Nexterone

DRUG DESCRIPTION

NEXTERONE contains amiodarone HCl (C25H29I2NO3•HCl), a class III antiarrhythmic drug. Amiodarone HC1 is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanonehydrochloride.

Amiodarone HC1 has the following structural formula:

NEXTERONE
  (amiodaronc HC1) Structural Formula Illustration

Amiodarone HC1 is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. NEXTERONE is a sterile clear, colorless to slightly yellow solution visually free from particulates. Each mL of NEXTERONE contains 50 mg of amiodarone HC1,225 mg sulfobutylether beta-cyclodextrin sodium, 3.8 mg citric acid monohydrate, 2.1 mg sodium citrate dihydrate and water for injection. Sodium hydroxide or citric acid monohydrate may have been added to adjust pH. NEXTERONE does not contain polysorbate 80 or benzyl alcohol.

What are the possible side effects of amiodarone injection (Nexterone)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects, even if they occur up to several months after you stop using amiodarone:

  • a new or a worsening irregular heartbeat pattern;
  • fast, slow, or pounding heartbeats;
  • feeling like you might pass out;
  • wheezing, cough, chest pain, trouble breathing, coughing up...

Read All Potential Side Effects and See Pictures of Nexterone »


Nexterone Patient Information Including Side Effects

Brand Names: Nexterone

Generic Name: amiodarone (injection) (Pronunciation: A mi OH da rone)

  • What is amiodarone injection (Nexterone)?
  • What are the possible side effects of amiodarone injection (Nexterone)?
  • What is the most important information I should know about amiodarone injection (Nexterone)?
  • What should I discuss with my healthcare provider before using amiodarone injection (Nexterone)?
  • How is amiodarone injection given (Nexterone)?
  • What happens if I miss a dose (Nexterone)?
  • What happens if I overdose (Nexterone)?
  • What should I avoid while using amiodarone injection (Nexterone)?
  • What other drugs will affect amiodarone injection (Nexterone)?
  • Where can I get more information?

What is amiodarone injection (Nexterone)?

Amiodarone is an antiarrhythmic medication that affects the rhythm of heartbeats.

Amiodarone is used to help keep the heart beating normally in people with life-threatening heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Amiodarone is used to treat or prevent ventricular tachycardia or ventricular fibrillation.

Amiodarone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of amiodarone injection (Nexterone)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects, even if they occur up to several months after you stop using amiodarone:

  • a new or a worsening irregular heartbeat pattern;
  • fast, slow, or pounding heartbeats;
  • feeling like you might pass out;
  • wheezing, cough, chest pain, trouble breathing, coughing up blood;
  • feeling short of breath, even with mild exertion, swelling, rapid weight gain;
  • blurred vision, vision loss, headache or pain behind your eyes, sometimes with vomiting;
  • swelling, pain, redness, or irritation around your IV needle;
  • weight loss, thinning hair, feeling too hot or too cold, increased sweating, irregular menstrual periods, swelling in your neck (goiter);
  • pain in your upper stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • low fever;
  • slight dizziness; or
  • mild nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amiodarone injection (Nexterone)?

Amiodarone injection is for use only in life-threatening situations. This medication has the potential to cause side effects that could be fatal, and you will receive your injection in a hospital setting.

You should not receive this medication if you are allergic to amiodarone or iodine, or if you have a serious heart condition such as "AV block" (unless you have a pacemaker) or a history of slow heart beats.

Do not receive amiodarone injection without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your thyroid and liver function may also need to be tested, and you may need eye exams and chest x-rays. Do not miss any scheduled appointments.

You may continue to have side effects from amiodarone after you stop using it. It could take up to several months for the medicine to completely clear from your body.

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