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Nitroglycerin (Nitroglycerin In Dextrose)

Trade Name : Nitroglycerin In Dextrose

Baxter Healthcare Company

INJECTION

Strength 10 mg/100mL

NITROGLYCERIN Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]

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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 Nitroglycerin (Nitroglycerin In Dextrose) which is also known as Nitroglycerin In Dextrose and Manufactured by Baxter Healthcare Company. It is available in strength of 10 mg/100mL per ml. Read more

Nitroglycerin (Nitroglycerin In Dextrose) 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

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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.

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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.

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  • No data
  • Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is
  • whose empiric formula is CHNO, and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins.
  • Dextrose (Dextrose Hydrous, USP) is D-glucose monohydrate, a hexose sugar whose structural formula is
  • whose empiric formula is CHO u2022 HO, and whose molecular weight is 198.17.
  • Dextrose is derived from corn.
  • Nitroglycerin in 5% Dextrose Injection is a sterile, nonpyrogenic solution of nitroglycerin and dextrose in water for injection. The solution is clear and practically colorless. Each 100 mL contains 10 mg, 20 mg, or 40 mg nitroglycerin (added as Diluted Nitroglycerin, USP with propylene glycol); 5 g Dextrose Hydrous, USP; 0.84 mL Alcohol, USP (added as a dissolution aid); and 105 mg Citric Acid Hydrous, USP (added as a buffer). The pH of the solution is adjusted with sodium hydroxide and, if necessary, hydrochloric acid.
  • Although dry nitroglycerin is explosive, nitroglycerin in 5% dextrose is not.
  • Composition, osmolarity and pH are given in Table 1.
  • The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction, and coronary dilatation remains undefined.
  • Dosing regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration. This strategy is inappropriate for organic nitrates. Several well-controlled clinical trials have used exercise testing to assess the anti-anginal efficacy of continuously-delivered nitrates. In the large majority of these trials, active agents were indistinguishable from placebo after 24 hours (or less) of continuous therapy. Attempts to overcome nitrate tolerance by dose escalation, even to doses far in excess of those used acutely, have consistently failed. Only after nitrates have been absent from the body for several hours has their anti-anginal efficacy been restored.
  • Nitroglycerin in 5% Dextrose Injection is indicated for treatment of peri-operative hypertension; for control of heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and u00df-blockers; and for induction of intraoperative hypotension.
  • Nitroglycerin in 5% Dextrose Injection is contraindicated in patients who are allergic to it.
  • In patients with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, cardiac output is dependent upon venous return. Intravenous nitroglycerin is contraindicated in patients with these conditions.
  • Nitroglycerin is also contraindicated in patients with increased intracranial pressure.
  • Do not use Nitroglycerin in 5% Dextrose Injection in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors) such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia.
  • Do not use Nitroglycerin in 5% Dextrose Injection in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
  • Use of PVC (polyvinyl chloride) tubing in infusion sets may lead to loss of active ingredient due to adsorption of nitroglycerin to PVC tubing, therefore dosage is affected (see ). Nitroglycerin adsorption by PVC tubing is increased when the tubing is long, the flow rates are low, and the nitroglycerin concentration of the solution is high. The delivered fraction of the solution's original nitroglycerin content has been 20-60% in published studies using PVC tubing; the fraction varies with time during a single infusion, and no simple correction factor can be used. PVC tubing has been used in most published studies of intravenous nitroglycerin, but the reported doses have been calculated by simply multiplying the flow rate of the solution by the solution's original concentration of nitroglycerin. n
  • Relatively non-adsorptive intravenous administration sets are available. n
