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I2326e-if2326e- savage nitrobid

NITRO-BID®
NITRO-BID
FOR TOPICAL USE ONLY
can result in severe hypotension. The time course and dose dependence of this
diarrhea); syncope (especially in the upright posture); air hunger and dyspnea, later DESCRIPTION: Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate
interaction have not been studied. Appropriate supportive care has not been stud-
followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold ied, but it seems reasonable to treat this as a nitrate overdose, with elevation of
and clammy; heart block and bradycardia; paralysis; coma; seizures; and death.
the extremities and with central volume expansion.
Laboratory determinations of serum levels of nitroglycerin and its metabolites are not The benefits of transdermal nitroglycerin in patients with acute myocardial infarction widely available, and such determinations have, in any event, no established role in or congestive heart failure have not been established. If one elects to use nitroglyc- the management of nitroglycerin overdose.
erin in these conditions, careful clinical or hemodynamic monitoring must be used to No data are available to suggest physiological maneuvers (e.g., maneuvers to change avoid the hazards of hypotension and tachycardia.
the pH of the urine) that might accelerate elimination of nitroglycerin and its active and whose molecular weight is 227.09. The organic nitrates are vasodilators, metabolites. Similarly, it is not known which—if any—of these substances can use- PRECAUTIONS: General: Severe hypotension, particularly with upright posture, may
fully be removed from the body by hemodialysis.
NITRO-BID® for topical use contains lactose and 2% nitroglycerin in a base of occur with even small doses of nitroglycerin. This drug should therefore be used with No specific antagonist to the vasodilator effects of nitroglycerin is known, and no lanolin, white petrolatum and purified water. Each inch (2.5 cm), as squeezed caution in patients who may be volume depleted or who, for whatever reason, are intervention has been subject to controlled study as a therapy of nitroglycerin over- from the tube, contains approximately 15 mg of nitroglycerin.
already hypotensive. Hypotension induced by nitroglycerin may be accompanied by dose. Because the hypotension associated with nitroglycerin overdose is the result of paradoxical bradycardia and increased angina pectoris.
venodilatation and arterial hypovolemia, prudent therapy in this situation should be CLINICAL PHARMACOLOGY: The principal pharmacological action of nitroglyc-
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
directed toward increase in central fluid volume. Passive elevation of the patient’s legs erin is relaxation of vascular smooth muscle and consequent dilatation of periph- As tolerance to other forms of nitroglycerin develops, the effect of sublingual nitro- may be sufficient, but intravenous infusion of normal saline or similar fluid may also eral arteries and veins, especially the latter. Dilatation of the veins promotes glycerin on exercise tolerance, although still observable, is somewhat blunted. In peripheral pooling of blood and decreases venous return to the heart, thereby industrial workers who have had long-term exposure to unknown (presumably high) The use of epinephrine or the arterial vasoconstrictors in this setting is likely to do reducing left ventricular end-diastolic pressure and pulmonary capillary wedge doses of organic nitrates, tolerance clearly occurs. Chest pains, acute myocardial pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, infarction, and even sudden death have occurred during temporary withdrawal of In patients with renal disease or congestive heart failure, therapy resulting in central systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the nitrates from these workers, demonstrating the existence of true physical depen- volume expansion is not without hazard. Treatment of nitroglycerin overdose in these coronary arteries also occurs. The relative importance of preload reduction, after- patients may be subtle and difficult, and invasive monitoring may be required.
load reduction, and coronary dilatation remains undefined.
