DRUGS & SUPPLEMENTS

Nitricum Acidum

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Nitricum Acidum uses


1 INDICATIONS AND USAGE

Nitricum Acidum ® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Nitricum Acidum is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

2 DOSAGE AND ADMINISTRATION

The recommended dose is 20 ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved.

Doses greater than 20 ppm are not recommended (2.1, 5.2)

Administration:

  • Use only with an Nitricum Acidum DSIR ® operated by trained personnel (2.2)
  • Avoid abrupt discontinuation (2.2, 5.1).

2.1 Dosage

Term and near-term neonates with hypoxic respiratory failure

The recommended dose of Nitricum Acidum is 20 ppm. Maintain treatment up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from Nitricum Acidum therapy.

Doses greater than 20 ppm are not recommended .

2.2 Administration

Training in Administration

The user of Nitricum Acidum and Nitricum Acidum Oxide Delivery Systems must satisfactorily complete a comprehensive periodic training program for health care professionals provided by the delivery system and drug manufacturers. Health professional staff that administers Nitricum Acidum oxide therapy have access to supplier-provided 24 hour/365 days per year technical support on the delivery and administration of Nitricum Acidum at 1-877-566-9466.

Nitricum Acidum Oxide Delivery Systems

Nitricum Acidum must be administered using a calibrated Nitricum Acidum DSIR ® Nitricum Acidum Oxide Delivery System. Only validated ventilator systems should be used in conjunction with Nitricum Acidum. Consult the Nitricum Acidum Oxide Delivery System label or call 1-877-566-9466/visit Nitricum Acidum.com for a current list of validated systems.

Keep available a backup battery power supply and an independent reserve Nitricum Acidum oxide delivery system to address power and system failures.

Monitoring

Measure methemoglobin within 4-8 hours after initiation of treatment with Nitricum Acidum and periodically throughout treatment .

Monitor for PaO2 and inspired NO2 during Nitricum Acidum administration .

Weaning and Discontinuation

Avoid abrupt discontinuation of Nitricum Acidum . To wean Nitricum Acidum, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.

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3 DOSAGE FORMS AND STRENGTHS

Nitricum Acidum (nitric oxide) gas is available in a 800 ppm concentration.

Nitricum Acidum (nitric oxide) is a gas available in a 800 ppm concentration (3).

4 CONTRAINDICATIONS

Nitricum Acidum is contraindicated in neonates dependent on right-to-left shunting of blood.

Neonates dependent on right-to-left shunting of blood (4).

5 WARNINGS AND PRECAUTIONS

Rebound: Abrupt discontinuation of Nitricum Acidum may lead to worsening oxygenation and increasing pulmonary artery pressure.

Methemoglobinemia: Methemoglobin increases with the dose of Nitricum Acidum oxide; following discontinuation or reduction of Nitricum Acidum oxide, methemoglobin levels return to baseline over a period of hours (5.2).

Elevated NO2 Levels: Monitor NO2 levels (5.3).

Heart Failure: In patients with pre-existing left ventricular dysfunction, Nitricum Acidum may increase pulmonary capillary wedge pressure leading to pulmonary edema (5.4).

5.1 Rebound Pulmonary Hypertension Syndrome following Abrupt Discontinuation

Wean from Nitricum Acidum . Abrupt discontinuation of Nitricum Acidum may lead to worsening oxygenation and increasing pulmonary artery pressure, i.e., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate Nitricum Acidum therapy immediately.

5.2 Hypoxemia from Methemoglobinemia

Nitricum Acidum oxide combines with hemoglobin to form methemoglobin, which does not transport oxygen. Methemoglobin levels increase with the dose of Nitricum Acidum; it can take 8 hours or more before steady-state methemoglobin levels are attained. Monitor methemoglobin and adjust the dose of Nitricum Acidum to optimize oxygenation.

If methemoglobin levels do not resolve with decrease in dose or discontinuation of Nitricum Acidum, additional therapy may be warranted to treat methemoglobinemia.

5.3 Airway Injury from Nitrogen Dioxide

Nitrogen dioxide (NO2) forms in gas mixtures containing NO and O2. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.

If there is an unexpected change in NO2 concentration, or if the NO2 concentration reaches 3 ppm when measured in the breathing circuit, then the delivery system should be assessed in accordance with the Nitricum Acidum Oxide Delivery System O&M Manual troubleshooting section, and the NO2 analyzer should be recalibrated. The dose of Nitricum Acidum and/or FiO2 should be adjusted as appropriate.

