TAMSULOSIN HYDROCHLORIDE capsule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

St. Mary's Medical Park Pharmacy

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

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: NDC 60760-450-90 BOTTLES OF 90 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.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
ST. MARY'S MEDICAL PARK PHARMACY
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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 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