NITROLINGUAL

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

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

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

11 DESCRIPTION

DESCRIPTION SECTION

Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C 3 H 5 N 3 O 9 ). The compound has a molecular weight of 227.09. The chemical structure is: CH 2 –ONO 2 | CH–ONO 2 | CH 2 –ONO 2 Nitrolingual Pumpspray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil, sodium lactate, lactic acid.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

In a randomized, double-blind single-dose, 5-period cross-over study in 51 patients with exertional angina pectoris significant dose-related increases in exercise tolerance, time to onset of angina and ST-segment depression were seen following doses of 0.2, 0.4, 0.8 and 1.6 mg of nitroglycerin delivered by metered pumpspray as compared to placebo. The drug showed a profile of mild to moderate adverse events.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

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 14.1 g (Net Contents) 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 70007-300-65 200-dose (14.1 g) single bottle NDC 70007-300-20 Store at 20°C - 25°C (68°F - 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.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling (Instructions for Use) 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; Nitrolingual Pumpspray shapes, Nitrolingual Pumpspray colors. U.S. Patent No. 7,872,049 Manufactured for Espero Pharmaceuticals, Inc. Jacksonville, FL 32250 by G. Pohl-Boskamp GmbH & Co. KG, 25551 Hohenlockstedt, Germany.

SPL PATIENT PACKAGE INSERT SECTION

SPL PATIENT PACKAGE INSERT SECTION

Instructions for Use Nitrolingual® Pumpspray ( nī-trō-ling´gwal) (nitroglycerin ) lingual spray Read this Instructions for Use before you start using Nitrolingual Pumpspray and each time you get your prescription refilled. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Important information: Nitrolingual Pumpspray is for use on to or under the tongue. Do not inhale Nitrolingual Pumpspray. A dose of Nitrolingual Pumpspray may be either 1 or 2 sprays. Follow your healthcare provider’s instructions about how many sprays you should use for each dose. Doses should be separated by approximately 5 minutes. You should not use more than 3 sprays of Nitrolingual Pumpspray within 15 minutes. Get emergency medical help right away if you still have chest pain after using a total of 3 sprays of Nitrolingual Pumpspray . Nitrolingual Pumpspray parts: Figure A How should I use Nitrolingual Pumpspray ? It is best to use Nitrolingual Pumpspray while you are resting and in a sitting position. Do not shake the Nitrolingual Pumpspray container. Priming Nitrolingual Pumpspray : Before you use Nitrolingual Pumpspray for the first time, you must prime it. To prime your Nitrolingual Pumpspray, follow the steps below: Step 1. Remove the plastic cap from the container. (See Figure B) Figure B Step 2. Hold the container upright and facing away from yourself and others. Press down on the top of the grooved button 5 times. (See Figure C) Figure C Your Nitrolingual Pumpspray is now primed. You are ready to give your first dose. If you do not use your Nitrolingual Pumpspray within 6 weeks, you will need to prime it again by pressing down on the top of the grooved button 1 time. If you do not use your Nitrolingual Pumpspray within 3 months, you will need to re-prime it by pressing down on the top of the grooved button up to 5 times. Giving a dose of Nitrol i ngual Pumpspray : Step 3. Hold your Nitrolingual Pumpspray container upright with your index finger on top of the grooved button. Step 4. Open your mouth and bring the Nitrolingual Pumpspray container as close to your mouth as possible. Step 5. Press down on the top of the grooved button firmly with your index finger to release the spray onto or under your tongue. (See Figure D). The grooved button can help you make sure the canister is turned to the correct position if you are administering the spray in the dark. Figure D Step 6. Release the grooved button and close your mouth right away. Avoid swallowing right after using Nitrolingual Pumpspray. Do not spit out Nitrolingual Pumpspray or rinse your mouth for 5 to 10 minutes after using Nitrolingual Pumpspray. Step 7. If a second dose of Nitrolingual Pumpspray is needed, repeat Steps 3 through 6 above. Step 8. Replace the plastic cap. Check the level of the fluid in your Nitrolingual Pumpspray container regularly. Check the container in an upright position. The end of the center tube should be covered by the fluid in the Nitrolingual Pumpspray container. If the level of the fluid falls below the end of the center tube, sprays will not provide enough Nitrolingual Pumpspray. Replace your Nitrolingual Pumpspray container before the fluid level falls below the end of the center tube. How should I store Nitrolingual Pumpspray? Store Nitrolingual Pumpspray at room temperature between 68°F - 77°F (20°C - 25°C). Do not forcefully open or burn the Nitrolingual Pumpspray container after use. Do not spray Nitrolingual Pumpspray toward flames. Keep Nitrolingual Pumpspray and all medicines out of the reach of children . This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for Espero Pharmaceuticals, Inc. Jacksonville, FL 32250 by G. Pohl-Boskamp GmbH & Co. KG, 25551 Hohenlockstedt, Germany. Revised: 07/2018 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; Nitrolingual Pumpspray shapes, Nitrolingual Pumpspray colors.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL Nitrolingual Pumpspray Rx Only 400 Mcg per spray 200 Metered Sprays 14.1 g Net Contents

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL Nitrolingual Pumpspray Rx Only 400 Mcg per spray 60 Metered Sprays 4.9 g Net Contents