Nitro-time
Loading...Nitro-time Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
The benefits of oral nitroglycerin in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use nitroglycerin in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.
Because the effects of capsules are so difficult to terminate rapidly, they are not recommended in these settings.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
History
There is currently no drug history available for this drug.
Other Information
Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is:
The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg, or 9 mg of Nitroglycerin.
The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose monohydrate, pharmaceutical glaze, sugar, talc, and wax. Additionally the 2.5 mg capsule contains FD&C Blue #1, D&C Yellow #10, FD&C Red #40, D&C Red #28; the 6.5 mg capsule contains D&C Yellow #10, FD&C Yellow #6, FD&C Blue #1, D&C Red #33; the 9 mg capsule contains D&C Yellow #10, FD&C Yellow #6, FD&C Green #3, and titanium dioxide.
Sources
Nitro-time Manufacturers
-
Major Pharmaceuticals
![Nitro-time (Nitroglycerin) Capsule [Major Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Nitro-time | Major Pharmaceuticals
As noted above (CLINICAL PHARMACOLOGY) careful studies with other formulations of nitroglycerin have shown that maintenance of continuous 24-hour plasma levels of nitroglycerin results in tolerance (i.e., loss of clinical response). Every dosing regimen for Nitroglycerin Extended-Release Capsules should provide a daily nitrate-free interval to avoid the development of this tolerance. The minimum necessary length of such an interval has not been defined, but studies with other nitroglycerin formulations have shown that 10 to 12 hours is sufficient. Large controlled studies with other formulations of nitroglycerin show that no dosing regimen with Nitroglycerin Extended-Release Capsules should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.
The pharmacokinetics of Nitroglycerin capsules, and the clinical effects of multiple-dose regimens, have not been well studied. In clinical trials, the initial regimen of Nitroglycerin has been 2.5 to 6.5 mg three to four times a day, with subsequent upward dose adjustment guided by symptoms and side effects. In one trial, 5 of the 18 subjects were titrated up to a dose of 26 mg four times a day.
-
Time Cap Laboratories, Inc
Nitro-time | Time Cap Laboratories, Inc
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Carilion Materials Management
Nitro-time | Carilion Materials Management
As noted above ( ) careful studies with other formulations of nitroglycerin have shown that maintenance of continuous 24-hour plasma levels of nitroglycerin results in tolerance (i.e., loss of clinical response). Every dosing regimen for Nitroglycerin Extended-Release Capsules should provide a daily nitrate-free interval to avoid the development of this tolerance. The minimum necessary length of such an interval has not been defined, but studies with other nitroglycerin formulations have shown that 10 to 12 hours is sufficient. Large controlled studies with other formulations of nitroglycerin show that no dosing regimen with Nitroglycerin Extended-Release Capsules should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day. CLINICAL PHARMACOLOGY
The pharmacokinetics of Nitroglycerin capsules, and the clinical effects of multiple-dose regimens, have not been well studied. In clinical trials, the initial regimen of Nitroglycerin has been 2.5 to 6.5 mg three to four times a day, with subsequent upward dose adjustment guided by symptoms and side effects. In one trial, 5 of the 18 subjects were titrated up to a dose of 26 mg four times a day.
-
Carilion Materials Management
Nitro-time | Carilion Materials Management
As noted above ( ) careful studies with other formulations of nitroglycerin have shown that maintenance of continuous 24-hour plasma levels of nitroglycerin results in tolerance (i.e., loss of clinical response). Every dosing regimen for Nitroglycerin Extended-Release Capsules should provide a daily nitrate-free interval to avoid the development of this tolerance. The minimum necessary length of such an interval has not been defined, but studies with other nitroglycerin formulations have shown that 10 to 12 hours is sufficient. Large controlled studies with other formulations of nitroglycerin show that no dosing regimen with Nitroglycerin Extended-Release Capsules should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day. CLINICAL PHARMACOLOGY
The pharmacokinetics of Nitroglycerin capsules, and the clinical effects of multiple-dose regimens, have not been well studied. In clinical trials, the initial regimen of Nitroglycerin has been 2.5 to 6.5 mg three to four times a day, with subsequent upward dose adjustment guided by symptoms and side effects. In one trial, 5 of the 18 subjects were titrated up to a dose of 26 mg four times a day.
-
Carilion Materials Management
Nitro-time | Carilion Materials Management
As noted above ( ) careful studies with other formulations of nitroglycerin have shown that maintenance of continuous 24-hour plasma levels of nitroglycerin results in tolerance (i.e., loss of clinical response). Every dosing regimen for Nitroglycerin Extended-Release Capsules should provide a daily nitrate-free interval to avoid the development of this tolerance. The minimum necessary length of such an interval has not been defined, but studies with other nitroglycerin formulations have shown that 10 to 12 hours is sufficient. Large controlled studies with other formulations of nitroglycerin show that no dosing regimen with Nitroglycerin Extended-Release Capsules should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day. CLINICAL PHARMACOLOGY
The pharmacokinetics of Nitroglycerin capsules, and the clinical effects of multiple-dose regimens, have not been well studied. In clinical trials, the initial regimen of Nitroglycerin has been 2.5 to 6.5 mg three to four times a day, with subsequent upward dose adjustment guided by symptoms and side effects. In one trial, 5 of the 18 subjects were titrated up to a dose of 26 mg four times a day.
![Nitro-time (Nitroglycerin) Capsule [Time Cap Laboratories, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3c11c1c2-8e62-4f63-8293-2f8b8d845f7e&name=25.jpg)
![Nitro-time (Nitroglycerin) Capsule [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d308e2b0-9526-4efc-9566-a33717a87bcc&name=68151-1738.jpg)
![Nitro-time (Nitroglycerin) Capsule [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=93ee7bb4-4be0-45a4-8f5b-6b17c9f8cfdf&name=68151-2502.jpg)
![Nitro-time (Nitroglycerin) Capsule [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=04fa3e36-e782-4b33-bc1d-a3ca0990f490&name=68151-2503.jpg)
Login To Your Free Account