Guide to Monographs

Medication name

Generic or Australian approved name or active ingredient. The salt may not always be included. Other generic names (synonyms) are listed. 

The monograph medicine names have been updated in line with the Therapeutic Goods Administration name change recommendations to align with names used internationally. The new medicine names have links to the old names.

The full list of affected medicines appears on the TGA website: https://www.tga.gov.au/updating-medicine-ingredient-names-list-affected-ingredients.

Trade name

The registered trade or proprietary brand names of products that are available in Australia including medicines not licenced in Australia and sourced via the Special Access Scheme (SAS). Information on SAS medicines applies to the specified brand and strength. Not all brands may be included  when there are multiple generics or new brand additions, discontinuations and change of manufacturers.

Therapeutic class

Classification or category of medications.

Availability

The strengths and volumes of the medicine that are available. Not all strengths and volumes may be available at the pharmacy. Strengths and volumes may change.

Storage

The manufacturer's storage conditions (temperature and protection from light where applicable) are provided for the injectable medicines (ampoules, pre-filled syringes and vials). The recommendation for storage at room temperature is 15–25 oC and refrigeration is 2–8 oC (not frozen). Medicines that need to be protected from light should remain in the original manufacturer's outer carton (where possible) or stored in boxes or light protected bags. Caution: if medicines are stored outside the manufacturer's recommendations, this can cause degradation of the medicine that may result in decreased potency or a harmful product.

pH

Only available pH is reported. The pH of the medicine may influence its irritant properties. Avoid extravasation  of parenteral medicines with pH <5.5  or  >8.5 as they are more highly irritant and can cause tissue damage. If extravasation occurs, refer to SCHN IV Extravasation Management Practice Guideline.

Preparation

Contains information on the preparation of the medicine prior to administration including the reconstitution and any special conditions or precautions that may apply.  

Reconstitution is to add a compatible fluid or diluent  to the dry powder, mix by shaking or gently swirling to form a solution or suspension. Where applicable, recommended diluents and volumes are provided in the individual medicine monographs. A diluent is the compatible fluid to reconstitute a powder or further dilute a medicine in solution. All diluents for reconstitution or dilution must be sterile and suitable for injection. Use preservative-free diluents where possible. Benzyl alcohol is sometimes present in diluents or medications as a preservative. Its use should be avoided in neonates or premature infants as it may be associated with a fatal "gasping syndrome." The recommended compatible fluid or diluent must be used to prevent or minimise degradation of the solution.

  • Injectable medicines must be prepared immediately before use.
  • Bring medicines stored in the fridge to room temperature before administration.
  • NEVER add IV medicine to a bag of fluids already hanging as a bolus dose could be administered inadvertently.
  • Care must be taken to adequately mix the final solution prior to administration.
  • Visually inspect all solutions before administration.
    • Solutions that show some precipitate should be discarded.
      • However, colour change can be normal for some additives so check manufacturers’ recommendations.
  • All additive solutions prepared and medications/IV fluids must be accurately and adequately labelled in accordance with NSW Ministry of Health Policy Directive (PD2012_007): ‘User applied Labelling of Injectable Medicines, Fluids and Lines’

Displacement volume is the volume that the powder component of a medicine occupies upon reconstitution. It needs to be added to the diluent volume to make accurate calculation of doses that are less than a full vial.

Volume of diluent to reconstitute a vial + displacement volume of drug powder = Final volume in vial 

Thus, the diluent volume recommended in the Product Information (PI) may sometimes differ from the volume recommended in this guideline. If there is a displacement volume for a medicine this has been included in the individual monograph. Medicine displacement values that are negligble are not included. The displacement volume provided is an estimate and this may vary between brands. Please check the Product Information or the manufacturer.

Hazardous medicines

Hazardous medicines include cytotoxics, immunosuppressants, immunomodulating agents/ (monoclonal antibodies) and antivirals that cause harm or is potentially harmful on occupational exposure during administration or handling. Sometimes the occupational hazard is unknown. Take additional precautions when handling and diluting to minimise exposure. Wear protective clothing including gloves and face mask. Follow local guidelines on the administration and handling of hazardous and cytotoxic medications.

