Rx Item-Flomax 0.4MG 100 Cap by Aventis Pharma USA , Clinical Information:
Generic Code And Description: 27546 Tamsulosin Hcl Oral Capsule 0.4 Mg
Strength: 0.4 Mg
Dose Form: Capsule
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 12160412 Selective Alpha-1-Adrenergic Block.Agent
Active Ingredients: 6116 Tamsulosin Hcl 106463176
Inactive Ingredients: 10138 Blue Dye
2549 Gelatin 9000708 Drug Class: Drug Class: 12160412 Selective Alpha-1- Adrenergic , OMP Family: Waiting for Details, Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 100 , Brand Label Flag: BRAND , Storage Temperature Zone: 10 Room Temperature, Item Size Code:100 , Item Strength Code:0.4MG , Item Abbreviation: Flomax , Generic Form: CAP
These highlights do not include all the information needed to use FLOMAX safely and effectively. See full prescribing information for FLOMAX.
FLOMAX ® (tamsulosin hydrochloride, USP) capsules, for oral use
Initial U.S. Approval: 1997
INDICATIONS AND USAGE
FLOMAX is an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia ( 1)
FLOMAX 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. FLOMAX 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 FLOMAX 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 FLOMAX 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 sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
FLOMAX capsules 0.4 mg should not be used with strong inhibitors of CYP3A4 (e.g., ketoconazole). FLOMAX 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: 1/2019