5.4 Worsening Heart Failure

Patients with left ventricular dysfunction treated with Nitricum Acidum may experience pulmonary edema, increased pulmonary capillary wedge pressure, worsening of left ventricular dysfunction, systemic hypotension, bradycardia and cardiac arrest. Discontinue Nitricum Acidum while providing symptomatic care.

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6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in the label;

Hypoxemia

Worsening Heart Failure

The most common adverse reaction is hypotension. (6).

To report SUSPECTED ADVERSE REACTIONS, contact INO Therapeutics at 1-877-566-9466 and http://www.inomax.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Controlled studies have included 325 patients on Nitricum Acidum doses of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials was 11% on placebo and 9% on Nitricum Acidum, a result adequate to exclude Nitricum Acidum mortality being more than 40% worse than placebo.

In both the NINOS and CINRGI studies, the duration of hospitalization was similar in Nitricum Acidum and placebo-treated groups.

From all controlled studies, at least 6 months of follow-up is available for 278 patients who received Nitricum Acidum and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae.

In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.

In CINRGI, the only adverse reaction (>2% higher incidence on Nitricum Acidum than on placebo) was hypotension (14% vs. 11%).

6.2 Post-Marketing Experience

Post marketing reports of accidental exposure to Nitricum Acidum oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache.

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7 DRUG INTERACTIONS

Nitricum Acidum oxide donor compounds may increase the risk of developing methemoglobinemia.

7.1 Nitric Oxide Donor Agents

Nitricum Acidum oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Nitricum Acidum. It is not known if Nitricum Acidum can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Nitricum Acidum is not indicated for use in adults.

8.3 Nursing Mothers

Nitricum Acidum oxide is not indicated for use in the adult population, including nursing mothers. It is not known whether Nitricum Acidum oxide is excreted in human milk.

8.4 Pediatric Use

The safety and efficacy of Nitricum Acidum oxide for inhalation has been demonstrated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension. Additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy . No information about its effectiveness in other age populations is available.

8.5 Geriatric Use

Nitricum Acidum oxide is not indicated for use in the adult population.

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10 OVERDOSAGE

Overdosage with Nitricum Acidum is manifest by elevations in methemoglobin and pulmonary toxicities associated with inspired NO2. Elevated NO2 may cause acute lung injury. Elevations in methemoglobin reduce the oxygen delivery capacity of the circulation. In clinical studies, NO2 levels >3 ppm or methemoglobin levels >7% were treated by reducing the dose of, or discontinuing, Nitricum Acidum.

Methemoglobinemia that does not resolve after reduction or discontinuation of therapy can be treated with intravenous vitamin C, intravenous methylene blue, or blood transfusion, based upon the clinical situation.

11 DESCRIPTION

Nitricum Acidum (nitric oxide gas) is a drug administered by inhalation. Nitricum Acidum oxide, the active substance in Nitricum Acidum, is a pulmonary vasodilator. Nitricum Acidum is a gaseous blend of Nitricum Acidum oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm). Nitricum Acidum is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]).

The structural formula of Nitricum Acidum oxide (NO) is shown below:

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Nitricum Acidum oxide relaxes vascular smooth muscle by binding to the heme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation. When inhaled, Nitricum Acidum oxide selectively dilates the pulmonary vasculature, and because of efficient scavenging by hemoglobin, has minimal effect on the systemic vasculature.

Nitricum Acidum appears to increase the partial pressure of arterial oxygen by dilating pulmonary vessels in better ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward regions with normal ratios.

12.2 Pharmacodynamics

Effects on Pulmonary Vascular Tone in PPHN

Persistent pulmonary hypertension of the newborn (PPHN) occurs as a primary developmental defect or as a condition secondary to other diseases such as meconium aspiration syndrome (MAS), pneumonia, sepsis, hyaline membrane disease, congenital diaphragmatic hernia (CDH), and pulmonary hypoplasia. In these states, pulmonary vascular resistance (PVR) is high, which results in hypoxemia secondary to right-to-left shunting of blood through the patent ductus arteriosus and foramen ovale. In neonates with PPHN, Nitricum Acidum improves oxygenation (as indicated by significant increases in PaO2).