Stability

From a microbiological perspective, in clinical areas, injectable medications must be prepared immediately prior to administration using aseptic technique.  For sterility purpose all IV fluid bags must be changed every 24 hours, unless chemical stability is of a shorter duration and the guidelines on individual medicine monographs should be followed. Some stability information is provided where available to guide the administration times and changing of the infusion solution or for the exceptional circumstance where the prepared medicine cannot be administered immediately. Follow state or local policies regarding reconstitution or dilution injections before use and discarding any unused solution regardless of stability data.

Injectable medicines prepared under controlled environmental conditions (eg. the pharmacy aseptic suite) may be given a longer shelf-life and will be labelled accordingly. Some local institional protocols may provide additional information. 

Some reconstituted and diluted medicine solutions are light-sensitive and need to be protected from light to prevent photodegradation of the medicine.

Some medicines (eg. amiodarone, clonazepam, glyceryl trinitrate, insulin (neutral and ultra-short acting), liothyronine, nimodipine, tacrolimus, thiopental) adsorbs to certain plastics, mainly polyvinyl chloride (PVC), so PVC-free syringes, infusion bags and administration sets must be used.

Some medicine (eg. ciclosporin) may also leach (leak) out toxic plasticisers especially from PVC material and can affect the stability of the medicine.

Parenteral medicine products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit. Do NOT use if the solution is cloudy or precipitated or if the seal is not intact.

Spiked solutions

Begin/ initiate administration of spiked IV solutions (IV bag entered by the tubing spike) within one hour of preparation. If administration has not begun within one hour of spiking, the IV bag and tubing shall be promptly discarded.

Single use injections

When only a portion of the dose is required for a patient, the unused medication should be discarded. “No ampoule or vial should be shared between patients ("multi-dosed"), due to the possibility of compromising the sterility of the medicine, the risk of cross-infection and the difficulty in accounting for each dose.” Refer to NSW Health Medication Handling policy PD 2013_043.

Multi-dose injections

Medications supplied in multi-dose vials must only be used in accordance with NSW Health and CEC: Infection Prevention and Control Policy and Infection Prevention and Control Practice Handbook . Injectable products packaged in multi-dose vials or ampoules (or other similar containers) must not be used except where the product is intended solely for the exclusive use of a single patient or there is no other alternative available on the Australian pharmaceutical market. Where there is no other alternative, precautions must be taken to ensure that the injection of contaminated material or fluid into a multi-dose vial or ampoule (or other similar container) does not happen.”

Sodium content

The amount of sodium contained in the medicine is included where available and should be considered when patients are sodium restricted.

Administration

Contains information on the recommended administration method (intravenous injection, intravenous infusion (intermittent or continuous), intramuscular or subcutaneous) generally for children above one month, concentration of medicine solution, rates of administration, and other guidelines for proper administration. Consult local protocols. For administration in neonates consult The Australasian Neonatal Medicines Formulary (ANMF). Limited information for preparation of medicines and administration in neonates exist for medicines not included in the ANMF. 

Glass ampoules

Recommend to always use a 5 micron (particulate) filter to remove glass particles, when breaking glass ampoules to prepare aqueous injection.

Dose dilution

Nursing policy on the Administration of Intravenous Medication advises dilution of all injections up to 5 mL for children to the age of 5 years, and up to 10 mL for older children. For most medicines included in the Paediatric Injectable Medicines Handbook, this would fall within the manufacturer's recommendations. Where this does not occur, the dilutions recommended by the manufacturers and in the Paediatric Injectable Medicines Handbook should be followed.  For further dilution of the concentrated solution or reconstituted solution, draw up the required dose from the ampoule or vial  and then further dilute with the compatible fluid to the final concentration for administration.

