Acetylcysteine Inhalant

Acetylcysteine Inhalant Manufacturers

• Cardinal Health
  

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  Acetylcysteine Inhalant | Actavis Pharma, Inc.

  

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  LILETTA contains 52 mg of levonorgestrel (LNG). Initially, LNG is released at a rate of 18.6 mcg/day. This rate decreases progressively to approximately 16.3 mcg/day at 1 year, 14.3 mcg/day at 2 years, and 12.6 mcg/day at 3 years after insertion. The average in vivo release rate of LNG is approximately 15.6 mcg/day over a period of 3 years. 

  LILETTA can be removed at any time but must be removed by the end of the third year. LILETTA can be replaced at the time of removal with a new LILETTA if continued contraceptive protection is desired.

  2.1 Insertion Instructions

  LILETTA (Figure 1) is provided in a sterile pouch [see Description (11)] and is inserted into the uterine cavity with the provided inserter (Figure 2) by carefully following the insertion instructions. Use strict aseptic techniques throughout the insertion procedure [see Warnings and Precautions (5.3)].

  2.1. Insertion

  Figure 1  LILETTA Intrauterine Contraceptive System (IUS)

  Figure 2:  LILETTA IUS with Inserter

  LILETTA should only be inserted by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the product, product educational materials, product insertion instructions, prescribing information, and patient labeling before attempting insertion of LILETTA.

  Obtain a complete medical and social history to determine conditions that might influence the selection of a levonorgestrel-releasing intrauterine system (LILETTA) for contraception. If indicated, perform a physical examination and appropriate tests for genital or sexually transmitted infections. [See Contraindications (4) and Warnings and Precautions (5.4, 5.10).]
  Check the expiration date on the box before opening it. Do not insert LILETTA after the expiration date.
  Visually inspect the packaging (sealed pouch) containing LILETTA to verify that the packaging has not been damaged (e.g., torn, punctured, etc.). If the packaging has any visual damage that could compromise sterility, do not use the unit for insertion [see Warnings and Precautions (5.3)].
  Ensure that the patient understands the contents of the Patient Information Booklet and obtain consent. A sample consent form that includes the lot number is on the last page of the Patient Information Booklet.
  Complete the pelvic examination, speculum placement, tenaculum placement, and sounding of the uterus before opening the LILETTA pouch.
  Do not open the pouch to insert LILETTA if the cervix is unable to be properly visualized, if the uterus cannot be adequately instrumented (during sounding), or if the uterus sounds to less than 5.5 cm.

  Timing of Insertion

  Refer to Table 1 for instructions on when to start use of LILETTA.

  Table 1: When to Insert LILETTA Starting LILETTA in women not currently using hormonal or intrauterine contraception   
  
  
  
  
  
  
  
  
     LILETTA can be inserted any time the provider can be reasonably certain the woman is not pregnant. Consider the possibility of ovulation and conception prior to initiation of this product.
  If LILETTA is not inserted during the first 7 days of the menstrual cycle, a barrier method of contraception (such as condoms and spermicide) should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy. Switching to LILETTA from an oral, transdermal or vaginal hormonal contraceptive
     
     
   
   
   
   
   
   
       LILETTA may be inserted at any time.
  •    May be inserted during the hormone-free interval of the previous method
  •    If inserted during active use of the previous method, continue the previous method after LILETTA insertion for seven days or until the end of the current cycle.
  If using continuous hormonal contraception, discontinue the method seven days after LILETTA insertion. Switching to LILETTA from an injectable progestin contraceptive
      
                              
           LILETTA may be inserted at any time; a barrier method of contraception (such as condoms and spermicide) should also be used for 7 days if LILETTA is inserted as instructed more than 3 months (13 weeks) after the last injection. Switching to LILETTA from a contraceptive implant or another IUS
                            
