NITROSOL Nitroglycerin Injection USP

25 mg/5 ml,  50 mg/10 ml


For the use of a Registered Medical Practitioner or a Hospital or a Institution only. 

Congestive Heart Failure
In Prophylaxis and Treatment of Stable Angina
To Control Pain of Unstable Angina
Acute MI with Hypertension
Controlled Hypotension during Surgery

NITROSOL (Nitroglycerin) is an organic nitrate vasodilator, active on both arteries and veins. Chemically, Nitroglycerin is 1,2,3-propanetriol trinitrate. The molecular formula is C3H5N3O9 and the molecular  weight  is  227.09.

Its  structural  formula  is :

Nitroglycerin Injection


NITROSOL is a sterile, clear, practically colourless solution  for intravenous infusion after dilution. The solution is sterile, nonpyrogenic and nonexplosive.

Each  ml  contains  :
Diluted  Nitroglycerin  USP
equivalent to  Nitroglycerin 5 mg
Absolute  Alcohol  USP 30 % v/v
Propylene  Glycol  USP 30 % v/v
Water  for  Injection  USP q.s.
Contains no preservatives.

Nitroglycerin, an organic nitrate, is a vasodilator. Its principal pharmacological action is the relaxation of vascular smooth muscle. Nitroglycerin produces, in a dose-related manner, dilation of both arterial and venous beds. Dilation of the post-capillary vessels, including large veins, promotes peripheral pooling of blood and decreases venous return to the heart reducing left ventricular end diastolic pressure (pre-load). Arteriolar relaxation reduces systemic vascular resistance and arterial pressure (after-load). Myocardial oxygen consumption or demand (as measured by the pressure rate product, tension time index and stroke work index) is decreased by both the arterial and venous effect of Nitroglycerin and a more favourable  supply  demand  ratio  can  be  achieved. Therapeutic doses of intravenous Nitroglycerin reduce systolic, diastolic and mean arterial blood pressure. Effective coronary perfusion pressure is usually maintained, but can be compromised if blood pressure falls excessively or increased heart rate decreases  diastolic  filling  time. Nitroglycerin reduces elevated central venous and pulmonary capillary wedge pressures, pulmonary vascular resistance and systemic vascular resistance. Heart rate is usually slightly increased, presumably a reflex response to the fall in blood pressure, Cardiac index  may  be  increased, decreased  or  unchanged. Patients with elevated left ventricular fillings pressure and systemic vascular resistance values in conjunction with a depressed cardiac index are likely to experience an improvement in cardiac index. Alternatively, when filling pressures and cardiac index are normal, cardiac index may be slightly reduced by intravenous  Nitroglycerin.

Nitroglycerin is widely distributed in the body with an apparent volume of distribution of 200 L in adult male subjects. It is rapidly metabolised in the liver to dinitrates and mononitrates, with a short half life estimated at 1-4 minutes. This results in a low plasma concentration after  intravenous  infusion. At plasma concentrations of between 50 - 500 mg/ml, the binding of Nitroglycerin to plasma proteins is approximately 60 % while those of its metabolites, 1,3-glyceryldinitrate and 1,2-glyceryldinitrate are approximately 60 % and 30 % respectively. The activity and half-life of dinitroglycerin metabolities are not well characterized. Glyceryl mononitrate, the principal  metabolite, is  inactive.

NITROSOL permits rapid attainment of high concentration of drug in the systemic circulation and prompt initiation of therapy. Because of its rapid degradation, the concentration can be titrated quickly and  safely.

NITROSOL  is  indicated  for :
1. Control of blood pressure in pre-operative hypertension i.e. hypertension associated with surgical procedures, especially cardiovascular procedures such as hypertension during intra-tracheal intubation, anaesthesia, skin incisions, sternotomy, cardiac bypass and in immediate post- surgical  period.
2. The treatment of congestive heart failure associated  with  acute  myocardial  infarction.
3. The treatment of angina pectoris in the patients who have not responded to the recommended doses of organic nitrates and/or a beta blocker, unstable angina  pectoris  and  coronary  vasospasm.
4.The production of controlled hypotension during surgical  procedures.



The ampoule used in this product is equipped with O.P.C (One Point Cut) opening system. No ampoule file is needed to open the ampoule. The neck of the ampoule is prescored at the point of constriction. A coloured dot on the ampoule head helps to orientate the ampoule. Take the ampoule and face the coloured dot. Let the solution at the head of the ampoule to flow down by shaking or a gentle stroke. The ampoule opens easily by placing the thumb on the coloured dot  and  gently  pressing  downwards  as  shown.

