NITROGLYCERIN SLOCAPS- nitroglycerin sustained-release capsules capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

NITROGLYCERIN

Composition:

NITROGLYCERIN 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitroglycerin Slocaps® (Nitroglycerin) 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.

Product summary:

Nitroglycerin Slocaps® capsules are available in bottles of 60 and are supplied as: Nitroglycerin Slocaps® 2.5 mg NDC 21695-635 amethyst and clear capsule with white pellets; imprinted E 5174. Nitroglycerin Slocaps® 6.5 mg NDC 21695-635-60 blue and yellow capsule with white pellets; imprinted E 1235. Store at 20°-25°C (68°-77°F)[See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container, as defined in the USP. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Rev. 10/08 MF1235REV10/08 OS7288 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

unapproved drug other

Summary of Product characteristics

NITROGLYCERIN SLOCAPS- NITROGLYCERIN SUSTAINED-RELEASE CAPSULES
CAPSULE
REBEL DISTRIBUTORS CORP
_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 SLOCAPS NITROGLYCERIN SUSTAINED-RELEASE CAPSULES 2.5 MG,
6.5 MG, 9 MG
DESCRIPTION
Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate
whose structural formula is:
and whose molecular weight is 227.09. The organic nitrates are
vasodilators, active on both arteries
and veins.
Each NITROGLYCERIN SLOCAP®, for oral administration, contains 2.5 mg,
6.5 mg, or 9 mg of
nitroglycerin. Each capsule also contains the following inactive
ingredients: gelatin, lactose,
pharmaceutical glaze, corn starch, sucrose, talc and other
ingredients. In addition, the 2.5 mg capsule
contains FD&C Blue #1, FD&C Red #3 and D&C Yellow #10; the 6.5 mg
capsule contains FD&C Blue
#1, D&C Red #33, FD&C Yellow #6, and D&C Yellow #10; and the 9 mg
capsule contains FD&C
Green #3, FD&C Yellow #6, D&C Yellow #10 and titanium dioxide.
CLINICAL PHARMACOLOGY
The principal pharmacological action of nitroglycerin is relaxation of
vascular smooth muscle and
consequent dilatation 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 nappropriate for
organic nitrates. Sev