Dutasteride and Tamsulosin Capsules

July 26 [Fri], 2019, 22:42
Dutasteride and Tamsulosin Capsules



Dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.

Limitations of Use
Dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer.

Dutasteride and Tamsulosin Capsules Dosage and Administration
The recommended dosage of dutasteride and tamsulosin hydrochloride capsules 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 dutasteride and tamsulosin hydrochloride capsule may result in irritation of the oropharyngeal mucosa.

Dosage Forms and Strengths
Dutasteride and tamsulosin hydrochloride Capsules, containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, hard shell, with an opaque yellow cap printed '640' with black ink and opaque white body.
Contraindications
Dutasteride and tamsulosin hydrochloride capsules are contraindicated for use in:
Pregnancy. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. Therefore, dutasteride and tamsulosin hydrochloride capsules may cause fetal harm when administered to a pregnant woman. If dutasteride and tamsulosin hydrochloride capsules are used during pregnancy, or if the patient becomes pregnant while taking dutasteride and tamsulosin hydrochloride, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)] .
Women of childbearing potential [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)] .
Pediatric patients [see Use in Specific Populations (8.4)] .
Patients with previously demonstrated, clinically significant hypersensitivity (e.g. serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5 alpha-reductase inhibitors, tamsulosin, or any other component of dutasteride and tamsulosin hydrochloride capsules[see Adverse Reactions (6.2)] .https://www.aasraw.com/products/dutasteride-powder/
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