Ampoules equipped with One Point Cut (OPC) technology

Initial  Dilution  : 
Aseptically transfer the desired volume of NITROSOL (see the Dilution Table) into the glass bottle containing stated volume of either 5 % w/v Dextrose Injection or 0.9 % w/v Sodium Chloride Injection (Diluent Volume). This yields a final concentration of 100 to 400 microgram/ml (see the Dilution Table). Invert the glass parenteral bottle several times following admixture to assure uniform dilution of NITROSOL. 

Nitroglycerin Injection

Maintenance  Dilution  : 
It is important to consider the fluid requirements of the patients as well as the expected duration of the infusion in selecting the appropriate dilution of NITROSOL. After initial dosage titration, the concentration of the admixture solution may be increased, if necessary, to limit fluids given to the patient. The concentration of the infusion solution should not exceed  400  mcg/ml  of  Nitroglycerin. Invert the glass parenteral bottle several times following admixture to assure uniform dilution of Nitroglycerin. When stored in glass containers, the diluted solution is physically and chemically stable for upto 40 hours when stored below 25°C and upto seven days under refrigeration. However, to avoid microbial contamination hazards infusion should be commenced as soon as practicable  after  preparation  of  the solution. Infusion should be completed within 24 hours and any residue  discarded. Dosage is affected by the type of containers and administration sets used. If the concentration is adjusted, it is imperative to flush or replace the infusion set, before a new concentration is utilised. If the set were not flushed or replaced, it could take minutes to hours, depending upon the flow rates and dead space of the set, for the new concentration to reach  the  patient.

NITROSOL should not be administered to individuals with :
1.A known hypersensitivity to Nitroglycerin or a known  idiosyncratic  reaction  to  organic  nitrates.
2.Hypotension or uncorrected hypovolemia, as the use of NITROSOL such states could produce severe hypotension  or  shock.
3.Increased intracranial pressure (e.g. head trauma or  cerebral  hemorrhage).
4. Inadequate  cerebral  circulation.
5.Constrictive pericarditis and pericardial  tamponade.
6.Severe  anaemia  and  arterial  hypoxaemia.
7.Concomitant administration of Nitroglycerin with Viagra (sildenafil), as sildenafil has been shown to potentiate the vasodilatory effects of glyceryl trinitrate, resulting in severe hypotension.

1.Nitroglycerin readily migrates into many plastics. To avoid absorption of Nitroglycerin into plastic parenteral solution containers, the dilution of NITROSOL should be made in glass parenteral solution  bottles.
2.Some filters absorb Nitroglycerin; they should be avoided.
3.40% to 80% of the total amount of Nitroglycerin in the final diluted solution for infusion is absorbed by the Polyvinyl Chloride (PVC) tubing of the intravenous administration sets currently in general use. The higher rates of absorption occur when flow-rates are low, Nitroglycerin concentrations are high and tubing is long. Although the rate of loss is highest during the early phase of administration (when flow rates are lowest) the loss is either constant nor self-limiting, consequently, no simple calculation or correction can be performed to convert the theoretical infusion rate (based on the concentration of the infusion solution) to the actual delivery rate. Because of this problem, we recommend the use of the least absorptive infusion tubing available (i.e. non-PVC  tubing)  for  infusion  of NITROSOL.
4.A potential safety problem exists with the combined use of some infusion pumps and some non-PVC infusion sets. Because special tubing required to prevent the absorption of Nitroglycerin (Non-PVC tubing) tends to be less pliable than the conventional PVC tubing normally used with such infusion pumps, the pumps may fail to occlude the infusion sets completely. The results may be excessive flow at low infusion rate settings, causing alarms or unregulated gravity flow when the infusion pump is stopped; this could lead to over-infusion of Nitroglycerin. All infusion pumps should be tested with the infusion sets to ensure their ability to deliver Nitroglycerin accurately at low flow rates and to occlude the infusion sets properly  when  the  infusion  is  stopped.5.Acute Myocardial Infarction : NITROSOL should only be used in acute myocardial infarction for treating definite left ventricular failure. Careful haemodynamic monitoring must be observed during infusion of Nitroglycerin in patients with acute myocardial infraction to avoid a sudden fall in arterial blood pressure and reflex tachycardia, which might by reducing coronary perfusion and increasing myocardial oxygen demand, extend the area of ischaemic tissue  injury.
6.Hypotension  :  Dosage must be carefully titrated to avoid the significant risk of precipitous fall in blood pressure, particularly in patients with severe coronary or cerebral atherosclerosis. Profound hypotension and bradycardia have been reported with sublingual,  topical  and  intravenous  Nitroglycerin.

