Source: Health Products Regulatory Authority (IE) Revision Year: 2018 Publisher: Merus Labs Luxco II S.à.R.L., 26-28 rue Edward Steichen, L-2540, Luxembourg
Pharmacotherapeutic group: vasodilators used in cardiac diseases
ATC Code: C01DA 02 – Organic Nitrates
Glyceryl trinitrate reduces the tone of vascular smooth muscle. This action is more marked on the venous capacitance vessels than the arterial vessels. There is a reduction in venous return to the heart and a lowering of elevated filling pressure. This lowering of filling pressure reduces the left ventricular end diastolic volume and preload. The net effect is a lowering of myocardial oxygen consumption.
Systemic vascular resistance, pulmonary vascular pressure and arterial pressure are also reduced by glyceryl trinitrate and there is a net reduction in the afterload.
By reducing the preload and afterload, glyceryl trinitrate reduces the workload on the heart.
Glyceryl trinitrate affects oxygen supply by redistributing blood flow along collateral channels from the epicardial to endocardial regions.
As with all commonly used organic nitrates the metabolic degradation of glyceryl trinitrate occurs via denitration and glucuronidation. The less active metabolites resulting from this biotransformation can be recovered from the urine within 24 hours.
Glyceryl trinitrate is eliminated from plasma with a short half-life of about 2-3 minutes. This rapid disappearance from plasma is consistent with the high systemic clearance values for this drug (up to 3270 L/hour).
Conventional studies of acute and repeated dose toxicity reveal no special hazard to humans.
Reproductive toxicity studies, in rats and rabbits using various routes of administration did not show any adverse effects on fertility or embryo fetal development at dosages which did not induce parental toxicity.
Standard mutagenicity tests provided contradictory results in vitro, however in vivo studies provided no evidence of genotoxicity.
Long term dietary studies in rodents led to the conclusion that Glyceryl trinitrate has no carcinogenicity effect relevant for the therapeutic dose range in humans.
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