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JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): FULL PRESCRIBING INFORMATION

DESCRIPTION

Jalyn description


INDICATIONS AND USAGE

Benign Prostatic Hyperplasia (BPH) Treatment

Jalyn (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 Jalyn, are not approved for the prevention 8 of prostate cancer.


DOSAGE AND ADMINISTRATION

The recommended dosage of Jalyn 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 Jalyn capsule may result in irritation of the oropharyngeal mucosa.


DOSAGE FORMS AND STRENGTHS

Jalyn capsules, containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, are oblong, hard-shell capsules with a brown body and an orange cap imprinted with "GS 7CZ" in black ink.


CONTRAINDICATIONS

Jalyn (Dutasteride, Tamsulosin Hydrochloride) is contraindicated for use in:

  • Pregnancy. In animal reproduction and developmental toxicity studies, dutasteride inhibited 22 development of male fetus external genitalia. Therefore, Jalyn may cause fetal harm when administered to a pregnant woman. If Jalyn (Dutasteride, Tamsulosin Hydrochloride) capsules are used during pregnancy, or if the patient becomes pregnant while taking this medication, the patient should be apprised of the potential hazard to the fetus.
  • Women of childbearing potential.
  • Pediatric patients.
  • Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to dutasteride, other 5 alpha-reductase inhibitors, tamsulosin, or any other component of Jalyn (Dutasteride and Tamsulosin).


    WARNINGS

    Jalyn warnings


    PRECAUTIONS

    Jalyn precautions


    DRUG-DRUG INTERACTIONS

    Jalyn drug-drug interactions


    ADVERSE REACTIONS

    Jalyn adverse reactions


    DRUG INTERACTIONS

    Jalyn drug interactions


    USE IN SPECIFIC POPULATIONS

    Jalyn use in specific populations


    CLINICAL PHARMACOLOGY

    Jalyn clinical pharmacology


    PHARMACODYNAMICS

    Jalyn pharmacodynamics


    PHARMACOKINETICS

    Jalyn pharmacokinetics


    PHARMACOKINETICS IN SPECIFIC POPULATIONS

    Jalyn pharmacokinetics in specific populations


    PHARMACOKINETICS OF DRUG INTERACTIONS

    Jalyn pharmacokinetics for drug interactions


    NONCLINICAL TOXICOLOGY

    Jalyn nonclinical toxicology


    CLINICAL STUDIES

    Jalyn clinical studies


    OVERDOSAGE

    Jalyn overdosage


    HOW SUPPLIED / STORAGE AND HANDLING

    Jalyn capsules, containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, are oblong hard-shell capsules with a brown body and an orange cap imprinted with "GS 7CZ" in black ink. They are available in bottles with child-resistant closures).

    Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F). Capsules may become deformed and/or discolored if kept at high temperatures.

    Dutasteride is absorbed through the skin. Jalyn capsules should not be handled by women who are pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus.

    Manufactured and distributed by GlaxoSmithKline pharmaceutical company and its divisions.

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