Nexterone injection

You should not receive this medicine if you are allergic to amiodarone or iodine, or if you have:

• certain serious heart conditions, especially "AV block" (unless you have a pacemaker);

• a history of slow heart beats that have caused you to faint; or

• if your heart cannot pump blood properly.

If possible before you receive amiodarone injection, tell your doctor if you have:

• breathing problems or lung disorder;

• liver disease;

• vision problems;

• high or low blood pressure;

• a thyroid disorder;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• if you have recently been ill with vomiting or diarrhea;

• if your heart rhythm disorder has recently become worse; or

• if you have a pacemaker or defibrillator implanted in your chest.

In an emergency situation it may not be possible to tell your caregivers about your health conditions. Make sure any doctor caring for you afterward knows you have received this medicine.

Do not use amiodarone if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Amiodarone can pass into breast milk and may harm a nursing baby. You should not breast-feed while receiving this medication.

In an emergency situation, it may not be possible before you are treated with amiodarone injection to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

You should not receive Nexterone if you are allergic to amiodarone or iodine, or if you have:

• certain serious heart conditions, especially "AV block" (unless you have a pacemaker); or

• a history of slow heart beats that have caused you to faint.

If possible before you receive Nexterone injection, tell your doctor if you have:

• breathing problems or lung disorder;

• liver disease;

• vision problems;

• high or low blood pressure;

• a thyroid disorder;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• if you have recently been ill with vomiting or diarrhea;

• if your heart rhythm disorder has recently become worse; or

• if you have a pacemaker or defibrillator implanted in your chest.

In an emergency situation it may not be possible to tell your caregivers about your health conditions. Make sure any doctor caring for you afterward knows you have received this Nexterone.

FDA pregnancy category D. Do not use Nexterone if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Amiodarone can pass into breast milk and may harm a nursing baby. You should not breast-feed while receiving this medication.

In an emergency situation, it may not be possible before you are treated with Nexterone injection to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

Nexterone is injected into a vein through an IV. Nexterone injection is often given directly into a large vein in the upper chest (central IV line). You will receive this injection in a clinic or hospital setting where your heart can be monitored in case the medicine causes serious side effects.

To be sure Nexterone is not causing harmful effects, your blood will need to be tested often. Your thyroid and liver function may also need to be tested, and you may need eye exams and chest x-rays.

If you need surgery (including laser eye surgery), tell the surgeon ahead of time that you have received Nexterone injection.

This medicine can cause unusual results with certain thyroid tests, even after you stop using it. Tell any doctor who treats you that you have received Nexterone injection.

After treatment with Nexterone injection, your doctor may switch you to a tablet form of this medication. Be sure to read the medication guide or patient instructions for amiodarone oral.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Many drugs can interact with amiodarone. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Nexterone, especially:

• an antibiotic - azithromycin, ciprofloxacin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine, and others;

• an antidepressant - amitriptyline, citalopram, desipramine, doxepin, imipramine, maprotiline, nortriptyline, and others;

• cancer medicines;

• a diuretic or "water pill";

• heart rhythm medication - dofetilide, dronedarone, ibutilide, propafenone, sotalol;

• HIV or AIDS medication - indinavir, nelfinavir, rilpivirine, ritonavir, saquinavir; OR

• medicine to treat mental illness - chlorpromazine, fluphenazine, haloperidol, lithium, pimozide, promethazine, thioridazine, ziprasidone, and others.

This list is not complete and many other drugs can interact with amiodarone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Amiodarone takes a long time to completely clear from your body, and drug interactions are possible for up to several months after you stop using Nexterone injection. Talk to your doctor before taking any medication during this time. Keep track of how long it has been since your last dose.

Applies to amiodarone: compounding powder, intravenous solution, oral tablet

General

The most common adverse reactions were corneal microdeposits, hypotension, and photosensitivity.[Ref]

Cardiovascular

Very common (10% or more): Hypotension (up to 20.2%)
Common (1% to 10%): Bradycardia, blood pressure decreased, congestive heart failure, heart arrest, ventricular tachycardia, cardiac arrhythmia, sinoatrial node dysfunction, flushing
Uncommon (0.1% to 1%): Conduction disturbances
Very rare (less than 0.01%): Marked bradycardia, sinus arrest, vasculitis, hot flushes
Frequency not reported: Torsade de pointes, collapse, atrial fibrillation, nodal arrhythmia, QT interval prolonged, sinus bradycardia, ventricular fibrillation, shock, asystole, pulseless electrical activity, cardiogenic shock, atrioventricular block, severe hypotension
Postmarketing reports: Sinoatrial block, intraventricular conduction disorders, bundle branch block, infra-His block, ventricular extrasystole, antegrade conduction via an accessory pathway[Ref]

