NITRO-TIME 6.5 mg/1

NITROGLYCERIN · CAPSULE · TIME CAP LABORATORIES, INC

No Recall HistoryCurrently in Shortage

Plain English

NITRO-TIME is a capsule containing nitroglycerin at 6.5 mg/1, taken oral. Manufactured by TIME CAP LABORATORIES, INC.

Key Facts

Brand Name: NITRO-TIME
Generic Name: NITROGLYCERIN
NDC Code (Product): 49483-222
Manufacturer: TIME CAP LABORATORIES, INC
Strength: 6.5 mg/1
Dosage Form: CAPSULE
Route: ORAL
Marketing Status
Drug Class: Nitrate Vasodilator [EPC]
Marketing Start: 06/19/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea3,358 reports

pain3,091 reports

myocardial infarction2,685 reports

fatigue2,681 reports

nausea2,573 reports

fall2,373 reports

chest pain2,331 reports

dizziness2,302 reports

drug ineffective2,276 reports

headache2,097 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE: 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.

Dosage & Administration

DOSAGE AND ADMINISTRATION: As noted above (CLINICAL PHARMACOLOGY) , careful studies with other formulations of nitroglycerin have shown that maintenance of continuous 24-hour plasma levels of nitroglycerin result in tolerance (i.e. loss of clinical response). Every dosing regimen for Nitroglycerin Extended-Release Capsules should provide a daily nitrate-free interval 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 10-12 hours is sufficient. Large controlled studies with other formulations of nitroglycerin show that no dosing regimen with Nitroglycerin Extended-Release 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 d…

Contraindications

CONTRAINDICATIONS: Allergic reactions to organic nitrates are extremely rare, but they do occur. Nitroglycerin is contraindicated in patients who are allergic to it. Do not use nitroglycerin extended-release capsules in patients who are taking phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil) for erectile dysfunction or pulmonary arterial hypertension.Concomitant use can cause severe drops in blood pressure. Do not use nitroglycerin extended-release capsules in patients who are taking soluble guanylate cyclase stimulators (such as riociguat). Concomitant use can cause hypotension.

Drug Interactions

Drug interactions: The vasodilating effects of nitroglycerin may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety. Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

Adverse Reactions

ADVERSE REACTIONS: Adverse reactions to nitroglycerin are generally dose-related, and almost all of these reactions are the result of nitroglycerin's activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon. Allergic reactions to nitroglycerin are also uncommon, and the great majority of those reported have been cases of contact dermatitis or fixed drug eruptions in patients receiving nitroglycerin in ointments or patches. There have been a few reports of genuine anaphylactoid reactions, and these reactions can probably occur in patients receiving nitroglycerin by any route. Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal seeming patients; for further discussion of its diagnosis and treatment see OVERDOSAGE. Data are not…

Frequently Asked Questions

What is NITRO-TIME used for?

NITRO-TIME contains NITROGLYCERIN. It is a capsule taken oral. Consult your doctor for specific uses.

Is NITRO-TIME a controlled substance?

NITRO-TIME is not classified as a controlled substance by the DEA.

What is the generic name for NITRO-TIME?

The generic name for NITRO-TIME is NITROGLYCERIN. There are 11 other brand versions of NITROGLYCERIN.

What is the NDC code for NITRO-TIME 6.5 mg/1?

The NDC (National Drug Code) for NITRO-TIME 6.5 mg/1 is 49483-222, listed by TIME CAP LABORATORIES, INC.

Product NDC

49483-222

Package NDC

49483-222-06

Other Nitroglycerin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)