May 26, 2016
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Nitrolingual Pumpspray

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Nitrolingual Pumpspray




Indications
Dosage
How Supplied

INDICATIONS

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

DOSAGE AND ADMINISTRATION

Recommended dosage

Instruct the patient to administer one or two metered sprays (400 mcg of nitroglycerin per spray) at the onset of an attack onto or under the tongue. A spray may be repeated approximately every five minutes as needed. No more than three metered sprays are recommended within a 15-minute period. If the chest pain persists after a total of three sprays, advise prompt medical attention. Nitrolingual Pumpspray may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.

Priming

The pump must be primed prior to the first use. Each metered spray of Nitrolingual Pumpspray delivers 48 mg of solution containing 400 mcg of nitroglycerin after an initial priming of five sprays. It will remain adequately primed for 6 weeks. If the product is not used within 6 weeks it can be adequately re-primed with one spray. If the product is not usedwithin 3 months it can be adequately re-primed with up to five 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 priming.

Administration

Instruct patients that during administration, the patient should rest, ideally in the sitting position. Hold the container vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. Spray the dose preferably onto or under the tongue by pressing the grooved-button firmly and the mouth 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. Instruct patients 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 [see PATIENT INFORMATION].

The amount of liquid remaining in the container should be checked periodically. The transparent container can be used for continuous monitoring of the consumption. With the container upright and level, check to be sure the end of the center tube extends below the level of the liquid. Once fluid falls below the level of the center tube, remaining sprays will not deliver intended dose.

HOW SUPPLIED

Dosage Forms And Strengths

Lingual spray, 400 mcg per spray available in either 60 or 200 metered sprays per container.

Storage And Handling

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.

Manufactured for Arbor Pharmaceuticals, LLC. Atlanta, GA 30328. by G. Pohl-Boskamp GmbH & Co. KG, 25551 Hohenlockstedt, Germany. Revised: Jan 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/23/2016

Indications
Dosage
How Supplied

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