nitrolingual- nitroglycerin spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

nitroglycerin (UNII: G59M7S0WS3) (nitroglycerin - UNII:G59M7S0WS3)

Available from:

FIRST HORIZON PHARMACEUTICAL CORPORATION

INN (International Name):

nitroglycerin

Pharmaceutical form:

SPRAY

Composition:

400 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitrolingual® Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Allergic reactions to organic nitrates are rare.  Nitroglycerin is contraindicated in patients who are allergic to it.  Nitrolingual® Pumpspray is contraindicated in patients taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), as their concomitant use can cause severe hypotension.  The time course and dose-dependency of this interaction are not known. Safety and effectiveness of nitroglycerin in pediatric patients have not been established.

Product summary:

Each box of Nitrolingual® Pumpspray, contains one clear glass bottle coated with red transparent plastic which assists in containing the glass and medication should the bottle be shattered. Each unit contains 4.9 g (NDC 59630- 300-65) or 12 g (NDC 59630-300-20) (Net Content) of nitroglycerin lingual spray which will deliver 60 or 200 metered sprays containing 400 mcgs of nitroglycerin per spray after priming.   Store at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F) [see USP Controlled Room Temperature].   Note: Nitrolingual® Pumpspray contains 20% alcohol. Do not forcefully open or burn container after use. Do not spray toward flames.   Rx Only.   Manufactured for FIRST HORIZON PHARMACEUTICAL® CORPORATION, Alpharetta, GA 30005 by G. Pohl-Boskamp GmbH & Co., D-25551 Hohenlockstedt, Germany.   NLPS-PI-2 Rev. 10/05

Summary of Product characteristics

NITROLINGUAL- NITROGLYCERIN SPRAY
FIRST HORIZON PHARMACEUTICAL CORPORATION
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NITROLINGUAL PUMPSPRAY
NITROLINGUAL PUMPSPRAY
(NITROGLYCERIN LINGUAL SPRAY)
400 MCG PER SPRAY, 60 OR 200 METERED SPRAYS
Before using your Nitrolingual
Pumpspray (nitroglycerin lingual spray) 400 mcg per spray, 60 or 200
metered sprays, read carefully the following directions for use.
Nitrolingual
Pumpspray is a metered dose spray which delivers 48 mg of solution
containing 400 mcg
of nitroglycerin with each spray. Nitroglycerin is absorbed from the
tongue and surrounding mucosa
producing a prompt therapeutic effect. It is best to use Nitrolingual
Pumpspray in a sitting position.
INFORMATION FOR THE PATIENT
HOW TO USE NITROLINGUAL PUMPSPRAY
BEFORE USING THIS PRODUCT FOR THE FIRST TIME, THE PUMP MUST BE SPRAYED
5 TIMES INTO THE AIR (THIS IS
KNOWN AS PRIMING). THE PUMP SHOULD BE PRIMED EVERY 6 WEEKS TO REMAIN
READY FOR USE. IF THE
PRODUCT HAS NOT BEEN USED FOR 6 WEEKS, A PRIME OF 1 SPRAY IS
NECESSARY.
1. Remove the plastic cover.
2. DO NOT SHAKE.
3. Hold the container upright with forefinger on top of the grooved
button.
4. Open the mouth and bring the container as close to it as possible.
5. Press the button firmly with the forefinger to release the spray
onto or under the tongue. DO NOT
INHALE THE SPRAY.
6. Release button and close mouth. Avoid swallowing immediately after
administering the spray. The
medication should not be expectorated or the mouth rinsed for 5 to 10
minutes following
administration.
7. If you require a second administration to obtain relief, repeat
steps 4, 5, and 6.
8. Replace the plastic cover.
®
®
®
®
NOTE: To familiarize yourself with the product and while priming the
container, actuate the spray into
the air (away from yourself and others). Get the feel of your finger
resting on the grooved button so that
you can use the spray in the dark. DO NOT SHAKE the container before
use. You may wish to keep
additional pumpspray containers handy in convenient locations.
DOS AGE
During an anginal attack, one or