Tamsulosin Hydrochloride

1 INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

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.

2 DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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 Capsule 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.

3 DOSAGE FORMS & STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Capsule: 0.4 mg, White to off white pellets filled in hard gelatin capsule size " 1" Olive green opaque cap & orange opaque body imprinted with "TAM' on cap & " 0.4 mg” on body in black ink.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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) ].

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Should overdosage of Tamsulosin Hydrochloride Capsules lead to hypotension [ see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ], support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then administration of intravenous fluids should be considered. If necessary, vasopressors should then be used and renal function should be monitored and supported as needed. Laboratory data indicate that tamsulosin hydrochloride is 94% to 99% protein bound; therefore, dialysis is unlikely to be of benefit.

11 DESCRIPTION

DESCRIPTION SECTION

Tamsulosin hydrochloride is an antagonist of alpha 1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-( R )-5-[2-[[2-( o -Ethoxyphenoxy) ethyl]amino]propyl]-2 methoxybenzenesulfonamide,monohydrochloride. Tamsulosin hydrochloride is a white or almost white crystalline powder that melts with decomposition at approximately 230°C. It is freely soluble in formic acid,sparingly soluble in methanol,slightly soluble in water and dehydrated alcohol,practically insoluble in ether.The empirical formula of tamsulosin hydrochloride is C 20 H 28 N 2 O 5 S • HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is: Each Tamsulosin Hydrochloride Capsules, USP for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, Eudragit L30D-55 dispersion, hypromellose, triacetin ,calcium stearate, talc, iron oxide red, iron oxide yellow, FD&C blue 2, titanium dioxide, gelatin and trace amounts of black edible ink (containing: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide). FDA approved dissolution test specifications differ from USP.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

