Home – Tamsulosin Hydrochloride

Tamsulosin Hydrochloride

Sun Pharmaceutical Industries Limited

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 USP, 0.4 mgInitial U.S. Approval: 1997 RECENT MAJOR CHANGES5.5INDICATIONS 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 (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 possibility and seriousness of priapism (5.3) Intraoperative Floppy Iris Syndrome has been observed during cataract surgery in some patients. Advise patients considering cataract surgery to tell their ophthalmologist that they have taken tamsulosin hydrochloride capsules. (5.5) Advise patients to be screened for the presence of prostate cancer prior to treatment and at regular intervals afterwards (5.4) Side Effects 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 CARACO Pharmaceutical Laboratories Ltd. at 1-800-818-4555, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.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) USE IN SPECIFIC POPULATIONS 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) Hepatic Impairment: Has not been studied in patients with severe hepatic impairment (8.7, 12.3)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 TAMSULOSIN HYDROCHLORIDE INDICATIONS AND USAGE
2 TAMSULOSIN HYDROCHLORIDE DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 TAMSULOSIN HYDROCHLORIDE CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 TAMSULOSIN HYDROCHLORIDE ADVERSE REACTIONS
- 6.1 Clinical Trials Experience
- 6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
10 OVERDOSAGE
11 TAMSULOSIN HYDROCHLORIDE DESCRIPTION
12 CLINICAL PHARMACOLOGY
13 NONCLINICAL TOXICOLOGY
- 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
PRINCIPAL DISPLAY PANEL-Label

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

see Clinical Studies (14)

2 DOSAGE AND ADMINISTRATION

see Warnings and Precautions (5.2)

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

see Adverse Reactions (6.2).

5 WARNINGS AND PRECAUTIONS

5.1 Orthostasis

see Adverse Reactions (6.1)see Patient Counseling Information (17.1)

5.2 Drug Interactions

see Drug Interactions (7.1) and Clinical Pharmacology (12.3)see Drug Interactions (7.1) and Clinical Pharmacology (12.3)

see Drug Interactions (7.1) and Clinical Pharmacology (12.3)

see Drug Interactions (7.2) and Clinical Pharmacology (12.3)

see Drug Interactions (7.3) and Clinical Pharmacology (12.3)

see Drug Interactions (7.4) and Clinical Pharmacology (12.3).

5.3 Priapism

₁see Patient Counseling Information (17.2)

5.4 Screening for Prostate Cancer

see Patient Counseling Information (17.3)

5.5 Intraoperative Floppy Iris Syndrome

Intraoperative₁see Adverse Reactions (6.2)₁₁₁₁
IFIS₁

5.6 Sulfa Allergy

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Table 1 Treatment-EmergentA treatment-emergent adverse event was defined as any event satisfying one of the following criteria:•The adverse event occurred for the first time after initial dosing with double-blind study medication.•The adverse event was present prior to or at the time of initial dosing with double-blind study medication and subsequently increased in severity during double-blind treatment; or•The adverse event was present prior to or at the time of initial dosing with double-blind study medication, disappeared completely, and then reappeared during double-blind treatment. Adverse Events Occurring in ≥2% of Tamsulosin Hydrochloride Capsules or Placebo Patients in Two U.S. Short-Term Placebo-Controlled Clinical Studies
BODY SYSTEM/ADVERSE EVENT	TAMSULOSIN HYDROCHLORIDE CAPSULES GROUPS		PLACEBO n=493
BODY SYSTEM/ADVERSE EVENT	0.4 mg n=502	0.8 mg n=492	PLACEBO n=493
BODY AS WHOLE
Headache	97 (19.3%)	104 (21.1%)	99 (20.1%)
InfectionCoding preferred terms also include cold, common cold, head cold, flu, and flu-like symptoms.	45 (9%)	53 (10.8%)	37 (7.5%)
Asthenia	39 (7.8%)	42 (8.5%)	27 (5.5%)
Back pain	35 (7%)	41 (8.3%)	27 (5.5%)
Chest pain	20 (4%)	20 (4.1%)	18 (3.7%)
NERVOUS SYSTEM
Dizziness	75 (14.9%)	84 (17.1%)	50 (10.1%)
Somnolence	15 (3%)	21 (4.3%)	8 (1.6%)
Insomnia	12 (2.4%)	7 (1.4%)	3 (0.6%)
Libido decreased	5 (1%)	10 (2%)	6 (1.2%)
RESPIRATORY SYSTEM
RhinitisCoding preferred terms also include nasal congestion, stuffy nose, runny nose, sinus congestion, and hay fever.	66 (13.1%)	88 (17.9%)	41 (8.3%)
Pharyngitis	29 (5.8%)	25 (5.1%)	23 (4.7%)
Cough increased	17 (3.4%)	22 (4.5%)	12 (2.4%)
Sinusitis	11 (2.2%)	18 (3.7%)	8 (1.6%)
DIGESTIVE SYSTEM
Diarrhea	31 (6.2%)	21 (4.3%)	22 (4.5%)
Nausea	13 (2.6%)	19 (3.9%)	16 (3.2%)
Tooth disorder	6 (1.2%)	10 (2%)	7 (1.4%)
UROGENITAL SYSTEM
Abnormal ejaculation	42 (8.4%)	89 (18.1%)	1 (0.2%)
SPECIAL SENSES
Blurred vision	1 (0.2%)	10 (2%)	2 (0.4%)

