Nefrosave Dosage

• Dosage of Nefrosave in details
• Nefrosave interactions
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Dosage of Nefrosave in details

Nefrosave AS A MUCOLYTIC AGENT

General

Nefrosave Solution, USP (n-acetyl-l-cysteine) is available in rubber stoppered glass vials containing 10 mL or 30 mL. The 20% solution may be diluted to a lesser concentration with either Sodium Chloride Injection, Sodium Chloride for Inhalation, Sterile Water for Injection, or Sterile Water for Inhalation. The 10% solution may be used undiluted.

Nefrosave does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. If only a portion of the solution in a vial is used, store the remainder in a refrigerator and use for inhalation only within 96 hours.

Nebulization - Face Mask, Mouthpiece, Tracheostomy: When nebulized into a face mask, mouthpiece, or tracheostomy, 1 to 10 mL of the 20% solution or 2 to 20 mL of the 10% solution may be given every 2 to 6 hours; the recommended dose for most patients is 3 to 5 mL of the 20% solution or 6 to 10 mL of the 10% solution three to four times a day.

Nebulization - Tent, Croupette: In special circumstances it may be necessary to nebulize into a tent or Croupette, and this method of use must be individualized to take into account the available equipment and the patient's particular needs. This form of administration requires very large volumes of the solution, occasionally as much as 300 mL during a single treatment period.

If a tent or Croupette must be used, the recommended dose is the volume of Nefrosave (using 10 or 20%) that will maintain a very heavy mist in the tent or Croupette for the desired period. Administration for intermittent or continuous prolonged periods, including overnight, may be desirable.

Direct Instillation: When used by direct instillation, 1 to 2 mL of a 10% to 20% solution may be given as often as every hour.

When used for the routine nursing care of patients with tracheostomy, 1 to 2 mL of a 10% to 20% solution may be given every 1 to 4 hours by instillation into the tracheostomy.

Nefrosave may be introduced directly into a particular segment of the bronchopulmonary tree by inserting (under local anesthesia and direct vision) a small plastic catheter into the trachea. Two to 5 mL of the 20% solution may then be instilled by means of a syringe connected to the catheter.

Nefrosave may also be given through a percutaneous intratracheal catheter. One to 2 mL of the 20% or 2 to 4 mL of the 10% solution every 1 to 4 hours may then be given by a syringe attached to the catheter.

Diagnostic Bronchograms: For diagnostic bronchial studies, 2 or 3 administrations of 1 to 2 mL of the 20% solution or 2 to 4 mL of the 10% solution should be given by nebulization or by instillation intratracheally, prior to the procedure.

Administration of Aerosol

Materials: Nefrosave solution (n-acetyl-l-cysteine) may be administered using conventional nebulizers made of plastic or glass. Certain materials used in nebulization equipment react with Nefrosave. The most reactive of these are certain metals (notably iron and copper) and rubber. Where materials may come into contact with Nefrosave solution (n-acetyl-l-cysteine), parts made of the following acceptable materials should be used: glass, plastic, aluminum, anodized aluminum, chromed metal, tantalum, sterling silver, or stainless steel. Silver may become tarnished after exposure, but this is not harmful to the drug action or to the patient.

Nebulizing Gases: Compressed tank gas (air) or an air compressor should be used to provide pressure for nebulizing the solution. Oxygen may also be used but should be used with usual precautions in patients with severe respiratory disease and CO if prothrombin time ratio exceeds 1.5 or fresh frozen plasma if the prothrombin time ratio exceeds 3.0.

Dosage Guide and Preparation

Doses in relation to body weight are:

Loading Dose of Nefrosave* Solution

Hours Post-Ingestion

Adapted from Rumack and Mathews, Pediatrics 1975; 55:871-876.

How supplied

Nefrosave Solution, USP (n-acetyl-l-cysteine), is available in rubber stopped glass vials containing 10 or 30 mL. The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for Injection, Sodium Chloride for Inhalation, Sterile Water for Injection, or Sterile Water for Inhalation. The 10% solution may be used undiluted.

Acetycysteine is sterile, not for injection and can be used for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). It is available as follows:

10% Nefrosave Solution, USP (n-acetyl-l-cysteine) (100 mg Nefrosave per mL).

