Packaging Change for Bicillin L-A

Notice of Packaging Change

Bicillin® L-A

HPS Pharmacies wish to advise that Pfizer Australia has given notice of a packaging change for Bicillin® L-A as follows:

Element Old packaging New packaging
Active ingredient name Benzathine benzylpenicillin Benzathine benzylpenicillin tetrahydrate
Expression of strength 900mg/2.3mL 1,200,000 units/2.3mL
Storage conditions 2-8°C. Refrigerate, do not freeze. 2-8°C. Refrigerate, do not freeze.

May be stored below 30°C for a single period of up to 2 months prior to expiry. Do not return to refrigerated storage.

There has been no change to the active ingredient, strength, formulation, dosing, or administration instructions.

To avoid dosing confusion, it is important to be aware of the dose equivalence for the two different forms of strength expression. The product information has been updated to include a dose equivalence between mg and units for benzathine benzylpenicillin tetrahydrate. However, some commonly used references may still provide equivalents for benzathine benzylpenicillin.

The following doses are equivalent:

  • 1,200,000 units Benzathine benzylpenicillin tetrahydrate.
  • 1016.6mg Benzathine benzylpenicillin tetrahydrate.
  • 900mg Benzathine benzylpenicillin.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Pfizer on 1800 675 229.

Availability of Local Anaesthetic Products

Drug Availability Update

Further to DrugAlert Volume 437, HPS Pharmacies wish to give notice that Aspen Pharmacare Australia Pty Ltd is continuing to experience a supply interruption for the following local anaesthetic products:

Product ARTG Current Status
Marcain 0.25% 5 x 20mL 48380 Currently out of stock
Marcain 0.5% 5 x 10mL 11937 Currently out of stock
Marcain 0.5% 5 x 20mL 48328 Limited supply
Naropin 0.2% 5 x 10mL 52406 Currently available
Naropin 0.2% 5 x 20mL 52405 Currently available
Naropin 0.75% 5 x 10mL 52400 Currently out of stock
Naropin 0.75% 5 x 20mL 52399 Currently out of stock
Naropin 1% 5 x 10mL 52398 Currently available
Naropin 1% 5 x 20mL 52397 Currently out of stock
Xylocaine® 1% 5 x 20mL 48361 Currently available
Xylocaine® 2% 5 x 20mL 48364 Currently out of stock
Xylocaine® 2% with adrenaline 1:80,000 10 x 5mL 54520 Expected return early March 2019
Xylocaine® 1% with adrenaline 1:200,000 5 x 20mL 12015 Expected return mid-April 2019
Xylocaine® 2% with adrenaline 1:200,000 5 x 20mL 12021 Expected return late March 2019
Xylocaine® 0.5% with adrenaline 1:200,000 5 x 20mL 12008 Currently available
Xylocaine® 1% with adrenaline 1:100,000 10 x 5mL 12017 Limited supply. Expected return mid-April 2019.
Marcain 0.25% with adrenaline 1:400,000 5 x 20mL 125878 Limited supply. Expected return May 2019.
Marcain 0.5% with adrenaline 1:200,000 5 x 20mL 48329 Currently available

This supply interruption is due to a fire at the manufacturing site. No other local anaesthetic products manufactured by AstraZeneca on behalf of Aspen are currently affected by this issue.

Aspen advises that the following substitutions could be considered during this supply interruption:

  • Marcain 0.25% 5 x 20mL – one 10mL Marcain 0.5% non-sterile theatre packed polyamp can be diluted with 10mL saline to obtain 20mL Marcain 0.25%.
  • Marcain 0.5% 5 x 10mL – one 10mL Marcain 0.5% non-sterile theatre packed polyamp can be considered as an indirect substitute.
  • Xylocaine 2% 5 x 20mL – four 5mL Xylocaine 2% 50 x 5mL polyamps (non-sterile theatre packed) can be considered as an indirect substitute.

The product information should be consulted for further information on the appropriate use of these agents. In order to avoid medication errors, it is also requested that all staff exercise additional diligence when prescribing, supplying, and administering these products during this supply interruption.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Aspen Pharmacare Australia on 1300 659 646.

Availability of Dicloxacillin

Drug Availability

HPS Pharmacies wish to give notice that Alphapharm is experiencing a supply interruption for dicloxacillin capsules as follows:

Product Strength ARTG Expected Return Date
Distaph® 250mg 226506 1st July 2019
Distaph® 500mg 226508 1st July 2019
Dicloxacillin Mylan 250mg 289105 1st July 2019
Dicloxacillin Mylan 500mg 289107 1st July 2019

Supplies are expected to return to normal in early July 2019. There are currently no alternative preparations available.