  • Some in-line intravenous filters also adsorb nitroglycerin; these filters should be avoided.
  • Solutions containing dextrose without electrolytes should not be administered through the same administration set as blood, as this may result in pseudoagglutination or hemolysis.
  • The intravenous administration of solutions may cause fluid overloading resulting in dilution of serum electrolyte concentrations, overhydration and congested states of pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration of the injections.
  • Severe hypotension and shock may occur with even small doses of nitroglycerin. Monitor patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris.
  • Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
  • Tolerance development and occurrence of cross tolerance to other nitro compounds have been reported.
  • In industrial workers who have long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.
  • Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day. During the nitrate-free intervals in some of these trials, anginal attacks have been more easily provoked than before treatment, and patients have demonstrated hemodynamic rebound and exercise tolerance. The importance of these observations to the routine, clinical use of intravenous nitroglycerin is not known.
  • Lower concentrations of Nitroglycerin in 5% Dextrose Injection increase the potential precision of dosing, but these concentrations increase the total fluid volume that must be delivered to the patient. Total fluid load may be a dominant consideration in patients with compromised function of the heart, liver, and/or kidneys.
  • Administer nitroglycerin in 5% Dextrose Injection via an infusion pump that can maintain a constant infusion rate.
  • Intracoronary injection of Nitroglycerin in 5% Dextrose Injection has not been studied.
  • Monitor patients with known sub-clinical or overt diabetes mellitus when using solutions containing dextrose.
  • 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 it 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. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred (see ).
  • Dyspnea has also been reported.
  • Data are not available to allow estimation of the frequency of adverse reactions during treatment with Nitroglycerin in 5% Dextrose Injection.
  • Signs and symptoms of overdose are generally similar to the described adverse reactions (see ).
  • There is no specific antidote for overdose of nitroglycerin. The risk of overdose can be minimized by close monitoring during treatment.
  • Nitroglycerin in 5% Dextrose Injection is intended for intravenous administration using sterile equipment. Administer Nitroglycerin in 5% Dextrose Injection only via an infusion pump that can maintain a constant infusion rate. Do not use a container which has lost its vacuum, or one in which particulate matter is visible.
  • Dosage is affected by the type of infusion set used (see ). Although the usual adult starting dose in published studies has been 25 mcg/min or more, these studies used PVC tubing, so the delivered doses were less than those reported. (see and n
  • The dosage must be determined by the patientu2019s individual requirement and depending on the required response and possible adverse effects (see ).
  • Even using nonadsorptive tubing, the dose necessary to achieve a given response will vary greatly from patient to patient. Patients with normal or low left-ventricular filling pressure (, patients with uncomplicated angina pectoris) may respond fully to as little as 5 mcg/min, while other patients may require a dose that is one or even two orders of magnitude higher. Continuous monitoring of blood pressure and heart rate is necessary in all patients receiving this medication; in many cases, invasive monitoring of pulmonary capillary wedge pressure will also be indicated.
  • Lower concentrations of Nitroglycerin in 5% Dextrose Injection increase the potential precision of dosing, but these concentrations increase the total fluid volume that must be delivered to the patient. Total fluid load may be a dominant consideration in patients with compromised function of the heart, liver, and/or kidneys. The necessary flow rates to achieve various dose rates with the available concentrations are shown in the following table.
  • Using nonadsorptive tubing, the initial adult dosage of Nitroglycerin in 5% Dextrose Injection should be 5 mcg/min. Subsequent titration must be guided by the clinical results, with dose increments becoming more cautious as partial response is seen. Initial titration should be in 5 mcg/min increments at intervals of 3 to 5 minutes. If no response is seen at 20 mcg/min, increments of 10 and even 20 mcg/min can be used. Once some hemodynamic response is observed, dosage increments should be smaller and less frequent.