NDC 0054-3027-02....................................10 mL vials; carton of 3

NDC 0054-3025-02....................................30 mL vials; carton of 3

20% Nefrosave Solution, USP (n-acetyl-l-cysteine) (200 mg Nefrosave per mL).

NDC 0054-3028-02.....................................10 mL vials; carton of 3

NDC 0054-3026-02.....................................30 mL vials; carton of 3

Store unopened vials at controlled room temperature, 15° to 30°C (59° to 86°F).

Nefrosave Solution, USP (n-acetyl-l-cysteine) does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. Dilutions of Nefrosave should be used freshly prepared and utilized within one hour. If only a portion of the solution in a vial is used, store the remaining undiluted portion in a refrigerator and use within 96 hours.

REFERENCES

1. Bonanomi L, Gazzaniga A. Toxicological pharmacokinetic and metabolic studies on Nefrosave. Eur J Respir Dis 1981 61 (Suppl III):45-51.

2. Amer Rev Resp Dis 1960 82:627-639.

Mfd. by Ben Venue Laboratories, Inc., Bedford, Ohio 44146. Revised March 2007. Mfd. for Boehringer Ingelheim Roxane Laboratories. FDA Rev date: 8/28/2000

What other drugs will affect Nefrosave?

Other drugs may affect Nefrosave, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

See also:

Nefrosave drug interactions (in more detail)

Nefrosave interactions

With simultaneous use of antacids containing magnesium and / or aluminum hydroxide, slow down and reduce the absorption of acetylsalicylic acid.

With simultaneous use of calcium channel blockers, means limiting intake of calcium or increasing the excretion of calcium from the body, increases the risk of bleeding.

With simultaneous use with acetylsalicylic acid enhances the action of heparin and indirect anticoagulants, hypoglycemic funds derived sulfonylureas, insulin, methotrexate, phenytoin, valproic acid.

With simultaneous use of Nefrosave Industrias Quimico Farmaceuticas Americanas with SCS increases the risk of ulcerogenic effect and occurrence of gastrointestinal bleeding.

With simultaneous use of decreasing the effectiveness of diuretics (spironolactone, furosemide).

With simultaneous use of other NSAIDs increases the risk of side effects. Acetylsalicylic acid may reduce plasma concentrations indomethacin, piroxicam.

With simultaneous use of gold drugs acetylsalicylic acid can induce liver damage.

With simultaneous use decreases effectiveness of uricosuric medications (including probenecid, sulfinpirazon, benzbromarone).

With simultaneous use of acetylsalicylic acid and alendronate sodium may develop severe esophagitis.

With simultaneous use of griseofulvin may be in breach Absorption of acetylsalicylic acid.

There is one case of spontaneous hemorrhage in the iris while taking Ginkgo Biloba extract on the background of prolonged use of aspirin in a dose of 325 mg / day. It is believed that this may be due to additive inhibitory effect on platelet aggregation.

With simultaneous use of dipyridamole may increase C_max of salicylate in plasma and AUC.

When applied simultaneously with acetylsalicylic acid increased concentration of digoxin, barbiturates and lithium salts in the blood plasma.

With simultaneous use of salicylates in high doses with carbonic anhydrase inhibitors can intoxication salicylates.

Acetylsalicylic acid in doses of less than 300 mg have little effect on the effectiveness of captopril and enalapril. When aspirin (acetylsalicylic acid) is admistered in high doses may decrease the effectiveness of captopril and enalapril.

With simultaneous application of caffeine increases the rate of absorption, plasma concentrations and bioavailability of acetylsalicylic acid.

With simultaneous use of Nefrosave Industrias Quimico Farmaceuticas Americanas with metoprolol may increase C_max of salicylate in blood plasma.

In the application of pentazocine on the background of long-term use of aspirin in high doses there is a risk of severe adverse reactions in the kidneys.

With simultaneous application phenylbutazone reduces uricosuria caused by acetylsalicylic acid.

With simultaneous application of ethanol may exacerbate the effects of acetylsalicylic acid on the gastrointestinal tract.

References

1. FDA/SPL Indexing Data. "1EQV5MLY3D: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
2. MeSH. "MeSH Tree: MeSH (Medical Subject Headings) is the NLM controlled vocabulary thesaurus used for indexing articles for PubMed.". http://www.nlm.nih.gov/mesh/meshhome... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "Taurine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology