TAMSULOSIN HYDROCHLORIDE- tamsulosin hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

TAMSULOSIN HYDROCHLORIDE

Composition:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tamsulosin hydrochloride  capsules, USP 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 capsule is not indicated for use in women. There are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride capsules 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

Product summary:

Tamsulosin hydrochloride capsules USP, 0.4 mg are supplied in high density polyethylene bottles as follows: Hard gelatin capsules, size ‘2’ Olive Green colored cap and Light Yellow colored body with “160” imprinted in black ink on cap and body, containing white to off white pellets. Bottle of 20 - 68788-9421-2 Bottle of 30 - 68788-9421-3 Bottle of 60 - 68788-9421-6 Bottle of 90 - 68788-9421-9 Bottle of 100 - 68788-9421-1 Bottle of 120 - 68788-9421-8 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules and all medicines out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
PREFERRED PHARMACEUTICALS, INC.
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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 CAPSULES.
TAMSULOSIN HYDROCHLORIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SUN PHARMACEUTICAL
INDUSTRIES, INC. AT 1-800-818-
4555, OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Tamsulosin hydrochloride is an alpha adrenoceptor antagonist indicated
for treatment of the signs and symptoms of
benign prostatic hyperplasia (1)
1
Tamsulosin hydrochloride capsules are not indicated for the treatment
of hypertension (1)
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)
Capsules: 0.4 mg (3)
Contraindicated in patients known to be hypersensitive to tamsulosin
hydrochloride or any component of tamsulosin
hydrochloride capsules (4, 6.2)
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