Nitrolingual

Name: Nitrolingual

Uses of Nitrolingual

Nitrolingual Pumpspray is a prescription medicine used to treat and prevent angina associated with coronary artery disease (CAD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

  • Arbor Pharmaceuticals, Inc.

Nitrolingual Precautions

Do not use Nitrolingual Pumpspray if you:

  • are allergic to organic nitrates.
  • have had a very recent heart attack
  • have severe anemia
  • have increased pressure in the head
  • have acute circulatory failure or shock
  • take drugs for erectile dysfunction, like Viagra (sildenafil), Cialis (tadalafil), or Levitra (vardenafil), as this may lead to extreme lowering of your blood pressure.

Inform MD

Before using Nitrolingual Pumpspray, tell your doctor if you are taking:

  • any medicines that are used to treat angina, heart failure, or an irregular heartbeat.
  • any medicines that reduce blood pressure.
  • any diuretics (water pills).
  • medications to treat depression or psychiatric illness.
  • ergotamine or similar drugs for migraine headaches.
  • aspirin.
  • the blood thinner medicine heparin.
  • any medicines for erectile dysfunction.

Tell your doctor if you are pregnant or plan to become pregnant or if you are breastfeeding.

Nitrolingual Overdose

If you use too much of Nitrolingual Pumpspray, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Before Using Nitrolingual

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nitroglycerin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nitroglycerin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Avanafil
  • Riociguat
  • Sildenafil
  • Tadalafil
  • Vardenafil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alteplase, Recombinant

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acetylcysteine
  • Aspirin
  • Dihydroergotamine
  • Pancuronium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia, severe or
  • Brain tumor or
  • Circulatory failure or shock or
  • Heart attack, acute (already occurring) or
  • Head injury, severe with increased pressure in the head—Should not be used in patients with these conditions.
  • Congestive heart failure or
  • Heart attack, recent or
  • Heart disease (eg, hypertrophic cardiomyopathy, constrictive pericarditis, aortic or mitral stenosis) or
  • Hypotension (low blood pressure) or
  • Hypovolemia (low amount of blood)—Use with caution. May make these conditions worse.

Proper Use of nitroglycerin

This section provides information on the proper use of a number of products that contain nitroglycerin. It may not be specific to Nitrolingual. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Nitroglycerin is available as two types of products that are used for different reasons. The extended-release capsules are used every day on a specific schedule to prevent angina attacks. The oral spray, sublingual powder, and sublingual tablets work quickly to stop an angina attack that has already started or they can be used to prevent angina if you plan to exercise or expect a stressful event.

When you begin to feel an attack of angina starting (chest pains, tightness or squeezing in the chest), sit down. Then place a sublingual powder or tablet in your mouth or under your tongue. If you use the oral spray, you should spray it on or under the tongue. You may become dizzy, lightheaded, or faint soon after using a tablet or spray, so it is safer to sit rather than stand while the medicine is working. If you become dizzy or faint while sitting, take several deep breaths and bend forward with your head between your knees. Remain calm and you should feel better in a few minutes.

If you are taking the nitroglycerin sublingual powder: Empty the contents of a packet under your tongue. Close your mouth and breathe normally. Allow powder to dissolve without swallowing. Do not rinse or spit for 5 minutes after taking this medicine. Do not take more than 3 packets in 15 minutes. If you still have pain after you take a total of 3 packets, this is an emergency. Call 911. Do not drive yourself to the hospital.

Nitroglycerin sublingual tablets should not be chewed, crushed, or swallowed. They work much faster when absorbed through the lining of the mouth. Place the tablet under the tongue or between the cheek and gum, and let it dissolve. Do not eat, drink, smoke, or use chewing tobacco while a tablet is dissolving.

Nitroglycerin sublingual tablets usually give relief in 1 to 5 minutes. However, if the pain is not relieved, you may use a second tablet 5 minutes after you take the first tablet. If the pain continues for another 5 minutes, a third tablet may be used. If you still have chest pain after a total of 3 tablets, contact your doctor or go to a hospital emergency room right away. Do not drive yourself and call 911, if necessary.

You may administer 1 or 2 sprays of Nitroglycerin oral spray at the onset of chest pain. If the pain continues after 5 minutes, a third spray may be used. You must wait 5 minutes after the first 1 or 2 sprays before using a third spray. If you still have chest pain after a total of 3 sprays, contact your doctor or go to a hospital emergency room right away. Do not drive yourself and call 911 if necessary. Do not use more than 3 sprays in a 15-minute period.

Swallow the extended-release capsule whole. Do not split, crush, or chew it.

You should take the extended-release capsule first thing in the morning and follow the same schedule each day. This medicine works best if you have a "drug-free" period of time every day when you do not take it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.