  
                 Insert LILETTA on the same day the implant or IUS is removed.
  LILETTA may be inserted at any time during the menstrual cycle. Inserting LILETTA after abortion or miscarriage First-trimester
  LILETTA may be inserted immediately after a first-trimester abortion or miscarriage. Second-trimester
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  Do not insert LILETTA until a minimum of 6 weeks after second trimester abortion or miscarriage, or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion [see Warnings and Precautions (5.5, 5.6)].
  If the woman has not yet had a period, consider the possibility of ovulation and conception occurring prior to insertion of LILETTA. [See Contraindications (4), Warnings and Precautions (5.2), and FDA-Approved Patient Labeling.] LILETTA can be inserted any time the provider can be reasonably certain the woman is not pregnant.
  If LILETTA is not inserted during the first 7 days of the menstrual cycle, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy. Inserting LILETTA after Childbirth
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  Do not insert LILETTA until a minimum of 6 weeks after delivery, or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion [see Warnings and Precautions (5.5, 5.6)].
  If the woman has not yet had a period, consider the possibility of ovulation and conception occurring prior to insertion of LILETTA. [See Contraindications (4), Warnings and Precautions (5.2), and FDA-Approved Patient Labeling.] LILETTA can be inserted any time the provider can be reasonably certain the woman is not pregnant.
  If LILETTA is not inserted during the first 7 days of the menstrual cycle, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy.
  There appears to be an increased risk of perforation in lactating women. [See Warnings and Precautions (5.5).]

  Planning for Insertion

  Ensure all needed items for LILETTA insertion are readily available:
  ○ Gloves
  ○ Speculum
  ○ Sterile uterine sound
  ○ Sterile tenaculum
  ○ Antiseptic solution
  ○ LILETTA with inserter in sealed pouch 
  ○ Sterile, blunt-tipped scissors
  ○ Additional items that may be useful could include:
       •   Local anesthesia, needle, and syringe
       •   Os finder and/or cervical dilators
       •   Ultrasound with abdominal probe
  Exclude pregnancy and confirm that there are no other contraindications to the insertion and use of LILETTA.
  Follow the insertion instructions exactly as described in order to ensure proper insertion.
  If you encounter cervical stenosis at any time during uterine sounding or LILETTA insertion, use cervical dilators, not force, to overcome resistance. If necessary, dilation, sounding, and insertion may be performed with ultrasound guidance.
  Insertion may be associated with some pain and/or bleeding or vasovagal reactions (e.g., diaphoresis, syncope, bradycardia, or seizure), especially in patients with a predisposition to these conditions. Consider administering analgesics prior to insertion.

  Use aseptic technique during the entire insertion procedure. Loading and inserting LILETTA does not require sterile gloves. If not using sterile gloves, complete all steps for loading the IUS (Steps 1-7) inside the pouch. Maintain sterility during LILETTA insertion; do not touch LILETTA or parts of any sterile instrument that will pierce tissue (e.g., a tenaculum on the cervix) or go into the uterine cavity.

  Preparation for Insertion

  With the patient comfortably in lithotomy position, do a bimanual exam to establish the size, shape, and position of the uterus and to evaluate any signs of uterine infection.
  Gently insert a speculum to visualize the cervix.
  Thoroughly cleanse the cervix and vagina with antiseptic solution.
  Administer cervical anesthetic, if needed.
  Apply a tenaculum to the cervix and use gentle traction to align the cervical canal with the uterine cavity. If the uterus is retroverted, it may be more appropriate to grasp the lower lip of the cervix. Keep the tenaculum in position and maintain gentle traction on the cervix throughout the insertion procedure.
  Carefully sound the uterus to measure its depth.
  The uterus should sound to a depth of at least 5.5 cm. Insertion of LILETTA into a uterine cavity that sounds to less than 5.5 cm may increase the incidence of expulsion, bleeding, pain, perforation, and possibly pregnancy. LILETTA should not be inserted if the uterus sounds to less than 5.5 cm.  
  After ascertaining that the patient is appropriate for LILETTA, open the pouch containing LILETTA.

