Aminosol

Aminosol is a drug combination that contains theophylline and ethylenediamine in a 2:1 ratio. Once in the body, theophylline is released and acts as a phosphodiesterase inhibitor, adenosine receptor blocker, and histone deacetylase activator. Similar to other theophyllines, Aminosol is indicated for the treatment of lung diseases such as asthma, chronic bronchitis, and COPD. The majority of Aminosol medications are discontinued and the remaining medications on the market are in short supply.

Oral

Chronic bronchospasm

Adult: As hydrate: Initially, 225-450 mg bid, increased if necessary.

Child: >3 yr: As modified-release hydrate: 12 mg/kg daily increased to 24 mg/kg daily in 2 divided doses after 1 wk.

Elderly: Dose reduction may be ncessary.

Hepatic impairment: Dose reduction may be ncessary.

Incompatibility: Incompatible with metals.

Intravenous

Acute severe bronchospasm

Adult: Loading dose: 5 mg/kg (ideal body weight) or 250-500 mg (25 mg/ml) by slow inj or infusion over 20-30 min. Maintenance infusion dose: 0.5 mg/kg/hr. Max rate: 25 mg/min.

Child: Loading dose: same as adult dose. Maintenance dose: 6 mth-9 yr: 1 mg/kg/hr and 10-16 yr: 0.8 mg/kg/hr.

Elderly: Dose reduction may be ncessary.

Hepatic impairment: Dose reduction may be ncessary.

Incompatibility: Incompatible with metals.

Special Populations: Reduce maintenance dose in patients with cor pulmonale or heart failure. Increase maintenance dose for smokers.

Aminosol is a bronchodilator. Aminosol works in several ways: it relaxes muscles in your lungs and chest to allow more air in, decreases the sensitivity of your lungs to allergens and other substances that cause inflammation, and increases the contractions of your diaphragm to draw more air into the lungs.

Aminosol is used to treat the symptoms of asthma, bronchitis, and emphysema.

Aminosol may also be used for purposes other than those listed in this medication guide.

Usual Adult Dose for Asthma -- Acute:

IV: (all dosages based on Aminosol-patient not receiving Aminosol or theophylline}

Loading dose:

6 mg/kg in 100 to 200 mL of IV fluid intravenously once over 20 to 30 minutes.

Maintenance dose (following loading dose):

Otherwise healthy nonsmoking

Adult: 0.7 mg/kg/hr continuous intravenous infusion.

Young adult smoker: 0.9 mg/kg/hr continuous intravenous infusion.

Patient with cor pulmonale or congestive heart failure: 0.25 mg/kg/hr continuous intravenous infusion.

Oral: (Patient not receiving Aminosol or theophylline)

Loading dose: 6.3 mg/kg orally once.

Maintenance dose (following loading dose):

Otherwise healthy nonsmoking

Adult: 12.5 mg/kg/day in divided doses. Do not exceed 1,125 mg/day.

Young adult smoker: 19 mg/kg/day in divided doses.

Patient with cor pulmonale or congestive heart failure: 6.25 mg/kg/day in divided doses. Do not exceed 500 mg/day.

Usual Geriatric Dose for Asthma -- Acute:

IV: (all dosages based on Aminosol)

Patient not receiving Aminosol or theophylline:

Loading dose: 6 mg/kg in 100 to 200 mL of IV fluid intravenously once over 20 to 30 minutes.

Maintenance dose (following loading dose): 0.2 to 0.3 mg/kg/hr continuous intravenous infusion.

Oral: Patient not receiving Aminosol or theophylline:

Loading dose: 6.3 mg/kg orally once.

Maintenance dose (following loading dose): 1.7 to 2 mg/kg orally every 8 hours.

Usual Pediatric Dose for Apnea of Prematurity:

<= 4 weeks: (IV or oral, all dosages based on Aminosol):

Loading dose: (Patient not receiving Aminosol or theophylline): 5 to 6 mg/kg once - if IV, dilute in IV fluid and give intravenously once over 20 to 30 minutes.

Maintenance dose: 3 to 8 mg/kg/day divided every 6 to 12 hours.

Usual Pediatric Dose for Asthma -- Acute:

IV: (all dosages based on Aminosol and patient not receiving Aminosol or theophylline):

Loading dose:: 6 mg/kg diluted in IV fluid intravenously once over 20 to 30 minutes.

Maintenance dose (following loading dose):

6 weeks to 6 months: 0.5 mg/kg/hour continuous intravenous infusion.

6 months to 1 year: 0.6 to 0.7 mg/kg/hr continuous intravenous infusion.

1 year to 9 years: 1 to 1.2 mg/kg/hr continuous intravenous infusion.

9 years to 12 years: 0.9 mg/kg/hr continuous intravenous infusion.

>12 years: 0.7 mg/kg/hr continuous intravenous infusion.

Oral: (Patient not receiving Aminosol or theophylline):

Loading dose: 6.3 mg/kg orally once.

Maintenance dose (following loading dose):

>=42 < 182 days: 12 to 13.5 mg/kg/day in divided doses.

>= 6 < 12 months: 15 to 22.5 mg/kg/day in divided doses.

>=1 year to <9 years: 25 to 30 mg/kg/day in divided doses.

>=9 years to <12 years: 17 to 20 mg/kg/day in divided doses.

>=12 to <16 years: 15 to 17 mg/kg in divided doses.

>=16 years: 6.25 to 20 mg/kg orally divided every 6 hours.