  • When the concentration is changed, the tubing must be disconnected from the patient and flushed with the new solution before therapy is continued. If this precaution is not taken, then depending upon the tubing, pump, and flow rate used, it might be several hours before nitroglycerin is delivered at the desired rate.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact.
  • Do not add supplementary medication to Nitroglycerin in 5% Dextrose Injection.
  • Infusion Rate (mL/h) = n
  • t Concentration (mcg/mL)
  • Example calculations for infusion rates are as follows:
  • Infusion Rate n- = n n- (mcg/min)(min/h)n n- = 18
  • t100
  • Infusion Rate n- = n n- (mcg/min)(min/h)n n- = 36
  • t400
  • Nitroglycerin in 5% Dextrose Injection is supplied in glass container as follows:
  • Minimize exposure of pharmaceutical products to heat. Avoid excessive heat. Protect from freezing. Store the product at room temperature (25u00b0C). Brief exposure up to 40u00b0C does not adversely affect the product. Discard any unused portion.
  • Baxter Healthcare Corporation
  • Printed in USA
  • Baxter is a registered trademark of Baxter International Inc.
  • 07-19-76-571
  • Rev. August 2016
  • Lot Exp 07-09-72-122
  • 1A0692NDC 0338-1047-02
  • Baxter Logo
  • Nitroglycerin
  • 25 mg per 250 mL
  • (100 mcg / mL)
  • Protect frm light until time of use.
  • 250 mLn- Rx Only.
  • Use only with a calibrated infusion device.
  • Do not add supplementary medication.
  • Storage: Room temperature (25u00baC). Avoid excessive heat. Protect from freezing. Exposure to ambient light for up to 72 hours, including time for administration, does not adversely affect the product.
  • Baxter Healthcare Corporation, USA
  • 3 0 3 3 8 1 0 4 7 0 2 3*Bar Code Position Only
  • Nitroglycerin in 5% Dextrose Injection 25 mg per 250 mL
  • 25 mg Nitroglycerinin 5% Dextrose Injection
  • 250 ML
  • Qty12
  • NDC 0338-1047-02 1A0692
  • EXP LOT #
  • (01)50303381047028 (17) 090331 (10) G012345
  • 25 mg Nitroglycerinin 5% DextroseInjection
  • 250 ml
  • QTY 12
  • NDC 0338-1047-02
  • 1A0692
  • Bar code(01) 50303381047028(21) 35174(17) 171031(10) G222009
  • EXP OCT 17 LOT G222009
  • Bar code(01) 50303381047028 (21) 35174 (17) 171031 (10) G222009
  • LotExp 07-09-72-120
  • 1A0694NDC 0338-1049-02
  • Baxter Logo
  • Nitroglycerin
  • 50 mg per 250 mL
  • (200 mcg / mL)
  • Protect from light until time of use.
  • 250 mLn- Rx Only.
  • Use only with a calibrated infusion device.
  • Do not add supplementary medication.
  • Storage: Room temperature (25u00baC). Avoid excessive heat. Protect from freezing. Exposure to ambient lightfor up to 72 hours, including time for administration, does not adversely affect the product.
  • Baxter Healthcare Corporation
  • 303381049027 *Bar Code Position Only
  • Nitroglycerin in 5% Dextose Injecton 50 mg per 250 mL
  • 50 mg Nitroglycerinin 5% Dextrose Injection
  • 250 ML
  • Qty12
  • NDC 0338-1049-02 1A0694
  • EXP LOT #
  • (01)50303381049022 (17) 090331 (10) G012345
  • 50 mg Nitroglycerinin 5% DextroseInjection
  • 250 ml
  • QTY12
  • NDC 0338-1049-02
  • 1A0694
  • Bar code(01) 50303381049022(21) 89548(17) 180131(10) G888852
  • EXP JAN 18 LOT G888852
  • Bar code(01) 50303381049022 (21) 89548 (17) 180131 (10) G888852
  • LotExp
  • 07-09-72-121
  • 1A0696NDC 0338-1051-02
  • Baxter Logo
  • Nitroglycerin
  • 100 mg per 250 mL
  • Protect from light until time of use.
  • 250 mLn- Rx Only.
  • Use only with calibrated infusion device.
  • Do not add supplementary medication.
  • Storage: Room temperature (25u00baC). Avoid excessive heat. Protect from freezing. Exposure to ambient light for up to 72 hours, including time for administration, does not adversely affect the product.
  • Baxter Healthcare Corporation
  • 303381051020 *Bar Code Position Only
  • Nitrogycerin in 5% Dextrose Injection 100 mg per 250 mL
  • 100 mg Nitroglycerinin 5% Dextrose Injection
  • 250 ML
  • Qty12
  • NDC 0338-1051-02 1A0696
  • EXP LOT #
  • (01)50303381051025 (17) 090331 (10) G012345
  • 100 mg Nitroglycerinin 5% DextroseInjection
  • 250 ml
  • QTY12
  • NDC 0338-1051-02
  • 1A0696
  • Bar code(01) 50303381051025(21) 31(17) 190228(10) G222228
  • EXP FEB 19 LOT G222228
  • Bar code(01) 50303381051025 (21) 31 (17) 190228 (10) G222228

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