  Insertion Procedure

  Loading the IUS into the Inserter

  Step 1

  Place the LILETTA pouch on a flat surface with the clear side of the pouch facing up (Figure 3).

  Figure 3:  Place the LILETTA pouch on a flat surface.

  Open the sterile LILETTA pouch from the bottom (end with the rod ring) approximately 1/3 of the way until the lower ends of the IUS threads, the rod, and the insertion tube are exposed (Figure 4).

  If using sterile gloves, you can open the pouch completely before putting on the sterile gloves.

  Figure 4:  Release the threads from the flange and insert the rod.

  Step 2

  Pull back the blue threads to dislodge them from the flange.
  Be careful to not pull the IUS down at the same time (Figure 4).

  Step 3

  Hold the exposed end of the insertion tube containing the IUS (Figure 4) while keeping the end of the insertion tube with the IUS inside the packaging.
  Remove the rod from the pouch.
  Do not touch the end of the rod that will go into the insertion tube.
  Place the rod into the insertion tube (alongside the IUS threads) to about the 5 cm marking (Figure 4).

  Step 4

  While holding the insertion tube and the rod firmly between the fingers and thumb of one hand, pull downward on both blue threads with the other hand to draw the IUS into the insertion tube (Figure 5).
  The arms of the IUS should be kept in a horizontal plane, parallel to the flat side of the flange (refer to Figure 4).
  Do not pull the IUS all of the way through the insertion tube; only pull the threads until the IUS is loaded at the top of the insertion tube. Note: If you accidentally remove the IUS completely out of the insertion tube, do not use or attempt to re-load. Figure 5: Pull on the threads to pull the IUS into the tube. Figure 6: Adjust the Flange.

  Step 5

  Hold the insertion tube and the rod firmly with one hand.
  With the other hand, adjust the position of the flange (through the sterile packaging if not using sterile gloves) by moving the tube to correspond to the sound measurement (Figure 6).
  The top end of the flange should be at the measurement corresponding to the sounded depth of the uterus.

  Step 6

  Final IUS positioning: position the IUS in the tube so that the knobs of the lateral arms are opposed to each other and protrude slightly above the tip of the insertion tube to form a hemispherical dome (Figure 7).
  Hold the tube at its proximal end between your fingers and thumb of one hand.
  With the other hand, while pulling on the blue threads, slowly advance the rod forward to adjust the position of the IUS.
  When the IUS tips are in the correct position (slightly protruding), pinch and hold the proximal end of the tube firmly to maintain rod position.
  The proximal end of the insertion tube will be approximately at the top of the first indent on the rod (Figure 7).

  Figure 7:  Final IUS Positioning

  ENSURE A HEMISPHERICAL DOME IS ACHIEVED.
  When the IUS is in the correct position, the lower end of the tube will be aligned approximately at the upper edge of the upper indent on the rod.

  Step 7

  Check to make sure the IUS is correctly loaded. You should note the following:

  The IUS is completely within the insertion tube with the knobs of the arms forming a hemispherical dome at the top of the tube.
  The top of the rod is touching the bottom of the IUS.
  The blue threads are hanging through the end of the insertion tube.
  The flange is marking the depth of the uterus based on pre-insertion sounding.

  Step 8

  Remove the loaded IUS insertion tube from the pouch while holding the lower end of the tube firmly between your fingers and thumb.

  If not using sterile gloves, do not touch the flange and any part of the insertion tube above the flange during this step and through the IUS insertion procedure.