See also:
What is the most important information I should know about Aminosol?

Hypersensitivity to Aminosol, theophylline, ethylenediamine, or any component of the formulation.

Canadian labeling: Additional contraindications (not in US labeling): Coronary artery disease where cardiac stimulation might prove harmful; peptic ulcer disease.

Use Aminosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Aminosol is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Aminosol at home, carefully follow the injection procedures taught to you by your health care provider.
• If Aminosol contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Aminosol, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Aminosol.

Use: Labeled Indications

Reversible airflow obstruction: Treatment of acute exacerbations of symptoms and reversible airflow obstruction due to asthma or other chronic lung diseases (eg, emphysema, chronic bronchitis) as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids.

Guideline recommendations:

Asthma: The 2007 National Heart, Lung, and Blood Institute Asthma Guidelines and the 2019 Global Initiative for Asthma Guidelines recommend against Aminosol for the treatment of asthma exacerbations because of poor efficacy and safety concerns (GINA 2019; NAEPP 2007).

Chronic obstructive pulmonary disease: The 2019 Global Initiative for Chronic Obstructive Lung Disease Guidelines recommends against Aminosol for the treatment of chronic obstructive pulmonary disease exacerbations because of significant adverse effects (GOLD 2019).

Off Label Uses

Reversal of dipyridamole- or regadenoson-induced adverse reactions (eg, angina, hypotension) during nuclear cardiac stress testing

Based on the American Society of Nuclear Cardiology (ASNC) Guidelines for Nuclear Cardiology Procedures, Aminosol given for the reversal of adenosine-, dipyridamole-, or regadenoson-induced adverse reactions (eg, angina, hypotension) during nuclear cardiac stress testing is effective and recommended in this setting. Use of Aminosol with adenosine-induced adverse reactions specifically is usually not warranted due to adenosine's short half-life (adverse reactions will usually stop within seconds of stopping adenosine). In the setting of Aminosol shortage, theophylline or caffeine may be used as alternatives to reverse regadenoson or dipyridamole. In addition, to reduce Aminosol use overall, adenosine or dobutamine can be used as alternative pharmacologic testing agents, if appropriate, since Aminosol reversal is not typically required.

See also:
What other drugs will affect Aminosol?

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: adenosine, adrenaline-like drugs (e.g., ephedrine, phenylephrine, pseudoephedrine), allopurinol, aminoglutethimide, certain antiarrhythmic drugs (e.g., mexiletine, propafenone), anti-seizure drugs (e.g., carbamazepine, phenytoin, phenobarbital), benzodiazepines (e.g., flurazepam), certain beta blockers (e.g., propranolol), birth control pills, cimetidine, digoxin, disulfiram, fluvoxamine, interferon, macrolide antibiotics (e.g., erythromycin, clarithromycin), isoproterenol, lithium, methotrexate, moricizine, pentoxifylline, certain quinolones (e.g., ciprofloxacin, enoxacin), rifampin, riociguat, St John's wort, sulfinpyrazone, tacrine, thiabendazole, ticlopidine, verapamil.

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase the side effects of this medication. Ask your pharmacist about using those products safely.

Tobacco/marijuana smoking decreases blood levels of this medication. Tell your doctor if you smoke or have recently stopped smoking. Your dose of medication may need to be adjusted.

Caffeine and alcohol can increase the side effects of this medication. Avoid drinking large amounts of beverages containing alcohol or caffeine (e.g., coffee, tea, colas) or eating large amounts of chocolate.

Certain diets (e.g., high protein/low carbohydrate or high carbohydrate/low protein) may change the effect of Aminosol. Tell your doctor if you are following a dietary plan or eat beef every day. The dose of your medicine may need to be adjusted.

Aminosol is very similar to theophylline. Do not take medications containing theophylline while using Aminosol.

This medication may interfere with certain laboratory tests (e.g., blood sugar, cholesterol, uric acid, dipyridamole-thallium imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Laboratory tests for drug blood levels may be affected by other drugs/foods, possibly causing false test results. Tell laboratory personnel and all your doctors if you take or use any of the following products: caffeine, theobromine, chocolate, furosemide, sulfathiazole, phenylbutazone, probenecid, acetaminophen, cefazolin, cephalothin.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

See also:
What are the possible side effects of Aminosol?

Applies to Aminosol: oral solution, oral tablet, oral tablet extended release

Other dosage forms:

• intravenous solution

As well as its needed effects, Aminosol (the active ingredient contained in Aminosol) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Aminosol, check with your doctor immediately:

Rare

• Cracks in the skin
• loss of heat from the body
• red, swollen skin
• scaly skin
• skin rash

• Chest pain or discomfort
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• increase in urine volume
• lightheadedness
• persistent vomiting
• pounding or rapid pulse
• seizures
• shakiness

If any of the following symptoms of overdose occur while taking Aminosol, get emergency help immediately:

Symptoms of overdose:

• Abdominal or stomach pain
• blurred vision
• confusion
• confusion about identity, place, and time
• dark-colored urine
• decrease in frequency of urination
• decreased urine
• diarrhea
• difficulty in passing urine (dribbling)
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast, pounding, or irregular heartbeat or pulse
• fever
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle cramps or spasms
• muscle pain or stiffness
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the arms, jaw, back, or neck
• painful urination
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• sweating
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds

Minor Side Effects

Some Aminosol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Incidence not known:

• Headache
• irritability
• restlessness
• sleeplessness
• trouble sleeping
• unable to sleep