Label: TAMSULOSIN HYDROCHLORIDE capsule

  • NDC Code(s): 68382-132-01, 68382-132-05, 68382-132-06, 68382-132-10, view more
  • Packager: Zydus Pharmaceuticals USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 8, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride ...
  • 2 DOSAGE AND ADMINISTRATION
    Tamsulosin hydrochloride capsules, 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Capsule: 0.4 mg, white to off-white free flowing pellets filled in size '2' empty hard gelatin capsules with green colored cap printed with "ZA-18" in black ink and peach colored body printed ...
  • 4 CONTRAINDICATIONS
    Tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. Reactions have ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Orthostasis - The signs and symptoms of orthostasis (postural hypotension, dizziness, and vertigo) were detected more frequently in tamsulosin hydrochloride capsule-treated patients than in ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    7.1 Cytochrome P450 Inhibition - Strong and Moderate Inhibitors of CYP3A4 or CYP2D6 - Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6. Concomitant treatment with ketoconazole ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Tamsulosin hydrochloride capsules are not indicated for use in women. There are no adequate data on the developmental risk associated with the use of Tamsulosin ...
  • 10 OVERDOSAGE
    Should overdosage of tamsulosin hydrochloride capsules lead to hypotension [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)], support of the cardiovascular system is of first ...
  • 11 DESCRIPTION
    Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Rats administered doses up to 43 mg/kg/day in males and 52 mg/kg/day in females had no increases in tumor incidence, with the ...
  • 14 CLINICAL STUDIES
    Four placebo-controlled clinical studies and one active-controlled clinical study enrolled a total of 2296 patients (1003 received tamsulosin hydrochloride capsules, 0.4 mg once daily, 491 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Tamsulosin Hydrochloride Capsules USP, 0.4 mg are white to off-white free flowing pellets filled in size '2' empty hard gelatin capsules with green colored cap printed with "ZA-18" in black ink ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information)   Hypotension - Advise the patient about the possible occurrence of symptoms related to postural hypotension ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India - Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 - Rev.: 01/23
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION - Tamsulosin Hydrochloride (tam soo' loe sin hye'' droe klor' ide) Capsules, USP - Read the Patient Information that comes with tamsulosin hydrochloride capsules before you ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 68382-132-01 in bottle of 100 Capsules - Tamsulosin Hydrochloride Capsules USP, 0.4 mg - Rx only - 100 Capsules - ZYDUS
  • INGREDIENTS AND APPEARANCE
    Product Information