WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here. NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Racepinephrine hydrochloride is a bronchodilator that is FDA approved for the treatment of mild symptoms of intermittent asthma. Common adverse reactions include headache, nausea, tremor, sweating and restlessness.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
For temporary relief of mild symptoms of intermittent asthma:
Add 0.5 ml (contents of one vial) of solution to nebulizer.
Children 4 years of age and over:
1 to 3 inhalations not more often than every 3 hours.
Do not use more than 12 inhalations in 24 hours.
The use of this product by children should be supervised by an adult.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Racepinephrine hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Racepinephrine hydrochloride in pediatric patients.
Contraindications
Condition1
Warnings
Asthma alert
Because asthma may be life threatening, see a doctor if you:
Are not better in 20 minutes
Get worse
Need more than 12 inhalations in 24 hours
Use more than 9 inhalations in 24 hours for 3 or more days a week
Have more than 2 asthma attacks in a week
These may be signs that your asthma is getting worse.
Do not use:
Unless a doctor said you have asthma
If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.
If product is brown in color or cloudy
Ask a doctor before use if you have:
Ever been hospitalized for asthma
Heart disease
High blood pressure
Diabetes
Thyroid disease
Seizures
Narrow angle glaucoma
A psychiatric or emotional condition
Trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are:
Taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions.
Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain).
Stop use and ask a doctor if:
Your asthma is getting worse (See ASTHMA ALERT)
You have difficulty sleeping
You have a rapid heartbeat
You have tremors, nervousness, or seizure
When using this product:
Your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.
Your risk of heart attack or stroke increases if you:
Have a history of high blood pressure or heart disease
Take this product more frequently or take more than the recommended dose.
Avoid foods or beverages that contain caffeine
Avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Racepinephrine hydrochloride in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Racepinephrine hydrochloride in the drug label.
Drug Interactions
There is limited information regarding Racepinephrine hydrochloride Drug Interactions in the drug label.
There is limited information regarding Patient Counseling Information of Racepinephrine hydrochloride in the drug label.
Precautions with Alcohol
Alcohol-Racepinephrine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.