FDA Approval of Isosorbide Mononitrate Extended-Release Tablets
The FDA has approved Isosorbide Mononitrate Extended-Release Tablets‚ with varying dissolution acceptance criteria from USP standards. Long-term use revealed continued improvement in exercise performance. The tablets contain either 30mg or 60mg of Isosorbide Mononitrate and are recommended to be taken daily in specified doses.
Details of FDA Approval
The FDA has approved Isosorbide Mononitrate Extended-Release Tablets‚ with unique dissolution acceptance criteria compared to USP standards. Clinical trials demonstrated the tablets’ long-term benefits in improving exercise performance. The manufacturer‚ Elan Pharmaceutical Research Corp.‚ received approval for application No. 75-041 on 9/22/1998‚ marking a significant milestone in pharmaceutical development. For dosing‚ the tablets contain either 30mg or 60mg of Isosorbide Mononitrate‚ with specific dosage recommendations for optimal efficacy.
Composition and Dosage Information
Isosorbide Mononitrate Extended-Release Tablets come in two strengths⁚ 30mg and 60mg. These tablets have unique dissolution acceptance criteria approved by the FDA‚ differing from USP standards. The recommended dosages are 30mg daily or 60mg once daily‚ with the possibility of increasing to 120mg based on individual response. Consult a healthcare provider for proper usage guidance.
Contents of Isosorbide Mononitrate Tablets
Isosorbide Mononitrate Extended-Release Tablets are formulated in strengths of 30mg and 60mg. The tablets have unique dissolution acceptance criteria approved by the FDA‚ differing from USP standards. These extended-release tablets offer a gradual release of medication over 8 to 10 hours‚ allowing for sustained efficacy in preventing angina attacks. Consult a healthcare provider for personalized dosing recommendations based on individual needs.
Recommended Dosage Guidelines
The recommended starting dose for Isosorbide Mononitrate Extended-Release Tablets is either 30mg daily or 60mg once daily. Patients can begin with a single 30mg tablet or a 60mg tablet‚ depending on the prescribed strength. Dosage adjustments may increase to 120mg taken once daily‚ either as a single 120mg tablet or two 60mg tablets‚ under medical supervision.
Pharmacological Action of Isosorbide Mononitrate
Isosorbide Mononitrate Extended-Release Tablets‚ approved by the FDA‚ show vasodilator effects on both arteries and veins‚ aiming to increase blood and oxygen supply to the heart. This medication belongs to the nitrate group and works by reducing the heart’s workload‚ thereby preventing chest pain (angina) episodes efficiently;
Mechanism of Action
Isosorbide Mononitrate Extended-Release Tablets exert their pharmacological effects through vasodilation of both arteries and veins. By increasing blood flow and oxygen delivery to the heart‚ this nitrate compound reduces the cardiac workload‚ effectively preventing angina episodes. The tablets provide sustained release over 8 to 10 hours‚ ensuring prolonged action in managing angina symptoms.
Isosorbide Mononitrate Extended-Release Tablets‚ during long-term use at a dose of 120mg once daily‚ showed sustained improvement in exercise performance at both 4 hours and 12 hours post-dosing. The tablets’ efficacy in enhancing exercise capacity over 42 days was consistent‚ indicating potential benefits for individuals with angina.
Clinical Trials and Efficacy
An analysis of long-term use of Isosorbide Mononitrate Extended-Release Tablets at 120mg once daily over 42 days highlighted a consistent improvement in exercise performance at both 4 hours and 12 hours post-dosing. The tablets showcased sustained efficacy‚ indicating potential benefits for individuals suffering from angina.
Manufacturing and Company Information
Elan Pharmaceutical Research Corp. manufactured Isosorbide Mononitrate Extended-Release Tablets. The FDA approved application No. 75-041 on 9/22/1998. The tablets come in strengths of 30mg and 60mg‚ following unique dissolution acceptance criteria separate from USP standards.
Manufacturer⁚ Elan Pharmaceutical Research Corp.
Elan Pharmaceutical Research Corp. is the manufacturer of Isosorbide Mononitrate Extended-Release Tablets. The FDA approved application No. 75-041 on 9/22/1998 for these tablets‚ which come in strengths of 30mg and 60mg. The efficacy of the tablets and their formulation have been validated to meet regulatory standards.
Application No.⁚ 75-041
Elan Pharmaceutical Research Corp. received FDA approval for Isosorbide Mononitrate Extended-Release Tablets under application No. 75-041 on 9/22/1998. The tablets are available in strengths of 30mg and 60mg‚ offering sustained efficacy with unique dissolution acceptance criteria different from USP standards.
Dissolution Criteria Variance
The FDA-approved dissolution acceptance criteria for Isosorbide Mononitrate Extended-Release 30mg and 60mg Tablets differ from those of the USP. Clinical data validated this variance‚ showing sustained improvement in exercise performance at both 4 hours and 12 hours post-dosing during long-term use over 42 days at a dose of 120mg once daily.
Differences in Dissolution Acceptance Criteria
The FDA-approved dissolution acceptance criteria for Isosorbide Mononitrate Extended-Release 30mg and 60mg Tablets diverge from those of the USP standards. Long-term use over 42 days at a dose of 120mg once daily showcased continued improvement in exercise performance at both 4 hours and 12 hours post-dosing.
Revision of Monograph and Expert Committee Involvement
The revision of the Isosorbide Mononitrate Extended-Release Tablets monograph involved the Expert Committee introducing Dissolution Test 7 to align with FDA-approved drug products having different tolerances than the existing dissolution tests. The revision aims to enhance regulatory compliance and ensure consistent efficacy of the tablets.
Revision of Isosorbide Mononitrate Extended-Release Tablets Monograph
The revision of the Isosorbide Mononitrate Extended-Release Tablets monograph involved updating Dissolution Test 2 to align with FDA-approved drug products that have different tolerances. The purpose of the revision is to enhance regulatory compliance and ensure consistent efficacy of the tablets.
Alternative Approaches and Contact Information
Alternative approaches can be pursued for FDA-approved drug products with distinct dissolution acceptance criteria or dosage forms compared to conventional standards. Please refer to the provided contacts for further guidance.
Information on Alternative Approaches
When dealing with FDA-approved drug products exhibiting unique dissolution acceptance criteria or dosage forms compared to conventional standards‚ considering alternative approaches is essential. If seeking guidance‚ do not hesitate to reach out using the provided contact information.
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