12.3 Pharmacokinetics

The pharmacokinetics of Nitricum Acidum oxide has been studied in adults.

Absorption and Distribution

Nitricum Acidum oxide is absorbed systemically after inhalation. Most of it traverses the pulmonary capillary bed where it combines with hemoglobin that is 60% to 100% oxygen-saturated. At this level of oxygen saturation, Nitricum Acidum oxide combines predominantly with oxyhemoglobin to produce methemoglobin and nitrate. At low oxygen saturation, Nitricum Acidum oxide can combine with deoxyhemoglobin to transiently form nitrosylhemoglobin, which is converted to nitrogen oxides and methemoglobin upon exposure to oxygen. Within the pulmonary system, Nitricum Acidum oxide can combine with oxygen and water to produce nitrogen dioxide and nitrite, respectively, which interact with oxyhemoglobin to produce methemoglobin and nitrate. Thus, the end products of Nitricum Acidum oxide that enter the systemic circulation are predominantly methemoglobin and nitrate.

Metabolism

Methemoglobin disposition has been investigated as a function of time and Nitricum Acidum oxide exposure concentration in neonates with respiratory failure. The methemoglobin (MetHb) concentration-time profiles during the first 12 hours of exposure to 0, 5, 20, and 80 ppm Nitricum Acidum are shown in Figure 1.

Figure 1: Methemoglobin Concentration-Time Profiles Neonates Inhaling 0, 5, 20 or 80 ppm Nitricum Acidum

Methemoglobin concentrations increased during the first 8 hours of Nitricum Acidum oxide exposure. The mean methemoglobin level remained below 1% in the placebo group and in the 5 ppm and 20 ppm Nitricum Acidum groups, but reached approximately 5% in the 80 ppm Nitricum Acidum group. Methemoglobin levels >7% were attained only in patients receiving 80 ppm, where they comprised 35% of the group. The average time to reach peak methemoglobin was 10 ± 9 (SD) hours (median, 8 hours) in these 13 patients, but one patient did not exceed 7% until 40 hours.

Figure 1

Elimination

Nitrate has been identified as the predominant Nitricum Acidum oxide metabolite excreted in the urine, accounting for >70% of the Nitricum Acidum oxide dose inhaled. Nitrate is cleared from the plasma by the kidney at rates approaching the rate of glomerular filtration.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 hr/day for up to two years. Higher exposures have not been investigated.

Nitricum Acidum oxide has demonstrated genotoxicity in Salmonella (Ames Test), human lymphocytes, and after in vivo exposure in rats. There are no animal or human studies to evaluate Nitricum Acidum oxide for effects on fertility.

14 CLINICAL STUDIES

14.1 Treatment of Hypoxic Respiratory Failure

The efficacy of Nitricum Acidum has been investigated in term and near-term newborns with hypoxic respiratory failure resulting from a variety of etiologies. Inhalation of Nitricum Acidum reduces the oxygenation index (OI= mean airway pressure in cm H2O × fraction of inspired oxygen concentration [FiO2]× 100 divided by systemic arterial concentration in mm Hg [PaO2]) and increases PaO2 .

NINOS Study

The Neonatal Inhaled Nitricum Acidum Oxide Study (NINOS) was a double-blind, randomized, placebo-controlled, multicenter trial in 235 neonates with hypoxic respiratory failure. The objective of the study was to determine whether inhaled Nitricum Acidum oxide would reduce the occurrence of death and/or initiation of extracorporeal membrane oxygenation (ECMO) in a prospectively defined cohort of term or near-term neonates with hypoxic respiratory failure unresponsive to conventional therapy. Hypoxic respiratory failure was caused by meconium aspiration syndrome (MAS; 49%), pneumonia/sepsis (21%), idiopathic primary pulmonary hypertension of the newborn (PPHN; 17%), or respiratory distress syndrome (RDS; 11%). Infants ≤14 days of age (mean, 1.7 days) with a mean PaO2 of 46 mm Hg and a mean oxygenation index (OI) of 43 cm H2O / mm Hg were initially randomized to receive 100% O2 with (n=114) or without (n=121) 20 ppm Nitricum Acidum oxide for up to 14 days. Response to study drug was defined as a change from baseline in PaO2 30 minutes after starting treatment (full response = >20 mm Hg, partial = 10–20 mm Hg, no response = <10 mm Hg). Neonates with a less than full response were evaluated for a response to 80 ppm Nitricum Acidum oxide or control gas. The primary results from the NINOS study are presented in Table 1.

Control

(n=121)

NO

(n=114)

P value
Death or ECMOExtracorporeal membrane oxygenation , Death or need for ECMO was the study's primary end point 77 (64%) 52 (46%) 0.006
Death 20 (17%) 16 (14%) 0.60
ECMO 66 (55%) 44 (39%) 0.014

Although the incidence of death by 120 days of age was similar in both groups (NO, 14%; control, 17%), significantly fewer infants in the Nitricum Acidum oxide group required ECMO compared with controls (39% vs. 55%, p = 0.014). The combined incidence of death and/or initiation of ECMO showed a significant advantage for the Nitricum Acidum oxide treated group (46% vs. 64%, p = 0.006). The Nitricum Acidum oxide group also had significantly greater increases in PaO2 and greater decreases in the OI and the alveolar-arterial oxygen gradient than the control group (p<0.001 for all parameters). Significantly more patients had at least a partial response to the initial administration of study drug in the Nitricum Acidum oxide group (66%) than the control group (26%, p<0.001). Of the 125 infants who did not respond to 20 ppm Nitricum Acidum oxide or control, similar percentages of NO-treated (18%) and control (20%) patients had at least a partial response to 80 ppm Nitricum Acidum oxide for inhalation or control drug, suggesting a lack of additional benefit for the higher dose of Nitricum Acidum oxide. No infant had study drug discontinued for toxicity. Inhaled Nitricum Acidum oxide had no detectable effect on mortality. The adverse events collected in the NINOS trial occurred at similar incidence rates in both treatment groups . Follow-up exams were performed at 18–24 months for the infants enrolled in this trial. In the infants with available follow-up, the two treatment groups were similar with respect to their mental, motor, audiologic, or neurologic evaluations.

CINRGI Study

This study was a double-blind, randomized, placebo-controlled, multicenter trial of 186 term and near-term neonates with pulmonary hypertension and hypoxic respiratory failure. The primary objective of the study was to determine whether Nitricum Acidum would reduce the receipt of ECMO in these patients. Hypoxic respiratory failure was caused by MAS (35%), idiopathic PPHN (30%), pneumonia/sepsis (24%), or RDS (8%). Patients with a mean PaO2 of 54 mm Hg and a mean OI of 44 cm H2O / mm Hg were randomly assigned to receive either 20 ppm Nitricum Acidum (n=97) or nitrogen gas (placebo; n=89) in addition to their ventilatory support. Patients who exhibited a PaO2 >60 mm Hg and a pH < 7.55 were weaned to 5 ppm Nitricum Acidum or placebo. The primary results from the CINRGI study are presented in Table 2.

Placebo Nitricum Acidum P value
ECMOExtracorporeal membrane oxygenation , ECMO was the primary end point of this study 51/89 (57%) 30/97 (31%) <0.001
Death 5/89 (6%) 3/97 (3%) 0.48

Significantly fewer neonates in the Nitricum Acidum group required ECMO compared to the control group (31% vs. 57%, p<0.001). While the number of deaths were similar in both groups (INOmax, 3%; placebo, 6%), the combined incidence of death and/or receipt of ECMO was decreased in the Nitricum Acidum group (33% vs. 58%, p<0.001).

In addition, the Nitricum Acidum group had significantly improved oxygenation as measured by PaO2, OI, and alveolar-arterial gradient (p<0.001 for all parameters). Of the 97 patients treated with Nitricum Acidum, 2 (2%) were withdrawn from study drug due to methemoglobin levels >4%. The frequency and number of adverse events reported were similar in the two study groups .

In clinical trials, reduction in the need for ECMO has not been demonstrated with the use of inhaled Nitricum Acidum oxide in neonates with congenital diaphragmatic hernia (CDH).

14.2 Ineffective in Adult Respiratory Distress Syndrome

In a randomized, double-blind, parallel, multicenter study, 385 patients with adult respiratory distress syndrome (ARDS) associated with pneumonia (46%), surgery (33%), multiple trauma (26%), aspiration (23%), pulmonary contusion (18%), and other causes, with PaO2/FiO2 <250 mm Hg despite optimal oxygenation and ventilation, received placebo (n=193) or Nitricum Acidum (n=192), 5 ppm, for 4 hours to 28 days or until weaned because of improvements in oxygenation. Despite acute improvements in oxygenation, there was no effect of Nitricum Acidum on the primary endpoint of days alive and off ventilator support. These results were consistent with outcome data from a smaller dose ranging study of Nitricum Acidum oxide (1.25 to 80 ppm). Nitricum Acidum is not indicated for use in ARDS.

14.3 Ineffective in Prevention of Bronchopulmonary Dysplasia

The safety and efficacy of Nitricum Acidum for the prevention of chronic lung disease [bronchopulmonary dysplasia, (BPD)] in neonates ≤ 34 weeks gestational age requiring respiratory support has been studied in four large, multi-center, double-blind, placebo-controlled clinical trials in a total of 2,600 preterm infants. Of these, 1,290 received placebo, and 1,310 received inhaled Nitricum Acidum oxide at doses ranging from 5-20 ppm, for treatment periods of 7-24 days duration. The primary endpoint for these studies was alive and without BPD at 36 weeks postmenstrual age (PMA). The need for supplemental oxygen at 36 weeks PMA served as a surrogate endpoint for the presence of BPD. Overall, efficacy for the prevention of bronchopulmonary dysplasia in preterm infants was not established. There were no meaningful differences between treatment groups with regard to overall deaths, methemoglobin levels, or adverse events commonly observed in premature infants, including intraventricular hemorrhage, patent ductus arteriosus, pulmonary hemorrhage, and retinopathy of prematurity.

The use of Nitricum Acidum for prevention of BPD in preterm neonates ≤ 34 weeks gestational age is not recommended.

16 HOW SUPPLIED/STORAGE AND HANDLING

Nitricum Acidum (nitric oxide) is available in the following sizes:

Size D Portable aluminum cylinders containing 353 liters at STP of Nitricum Acidum oxide gas in 800 ppm concentration in nitrogen (delivered volume 344 liters) (NDC 64693-002-01)
Size 88 Aluminum cylinders containing 1963 liters at STP of Nitricum Acidum oxide gas in 800 ppm concentration in nitrogen (delivered volume 1918 liters) (NDC 64693-002-02)

Store at 25°C (77°F) with excursions permitted between 15–30°C (59–86°F).

All regulations concerning handling of pressure vessels must be followed.

Protect the cylinders from shocks, falls, oxidizing and flammable materials, moisture, and sources of heat or ignition.

Occupational Exposure

The exposure limit set by the Occupational Safety and Health Administration (OSHA) for Nitricum Acidum oxide is 25 ppm, and for NO2 the limit is 5 ppm.

Distributed by

INO Therapeutics LLC

675 McDonnell Blvd.

Hazelwood, MO 63042

USA

© 2015 Mallinckrodt

Rx only

Nitricum Acidum®

Nitricum Acidum oxide

FOR

INHALATION

800 PPM

CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated

for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve

after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS.

WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under

the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and

is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and

with the hazards, contraindications and side effects and the precautions to be taken.

FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is

difficult, give oxygen. Get medical help.

RETURN WITH 25 PSIG.

TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY INO Therapeutics LLC

Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs).

DO NOT REMOVE THIS PRODUCT LABEL.

Store at 25°C (77°F)

.

Volume 1963 Liters

Mallinckrodt

Pharmaceuticals

Manufactured by:

Mallinckrodt Manufacturing LLC

1060 Allendale Dr.

Port Allen, LA 70767 USA

For Product Inquiry 1-877-KNOW INO

(566-9466)

UN 1956

Compressed Gas, N.O.S.

(Nitric Oxide, Nitrogen)

2.2

Net Weight: 2.5 Kg

NDC 64693-002-02

MADE IN USA

Label No. SPC-LBL-0060 R8

Nitricum Acidum pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Nitricum Acidum available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Nitricum Acidum destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Nitricum Acidum Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Nitricum Acidum pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. "NITRIC ACID". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  2. "411VRN1TV4: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Dat... (accessed August 28, 2018).
  3. "Praseodymium nitrate: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Nitricum Acidum?

Depending on the reaction of the Nitricum Acidum after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Nitricum Acidum not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Nitricum Acidum addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Nitricum Acidum, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Nitricum Acidum consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported doses

What is the dose of Nitricum Acidum drug you are taking?
According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 11-50mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
11-50mg1
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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