Alfuzosin hydrochloride

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Overview

What is Alfuzosin hydrochloride?

Each alfuzosin hydrochloride extended-release tablet, USP contains 10 mg alfuzosin hydrochloride, USP as the active ingredient. Alfuzosin hydrochloride is a white to almost white powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane.

Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino]propyl]tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is CHNO•HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is:

The tablet also contains the following inactive ingredients: hypromellose, lactose monohydrate, povidone, colloidal silicon dioxide and magnesium stearate.

Meets USP Dissolution test 4

What does Alfuzosin hydrochloride look like?

What are the available doses of Alfuzosin hydrochloride?

Alfuzosin hydrochloride extended-release tablets 10 mg are available as white round, beveled edged tablets with '155' debossed on one side and "U" debossed on other side.

What should I talk to my health care provider before I take Alfuzosin hydrochloride?

How should I use Alfuzosin hydrochloride?

Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.

What interacts with Alfuzosin hydrochloride?

Sorry No Records found

What are the warnings of Alfuzosin hydrochloride?

Sorry No Records found

What are the precautions of Alfuzosin hydrochloride?

Sorry No Records found

What are the side effects of Alfuzosin hydrochloride?

Sorry No records found

What should I look out for while using Alfuzosin hydrochloride?

Moderate or severe hepatic impairment (, , )

Co-administration with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) (, , , )

Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or any of the ingredients (, )

What might happen if I take too much Alfuzosin hydrochloride?

Should overdose of alfuzosin hydrochloride extended-release tablets lead to hypotension, 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 the administration of intravenous fluids should be considered. If necessary, vasopressors should then be used, and the renal function should be monitored and supported as needed. Alfuzosin is 82% to 90% protein bound; therefore, dialysis may not be of benefit.

How should I store and handle Alfuzosin hydrochloride?

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.Afluzosin Hydrochloride Extended-Release Tablets, USP 10 mg White, round, beveled edged tablets with '155' debossed on one side and 'U' debossed on other side.Bottles of 30 : NDC 29300-155-13Bottles of 90 : NDC 29300-155-19Bottles of 100 : NDC 29300-155-01Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from light and moisture.Keep this and all drugs out of reach of children. Afluzosin Hydrochloride Extended-Release Tablets, USP 10 mg White, round, beveled edged tablets with '155' debossed on one side and 'U' debossed on other side.Bottles of 30 : NDC 29300-155-13Bottles of 90 : NDC 29300-155-19Bottles of 100 : NDC 29300-155-01Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from light and moisture.Keep this and all drugs out of reach of children. Afluzosin Hydrochloride Extended-Release Tablets, USP 10 mg White, round, beveled edged tablets with '155' debossed on one side and 'U' debossed on other side.Bottles of 30 : NDC 29300-155-13Bottles of 90 : NDC 29300-155-19Bottles of 100 : NDC 29300-155-01Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from light and moisture.Keep this and all drugs out of reach of children. Afluzosin Hydrochloride Extended-Release Tablets, USP 10 mg White, round, beveled edged tablets with '155' debossed on one side and 'U' debossed on other side.Bottles of 30 : NDC 29300-155-13Bottles of 90 : NDC 29300-155-19Bottles of 100 : NDC 29300-155-01Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from light and moisture.Keep this and all drugs out of reach of children. Afluzosin Hydrochloride Extended-Release Tablets, USP 10 mg White, round, beveled edged tablets with '155' debossed on one side and 'U' debossed on other side.Bottles of 30 : NDC 29300-155-13Bottles of 90 : NDC 29300-155-19Bottles of 100 : NDC 29300-155-01Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from light and moisture.Keep this and all drugs out of reach of children. Afluzosin Hydrochloride Extended-Release Tablets, USP 10 mg White, round, beveled edged tablets with '155' debossed on one side and 'U' debossed on other side.Bottles of 30 : NDC 29300-155-13Bottles of 90 : NDC 29300-155-19Bottles of 100 : NDC 29300-155-01Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from light and moisture.Keep this and all drugs out of reach of children. Afluzosin Hydrochloride Extended-Release Tablets, USP 10 mg White, round, beveled edged tablets with '155' debossed on one side and 'U' debossed on other side.Bottles of 30 : NDC 29300-155-13Bottles of 90 : NDC 29300-155-19Bottles of 100 : NDC 29300-155-01Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from light and moisture.Keep this and all drugs out of reach of children. Afluzosin Hydrochloride Extended-Release Tablets, USP 10 mg White, round, beveled edged tablets with '155' debossed on one side and 'U' debossed on other side.Bottles of 30 : NDC 29300-155-13Bottles of 90 : NDC 29300-155-19Bottles of 100 : NDC 29300-155-01Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from light and moisture.Keep this and all drugs out of reach of children.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Alfuzosin is a selective antagonist of post-synaptic alpha-adrenoreceptors, which are located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra.

Non-Clinical Toxicology

Moderate or severe hepatic impairment (, , )

Co-administration with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) (, , , )

Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or any of the ingredients (, )

Cytochrome inducers/inhibitors:

HMG-CoA reductase inhibitors:

Co-administration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone. Limit the dose of simvastatin in patients on verapamil to 10 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs.

Ivabradine:

Aspirin:

Grapefruit juice:

Alcohol:

Beta-blockers:

In one study involving 15 patients treated with high doses of propranolol (median dose: 480 mg/day; range: 160 to 1,280 mg/day) for severe angina, with preserved left ventricular function (ejection fraction greater than 35%), the hemodynamic effects of additional therapy with verapamil HCl were assessed using invasive methods. The addition of verapamil to high-dose beta-blockers induced modest negative inotropic and chronotropic effects that were not severe enough to limit short-term (48 hours) combination therapy in this study. These modest cardiodepressant effects persisted for greater than 6 but less than 30 hours after abrupt withdrawal of beta-blockers and were closely related to plasma levels of propranolol. The primary verapamil/beta-blocker interaction in this study appeared to be hemodynamic rather than electrophysiologic.

In other studies, verapamil did not generally induce significant negative inotropic, chronotropic, or dromotropic effects in patients with preserved left ventricular function receiving low or moderate doses of propranolol (less than or equal to 320 mg/day); in some patients, however, combined therapy did produce such effects. Therefore, if combined therapy is used, close surveillance of clinical status should be carried out. Combined therapy should usually be avoided in patients with atrioventricular conduction abnormalities and those with depressed left ventricular function.

Asymptomatic bradycardia (36 beats/min) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta-adrenergic blocker) eyedrops and oral verapamil.

A decrease in metoprolol and propranolol clearance has been observed when either drug is administered concomitantly with verapamil. A variable effect has been seen when verapamil and atenolol were given together.

Digitalis:

Antihypertensive agents:

Antiarrhythmic agents:

The electrophysiologic effects of quinidine and verapamil on AV conduction were studied in 8 patients. Verapamil significantly counteracted the effects of quinidine on AV conduction. There has been a report of increased quinidine levels during verapamil therapy.

Other agents:

Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of alfuzosin hydrochloride extended-release tablets. As with other alpha adrenergic antagonists, there is a potential for syncope. Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result should syncope occur. There may be an increased risk of hypotension/postural hypotension and syncope when taking alfuzosin hydrochloride extended-release tablets concomitantly with anti-hypertensive medication and nitrates. Care should be taken when alfuzosin hydrochloride extended-release tablets are administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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