Nitrolingual (Nitroglycerin) - Indications and Dosage

INDICATIONS AND USAGE

Nitrolingual^® Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

DOSAGE AND ADMINISTRATION

At the onset of an attack, one or two metered sprays should be administered onto or under the tongue. No more than three metered sprays are recommended within a 15-minute period. If the chest pain persists, prompt medical attention is recommended. Nitrolingual^® Pumpspray may be used prophylactically five to ten minutes prior to engaging in activities which might precipitate an acute attack.

Each metered spray of Nitrolingual^® Pumpspray delivers 48 mg of solution containing 400 mcg of nitroglycerin after an initial priming of 5 sprays. It will remain adequately primed for 6 weeks. If the product is not used within 6 weeks it can be adequately reprimed with 1 spray. Longer storage periods without use may require up to 5 repriming sprays. There are 60 or 200 metered sprays per bottle. The total number of available doses is dependent, however, on the number of sprays per use (1 or 2 sprays), and the frequency of repriming.

The transparent container can be used for continuous monitoring of the consumption. The end of the pump should be covered by the fluid level. Once fluid falls below the level of the center tube, sprays will not be adequate and the container should be replaced. As with all other sprays, there is a residual volume of fluid at the bottom of the bottle which cannot be used.

During application the patient should rest, ideally in the sitting position. The container should be held vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. The dose should preferably be sprayed onto the tongue by pressing the button firmly and the mouth should be closed immediately after each dose. THE SPRAY SHOULD NOT BE INHALED. The medication should not be expectorated or the mouth rinsed for 5 to 10 minutes following administration. Patients should be instructed to familiarize themselves with the position of the spray orifice, which can be identified by the finger rest on top of the valve, in order to facilitate orientation for administration at night.

HOW SUPPLIED

Each box of Nitrolingual^® Pumpspray contains one glass bottle coated with red transparent plastic which assists in containing the glass and medication should the bottle be shattered. Each bottle contains 4.9 g or 14.6 g (Net Content) of nitroglycerin lingual spray which will deliver 60 or 200 metered sprays containing 400 mcg of nitroglycerin per spray after priming.

Nitrolingual^® Pumpspray is available as:

• 60-dose (4.9 g) single bottle	NDC 24338-300-65
• 200-dose (14.6 g) single bottle	NDC 24338-300-20

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.

The following trademarks are either registered trademarks or trademarks of Pohl-Boskamp in the United States and/or other countries: Pohl-Boskamp word mark; Pohl-Boskamp logo; Nitrolingual word mark; Peppermint flavor of nitroglycerin; Peppermint scent of nitroglycerin; Nitrolingual Pumpspray shapes, Nitrolingual Pumpspray colors, and the sound of Nitrolingual Pumpspray.

U.S. Patent No. 7,872,049

arbor™
PHARMACEUTICALS, INC.

Manufactured for
Arbor Pharmaceuticals, Inc. Atlanta, GA 30328
by G. Pohl-Boskamp GmbH & Co. KG,
25551 Hohenlockstedt, Germany.

2205500U3/1

Rev. 03/12