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Published: 24 April 2019
 Revised: 30 May 2019

Safety Information

Alert

Take care when prescribing and dispensing levodopa-containing products (Madopar, Sinemet, Kinson, Mylan)

Update

This alert was updated on 30 May 2019 due to ongoing supply issues with the Sinemet (carbidopa + levodopa) range of products. The changes include the following:

  • Table 1 updated to include additional carbidopa + levodopa products.
  • Table 2 added to provide advice for continuing patients on carbidopa + levodopa treatment.
  • Advice for patients, caregivers, prescribers and pharmacists has been updated.
  • Additional information section updated to include more links.

Revised: 30 May 2019

Products Affected
Information for consumers and caregivers
Information for prescribers and pharmacists
Detailed Information
How to report adverse events
Additional Information

Description

Medsafe is aware there is a potential for confusion between the various levodopa-containing products. Currently funded medicines include:

  •  Madopar (benserazide + levodopa)
  •  Sinemet (carbidopa + levodopa)
  •  Kinson (carbidopa + levodopa)
  •  Mylan (carbidopa + levodopa) (s29 unapproved medicine).

The large range of strengths and formulations available can also be confusing, particularly for patients. Adding to the confusion are the ongoing supply issues with the Sinemet (carbidopa + levodopa) range.

Healthcare professionals should take extra care when prescribing and dispensing these products to ensure the correct medicine reaches the patient.

Products Affected


Levodopa-containing medicines are used in the treatment of Parkinson’s disease. There are different strengths, combinations and also different formulations as shown in Table 1.

Table 1: Summary of products containing benserazide + levodopa or carbidopa + levodopa
benserazide + levodopa
Product name Formulation Strength Sponsor
Madopar Rapid dispersible tablet benserazide 12.5 mg, levodopa 50 mg Roche Products (NZ) Ltd
Madopar 62.5 capsule benserazide 12.5 mg, levodopa 50 mg
Madopar 125 capsule benserazide 25 mg, levodopa 100 mg
Madopar HBS long-acting capsule benserazide 25 mg, levodopa 100 mg
Madopar 250 capsule benserazide 50 mg, levodopa 200 mg
carbidopa + levodopa
Sinemet 25/100 tablet carbidopa 25 mg, levodopa 100 mg Merck Sharp & Dohme (New Zealand) Limited
Sinemet 25/250 tablet carbidopa 25 mg, levodopa 250 mg
Sinemet CR long-acting tablet carbidopa 50 mg, levodopa 200 mg
Kinson tablet carbidopa 25 mg, levodopa 100 mg Mylan New Zealand Ltd
Mylan carbidopa + levodopa (unapproved) long-acting tablet carbidopa 25 mg, levodopa 100 mg Mylan New Zealand Ltd


Stock supply issues of the Sinemet (carbidopa + levodopa) brand have resulted in some additional products being funded. Please note the changes shown in Table 2. Efforts should be made to reduce any unnecessary changes to the brand a patient receives.

Table 2: Advice on what to do for patients taking the Sinemet (carbidopa + levodopa) range of products

Patients taking: Switch to: Additional notes:
Sinemet 25/100 Kinson 25/100 These products are bioequivalent (Kinson was approved by Medsafe as a generic to Sinemet 25/100 in 1994).
Sinemet 25/250 No change The Sinemet 25/250 is being sourced from the United States and the labelling may look different.
Sinemet CR 50/200 long-acting tablet Mylan 25/100 long-acting tablet The Mylan product has not been approved by Medsafe and will need to be supplied under section 29 of the Medicines Act.
Patients will need to take double the amount of tablets to remain on the same dose.

For each individual with Parkinson’s disease, the therapeutic window for levodopa becomes narrower with time [1, 2]. Therefore, patients on long-term therapy have a risk of experiencing complications when changing brands. Additional monitoring of a patient’s symptoms is recommended if there are any changes in brand to assess how it may impact that individual.

Advice For Patients and Caregivers

  • Confirm the name of the medicine (ie, Madopar, Sinemet, Kinson, Mylan) with your prescriber and pharmacist.
  • The Sinemet (carbidopa + levodopa) range of products are currently in short supply. You may be changed to another product. Your prescriber and pharmacist will tell you about the change.
  • Check that the tablets or capsules look familiar to you when you are at the pharmacy.
  • Contact your prescriber or pharmacist if you notice any changes in the control of your symptoms.
  • Contact your prescriber or pharmacist if you experience any side effects.  You can also report side effects using this online reporting form: https://nzphvc.otago.ac.nz/consumer-reporting/.

Information for Prescribers and pharmacists

  • Ask each patient and check their records when prescribing and dispensing levodopa-containing medicines, including the product name (ie, Madopar, Sinemet, Kinson, Mylan), strength and formulation.
  • The Sinemet range of products are currently in short supply. Please refer to Table 2 for advice on what to do for patients taking Sinemet. Explain any changes to patients and/or their caregivers and check that they understand the change.
  • Additional monitoring of a patient’s symptoms is recommended if there are any changes in the product they receive to assess how it may impact them.
  • Efforts should be made to reduce any unnecessary changes to the brand a patient receives.
  • Show patients and/or their caregivers what their tablets or capsules look like before they leave the pharmacy.

Detailed Information

There is currently a shortage of the Sinemet (carbidopa + levodopa) range of products. Please refer to Table 2 for advice on what to do for patients taking Sinemet.  

The Centre for Adverse Reactions Monitoring (CARM) has received five brand switch reports with Kinson since it was listed on the pharmaceutical schedule up to 24 April 2019 . These reports are summarised in Table 3.

It is important to take care when prescribing or dispensing levodopa-containing medicines due to the different products available. 

Table 3: Summary of brand switch reports with Kinson reported to the Centre for Adverse Reactions Monitoring (CARM) up to 24 April 2019

Report Date Gender Age Medicine(s) Reaction(s)
130438 Oct 2018 M 83 Kinson (suspect) periorbital oedema, throat tightness, face oedema
131470 Jan 2019 M 79 Kinson (suspect), Sinemet CR (continuing), omeprazole, bezafibrate, fluticasone inhaler, salbutamol inhaler, fluticasone nasal spray, lactulose, paracetamol, polytears eye drops delirium
131751 Feb 2019 M 74 Kinson (suspect), gabapentin dizziness, blurred vision, gait disturbance, salivary hypersecretion
130243 Mar 2019 M 77 Kinson (suspect) blurred vision, salivary hypersecretion, dizziness
132343 Mar 2019 F Unk Kinson (suspect) therapeutic response decreased, fall, depression, hallucination, anxiety

How to Report Adverse Events


Reporting is easiest online: https://nzphvc.otago.ac.nz/reporting/

Other ways of reporting include:

  • electronic reporting through GP Practice Management Systems
  • completing a freepost yellow card
  • using the Apple iOS app on your iPhone or iPad (download from https://nzphvc.otago.ac.nz/app/))
  • contacting CARM by phone on 03 479 7247 or emailing carmnz@otago.ac.nz

Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking, Medsafe encourages you to talk to your healthcare professional.

Additional information

References
  1. Stocchi F, Bonamartini A, Vacca L, et al. 1996. Motor fluctuations in levodopa treatment: clinical pharmacology. Eur Neurol 36 Suppl 1(38-42). 10.1159/000118882
  2.  Lundqvist C. 2007. Continuous levodopa for advanced Parkinson's disease. Neuropsychiatr Dis Treat 3(3): 335-48.
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