Two-syringe technique to dilute: Used for some medicines like digoxin where residual medicine left in the syringe can cause an over administration. Draw up the medicine in one syringe and the diluent in another. Inject the medicine into the diluent syringe and mix well. Two-syringe technique prevents " syringe dead space overdose" which can occur when medicine in the dead-space is drawn up also resulting in a significantly larger dose than intended.3

Diluted solutions should be mixed thoroughly before administration. Medicines that require dilution in large volumes of fluid may be problematic in fluid restricted patients. The minimum and maximum concentration of the medicine solution is provided in the monographs.

 

Administration method

Description

IV injection

Intravenous injection or bolus of a small volume of medicine solution directly into a vein or a free flowing IV line. Usually injected over less than 5 minutes. Follow the recommendations within the medicine monograph.

Intermittent IV infusion

Intermittent intravenous infusion over a set period  (generally longer than 10 minutes). The dose is diluted in a bag, burette or syringe. Cap the line once the flush after the infusion is complete, therefore ensuring the line remains in situ and capped until the next IV medication is required. If any intravenous giving set is used this must be discarded once disconnected. Ensure the appropriate volume of flush is given after the volume of fluid containing the medication is given. 

Continuous IV infusion

Continuous (longer than 24 hours) intravenous infusion. If small volumes of medication are to be infused continuously over a given time e.g. an opioid infusion, a syringe pump is to be used.

IM injection

Injection of a small volume of medicine solution into a muscle. IM injection is not preferred in children due to reduced muscle mass and is painful. Inject into a large muscle. The injection site is selected based on clinical judgement, the child’s age and size, and the type and volume of medication to be injected IM. 

  • Select a muscle that is accessible, well vascularised and well-developed.
  • In infants and toddlers the largest muscle is the vastus lateralis (thigh muscle) which is the preferred site. The vastus lateralis is an appropriate injection site for children of all ages as it is easily accessible and has no major blood vessels or nerves in the area.
  • The dorsogluteal (buttocks) is not recommended in neonates, infants and smaller children with small muscle mass as this can result in  damage to sciatic nerve and gluteal artery. 

To minimise pain it is recommended to divide the dose among multiple injection sites for large volumes depending on the size and muscle mass of the child. With increased muscle development a greater volume can be tolerated per injection site.

  • As a guide the recommended maximum volume to be injected IM per site is:
    • 0.5 mL for newborns and small infants
    • 1 mL  for older infants and small children
    •  2 mL may be tolerated in older children with well-developed muscle mass.
  • Rotate the site of injection for multiple administrations to avoid fibrosis.

Do not give IM injection to patients receiving anticoagulant medicines or patients with clotting diseases such as haemophilia as they may bleed.

Subcut

Injection or infusion of medicine solution into the subcutaneous part of the skin. Slower absorption than IM route as SC tissue has less blood supply. For a subcut injection the maximum recommended volume is 0.5–1 mL. Site of subcut injection include the deltoid or anterior thigh. Rotate injection sites to prevent fibrosis and to ensure adequate absorption.

Intravenous administration can be via a peripheral or central vascular access device (catheter or cannula). Consult SCHN Central Venous Access Device practice guideline. A peripheral line is a catheter or cannula placed into a peripheral vein to administer the medication or fluid.  A peripheral line has a greater risk of extravasation or phlebitis compared to a central line. A large peripheral vein which has adequate blood flow so that the medicine is rapidly diluted and distributed is generally recommended when peripheral administration is possible. Administration into a large vein also avoids thrombosis and phlebitis of irritant medicines. A central line has the tip of a central venous catheter located in a large central vein (the superior or inferior vena cava of the right atrium) which is used to administer the medication or fluid. The central line allows the administration of irritant or concentrated solutions, rapid administration of large volumes of fluid and  may have more than one lumen (with different exit sites) that allows for the co-administration of multiple medicines.

Specialised parenteral routes of administration

These routes may be required  for specIfic medications, indications or situations. Follow local guidelines.