Dicloxacillin is a narrow-spectrum penicillin antibiotic indicated for the treatment of staphylococcal and other Gram positive coccal infections such as cellulitis, osteomyelitis, wound infections, and pneumonia. It has a similar spectrum of activity to flucloxacillin which may be considered as an alternative. Both dicloxacillin and flucloxacillin are resistant to staphylococcal penicillinase but are inactive against methicillin-resistant Staphylococcus aureus (MRSA). Benzylpenicillin provides greater activity against Streptococcus pneumoniae and Streptococcus pyogenes and is preferred for the treatment of streptococcal pneumonia. The appropriate product information should be consulted for further information and the advice of an Infectious Disease Physician sought for individual cases.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Alphapharm on 1800 274 276.

Product Defect Correction for Jurnista®

Product Defect Correction

HPS Pharmacies wish to advise that Janssen-Cilag, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a product defect correction for Jurnista® as follows:

Jurnista® Prolonged Release Tablets
Hydromorphone hydrochloride 8mg
ARTG 141508

The only batch affected by this issue is IALS400 with an expiry date of December 2019.

This product defect correction has been initiated due to reports of damage to the tablets as a result of a misalignment issue with the packaging machine. Damage to the outer coating of Jurnista® tablets may alter the release rate of the active ingredient, potentially resulting in overdose or lack of steady-state condition due to more rapid absorption. Alternatively, degradation of the active ingredient may occur due to oxygen exposure, potentially leading to drug under-dosing.

There is no quality issue with tablets that have not been physically damaged. Please inspect your stock and only quarantine packets containing damaged tablets. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Janssen-Cilag on 1800 226 334.

Availability of Sulfamethoxazole + Trimethoprim

Drug Availability

HPS Pharmacies wish to give notice that all suppliers are experiencing a supply interruption for sulfamethoxazole + trimethoprim as follows:

Product Strength

(Sulfamethoxazole / trimethoprim)

ARTG Expected return date
Bactrim® Sugar-Free Oral Liquid 40mg/8mg/mL 119404 Discontinued
Septrin® Sugar-Free Oral Liquid 40mg/8mg/mL 11000 Mid-March 2019
Resprim® Tablets 400mg/80mg 17681 Currently available
Resprim® Forte Tablets 800mg/160mg 17682 Late February 2019
Septrim® Forte Tablets 800mg/160mg 10998 Mid-July 2019
Bactrim® DS Tablets 800mg/160mg 162563 Discontinued

This supply interruption is due to an unexpected increase in demand following the discontinuation of the Bactrim® brand of sulfamethoxazole + trimethoprim tablets and oral liquid. An internationally registered brand of sulfamethoxazole + trimethoprim oral liquid has been approved for supply under Section 19A of the Therapeutic Goods Act 1989. Please note that this alternative is subject to a longer lead time and different pricing as it must be sourced internationally. Additional care is also required as pertinent information is printed on the packaging in German. To ensure this product is used correctly, it must be shaken well before use, stored below 30°C, and discarded within 4 weeks of opening. For additional information, refer to the Australian product information and consumer medicines information for Septrin® Sugar-Free Oral Liquid.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies.

Availability of Local Anaesthetic Products

Drug Availability Update

Further to DrugAlert Volume 401, HPS Pharmacies wish to give notice that Aspen Pharmacare Australia Pty Ltd is continuing to experience a supply interruption for the following local anaesthetic products:

Product ARTG Current Status
Marcain 0.25% 5 x 20mL 48380 Currently out of stock
Marcain 0.5% 5 x 10mL 11937 Currently out of stock
Marcain 0.5% 5 x 20mL 48328 Limited supply
Naropin 0.2% 5 x 10mL 52406 Currently available
Naropin 0.2% 5 x 20mL 52405 Currently available
Naropin 0.75% 5 x 10mL 52400 Currently out of stock
Naropin 0.75% 5 x 20mL 52399 Currently out of stock
Naropin 1% 5 x 10mL 52398 Currently available
Naropin 1% 5 x 20mL 52397 Currently out of stock
Xylocaine® 1% 5 x 20mL 48361 Currently available
Xylocaine® 2% 5 x 20mL 48364 Currently out of stock
Xylocaine® 2% with adrenaline 1:80,000 10 x 5mL 54520 Possible temporary supply interruption
Xylocaine® 1% with adrenaline 1:200,000 5 x 20mL 12015 Expected return late March 2019
Xylocaine® 2% with adrenaline 1:200,000 5 x 20mL 12021 Expected return late March 2019
Xylocaine® 0.5% with adrenaline 1:200,000 5 x 20mL 12008 Possible temporary supply interruption
Xylocaine® 1% with adrenaline 1:100,000 10 x 5mL 12017 Possible temporary supply interruption
Marcain 0.25% with adrenaline 1:400,000 5 x 20mL 125878 Possible temporary supply interruption
Marcain 0.5% with adrenaline 1:200,000 5 x 20mL 48329 Possible temporary supply interruption

