Description

Indication & Scope

PaiTeMei® (Dutasteride Soft Capsules) is a prescription 5α-reductase inhibitor indicated for the treatment of moderate-to-severe symptoms of benign prostatic hyperplasia (BPH) associated with prostate enlargement. It reduces dihydrotestosterone (DHT) levels, leading to prostate volume reduction and lowering the risks of acute urinary retention (AUR) and BPH-related surgical intervention.

Mechanism: Dutasteride is a dual inhibitor of type 1 and type 2 5α-reductase enzymes, blocking the conversion of testosterone to dihydrotestosterone (DHT), the primary androgen responsible for prostate growth.
Drug class: Dual 5α-reductase inhibitor.
Clinical use: Long-term treatment of men with enlarged prostate and moderate-to-severe BPH symptoms, including urinary frequency, nocturia, weak urinary stream, and difficulty urinating.

Specification

Generic Name	Dutasteride Soft Capsules
Brand Name	PaiTeMei®
Ingredient	Dutasteride
Dosage Form	Soft Capsule
Package	0.5 mg/soft capsule, 30 capsules/carton
Conditions Treated	Moderate-to-severe symptoms of benign prostatic hyperplasia (BPH) associated with prostate enlargement
Taboos	Hypersensitivity to dutasteride, other 5α-reductase inhibitors, or any component of the product; severe hepatic impairment; women, pregnant women, breastfeeding women, and individuals under 18 years old
Place of origin	China
Prescription type	Prescription Drug (Rx)
Storage Conditions	Store in a sealed container at 15–30°C, protected from light and moisture
Manufacturer	Qilu Pharmaceutical Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA), China
Approval Number	H20223596
Approval Date	August 10, 2022
Shelf Life	24 months

How to use ?

Recommended Dose: The recommended dose is 0.5 mg orally once daily. Swallow the soft capsule whole with water. Do not chew, open, or puncture the capsule. The medicine may be taken with or without food. Continuous treatment for at least 6 months is usually required to achieve maximum prostate volume reduction.

Time: Take once daily at approximately the same time each day. Treatment should be continued regularly, as symptom improvement and prostate shrinkage occur gradually over months.

Instructions for use: Administer orally as a whole soft capsule. Do not break or crush the capsule because the contents may be absorbed through the skin. Women, especially pregnant women, should avoid contact with leaking capsule contents due to the potential risk of fetal male reproductive development abnormalities. Patients should undergo appropriate prostate evaluation, including PSA monitoring, before and during treatment.

Interaction: Dutasteride is metabolized mainly by CYP3A4. Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, clarithromycin, and ritonavir may increase dutasteride exposure and require clinical monitoring. Concomitant use with other 5α-reductase inhibitors is not recommended.

Side effects: Common adverse reactions include erectile dysfunction, decreased libido, ejaculation disorders, reduced semen volume, and breast tenderness or enlargement. Other possible reactions include dizziness, fatigue, hair loss, skin rash, itching, and testicular discomfort. Rarely, serious allergic reactions, angioedema, significant liver function abnormalities, or worsening depression may occur.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What is PaiTeMei® used for?

PaiTeMei® is used to treat moderate-to-severe symptoms of benign prostatic hyperplasia (BPH) associated with prostate enlargement. It helps reduce prostate size and lowers the risk of acute urinary retention and BPH-related surgery.

How long does dutasteride take to work?

Dutasteride works gradually. Improvement in urinary symptoms may take several months, and maximum prostate shrinkage generally requires continuous treatment for about 6 months or longer.

Can women take or touch dutasteride capsules?

No. Women, especially pregnant women, should not handle leaking or damaged capsules because dutasteride may be absorbed through the skin and may affect male fetal development.

Does dutasteride affect PSA test results?

Yes. Long-term dutasteride treatment can reduce PSA levels by approximately 50%. Doctors should consider this adjustment when interpreting PSA results.