects

Common side effects reported with Prostacin include dizziness and abnormal ejaculation. Less frequently, patients may experience headache, fatigue, postural hypotension, or palpitations.

Pregnancy & Lactation

Tamsulosin is not recommended for use during pregnancy or lactation.

Precautions & Warnings

Transient postural symptoms can occur after the first dose in rare cases. It is not advisable to use Tamsulosin in patients prone to micturition syncope.

Effects on Driving and Machinery Use

Currently, there is no data indicating that Prostacin negatively impacts driving or machine operation abilities. However, patients should be cautious as dizziness may occur.

Overdose Effects

While no acute overdose cases have been documented, acute hypotension is a potential risk. If overdose occurs, cardiovascular support should be provided, and blood pressure can often be normalized by positioning the patient flat. If necessary, volume expanders and vasopressors may be used. Monitoring renal function and applying general supportive care is essential. Dialysis is unlikely to be beneficial due to Tamsulosin’s high protein binding. Measures such as emesis, gastric lavage, or activated charcoal may be considered to reduce absorption.

Therapeutic Class

BPH / Urinary Retention / Urinary Incontinence

Storage Conditions

Store in a cool, dry place, below 30°C, away from light.