“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Alfuzosin Hydrochloride (Alfuzosin Hydrochloride)

Trade Name : Alfuzosin Hydrochloride

Aidarex Pharmaceuticals LLC

TABLET, EXTENDED RELEASE

Strength 10 mg/1

ALFUZOSIN HYDROCHLORIDE Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Alfuzosin Hydrochloride (Alfuzosin Hydrochloride) which is also known as Alfuzosin Hydrochloride and Manufactured by Aidarex Pharmaceuticals LLC. It is available in strength of 10 mg/1 per ml. Read more

Alfuzosin Hydrochloride (Alfuzosin Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • Indications and Usage () 12/2010Warnings and Precautions, PDE5 inhibitors ()u00a004/2010Warnings and Precautions, Priapism ()u00a012/2010
  • Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
  • Alfuzosin hydrochloride extended-release tablets are not indicated for the treatment of hypertension.n n hydrochloride extended-release tablets are not indicated for use in the pediatric population.
  • Alfuzosin hydrochloride is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. ()u00a0 Important Limitations of Use:n Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. ()Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. (, , )
  • The recommended dosage is one 10 mg alfuzosin hydrochloride extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, alfuzosin hydrochloride extended-release tablets should be taken with food and with the same meal each day. The tablets should not be chewed or crushed.
  • 10 mg once daily with food and with the same meal each day. ()Tablets should not be chewed or crushed (, )
  • Alfuzosin hydrochloride extended-release tablets 10 mg are available as white to off-white, round shaped, biconvex, uncoated tablet debossed with u2018956u2019 on one side and plain on other side.
  • Extended-release tablet: 10 mg ()
  • Alfuzosin hydrochloride extended-release tablets are contraindicated for use:
  • Moderate or severe hepatic impairment (, , )
  • Coadministration with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) (, , , )
  • Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or any of the ingredients (, )
  • No data
  • Postural hypotension/syncope: Care should be taken in patients with symptomatic hypotension or who have had a hypotensive response to other medications or are concomitantly treated with antihypertensive medication or nitrates ()
  • Use with caution in patients with severe renal impairment (creatinine clearance <30 mL/min) (, , )
  • Use with caution in patients with mild hepatic impairment (, , )
  • Should not be used in combination with other alpha adrenergic antagonists (, )
  • Prostate carcinoma should be ruled out prior to treatment ()
  • Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may require modifications to the surgical technique ()
  • Discontinue alfuzosin hydrochloride extended-release tablets if symptoms of angina pectoris appear or worsen ()
  • Use with caution in patients with a history of QT prolongation or who are taking medications which prolong the QT interval (, )
  • No data
  • Most common adverse reactions in clinical studies (incidence u22652% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue. ()
  • No data
  • Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including alfuzosin hydrochloride, can potentially cause symptomatic hypotension (, )
  • No data
  • 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.
  • Each alfuzosin hydrochloride extended-release tablet contains 10 mg alfuzosin hydrochloride, USP as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240u00b0C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane.u00a0 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 CHNOu2022HCl. The molecular weight of alfuzosin hydrochloride is 425.9.u00a0 n Its structural formula is:
  • No data
  • There was no evidence of a drug-related increase in the incidence of tumors in mice following dietary administration of 100 mg/kg/day alfuzosin for 98 weeks (13 and 15 times the maximum recommended human dose [MRHD] of 10 mg based on AUC of unbound drug), in females and males, respectively. The highest dose tested in female mice may not have constituted a maximally tolerated dose. Likewise, there was no evidence of a drug-related increase in the incidence of tumors in rats following dietary administration of 100 mg/kg/day alfuzosin for 104 weeks (53 and 37 times the MRHD in females and males, respectively).
  • Alfuzosin showed no evidence of mutagenic effect in the Ames and mouse lymphoma assays, and was free of any clastogenic effects in the Chinese hamster ovary cell and in vivo mouse micronucleus assays. Alfuzosin treatment did not induce DNA repair in a human cell line.
  • There was no evidence of reproductive organ toxicity when male rats were administered oral doses of several hundred times (250 mg/kg/day for 26 weeks) the MRHD of alfuzosin. No impairment of fertility was observed following oral (gavage) administration to male rats at doses of up to 125 mg/kg/day for 70 days. Estrous cycling was inhibited in rats and dogs at approximately 12 and 18 times the MRHD respectively (doses of 25 mg/kg and 20 mg/kg, respectively), but did not result in impaired fertility in female rats.
  • Three randomized placebo-controlled, double-blind, parallel-arm, 12-weeku00a0trials were conducted with the 10 mg daily dose of alfuzosin. In these three trials, 1,608 patients [mean age 64.2 years, range 49 to 92 years; Caucasian (96.1%), Black (1.6%), Asian (1.1%), Other (1.2%)] were randomized and 473 patients received alfuzosin hydrochloride extended-release 10 mg tablet daily. Table 4 provides the results of the three trials that evaluated the 10 mg dose.n There were two primary efficacy variables in these three studies. The International Prostate Symptom Score (IPSS, or AUA Symptom Score) consists of seven questions that assess the severity of both irritative (frequency, urgency, nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing or straining) symptoms, with possible scores ranging from 0 to 35 with higher numerical scores on the IPSS total symptom score representing greater severity of symptoms. The second efficacy variable was peak urinary flow rate. The peak flow rate was measured just prior to the next dose in study 2 and on average at 16 hours post-dosing in trials 1 and 3.n There was a statistically significant reduction from baseline to last assessment (Week 12) in the IPSS total symptom score versus placebo in all three studies, indicating a reduction in symptom severity (Table 5 and Figures 2, 3, and 4).
  • Figure 4 u2014 Mean Change from Baseline in IPSS Total Symptom Score: Trial 3
  • Figure 7 u2014 Mean Change from Baseline in Peak Urine Flow Rate (mL/s): Trial 3
  • Alfuzosin hydrochloride extended-release tablets 10 mg are available as white to off white, round shaped, biconvex, uncoated tablet debossed with u2018956u2019 on one side and plain on other side.u00a0Alfuzosin hydrochloride extended-release tablets are supplied as follows:u00a0 Bottles of 30u2019s with Child Resistant Capu2026....................NDC 33261-0994-30Bottles of 60u2019su00a0with Child Resistant Capu2026....................NDC 33261-0994-60Bottles of 90u2019su00a0with Child Resistant Capu2026....................NDCu00a033261-0994-90u00a0 Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 and 30u00b0C (59u00b0 and 86u00b0F) [see USP Controlled Room Temperature].u00a0 Protect from light and moisture.u00a0 Keep alfuzosin hydrochloride extended-release tablets out of reach of children.u00a0Dispense in a tight, light-resistant container as defined in the USP.
  • No data
  • Distributed by:n 1150 Elijah McCoy Drive, Detroit, MI 48202u00a0Manufactured by:n Halol-Baroda Highway,Halol-389 350, Gujarat, India.u00a0
  • Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880
  • ISS. 08/2011PJPI0348A
  • No data

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.