  IUS Insertion into the Uterus

  Step 1

  Apply gentle traction on the tenaculum to straighten the alignment of the cervical canal and uterine cavity.
  While still firmly pinching the proximal end of the insertion tube to maintain the IUS in the correct position (Hand A), slide the loaded IUS insertion tube through the cervical canal until the upper edge of the flange is approximately 1.5 – 2.0 cm from the cervix (Figure 8).
  DO NOT advance flange to the cervix at this step.
  DO NOT force the inserter. If necessary, dilate the cervical canal. Figure 8:  While holding the rod and the tube, advance into the uterine cavity.
  Advance to 1.5 – 2.0 cm from the cervix. Figure 9: Hold the rod still and pull back the tube until the second indent on the rod.

  Step 2

  Release hold on the tenaculum.
  Hold the insertion tube with the fingers of one hand (Hand A) and the rod with the fingers of the other hand (Hand B).
  Hold the rod still (Hand B), relax the firmness of the pinch on the tube, and pull the insertion tube back with Hand A to the edge of the second indent of the rod (Figure 9).
  This will allow the IUS arms to open in the lower uterine segment.

  Step 3

  Wait 10 – 15 seconds for the arms of the IUS to fully open.

  Step 4

  Apply gentle traction with the tenaculum before advancing the IUS.
  With Hand A still holding the proximal end of the tube, advance both the insertion tube and rod simultaneously up to the uterine fundus (Figure 10). You will feel slight resistance when the IUS is at the fundus.
  The flange should be touching the cervix when the IUS reaches the uterine fundus.

  Note: Fundal positioning is important to prevent expulsion.

  Figure 10:  After 10 – 15 seconds, advance to the fundus while holding both the rod and the tube.

  Step 5

  Hold the rod still (Hand B) while pulling the insertion tube back with Hand A to the ring of the rod (Figure 11).

  Figure 11:  Hold the rod still and pull back the tube to the ring on the rod.

  Step 6

  While holding the inserter tube with Hand A, withdraw the rod from the insertion tube all of the way out to prevent the rod from catching on the knot at the lower end of the IUS.

  Note: Ensure the tube is held firmly in place until the rod is completely pulled outside of the tube as there will be some slight resistance while removing the rod from the tube.

  Step 7

  Completely remove the insertion tube.

  Step 8

  Use blunt-tipped sharp scissors to cut the IUS threads perpendicular to the thread length, leaving about 3 cm outside of the cervix (Figure 12). Note: Cutting threads at an angle may leave sharp ends.
  Do not apply tension or pull on the threads when cutting to prevent displacing the IUS.

  Figure 12: Cut the threads about 3 cm from the cervix.

  Insertion of LILETTA is now complete.

  Important information to consider during or after insertion:

  If you suspect the IUS is not in the correct position: Check insertion with an ultrasound or other appropriate radiologic test.
  If incorrect insertion is suspected, remove LILETTA. A removed LILETTA must not be re-inserted.

  Difficult insertion

  If insertion is difficult because the uterus cannot be appropriately instrumented, the following measures can be considered: Use of cervical anesthesia to make sounding and manipulation more tolerable.
  Use of dilators to dilate the cervix if needed to allow passage of the sound.
  Abdominal ultrasound guidance during dilation and/or insertion.
  If there is clinical concern, exceptional pain, or bleeding during or after insertion, take appropriate steps, such as physical examination and ultrasound, immediately to exclude perforation. 2.2 Patient Counseling and Record-Keeping Keep a copy of the consent form and LILETTA lot number for your records.
  Counsel the patient on what to expect following LILETTA insertion. Give her the Patient Information Booklet, which includes the website address (www.LILETTA.com). Discuss expected bleeding patterns with LILETTA use. Review the signs and symptoms of LILETTA expulsion. [See Patient Counseling Information (17).]
  Prescribe analgesics, if indicated. 2.3 Patient Follow-Up

  Re-examine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.

  2.4 Removal of LILETTA

  Timing of Removal

  If pregnancy is desired, LILETTA can be removed at any time.
  If pregnancy is not desired, LILETTA can be removed at any time; however, a contraception method should be started prior to removal of LILETTA [see Dosage and Administration (2.5)]. Counsel your patient that if she has intercourse in the week prior to removal without use of a backup contraceptive method, she is at risk of pregnancy.
  LILETTA should be removed after 3 years. LILETTA can be replaced at the time of removal with a new LILETTA if continued contraceptive protection is desired.