NITROSOL should be used with caution in patients with severe liver or renal disease. Paradoxical bradycardia and increased angina pectoris may accompany  Nitroglycerin  induced  hypotension. Nitrate dependence is a potentially serious problem. Death, myocardial infarction, coronary spasm and chest pain syndromes have been documented in  industrial workers  who leave the  work  environment for several days after exposure to Nitroglycerin and Nitroglycol.  There is some clinical evidence of nitrate dependence in patients with both angina and congestive heart failure. Although withdrawal syndromes have not been reported to occur following I.V. infusion of Nitroglycerin for upto 9 days, it may be necessary to carefully taper therapy in patients with proven coronary atherosclerosis who have received prolonged  high-dose  infusion  of  the  drug. Arterial oxygen tension decreases after administration of Nitroglycerin in normal subjects and in patients with coronary artery disease. Hypoxaemia occurs as a result of increased pulmonary ventilation-perfusion mismatch; however, the clinical significance of this effect is unknown. Caution should be observed in patients with severe ischaemic heart disease as a decrease in available oxygen may oppose its antianginal  effect. Methaemoglobinaemia has been reported in association with Nitroglycerin therapy. Methaemoglobinaemia may be clinically significant especially in the presence of methaemoglobin reductase deficiencies or in congenital Methaemoglobinaemia  variants. 

Use  in  Pregnancy  :  
Pregnancy  category  B2 
No studies have been conducted. NITROSOL should be given  to pregnant  woman only  if  clearly  needed.

Use  in  Lactation  :
It is not known whether Nitroglycerin is excreted into breast milk. Caution should be exercised if there is a need to administer NITROSOL to a nursing woman.

Paediatric  Use  : 
The use of NITROSOL in children is not recommended, as its safety and effectiveness in children  have  not  been  established.

1.Alcohol : Concomitant use with Alcohol may cause hypotension due to enhanced vasodilatory effects of Nitroglycerin.
2.Other drugs : Information on potential interaction with other drugs is poorly documented. Caution should be observed if other drugs are given concomitantly during infusion of NITROSOL as an interaction may adversely affect the haemodynamic response to the drug. Careful haemodynamic monitoring  is  essential.
3.Pancuronium : Infusion of  Nitroglycerin Injection increases the duration of Pancuronium induced neuromuscular blockade. This clinical observation has been reported by studies in the cat, however neuromuscular blockade induced by  Succinylcholine and d-tubocurarine were not prolonged by Nitroglycerin. The mechanism of interaction is unknown.
4.Morphine : One patient who received four 3 mg doses of I.V. Morphine sulphate during 24 hour period with I.V. Nitroglycerin became unarousable, eventually responding to Nalorphin. The possibility that I.V. Nitroglycerin slows the Morphine metabolism in this patient has been suggested. Caution should be observed when administering these two drugs simultaneously.

The most frequent possible side effect (natural, expected and unavoidable drug actions) in patients treated with NITROSOL is headache which occurs in approximately 2 % of patients. Other side effects (unusual, unexpected and infrequent reactions) occurring in less than 1 % patients are the following tachycardia, nausea, vomiting, apprehension, restlessness, muscle twitching, retrosternal discomfort, palpitations, dizziness and abdominal plain.

Accidental overdosage of NITROSOL may result in severe hypotension and reflex tachycardia which can be treated by elevating the legs and decreasing or temporarily terminating the infusion until patients condition  stabilises. Since the duration of haemodynamic effects following administration is quite short, additional corrective measures are usually not required. However, if further therapy is indicated, administration of an intravenous alphaadrenergic agonist (e.g. Methoxamine or Phenylephrine) should be considered. Infusions of plasma or suitable electrolyte solutions should also be considered.

NITROSOL ampoules are intended for single use only. Properly  discard  any  unused  portion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container  permit. The solution is sterile, nonpyrogenic and nonexplosive. 

Store  below  30°C (86°F), protected from light. 
Do not refrigerate.

24  months  from  the  date  of  manufacture.

NITROSOL is supplied as Diluted Nitroglycerin USP equivalent to Nitroglycerin 5 mg/ml in 5 ml and 10 ml  sterile  solution.

Nitroglycerin Injection


Disclaimer : For the use of a Registered Medical Practitioner or a Hospital or a Institution only. Also it is not intended to be used by healthcare professionals or patients for the purpose of prescribing or administering these products. Questions regarding the complete and current content of product labeling / specification / presentation should be directed to SGPharma.

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