NITROGLYCERIN ER- nitroglycerin capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

Compra'l ara

Descargar Fitxa tècnica (SPC)
01-02-2021

ingredients actius:

NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)

Disponible des:

AvKARE

Designació comuna internacional (DCI):

NITROGLYCERIN

Composición:

NITROGLYCERIN 2.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. Allergic reactions to organic nitrates are extremely rare, but they do occur. Nitroglycerin is contraindicated in patients who are allergic to it.

Resumen del producto:

2.5 mg, Nitroglycerin Extended-Release (Pink and Clear capsules imprinted TCL-1221) in bottles of 90. NDC 42291-648-90 6.5 mg, Nitroglycerin Extended-Release (Blue and Yellow capsules imprinted TCL-1222) in bottles of 90. NDC 42291-649-90 9 mg, Nitroglycerin Extended-Release (Green and Yellow capsules imprinted TCL-1223) Rx only

Estat d'Autorització:

unapproved drug other

Fitxa tècnica

                                NITROGLYCERIN ER- NITROGLYCERIN CAPSULE
AVKARE
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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NITROGLYCERIN EXTENDED-RELEASE CAPSULES
RX ONLY
DESCRIPTION:
Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate
whose structural formula is Molecular
Structure:
Molecular Structure
CLINICAL PHARMACOLOGY
The principal pharmacological action of nitroglycerin is relaxation of
vascular smooth muscle and
consequent dilation of peripheral arteries and veins, especially the
latter. Dilatation of the veins
promotes peripheral pooling of blood and decreases venous return to
the heart, thereby reducing left
ventricular end-diastolic pressure and pulmonary capillary wedge
pressure (preload). Arteriolar
relaxation reduces systemic vascular resistance, systolic arterial
pressure, and mean arterial pressure
(afterload). Dilatation of the coronary arteries also occurs. The
relative importance of preload
reduction, afterload reduction, and coronary dilatation remains
undefined. Dosing regimens for most
chronically used drugs are designed to provide plasma concentrations
that are continuously greater than
a minimally effective concentration. This strategy is inappropriate
for organic nitrates. Several well-
controlled clinical trials have used exercise testing to assess the
anti-anginal efficacy of continuously-
delivered nitrates. In the large majority of these trials, active
agents were indistinguishable from
placebo after 24 hours (or less) of continuous therapy. Attempts to
overcome nitrate tolerance by dose
escalation, even to doses far in excess of those used acutely, have
consistently failed. Only after
nitrates had been absent from the body for several hours was their
anti-anginal efficacy restored.
PHARMACOKINETICS: The volume of distribution of nitroglycerin is about
3 L/kg, and nitroglycerin is
cleared from this volume at extremely rapid rates, with a resulting
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