  Planning for Removal

  Ensure all needed items for LILETTA removal are readily available:
  ○ Gloves
  ○ Speculum
  ○ Sterile forceps
  ○ Additional items that may be required could include:
        •     Local anesthetic, needle, and syringe
        •     Os finder and/or cervical dilators
        •     Ultrasound with abdominal probe
        •     Sterile tenaculum
        •     Antiseptic solution
        •     Long, narrow forceps
  Removal may be associated with some pain and/or bleeding or vasovagal reactions (e.g., syncope, bradycardia, or seizure), especially in patients with a predisposition to these conditions.
  After removal of LILETTA, examine the system to ensure that it is intact.

  Removal Instructions

  With the patient comfortably in lithotomy position, place a speculum and visualize the cervix.
  When the threads of LILETTA are visible:
  ○ Remove the IUS by applying gentle traction on the threads with forceps (Figure 13).
  ○ The arms of the device will fold upward as it is withdrawn from the uterus.
  ○ If the IUS cannot be removed with traction on the threads, perform an ultrasound examination to confirm location of the IUS, including assessment for partial or total perforation. If the IUS is in the uterus, use a long, narrow forceps to grasp LILETTA. Consider use of a tenaculum, cervical anesthesia, cervical dilators, and/or ultrasound guidance as needed.
  If the threads of LILETTA are not visible:
  ○ Determine location of the IUS by ultrasound examination.
  ○ If the IUS is in the uterine cavity, use a long, narrow forceps (e.g., Alligator forceps) to grasp LILETTA. Consider use of a tenaculum, cervical anesthesia, cervical dilators, and/or ultrasound guidance as needed. If LILETTA cannot be removed using the above techniques, consider hysteroscopic evaluation for removal.
  ○ If the IUS is not in the uterine cavity, consider an abdominal x-ray or CT scan to evaluate if the IUS is in the abdominal cavity.  Consider laparoscopic evaluation for removal, as clinically indicated.

  Figure 13:  Removal of LILETTA

  2.5 Continuation of Contraception After Removal If pregnancy is not desired and if a woman wishes to continue using LILETTA, a new system can be inserted immediately after removal any time during the cycle.
  If a patient with regular cycles wants to start a different birth control method, time the removal and initiation of a new method to ensure continuous contraception. Either remove LILETTA during the first 7 days of the menstrual cycle and start the new method or start the new method at least 7 days prior to removing LILETTA if removal is to occur at other times during the cycle.
  If a patient with irregular cycles or amenorrhea wants to start a different birth control method, start the new method at least 7 days before LILETTA removal.
  If LILETTA is removed but no other contraceptive method has already been started, the new contraceptive method can be started on the day LILETTA is removed. The patient should use a backup barrier method of contraception (e.g., condoms and spermicide) or abstain from vaginal intercourse for 7 days to prevent pregnancy.

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• American Regent, Inc.
  

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  Acetylcysteine Inhalant | American Regent, Inc.

  

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  General

  Acetylcysteine is available in rubber stoppered glass vials containing 4, 10, or 30 mL. The 20% solution may be diluted to a lesser concentration with either Sodium Chloride Injection, Sodium Chloride Inhalation Solution, Sterile Water for Injection, or Sterile Water for Inhalation. The 10% solution may be used undiluted.

  Acetylcysteine 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 for inhalation, store the remainder in a refrigerator and use within 96 hours.

  Nebulization-face mask, mouth piece, tracheostomy

  When nebulized into a face mask, mouth piece, 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 3 to 4 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 acetylcysteine (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.

  Acetylcysteine 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.