Signs and Symptoms of Orthostasis

see Warnings and Precautions (5.1)

Abnormal Ejaculation

Laboratory Tests

6.2 Postmarketing Experience

₁see Warnings and Precautions (5.5)

7 DRUG INTERACTIONS

7.1 Cytochrome P450 Inhibition

Strong and Moderate Inhibitors of CYP3A4 or CYP2D6

_maxsee Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)

_maxsee Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)

see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)

see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)

Cimetidine

see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)

7.2 Other Alpha Adrenergic Blocking Agents

see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)

7.3 PDE5 Inhibitors

see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)

7.4 Warfarin

in vitro in vivosee Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)

7.5 Nifedipine, Atenolol, Enalapril

see Clinical Pharmacology (12.3)

7.6 Digoxin and Theophylline

see Clinical Pharmacology (12.3)

7.7 Furosemide

_maxsee Clinical Pharmacology (12.3)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects, Pregnancy Category B.

8.3 Nursing Mothers

8.4 Pediatric Use

^®

8.5 Geriatric Use

see Clinical Pharmacology (12.3)

8.6 Renal Impairment

_cr²see Clinical Pharmacology (12.3)

8.7 Hepatic Impairment

see Clinical Pharmacology (12.3)

10 OVERDOSAGE

see Warnings and Precautions (5.1) and Adverse Reactions (6.1),

11 DESCRIPTION

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

₁

₁₁₁_1A_1B_1D₁_1A

12.2 Pharmacodynamics

see Use in Specific Populations (8.4) and Clinical Studies (14)

12.3 Pharmacokinetics

Absorption

Effect of Food

_max_max

Figure 1 Mean Plasma Tamsulosin Hydrochloride Concentrations Following Single-Dose Administration of Tamsulosin Hydrochloride Capsules 0.4 mg Under Fasted and Fed Conditions (n=8)

Table 2 Mean (± S.D.) Pharmacokinetic Parameters Following Tamsulosin Hydrochloride Capsules 0.4 mg Once Daily or 0.8 mg Once Daily with a Light Breakfast, High-Fat Breakfast or Fasted
Pharmacokinetic Parameter	0.4 mg QD to healthy volunteers; n=23 (age range 18 to 32 years)		0.8 mg QD to healthy volunteers; n=22 (age range 55 to 75 years)
Pharmacokinetic Parameter	Light Breakfast	Fasted	Light Breakfast	High-Fat Breakfast	Fasted
C_min (ng/mL)	4 ± 2.6	3.8 ± 2.5	12.3 ± 6.7	13.5 ± 7.6	13.3 ± 13.3
C_max (ng/mL)	10.1 ± 4.8	17.1 ± 17.1	29.8 ± 10.3	29.1 ± 11	41.6 ± 15.6
C_max/C_min Ratio	3.1 ± 1	5.3 ± 2.2	2.7 ± 0.7	2.5 ± 0.8	3.6 ± 1.1
T_max (hours)	6	4	7	6.6	5
T_1/2 (hours)	-	-	-	-	14.9 ± 3.9
AUC_t (ng•hr/mL)	151 ± 81.5	199 ± 94.1	440 ± 195	449 ± 217	557 ± 257