Some clinical trials in angina patients have provided nitroglycerin for about 12 con- Methemoglobinemia: Nitrate ions liberated during metabolism of nitroglycerin can
Dosing regimens for most chronically used drugs are designed to provide plas- tinuous hours of every 24-hour day. During the nitrate-free intervals in some of these oxidize hemoglobin into methemoglobin. Even in patients totally without cytochrome ma concentrations that are continuously greater than a minimally effective con- trials, anginal attacks have been more easily provoked than before treatment, and centration. This strategy is inappropriate for organic nitrates. Several well-con- 5 reductase activity, however, and even assuming that the nitrate moieties of nitro- patients have demonstrated hemodynamic rebound and decreased exercise tolerance.
glycerin are quantitatively applied to oxidation of hemoglobin, about 1 mg/kg of nitro- trolled clinical trials have used exercise testing to assess the anti-anginal effica- The importance of these observations to the routine, clinical use of transdermal nitro- glycerin should be required before any of these patients manifests clinically significant cy of continuously-delivered nitrates. In the large majority of these trials, active (> 10%) methemoglobinemia. In patients with normal reductase function, significant agents were indistinguishable from placebo after 24 hours (or less) of continu- Information for Patients: Daily headaches sometimes accompany treatment with
production of methemoglobin should require even larger doses of nitroglycerin. In ous therapy. Attempts to overcome nitrate tolerance by dose escalation, even to nitroglycerin. In patients who get these headaches, the headaches are a marker of the one study in which 36 patients received 2 to 4 weeks of continuous nitroglycerin ther- doses far in excess of those used acutely, have consistently failed. Only after activity of the drug. Patients should resist the temptation to avoid headaches by alter- apy at 3.1 to 4.4 mg/hr, the average methemoglobin level measured was 0.2%; this nitrates had been absent from the body for several hours was their anti-anginal ing the schedule of their treatment with nitroglycerin, since loss of headache is likely was comparable to that observed in parallel patients who received placebo.
to be associated with simultaneous loss of antianginal efficacy.
Notwithstanding these observations, there are case reports of significant methemo- Pharmacokinetics: The volume of distribution of nitroglycerin is about 3
Treatment with nitroglycerin may be associated with lightheadedness on standing, globinemia in association with moderate overdoses of organic nitrates. None of the L/kg, and nitroglycerin is cleared from this volume at extremely rapid rates, with especially just after rising from a recumbent or seated position. This effect may be affected patients had been thought to be unusually susceptible.
a resulting serum half-life of about three minutes. The observed clearance rates more frequent in patients who have also consumed alcohol. Patient instruction leaflet Methemoglobin levels are available from most clinical laboratories. The diagnosis (close to 1 L/kg/min) greatly exceed hepatic blood flow; known sites of extra- should be suspected in patients who exhibit signs of impaired oxygen delivery despite hepatic metabolism include red blood cells and vascular walls.
adequate cardiac output and adequate arterial pO2. Classically, methemoglobinemic The first products in the metabolism of nitroglycerin are inorganic nitrate and the Drug Interactions: The vasodilating effects of nitroglycerin may be additive with those
blood is described as chocolate brown, without color change on exposure to air.
1,2- and 1,3-dinitroglycerols. The dinitrates are less effective vasodilators than of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects When methemoglobinemia is diagnosed, the treatment of choice is methylene blue, nitroglycerin, but they are longer-lived in the serum, and their net contribution to the overall effect of chronic nitroglycerin regimens is not known. The dinitrates Marked symptomatic orthostatic hypotension has been reported when calcium chan- are further metabolized to (non-vasoactive) mononitrates and, ultimately, to glyc- nel blockers and organic nitrates were used in combination. Dose adjustments of DOSAGE AND ADMINISTRATION: As noted above (CLINICAL PHARMACOLOGY), con-
either class of agents may be necessary.
trolled trials have demonstrated that nitroglycerin ointment can effectively reduce To avoid development of tolerance to nitroglycerin, drug-free intervals of 10 Carcinogenesis, Mutagenesis, and Impairment of Fertility: Studies to evaluate the
exercise-related angina for up to 7 hours after a single application. Doses used in clin- - 12 hours are known to be sufficient; shorter intervals have not been well stud- carcinogenic or mutagenic potential of nitroglycerin have not been performed.
ical trials have ranged from 1/2 inch (1.3 cm; 7.5 mg) to 2 inches (5.1 cm; 30 mg), ied. In one well-controlled clinical trial, subjects receiving nitroglycerin appeared Nitroglycerin's effect upon reproductive capacity is similarly unknown.
typically applied to 36 square inches (232 square centimeters) of truncal skin.
to exhibit a rebound or withdrawal effect, so that their exercise tolerance at the Pregnancy Category C: Animal reproduction studies have not been conducted with
It is reasonable to believe that the rate and extent of nitroglycerin absorption from end of the daily drug-free interval was less than that exhibited by the parallel group nitroglycerin. It is also not known whether nitroglycerin can cause fetal harm when ointment may vary with the site and square measure of the skin over which a given administered to a pregnant woman or whether it can affect reproductive capacity.
dose of ointment is spread, but these relationships have not been adequately studied.