  Acetylcysteine 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, two or three 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

  Acetylcysteine may be administered using conventional nebulizers made of plastic or glass. Certain materials used in nebulization equipment react with acetylcysteine. The most reactive of these are certain metals (notably iron and copper) and rubber. Where materials may come into contact with acetylcysteine solution, 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 the usual precautions in patients with severe respiratory disease and CO2 retention.

  Apparatus

  Acetylcysteine is usually administered as fine nebulae and the nebulizer used should be capable of providing optimal quantities of a suitable range of particle sizes.

  Commercially available nebulizers will produce nebulae of acetylcysteine satisfactory for retention in the respiratory tract. Most of the nebulizers tested will supply a high proportion of the drug solution as particles of less than 10 microns in diameter. Mitchell2 has shown that particles less than 10 microns should be retained in the respiratory tract satisfactorily.

  Various intermittent positive pressure breathing devices nebulized acetylcysteine with a satisfactory efficiency including: No. 40 De Vilbiss (The De Vilbiss Co., Somerset, Pennsylvania), and the Bennett Twin-Jet Nebulizer (Puritan Bennett Corp., Oak at 13th., Kansas City, Missouri).

  The nebulized solution may be inhaled directly from the nebulizer. Nebulizers may also be attached to the plastic face masks or plastic mouthpieces. Suitable nebulizers may also be fitted for use with the various intermittent positive pressure breathing (IPPB) machines. The nebulizing equipment should be cleaned immediately after use because the residues may clog the smaller orifices or corrode metal parts.

  Hand bulbs are not recommended for routine use in nebulizing acetylcysteine because their output is generally too small. Also, some hand-operated nebulizers deliver particles that are larger than optimum for inhalation therapy.

  Acetylcysteine should not be placed directly into the chamber of a heated (hot pot) nebulizer. A heated nebulizer may be part of the nebulization assembly to provide a warm saturated atmosphere if the acetylcysteine aerosol is introduced by means of a separate unheated nebulizer. Usual precautions for administration of warm saturated nebulae should be observed.

  The nebulized solution may be breathed directly from the nebulizer. Nebulizers may also be attached to plastic face masks, plastic face tents, plastic mouth pieces, conventional plastic oxygen tents, or head tents. Suitable nebulizers may also be fitted for use with the various intermittent positive pressure breathing (IPPB) machines.

  The nebulizing equipment should be cleaned immediately after use, otherwise the residues may occlude the fine orifices or corrode metal parts.

  Prolonged Nebulization

  When three fourths of the initial volume of acetylcysteine solution has been nebulized, a quantity of Sterile Water for Injection, USP (approximately equal to the volume of solution remaining) should be added to the nebulizer. This obviates any concentration of the agent in the residual solvent remaining after prolonged nebulization.

  Compatibility

  The physical and chemical compatibility of acetylcysteine solutions with certain other drugs that might be concomitantly administered by nebulization, direct instillation, or topical application has been studied.

  Acetylcysteine should not be mixed with certain antibiotics. For example, the antibiotics, tetracycline hydrochloride, oxytetracycline hydrochloride, and erythromycin lactobionate, were found to be incompatible when mixed in the same solution. These agents may be administered from separate solutions if administration of these agents is desirable.

  The supplying of these data should not be interpreted as a recommendation for combining acetylcysteine with other drugs. The table is not presented as positive assurance that no incompatibility will be present, since these data are based only on short-term compatibility studies done in the Mead Johnson Research Center. Manufacturers may change their formulations, and this could alter compatibilities. These data are intended to serve only as a guide for predicting compounding problems.

  If it is deemed advisable to prepare an admixture, it should be administered as soon as possible after preparation. Do not store unused mixtures.

