Presentation

Prostacin D : Each capsule contains combination of Dutasteride USP 0.5 mg and Tamsulosin Hydrochloride BP 0.4 mg.

Description

Dutasteride-Tamsulosin combination capsules contain Dutasteride (a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT) and Tamsulosin (an antagonist of alpha1A-adrenoceptors in the prostate). Dutasteride is a synthetic 4-azasteroid compound which inhibits the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5 alpha-reductase isoenzymes, with which it forms a stable enzyme complex. Smooth muscle tone is mediated by the sympathetic nervous stimulation of alpha1-adrenoceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Tamsulosin, an alpha1-adrenoceptor blocking agent, exhibits selectivity for alpha1-receptors in the human prostate.

Indications

Dutasteride-Tamsulosin combination capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Dosage & Administration

The recommended dosage is 1 capsule (0.5 mg Dutasteride and 0.4 mg Tamsulosin Hydrochloride) taken once daily approximately 30 minutes after the same meal each day.

The capsules should be swallowed whole and not chewed or opened. Contact with the contents of the capsule may result in irritation of the oropharyngeal mucosa.

Side Effects

Impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, erectile dysfunction and dizziness etc. may occur. Again, infection, asthenia, back pain, chest pain, somnolence, insomnia, rhinitis, pharyngitis, cough, sinusitis, and diarrhea etc. may occur.

Precautions

Dutasteride-Tamsulosin combination capsules are used with caution because it-

- Can occur orthostatic hypotension and syncope

- Reduces serum prostate-specific antigen (PSA) concentration by approximately 50%

- Do not use with strong inhibitors of cytochrome P450 (CYP) 3A4 (e.g. Ketoconazole)

- Exercise caution with concomitant use of PDE-5 inhibitors, as this may increase the risk of hypotension

Drugs that contain Dutasteride, may increase the risk of high-grade prostate cancer

Women who are pregnant or could become pregnant should not handle due to potential risk to a male fetus

Advise patients about the possibility and seriousness of priapism

Patients should not donate blood until 6 months after their last dose

Intraoperative Floppy Iris Syndrome has been observed during cataract surgery after alpha adrenergic antagonist exposure

Exercise caution with concomitant use of Warfarin

Drug Interaction

Dutasteride-Tamsulosin combination capsules are used with caution because it-

- Can occur orthostatic hypotension and syncope

- Reduces serum prostate-specific antigen (PSA) concentration by approximately 50%

- Do not use with strong inhibitors of cytochrome P450 (CYP) 3A4 (e.g. Ketoconazole)

- Exercise caution with concomitant use of PDE-5 inhibitors, as this may increase the risk of hypotension

- Drugs that contain Dutasteride, may increase the risk of high-grade prostate cancer

- Women who are pregnant or could become pregnant should not handle due to potential risk to a male fetus

- Advise patients about the possibility and seriousness of priapism

- Patients should not donate blood until 6 months after their last dose

- Intraoperative Floppy Iris Syndrome has been observed during cataract surgery after alpha adrenergic antagonist exposure

- Exercise caution with concomitant use of Warfarin

Over Dose

No data are available with regard to overdosage.

Commercial Pack

Prostacin D : Each box contains 4 Alu-Alu blister strips of 4 capsules.