Four placebo-controlled clinical studies and one active-controlled clinical study enrolled a total of 2296 patients (1003 received Tamsulosin Hydrochloride Capsules 0.4 mg once daily, 491 received Tamsulosin Hydrochloride Capsules 0.8 mg once daily, and 802 were control patients) in the U.S. and Europe. In the two U.S. placebo-controlled, double-blind, 13-week, multicenter studies [Study 1 (US92-03A) and Study 2 (US93-01)], 1486 men with the signs and symptoms of BPH were enrolled. In both studies, patients were randomized to either placebo, Tamsulosin Hydrochloride Capsules 0.4 mg once daily, or Tamsulosin Hydrochloride Capsules 0.8 mg once daily. Patients in Tamsulosin Hydrochloride Capsules 0.8 mg once-daily treatment groups received a dose of 0.4 mg once daily for one week before increasing to the 0.8 mg once-daily dose. The primary efficacy assessments included: 1) total American Urological Association (AUA) Symptom Score questionnaire, which evaluated irritative (frequency, urgency, and nocturia), and obstructive (hesitancy, incomplete emptying, intermittency, and weak stream) symptoms, where a decrease in score is consistent with improvement in symptoms; and 2) peak urine flow rate, where an increased peak urine flow rate value over baseline is consistent with decreased urinary obstruction. Mean changes from baseline to Week 13 in total AUA Symptom Score were significantly greater for groups treated with Tamsulosin Hydrochloride Capsules 0.4 mg and 0.8 mg once daily compared to placebo in both U.S. studies (Table 3, Figures 2A and 2B). The changes from baseline to Week 13 in peak urine flow rate were also significantly greater for the Tamsulosin Hydrochloride Capsules 0.4 mg and 0.8 mg once-daily groups compared to placebo in Study 1, and for the Tamsulosin Hydrochloride Capsules 0.8 mg once-daily group in Study 2 (Table 3, Figures 3A and 3B). Overall there were no significant differences in improvement observed in total AUA Symptom Scores or peak urine flow rates between the 0.4 mg and the 0.8 mg dose groups with the exception that the 0.8 mg dose in Study 1 had a significantly greater improvement in total AUA Symptom Score compared to the 0.4 mg dose. 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 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 ± 5.0 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 ± 6.0 n=239 -3.6 ± 5.7 n=235 9.95 ± 3.12 n=239 0.93 ± 3.28 n=235 * Statistically significant difference from placebo (p-value ≤0.050; 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. Mean total AUA Symptom Scores for both Tamsulosin Hydrochloride Capsules 0.4 mg and 0.8 mg once-daily groups showed a rapid decrease starting at 1 week after dosing and remained decreased through 13 weeks in both studies (Figures 2A and 2B).In Study 1, 400 patients (53% of the originally randomized group) elected to continue in their originally assigned treatment groups in a double-blind, placebo-controlled, 40-week extension trial (138 patients on 0.4 mg, 135 patients on 0.8 mg, and 127 patients on placebo). Three hundred twenty-three patients (43% of the originally randomized group) completed one year. Of these, 81% (97 patients) on 0.4 mg, 74% (75 patients) on 0.8 mg, and 56% (57 patients) on placebo had a response ≥25% above baseline in total AUA Symptom Score at one year. Figure 2A Mean Change from Baseline in Total AUA Symptom Score (0-35) Study * indicates significant difference from placebo (p-value ≤0.050). B = Baseline determined approximately one week prior to the initial dose of double-blind medication at Week 0. Subsequent values are observed cases. LOCF = Last observation carried forward for patients not completing the 13-week study. Note: Patients in the 0.8 mg treatment group received 0.4 mg for the first week. Note: Total AUA Symptom Scores range from 0 to 35. Figure 2B Mean Change from Baseline in Total AUA Symptom Score (0-35) Study 2 * indicates significant difference from placebo (p-value ≤0.050). Baseline measurement was taken Week 0. Subsequent values are observed cases. LOCF = Last observation carried forward for patients not completing the 13-week study. Note: Patients in the 0.8 mg treatment group received 0.4 mg for the first week. Note: Total AUA Symptom Scores range from 0 to 35. Figure 3A Mean Increase in Peak Urine Flow Rate (mL/Sec) Study 1 * indicates significant difference from placebo (p-value ≤0.050). B = Baseline determined approximately one week prior to the initial dose of double-blind medication at Week 0. Subsequent values are observed cases. LOCF = Last observation carried forward for patients not completing the 13-week study. Note: The uroflowmetry assessments at Week 0 were recorded 4 to 8 hours after patients received the first dose of double-blind medication. Measurements at each visit were scheduled 4 to 8 hours after dosing (approximate peak plasma tamsulosin concentration). Note: Patients in the 0.8 mg treatment groups received 0.4 mg for the first week. Figure 3B Mean Increase in Peak Urine Flow Rate (mL/Sec) Study 2 * indicates significant difference from placebo (p-value ≤0.050). Baseline measurement was taken Week 0. Subsequent values are observed cases. LOCF = Last observation carried forward for patients not completing the 13-week study. Note: Patients in the 0.8 mg treatment group received 0.4 mg for the first week. Note: Week 1 and Week 2 measurements were scheduled 4 to 8 hours after dosing (approximate peak plasma tamsulosin concentration). All other visits were scheduled 24 to 27 hours after dosing (approximate trough tamsulosin concentration).

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Tamsulosin Hydrochloride Capsules 0.4 mg are supplied in Alu-Alu blisters containing 50 hard gelatin capsules with olive green opaque cap and orange opaque body. The capsules are imprinted on one side with "TAM" on cap & "0.4 mg" on body in black ink. They are available as follows: 50 Capsules (5 x 10 Unit Dose) NDC 50268-740-15 100 Capsules (10 x 10 Unit Dose) NDC 50268-740-01 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep Tamsulosin Hydrochloride Capsules and all medicines out of reach of children..

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling (Patient Information) · Hypotension Advise the patients about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when taking Tamsulosin Hydrochloride Capsules, and they should be cautioned about driving, operating machinery, or performing hazardous tasks [ see Warnings and Precautions (5.1) ]. · Drug Interactions Advise the patient that Tamsulosin Hydrochloride Capsules should not be used in combination with strong inhibitors of CYP3A4 [see Warnings and Precautions (5.2) and Drug Interactions (7.1)]. · Priapism Advise the patient should be advised about the possibility of priapism as a result of treatment with Tamsulosin Hydrochloride Capsules and other similar medications. Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence) [ see Warnings and Precautions (5.3) ]. · Screening for Prostate Cancer Prostate cancer and BPH frequently co-exist; therefore, screened for the presence of prostate cancer prior to treatment with Tamsulosin Hydrochloride Capsules and at regular intervals afterwards [ see Warnings and Precautions (5.4) ]. · Intraoperative Floppy Iris Syndrome Advise the patient when considering cataract or glaucoma surgery to tell their ophthalmologist that they have taken Tamsulosin Hydrochloride Capsules [see Warnings and Precautions (5.5)]. · Administration Advise the patient that Tamsulosin Hydrochloride Capsules should not be crushed, chewed or opened [see Dosage and Administration (2)] . FDA-approved Patient Labeling Patient labeling is provided as a tear-off leaflet at the end of this prescribing information. Manufactured by: Alkem Laboratories Ltd., INDIA. Manufactured for: AvKARE Pulaski, TN 38478