Reliable assay techniques for plasma nitroglycerin levels have only recently Nitroglycerin should be given to a pregnant woman only if clearly needed.
Controlled trials with other formulations of nitroglycerin have demonstrated that if become available, and studies using these techniques to define the pharmacoki- plasma levels are maintained continuously, all anti-anginal efficacy is lost within 24 netics of nitroglycerin ointment have not been reported. Published studies using Nursing Mothers: It is not known whether nitroglycerin is excreted in human milk.
hours. This tolerance cannot be overcome by increasing the dose of nitroglycerin. As older techniques provide results that often differ, in similar experimental settings, Because many drugs are excreted in human milk, caution should be exercised when a result, any regimen of NITRO-BID® administration should include a daily nitrate- by an order of magnitude. The data are consistent, however, in suggesting that nitroglycerin is administered to a nursing woman.
free interval. The minimum necessary length of such an interval has not been defined, nitroglycerin levels rise to steady state within an hour or so of application of oint- but studies with other nitroglycerin formulations have shown that 10 to 12 hours is ment, and that after removal of nitroglycerin ointment, levels wane with a half-life Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Thus, one appropriate dosing schedule for NITRO-BID® would begin with two daily The onset of action of transdermal nitroglycerin is not sufficiently rapid for this ADVERSE REACTIONS: Adverse reactions to nitroglycerin are generally dose-related,
1/2- inch (7.5 mg) doses, one applied on rising in the morning and one applied six product to be useful in aborting an acute anginal episode.
and almost all of these reactions are the result of nitroglycerin’s activity as a vasodila- hours later. The dose could be doubled, and even doubled again, in patients tolerat- The maximal achievable daily duration of anti-anginal activity provided by nitro- tor. Headache, which may be severe, is the most commonly reported side effect.
ing this dose but failing to respond to it. The foilpac is intended as a unit dose pack- glycerin ointment therapy has not been studied. Recent studies of other formu- Headache may be recurrent with each daily dose, especially at higher doses. Transient age only and is equivalent to approximately 1 inch as squeezed from the tube. Use lations of nitroglycerin suggest that the maximal achievable daily duration of anti- episodes of lightheadedness, occasionally related to blood pressure changes, may entire contents of foilpac to obtain full dose and discard immediately after use.
anginal effect from nitroglycerin ointment will be about 12 hours.
also occur. Hypotension occurs infrequently, but in some patients it may be severe Each tube of ointment and each box of foilpacs is supplied with a pad of ruled, imper- It is reasonable to believe that the rate and extent of nitroglycerin absorption from enough to warrant discontinuation of therapy. Syncope, crescendo angina, and meable, paper applicators. These applicators allow ointment to be absorbed through ointment may vary with the site and square measure of the skin over which a given rebound hypertension have been reported but are uncommon.
a much smaller area of skin than that used in any of the reported clinical trials, and dose of ointment is spread, but these relationships have not been adequately studied.
Allergic reactions to nitroglycerin are also uncommon, and the great majority of those the significance of this difference is not known. To apply the ointment using one of reported have been cases of contact dermatitis or fixed drug eruptions in patients the applicators, place the applicator on a flat surface, printed side down. Squeeze the Clinical Trials: Controlled trials have demonstrated that nitroglycerin ointment can
receiving nitroglycerin in ointments or patches. There have been a few reports of gen- necessary amount of ointment from the tube onto the applicator, place the applicator effectively reduce exercise-related angina for up to 7 hours after a single application.
uine anaphylactoid reactions, and these reactions can probably occur in patients (ointment side down) on the desired area of the skin, and tape the applicator into place.