This supply interruption is due to a fire at the manufacturing site. No other local anaesthetic products manufactured by AstraZeneca on behalf of Aspen are currently affected by this issue.

Aspen advises that the following substitutions could be considered during this supply interruption:

  • Marcain 0.25% 5 x 20mL – one 10mL Marcain 0.5% non-sterile theatre packed polyamp can be diluted with 10mL saline to obtain 20mL Marcain 0.25%.
  • Marcain 0.5% 5 x 10mL – one 10mL Marcain 0.5% non-sterile theatre packed polyamp can be considered as an indirect substitute.
  • Xylocaine 2% 5 x 20mL – four 5mL Xylocaine 2% 50 x 5mL polyamps (non-sterile theatre packed) can be considered as an indirect substitute.

The product information should be consulted for further information on the appropriate use of these agents. In order to avoid medication errors, it is also requested that all staff exercise additional diligence when prescribing, supplying, and administering these products during this supply interruption.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Aspen Pharmacare Australia on 1300 659 646.

Recall for Empovir® Vials

Drug Recall

HPS Pharmacies wish to advise that Luminarie, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a drug recall for Empovir® vials as follows:

Empovir® Vials
Cidofovir 375mg/5mL
ARTG 287040

This drug recall has been initiated following the identification of a manufacturing defect in the glass vial. The only affected batch is VCIA082 with an expiry date of 1st October 2019.

Please inspect your stock and quarantine all vials from the affected batch. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Luminaire on 0424 439 936.

Discontinuation of Emend® Capsules

Drug Discontinuation

HPS Pharmacies wish to give notice that Merck Sharp & Dohme have announced the discontinuation of Emend® capsules as follows:

Emend® Capsules
Aprepitant 165mg
ARTG 182320

Wholesaler stock of Emend® capsules is expected to be depleted by April 2019. Emend® IV (fosaprepitant) is currently in stock and will remain available to order.

Aprepitant is a substance P antagonist. Other substance P antagonists available include fosaprepitant and netupitant. Fosaprepitant is a prodrug that is rapidly converted to aprepitant following IV administration. A randomised, double-blind study demonstrated non-inferiority of fosaprepitant to a three-day regimen of oral aprepitant in patients receiving highly emetogenic chemotherapy. Netupitant is an orally active substance P antagonist that is only available in combination with the 5HT3 antagonist, palonosetron. Please consult with the product information for full prescribing guidelines.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Merck Sharp & Dohme on 1800 678 883.

Availability of Chlorvescent® Tablets

Drug Availability

HPS Pharmacies wish to give notice that Aspen Australia is experiencing a supply interruption for Chlorvescent® effervescent tablets as follows:

Chlorvescent® Effervescent Tablets
Potassium 14mmol & chloride 8mmol
ARTG 71981

This supply interruption is due to an unexpected increase in demand following manufacturing issues and the discontinuation of some brands of slow-release potassium chloride tablets. Supplies of Chlorvescent® effervescent tablets are expected to return to normal in mid-February 2019.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Aspen Australia on 1300 659 646.

Availability of Citracal Tablets

Drug Availability Update

Dear Valued Client,

HPS Pharmacies wish to give notice that Bayer is continuing to experience a supply interruption for Citracal tablets as follows:

Citracal® Tablets
Calcium (as citrate) 250mg
ARTG 80764

Citracal® Plus D Tablets
Calcium (as citrate) + Colecalciferol 315mg/12.5mcg
ARTG 129696

Bayer are currently unable to advise of an expected date of return for Citracal® tablets or Citracal® Plus D tablets. Calcium carbonate may be considered as an alternative to calcium citrate for some patients, although its absorption is more dependent upon gastric pH.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Bayer Australia on 1800 678 368.