Racepinephrine hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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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:
Dosage
- Do not use more than directed
- For use in a hand-held rubber bulb nebulizer:
- Add 0.5 ml (contents of one vial) of solution to nebulizer.
- Adults and 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of Racepinephrine hydrochloride in adult patients.
Non–Guideline-Supported Use
- There is limited information regarding Off-Label Non–Guideline-Supported Use of Racepinephrine hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
- For temporary relief of mild symptoms of intermittent asthma:
Dosage
- Do not use more than directed
- For use in a hand-held rubber bulb nebulizer:
- 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
- There is limited information regarding Contraindication of Racepinephrine hydrochloride in pediatric patients.
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.
Use in Specific Populations
Pregnancy
- Pregnancy Category
- There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Racepinephrine hydrochloride in women who are pregnant.
Labor and Delivery
- There is no FDA guidance on use of Racepinephrine hydrochloride during labor and delivery.
Nursing Mothers
- There is no FDA guidance on the use of Racepinephrine hydrochloride with respect to nursing mothers.
Pediatric Use
- There is no FDA guidance on the use of Racepinephrine hydrochloride with respect to pediatric patients.
Geriatic Use
- There is no FDA guidance on the use of Racepinephrine hydrochloride with respect to geriatric patients.
Gender
- There is no FDA guidance on the use of Racepinephrine hydrochloride with respect to specific gender populations.
Race
- There is no FDA guidance on the use of Racepinephrine hydrochloride with respect to specific racial populations.
Renal Impairment
- There is no FDA guidance on the use of Racepinephrine hydrochloride in patients with renal impairment.
Hepatic Impairment
- There is no FDA guidance on the use of Racepinephrine hydrochloride in patients with hepatic impairment.
Females of Reproductive Potential and Males
- There is no FDA guidance on the use of Racepinephrine hydrochloride in women of reproductive potentials and males.
Immunocompromised Patients
- There is no FDA guidance one the use of Racepinephrine hydrochloride in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
Monitoring
- There is limited information regarding Monitoring of Racepinephrine hydrochloride in the drug label.
IV Compatibility
- There is limited information regarding IV Compatibility of Racepinephrine hydrochloride in the drug label.
Overdosage
- There is limited information regarding Chronic Overdose of Racepinephrine hydrochloride in the drug label.
Pharmacology
There is limited information regarding Racepinephrine hydrochloride Pharmacology in the drug label.
Mechanism of Action
- There is limited information regarding Mechanism of Action of Racepinephrine hydrochloride in the drug label.
Structure
- There is limited information regarding Structure of Racepinephrine hydrochloride in the drug label.
Pharmacodynamics
- There is limited information regarding Pharmacodynamics of Racepinephrine hydrochloride in the drug label.
Pharmacokinetics
- There is limited information regarding Pharmacokinetics of Racepinephrine hydrochloride in the drug label.
Nonclinical Toxicology
- There is limited information regarding Nonclinical Toxicology of Racepinephrine hydrochloride in the drug label.
Clinical Studies
- There is limited information regarding Clinical Studies of Racepinephrine hydrochloride in the drug label.
How Supplied
- How Supplied: S 2® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials.
- NDC 0487-5901-99 30 vials, each vial in an individual foil pouch.
- NDC 0487-5901-10 10 vials, each vial in an individual foil pouch.
- NDC 0487-5901-02 30 vials, each vial in an individual foil pouch, robot ready.
Storage
- Store between 2°C and 25°C (36°F and 77°F).
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
- 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.
Brand Names
- S2®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ "S2- racepinephrine hydrochloride solution".
- ↑ "http://www.ismp.org". External link in
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