Epidural

Injection of medication into the epidural (space around the dura mater of the spinal cord).

Intra-articular

Injection of medication into a joint.

Intraosseous

Injection of medication into the bone in an emergency where IV access is not possible.

Intrathecal

Injection of medication into the cerebrospinal fluid (CSF) around the spinal cord

Intracameral

Injection of medication into the anterior chamber of the eye.

Intravitreal

Injection of medication into the vitreous inside the eye

 

Smart infusion pumps

Smart infusion pumps have been implemented across SCHN utilising B Braun medication libraries with dosing parameters and safety limits for IV medications across all major care units. Consult the Smart pump practice guideline and intranet page, which includes, medication libraries, training resources and incident reporting processes For any questions or queries please contact SCHN-smartpump@health.nsw.gov.au.

Infusion rate

          Rate is the time period over which the medicine should be administered.

Calculation of infusion rate:

Dose can be expressed in mg or microgram or nanogram or units.

Ensure that the concentration is in the same unit as the dose. Convert to the same units if necessary.

1 mg            = 1000 microgram

1 microgram = 1000 nanogram

 

  • If the volume of medication to be infused and time to infuse is known:

Infusion rate per hour (mL/hr)  =   Volume to be infused X 60 min/hr 

                                                       —--------------------------------------------------                                                        Time to infuse (min)

 

  • If the dose is expressed as mg/kg/min

Infusion rate per hour (mL/hr)  =   Dose (mg/kg/min) X weight (kg) X 60 min/hr 

                                                       —----------------------------------------------------                                                        Drug concentration (mg/mL)

 
  • If the dose is expressed as mg/min

Infusion rate per hour (mL/hr )   =  Dose (mg/min) X 60 min/hr 

                                                      —--------------------------------                                                       Drug concentration (mg/mL)

 

  • Infusion rate in mL/min

           Infusion rate per minute (mL/min)    =   Dose (mg/min)

                                                              —------------------------------                                                                             Drug concentration (mg/mL)

 

Medicines may be infused using devices such as a volumetric or syringe pump or syringe driver which delivers the solution from an infusion bag or syringe through an administration set at a preset rate. Consult local protocols.

Flushing

  • Flushing of the cannula, catheter or administration set before and after the administration of a medicine with a compatible intravenous fluid ensures administration of the full medication dose and prevents mixing of  incompatible parenteral medicines or IV fluids. In the case of continuous intravenous therapy, an additional flush prior to medication administration may not be required if the infusate contains a compatible intravenous fluid solution.
  • Peripheral cannulas and central venous catheters not being used should also be flushed or locked to maintain their patency as per the recommend intervals outlined in local policies and procedures.
  • Flush with sufficient volume of a compatible fluid which should be at least twice the internal priming volume of the catheter and any add on devices such as IV lines and add on devices, considering the age and fluid balance and any volume restrictions in place for the child
  • Flush at the same rate that the parenteral medicine was administered to avoid adverse effects from an "unintentional" bolus.
  • Do NOT flush after infusion of:
    • some medications usually given via a syringe pump eg. inotropes, vasopressors and insulin to prevent undesirable effects from administration of a large dose. Once the infusion stops, disconnect and discard the administration set. Aspirate the catheter to remove any medication and flush with a compatible fluid.
    • medications incompatible with IV fluids as precipitation may occur.

Hospital in the Home (HITH) and Outpatient Parenteral Antimicrobial Therapy (OPAT)

  • Antimicrobials may be delivered in HITH setting with proven benefits in mortality, readmission rates and cost.#1,2
  • The availability and choice of treatment depends on published stability or compounding pharmacy data.
  • Antibiotics that can be delivered in the HITH setting.
    • Aciclovir (maximum dose of 2.4 g/day) #2,3
    • Amikacin (use vials)
    • Ampicillin (maximum dose of 7.2 g/day) #4
    • Aztreonam
    • Benzylpenicillin
    • Cefazolin
    • Cefepime
    • Cefotaxime
    • Ceftazidime#5 
    • Ceftolozane-tazobactam (maximum dose 6/3 g/day) #6
    • Ceftaroline (Maximum dose 1.44 g/day) #7
    • Ceftriaxone (use vials)
    • Flucloxacillin
    • Gentamicin (use vials)
    • Meropenem (maximum dose 4.8 g/day) #8
    • Piperacillin/tazobactam
    • Teicoplanin (use vials)
    • Tigecycline
    • Tobramycin (use vials)
    • Vancomycin
  • Consult the Antimicrobial Stewardship (AMS) pharmacist for advice.