To use the oral spray:

  • Remove the plastic cap.
  • Do not shake the container.
  • If this is a new bottle or container, prime the pump before use by releasing a test spray. This must be done 5 or 10 times into the air away from your face and other people.
  • If this is an old bottle and you have not used it for more than 6 weeks, you must prime it again with 1 or 2 test sprays. If it is not been used within 3 months, prime it up to 5 sprays.
  • Hold the container upright with your forefinger on top of the grooved button. Open your mouth and bring the container as close to it as possible.
  • Press the button firmly with the forefinger to release the spray 1 or 2 times onto or under the tongue. Do not inhale or breathe in the spray.
  • Release the button and close your mouth, but do not swallow right away. Do not spit out the spray or rinse your mouth for at least 5 to 10 minutes.
  • If you need a third spray, you must wait 5 minutes after the second spray. Use exactly the same steps you used for the first spray. No more than 3 sprays should be given within 15 minutes.
  • Replace the cover after using the medicine.
  • Always place the spray bottle in an upright position if not in use. Also, check the fluid level of Nitromist® container regularly. If the fluid reaches the top or middle of the hole on the side of container, this is an indicator that you must get a refill.
  • Do not use the spray near heat, an open flame, or while smoking.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For prevention or treatment of angina:
    • For oral dosage form (extended-release capsules):
      • Adults—2.5 to 6.5 milligrams (mg) 3 to 4 times a day. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For sublingual dosage form (powder):
      • Adults—1 or 2 packets placed under the tongue at the first sign of an angina attack. 1 packet may be used every 5 minutes as needed, for up to 15 minutes. Do not take more than 3 packets in 15 minutes.
      • Children—Use and dose must be determined by your doctor.
    • For sublingual dosage form (spray):
      • Adults—1 or 2 sprays on or under the tongue at the first sign of an chest pain. Sprays may be repeated every 5 minutes as needed. You must wait 5 minutes before administering a third spray if 2 sprays are used initially. Do not use more than 3 sprays in 15 minutes. To prevent angina from exercise or stress, use 1 or 2 sprays 5 to 10 minutes before the activity.
      • Children—Use and dose must be determined by your doctor.
    • For sublingual dosage form (tablets):
      • Adults—1 tablet placed under the tongue or between the cheek and gum at the first sign of an angina attack. 1 tablet may be used every 5 minutes as needed, for up to 15 minutes. Do not take more than 3 tablets in 15 minutes. To prevent angina from exercise or stress, use 1 tablet 5 to 10 minutes before the activity.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the extended-release capsules in a closed container at room temperature, away from heat, moisture, and direct light.

Store the sublingual powder at room temperature, away from heat, moisture, and direct light.

Sublingual tablets should be kept in the original glass bottle. Screw the cap on tightly after each use and store the bottle at room temperature, away from heat, moisture, and direct light.

Store the oral spray at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not forcefully open the container or throw it into a fire, even if it is empty.

Warnings and Precautions

Tolerance

Excessive use may lead to the development of tolerance. Only the smallest number of doses required for effective relief of the acute angina attack should be used [see Dosage and Administration (2.1)].

Hypotension

Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin particularly in patients with constrictive pericarditis, aortic or mitral stenosis, patientswho may be volume-depleted, or are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris. Symptoms of severe hypotension (nausea, vomiting, weakness, pallor, perspiration and collapse/syncope) may occur even with therapeutic doses.

Hypertrophic Obstructive Cardiomyopathy

Nitrate therapy may aggravate the angina caused by hypertrophic obstructive cardiomyopathy.

Headache

Nitroglycerin produces dose-related headaches, especially at the start of nitroglycerin therapy, which may be severe and persistent but usually subside with continued use.

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; 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

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

PRINCIPAL DISPLAY PANEL - 4.9 g Spray Bottle Carton

Nitrolingual®
Pumpspray

(nitroglycerin
lingual spray)

400 mcg per spray
60 Metered Sprays
4.9 g Net Contents

DO NOT SHAKE
HOLD CONTAINER UPRIGHT
PRIME BEFORE USE

NDC 24338-300-65

arbor™
PHARMACEUTICALS, INC.

Nitrolingual PUMPSPRAY 
nitroglycerin spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24338-300
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitroglycerin (nitroglycerin) nitroglycerin 400 ug
Inactive Ingredients
Ingredient Name Strength
medium-chain triglycerides  
alcohol  
peppermint oil  
sodium lactate  
lactic acid  
Product Characteristics
Color      Score     
Shape Size
Flavor PEPPERMINT Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:24338-300-65 1 BOTTLE in 1 CARTON
1 60 SPRAY, METERED in 1 BOTTLE
2 NDC:24338-300-66 1 BOTTLE in 1 CARTON
2 60 SPRAY, METERED in 1 BOTTLE
3 NDC:24338-300-20 1 BOTTLE in 1 CARTON
3 200 SPRAY, METERED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018705 02/01/2000
Labeler - Arbor Pharmaceuticals, Inc. (781796417)
Revised: 01/2015   Arbor Pharmaceuticals, Inc.
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