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Nexterone

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Nexterone

Nexterone Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Nexterone (amiodarone HC1) Injection is an antiarrhythmic drug 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). It is used to treat or prevent ventricular tachycardia or ventricular fibrillation. This medication is available in generic form. Common side effects include low fever, slight dizziness, nausea or vomiting.

The recommended starting dose of Nexterone is about 1000 mg over the first 24 hours of therapy. Close monitoring with adjustment of dose is essential. Nexterone may interact with cimetidine, clopidogrel, cyclosporine, dextromethorphan, digoxin, fentanyl, loratadine, phenytoin, St. John's wort, blood thinners, diuretics, antibiotics, antifungals, arthritis medications, cholesterol-lowering medicines, heart or blood pressure medications, heart rhythm medications, insulin or oral diabetes medication, or medication to treat HIV or AIDS. Tell your doctor all medications and supplements you use. Do not use Nexterone if you are pregnant. It could harm the fetus. Use birth control, and tell your doctor if you become pregnant during treatment. This drug can pass into breast milk and may harm a nursing baby. Do not breastfeed while receiving this medication.

Our Nexterone (amiodarone HC1) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nexterone in Detail - Patient Information: Side Effects

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.

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.

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.

Read the entire detailed patient monograph for Nexterone (Amiodarone HCl Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nexterone FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a total of 1836 patients in controlled and uncontrolled clinical trials, 14% of patients received intravenous amiodarone for at least one week, 5% received it for at least 2 weeks, 2% received it for at least 3 weeks, and 1% received it for more than 3 weeks, without an increased incidence of severe adverse reactions. The mean duration of therapy in these studies was 5.6 days; median exposure was 3.7 days.

The most important adverse reactions were hypotension, asystole/cardiac arrest/pulseless electrical activity (PEA), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, VT, and AV block. Overall, treatment was discontinued for about 9% of the patients because of adverse reactions. The most common adverse reactions leading to discontinuation of intravenous amiodaronejherapy were hypotension (1.6%), asystole/cardiac arrest/PEA (1.2%), VT (1.1%), and cardiogenic shock (1%).

Table 4 lists the most common (incidence ≥ 2%) adverse reactions during intravenous amiodarone therapy considered at least possibly drug-related. These data were collected in clinical trials involving 1836 patients with life-threatening VT/VF. Data from all assigned treatment groups are pooled because none of the adverse reactions appeared to be dose-related.

Table 4: ADVERSE REACTIONS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE IN CONTROLLED AND OPEN-LABEL STUDIES ( ≥ 2% INCIDENCE)

Study Event Controlled Studies
(n = 814)
Open-Label Studies
(n = 1022)
Total
(n = 1836)
Body as a whole
  Fever 24 (2.9%) 13 (1.2%) 37 (2.0%)
Cardiovascular System
  Bradycardia 49 (6.0%) 41 (4.0%) 90 (4.9%)
  Congestive heart failure 18 (2.2%) 21 (2.0%) 39 (2.1%)
  Heart arrest 29 (3.5%) 26 (2.5%) 55 (2.9%)
  Hypotension 165 (20.2%) 123 (12.0%) 288 (15.6%)
  Ventricular tachycardia 15 (1.8%) 30 (2.9%) 45 (2.4%)
Digestive System
  Liver function tests abnormal 35 (4.2%) 29 (2.8%) 64 (3.4%)
  Nausea 29 (3.5%) 43 (4.2%) 72 (3.9%)

Other adverse reactions reported in less than 2% of patients receiving intravenous amiodaronejn controlled and uncontrolled studies included the following: abnormal kidney function, atrial fibrillation, diarrhea, increased ALT, increased AST, lung edema, nodal arrhythmia, prolonged QT interval, respiratory disorder, shock, sinus bradycardia, Stevens-Johnson syndrome, thrombocytopenia, VF, and vomiting.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of amiodarone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: anaphylactic/anaphylactoid reaction (including shock), fever

Cardiovascular: hypotension (sometimes fatal), sinus arrest

Dermatologic: toxic epidermal necrolysis (sometimes fatal), exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, skin cancer, pruritus, angioedema

Endocrine: syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Hematologic: pancytopenia, neutropenia, hemolytic anemia, aplastic anemia, thrombocytopenia, agranulocytosis, granuloma

Hepatic: hepatitis, cholestatic hepatitis, cirrhosis

Injection Site Reactions: pain, erythema, edema, pigment changes, venous thombosis, phlebitis, thrombophlebitis, cellulitis, necrosis, and skin sloughing

Musculoskeletal: myopathy, muscle weakness, rhabdomyolysis

Nervous System: hallucination, confusional state, disorientation, and delirium, pseudotumor cerebri

Pancreatic: pancreatitis

Renal: renal impairment, renal insufficiency, acute renal failure,

Respiratory: bronchospasm, possibly fatal respiratory disorders (including distress, failure, arrest and ARDS), bronchiolitis obliterans organizing pneumonia (possibly fatal), dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates, and /or mass, pleuritis

Thyroid: thyroid nodules/thyroid cancer

Vascular: vasculitis

Read the entire FDA prescribing information for Nexterone (Amiodarone HCl Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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