IV Compatibility

Whenever IV medications or substances are added to IV fluids, their physical and chemical compatibility with the fluid and with any other added substance must be checked prior to making the addition.  It is the responsibility of the administering nurse to understand compatibility and stability of any IV additives and the ratio of fluid to the additive and to assess the patient’s condition at least hourly during the administration.

  •  Generally, no more than one substance should be added to any IV fluid (the exception is for oncology patients with some pre-approved fluid regimens for cytotoxic administration).
  •  IV Fluid containing potassium chloride (KCl) must not be used as a base solution to administer IV medications.
  • Do NOT add IV fluids or medications to any blood component or blood administration set/IV line prior to or during its transfusion unless there is data to support compatibility with the blood component.          

Avoid administering IV fluids or medicines which are not compatible such as different pH values (acidic and alkaline) and those with known interactions as they may precipitate. Precipitates must be avoided as they can block the IV-line, cause capillary damage and may lead to coronary and pulmonary emboli.

For individual medicine, IV compatibility with fluids/solutions, Y-site administration, or with parenteral nutrition, please consult Trissel's™ 2 IV compatibility on Micromedex.®  To determine the compatibility of a medicine: Click on the IV compatibility tab, enter the medicine  to check, then click submit. Then click on the relevant tab: Solution (for IV fluids), Y-site or TPN/TNA. The compatibility tab may be used to filter the compatible or incompatible information. In cases where the medicine was not tested with the solution, medicine or TPN/TNA listed, (Compatibility = Not Tested) there is no link to further information.

Please contact the pharmacist if you have any questions or unclear about the interpretation of the Micromedex compatibility information.

Compatible fluids

Medicines compatibility with commonly used IV fluids are listed where published compatibility data exists. If an IV fluid is not listed in the monograph as compatible, do NOT use this fluid to further dilute or administer the medicine. If a medicine is compatible in single component IV fluids e.g. G5W and NS,  it does not infer that it is compatible in a combination IV fluid of the individual component IV fluids e.g. G5W/NS.  The "Solution" tab of IV compatibility on Micromedex will list the compatible solutions. Click the individual solution to obtain further information of the concentration, duration and conditions under which the individual medicine is compatible. Compatibility of medicines with IV fluids is for 24 hours, unless otherwise indicated. Consult the pharmacist if further information is required.

Plasma-Lyte 148

Plasma-Lyte 148 is a multiple-electrolyte solution used mainly in the acute care setting. 

Plasma-Lyte 148 available with or without 5% glucose is the only form of plasma-lyte considered appropriate for use in children under the direction of a specialist. Use in children is off-label.

For further information consult the Product Information

For compatibility information refer to Baxter Summary of available drug compatibility and Y-site compatibility of IV medicines; Physico-chemical stability of Plasma-Lyte 148[R]   and  Plasma-Lyte 148 [R] + 5% Glucose with eight common intravenous medications

Y-site compatibility

A comprehensive list and detailed information are available on  the "Y-site" tab of IV compatibility on Micromedex.® Compatibility with other medicines is generally for a specific time and concentration and this should be considered. Consult Micromedex to determine appropriate concentrations for infusion and diluents. Assume everything is incompatible unless stated compatible. If in doubt, avoid mixing with other medicines or check with the pharmacist if mixing infusion solutions is unavoidable. The site of mixing should be monitored for signs of colour change or precipitation.

