Sasolin D^®

Sasolin D is a preparation of Dutasteride, a 5α- reductase inhibitor and Tamsulosin, an antagonist of α1A- adrenoreceptors.
Mechanism of action: Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. Smooth muscle tone is mediated by the sympathetic nervous stimulation of α-adrenoceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra and bladder neck. Tamsulosin blocks these adrenoceptors and 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 Benign Prostatic Hyperplasia (BPH).

No Data

Sasolin D is indicated for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH) in men with an enlarged prostate.

Route of administration:

Sasolin® D should be taken orally.
The recommended dosage of Sasolin® D is 1 capsule taken once daily approximately 30 minutes after the same meal each day.

Pregnancy: This combination is contraindicated during pregnancy.

Lactation: This combination is contraindicated for use in women of childbearing potential including nursing women.

Use in children and adolescents
This combination is contraindicated for use in pediatric patients.

- Orthostatic hypotension may occur in patients treated with tamsulosin and result in syncope.
- This combination should not be coadministered with alpha adrenergic antagonist and phosphodiesterase-5 inhibitors (PDE-5 inhibitors) as there is risk of symptomatic hypotension.-
- Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with this combination.
- Patients taking this combination should not donate blood until atleast 6 months following their last dose.

The most common side effects of this combination are impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders and dizziness.

This combination is contraindicated in patients with known hypersensitivity to dutasteride or tamsulosin or any components of this product. It is also contraindicated in pregnancy, women of childbearing potential and pediatric patients.

No Data

No data are available with regard to overdosage with tamsulosin and dutasteride.

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Sasolin D capsule: Each capsule contains blended pellets of Tamsulosin Hydrochloride USP 0.4 mg and Dutasteride EP 0.5 mg.

Storage
Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.

Packing
Sasolin D capsule: Carton of 30 capsules in blister.