_min
_max
_max
_1/2
_t

Distribution

₁in vitro

Metabolism

see Warnings and Precautions (5.2) and Drug Interactions (7.1)

in vitro

Excretion

Specific Populations

Pediatric Use

see Use in Specific Populations (8.4)

Geriatric (Age) Use

see Use in Specific Populations (8.5)

Renal Impairment

_cr²_cr²_cr²_cr²see Use in Specific Populations (8.6)

Hepatic Impairment

see Use in Specific Populations (8.7)

Drug Interactions

Cytochrome P450 Inhibition

Strong and Moderate Inhibitors of CYP3A4 or CYP2D6

_maxsee Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)see Warnings and Precautions (5.2) and Drug Interactions (7.1)

_maxsee Warnings and Precautions (5.2) and Drug Interactions (7.1)see Warnings and Precautions (5.2) and Drug Interactions (7.1)

see Warnings and Precautions (5.2) and Drug Interactions (7.1)

see Warnings and Precautions (5.2) and Drug Interactions (7.1)

Cimetidine

see Warnings and Precautions (5.2) and Drug Interactions (7.1)

Other Alpha Adrenergic Blocking Agents

see Warnings and Precautions (5.2) and Drug Interactions (7.2)

PDE5 Inhibitors

see Warnings and Precautions (5.2) and Drug Interactions (7.3)

Warfarin

in vitro in vivosee Warnings and Precautions (5.2) and Drug Interactions (7.4)

Nifedipine, Atenolol, Enalapril

see Drug Interactions (7.5)

Digoxin and Theophylline

see Drug Interactions (7.6)

Furosemide

_maxsee Drug Interactions (7.7)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

in vitroin vivo

14 CLINICAL STUDIES

Table 3 Mean (±S.D.) Changes from Baseline to Week 13 in Total AUA Symptom Score** and Peak Urine Flow Rate (mL/sec)
	Total AUA Symptom Score		Peak Urine Flow Rate
	Mean Baseline Value	Mean Change	Mean Baseline Value	Mean Change
* Statistically significant difference from placebo (p-value ≤0.05; Bonferroni-Holm multiple test procedure). ** Total AUA Symptom Scores ranged from 0 to 35. † Peak urine flow rate measured 4 to 8 hours post dose at Week 13. ‡ Peak urine flow rate measured 24 to 27 hours post dose at Week 13. Week 13: For patients not completing the 13-week study, the last observation was carried forward.
Study 1 ^†
Tamsulosin hydrochloride capsules 0.8 mg once daily	19.9 ± 4.9 n=247	-9.6* ± 6.7 n=237	9.57 ± 2.51 n=247	1.78* ± 3.35 n=247
Tamsulosin hydrochloride capsules 0.4 mg once daily	19.8 ± 5 n=254	-8.3* ± 6.5 n=246	9.46 ± 2.49 n=254	1.75* ± 3.57 n=254
Placebo	19.6 ± 4.9 n=254	-5.5 ± 6.6 n=246	9.75 ± 2.54 n=254	0.52 ± 3.39 n=253
Study 2 ^‡
Tamsulosin hydrochloride capsules 0.8 mg once daily	18.2 ± 5.6 n=244	-5.8* ± 6.4 n=238	9.96 ± 3.16 n=244	1.79* ± 3.36 n=237
Tamsulosin hydrochloride capsules 0.4 mg once daily	17.9 ± 5.8 n=248	-5.1* ± 6.4 n=244	9.94 ± 3.14 n=248	1.52 ± 3.64 n=244
Placebo	19.2 ± 6 n=239	-3.6 ± 5.7 n=235	9.95 ± 3.12 n=239	0.93 ± 3.28 n=235

Figure 2A Mean Change from Baseline in Total AUA Symptom Score (0 to 35) Study 1
Tamsulosin Hydrochloride

Figure 2B Mean Change from Baseline in Total AUA Symptom Score (0 to 35) Study 2
Tamsulosin Hydrochloride

Figure 3A Mean Increase in Peak Urine Flow Rate (mL/sec) Study 1
Tamsulosin Hydrochloride

Figure 3B Mean Increase in Peak Urine Flow Rate (mL/sec) Study 2
Tamsulosin Hydrochloride

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (17.6).

