NITROLINGUAL (Page 3 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal carcinogenesis studies with sublingual nitroglycerin have not been performed.

Rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years developed dose-related fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes. At high dose, the incidences of hepatocellular carcinomas in both sexes were 52 % vs. 0 % in controls, and incidences of testicular tumors were 52 % vs. 8 % in controls. Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice.

Nitroglycerin was weakly mutagenic in Ames tests performed in two different laboratories. There was no evidence of mutagenicity in an in vivo dominant lethal assay with male rats treated with doses up to about 363 mg/kg/day, p.o., or in in vitro cytogenic tests in rat and dog tissues and for chromosomal aberration in Chinese hamster ovary cells.

In a three-generation reproduction study, rats received dietary nitroglycerin at doses up to about 434 mg/kg/day for six months prior to mating of the F0 generation with treatment continuing through successive F1 and F2 generations. The high dose was associated with decreased feed intake and body weight gain in both sexes at all matings. No specific effect on the fertility of the F0 generation was seen. Infertility noted in subsequent generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis in the high- dose males. In this three-generation study there was no clear evidence of teratogenicity.

14 CLINICAL STUDIES

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

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

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.

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

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

Remove the plastic cap from the container. (See 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

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)
  • 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

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.

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.

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