PATIENT INFORMATION

INFORMATION FOR PATIENTS SECTION

Tamsulosin Hydrochloride Capsules 0.4 mg Read the Patient Information that comes with Tamsulosin Hydrochloride Capsules before you start taking it and each time you refill your prescription. The information may have changed. This leaflet does not take the place of discussions with your doctor about your medical condition or your treatment. What are Tamsulosin Hydrochloride Capsules? Tamsulosin Hydrochloride Capsules is a prescription alpha-blocker medicine used to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition your doctor may refer to as an enlarged prostate. Tamsulosin Hydrochloride Capsules is not for women. Tamsulosin Hydrochloride Capsules is not for children. Who should not take Tamsulosin Hydrochloride Capsules? Do not take Tamsulosin Hydrochloride Capsules if you are allergic to any of its ingredients. See the end of this leaflet for a complete list of ingredients in 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 or glaucoma 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. Some of your other medicines may affect the way Tamsulosin Hydrochloride Capsules work. Especially tell your doctor if you take a medicine for high blood pressure. You should not take Tamsulosin Hydrochloride Capsules if you are already taking certain blood pressure medicines. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. 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? Possible side effects of Tamsulosin Hydrochloride Capsules may include: 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 or glaucoma surgery. During cataract or glaucoma 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 or glaucoma surgery, be sure to tell your surgeon if you take or have taken Tamsulosin Hydrochloride Capsules. Common side effects of Tamsulosin Hydrochloride Capsules may include: runny nose dizziness decreased semen These are not all the possible side effects with Tamsulosin Hydrochloride Capsules. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA1088 or www.fda.gov/medwatch. What should I avoid while taking Tamsulosin Hydrochloride Capsules? Avoid driving, operating machinery, or other dangerous activities, until you know how Tamsulosin Hydrochloride Capsules affects you. Tamsulosin Hydrochloride Capsules may cause a sudden drop in blood pressure upon standing, especially after the first dose or when changing doses. See " What are the possible side effects of Tamsulosin Hydrochloride Capsules? " How do I store Tamsulosin Hydrochloride Capsules? Store Tamsulosin Hydrochloride Capsules at Room Temperature [77°F (25°C)]. Short-term exposure to higher or lower temperatures [from 59°F (15°C) to 86°F (30°C)] is acceptable. Ask your doctor or pharmacist if you have any questions about storing your capsules. Keep Tamsulosin Hydrochloride Capsules and all medicines out of the reach of children. General information This medicine was prescribed for you by your doctor for your condition. Do not use it for another condition. Do not give Tamsulosin Hydrochloride Capsules to other people, even if they have the same symptoms that you have. It may harm them. While taking Tamsulosin Hydrochloride Capsules, you must have regular checkups. Follow your doctor's advice about when to have these checkups. BPH can occur with other more serious conditions, including prostate cancer. Therefore, ask your doctor about screening for prostate cancer prior to treatment with Tamsulosin Hydrochloride Capsules and at regular intervals afterwards. This patient information leaflet summarizes the most important information about Tamsulosin Hydrochloride Capsules. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Tamsulosin Hydrochloride Capsules that is written for health professionals. For more information call AvKARE, Inc. at 1-855-361-3993. What are the ingredients in Tamsulosin Hydrochloride Capsules? Active Ingredient: tamsulosin hydrochloride Inactive Ingredients: microcrystalline cellulose, Eudragit L30D-55 dispersion, hypromellose, triacetin ,calcium stearate, talc,iron oxide red,iron oxide yellow,FD&C blue 2,titanium dioxide,gelatin and trace amounts of black edible ink (containing:shellac,dehydrated alcohol,isopropyl alcohol,butyl alcohol,propylene glycol,strong ammonia solution,black iron oxide and potassium hydroxide). Manufactured by: Alkem Laboratories Ltd., INDIA. Manufactured for: AvKARE Pulaski, TN 38478 Revised: May 2025

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL