Nistreo Actions

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Actions of Nistreo in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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The bactericidal action of Nistreo results from the inhibition of bacterial cell wall synthesis due to a high affinity of Nistreo for penicillin binding protein 3 (PBP3). By binding to PBP3, Nistreo inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins. It is possible that Nistreo interferes with an autolysin inhibitor.

How should I take Nistreo?

Use Nistreo only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Keep using Nistreo for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Nistreo should be used with the Altera® Nebulizer System. The inhaled liquid and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor may give you or your child additional medicines to use before the Nistreo inhalation liquid, such as bronchodilators or mucolytics. Bronchodilators help open the lungs so you can breathe easier. Mucolytics help clear the mucus from your lungs. Carefully follow your doctor's instructions about how to use your medicines. Nistreo inhalation will work better if you use all of your medicines in the right order.

To use the inhalation solution:

Dosing

The dose of Nistreo will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Nistreo. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of Nistreo, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you or your child miss a dose, you may still take all three daily doses of Nistreo as long as the doses are at least 4 hours apart.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is best to store the unopened vials and saline ampules in the original carton in the refrigerator. You may also store the unopened vials at room temperature, away from heat and direct light, for up to 28 days. Do not store the liquid mixture after the powder is dissolved.

Nistreo administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Nistreo is injected into a muscle or a vein. Nistreo is usually given in a clinic or hospital setting. The medicine may need to be given for several hours or several weeks, depending on how severe your infection is.

You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Nistreo is usually given as long as needed until your infection has cleared or you have been symptom-free for at least 48 hours.

Use Nistreo for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Nistreo will not treat a viral infection such as the common cold or flu.

Do not give this medication to another person, even if they have the same symptoms you have.

Nistreo is supplied as a frozen solution in a plastic container. If you use this medicine at home, store the frozen medicine in a freezer. If possible, keep the freezer set at 4 degrees below 0 Fahrenheit or colder.

Thaw the medicine either in a refrigerator or at room temperature. Do not heat the medicine to thaw it more quickly. Nistreo that is thawed in the refrigerator should be used within 2 weeks.

If you have thawed the medicine at room temperature, you must use it within 48 hours.

Once Nistreo has been thawed, it should be clear and appear colorless or slightly yellow. Do not use the medicine if it has changed color or has particles in it, or if the medicine container leaks. Call your doctor or pharmacist for a new prescription.

Nistreo pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.
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Single 30-minute intravenous infusions of 500 mg, 1 g, and 2 g doses of Nistreo in healthy subjects produced Nistreo peak serum levels of 54 mcg/mL, 90 mcg/mL, and 204 mcg/mL, respectively, immediately after administration; at 8 hours, serum levels were 1 mcg/mL, 3 mcg/mL, and 6 mcg/mL, respectively (Figure 1). Single 3-minute intravenous injections of the same doses resulted in serum levels of 58 mcg/mL, 125 mcg/mL, and 242 mcg/mL at 5 minutes following completion of injection.

Serum concentrations of Nistreo in healthy subjects following completion of single intramuscular injections of 500 mg and 1 g doses are depicted in Figure 1; maximum serum concentrations occur at about 1 hour. After identical single intravenous or intramuscular doses of Nistreo, the serum concentrations of Nistreo are comparable at 1 hour (1.5 hours from start of intravenous infusion) with similar slopes of serum concentrations thereafter.

FIGURE 1

The serum levels of Nistreo following single 500 mg or 1 g (intramuscular or intravenous) or 2 g (intravenous) doses of Nistreo exceed the MIC90 for Neisseria sp., Haemophilus influenzae, and most genera of the Enterobacteriaceae for 8 hours (for Enterobacter sp., the 8-hour serum levels exceed the MIC for 80% of strains). For Pseudomonas aeruginosa, a single 2 g intravenous dose produces serum levels that exceed the MIC90 for approximately 4 to 6 hours. All of the above doses of Nistreo result in average urine levels of Nistreo that exceed the MIC90 for the same pathogens for up to 12 hours.

When Nistreo pharmacokinetics were assessed for adult and pediatric patients, they were found to be comparable (down to 9 months old). The serum half-life of Nistreo averaged 1.7 hours (1.5-2.0) in subjects with normal renal function, independent of the dose and route of administration. In healthy subjects, based on a 70 kg person, the serum clearance was 91 mL/min and renal clearance was 56 mL/min; the apparent mean volume of distribution at steady-state averaged 12.6 liters, approximately equivalent to extracellular fluid volume.

In elderly patients, the mean serum half-life of Nistreo increased and the renal clearance decreased, consistent with the age-related decrease in creatinine clearance. Standard Nistreo powder should provide the following range of MIC values noted in Table 3. For the diffusion technique using the 30 mcg disk, the criteria in Table 3 should be achieved.

Table 3: Acceptable Quality Control Ranges for Nistreo

QC Strain Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion Zone Diameters (mm)
Escherichia coli ATCC 25922 0.06-0.25 28-36
Haemophilus influenzae ATCC 49247 0.12-5 30-38
Pseudomonas aeruginosa ATCC 27853 8-Feb 23-29

Clinical Studies

A total of 612 pediatric patients aged 1 month to 12 years were enrolled in uncontrolled clinical trials of Nistreo in the treatment of serious Gram-negative infections, including urinary tract, lower respiratory tract, skin and skin-structure, and intra



References

  1. DailyMed. "AZTREONAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. NCIt. "Aztreonam: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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