Avoid administering intravenous aminoglycosides (tobramycin, gentamicin, amikacin) and penicillins via the same line as there is potential for inactivation. Lines should be flushed well between these antibiotics and, particularly in patients with reduced renal function; it is advised that the drugs are administered at least 2 hours apart.  

Medicine compatibility with parenteral nutrition

It is recommended to administer lipids via a dedicated line and NOT to co-administer with IV medicines or fluids. Refer to SCHN Parenteral Nutrition Practice Guideline.

Information on  individual medicine compatibility with Total Parenteral Nutrition (TPN) and medicine administration with PN solutions via a Y-site is available by clicking on the "TPN/TNA" tab of IV compatibility on Micromedex.® Compatibility with TPN therapies is only available when a single medicine is selected for consideration. Single medicine IV Compatibility checks provide single medicine TPN (2-in-1) (total parenteral nutrition) compatibility, followed by TNA (3-in-1) (total nutritive admixture) compatibility.

TPN and TNA results are not result type specific: they can be a Y-Site, solution, or admixture result. Results are comprised of all compatibility tests where the medicine name searched is being included with a TPN or TNA solution.

Within each TPN/TNA table, the results are sorted alphabetically by TPN or TNA admixture name. Clicking the icon preceding the TPN (2-IN-1) Test Detail and TNA (3-in-1) Test Detail, provides a description and information on the test.

Compatibility information is then listed by the concentration of the medicine tested for the specific TPN or TNA admixture. Clicking the concentration of the medicine provides details of the TPN/TNA compatibility or incompatibility which are as follows:

  • The first column contains the TPN or TNA name, the compatibility icon and description, delivery method, and test notes for the test (if applicable) shown in red text.
  • The second column shows the medicine name, concentration, and manufacturer's name.
  • The third column displays the physical compatibility, chemical stability (if applicable), and storage information.
  • The fourth column contains a link to the reference, the study period, the study methods, and the container information for this particular combination.

In cases where the medicine was not tested with the solution listed, (Compatibility = Not Tested) there is no link to further information.

Please contact the TPN or clinical pharmacist  if you have any questions or  are unclear about the interpretation of the Micromedex TPN/TNA compatibility information.

Caution/comments

This contains information on infusion-related cautions, extravasation risk, significant adverse effects, monitoring and excipients where appropriate and is not comprehensive. If this information is not included it does not infer that there is no information. Consult the Product Information, local guidelines and other published resources for more information.

Avoid extravasation

  • All cannula sites and central venous access devices (CVAD) pose a risk of extravasation. The "Avoid extravasation" caution is included for those medicines considered to be irritant or a vesicant where inadvertent administration or leakage of the IV fluid or medicine into the surrounding tissue has the potential to cause tissue damage.
  • Ensure proper needle or catheter placement prior to and during infusion. Avoid administering irritant or vesicant solutions via a peripheral cannula, either as a push or infusion. 
  • Ensure patency of line before beginning an infusion.
  • Flush the IV access device prior to giving irritant or vesicant agents. Local pain and irritation may be reduced by increasing the dilution of the medicine or slowing the rate of infusion.
  • Irritant or vesicant agents include cytotoxic medicines medicines, solutions with a pH less than 5.5 or greater than 8.5, high osmolarity (greater than 500 mOsmol/L) solutions and medicines formulated with polyethylene glycol and ethanol.27 
  • Extravasation can lead to skin necrosis, scarring around tendons, nerves and joints, contracture of affected limb or amputation of digits and limbs.27
  • If extravasation occurs stop the administration of the medicine immediately; leave the cannula/needle in place; notify treating medical team and follow the guidelines in the SCHN  IV Extravasation management - Practice Guideline.
  • Further information is available in the NSW Health safety notice SN 013/07 Extravasation of IV fluids: Care of the cannula site in neonates and children.

Hyperlinks

  • Click on hyperlinks within the individual monographs to access relevant clinical resources such as the Australasian Neonatal Medicines Formulary, e-policy.