DORALESE Film-coated tablets Ref.[9312] Active ingredients: Indoramin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Chemidex Pharma Ltd., T/A Essential Generics, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom

Pharmacodynamic properties

Pharmacotherapeutic group: Alpha-adrenoreceptor antagonists
ATC code: C02CA02

Mechanism of action

Indoramin is an alpha adrenoceptor blocking agent. It acts selectively and competitively on post-synaptic alpha-1 receptors, causing a decrease in peripheral resistance. It also produces relaxation of hyperplastic muscle in the prostate.

Pharmacokinetic properties

Absorption

Indoramin is rapidly absorbed from indoramin tablets and has a half-life of about five hours.

Distribution

There is little accumulation during long-term treatment.

Biotransformation

When three volunteers and four hypertensive patients were treated with radiolabelled indoramin at doses of 40-60 mg daily for up to three days, plasma concentrations reached a peak one to two hours after administration of single doses. Over 90% of plasma indoramin was protein bound.

Elimination

After two or three days 35% of the radioactivity was excreted in the urine and 46% in the faeces. Extensive first pass metabolism was suggested.

Elderly

Clearance of indoramin may be affected in the elderly. A reduced dose or reduced frequency of dosing may be sufficient in some elderly patients.

Preclinical safety data

Not applicable.

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