TAMSULOSIN HYDROCHLORIDE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Macleods Pharmaceuticals Limited

INN (Internationale Bezeichnung):

TAMSULOSIN HYDROCHLORIDE

Zusammensetzung:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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)]. Risk Summary Tamsulosin hydrochloride is not indicated for use in women. There are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride in pregnant women. No adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (GD 7 to 17 in the rat and GD 6 to 18 in the rabbit) [see Data]. In the U.S. general population, the e

Produktbesonderheiten:

Tamsulosin hydrochloride capsules, USP are comprising of olive green opaque cap imprinted “CL 23", and orange opaque body imprinted "0.4" in black ink. Tamsulosin hydrochloride capsules, USP 0.4 mg are supplied as below:  Bottle of 30 capsules          NDC 33342-159-07 Bottle of 100 capsules       NDC 33342-159-11 Bottle of 500 capsules       NDC 33342-159-15 Bottle of 1000 capsules    NDC 33342-159-44  Unit dose package of 100 capsules     NDC 33342-159-12 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules and all medicines out of reach of children.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TAMSULOSIN HYDROCHLORIDE - TAMSULOSIN HYDROCHLORIDE CAPSULE
MACLEODS PHARMACEUTICALS LIMITED
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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.
TAMSULOSIN HYDROCHLORIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
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)
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