  IN VITRO COMPATIBILITY1 TESTS OF ACETYLCYSTEINE
  1. The rating, Incompatible, is based on the formation of a precipitate, a change in clarity, immiscibility, or a rapid loss of potency of acetylcysteine or the active ingredient of the PRODUCT AND/OR AGENT in the admixture.  The rating, Compatible, means that there was no significant physical change in the admixture when compared with a control solution of the PRODUCT AND/OR AGENT, and that there was no predicted chemical incompatibility. All of the admixtures have been tested for short-term chemical compatibility by assaying for the concentration of acetylcysteine after mixing. 2. The active ingredient in the PRODUCT AND/OR AGENT was also assayed after mixing. Some of the admixtures developed minor physical changes which were considered to be insufficient to rate the admixture Incompatible. These are listed in footnotes 3, 4, and 5.

  3. A strong odor developed after storage for 24 hours at room temperature.

  4. The admixture was a slightly darker shade of yellow than a control solution of the PRODUCT AND/OR AGENT.

  5. A light tan color developed after storage for 24 hours at room temperature.

  6. Entries are final concentrations. Values in parentheses relate volumes of acetylcysteine solutions to volume of test solutions.      RATIO TESTED6  PRODUCT AND/OR AGENT  COMPATIBILITY  ACETYLCYSTEINE  PRODUCT    RATING    OR AGENT  ANESTHETIC, GAS        Halothane  Compatible  20%  Infinite  Nitrous Oxide  Compatible  20%  Infinite  ANESTHETIC, LOCAL        Cocaine HCl  Compatible  10%  5%  Lidocaine HCl  Compatible  10%  2%  Tetracaine HCl  Compatible  10%  1%  ANTIBACTERIALS (A parenteral form of each antibiotic was used)        Bacitracin2,3 (mix and use at once)  Compatible  10%  5,000 U/mL  Chloramphenicol Sodium Succinate  Compatible  20%  20 mg/mL  Carbenicillin Disodium2 (mix and use at once)  Compatible  10%  125 mg/mL  Gentamicin Sulfate2  Compatible  10%  20 mg/mL  Kanamycin Sulfate2 (mix and use at once)  Compatible  10%  167 mg/mL    Compatible  17%  85 mg/mL  Lincomycin HCl2  Compatible  10%  150 mg/mL  Neomycin Sulfate2  Compatible  10%  100 mg/mL  Novobiocin Sodium2  Compatible  10%  25 mg/mL  Penicillin G Potassium2 (mix and use at once)  Compatible  10%  25,000 U/mL    Compatible  10%  100,000 U/mL  Polymyxin B Sulfate2  Compatible  10%  50,000 U/mL  Cephalothin Sodium  Compatible  10%  110 mg/mL  Colistimethate Sodium2 (mix and use at once)  Compatible  10%  37.5 mg/mL  Vancomycin HCl2  Compatible  10%  25 mg/mL  Amphotericin B  Incompatible  4% - 15%  1 - 4 mg/mL  Chlortetracycline HCl2  Incompatible  10%  12.5 mg/mL  Erythromycin Lactobionate  Incompatible  10%  15 mg/mL  Oxytetracycline HCl  Incompatible  10%  12.5 mg/mL  Ampicillin Sodium  Incompatible  10%  50 mg/mL  Tetracycline HCl  Incompatible  10%  12.5 mg/mL  BRONCHODILATORS        Isoproterenol HCl2  Compatible  3%  0.5%  Isoproterenol HCl2  Compatible  10%  0.05%  Isoproterenol HCl2  Compatible  20%  0.05%  Isoproterenol HCl  Compatible  13.3% (2 parts)  0.33% (1 part)  Isoetharine HCl  Compatible  13.3% (2 parts)  (1 part)  Epinephrine HCl  Compatible  13.3% (2 parts)  0.33% (1 part)  CONTRAST MEDIA        Iodized Oil  Incompatible  20%/20 mL  40%/10 mL  DECONGESTANTS        Phenylephrine HCl2  Compatible  3%  0.25%  Phenylephrine HCl  Compatible  13.3% (2 parts)  0.17% (1 part)  ENZYMES        Chymotrypsin  Incompatible  5%  400 γ/mL  Trypsin  Incompatible  5%  400 γ/mL  SOLVENTS        Alcohol  Compatible  12%  10% - 20%  Propylene Glycol  Compatible  3%  10%  STEROIDS        Dexamethasone Sodium Phosphate  Compatible  16%  0.8 mg/mL  Prednisolone Sodium Phosphate5  Compatible  16.7%  3.3 mg/mL  OTHER AGENTS        Hydrogen Peroxide  Incompatible  (All ratios)    Sodium Bicarbonate  Compatible  20% (1 part)  4.2% (1 part) General

