赛洛多辛(Silodosin)的用法用量:用药指南,剂量调整,特殊人群用药

Silodosin was developed by Kissei Pharmaceutical Co., Ltd. of Japan.

Silodosin usage and dosage

1. Dosage information

The recommended dose is 8 mg once a day, taken orally with food.

2. How to take the medicine

Patients who have difficulty swallowing tablets or capsules can carefully open them and sprinkle the contained powder on a tablespoon of applesauce. Applesauce should be swallowed immediately (within 5 minutes) without chewing, followed by drinking 8 ounces of cool water to ensure complete swallowing of the powder. The applesauce should not be hot and should be soft enough to be swallowed without chewing. Any powder/applesauce mixture should be used immediately (within 5 minutes) and should not be stored for later use.

Dose adjustment of Silodosin for special groups

1. Renal insufficiency

(1) Silodosin capsules are contraindicated in patients with severe renal insufficiency (creatinine clearance CCr<30mL/min).

(2) For patients with moderate renal insufficiency (CCr30-50mL/min), the dose should be reduced to 4 mg once a day, taken with meals.

(3) For patients with mild renal insufficiency (CCr50-80mL/min), no dose adjustment is required.

2. Hepatic insufficiency

(1) Silodosin capsules have not been studied in patients with severe hepatic insufficiency (Child-Pugh score ≥ 10), so it is contraindicated in such patients.

(2) No dose adjustment is required for patients with mild or moderate hepatic insufficiency.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Silodosin (Silodosin) Medication for Special Populations

1. Pregnancy

Silodosin capsules are not suitable for women.

2. Lactation period

Silodosin capsules are not suitable for women.

3. Men of reproductive potential

Silodoxin may have an effect on male fertility. These findings may be reversible and their clinical relevance is unknown.

4. Pediatric use

Silodosin capsules are not suitable for pediatric patients, and the safety and effectiveness in pediatric patients have not yet been determined.

5. Medication for the elderly

In the 12-week double-blind, placebo-controlled clinical study of silodosin capsules, 259 (55.6%) patients were under 65 years old, 207 (44.4%) patients were 65 years old and above, and 60 (12.9%) patients were 75 years old and above.

Orthostatic hypotension was reported in 2.3% of silodosin patients aged <65 years (1.2% in the placebo group), 2.9% in silodosin patients aged ≥65 years (1.9% in the placebo group), and 5.0% in patients aged ≥75 years (0% in the placebo group). Otherwise, there were no significant differences in safety or effectiveness between older and younger patients.

6. Renal insufficiency

The plasma concentration of silodosin in subjects with moderate renal insufficiency was approximately three times higher than that in subjects with normal renal function.

In patients with moderate renal insufficiency, the dose of silodosin capsules should be reduced to 4 mg per day, caution should be exercised, and patients should be monitored for adverse reactions.

Silodoxin capsules have not been studied in patients with severe renal insufficiency. Silodosin capsules are contraindicated in patients with severe renal insufficiency.

7. Hepatic insufficiency

The pharmacokinetics of a single dose of silodosin are not significantly changed in patients with hepatic insufficiency, and no dose adjustment is required in patients with mild or moderate hepatic insufficiency.

Silodosin capsules have not been studied in patients with severe hepatic impairment and are contraindicated in patients with severe hepatic impairment.