Description
Etripamil nasal spray is used to help restore normal heart rhythm in patients who have sudden episodes of fast heartbeat called paroxysmal supraventricular tachycardia (PSVT).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Spray
Before Using
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 etripamil nasal spray 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 etripamil nasal spray in the elderly.
Breastfeeding
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.
Drug Interactions
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Fainting, history of or
- Heart disease or
- Low blood pressure—Use with caution. May make these conditions worse.
- Heart failure (Class II to IV), moderate to severe or
- Heart rhythm problems (eg, atrioventricular block, Mobitz type II or higher degree heart block, Wolff-Parkinson-White, Lown-Ganong-Levine syndrome, pre-excitation on electrocardiogram) or
- Sick sinus syndrome without a permanent pacemaker—Should not be used in patients with these conditions.
Proper Use
This medicine should be given immediately when symptoms begin. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.
This medicine is for use only in the nose. Do not get any of it in your eyes or on your mouth. If it does get on these areas, rinse it off with water and call your doctor right away.
This medicine comes with a patient information leaflet and patient instructions. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
To use the nasal spray:
- Remove the nasal spray from the carrying case.
- Do not prime or test the nasal spray.
- Sit down and hold the nasal spray in an upright position with your thumb on the bottom of the plunger and the tip between your index and middle fingers. Do not press the plunger yet.
- Insert the tip of the nasal spray into one nostril until your fingers are touching the bottom of your nose.
- Press the plunger firmly and quickly all the way up. Breathe normally and avoid inhaling deeply. Remove the nasal spray from the nostril. Repeat the same steps with the other nostril.
- Keep your head straight for 10 minutes for the nasal spray to work right away. Do not blow your nose for 10 minutes. If the medicine drips out, wipe your nose. If you do not get the first full dose, wait 10 minutes before using another device. Throw away device after use.
If your symptoms do not improve within 20 minutes after the second dose, call your doctor or get emergency medical help right away.
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 nasal dosage form (spray):
- For symptoms of fast heartbeat:
- Adults—One spray into each nostril using 1 nasal spray device. If you still have symptoms after 10 minutes, use one spray into each nostril using a new nasal spray device. Each spray device contains 70 milligrams (mg) of etripamil. Do not use more than 2 devices within a 24 hour period.
- Children—Use and dose must be determined by your doctor.
- For symptoms of fast heartbeat:
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
Precautions
It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.
This medicine may cause dizziness or fainting while using this medicine. Lie down if you feel dizzy or lightheaded after using this medicine.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bloody nose
- stuffy or runny nose
- throat irritation
Rare
- Dizziness, lightheadedness, or fainting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80008578
