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Midodrine SCP, Midodrine ANS, Vasodrine

2 January 2020

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Product name
Midodrine SCP, Midodrine ANS, Vasodrine
Active ingredients
Midodrine hydrochloride
ATC codes
C01CA17
Decision
Approved
Date of decision
4 December 2019
Date of entry onto ARTG
18 December 2019
Original publication date
2 January 2020
ARTG numbers
309179, 309180, 309181, 309182, 309183, 309184
Black Triangle Scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Sponsor
Southern Cross Pharma Pty Ltd
Sponsor address
Suite 5/118 Church Street
Dose forms
Tablet
Strength
2.5 mg and 5 mg
Other ingredients
Microcrystalline cellulose, Pregelatinised maize starch, Magnesium stearate, Colloidal anhydrous silica
Containers
Blister pack
Pack sizes
60, 90 and 500 tablets
Routes of administration
Oral
Dosage

The initiation of midodrine should be undertaken under close medical supervision in a controlled clinical setting by a specialist with expertise in the treatment of severe orthostatic hypotension.

Initial dose: 2.5 mg three times a day. Depending on the results of supine and standing blood pressure recordings, this dose may be increased weekly up to a dose of 10 mg three times a day. This is the usual maintenance dosage. The maximum recommended dose should not exceed 30 mg daily.

For further information refer to the Product Information.

Pregnancy category

C

Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.

What was approved?

Midodrine SCP (midodrine hydrochloride), Midodrine ANS (midodrine hydrochloride) and Vasodrine (midodrine hydrochloride) were approved for the following therapeutic use:

Midodrine SCP (midodrine hydrochloride), Midodrine ANS (midodrine hydrochloride) and Vasodrine (midodrine hydrochloride) are indicated in adults for the treatment of severe symptomatic orthostatic hypotension due to autonomic dysfunction when exacerbating factors have been addressed and other forms of treatment remain inadequate.

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • Midodrine SCP (midodrine hydrochloride), Midodrine ANS (midodrine hydrochloride) and Vasodrine (midodrine hydrochloride) are to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Midodrine SCP (midodrine hydrochloride), Midodrine ANS (midodrine hydrochloride) and Vasodrine (midodrine hydrochloride) must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
  • The Midodrine SCP (midodrine hydrochloride), Midodrine ANS (midodrine hydrochloride) and Vasodrine (midodrine hydrochloride) Australian-Risk Management Plan (AUS-RMP) (version 1.2, dated November 2019, data lock point 23 April 2018), included with submission PM-2018-02754-1-3, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.

An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs). Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of this approval letter.

The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.