Tamsulosin 0.4 mg Capsules — Generic For Flomax — Aurobindo

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.

TAMSULOSIN HYDROCHLORIDE capsules, for oral use

Initial U.S. Approval: 1997

Indications And Usage

Tamsulosin hydrochloride capsules are an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1)

Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1)

Dosage And Administration

0.4 mg once daily taken approximately one-half hour following the same meal each day. Tamsulosin hydrochloride capsules should not be crushed, chewed or opened. (2)

Can be increased to 0.8 mg once daily for patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing (2)

If discontinued or interrupted for several days, therapy should start again with the 0.4 mg once-daily dose (2)

Dosage Forms And Strengths

Capsules: 0.4 mg (3)

Contraindications

Contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules (4, 6.2)

Warnings And Precautions

Advise patients about the possibility of symptoms related to postural hypotension and to avoid situations where injury could result should syncope occur (5.1)

Should not be used in combination with strong inhibitors of CYP3A4. Use with caution in combination with moderate inhibitors of CYP3A4, with strong or moderate inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers, or in combination with other cytochrome P450 inhibitors. (5.2, 7.1, 12.3)

Should not be used in combination with other alpha adrenergic blocking agents (5.2, 7.2, 12.3)

Exercise caution with concomitant administration of warfarin (5.2, 7.4, 12.3)

Advise patients about the possibility and seriousness of priapism (5.3)

Intraoperative Floppy Iris Syndrome has been observed during cataract and glaucoma surgery in some patients. Advise patients considering cataract or glaucoma surgery to tell their ophthalmologist that they have taken tamsulosin hydrochloride capsules. (5.5)

Advise patients to be screened for the presence of prostate cancer prior to treatment and at regular intervals afterwards (5.4)

Adverse Reactions

The most common adverse events (≥2% of patients and at a higher incidence than placebo) with the 0.4 mg dose or 0.8 mg dose were headache, dizziness, rhinitis, infection, abnormal ejaculation, asthenia, back pain, diarrhea, pharyngitis, chest pain, cough increased, somnolence, nausea, sinusitis, insomnia, libido decreased, tooth disorder, and blurred vision (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Tamsulosin hydrochloride capsules 0.4 mg should not be used with strong inhibitors of CYP3A4 (e.g., ketoconazole). Tamsulosin hydrochloride capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), in combination with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, or in patients known to be CYP2D6 poor metabolizers, particularly at a dose higher than 0.4 mg (e.g., 0.8 mg). (5.2, 7.1, 12.3)

Concomitant use of PDE5 inhibitors with tamsulosin can potentially cause symptomatic hypotension. (5.2, 7.3, 12.3)

Use In Specific Populations

Pediatric Use: Not indicated for use in pediatric populations. (8.4, 12.3)

Geriatric Use: No overall differences in efficacy or safety vs. younger patients, but greater sensitivity of some older adults cannot be ruled out (8.5, 12.3)

Renal Impairment: Has not been studied in patients with end-stage renal disease (8.6, 12.3)

Hepatic Impairment: Has not been studied in patients with severe hepatic impairment (8.7, 12.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 9/2021