TAMSULOSIN HYDROCHLORIDE capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)

Предлага се от:

Blenheim Pharmacal, Inc.

INN (Международно Name):

TAMSULOSIN HYDROCHLORIDE

Композиция:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14) ]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. Reactions have included skin rash, urticaria, pruritus, angioedema and respiratory symptoms [see Adverse Reactions (6.2) ]. - Contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules (4, 6.2) - 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

Каталог на резюме:

Tamsulosin hydrochloride capsules USP, 0.4 mg are supplied in high density polyethylene bottles containing 30 or 500 size '2', hard gelatin capsules with olive green opaque cap and orange opaque body, filled with white to off-white pellets. The capsules are imprinted with “W” on the cap with black ink.                                                                                                                                                                                                     516 Tamsulosin hydrochloride capsules USP, 0.4 mg, 30 capsules (NDC 64679-516-01) Tamsulosin hydrochloride capsules USP, 0.4 mg, 100 capsules (NDC 64679-516-02) Tamsulosin hydrochloride capsules USP, 0.4 mg, 500 capsules (NDC 64679-516-03) Tamsulosin hydrochloride capsules USP, 0.4 mg, 16 (2 x 8) unit dose blister carton (NDC 64679-516-04) Tamsulosin hydrochloride capsules USP, 0.4 mg, 30 (1 x 30) unit dose blister carton (NDC 64679-516-05) Store at 20° to 25°C (68°C to 77°F) [See USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules, USP and all medicines out of reach of children.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
BLENHEIM PHARMACAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TAMSULOSIN HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TAMSULOSIN
HYDROCHLORIDE.
TAMSULOSIN HYDROCHLORIDE CAPSULES USP*, 0.4 MG
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Dosage and Administration (2) 4/2009
Contraindications (4) 12/2009
Warnings and Precautions
Drug Interactions (5.2) 12/2009
Screening for Prostate Cancer (5.4) 12/2009
INDICATIONS AND USAGE
Tamsulosin hydrochloride is an alpha 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)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND PATIENT COUNSELING
INFORMATION.
REVISED: 10/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Orthostasis
5.2 Drug Interactions
5.3 Priapism
5.4 Screening for Prostate Cancer
5.5 Intraoperative Floppy Iris Syndrome
5.6 Sulfa Allergy
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Cytochrome P450 Inhibition
7.2 Other Alpha Adrenergic Blocking Agents
7.3 PDE5 Inhibitors
7.4 Warfarin
7.5 Nifedipine, Atenolol, Enalapril
7.6 Digoxin and Theophylline
7.7 Furosemide
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
1
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Hypotension
17.2 Priapism
17.3 Screening for Prostate Cancer
17.4 Intrao