Drugplain

Tamsulosin Hydrochloride .4 mg/1

Tamsulosin Hydrochloride · CAPSULE · NuCare Pharmaceuticals,Inc.

3 Recalls on Record
Plain English

Tamsulosin Hydrochloride is a capsule containing tamsulosin hydrochloride at .4 mg/1, taken oral. Manufactured by NuCare Pharmaceuticals,Inc..

Key Facts

Brand Name
Tamsulosin Hydrochloride
Generic Name
Tamsulosin Hydrochloride
NDC Code (Product)
68071-1840
Manufacturer
NuCare Pharmaceuticals,Inc.
Strength
.4 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA204645
Marketing Start
01/25/2017

Recall History

3 Recalls on Record
Class II04/22/2015

Wockhardt Usa Inc.

CGMP Deviations: Firm did not adequately investigate customer complaints.

TerminatedVoluntary: Firm initiated
Class II07/17/2019

Macleods Pharma Usa Inc

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated
Class II02/22/2019

Ascend Laboratories LLC

Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue1,463 reports
dyspnoea1,380 reports
dizziness1,191 reports
diarrhoea1,162 reports
off label use1,015 reports
drug ineffective941 reports
headache931 reports
fall874 reports
asthenia868 reports
nausea839 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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 an alpha 1 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 & Administration

2 DOSAGE AND ADMINISTRATION Tamsulosin hydrochloride 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. Tamsulosin hydrochloride capsules should not be crushed, chewed or opened. For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of tamsulosin hydrochloride capsules can be increased to 0.8 mg once daily. Tamsulosin hydrochloride capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2)]. If tamsulosin hydrochloride capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose. 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,…

Contraindications

4 CONTRAINDICATIONS 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)

Drug Interactions

7 DRUG INTERACTIONS • Tamsulosin hydrochloride capsules 0.4 mg should not be used with strong inhibitors of CYP3A4 (e.g., ketoconazole). Tamsulosin hydrochloride capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), in combination with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, or in patients known to be CYP2D6 poor metabolizers, particularly at a dose higher than 0.4 mg (e.g., 0.8 mg). ( 5.2 , 7.1 , 12.3 ) • Concomitant use of PDE5 inhibitors with tamsulosin can potentially cause symptomatic hypotension ( 5.2 , 7.3 , 12.3 ). 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 of CYP3A4) resulted in an increase in the C max and AUC of tamsulosin by a factor of 2.2 and 2.8, respectively [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. The effects of concomitant administration of a moderate CYP3A4 inhibitor (e.g., erythromycin) on the pharmacokinetics of tamsulosin hydrochloride have not been evaluated [see Warnings …

Adverse Reactions

6 ADVERSE REACTIONS The most common adverse events (≥2% of patients and at a higher incidence than placebo) with the 0.4 mg dose or 0.8 mg dose were headache, dizziness, rhinitis, infection, abnormal ejaculation, asthenia, back pain, diarrhea, pharyngitis, chest pain, cough increased, somnolence, nausea, sinusitis, insomnia, libido decreased, tooth disorder, and blurred vision (6.1) To report SUSPECTED ADVERSE REACTIONS, contact XLCare Pharmaceuticals, Inc. at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 another drug and may not reflect the rates observed in practice. The incidence of treatment-emergent adverse events has been ascertained from six short-term U.S. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg tamsulosin hydrochloride capsules were used. These studies evaluated safety in 1783 patients treated with tamsulosin hydrochloride capsules and 798 patients administered placebo. Table 1 s…

Frequently Asked Questions

What is Tamsulosin Hydrochloride used for?

Tamsulosin Hydrochloride contains Tamsulosin Hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.

Is Tamsulosin Hydrochloride a controlled substance?

Tamsulosin Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Tamsulosin Hydrochloride?

The generic name for Tamsulosin Hydrochloride is Tamsulosin Hydrochloride. There are 1 other brand versions of Tamsulosin Hydrochloride.

What is the NDC code for Tamsulosin Hydrochloride .4 mg/1?

The NDC (National Drug Code) for Tamsulosin Hydrochloride .4 mg/1 is 68071-1840, listed by NuCare Pharmaceuticals,Inc..

Product NDC

68071-1840

Package NDC

68071-1840-1

Other Tamsulosin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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