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Midodrine SCP, Midodrine ANS, Vasodrine
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.
Midodrine is the rapidly absorbed prodrug of the pharmacologically active constituent desglymidodrine. Desglymidodrine is a sympathomimetic agent with a direct and selective effect on the peripheral alpha 1 (α1)-adrenergic receptors. This α1-stimulative effect induces vasoconstriction of the venous system (causing a reduction in venous pooling). The α1-adrenergic effects of desglymidodrine are almost wholly attributable to the (-) enantiomer of desglymidodrine. After taking midodrine, which is a racemic mixture, (+) desglymidodrine is also present, though this contributes almost nothing to the desired effect.Desglymidodrine increases the peripheral arterial resistance, resulting in an increase in arterial blood pressure. Nonclinical experiments showed that midodrine had a selective effect on blood flow in various vascular beds, with the most effect observed in the femoral artery, and least in the mesenteric artery. Only limited data is available on the long-term effects of taking midodrine. Stimulation of the α-adrenergic receptors of the bladder and the ureter increases the sphincter muscle tone. Desglymidodrine has no beta (β)-adrenergic effects.
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Midodrine SCP, Midodrine ANS and Vasodrine was considered favourable for the therapeutic use approved.
- MIDODRINE SCP midodrine hydrochloride 2.5 mg immediate release tablet blister pack (309179)
- MIDODRINE SCP midodrine hydrochloride 5 mg immediate release tablet blister pack (309180)
- MIDODRINE ANS midodrine hydrochloride 2.5 mg immediate release tablet blister pack (309181)
- MIDODRINE ANS midodrine hydrochloride 5 mg immediate release tablet blister pack (309182)
- VASODRINE midodrine hydrochloride 2.5 mg immediate release tablet blister pack (309183)
- VASODRINE midodrine hydrochloride 5 mg immediate release tablet blister pack (309184)