Amiodarone Solution For Injection 50Mg Drug Medication Dosage Information
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Amiodarone: Solution for injection (50mg)

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What is this Medicine?

AMIODARONE (a MEE oh da rone) is an antiarrhythmic drug. It helps make your heart beat regularly. Because of the side effects caused by this medicine, it is only used when other medicines have not worked.

In-Depth Information
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Amiodarone Hydrochloride 50mg/ml Solution for Injection

NDC: 674570153
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Ventricular Tachycardia, Ventricular Fibrillation

Sometimes used for but not FDA approved for the following conditions:
Supraventricular Arrhythmias, Atrial Flutter, Paroxysmal Supraventricular Tachycardia (PSVT) Prophylaxis, Paroxysmal Supraventricular Tachycardia (PSVT), Atrial Fibrillation, Cardiac Arrest, Cardiopulmonary Resuscitation, Wolff-Parkinson-White (WPW) Syndrome

Storage Information
Avoid exposure to heat
Protect from light
Store in carton until time of use
Store at controlled room temperature (between 68 and 77 degrees F)
Amiodarone Hydrochloride 50mg/ml Solution for Injection

Reported Side Effects for Amiodarone Hydrochloride 50mg/ml Solution for Injection

Bruise Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Blurred Vision Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Skin Rash Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Hair Loss Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Rapid Heart Rate Incidence:
<2.0%*
Severity: SEVERE
Onset: EARLY
Torsade De Pointes Incidence:
<2.0%*
Severity: SEVERE
Onset: RAPID
Irregular Heart Beat Incidence:
<2.0%*
Severity: SEVERE
Onset: EARLY
Swelling Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: DELAYED
Decreased Sexual Desire Incidence:
1.0-3.0%*
Severity: MILD
Onset: DELAYED
Headache Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Flushing Incidence:
1.0-3.0%*
Severity: MILD
Onset: RAPID
Stomach Pain Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Inability To Sleep Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Metallic Taste Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Overactive Thyroid Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: DELAYED
Acute Lung Injury Incidence:
2.0%*
Severity: SEVERE
Onset: EARLY
Lung Inflammation Incidence:
2.0-15.0%*
Severity: MODERATE
Onset: DELAYED
Abnormal Heart Rhythm Incidence:
2.0-5.0%*
Severity: SEVERE
Onset: EARLY
Slow Heart Beat Incidence:
2.0-5.0%*
Severity: SEVERE
Onset: RAPID
Underactive Thyroid Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Constipation Incidence:
2.0-25.0%*
Severity: MODERATE
Onset: DELAYED
Heart Failure Incidence:
3.0%*
Severity: SEVERE
Onset: DELAYED
Lightheadedness Incidence:
4.0-9.0%*
Severity: MILD
Onset: EARLY
Paresthesias Incidence:
4.0-9.0%*
Severity: MILD
Onset: DELAYED
Elevated Hepatic Enzymes Incidence:
4.0-9.0%*
Severity: MODERATE
Onset: DELAYED
Feeling Sick Incidence:
4.0-9.0%*
Severity: MILD
Onset: EARLY
Incoordination Incidence:
4.0-9.0%*
Severity: MODERATE
Onset: DELAYED
Uncontrolled Movements Incidence:
4.0-9.0%*
Severity: MODERATE
Onset: DELAYED
Pulmonary Fibrosis Incidence:
4.0-9.0%*
Severity: SEVERE
Onset: DELAYED
Shaking Incidence:
4.0-9.0%*
Severity: MILD
Onset: EARLY
Tired Incidence:
4.0-9.0%*
Severity: MILD
Onset: EARLY
Photosensitivity Incidence:
10.0%*
Severity: MILD
Onset: DELAYED
Vomiting Incidence:
25.0%*
Severity: MILD
Onset: EARLY
Decreased Appetite Incidence:
25.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
25.0%*
Severity: MILD
Onset: EARLY
Injection Site Reaction Incidence:
25.0%*
Severity: MILD
Onset: RAPID
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for Amiodarone Hydrochloride 50mg/ml Solution for Injection

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Major Lifestyle Interaction
Grapefruit juice and Amiodarone Hydrochloride 50mg/ml Solution for Injection(Amiodarone Hydrochloride)
Grapefruit juice and Amiodarone Hydrochloride(Amiodarone Hydrochloride)
Avoid eating grapefruit or drinking grapefruit juice while taking Amiodarone, unless advised differently by your healthcare professional. Grapefruit juice may increase the level of Amiodarone in the blood, by decreasing the elimination of Amiodarone from the body. Contact your health care provider immediately if you experience palpitations, chest pain, passing out or dizziness, shortness of breath, or a change in your usual heartbeat while taking Amiodarone.
Moderate Lifestyle Interaction
Marijuana and Amiodarone Hydrochloride 50mg/ml Solution for Injection(Amiodarone Hydrochloride)
Marijuana and Amiodarone Hydrochloride(Amiodarone Hydrochloride)
Amiodarone can theoretically decrease the elimination of Marijuana, Medical from the body. Side effects from Marijuana, Medical may get worse if you take Amiodarone. You may feel drowsy or more tired. Do not drive or operate machinery until you know how these drugs affect you. Contact your health care provider immediately if you notice slurred speech, confusion, increases heart rate, or palpitations while taking Marijuana, Medical.
Minor Lifestyle Interaction
Caffeine-containing Foods/Beverages and Amiodarone Hydrochloride 50mg/ml Solution for Injection(Amiodarone Hydrochloride)
Caffeine-containing Foods/Beverages and Amiodarone Hydrochloride(Amiodarone Hydrochloride)
Side effects from Caffeine may get worse if you take Amiodarone. Too much Caffeine can cause effects like nausea, nervousness, or sleeplessness. You may need to limit your Caffeine intake. Common foods and beverages containing caffeine include coffee, teas, colas and chocolate. Many non-prescription drugs and diet aids may also contain caffeine.
Pregnancy & Lactation Information
FIRST Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

SECOND Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

THIRD Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


Learning More About
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