Doses used in clinical trials have ranged from 1/2 inch (1.3 cm; 7.5 mg) to 2 inches (5.1cm; 30 mg), typically applied to 36 square inches (232 square centimeters) of truncal skin.
receiving nitroglycerin by any route.
In some controlled trials of other organic nitrate formulations, efficacy has declined Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia HOW SUPPLIED: NITRO-BID® (Nitroglycerin Ointment USP, 2%), is a pale yellow
with time. Because controlled, long-term trials of nitroglycerin ointment have not been in normal-seeming patients; for further discussion of its diagnosis and treatment see ointment. (Package includes a supply of ruled applicators for convenient application.) reported, it is not known how the efficacy of nitroglycerin ointment may vary during OVERDOSAGE.
Data are not available to allow estimation of the frequency of adverse reactions dur- INDlCATlONS AND USAGE: Nitroglycerin ointment is indicated for the prevention of
ing treatment with nitroglycerin ointment.
angina pectoris due to coronary artery disease. The onset of action of transdermalnitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute Close tightly, immediately after each use.
OVERDOSAGE: Hemodynamic Effects: The ill effects of nitroglycerin overdose are
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].
generally the results of nitroglycerin’s capacity to induce vasodilation, venous pool- CONTRAINDICATIONS: Allergic reactions to organic nitrates are extremely rare, but
ing, reduced cardiac output, and hypotension. These hemodynamic changes may they do occur. Nitroglycerin is contraindicated in patients who are allergic to it.
have protean manifestations, including increased intracranial pressure, with any or all SAVAGE LABORATORIES®
of persistent throbbing headache, confusion, and moderate fever; vertigo; palpita- WARNINGS: Amplification of the vasodilatory effects of nitroglycerin by sildenafil
tions; visual disturbances; nausea and vomiting (possibly with colic and even bloody PATIENT INSTRUCTIONS FOR APPLICATIONS
Measure desired dosage of Nitroglycerin Ointment 2% by means of the dose measuring appli- Dosage Instructions: Dosage instructions should be obtained from your physician. One
cator supplied with the tube. Place the applicator on a flat surface, printed side down. Squeeze appropriate dosing schedule for NITRO-BID would begin with two daily 1/2 inch (7.5 mg) the necessary amount of ointment from the tube onto the applicator, and place the applicator doses, one applied on rising in the morning and one applied six hours later. The dose could (ointment side down) on the desired area of the skin.
be doubled, and even doubled again, in patients tolerating this dose but failing to respond toit. The foilpac is intended as a unit dose package only and is equivalent to approximately 1 Spread the ointment using the dose measuring applicator lightly onto the chest or other areas inch as squeezed from the tube. Use entire contents of foilpac to obtain full dose and dis- 2 of skin if preferred. Do not rub into the skin. Coverage of an area approximately the size of the dose measuring applicator (3 1/2” by 2 1/4”) should be sufficient to obtain the desired clinical INFORMATION FOR PATIENTS: Your daily regimen of NITRO-BID administration
should include a nitrate-free period. Studies have shown 10-12 hours is sufficient. The

most common side effect which is encountered is headache. Faintness, flushing and
dizziness may occur, especially when suddenly arising from the recumbent (lying hor-

NOTE: NITRO-BID® can stain clothing. Care should be taken to completely cover the dose izontal) position. If these latter symptoms do occur, it may warrant discontinuation of
measuring applicator with a plastic kitchen wrap.
therapy, and your physician should be notified. For changes in dosage and frequen-
cy of application consult your physician.

TUBE: KEEP TUBE TIGHTLY CLOSED.
foilpac®: DISCARD IMMEDIATELY AFTER USE.
® SAVAGE LABORATORIES®
Store at 20°-25°C (68°-77°F) [See USP Control ed Room Temperature].
A division of Nycomed US Inc.
Melville, New York 11747

Source: http://www.nitro-bid.com/pdfs/nitro-pi.pdf

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