Hepatic

Common (1% to 10%): Acute liver disorders with high serum transaminases and/or jaundice including hepatic failure, liver function tests abnormal, nonspecific hepatic disorder
Very rare (less than 0.01%): Pseudo alcoholic hepatitis, cirrhosis, serum transaminases increased
Frequency not reported: ALT increased, AST increased
Postmarketing reports: Cholestatic hepatitis, cholestasis, jaundice, alkaline phosphatase increased, blood lactate dehydrogenase increased[Ref]

Respiratory

Common (1% to 10%): Pulmonary toxicity, pulmonary inflammation or fibrosis, adult respiratory distress syndrome
Very rare (less than 0.01%): Bronchospasm, interstitial pneumonitis, severe respiratory complications, apnea
Frequency not reported: Pulmonary hemorrhage, lung edema, respiratory disorder, alveolar pneumonitis
Postmarketing reports: Possibly fatal respiratory disorder, bronchiolitis obliterans organizing pneumonia, dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates, pulmonary mass, pleuritis, pulmonary phospholipidosis, pleural effusion, eosinophilic pneumonia, acute respiratory distress syndrome[Ref]

Ocular

Very common (10% or more): Corneal microdeposits (up to 90% or more)
Common (1% to 10%): Visual disturbance
Very rare (less than 0.01%): Optic neuropathy/neuritis
Frequency not reported: Permanent blindness, papilledema, corneal degeneration, eye discomfort, scotoma, lens opacities, macular degeneration, keratopathy, gritty eyes, itching, burning
Postmarketing reports: Visual field defect, blurred vision[Ref]

Dermatologic

Very common (10% or more): Photosensitivity (up to 10%)
Common (1% to 10%): Slate-gray or bluish pigmentations of light-exposed skin
Very rare (less than 0.01%): Erythema, rash, exfoliative dermatitis, alopecia, sweating
Frequency not reported: Granuloma, angioedema, urticaria, Stevens-Johnson syndrome, spontaneous ecchymosis, pustular psoriasis enhanced
Postmarketing reports: Toxic epidermal necrolysis, erythema multiforme, skin cancer, pruritus, bullous dermatitis, drug rash with eosinophilia and systemic symptoms (DRESS), eczema[Ref]

Nervous system

Common (1% to 10%): Extrapyramidal symptoms, extrapyramidal tremor, tremor/abnormal involuntary movement, lack of coordination, gait abnormal/ataxia, dizziness, paresthesia, headache, abnormal taste and smell
Uncommon (0.1% to 1%): Peripheral sensorimotor neuropathy
Very rare (less than 0.01%): Cerebellar ataxia, benign intracranial hypertension, vertigo
Frequency not reported: Peripheral neuropathy, demyelinating polyneuropathy, nerve conduction abnormal, neurolipidosis, neuromyopathy, parosmia
Postmarketing reports: Confusional state, disorientation, delirium, intracranial pressure increased, hypoesthesia, Parkinsonian symptoms[Ref]

Psychiatric

Common (1% to 10%): Nightmare, sleep disorders, libido decreased, insomnia, sleep disturbance
Frequency not reported: Vivid dreams, chronic anxiety
Postmarketing reports: Hallucination[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, constipation, abdominal pain, salivation abnormal
Frequency not reported: Vomiting, dysgeusia, diarrhea
Postmarketing reports: Pancreatitis, acute pancreatitis, dry mouth[Ref]

Other

Common (1% to 10%): Fever, malaise, fatigue[Ref]

Endocrine

Common (1% to 10%): Hypothyroidism, hyperthyroidism
Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone secretion
Frequency not reported: Thyroid function tests abnormal
Postmarketing reports: Thyroid nodules/cancer[Ref]

Metabolic

Common (1% to 10%): Anorexia, edema
Frequency not reported: Weight gain, symptomatic hypercalcemia, appetite decreased[Ref]

Hematologic

Common (1% to 10%): Coagulation abnormalities
Very rare (less than 0.01%): Hemolytic anemia, aplastic anemia, thrombocytopenia
Frequency not reported: Bone marrow granuloma, bone marrow depression
Postmarketing reports: Pancytopenia, neutropenia, agranulocytosis, granulocytosis[Ref]

Musculoskeletal

Common (1% to 10%): Muscle weakness
Frequency not reported: Back pain
Postmarketing reports: Myopathy, rhabdomyolysis, muscle spasm, lupus-like syndrome[Ref]

Local

Common (1% to 10%): Injection site reactions[Ref]

Genitourinary

Very rare (less than 0.01%): Epididymo-orchitis, impotence
Postmarketing reports: Epididymitis[Ref]

Immunologic

Very rare (less than 0.01%): Anaphylactic shock
Frequency not reported: Hypersensitivity reaction, positive antinuclear antibodies, immunoglobulin level increased
Postmarketing reports: Anaphylactic/anaphylactoid reaction[Ref]

Renal

Very rare (less than 0.01%): Blood creatinine increased
Frequency not reported: Kidney function abnormal, chronic renal failure worsened
Postmarketing reports: Renal impairment, renal insufficiency, acute renal failure[Ref]

Some side effects of Nexterone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.