DOFETILIDE- dofetilide capsule
Ingenus Pharmaceuticals, LLC
(doe fet' i lide)
Read the Medication Guide before you start taking dofetilide capsules and each time you get a refill. This information does not take the place of talking with your doctor about your condition or treatment.
What is the most important information I should know about dofetilide capsules?
Dofetilide capsules can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death.
To establish the right dose of dofetilide capsules, treatment with dofetilide capsules must be started in a hospital where your heart rate and kidney function will be checked for the first 3 days of treatment. It is important that when you go home, you take the exact dose of dofetilide capsules that your doctor prescribed for you.
While you take dofetilide capsules, always watch for signs of abnormal heartbeat.
Call your doctor and go to the hospital right away if you:
Dofetilide capsules are prescription medicine that is used to treat an irregular heartbeat (atrial fibrillation or atrial flutter).
It is not known if dofetilide capsules are safe and effective in children under 18 years of age.
Who should not take dofetilide capsules?
Do not take dofetilide capsules if you:
Before taking dofetilide capsules, tell your doctor about all of your medical conditions including if you:
Ask your doctor if you are not sure about the medicines you take. Tell your doctor about all prescription and non-prescription medicines, vitamins, dietary supplements, and any natural or herbal remedies. Dofetilide capsules and other medicines may affect each other, causing serious side effects. If you take dofetilide capsules with certain medicines, you will be more likely to have a different type of abnormal heartbeat. See "Who should not take dofetilide capsules?"
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
How should I take dofetilide capsules?
Dofetilide capsules can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death. See "What is the most important information I should know about dofetilide capsules?"
The most common side effects of dofetilide capsules include:
These are not all the possible side effects of dofetilide capsules. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store dofetilide capsules?
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dofetilide capsules for a condition for which it was not prescribed. Do not give dofetilide capsules to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about dofetilide capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about dofetilide capsules that is written for health professionals.
What are the ingredients in dofetilide capsules?
Active ingredient: dofetilide
Capsule fill: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide and magnesium stearate.
Capsule shell: gelatin, titanium dioxide and FD&C green 3 (0.125 mg), gelatin and titanium dioxide (0.25 mg and 0.5 mg)
Imprinting ink: shellac, black iron oxide, propylene glycol, strong ammonia solution, potassium hydroxide.
* Listed trademarks are the property of their respective owners.
Ingenus Pharmaceuticals, LLC
Orlando, FL 32839-6408
Made in Spain
Revised: November 2019