The chemical stability of amiodarone hydrochloride in two intravenous iv fluids, 5% dextrose injection and 0. Bradycardia was reported as an adverse drug reaction in 4. Dobutamine was compatible at concentrations up to 4 mgml but incompatible at. The following prescribing information is provided in adobe pdf format. The optimal dose for changing from intravenous to oral administration of amiodarone will depend on the dose of nexterone already administered, as well as the bioavailability of oral amiodarone. Tikosyn is supplied for oral administration in three dosage strengths. Cordarone iv amiodarone hydrochloride intravenous is an antiarrhythmic drug used to treat and prevent frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Conventional iv amiodarone contains the preservative benzyl alcohol. If ingestion occurs, flush mouth with water and seek medical attention if any symptoms appear.
Noxafil delayedrelease tablets and oral suspension are not to be used interchangeably due to the differences in thedosing ofeach formulationsee dosage and administration 2. Prevymis injection is physically incompatible with amiodarone hydrochloride, amphotericin b liposomal, aztreonam, cefepime hydrochloride, ciprofloxacin, cyclosporine, diltiazem hydrochloride. Though vastly different, these tools share a basic truth. If administered outside of the standard concentration of 900 mg500ml it should be administered using a 0. Injectioninfusion called amiodarone in this leaflet contains a medicine called. Amiodarone hydrochloride for injection fresenius kabi. To avoid injection site reactions, amiodarone iv should, whenever possible, be administrated through a central venous line see section 4. Iv amiodarone may cause acute liver injury within one day of infusion. This product must not be given to children, premature babies or neonates. In some patients inserting a pacemaker is required. Each ml of the amiodarone hcl injection formulation contains 50 mg of amiodarone hcl, 20. Amiodarone hydrochloride marketed as cordarone and. Amiodarone injection fda prescribing information, side.
During or after treatment with nexterone, patients may be transferred to oral amiodarone therapy. While only a limited number of in vivo drugdrug interactions with amiodarone have been reported, chiefly with the oral formulation, the. The following table summarizes the mean ranges of pharmacokinetic parameters of amiodarone reported in single dose iv 5 mgkg over 15 min studies of healthy subjects. Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment. Sodium chloride injection, usp in viaflex plastic container description sodium chloride injection, usp is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. Black box warning may cause potentially fatal toxicities, including pulmonary toxicity, hepatic injury, and worsened arrhythmia. In that patient, the condition was diagnosed 3 months after treatment with intravenous amiodarone, during which time the patient received oral amiodarone.
Amiodarone iv should be administered via a central venous catheter. Multaq doubles the risk of death in these patients 4, 5. If amiodarone should be continued, this should be via intravenous. Find patient medical information for amiodarone intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Scroll down for indications, important risk information and full prescribing information. Conversely, intravenous iv amiodarone begins to act within one hour, with rapid onset of action within minutes following an iv bolus. Therefore, amiodarone has the potential for interactions with drugs or substances that may be substrates, inhibitors or inducers of cyp3a4. Flush eyes with large volumes of water for 15 minutes or more. Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone.
Cordarone amiodarone hcl is a member of a new class of antiarrhythmic drugs with predominantly class iii vaughan williams classification effects, available for oral administration as pink, scored tablets containing 200 mg of amiodarone hydrochloride. Iv administration of cardiodepressant calciumchannel antagonists e. Nexterone amiodarone hydrochloride injection label fda. Amiodarone is a cardiac drug that is indicated for the management of lifethreatening recurrent ventricular fibrillation vf or hemodynamicallyunstable ventricular tachycardia vt refractory to. Further electrophysiological manifestations of this drug effect include decreased sa. Package insert magnesium sulfate injection, usp 50% piengv1.
Hypotension hypotension is the most common adverse effect seen with amiodarone hcl injection. Seek medical attention if irritation or signs of exposure are noted. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for cordarone amiodarone skip to. A pharmacy workflow management system and automated compounding system can help streamline pharmacy operations. Newer iv formulation nexterone does not contain polysorbate 80 or benzyl alcohol. In a recent metaanalysis, adult patients taking lower doses of amiodarone 152330 mg daily for at least 12 months were more. Estimates of the elimination halflife of amiodarone vary, depending on how the halflife has been measured and the route of amiodarone administration. Pacerone, cordarone amiodarone dosing, indications. Amiodarone hydrochloride injection, solution dailymed. Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone. Noxafil injection administer via a central venous line, including a central venous catheter or peripherally inserted.
Adding to this complexity is amiodarones betablocking effects, which can. It takes spikes, syringes, and pumps to make an intravenous iv solution. Amiodarone is a class antiarrhythmic that prolongs the cardiac action potential and the. Nexterone also can be used to treat patients with vtvf for whom oral amiodarone is indicated, but who are unable to take oral medication. Pulmonary toxicity is a wellrecognized complication of longterm amiodarone use see package insert for oral amiodarone. Amiodarone is approved for use in the secondary prevention of lifethreatening ventricular arrhythmias. Amiodarone hcl injection is a sterile clear, paleyellow micellular solution visually free from particulates. Incidence, contributing factors, and clinical implications. Amiodarone is one of the most commonly used antiarrhythmic drugs. The solution after constitution is clear and colorless. However, among all of the included studies, total doses greater than 1 g were associated with increased phlebitis rates. After the first 24 hours, continue the maintenance infusion rate of 0. Ampicillin for injection, usp is white to offwhite crystalline powder. Dribofuranosyl9hpurine and has the following structural formula.
This products label may have been revised after this insert was used in production. Dailymed amiodarone hydrochloride injection, solution. Information from the accs raterhythm dosing table on the drug amiodarone, including recommended dosage and major side effects. Baxter healthcare corporation nexterone amiodarone. Wholesaler pic numbers wholesaler order details pdf, 0. Nexterone amiodarone hcl premixed injection for intravenous use. Amiodarone hcl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. Tikosyn capsules contain the following inactive ingredients.
Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone. Phlebitis in intravenous amiodarone administration. The north american society for pacing and electrophysiology naspe recommends amiodarone. Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice. To obtain the adobe acrobat reader for this file please click here click here to view the prescribing information for amiodaroneiv. Amiodarone 150mg3ml concentrate for solution for injectioninfusion. A placebocontrolled study of iv amiodarone 300 mg over 2 hours. Highlights of prescribing information nexterone safely and.
Each pharmacy bulk package bottle contains ampicillin sodium equivalent to 10 grams of ampicillin. Click here to view a print quality pdf of this table. Amiodarone is also known to be an inhibitor of cyp3a4. Nexterone amiodarone hcl injection for intravenous use.