17.1 Hypotension

see Warnings and Precautions (5.1)

17.2 Priapism

see Warnings and Precautions (5.3)

17.3 Screening for Prostate Cancer

see Warnings and Precautions (5.4).

17.4 Intraoperative Floppy Iris Syndrome

see Warnings and Precautions (5.5)

17.5 Administration

17.6 FDA-approved Patient Labeling

PATIENT INFORMATION

Tamsulosin Hydrochloride Capsules USP, 0.4 mg

What are tamsulosin hydrochloride capsules?

Tamsulosin hydrochloride capsules are not for women.
Tamsulosin hydrochloride capsules are not for children.

Who should not take tamsulosin hydrochloride capsules?

What should I tell my doctor before using tamsulosin hydrochloride capsules?

Before taking tamsulosin hydrochloride capsules, tell your doctor about all your medical conditions, including:

any kidney or liver problems.
any history of low blood pressure.
any allergies to sulfa or any other medicines.
if you are planning to have cataract surgery.

Tell your doctor about all the medicines you take, including:

any prescription medicines, including blood pressure medicines.
any non-prescription medicines, including vitamins and herbal supplements.

How should I take tamsulosin hydrochloride capsules?

Take tamsulosin hydrochloride capsules exactly as prescribed by your doctor.
Do not crush, chew, or open tamsulosin hydrochloride capsules.
Take tamsulosin hydrochloride capsules one time each day, about 30 minutes after the same meal each day. For example, you may take tamsulosin hydrochloride capsules 30 minutes after dinner each day.
If you miss a dose of tamsulosin hydrochloride capsules, take it as soon as you remember. If you miss your dose for the whole day, continue with your next dose on your regular schedule. Do not take two doses at the same time.
If you stop or forget to take tamsulosin hydrochloride capsules for several days, talk with your doctor before starting again.
If you take more tamsulosin hydrochloride capsules than prescribed, call your doctor right away.

What are the possible side effects of tamsulosin hydrochloride capsules?

Decreased blood pressure when changing positions. Tamsulosin hydrochloride capsules may cause a sudden drop in blood pressure upon standing, especially after the first dose or when changing doses.
Symptoms may include:
- fainting
- dizziness
- lightheadedness

Change positions slowly from lying down to sitting up or from a sitting to a standing position until you learn how you react to tamsulosin hydrochloride capsules. If you begin to feel dizzy, sit or lie down until you feel better. If the symptoms are severe or do not improve, call your doctor.

Allergic reactions. Make your doctor aware of any allergic reactions you may experience while taking tamsulosin hydrochloride capsules.
Allergic reactions may include:
- rash
- itching
- hives
Rare and more serious allergic reactions may also occur. Get medical help right away if you have any of the following reactions:
- swelling of face, tongue, or throat
- difficulty breathing
- blistering of the skin

A painful erection that will not go away. Tamsulosin hydrochloride capsules can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an erection in the future.
Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken tamsulosin hydrochloride capsules. If you need to have cataract surgery, be sure to tell your surgeon if you take or have taken tamsulosin hydrochloride capsules.

runny nose
dizziness
decreased semen

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088, or by visiting www.fda.gov/medwatch.

What should I avoid while taking tamsulosin hydrochloride capsules?

What are the possible side effects of tamsulosin hydrochloride capsules?

How do I store tamsulosin hydrochloride capsules?

Keep tamsulosin hydrochloride capsules and all medicines out of the reach of children.

General information

What are the ingredients in tamsulosin hydrochloride capsules?

Active Ingredient: tamsulosin hydrochloride
Inactive Ingredients: microcrystalline cellulose, methacrylic acid copolymer dispersion, hypromellose acetate succinate, triethyl citrate, talc, and sodium lauryl sulfate.

Caraco Pharmaceutical Laboratories, Ltd.

Sun Pharmaceutical Industries Ltd.

PRINCIPAL DISPLAY PANEL-Label

NDC 62756-160-83
Tamsulosin Hydrochloride Capsules, USP
0.4 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
PHARMACIST: PLEASE DISPENSE WITH PATIENT INFORMATION LEAFLET