FLOMAX Capsule (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Bryant Ranch Prepack
Λέξεις κλειδιά
63629-3384
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1. Indications and Usage
FLOMAX (tamsulosin hydrochloride, USP) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) <em>[see Clinical Studies (14)]</em>. FLOMAX capsules are ...
2. Dosage and Administration
FLOMAX 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 following the same meal each day. ...
3. Dosage Forms and Strengths
Capsule: 0.4 mg, olive green and orange hard gelatin, imprinted on one side with FLOMAX 0.4 mg and on the other side with BI 58.
4. Contraindications
FLOMAX capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of FLOMAX capsules. Reactions have included skin rash, urticaria, pruritus, angioedema, ...
5. Warnings and Precautions
5.1 Orthostasis The signs and symptoms of orthostasis (postural hypotension, dizziness, and vertigo) were detected more frequently in FLOMAX capsule-treated patients than in placebo recipients. As with ...
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 compared to rates in the clinical studies of ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of FLOMAX capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always ...
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 (a strong inhibitor ...
8.1. Pregnancy
Teratogenic Effects, Pregnancy Category B. Administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) ...
8.3. Nursing Mothers
FLOMAX capsules are not indicated for use in women.
8.4. Pediatric Use
FLOMAX capsules are not indicated for use in pediatric populations. Efficacy and positive benefit/risk of tamsulosin hydrochloride was not demonstrated in two studies conducted in patients 2 years to 16 ...
8.5. Geriatric Use
Of the total number of subjects (1783) in clinical studies of tamsulosin, 36% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger ...
8.6. Renal Impairment
Patients with renal impairment do not require an adjustment in FLOMAX capsules dosing. However, patients with end-stage renal disease (CL<sub>cr</sub> <10 mL/min/1.73 m²) have not been studied <em>[see ...
8.7. Hepatic Impairment
Patients with moderate hepatic impairment do not require an adjustment in FLOMAX capsules dosage. FLOMAX has not been studied in patients with severe hepatic impairment <em>[see Clinical Pharmacology (12.3)] ...
10. Overdosage
Should overdosage of FLOMAX capsules lead to hypotension <em>[see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]</em>, support of the cardiovascular system is of first importance. Restoration ...
11. Description
Tamsulosin hydrochloride is an antagonist of alpha<sub>1A</sub> adrenoceptors in the prostate. Tamsulosin hydrochloride is ()(<em><em>R</em></em>)5[2-[[2-(<em><em>o</em></em>-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, ...
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 dynamic. The static component is related ...
12.2. Pharmacodynamics
Urologic pharmacodynamic effects have been evaluated in neurologically impaired pediatric patients and in adults with BPH <em>[see Use in Specific Populations (8.4) and Clinical Studies (14)]</em>.
12.3. Pharmacokinetics
The pharmacokinetics of tamsulosin hydrochloride have been evaluated in adult healthy volunteers and patients with BPH after single and/or multiple administration with doses ranging from 0.1 mg to 1 mg. ...
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 exception of a modest increase in the frequency of mammary gland fibroadenomas ...
14. Clinical Studies
Four placebo-controlled clinical studies and one active-controlled clinical study enrolled a total of 2296 patients (1003 received FLOMAX capsules 0.4 mg once daily, 491 received FLOMAX capsules 0.8 mg ...
16.1. How Supplied
Product: 63629-3384 NDC: 63629-3384-1 30 CAPSULE in a BOTTLE NDC: 63629-3384-2 60 CAPSULE in a BOTTLE NDC: 63629-3384-3 90 CAPSULE in a BOTTLE NDC: 63629-3384-4 180 CAPSULE in a BOTTLE Distributed by: ...
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, such as dizziness, ...