  Regardless of the quantity of acetaminophen reported to have been ingested, administer acetylcysteine immediately if 24 hours or less have elapsed from the reported time of ingestion of an overdose of acetaminophen. Do not await results of assays for acetaminophen level before initiating treatment with acetylcysteine. The following procedures are recommended:

  The stomach should be emptied promptly by lavage or by inducing emesis with syrup of ipecac. Syrup of ipecac should be given in a dose of 15 mL for children up to age 12 and 30 mL for adolescents and adults followed immediately by drinking copious amounts of water. The dose should be repeated if emesis does not occur in 20 minutes. In the case of a mixed drug overdose activated charcoal may be indicated. However, if activated charcoal has been administered, lavage before administering acetylcysteine treatment. Activated charcoal adsorbs acetylcysteine in vitro and may do so in patients and thereby may reduce its effectiveness. Draw blood for predetoxification acetaminophen plasma assay and baseline SGOT, SGPT, bilirubin, prothrombin time, creatinine, BUN, blood sugar and electrolytes. Administer the loading dose of acetylcysteine, 140 mg per kg of body weight. (Prepare acetylcysteine for oral administration as described in the Dosage Guide and Preparation table). Determine subsequent action based on predetoxification plasma acetaminophen information. Choose ONE of the following four courses of therapy. Predetoxification plasma acetaminophen level is clearly in the toxic range (See Acetaminophen Assays - Interpretation and Methodology below):
  Administer a first maintenance dose (70 mg/kg acetylcysteine) 4 hours after the loading dose. The maintenance dose is then repeated at 4-hour intervals for a total of 17 doses. Monitor hepatic and renal function and electrolytes throughout the detoxification process. Predetoxification acetaminophen level could not be obtained
  Proceed as in A. Predetoxification acetaminophen level is clearly in the non-toxic range (beneath the dashed line on the nomogram) and you know that acetaminophen overdose occurred at least 4 hours before the predetoxification acetaminophen plasma assays
  Discontinue administration of acetylcysteine. Predetoxification acetaminophen level was in the non-toxic range, but time of ingestion was unknown or less than 4 hours
  Because the level of acetaminophen at the time of predetoxification assay may not be a peak value (peak may not be achieved before 4 hours post-ingestion), obtain a second plasma level in order to decide whether or not the full 17-dose detoxification treatment is necessary. If the patient vomits an oral dose within 1 hour of administration, repeat that dose. In the occasional instances where the patient is persistently unable to retain the orally administered acetylcysteine, the antidote may be administered by duodenal intubation. Repeat SGOT, SGPT, bilirubin, prothrombin time, creatinine, BUN, blood sugar and electrolytes daily if the acetaminophen plasma level is in the potentially toxic range as discussed below. Preparation of Acetylcysteine for Oral Administration

  Oral administration requires dilution of the 20% solution with diet cola or other diet soft drinks, to a final concentration of 5% (see Dosage Guide and Preparation table). If administered via gastric tube or Miller-Abbott tube, water may be used as the diluent. The dilutions should be freshly prepared and utilized within one hour. Remaining undiluted solutions in opened vials can be stored in the refrigerator up to 96 hours.
  
  ACETYLCYSTEINE IS NOT APPROVED FOR PARENTERAL INJECTION.

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